Past News Items - June 2014
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In the News
The Institute for Functional Medicine Delivered Grand Rounds At Cleveland Clinic
Broken gene found to protect against heart disease
ABC: "Botanical Adulterants Monitor" Published by Herb Quality Consortium
Allergy Experts Address Pivotal Questions in Treatment of Grass Pollen Allergy Sufferers
A New Approach to Alzheimer's Disease Research
Milestone Study Shows Oral Supplement Setria Glutathione Effectively Enhances Body's Most Important Protective Antioxidant
Delivering a Diabetes Prevention Program Through Cable Television Programming Can Be Effective in Tackling Growing Public Health Crisis
Cleveland HeartLab Presents Research Demonstrating its Prognostic Tests Can Save $180 Million in Healthcare costs Related to Cardiovascular Disease
MediNatura Inc. Announces Agreement to Purchase Heel Inc.
American College for Advancement in Medicine Offers World's First Live Chelation Therapy Webinars
Emerson Ecologics Selected As A Distribution Partner For Thorne Research
The Institute for Functional Medicine Delivered Grand Rounds At Cleveland Clinic
The Institute for Functional Medicine (IFM) presented the first Grand Rounds on Functional Medicine at theCleveland Clinic on June 10, 2014. Presenters were Mark Hyman, MD, the board chair of IFM, founder of the UltraWellness Center in Lenox, MA, and best-selling author of books such as The Blood Sugar Solution and The Daniel Plan; and Patrick Hanaway, MD, director of medical education at IFM and program chair of IFM's recent Annual International Conference, "Functional Perspectives on Food and Nutrition: The Ultimate Upstream Medicine."
The primary focus of the Grand Rounds was to present the Functional Medicine model to health professionals from all disciplines. Those attending were introduced to:
- The Functional Medicine GOTOIT operating system of patient management
- Seven core clinical imbalances used to develop treatment plans for patients with chronic disease
- Antecedents, triggers, and mediators critical when creating effective, individualized assessment and treatment plans
- The fundamental lifestyle components contributing to chronic disease
Source: Institute for Functional Medicine, functionalmedicine.org/
Broken gene found to protect against heart disease
By scouring the DNA of thousands of patients, researchers at the Broad Institute at Massachusetts General Hospital and their colleagues have discovered four rare gene mutations that not only lower the levels of triglycerides (a type of fat in the blood), but also significantly reduce a person's risk of coronary heart disease—dropping it by 40 percent. The mutations all cripple the same gene, called APOC3, suggesting a powerful strategy in developing new drugs against heart disease. The work, which appears in the June 18 issue of the New England Journal of Medicine (NEJM), sheds light on the biological role of triglycerides and contributes to a growing body of knowledge that suggests that high triglyceride levels—rather than low HDL, another type of fat in the blood—are a major culprit in heart disease.
"The combination of our genetic results, together with recent clinical trials of drugs that raised HDL levels but failed to prevent heart disease, are turning decades of conventional wisdom on its head," said senior author Sekar Kathiresan, a Broad associate member and director of preventive cardiology at Massachusetts General Hospital. "HDL and triglycerides are both correlated with heart attack, and have an inverse relationship with one another—the lower the HDL, the higher the triglycerides. It has long been presumed that low HDL is the causal factor in heart disease, and triglycerides are along for the ride. But our genetic data indicate that the true causal factor may not be HDL after all, but triglycerides."
Coronary artery disease, the most common form of heart disease, is the leading cause of death in the United States and a major cause of death worldwide. Fats circulating in the blood have long been associated with risk of the disease. These fats, or lipids, come in several forms, and include low-density lipoproteins (LDL cholesterol), high-density lipoproteins (HDL cholesterol), and triglycerides.
While the causal link between LDL, the so-called "bad cholesterol," and heart disease is well known—indeed, LDL is the target of the blockbuster drugs known as statins—the relationship between HDL, triglycerides, and heart disease has been murky. It is clear both are predictive of future heart disease in observational studies, but it wasn't clear if heart attack rates would be altered by changing levels of HDL, triglycerides, neither, or both.
Two years ago, a large-scale genetic study led by Kathiresan and his colleagues found no causal association between the so-called "good cholesterol," HDL, and heart disease, challenging the long-held view that increasing HDL levels will lower the risk of heart disease. These genetic studies are consistent with the recent negative results from multiple clinical trials of agents that raised HDL substantially, but failed to lower risk of heart disease.
In a similar vein, Kathiresan and his colleagues sought to harness genomic methods to explore the connection between triglycerides and heart disease. A study published last year in Nature Genetics examined the role of common genetic variation in influencing triglyceride levels, and it uncovered a pattern of association between triglycerides and coronary artery disease that suggested a causal link.
In the current study, the research team, which also includes senior authors Eric Boerwinkle of the University of Texas Health Science Center at Houston, and Alex Reiner of Fred Hutchinson Cancer Research Center and the University of Washington, set out to assess the role of rare genetic variants through DNA sequencing. Their goal: to pinpoint specific genes that affect both triglyceride levels and disease risk.
The work was conducted as part of the National Heart, Lung, and Blood Institute's Grand Opportunity Exome Sequencing Project (ESP), which aims to discover novel genes underlying major heart, lung, and blood disorders through exome sequencing—a process in which the portions of the genome that correspond to protein-coding genes, known collectively as the exome, are analyzed through DNA sequencing.
The researchers sequenced the exomes of nearly 4,000 people, searching for genetic variants associated with blood triglyceride levels. They discovered four distinct mutations, all within the gene APOC3, that are tied to lower blood triglycerides. Remarkably, individuals carrying a single APOC3 mutation had almost 40 percent lower blood triglyceride levels. Normal levels are generally less than 150 milligrams per deciliter (mg/dL); but with APOC3 mutations, triglyceride levels are around 85 mg/dL.
The APOC3 protein is mainly made in the liver and pours out into the blood stream. There, it is thought to prevent the removal of triglyceride-rich lipoproteins from the blood in a few distinct ways, particularly by delaying their clearance following a meal. The mutations uncovered in the NEJM study all decrease APOC3 activity—carriers have roughly half the normal level of APOC3 protein present in their blood. This is thought to lift the damper on triglyceride-rich lipoproteins, allowing them to be cleared more quickly so less enters the blood and the walls of the coronary arteries, where the ultimate damage is done.
One of the APOC3 mutations identified by Kathiresan and his colleagues had been previously found in a 2008 study of heart disease in the Lancaster Amish. That work also uncovered an association with lower blood triglyceride levels. There were hints that the mutation might protect against heart disease—carriers had less calcium in their coronary arteries, a sign of accumulating fat—but more work was needed to understand the connection to clinical disease events such as heart attack.
To definitively establish the relationship between these mutations and the risk of coronary heart disease—specifically, the incidence of heart attack—the researchers analyzed over 110,000 patient samples. They read out, or "genotyped," the relevant parts of the APOC3 gene, and they compared heart attack rates in those carrying mutations to those without them.
In the carriers, they found a 40 percent lower risk of coronary heart disease, suggesting inhibition of APOC3 as a new potential strategy for therapeutic development.
"Based on our findings, we predict that lowering triglycerides specifically through inhibition of APOC3 would have a beneficial effect by lowering disease risk," said senior co-author Alex Reiner, a member of the Public Health Sciences Division at Fred Hutchinson Cancer Research Center and a research professor of epidemiology at the University of Washington's School of Public Health.
Triglyceride-lowering therapies exist, but those that are currently available have not been proven yet to stave off heart disease. This lack of effect in the studies conducted so far could be due to the therapies' relatively modest impact on triglyceride levels compared to the sizeable effect of APOC3 mutations, which lower triglyceride levels by 80 to 90 mg/dL. The current therapies likely also act through multiple molecular targets.
Triglyceride-lowering drugs reflect an important clinical need. Doctors have recognized that even after patients are treated with drugs to lower LDL cholesterol, some still succumb to heart attacks. This so-called "residual risk" suggests there are other biological mechanisms at play that can raise a person's risk of heart disease.
"Although statins remain a powerful arrow in the quiver, the notion of residual risk of coronary heart disease continues to be a significant clinical problem," said Kathiresan. "Our study really reinvigorates the idea of lowering triglycerides and specifically, by blocking APOC3, as a viable therapeutic strategy for addressing residual risk."
This work was supported by the National Heart, Lung, and Blood Institute of the US National Institutes of Health. Additional support was provided by several sources. A complete listing can be found in the NEJM paper.
Other researchers who contributed to this work include co-first authors Jacy Crosby (University of Texas Health Science Center), Gina Peloso (Broad Institute and Massachusetts General Hospital), and Paul Auer (University of Wisconsin-Milwaukee, Joseph J. Zilber School of Public Health). Additional Broad Institute authors include David Altshuler and Stacey Gabriel, who were the Broad Institute's principal investigators for the NHLBI Exome Sequencing Study, as well as Mark DePristo, Ron Do, Deborah Farlow, and Namrata Gupta.
Paper cited
Crosby J., Peloso G., and Auer P. et al. Loss-of-function mutations in APOC3, triglycerides, and coronary disease. New England Journal of Medicine. Online June 18, 2014. DOI:10.1056/NEJMoa1307095
Source: Broad Institute, broadinstitute.org
ABC: "Botanical Adulterants Monitor" Published by Herb Quality Consortium
A consortium of nonprofit herbal advocacy and research organizations announced yesterday the publication of a new e-newsletter, the "Botanical Adulterants Monitor," the first issue of which is now available here. The publication's purpose is to provide information related to the prevention and detection of herbal adulteration, quality assurance challenges facing the global botanical products community, and the work of the ABC-AHP-NCNPR Botanical Adulterants Program, led by the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), and the University of Mississippi's National Center for Natural Products Research (NCNPR).
The ABC-AHP-NCNPR Botanical Adulterants Program was created in 2011 to educate members of the international herbal and dietary supplements industry about botanical ingredient and product adulteration. The program focuses on accidental adulteration that occurs as a result of poor quality control procedures as well as intentional adulteration of plant-based products for financial gain. Now, more than three years since the Program's creation—and with an ever-increasing number of questions from both the media and the general public about the quality of herbal and botanical medicines—the new "Botanical Adulterants Monitor" is the next logical step in the ABC-AHP-NCNPR Botanical Adulterants Program's growth.
"The purpose of our Program is primarily educational," said Mark Blumenthal, founder and executive director of ABC, and founder and director of the Program. "There are numerous publications on new analytical methods, recent regulatory actions, and a wide variety of workshops, seminars, webinars, and other educational resources that relate to botanical ingredient identity, authenticity, and ways that botanical materials and their extracts are accidentally or intentionally adulterated. Such adulteration results in cheapening the end product and reducing the likelihood that consumers will receive the benefits that they are seeking and expecting. The ‘Botanical Adulterants Monitor’ newsletter is a valuable way for people in the botanical community to be informed about new developments in areas related to ensuring the authenticity of botanical materials used in herbal products."
The editor of the "Botanical Adulterants Monitor" is ABC Chief Science Officer Stefan Gafner, PhD, who joined ABC's staff in 2013. In his introduction to the first issue, Dr. Gafner states, "Our goal for this newsletter is to provide newly available information on issues surrounding accidental and intentional adulteration—and, to a lesser extent, the equally important problem of contamination—as reported by regulatory agencies or in published studies.
"As such," he continues, "this newsletter is intended to be a helpful resource for members of industry, scientists at academic institutions interested in authentication of herbal materials and the detection of adulteration, as well as health professionals, herbalists, and other stakeholders."
Inside each issue of the "Botanical Adulterants Monitor," readers will find news from the Botanical Adulterants Program, recent regulatory activity by the US Food and Drug Administration and/or regulatory agencies in other countries, publications from other organizations, reviews of recently published analytical methods, and additional resources related to detection and prevention of botanical ingredient adulteration. In keeping with ABC's mission to provide the public with reliable, science-based herbal education, as well as the mission of the Botanical Adulterants Program, the newsletter will be free to access and available to all interested parties.
"The 'Botanical Adulterants Monitor' is an excellent vehicle to keep abreast of the latest news, information, and research on issues of interest to savvy consumers, healthcare professionals, researchers, managers, and technicians relative to the Botanical Adulterants Program," said ABC Board of Trustees President Steven Foster.
To receive the "Botanical Adulterants Monitor," members of the public need only visit the American Botanical Council website and register to receive the "Monitor" and other communications from the organization.
Source: American Botanical Council, herbalgram.org
Allergy Experts Address Pivotal Questions in Treatment of Grass Pollen Allergy Sufferers
A group of eminent allergy and respiratory professors presented data specifically addressing numerous key questions within the allergy community concerning grass SLIT-tablets—with specific focus on GRAZAX—for the treatment of grass pollen allergy. They cite 10 years of clinical evidence in more than 14,000 patients for GRAZAX SLIT-tablet as a well-tolerated and effective treatment with a sustained long-term effect for grass pollen allergy. They have invited colleagues to re-evaluate the robustness and strength of GRAZAX data, given the number of suitable patient candidates for grass SLIT-tablets. GRAZAX SLIT-tablet has been available in Europe since 2006, and it became available in North America in February 2014.
Data presented yesterday to physicians at the European Academy of Allergy and Clinical Immunology (EAACI) congress showed that the ALK grass SLIT-tablet, GRAZAX, is an efficacious treatment option for patients with clinically relevant symptoms to any of the temperate grasses. Indirect comparisons also demonstrated grass SLIT-tablets (sub-lingual immunotherapy) and grass SCIT (sub-cutaneous immunotherapy) are equally efficacious. Furthermore, grass SLIT-tablets have the benefit of being less invasive than SCIT, and it’s convenient for patients to take them in their own home rather than having to visit the hospital or doctor's office.
Importantly, data presented also support that the once-daily, fast dissolving GRAZAX SLIT-tablets are documented to have sustained long-term effect during three years of treatment and two years post-treatment, making it the only grass allergy immunotherapy tablet (AIT) with an authorized indication for disease-modifying treatment of grass pollen induced allergic rhinitis in adults and children.
"Compared with other therapies, GRAZAX SLIT-tablets have demonstrated a favorable risk-to-benefit profile, both among children and adults," said Professor Ronald Dahl at Odense University Hospital. "Given what we've learned on the proven efficacy, tolerability, and compliance of GRAZAX SLIT-tablets, I encourage all allergists to ask 'are we translating this clinical evidence into clinical practice?' when treating grass pollen allergy patients."
When compared with other grass AIT modalities, grass SLIT-tablets are the only AIT class for which robust clinical benefit in children has been demonstrated. In fact, the clinical benefit for grass SLIT-tablets in children is comparable to that in adults after one year of treatment. Data also demonstrated the safety profile and fast dissolving formulation makes GRAZAX SLIT-tablet especially suitable for use within the paediatric population (5 to 18 years of age).
Multiple sets of clinical data from the last 10 years were presented during the symposium specific to efficacy, safety, medication adherence, and favorable tolerability profile in patients with concomitant controlled asthma, among other areas. Additionally, faculty discussed suitable patient candidates for GRAZAX SLIT-tablets to effectively treat grass pollen allergic rhinitis.
Source: ALK, alk.net
A New Approach to Alzheimer's Disease Research
As part of its ongoing research to better understand the complexities of the human brain, the Allen Institute for Brain Science is embarking on the first effort to map connectivity patterns across the whole brain in mouse models of Alzheimer's disease, through its recent award of a $3.4 million grant over five years from the National Institute on Aging of the National Institutes of Health.
"Many studies on Alzheimer's disease focus on just one or a small number of areas in the brain, such as the hippocampus, for its role in memory," says Julie Harris, Assistant Investigator at the Allen Institute for Brain Science and primary investigator on the grant. "By studying connections across the entire cortex in both normal mice and mouse models of the disease, we hope to finally make the breakthroughs that will help us understand the pathways through which Alzheimer's disease spreads, and what interventions we can make against its progression."
According to the National Institute on Aging, Alzheimer's disease is characterized by diminishing memory and thinking skills, affecting as many as 5.1 million Americans, most over the age of 60. The causes of Alzheimer's disease are still largely unknown, though they are likely a combination of genetic, environmental and other factors.
So far, clinical trials for drugs developed in mouse models that typically focus on individual brain areas have yielded poor results. "Our expanded view of the disease that looks at connections across the whole brain will hopefully improve mouse models and their use in translational research to identify drugs and treatments that work in humans," says Harris.
The whole-brain model of Alzheimer's builds on the Allen Mouse Brain Connectivity Atlas, recently profiled in the journal Nature, which allows researchers to quantitatively analyze connections across the entire mouse brain.
Harris and her colleagues plan to expand the resource by focusing on areas of the brain that are hardest hit early in the disease. They will work backwards first, using viral tracers to discover which regions of the brain send their neurons to those hard-hit areas. Then, they will follow the other projections from those source regions to different parts of the brain, ultimately creating a detailed map showing how and which brain regions are interconnected, and how these connections are altered by disease. In the spirit of other Allen Institute resources, they plan to make the data publicly available through the Allen Brain Atlas data portal at brain-map.org.
"This is the kind of meaningful research that can only be done at a place like the Allen Institute," says Allan Jones, CEO of the Allen Institute for Brain Science. "Our ability to process enormous amounts of exceptionally high quality data makes us uniquely equipped to develop this valuable new perspective on a disease that has troubled researchers for decades, and that will hopefully yield new insights that will lead to effective treatments."
Milestone Study Shows Oral Supplement Setria Glutathione Effectively Enhances Body's Most Important Protective Antioxidant
A new long-term, randomized, double-blinded, placebo-controlled human clinical trial, published in the May issue of the European Journal of Nutrition, revealed for the first time that daily consumption of a Setria Glutathione supplement was effective at increasing body stores of glutathione – an antioxidant generated within our bodies to help fight disease – combating long-held contrary beliefs. Glutathione is a tripeptide that is naturally found in nearly all cells, tissues and organ systems in the body. It is also known as the "master antioxidant" due to its vast functions of antioxidant protection, detoxification and immune system fortification. But, for many reasons including age, prescription and OTC medication intake, health conditions, lifestyle, diet, weight and even time of day, the body's stores of glutathione may be in short supply. This six-month clinical trial – led by Dr. John P. Richie of Penn State University – evaluated the efficacy of Setria Glutathione supplementation at enhancing body stores of glutathione, and the results show that glutathione supplementation may represent an effective intervention strategy to not only enhance body stores but also boost the body's immune function.
Dr. Richie has studied glutathione for more than 25 years, and his body of research focuses primarily on fighting oxidative stress, which is a contributing factor to most fatal diseases. "It is well-known in the science community that glutathione is one of the primary protective molecules in the body; however, whether or not glutathione levels could be supplemented by oral glutathione administration has been hotly debated and clinical data has been lacking" said Dr. John P. Richie, Jr., PhD, Professor of Public Health Sciences and Pharmacology at Penn State University School of Medicine. "Now we have evidence to illustrate the potential benefit of glutathione supplementation on improved immune health, potentially decreased risk of cancer, and reduction of other diseases related to oxidative stress."
"Kyowa Hakko pioneered a fermentation technology that is used to manufacture amino acids, nucleic acids, vitamins and related compounds to dietary supplements," said Danielle Citrolo, PharmD, technical services manager at Kyowa Hakko USA, Inc. "We couldn't be more pleased about the publication of this study and its potential to help our customers. Even the healthiest individuals face environmental factors and toxins that can combat the positive effects of a well-rounded diet, and thus could benefit from an antioxidant supplementation, like Setria Glutathione."
About the Study:
- Trial measured effect of glutathione supplementation at 250 mg/day and 1000 mg/day on glutathione levels in different blood components and exfoliated buccal mucosal cells over a six month period.
- Subjects were 54 healthy adults (41 females/13 males), 28-72 years of age (mean=46.6 years).
- Results of the study showed glutathione levels in the blood increased after one, three and six months vs. baseline at both doses.
- At six months, mean glutathione levels increased 30-35 percent in erythrocytes, plasma, and lymphocytes, and 260 percent in buccal cells in the high dose group (P<0.05).
- Glutathione levels increased 17 and 29 percent in blood and erythrocytes, respectively, in the low dose group (P<0.05).
- Natural killer cytotoxicity increased two fold in the high-dose group versus placebo at three months.
- A reduction in oxidative stress in both glutathione dose groups was indicated by decreases in the oxidized to reduced glutathione ratio in whole blood after six months.
- According to the study, the effects of glutathione supplementation on the levels of the glutathione precursor cysteine in plasma and the activity of the rate-limiting glutathione biosynthetic enzyme GCL in erythrocytes were examined after the six-month study period.1 No changes were observed in cyst(e)ine concentrations or GCL activity in any of the groups.
SOURCE Kyowa Hakko USA
Delivering a Diabetes Prevention Program Through Cable Television Programming Can Be Effective in Tackling Growing Public Health Crisis
Research published by the peer-reviewed journal Obesity demonstrates the effectiveness of using video-on-demand (VOD) cable television programming to deliver core components of the Diabetes Prevention Program.
The Diabetes Prevention Program (DPP) is an evidence-based lifestyle-modification program developed by the Centers for Disease Control and Prevention (CDC) aimed at helping people who are at risk for developing type 2 diabetes reduce their risk of developing the disease. The success of the pilot study underscores the potential for television-based health programming offered in a reality TV format to help influence the health and behavior of millions of Americans.
The article, “A Randomized Comparative Effectiveness Trial of Using Cable Television to Deliver Diabetes Prevention Programming,” discusses study results from a 12-month pilot launched in early 2012 by UnitedHealth Group (NYSE: UNH) and Comcast Cable (Nasdaq: CMCSA, CMCSK). The study used VOD programming on Comcast’s Xfinity platform to deliver the adapted DPP in two test markets: Philadelphia, and Knoxville, Tenn. More than 300 people participated in the study, with the goal of losing 5-7 percent of their body weight. This percentage of weight loss has been clinically proven by the CDC-led National Diabetes Prevention Program to reduce the risk of developing type 2 diabetes by almost 60 percent for individuals at risk for developing the disease. The National DPP showed that even more modest weight loss has proved to be clinically meaningful: every 2.2 pounds of weight loss translates to a 16 percent decrease in the risk of developing type 2 diabetes.
The research included two strategies for delivering the DPP: one via video-on-demand cable television alone; and one in combination with Internet-based “virtual coaching” and supplemental diabetes-prevention and lifestyle-support tools. Participants in the study lost an average of 3.3 percent of their starting body weight; participants who watched more than nine episodes of the 16-episode programming were even more successful, losing an average of 4.9 percent of their starting body weight. These percentages are consistent with the results of other efforts to implement the Diabetes Prevention Program in face-to-face settings. The study also found that offering the web-based resources did not enhance the weight loss.
“Using video-on-demand cable television programming offers a promising strategy for making this proven health care intervention more broadly available in a convenient and cost-effective way,” said Deneen Vojta, MD, senior vice president, UnitedHealth Center for Health Reform & Modernization and one of the study’s authors. “Our pilot study provides evidence that delivering the DPP through new channels has the potential to reach more people who are at-risk and meets the critical need for effective, accessible and affordable treatment to reduce the risk of developing diabetes.”
The 16-episode NOT ME VOD programming, which includes the Mid-Atlantic Emmy Award-winning episode “Take Charge,” uses a reality TV format that follows six adults with prediabetes as they go through the DPP.
Each VOD episode features a health and wellness coach leading a class of real participants who are working to reach a healthier weight and to help reduce their risk of developing type 2 diabetes. Between each episode, study participants practiced at home the skills they learned from the program and weighed themselves using a cell-enabled scale. Study participants also had tracking assignments each week and opportunities to put what they learned into action.
The six people featured in the reality TV programming, representing a mix of ages, races and ethnicities, lost an average of 8.1 percent of their body weight during the 16-week program, for a total of 122 pounds. The 310 VOD study participants started with an average body mass index (BMI) of 35.6, with 19 percent of the group in the overweight category (with a BMI between 25 and 29) and 81 percent in the obese category (BMI 30 or higher).
Although the UnitedHealth Group/Comcast study was designed to evaluate weight loss among the 300 viewers in just two Comcast markets, subsequent use of the VOD episodes by the broader public was striking: between May 2012 and May 2013, nearly 50,000 customers in the two cities viewed or streamed this content more than 100,000 times.
According to the CDC, more than 35 percent of US adults are obese, putting them at grave risk of developing type 2 diabetes. Nearly 26 million Americans have diabetes, and another 79 million American adults are at risk for developing type 2 diabetes, according to the CDC. Diabetes cost the country an estimated $245 billion in 2012, according to the American Diabetes Association, and care for people with diabetes accounts for more than one in five health care dollars in the United States.
If current trends continue, more than half of all Americans will have diabetes or prediabetes at an annual cost of $512 billion by 2021, according to research from the UnitedHealth Center for Health Reform & Modernization.
The VOD study was designed in collaboration with Ronald T. Ackermann, MD, MPH of Northwestern University Feinberg School of Medicine, who has been a national leader in designing different approaches to implement the Diabetes Prevention Program over the past decade.
Cleveland HeartLab Presents Research Demonstrating its Prognostic Tests Can Save $180 Million in Healthcare costs Related to Cardiovascular Disease
Cleveland HeartLab (CHL), a premier cardiovascular disease (CVD) management company, will present new research today at the International Society of PharmacoEconomics and Outcomes Research (ISPOR) Annual Meeting that demonstrates substantial costs savings for US health plans through the addition of cardiovascular inflammatory testing to standard cholesterol testing. The study shows that averting mortality and morbidity from myocardial infarction (MI) and ischemic stroke (IS)—through the use of routine testing of multi-tiered cardiovascular risk markers of vascular inflammation—can save the US healthcare system at least $180 million, but likely much more. This research was generated in collaboration with a team of expert economists from the Analysis Group, a leading health economics consultancy.
The results of the research suggest that for a commercially insured US health plan with one million members, implementing routine testing with CHL multi-tiered cardiovascular risk markers, specifically Myeloperoxidase, Lp-Pla2 and hsCRP, can decrease non-fatal MI events by 2,018 and non-fatal IS events by 1,848, resulting in $180.6 million in cost savings over five years.
The poster presentation, "The Economic Impact of Implementing a Multiple Inflammatory Biomarker-Based Approach to Identify, Treat, and Reduce Cardiovascular Risk," was accepted for presentation at the prestigious ISPOR 19th Annual Meeting to be held May 31-June 4, 2014 in Montreal, Canada. This economic model, which will be presented today, Monday, June 2, is the first of its kind to quantify the potential economic and clinical benefits of more accurately stratifying near-term cardiovascular risk through use of multiple inflammatory biomarker tests.
"Traditional methods for assessing and mitigating risk are insufficient and may misclassify an individual's actual risk of a heart attack and death," said Marc Penn, MD, PhD, FACC, Director of Research at Summa Cardiovascular Institute, Professor of Integrative Medical Sciences at Northeast Ohio Medical University and Chief Medical Officer of CHL. "Routine inflammation testing helps identify individuals with previously unidentified risk so that steps can be taken to decrease vascular inflammation, improve their state of wellness and lower their risk of a heart attack and death."
This position is supported by data from the American Heart Association, which reports that 50 percent of all heart attacks and strokes occur in individuals with normal cholesterol and that, for approximately 30 percent of patients with cardiovascular disease, the first sign of disease is death.
"By more accurately assessing an individual's near-term cardiovascular risk, healthcare providers can deploy resources more strategically," said Jake Orville, President and Chief Executive Officer of CHL. "The model demonstrates that multi-marker inflammation testing not only can avert predictable CVD events and save lives, it can also help reduce the enormous cost burden of acute heart attack and stroke, which is the single most costly item in the nation's healthcare budget."
"We launched Cleveland HeartLab to make innovative inflammation testing a standard component of routine CVD risk assessment to help identify and prevent cardiovascular events in patients who were previously not known to have risk," Dr. Penn added. "We're very excited to report that the results of this collaboration demonstrate that along with improving outcomes, our approach can lead to a significant decrease in healthcare costs."
According to the Centers for Disease Control and Prevention, the total costs of cardiovascular diseases in the United States in 2010 exceeded $444 billion. Treatment of these diseases accounts for about $1 of every $6 spent on healthcare in this country. As the US population ages, the economic impact of cardiovascular diseases on our nation's healthcare system will become even greater.
With an impressive list of presenters at ISPOR, CHL and Analysis Group join industry leaders at this forum to share research in health economics and patient health outcomes as well as facilitate the translation of this research into useful information for healthcare decision makers. More information on the conference can be found at ispor.org/.
MediNatura Inc. Announces Agreement to Purchase Heel Inc.
MediNatura Incorporated, a Delaware Corporation headquartered in greater Philadelphia, announced an agreement last week to purchase the Heel Group's USA operations, which is expected to be completed in late August 2014. Completion of the stock transfer is subject to standard closing procedures.
Current Heel Inc. products will be available to USA distributors through August 2014, and to retailers and medical practitioners through December 2014.
"We remain committed to serving the needs of our practitioners, retailers and the many people that rely on these medicines, while providing outstanding customer service throughout this transition," said Jocelyn Levesque, MediNatura's vice president of sales, and director of sales for Heel Inc.
MediNatura's line of over-the-counter (OTC) products will be available to distributors and retailers beginning January 1, 2015. The following retail brands will be reformulated: ClearLife (allergy), Reboost (cold/flu), WellMind (calming, focus), and BodyAnew Cleanse. All will be available in the same dosage forms and sizes as currently sold.
The OTC Heel products Traumeel and Zeel will be phased out and replaced with T-Relief and T-Relief Arthritis from MediNatura. These products will be available in the same dosage forms and sizes as were Traumeel and Zeel, and they will feature all-natural active ingredients. The BHI line of products will remain unchanged.
"MediNatura is dedicated to manufacturing and distributing high quality, FDA-regulated products, just as we did as Heel Inc.," said Scott Mitchell, MediNatura's vice president of operations and director of operations for Heel Inc.
Heel's OTC products currently sold exclusively to medical practitioners will be replaced by MediNatura's OTC product line, most of which will be priced 40 percent lower than current products. OTC Heel brands with international trademarks will be discontinued, including: Traumeel, Neurexan, Zeel, Oculoheel, Luffeel, Sinusin, Vinceel, Nectadyn, Adrisin, Gripp Heel, Viburcol, Vertigoheel, Spascupreel, Engystol, and Lymphomyosot.
"We know people can improve their lives by making healthy lifestyle choices, healthy food choices, and healthy medicine choices," said Cliff Clive, CEO of Heel Inc., and founder and CEO of MediNatura. "MediNatura's mission is to improve lives with medicines from nature."
Source: MediNatura Inc., medinatura.com
American College for Advancement in Medicine Offers World's First Live Chelation Therapy Webinars
ACAM, the pre-eminent education and certification organization in chelation therapy, will present the world’s first live webinars on chelation therapy.The American College for Advancement in Medicine is the first in the world to present a live webinar-based course on Chelation therapy.
When: Tuesday, June 3rd from 7 p.m. to 9 p.m. EST
The course will run live for four weeks and will feature renowned speakers, including Dr. Tony Lamas, who is the lead investigator in the TACT (Trial to Assess Chelation Therapy) Study. The webinars will be archived for further reference, and ACAM will also be offering in-person, hands-on practicums at multiple locations throughout the USA.
Chelation therapy is an intravenous infusion of EDTA, a semi-synthetic amino acid that binds heavy metals and removes them from the body. A recent study published in the Journal of the American Medical Association (JAMA) showed that chelation therapy has a statistically significant benefit in preventing secondary cardiac events in patients with heart disease and notably in diabetic patients.
Source: American College for Advancement in Medicine, acam.org
Emerson Ecologics Selected As A Distribution Partner For Thorne Research
-- Emerson Ecologics, LLC, the leading provider of the highest quality professional nutritional supplements to healthcare practitioners and their patients for over 30 years, today announced its strategic partnership with Thorne Research, Inc., an innovative company that supplies nutritional supplements in the healthcare professional market channel. Effective today, June 2, 2014, Thorne Research products will be available to Emerson Ecologics practitioner customers throughout the United States. In addition, Emerson will offer access to Thorne Research's specialty product lines, including ThorneVET for animal health, OncoQOL for cancer supportive care and Thorne Therapeutics, launching August 2014, for skin and hair care support. While Thorne Research's direct sales of its product lines to healthcare professionals will continue, their decision to partner with Emerson Ecologics will further expand their reach in the practitioner market.
"Thorne Research is one of our most frequently requested product lines," commented Emerson Ecologics CEO, Andy Greenawalt. "Each company shares a commitment to high quality products and exceptional customer service to support healthcare practitioners and their patients. Our collaboration will truly provide customers an easy and convenient one-stop source for all their nutritional supplement products."
Paul Jacobson, the CEO of Thorne Research, stated, "Through this strategic partnership with Emerson Ecologics, we are making Thorne Research products more accessible to healthcare practitioners across the United States. We recognize that practitioners are seeking easier and more convenient ways to access high-quality nutritional supplement products for patients. We expect that our respective customer service capabilities will be greatly enhanced by this partnership."
Emerson Ecologics will offer the complete line of current Thorne Research healthcare practitioner products at the same price as direct through Thorne Research. In addition, Emerson continues to carry thousands of other products demanded by healthcare practitioners across the United States, enabling them to save time and money by selecting from over 275 brands in a single order. Orders can be placed online 24 hours a day at emersonecologics.com or by telephone at 800.654.4432 from 8:30 a.m. to 8:00 p.m. ET.
About Emerson Ecologics LLC
Founded in 1980, Emerson Ecologics, LLC is the leading distributor of professional-quality nutritional supplements, vitamins and natural health products -- representing over 275 brands. Customers include integrative healthcare practitioners, naturopathic, chiropractic and medical doctors, licensed acupuncturists, and nutritionists, as well as their patients. Widely-recognized for their innovative Emerson Quality ProgramSM (EQP) and headquartered in Manchester, NH with distribution centers in Virginia and California, Emerson Ecologics is GMP registered by NSF® International. For more information, visit emersonecologics.com/thorne.
About Thorne Research, Inc.
Since 1984, Thorne Research, with more than 400 nutritional supplement products, has set the standard for exceptional quality manufacturing and formulation of pure, highly absorbable nutritional supplements using advanced technology. Thorne Research is recognized as a global leader and provider of nutritional supplements and medical education to licensed healthcare practitioners. With locations in Sandpoint, Idaho, and New York City, Thorne Research operates a state-of-the-art manufacturing facility and employs more than 260 people. Further information about Thorne Research is available at thorne.com.
Contact:
Customer Support
Emerson Ecologics LLC
800.654.4432
cs@emersonecologics.com
emersonecologics.com/thorne