Past News Items - August 2013
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In the News
Neuroaugmentation Brings Relief To Chronic Migraine Sufferers
New Risk Score Predicts 10-Year Dementia Risk for Type 2 Diabetes Patients
Breakthrough Case Study Highlights New Biomarker for Cancer and Inflammation
NEBA Health earns patent for integration of NEBA biomarker with clinician’s ADHD evaluation
Looking for Ways to Maintain Medical Practice Independence? MGIS Provides Helpful Tips for Physicians
ABC Celebrates 30th Anniversary of HerbalGram
New Data Confirms Circulating Tumor Cells Are Useful Predictors of Progression-free and Overall Survival
Mechanism offers promising new approach for harnessing the immune system to fight cancer
ICPA and OTZ Join Forces to Break Barriers in Pediatric Chiropractic
Neuroaugmentation Brings Relief To Chronic Migraine Sufferers
Innovative, Minimally Invasive Therapy Now Offered by DISC Sports & Spine Center
This September, National Pain Awareness Month turns a spotlight on Americans who face chronic, often debilitating pain, including the estimated 37 million who suffer from migraine headaches. Those unresponsive to traditional migraine remedies may find new hope in an innovative therapy being offered by Dr. Standiford Helm of DISC Sports & Spine Center.
Called neuroaugmentation, this treatment is simple, minimally invasive, and effective, involving the same groundbreaking technology now being used to stop tremors in Parkinson’s Disease patients. Similar to deep brain stimulation (DBS), yet placed in a different part of the body, neuroaugmentation involves implanting electrodes beneath the skin to stimulate the occipital and supraorbital nerves. When stimulated, these nerves stop communicating the headache-causing pain signal.
World Health Organization statistics rank migraines as the 19th most common reason for disability. Migraine sufferers use twice the amount of prescription drugs and visit doctors and emergency rooms twice as often as those who don’t have the disorder. A study published by the International Headache Society (2010) suggests that neuroaugmentation can markedly ease the pain, neurological symptoms, and disability in 80% of patients with severe, chronic migraine and refractory chronic migraine headaches.
“I have seen wonderful improvement in patients who had all but given up on leading normal, productive lives,” said “Dr. Helm. “To be able to give them a second chance at life with a lot less pain is incredibly gratifying, and I’m thankful to DISC for giving me the collaborative team and venue at which to make it all possible.”
For more information, contact DISC at 866.481.DISC or visit www.discmdgroup.com.
New Risk Score Predicts 10-Year Dementia Risk for Type 2 Diabetes Patients
Researchers at Kaiser Permanente and the University Medical Centre Utrecht in the Netherlands have created the first risk score that predicts the 10-year individualized dementia risk for patients with type 2 diabetes, as reported in the inaugural issue of Lancet Diabetes & Endocrinology.
The researchers developed and validated the Diabetes-Specific Dementia Risk Score by examining data from nearly 30,000 patients with type 2 diabetes aged 60 and older over a 10-year period. They found eight factors that were most predictive of dementia—including microvascular disease, diabetic foot, and cerebrovascular disease—and assigned each a value related to their association with dementia to create an overall score for patients. The researchers found that individuals in the lowest category of the 20-point risk score had a 5.3 percent chance of developing dementia over the next 10 years, while those in the highest category had a 73 percent chance. Compared with those in the lowest category, those in the highest were 37 times more likely to get dementia, according to the study.
“Patients with type 2 diabetes are twice as likely to develop dementia as those without the disease, but predicting who has the highest future risk is difficult,” said Rachel Whitmer, PhD, an epidemiologist at the Kaiser Permanente Division of Research in Oakland, CA, who led the study. “While a few dementia risk scores exist, this is the first one that has been developed specifically for individuals with type 2 diabetes and encompasses diabetes-specific characteristics.”
All predictors included in the Diabetes-Specific Dementia Risk Score are easy to obtain and based primarily on medical history, so the risk score can be calculated during a routine medical visit or with electronic health records. No labor-intensive or expensive tests, such as cognitive function or brain imaging, are required.
“This risk score is crucial for the care of patients with diabetes since they are particularly susceptible to dementia. It provides clinicians with an easy and efficient tool to assess their patients’ chances of developing dementia over the next 10 years,” Whitmer said. “Early detection of diabetes patients who are at increased future risk of dementia could help to develop and target preventive treatment.”
According to the Centers for Disease Control and Prevention, more than 25 million children and adults in the United States have diabetes, with type 2 diabetes in particular accounting for more than 90 percent of these cases. In addition to being a risk factor for dementia, diabetes is the leading cause of kidney failure, non-traumatic lower-limb amputations, and new cases of blindness among adults in the United States.
“The risk score could be useful in the selection of high-risk patients for early intervention studies and for many applications of personalized medicine,” said Geert Jan Biessels, MD, professor of neurology at the University Medical Centre Utrecht and coauthor of the study. “Clinicians can use it to guide their decisions in terms of clinical attention to incipient cognitive impairment which makes people vulnerable to dangerous side effects of diabetes treatment. The risk score will also help us to understand the causes of diabetes associated increased dementia risk, because we can examine those at high risk in early stages of the dementia process.”
Additional authors on the study include Lieza G. Exalto, MD, of the Department of Neurology, University Medical Centre Utrecht, the Netherlands; Andrew J. Karter, PhD, of the Kaiser Permanente Division of Research, Oakland, CA.; Elbert S. Huang, MD, of the Department of Internal Medicine, University of Chicago; Wayne J. Katon, MD, of the Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine; and Jerome R. Minkoff, MD, of the Kaiser Permanente Department of Endocrinology, Santa Rosa, CA.
Research reported in this press release was supported by Kaiser Permanente Community Benefit and by the National Institute of Diabetes and Digestive and Kidney Disorders of the National Institutes of Health under award number DK081796.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Breakthrough Case Study Highlights New Biomarker for Cancer and Inflammation
A groundbreaking peer-reviewed case report by Isaac Eliaz, MD, of Amitabha Medical Clinic, demonstrates for the first time the clinical use of novel biomarker galectin-3 to assess cancer progression and inflammation. The case study titled, “The Role of Galectin-3 as a Marker of Cancer and Inflammation in a Stage IV Ovarian Cancer Patient with Underlying Pro-Inflammatory Comorbidities,” was published in the July 2013 issue of Case Reports in Oncology. This report is the first of its kind to expand the diagnostic and prognostic applications of the galectin-3 blood serum test, introducing an important clinical tool to assess risk and progression of metastatic cancer and inflammatory diseases.
In 2011, the galectin-3 blood test was approved by the US Food and Drug Administration for the screening and prognosis of congestive heart failure and cardiovascular disease. Approval was granted after an extensive body of published data, including long-term population studies, demonstrated the active role of elevated galectin-3 in cardiovascular conditions, fibrosis, and early mortality. However, a rapidly expanding field of published galectin-3 research also highlights the significance of this rogue molecule as a novel biomarker that is both an active culprit as well as a byproduct of numerous inflammatory and malignant cellular processes beyond cardiovascular disease.
An expert on galectin-3, Dr. Eliaz applies the data obtained in this case study to shed further light on excess galectin-3’s mechanisms of action, specifically inflammatory response to injury and cancer progression. In this report, Dr. Eliaz presents the first published case documenting the clinical use of galectin-3 to monitor cancer progression and treatment response, as well as inflammatory conditions. These findings point to an expanded clinical model using galectin-3 testing in the diagnostic and prognostic assessment of numerous chronic, inflammatory diseases.
Unlike biomarkers such as C-reactive protein (CRP), which only indicate the presence of inflammation, galactin-3 is shown to play a direct role in initiating disease progression. It is a protein normally present in the body at low concentrations, where it is involved in numerous functions including cell growth and communication. At elevated levels, however, galectin-3 fuels numerous pathologic processes including chronic inflammation and the progression of inflammation to fibrosis; cancer cell adhesion, migration, angiogenesis, and metastasis. Elevated galectin-3 also allows cancer cells to evade immune response. Research demonstrates elevated galectin-3 levels in patients with melanoma, lung, breast, prostate, colorectal, ovarian, and head and neck cancers as well as non-Hodgkin’s lymphoma and others. Galectin-3 levels are also found to be higher in patients with metastatic disease than in patients with localized tumors.
Dr. Eliaz states, “This new case report and significant clinical observation supports the need for further research on the role of galectin-3. The galectin-3 test could well become one of our most important clinical tools in assessing and monitoring a wide range of conditions beyond cardiovascular disease, including metastatic cancer and inflammatory conditions.”
NEBA Health earns patent for integration of NEBA biomarker with clinician’s ADHD evaluation
NEBA Health, LLC announces today that Dr. Steven M. Snyder, research and development vice president, has earned US Patent 8,509,884. The patent protects a key aspect of the NEBA system: integrating the biomarker with a clinician’s workup for ADHD. “NEBA is not a standalone diagnostic,” said Dr. Snyder. “After the clinician’s ADHD evaluation, NEBA helps them determine if the symptoms are due to ADHD, or if further testing is warranted.”
“Integrating the NEBA biomarker with a clinician’s initial diagnostic impression can bring a clinician’s diagnosis more in line with that of a multidisciplinary team,” said Dr. Snyder. Research supports that, compared to a clinician alone, a multidisciplinary team is better able to determine if ADHD-like symptoms are accounted for by another condition.
In order to diagnose ADHD, a clinician not only observes criteria regarding behavioral symptoms and impairment, but also must determine whether symptoms would be better accounted for by another condition. Because ADHD shares symptoms with other disorders, the diagnosis may be difficult. According to the US Center for Disease Control and Prevention (CDC), 9.5% of all children and adolescents have an ADHD diagnosis. The ADHD diagnosis rate is increasing. CDC states that rates of ADHD diagnosis increased an average of 3% per year from 1997 to 2006 and an average of 5.5% per year from 2003 to 2007.
“In their ADHD evaluation, clinicians may be challenged in the current medical environment to determine the primary diagnosis when overlapping symptoms are present,” said Howard Merry, President of NEBA Health. “We are delighted that the USPTO has awarded Dr. Snyder the patent. It covers NEBA’s core technology, and it’s another validation point for the 7 years we spent developing and validating NEBA.”
Looking for Ways to Maintain Medical Practice Independence? MGIS Provides Helpful Tips for Physicians
More than half of current MDs are searching for ways to maintain autonomy; insurance coverage is a key place to start
While the number of independent physicians continues to decline-down to an estimated 40 percent nationally1-the majority of those remaining want to find ways to stay that way. Insurance-from malpractice to liability-can be a major cause of concern for independent physicians. The MGIS Companies, Inc. (MGIS), the nation’s leading provider of insurance products and services designed specifically for physicians, has developed a list of eight tips to help physicians maintain autonomy:
1. Study your insurance policies, especially the fine print. Most physicians purchase their insurance policies early in their careers; and 42 percent haven’t reviewed them for five years or more.2 Knowing what your insurance policies cover-or do not-is key to ensuring strong protection for your practice.
2. Ask 360 degree questions. Physicians must consider all the possible implications of becoming disabled-one’s own income, the impact upon the practice/partners’ finances, retirement plan contributions, payment of medical malpractice premiums/tail/step-down. There is a lot more to think about than just replacing part of your income. For example, surgeons and specialists may have policies that cover disability, but often it is based on salaries for a primary care physician, not one providing their level of service.
3. Check how your transition to electronic medical records (EMR) is proceeding. Have you completed the transfer of patient records to electronic medical records (EMR)? If you are in the process of transferring, or if there are any lost records, you could be at increased risk for a lawsuit if there is a problem or a missed record, even missing information from a file. Talk to experts to ensure your EMR transfer process is done right and the process for maintaining it correctly is in place.
4. Protect against breaches in security. One of the most costly and prevalent types of new liability risks for physicians is security breaches-something as simple as leaving an office laptop in a public space or leaving a computer on where others can see the patient record. Guard against such breaches and ensure you have a policy that fully protects your practice in the event one occurs.
5. Look at how your practice has changed over the past few years. Have you added products such as weight loss programs or supplements? Are you offering nutrition, aesthetics, or some other service? Have you added independent contractors? If so, it’s time to take a look at the policies of the products and people now part of your office, as well as your own policy to ensure you are covered.
6. Work with a qualified broker. Medical insurance is more complex and subject to frequent changes and interpretations at the state and federal level. Make sure you work with a broker or agent who knows the market for physicians insurance and will be able to give you the advice and council you need.
7. Look for insurers and partners that provide the risk management services you need. Large hospital systems and medical groups work with risk managers to provide training and tips on avoiding risks. Independent physicians should look for this level of support and guidance through brokers, insurance carriers, and practice management partners that have the expertise and knowledge to help their practice learn how to avoid risk.
8. Don’t always go with the lowest price. Many physicians are looking to join small risk retention groups to reduce expenses. Make sure the insurer covering claims is rated at least an A+ or higher. Beware especially of new or discount carriers entering the market offering low costs to get business. Many of these are rated poorly and may not be around in a few years when you most need claims coverage.
“Independent physicians will continue to be an important part of our healthcare fabric and we need to provide viable, proven options to help those who want to retain their autonomy,” notes Jeff Brunken, president of MGIS. “Ensuring their practice is fully protected against malpractice, liability and disability is an important piece of a world-class foundation that will enable them to focus on continuing to practice medicine the way they choose.”
About MGIS
The MGIS Companies, Inc. is the nation’s leading provider of insurance products and services specifically for physicians. For more than 43 years the company has provided specialized group disability insurance, medical-professional liability insurance, and practice improvement ancillary products and services to more than 10,000 physician groups, 900,000 group members, and 300,000 physicians nationwide. The MGIS group disability policies are backed by Sun Life Financial®, one of the largest and highest-rated insurance companies in North America. The MGIS medical-professional liability insurance policies are backed by Freedom Specialty Insurance Company, a Nationwide® Company, rated A+ (Superior) by A.M. Best. With a rich tradition of service excellence, MGIS works exclusively through local brokers and benefit advisors to provide the ultimate in personalized, physician-focused insurance services. For more information visit our website www.mgis.com.
ABC Celebrates 30th Anniversary of HerbalGram
Respected Peer-Reviewed Magazine/Journal Has Stimulated Growth of Herbal Medicine
In August 2013, the American Botanical Council (ABC) is celebrating the 30th anniversary of its esteemed flagship publication HerbalGram. Over the course of its three decade-long existence, HerbalGram has transformed from a simple one-color newsletter to a full-color 80-page magazine/journal hybrid full of beautiful botanical photography and heavily researched and peer-reviewed articles. The evolution that HerbalGram has undergone is significant, yet its editorial mission to educate the public on medicinal and beneficial plants has remained steady.
Three decades ago, in the summer of 1983, ABC founder and executive director Mark Blumenthal produced the very first HerbalGram, which was then titled Herb News with “Herbalgram” as a subtitle. Herb News was the name of a previous publication that Blumenthal initiated as president of the now-defunct Herb Trade Association, an organization founded in the 1970s to focus on the emerging herb industry. Blumenthal, who also was running his former herb distribution business Sweethardt Herbs, spent his nights and weekends writing and editing articles for the HerbalGram newsletter, not yet realizing that one day it would birth an entire organization to help lead the botanical movement within the United States.
“One of the herb community’s biggest challenges, especially back in the early 1980s, was credibility,” said Blumenthal. “Herbs were like the Rodney Dangerfield of medicine; they got no respect. People considered herbs to be simply ‘folk medicines’ and they were unaware-and, unfortunately, many still are unaware-of the growing body of scientific and clinical research that supports many traditional uses, as well as modern applications. Throughout its history, starting with Rob McCaleb’s ‘Research Reviews,’ HerbalGram has been a leader in reporting the emerging science on herbs. Today, we see many publications, blogs, and websites reporting on the latest herbal research, and for this, we are grateful that what we helped start 30 years ago has gained so much interest and momentum.”
Originally published with the financial support of the newly formed American Herbal Products Association (AHPA), of which Blumenthal was a founding board member, the first HerbalGram was an eight-page, black-and-white, stapled-at-the-spine newsletter consisting of “herb blurbs” on herbal scientific happenings, media watch items on herbal-related news articles, a handful of paragraph-long “Rob’s Research Reviews” authored by then-associate editor Rob McCaleb (who, at the time, was also head of research at Celestial Seasonings), listings of herbal information resources and schools, and more. The editorial staff consisted of just Blumenthal, as editor, and McCaleb.
The second issue of the newsletter was published jointly by AHPA and the Herb Research Foundation (HRF), which was founded that year by McCaleb, as president, and Blumenthal, as vice-president. Barbara Johnston and Bobbi Close worked part-time as assistant editors. It now featured the title “Herbalgram” in larger, predominant font. This issue took on a more defined format, with organized sections on industry news, conferences/meetings, HRF news, and “potpourri”-a catch-all section featuring various news of possible interest to the growing herbal industry and surrounding community. In the years that followed, HerbalGram underwent many changes that transformed it into the publication it is today. In 1988, at five years old, HerbalGram (issue 18/19) welcomed color to its pages for the first time with a cover illustration of St. John’s wort (Hypericum perforatum) and doubled in size from 24 to 48 pages. That issue also was the first published by HRF as well as ABC, which Blumenthal founded that same year with ethnobotanist Jim Duke, PhD, and the late professor Norman Farnsworth, PhD, in order to help transition the publication from newsletter to magazine. In 1992, issue 28 was the first full-glossy, four-color issue, and featured the first plant photograph to grace the magazine’s cover (Harvard’s glass flowers). In 1999 came the first perfect-bound issue and an increase to 82 pages, along with the 32-page ABC book catalog. One year later, in 2000, issue 50 was the first to be published under ABC’s name alone (although HRF members still receive HerbalGram as a benefit of membership).
Thirteen years and 50 issues later, HerbalGram has remained a leading publication for the botanical community. Its staff has grown to include an art director and four full-time editors, including Blumenthal as editor-in-chief. In addition to its in-house writers, its articles are authored and peer reviewed by numerous botanical experts from around the world. HerbalGram and its monthly electronic version (HerbalEGram) are read by thousands of readers in more than 81 countries, representing a range of diverse professions, from research scientists (e.g., pharmacognosists, ethnobotanists, etc.) and health practitioners (e.g., herbalists, naturopathic physicians, pharmacists, conventional physicians) to industry members and government regulators.
“HerbalGram is a unique hybrid periodical blending popular interpretation of scientific studies on medicinal plants with original peer-reviewed research,” said ABC board of trustees president, Steven Foster. “Under Mark Blumenthal’s steady editorial guidance, the information has always been cutting-edge and, in a word-reliable. From history to new clinical studies, reporting on new regulatory and market developments to comprehensive reviews, and covering the world’s herbs and the world of herbs, no publication has provided more to all interested stakeholders in every aspect of herbal medicine. It’s been a remarkable journey.”
“As part of ABC’s public educational mission,” added Blumenthal, “we have always tried to ensure the accuracy, reliability, and authority of the information in HerbalGram. It is quite common for us to send a feature article out to four to five and, sometimes, up to eight or nine expert peer reviewers to check the facts.”
Starting early, HerbalGram was a leader in presenting extensive literature reviews on specific herbs, starting with sarsaparilla (Smilax spp.) in issue 17, then St. John’s wort in issue 18/19, followed by feverfew (Tanacetum parthenium) in issue 20, valerian (Valeriana officinalis) in issue 21, and hawthorn (Crataegus monogyna) in issue 22 - all of which were written by herbalist and author Christopher Hobbs, RH (AHG). Some of these reviews helped establish a scientific basis for the specific health benefits of each herb and, in other cases, helped clear up some erroneous and inappropriate marketing claims being made at the time. Issue 39 contained a 24-page literature review of kava (Piper methysticum) by Yadhu N. Singh, PhD, and Blumenthal, and issue 40 introduced the American Herbal Pharmacopoeia’s first-ever monograph (on St. John’s wort). Other literature reviews included a cover story on the increasingly popular adaptogenic herb Rhodiola rosea (issue 56) and a cover story on the South African antioxidant tea rooibos (Aspalathus linearis) in issue 59.
Recent HerbalGram issues have featured significant articles, such as the 2009 and 2010 feature stories on climate change’s impact on medicinal plants, the rising sales of pet supplements, and the usage of endangered animal parts in traditional medicines-all authored by then-managing editor Courtney Cavaliere. Each year, HerbalGram publishes its annual Herb Market Report, which is widely used and cited by numerous medical and scientific journals and industry publications and companies. Additional key articles published in recent issues have included the myth of the unregulated industry; the history, ethnobotany, and modern uses of Turkish rose (Rosa spp.); FDA’s approval of the second botanical drug, crofelemer; and much more.
In November 2011, HerbalGram became the main outlet for the ABC-AHP-NCNPR Adulteration Program’s important work. Issue 92 featured the first article in a series of adulteration pieces, titled “A Brief History of Adulteration of Herbs, Spices, and Botanical Drugs,” written by Foster. In 2012 and 2013, HerbalGram published four extensively peer-reviewed feature articles on the adulteration of bilberry (Vaccinium myrtillus) extract, skullcap (Scutellaria lateriflora) herb, so-called ”grapefruit seed extract,” and black cohosh (Actaea racemosa syn. Cimicifuga racemosa). (All are available for free on ABC’s website.)
In 2012, meanwhile, ABC brought HerbalGram into the digital age by launching an online page-flip version of the journal that is available on smartphones, tablets, and computers. According to an ABC press release on the development, “The flip-formatted HerbalGram creates a stunning visual display on numerous digital devices. Each issue contains dozens of full-color, high-quality photographs of botanicals that can now be appreciated on an even greater scale.”
ABC board of trustees member Peggy Brevoort-president of Brevoort, LLC-congratulated the organization and the many others involved with the magazine “who have had the perseverance and vision to make it and the entire herbal industry grow into the respected entities they each are today.
“Thinking back to the first early black-and-white, stapled-together HerbalGram,” Brevoort continued, “it reminds me so much of a parallel with the evolution and growth of the entire herbal industry: small, sincere, ready to share the ‘new’/old knowledge about our newly discovered herbal treasures.”
Founding ABC board of trustees member Dr. Duke also congratulated HerbalGram on its momentous birthday. “Here at the Green Farmacy Garden,” said Dr. Duke, “the garden crew eagerly awaits the arrival of the new issues, always seemingly improving. Mark Blumenthal and HerbalGram have admirably done a great job of keeping the quality and rigor of the science in HerbalGram A#1.”
“I consider HerbalGram the preeminent journal on medicinal herbs,” said Ed Smith, founder of herbal extract manufacturerHerb Pharm, “and it is invaluable in my work in the medicinal herb industry and herbal medicine education. It is both an entertaining magazine and a peer-reviewed academic journal. I liken it to other prestigious periodicals like Nature, Scientific American, and National Geographic.”
Renowned herbalist Rosemary Gladstar noted that she has in her library “one very long sturdy shelf completely devoted to HerbalGrams.”
“That’s a lot of magazine power filled with an intensive number of articles, research papers, conference announcements, and arguably the most comprehensive as well as thoughtfully written tributes to those herbalists and plant lovers who have passed away during these past 30 years,” said Gladstar. “To me this history alone makes HerbalGram far and away the most outstanding magazine devoted to herbs in the country, perhaps the world. I simply love this magazine. I love the way it challenged me to think, presented cutting edge articles on a huge variety of topics, provided an amazing number of resources, and balanced scientific research with traditional and empirical wisdom. Congratulations to you hard-working honey bees that gather the pollen and are so devoted to the cross-pollination of herbal wisdom!”
The most recent issue of HerbalGram features the annual Herb Market Report and articles on ABC’s first chief science officer, how to avoid hiring a “dry lab,” and cannabis (Cannabis spp.) and schizophrenia. The upcoming issue 100, due out in November, will mark an important milestone for HerbalGram as well as ABC’s 25th birthday. To commemorate the occasion, the magazine will feature an additional 16-page signature and a photo essay of ABC’s historic headquarters in Austin, Texas, shot by HerbalGram art director Matthew Magruder, among other articles.
About the American Botanical Council
Founded in 1988, the American Botanical Council is a leading international nonprofit organization that addresses research and educational issues regarding herbs, teas, medicinal plants, essential oils, and other beneficial plant-derived materials. ABC’s members include academic researchers and educators; libraries; health professionals and medical institutions; government agencies; members of the herb, dietary supplement, cosmetic, and pharmaceutical industries; journalists; consumers; and others in over 81 countries. The organization occupies a historic 2.5-acre site in Austin, Texas, where it publishes the peer-reviewed quarterly journal HerbalGram, the monthly e-publication HerbalEGram, the weekly e-newsletter Herbal News & Events, HerbClips (summaries of scientific and clinical publications), reference books, and other educational materials. ABC also hosts HerbMedPro, a powerful herbal database, covering scientific and clinical publications on more than 250 herbs. ABC also co-produces the “Herbal Insights” segment for Healing Quest, a television series on PBS.
ABC is tax-exempt under section 501(c)(3) of the IRS Code. Information: Contact ABC at P.O. Box 144345, Austin, TX 78714-4345, Phone: 512-926-4900. Website: www.herbalgram.org.
New Data Confirms Circulating Tumor Cells Are Useful Predictors of Progression-free and Overall Survival
First Study to Demonstrate Value of Circulating Tumor Cell Enumeration in Chinese Metastatic Breast Cancer Patients Published in Annals of Oncology
Janssen Diagnostics, LLC announced today that results from the study leading to the approval of CELLSEARCH® in China by that country’s State Food & Drug Administration (SFDA) as an in vitro diagnostic for women with metastatic breast cancer have been published in Annals of Oncology. The study, conducted in China, evaluated the utility of circulating tumor cell (CTC) measurements in predicting responses to anti-cancer therapies and assessed patients across various disease subtypes, including those whose tumors expressed human epidermal growth factor receptor-2 (HER-2). Results demonstrated that enumeration of CTCs utilizing Janssen Diagnostics’ CELLSEARCH® system in Chinese women with metastatic breast cancer (MBC) before and after the initiation of standard anti-cancer therapies is a useful predictor of progression-free survival (PFS) and overall survival (OS).
The CELLSEARCH® system is the only CTC test that has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for aiding in the monitoring of patients with metastatic breast, colorectal, or prostate cancer. In addition to its clearance in the United States and approval in China, CELLSEARCH® fulfills the requirements for CE marking in the European Union (EU). CE marking indicates compliance with EU legislation of a product, wherever in the world manufactured, and enables its free movement within the European market.
“This study has shown for the first time the prognostic utility of circulating tumor cells, as detected by CELLSEARCH®, in Chinese women with metastatic breast cancer,” said Massimo Cristofanilli, MD, director of the Jefferson Breast Care Center and one of the study investigators. “The utilization of circulating tumor cells to predict progression-free survival and overall survival will be beneficial to this patient population.”
“In China, the incidence of breast cancer has increased rapidly in recent years, in part due to changes in reproductive patterns, obesity, physical inactivity, and local breast cancer screening efforts,” said lead study author Zefei Jiang, MD, Department of Breast Cancer, Affiliated Hospital of Academy of Military Medical Sciences. “These results in HER-2 positive patients are very important since the anti-HER-2 diagnostics and treatment situation in China is different from many parts of the world due to economic constraints and available technology.”
The study, Circulating tumor cells predict progression-free and overall survival in Chinese patients with metastatic breast cancer, HER2-positive or triple-negative (CBCSG004): a multicenter, double-blind, prospective trial, was conducted in 300 measurable MBC Chinese patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 starting a new line of systemic therapy, including any form of endocrine manipulation, cytotoxic chemotherapy, or immunotherapy, alone or in combination. The primary objective was to evaluate whether a five CTC cut point (cutoff) is predictive of PFS and OS in this patient population. Approximately 10 mL of blood from each patient was drawn into a 10 mL CellSave Preservative Tube per standard specifications, and CELLSEARCH® was used to detect the number of CTCs in 7.5 mL of whole peripheral blood.
A total of 294 of the 300 patients enrolled between March 2010 and January 2011 from six leading Chinese cancer centers were evaluable. In multivariate Cox regression analyses, the baseline CTC number remained an independent prognostic factor for PFS and OS. Similar results were observed for CTC counts at the first follow-up visit for both PFS and OS.
“This study reinforces data generated from our US clinical trials,” remarked Robert McCormack, PhD, head of technology innovation at Janssen Diagnostics, LLC. “This agreement in study results obtained more than nine years and almost 7,000 miles apart demonstrates the consistency of CELLSEARCH® performance.”
At baseline, 115 (39.1%) patients had a CTC count of >5. These patients had a significantly shorter median PFS (6.7 months; 95% CI = 4.7 to 7.9) and OS (13.2 months; 95% CI = 10.6 to 15.9) compared with patients who had <5 CTC (median PFS = 9.0 months, 95% CI = 7.3 to 11.3, p<0.001; median OS >24.6 months, p<0.001). CTC levels correlated to the sites of metastatic disease, hormone receptor status and human epidermal growth factor receptor 2 (HER-2) status and ECOG performance status.
At first follow-up, patients with a CTC count of <5 (n=178) exhibited a significantly longer median PFS (8.2 vs. 5.9 months; p=0.012) and OS (20.1 vs. 12.4 months; p<0.001) compared to the 49 patients with >5 CTC. At the second CTC follow-up, the 39 (16.7%) patients with >5 CTC had a significantly shorter median PFS (2.0 months) and OS (9.5 months) than did the 194 patients with a CTC count of <5 (median PFS = 7.6 months, p<0.001; median OS >23.2 months, p<0.001). There were no differences in PFS between those HER-2 positive patients whether or not they received anti-HER-2 treatment at the first follow-up (p=0.622), as well as the second follow-up (p=0.479).
In the subset of triple negative breast cancer (TNBC patients), at both the first and second CTC follow-up visits, those with a CTC count of <5 had significantly longer median PFS (p<0.001 and 0.002) and OS (p=0.003 and <0.001) times compared to those with >5 CTC. For all 294 patients, the median PFS and OS were 7.9 months (95% CI = 6.8 to 8.9 months) and 20.9 months (95% CI = 17.3 to >24.8 months), respectively.
About Circulating Tumor Cells
Circulating tumor cells are cancer cells that have detached from the tumor and are found at extremely low levels in the bloodstream. The value of capturing and counting CTCs is evolving as more research data is gathered about the utility of these markers in monitoring disease progression and potentially guiding personalized cancer therapy.
Mechanism offers promising new approach for harnessing the immune system to fight cancer
St. Jude Children’s Research Hospital researchers discover how to unleash the immune system against cancer in mice without triggering autoimmune reactions
St. Jude Children’s Research Hospital scientists have discovered a way to target the immune system to shrink or eliminate tumors in mice without causing autoimmune problems. Researchers also found evidence that the same mechanism may operate in humans. The study was published today in the advance online edition of Nature.
The findings provide a new target for ongoing efforts to develop immunotherapies to harness the immune system to fight cancer and other diseases.
The work focused on white blood cells called regulatory T cells. These specialized cells serve as the immune system’s police force, working to control inflammation and guard against autoimmune and inflammatory disease. Regulatory T cells can, however, interfere with the immune system’s ability to fight cancer.
In this study, investigators identified a mechanism that boosts the ability of regulatory T cells to cause problems by blocking an effective anti-tumor immune response. The same process, however, plays no role in maintaining immune balance or preventing the misguided immune attack on healthy tissue that leads to autoimmune problems, researchers reported. Blocking this mechanism led to the elimination or dramatic reduction of melanoma by the immune system in mice, without causing the autoimmune and inflammatory problems often associated with current cancer-treatment efforts that target immune regulators, scientists said.
“Regulatory T cells are a major barrier to effective anti-tumor immunity,” said the study’s corresponding author, Dario Vignali, PhD, vice chair of the St. Jude Department of Immunology. “We have identified a mechanism that enhances the ability of regulatory T cells to put the brakes on the immune response in tumors but plays no role in immune system maintenance. For the first time, we may now have an opportunity to selectively target the activity of regulatory T cells for treatment of cancer without inducing autoimmune or inflammatory complications.”
The mechanism is built around two proteins. One, semaphorin-4a (Sema4a), is carried on the surface of various immune cells that can spark inflammation. The other, neuropilin-1 (Nrp1), is carried on the surface of regulatory T cells.
Vignali and his colleagues used a variety of molecular and cellular techniques to show that Sema4a binding to Nrp1 turns on a biochemical pathway in mouse regulatory T cells that enhances their function, stability, and survival. When scientists eliminated Nrp1 on just regulatory T cells, those cells were unable to respond to signals that normally bolstered their anti-inflammatory activity.
When investigators analyzed human regulatory T cells, they found evidence that the pathway may also serve the same role.
In addition, more than 16 months after losing Nrp1 activity in their regulatory T cells, the mice showed no signs of autoimmune or inflammatory complications. “That is significant because mice and humans that lack or have substantial defects in regulatory T cells develop lethal autoimmune disease,” Vignali said.
Knocking out or blocking the activity of Nrp1 on regulatory T cells in mouse models of several human cancers, including the deadly skin cancer melanoma, led to reduced, delayed, or complete elimination of the tumors. Blocking Sema4a had a similar anti-tumor effect, researchers reported. “The impact was particularly dramatic in a mouse model of human melanoma,” Vignali said. “Mice lacking Nrp1 on regulatory T cells were almost completely resistant to developing melanoma, but did not develop any autoimmune or inflammatory complications.”
Although investigators have not yet identified which cells carry Sema4a in tumors and boost regulatory T cell function, the scientists did report that immune cells called plasmacytoid dendritic cells (pDCs) provided more than half of the Sema4a in tumors in this study. That was surprising because pDCs make up a very small percentage of immune cells, and there is a long history of suppressive interactions between regulatory T cells and pDCs in tumors, Vignali said. Both cell types are recognized as inducing the immune system to tolerate, rather than attack, tumors.
Researchers also provided new details of how the Nrp1 pathway functions, including evidence that, along with bolstering the ability of regulatory T cells to suppress the immune response, the pathway also helps maintain a stable population of regulatory T cells. “This pathway does not just boost regulatory function. It may define how regulatory T cells maintain their identity,” said Greg Delgoffe, PhD, a postdoctoral fellow in Vignali's laboratory. Delgoffe and Seng-Ryong Woo, PhD, a former postdoctoral fellow in Vignali's laboratory, are co-first authors.
The other authors are Meghan Turnis, Cliff Guy, Abigail Overacre, Matthew Bettini, Peter Vogel, David Finkelstein, and Creg Workman, all of St. Jude; David Gravano, formerly of St. Jude; and Jody Bonnevier, R&D Systems, Inc., Minneapolis.
The study was funded in part by grants (AI091977, AI039480 and AI098383) from the National Institutes of Health; a grant (CA21765) from the National Cancer Center at NIH; and ALSAC.
ICPA and OTZ Join Forces to Break Barriers in Pediatric Chiropractic
One-To-Zero (OTZ) Health Education Systems hosted a special collaborative seminar with the International Chiropractic Pediatric Association (ICPA) this weekend in Philadelphia, presenting occipital-atlanto analysis and diversified adjusting techniques, also known as the OTZ Method, to ICPA members and board directors. OTZ was founded by Dr. Francis Murphy of Whole Health Partners and trains licensed chiropractors in the evaluation and care to improve nervous system function via the correction of occipital-atlanto subluxation. This subluxation pattern shows manifestation or dysfunction of the tissues involving the brainstem, the vagal nerve or cranial nerve 10 and the spinal accessory nerve or cranial nerve 11. When this occipital-atlanto manifestation is corrected in children, it seems to have an immediate impact on multiple disorders and behaviors including ADD, AD/HD, Autism and developmental delays.
The ICPA is a non-profit organization whose mission is to engage and serve family chiropractors worldwide through education, training, and research. The organization hosts seminars regularly throughout the world, which are taught from the vitalistic perspective, with great emphasis placed on clinical, hands on application.
“Every Chiropractor must take this seminar!” says Dr. Nanette Jarmain of New York City. She continues, “This technique is the most effective technique I have witnessed in 17 years of practice and the neurology clearly supports the technique. This seminar will change my health, the health of my family and patients and will change the health and well-being of America!”