Past News Items - October 2012

A large international study has identified three new gene variants associated with body mass index (BMI) levels in adults. The scientific consortium, numbering approximately 200 researchers, performed a meta-analysis of 46 studies, covering gene data from nearly 109,000 adults, spanning four ethnic groups.

In discovering intriguing links to lipid-related diseases, type 2 diabetes and other disorders, the IBC 50K SNP Array BMI Consortium's study may provide fundamental insights into the biology of adult obesity. Scientists from the Center for Applied Genomics at The Children's Hospital of Philadelphia led the study, using the CardioChip, a gene array containing probes for some 50,000 genetic variants across 2,100 genes relevant to cardiovascular and metabolic functions.

The study appeared online Sept. 21 in Human Molecular Genetics.

"BMI is a widely used measure of obesity, which affects one third of US adults, and approximately half a billion people worldwide," said first author Yiran Guo, PhD, of Children's Hospital, who led the meta-analysis. "Previous studies have shown that genetics plays an important role in obesity, and this study expands our knowledge of BMI genetics."

The researchers first analyzed a dataset of approximately 51,000 individuals of European ancestry (EA) to discover initial gene signals, and then performed replication studies in another 27,000 EA subjects, as well as 14,500 additional EA individuals. Further analyses of data from approximately 12,300 African Americans, 2,600 Hispanics and 1,100 East Asians strengthened the team's findings.

The researchers uncovered three novel signals, from the genes TOMM40-APOE-APOC1, SREBF2 and NTRK2) that were significantly associated with BMI in adults. All had previously been linked to other important disorders. The APOE locus is well known to be involved in blood lipid regulation and circulation, and plays an important role in Alzheimer's disease. The SREBF2 gene is in the same family as SREBF1, linked to type 2 diabetes in another CardioChip study. Finally, NTRK2 codes for a receptor of the BDNF protein, which is known to be related to BMI and is associated with the eating disorder anorexia.

Anorexia is a special interest of Guo, who holds a Davis Foundation Postdoctoral Fellowship in Eating Disorders. Guo added that the large dataset from the previous studies allowed the researchers "to enhance our understanding of BMI genetics, as well as the interplay between genetic variants and metabolic disorders such as obesity, type 2 diabetes and lipid-related conditions."

Guo also noted that the team was able to test for conditional associations within genes---independent signals from within the same gene locus. In particular, the researchers discovered that two genes, BDNF and MC4R, each harbor two independent signals for BMI. Both genes were among eight genes previously associated with BMI that the current study was able to replicate, including FTO, SH2B1 and COL4A3BP-HMGCR.

Guo concluded that "while the individual effects of each gene may be small, they may provide fundamental clues to the biology of adult obesity." He added that further studies will investigate gene-gene interactions for the same trait.

Released: 10/31/12

Announcing a new era in Alzheimer’s

The time for Tau is now as Phase 3 clinical trials get under way with a second-generation Tau Aggregation Inhibitor (TAI) aimed at halting the progression of Alzheimer’s

TauRx Therapeutics Ltd announced today the initiation of two global Phase 3 clinical trials in mild to moderate Alzheimer’s disease. These landmark studies could provide the first definitive data on a Tau-based approach to disease-modifying and preventative treatment of Alzheimer’s for at least the next five to seven years, said Professor Claude Wischik, Chairman of TauRx and Professor of Old Age Psychiatry at the University of Aberdeen, in a press conference at the 5th Clinical Trials Conference on Alzheimer’s Disease (CTAD) in Monte Carlo, Monaco today.

The studies culminate three decades of research by Professor Wischik and colleagues, including the original discovery of the Tau protein as the main constituent of the Tangle pathology of Alzheimer’s disease [‘Tau tangles’], the development of the first Tau Aggregation Inhibitor (TAI), and results from an earlier Phase 2 clinical trial involving more than 300 patients that showed a 90 percent reduction in the rate of disease progression over two years.

“These Phase 3 studies are bringing us closer to finding an effective treatment that can actually arrest the progression of the disease,” said Professor Wischik. “We are building on over thirty years of research, and the encouraging results from our previous Phase 2 clinical trial in Alzheimer’s disease support an approach which targets the abnormal Tau aggregates in the brain.”

The studies, which have already starting enrolling in the US, aim to confirm the disease-modifying effects seen in the Phase 2 studies in mild to moderate patients over an 18-month timeframe. The first study will involve 833 people with mild to moderate Alzheimer’s disease over 12 months. The second study will include 500 people with mild Alzheimer’s disease over 18 months.

“Clinicians devoted to Alzheimer’s disease have been waiting for a promising agent with disease-modifying properties,” said Professor Serge Gauthier of the McGill Centre for Studies in Aging, Quebec, Canada. “The basic science data for this agent, particularly in the tauopathies, looks sound and the interest among investigators and among families is high.” Professor Gauthier is a clinical investigator and scientific advisor for TauRx.

The tangles in the brain were first reported by Dr. Alois Alzheimer in 1907, starting the century-long journey to understand the pathology leading to their formation, their role in dementia, and, ultimately, how to stop their spread through the brain. Professor Lon Schneider, MD, of the Keck School of Medicine at the University of Southern California, a scientific advisor for TauRx, said: “Successfully targeting Tau may be an important approach towards slowing and ideally halting the neuro-degeneration that is characteristic of Alzheimer’s disease or frontotemporal dementia. Clinicians need these Phase 3 studies to produce clear evidence that such an approach could lead to improved patient outcomes.”

Countries in which the Phase 3 clinical trials will be conducted include Australia, Belgium, Canada, Finland, France, Germany, Italy, Russia, Spain, Netherlands, Singapore, Malaysia, Taiwan, US, and UK. Patients and caregivers are invited to sign up for study updates at AlzheimersStudies.com, as the clinical trials are initiated in the countries selected.

Released: 10/25/12

The Deficiency Of A Single B Vitamin Can Lead To Poor Health

Researchers Mikirova N, Taylor P, Feldcamp C. and Casciari J, under the supervision of Hugh D. Riordan, MD, at the Riordan Clinic in Wichita, Kansas, published "The Effects of a Primary Nutritional Deficiency (Vitamin B Study)" in Food and Nutrition Sciences.

Rats were deprived of a single B vitamin to determine the side effects of such deficiencies. B vitamins play major roles in support of carbohydrate metabolism, immune system function, and cell growth.

In fact all B vitamin deficient groups showed impaired weight gain compared to controls. B1 (thiamine) deficient rats ceased growth after two weeks and had little physical activity. In addition, fur became thin and brittle with up to 50 percent hair loss. Return of B1 to the diet restored normal growth rate and restored hair growth and alleviated other side effects.

B6 (pyridoxine) deficient rats grew at half the rate of the controls and developed painful inflammation of the nose, ears, feet, and tail; hair loss; weakness; and reduced appetite.

B5 (pantothenic acid) deficient rats had severe graying of fur and reduced weight gain but no other obvious signs of side effects other than appearing ill. However, extensive pathology was noted in organs after the study was completed.

B9 (folic acid), choline, and B12 (cobalamin) deficiency generated significant pathology including precancerous lesions of the liver in some animals.

In this study only single nutrient deficiency was examined, however, in many cases where malnutrition is involved, self-induced (through poor dietary choices) or lack of sufficient nutritious food, multiple nutrients deficiencies would be expected and the health and survival of animals and humans reduced further. The subsequent pathologies associated with multiple deficiencies would be expected to be greater.

Released: 10/23/12

FDA Approves New Non-Invasive, Non-Ionizing Radiation Therapy

InSightec Ltd, the leader in magnetic resonance imaging (MRI)-guided Focused Ultrasound therapy, announced that the US Food and Drug Administration (FDA) has approved ExAblate MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. This is the second FDA approval for ExAblate, which has been used widely since it was approved in 2004 as a non-invasive, outpatient, therapy for uterine fibroids.

Bone metastases occur when cancer cells break away from their primary site and spread to other parts of the body.

"Pain is the most common and severe symptom of bone metastases, often causing significant physical and emotional discomfort with a large impact on enjoyment of life," says Mark Hurwitz, MD, principal investigator of the international, multi-center, randomized study that formed the basis of InSightec's Pre-Market Approval (PMA) application with the FDA. "Pain palliation by ExAblate can dramatically improve the quality of life for cancer patients with bone metastases. Results from the clinical study showed that ExAblate therapy significantly reduces pain caused by bone metastases. Patients also reported lasting improvement in well being and function, along with a decrease in the need for medication."

Dr. Hurwitz, who is currently Director of Thermal Oncology and Vice Chair of the Radiation Oncology Department at Thomas Jefferson University in Philadelphia, led the study during his previous tenure as Director of Regional Program Development for the Department of Radiation Oncology at Brigham and Women's Hospital and Associate Professor of Radiation Oncology at Harvard Medical School.

According to the American Cancer Society, more than two-thirds of breast and prostate cancers that metastasize spread to the bones and this also occurs in up to 30 percent of metastatic lung, bladder and thyroid cancers. Up to thirty percent of patients with bone metastases either do not respond to radiation therapy or will be unable to undergo radiation for pain relief.

ExAblate combines therapeutic acoustic ultrasound waves and continuous guidance and treatment monitoring with an MRI. Physicians use the MRI to plan and guide the therapy and monitor treatment outcome. The focused ultrasound acoustic energy destroys the nerves causing the pain, resulting in rapid reduction in pain.

"The recent FDA approval of ExAblate for pain palliation will offer new options for cancer patients with crippling bone pain who are seeking pain-management options and are no longer eligible for radiation treatment," said Dr. Kobi Vortman, President and CEO of InSightec. "This is the second FDA approval for the ExAblate technology and represents a significant milestone in our quest to expand the applications for this innovative, non-invasive therapy. It also demonstrates our continued commitment to bringing ExAblate MRI-guided focused ultrasound into broad clinical use and improving our patients' quality of life."

The second FDA approval for ExAblate was based on the results of an international, multi-center, randomized clinical study comparing patients with painful bone metastases undergoing palliative therapy with ExAblate to a similar group undergoing a placebo therapy. Patients who underwent the ExAblate therapy reported clinically significant pain relief and improvement of quality-of-life during follow-up three months after treatment. Over 15 centers participated in the clinical trial including Fox Chase Cancer Canter, Stanford University, UCSD, UVA, Moffitt, and Brigham and Women's Hospital in the US as well as University of Toronto, La Sapienza University in Rome, Sheba and Rambam Medical Centers in Israel, Petrov Research Institute of Oncology and Rostov Medical University in Russia.

ExAblate is the only FDA-approved MRI-guided focused ultrasound system for treating uterine fibroids and bone metastases related pain management. It has also received European CE marking for uterine fibroids, bone metastases, and adenomyosis. Twenty hospitals in Europe and Asia-Pacific offer ExAblate as a palliative therapy for bone metastases.

Released: 10/18/12

Cancer Treatment Centers of America (CTCA) Names Katherine Anderson, ND, FABNO as National Director, Naturopathic Medicine

Cancer Treatment Centers of America (CTCA) announced the appointment of Katherine Anderson, ND, FABNO as National Director, Naturopathic Medicine. Dr. Anderson is based at the CTCA Southwestern Regional Medical Center in Tulsa, Oklahoma, where she is that facility's Director of Naturopathic Medicine and has served as the interim National Director for the past six months prior to her official appointment in September, 2012.

"We are pleased to have Dr. Anderson join our National Leadership team," said Carolyn Lammersfeld, MS, RD, CSO, LD, CNSC, CTCA Vice President of Integrative Medicine. "Her expertise in the field of naturopathic medicine, coupled with her leadership skills will help us to continue to be a leader in integrative medicine, and to offer our patients high quality of comprehensive cancer care."

A graduate of the Simon Fraser University, Burnaby, British Columbia with Bachelor of Science degrees in both Mathematics and Kinesiology, Dr. Anderson went on to receive her degree in Naturopathic Medicine from the Canadian College of Naturopathic Medicine in Toronto. She is currently working toward a Master in Business Administration from Oklahoma State University in Stillwater.

Dr. Anderson began her professional career as an Area Coordinator at Simon Fraser University. She went on to serve as an Electrocardiogram Assistant at the Nanaimo Regional Hospital in British Columbia before beginning her Naturopathic residency at the CTCA Southwestern Regional Medical Center in Tulsa in 2004. Upon completion of her residency, Dr. Anderson joined the Southwestern staff as a Naturopathic Staff Physician and was later named Senior Clinical Lead in 2007. She was promoted to Director of Naturopathic Medicine at Southwestern in 2009, a position she currently holds.

Dr. Anderson has conducted clinical research in the field of integrative medicine, most recently in the area of low level laser therapy for oral mucositis. The recipient of the Swiss Herbal Remedies Bursary in recognition of Excellence in the Promotion of Women's Health, Dr. Anderson is also a Fellow of the American Board of Naturopathic Oncologists, and a member of the American Association of Naturopathic Medicine, Oncology Association of Naturopathic Physicians, The American Society of Clinical Oncology and the Oklahoma Association of Naturopathic Physicians.

Released: 10/17/12

Brain Training Shown Effective for HIV-related Cognitive Problems

A new study shows the effectiveness of brain training in improving cognitive function in people with HIV. The study, recently published in the Journal of the Association of Nurses in AIDS Care, demonstrated that brain training exercises not only improve core brain processing speed but also crucial measures of real-world activities in adults with HIV. Posit Science was the system used in the study. The findings could have widespread implications.

Modern anti-retroviral therapy has turned HIV into a chronic condition people often live with for decades. Recent research has shown that HIV can have subtle but important effects on the brain, leading to cognitive slowing and difficulties performing everyday activities. In fact, 30 percent–60 percent of adults living with HIV experience cognitive problems at some point in the illness, a condition that researchers now recognize as "HIV-associated neurocognitive disorders" (HAND). Prior to this study, no noninvasive treatments have been proven effective in improving cognitive function in patients with HIV.

"It's imperative for people with HIV and their treatment teams be proactive in addressing cognitive problems as they emerge," comments David E. Vance , PhD, MGS, the study's lead author and Associate Professor, School of Nursing and Associate Director, Center for Nursing Research, University of Alabama at Birmingham. "Without effective treatment, these cognitive problems—which act like premature aging—can lead to difficulties with working and living independently."

Results from this study not only showed benefits on gold-standard measures of brain processing speed and independent living; but also more than 90% of volunteers who received the training reported improvement in their thinking abilities, memory, and attention. "This study shows people with HIV now have a non-pharmacologic, affordable tool that can improve cognitive functioning in areas that directly affect quality of life," states Vance. "Based on this research, my team would suggest these exercises to people with HIV who have noticed cognitive issues and who want to improve their brain health."

In the study, forty-six people with HIV took part in a randomized, blinded, controlled trial comparing computerized brain speed training from Posit Science to a control group that did no cognitive training. Researchers measured cognitive function before and after the study period. The Posit Science training group showed significant improvements relative to the control group in visual speed and attention, a core measure of brain function, as well as in timed instrumental activities of daily living, which measure how quickly a person can do everyday activities.

The Posit Science brain training exercises used in the study focused on processing speed, divided attention, attentional speed, sustained attention, and rapid visual search and memory tasks and are available online at BrainHQ.com. Each exercise uses an intelligent algorithm to constantly adjust, so that each user has a unique journey through the program and experiences maximum benefit."We are very excited to have clinical evidence of our brain training's effectiveness for people with HIV," said renowned neuroscientist Michael Merzenich, PhD, Co-Founder and Chief Scientific Officer of Posit Science and professor emeritus of the University of California San Francisco. "Our goal as a company is to make these training exercises available to everyone who can benefit from them—and as the studies pile up showing they work in different populations, we look forward to helping millions of people who would like to improve cognitive function for any one of a number of reasons."

Neil Giuliano , CEO of San Francisco AIDS Foundation, noted that this may open new possibilities for taking on the cognitive issues that are a key component of addressing HIV and aging.

"By 2015, most Americans with HIV will be over 50, and San Francisco AIDS Foundation is deeply committed to ensuring the evolving needs of this population are met," Giuliano said. "This is an important pilot study, and one that merits further research to better understand the role addressing cognitive function can play in achieving better long term outcomes for older adults with HIV."

Released: 10/15/12

IASP Sponsors Global Year Against Visceral Pain

Initiative promotes better visceral pain management through increased awareness

The Global Year Against Visceral Pain launches today, bringing global attention to pain that originates in or near the internal organs of the body. Visceral pain is the most frequent form of pain, felt by most people at one time or another, and the number one reason for patients to seek medical attention. Sponsored by the International Association for the Study of Pain (IASP), the 12 month campaign focuses on education for health care professionals and government leaders as well as public awareness.

Visceral pain associated with ailments such as gallstones, acute pancreatitis, acute appendicitis, and diverticulitis are the most common reasons for visits to outpatient and inpatient gastrointestinal (GI) clinics, but visceral pain may also include chronic chest pain, bladder pain, gynecological pain, and pelvic pain. Up to 25 percent of the population report visceral pain at any one time, leading to substantial health care costs.

Led by urogenital pain and gastroenterology experts Timothy Ness, MD, PhD (USA), and Qasim Aziz PhD, FRCP (UK), the IASP initiative will mobilize IASP's 8,000+ members and 88 national chapters, and forge partnerships with other organizations, to:

disseminate information about visceral pain worldwide;
educate pain researchers as well as health care professionals who see the issues associated with visceral pain firsthand in their interactions with patients;
increase awareness of visceral pain among government officials, members of the media, and the general public worldwide; and
encourage government leaders, research institutions, and others to support policies that result in improved pain treatment for people with visceral pain.

As part of the Global Year Against Visceral Pain, IASP offers a series of fact sheets for clinicians and health care professionals that cover specific topics related to visceral pain. These fact sheets are translated into multiple languages and available for free download. Also available on the web is a page of resources including links and free posters promoting the Global Year. Throughout the coming year, IASP and its chapters sponsor meetings, symposia, media interviews, publications, and other efforts to promote education on issues surrounding visceral pain. For more information, visit: iasp-pain.org/GlobalYear/VisceralPain.

Released: 10/12/12

Witchhunt Against Compounding Pharmacies Is Irresponsible and Political

Calls by politicians to expand the power of the Food and Drug Administration (FDA) over compounding pharmacies are nothing more than political demagoguery.

No one knows yet why some have died from fungal meningitis, a disease that is known to occur in individuals with weak immune systems. The CDC has not released any proof that the small outbreak was caused by anything improper done by a compounding pharmacy. If this is such a crisis, then why is there so little transparency in the information released by the CDC?

The media are irresponsibly jumping the gun, shooting first and asking questions later. The rush to judgment includes smearing a pharmacy in Massachusetts and then claiming that the Obama Administration could not have prevented this because the FDA is not powerful enough.

When bad outbreaks have occurred due to medication sold by the pharmaceutical industry, which donates heavily to politicians, no stampede for a crackdown happens.

Government officials in Massachusetts have been more responsible than congressmen in reacting to the stories. The state director of Bureau of Health Care Safety and Quality confirmed that there is no basis for thinking that any of the numerous other compounding pharmacies in the state have done anything wrong.

Compounding pharmacies play an essential role in the delivery of quality care. Some hospitals frequently turn to them when conventional suppliers run out. Shortages of essential medicines that already occur, owing largely to FDA overregulation, will become worse under ObamaCare.

The pharmacy at the center of this controversy, New England Compounding Center, was not a typical compounding pharmacy. It mass produced an injectable steroid and shipped it to 23 states, for administration to 13,000 patients. Most compounding pharmacies focus on customized preparations with tight quality controls, and they should remain under state, not federal, regulation.

NECC shares ownership with Ameridose, which does have an FDA license to manufacture large batches. The problem may have occurred despite already existing regulations.

But Big Pharma and its allies in Congress and the media dislike the competition provided by compounding pharmacies. Compounding pharmacies sell a progesterone medication to prevent preterm births for only $25, when similar medication costs $1,500 a dose from a big pharmaceutical company. Exploiting a crisis to unjustifiably expand federal power is a familiar political tactic used by enemies of freedom. When the demands are made before the facts are fully known, as is happening now, then it is a misuse of a tragedy for political gain.

Released: 10/12/12

Link Between Gluten and Immune Reaction Revealed

A link between gluten and the immune system has literally been visualized in new research published today in a leading scientific journal, Immunity. The discovery is the collaborative work of research groups in Australia, the Netherlands and ImmusanT Inc. based in Cambridge, Massachusetts, led by Professor Jamie Rossjohn and Dr. Hugh Reid at Monash University, Dr. Bob Anderson of ImmusanT and Professor Frits Koning at the University of Leiden.

The use of x-ray crystallography enabled the researchers to visually determine how T cells interact with gluten that causes celiac disease in patients who have the DQ8 susceptibility gene, thereby providing insight into how celiac disease pathology is triggered. About half the population is genetically susceptible to celiac disease because they carry the immune response genes HLA-DQ2 or HLA-DQ8. At least one in 20 people who carry HLA-DQ2 and about one in 150 who have HLA-DQ8 develop celiac disease, but people with other versions of the HLA-DQ genes are protected.

This has led researchers to question how the immune system senses gluten. "This is the first time that the intricacies of the interaction between gluten and two proteins that initiate immune responses have been visualized at a sub-molecular level. It is an important breakthrough for celiac disease and autoimmune disease," stated Professor Jamie Rossjohn , National Health and Medical Research Fellow, Monash University.

Future studies will investigate whether T cell activation by gluten in patients with HLA-DQ2 follows similar principles.

Released: 10/12/12

21 Genes Tied to Cholesterol Levels

In the largest-ever genetic study of cholesterol and other blood lipids, an international consortium has identified 21 new gene variants associated with risks of heart disease and metabolic disorders. The findings expand the list of potential targets for drugs and other treatments for lipid-related cardiovascular disease, a leading global cause of death and disability.

The International IBC Lipid Genetics Consortium used the Cardiochip, a gene analysis tool invented by Brendan J. Keating, PhD, a scientist at the Center for Applied Genomics at The Children's Hospital of Philadelphia. Since its creation in 2006, researchers have used the Cardiochip to pinpoint gene variants in dozens of studies. The device contains approximately 50,000 DNA markers across 2000 genes implicated in cardiovascular disease.

Keating and Fotios Drenos, PhD, of University College London, are senior authors of the current study, published today in the American Journal of Human Genetics.

Comprising over 180 researchers worldwide, the consortium analyzed genetic data from over 90,000 individuals of European ancestry. First the researchers used the Cardiochip in a discovery dataset of over 65,000 individuals from 32 previous studies. They then sought independent replication in other studies covering over 25,000 individuals, as well as in a previously reported study of 100,000 individuals.

From this meta-analysis, the consortium identified 21 novel genes associated with levels of low-density lipoproteins (LDL, or "bad cholesterol"), high-density lipoproteins (HDL, "good cholesterol"), total cholesterol (TC), and triglycerides (TG), as well as verifying 49 known signals. The researchers also found that some of the strongest signals appeared to be gender-specific—some variants were more likely to appear in men, others in women.

Keating said, "To date, this is the largest number of DNA samples ever used in a study for lipid traits, it clearly shows the value of using broad-ranging global scientific collaborations to yield new gene signals."

Drenos added, "While each of the genetic variants has a small effect on the specific lipid trait, their cumulative effect can significantly add up to put people at risk for disease." He continued, "This study underscores how international sharing of resources and datasets paves the way for robust, continuing discoveries of new and unexpected information from human genetic studies." Keating and Drenos coordinated efforts among four main data coordinating sites: the Center for Applied Genomics at The Children's Hospital of Philadelphia; the Institute of Cardiovascular Sciences at University College London; AMC, Amsterdam; and the Department of Cardiology at the University Medical Center, Utrecht.

The consortium is following this published work with a project to identify which of the loci reported directly cause disease, and how this knowledge can help in the development of novel drugs. The consortium will also devote its significant pooled resources to identifying interactions among genetic polymorphisms (single-base variations in DNA) and biological markers of downstream cardiovascular disease.

Lead author Folkert Asselbergs, MD, PhD, of University Medical Center, Utrecht, added, "Next to already established drug targets such as the LDL receptor and PCSK9, the current study identified 21 potential new targets for drug development that may be beneficial for the treatment of dyslipidaemia in the future. Our team of researchers are now initiating additional studies to investigate the impact of the found genes on cardiovascular disease."

More than 30 organizations and agencies funded this study, including the U.K. Medical Research Council, the British Heart Foundation, the National Institutes of Health and the Wellcome Trust. In addition to his position at The Children's Hospital of Philadelphia, Keating also is on the faculty of the Perelman School of Medicine at the University of Pennsylvania.

"Large-Scale Gene-Centric Meta-analysis across 32 Studies Identifies Multiple Lipid Loci," American Journal of Human Genetics, published online Oct. 11, 2012, to appear in print, Nov. 2, 2012.

Released: 10/10/12

ACPM TO ESTABLISH NATIONAL COORDINATING CENTER FOR INTEGRATIVE MEDICINE

The American College of Preventive Medicine (ACPM) has received a cooperative agreement award from the Health Resources and Services Administration (HRSA) to create a National Coordinating Center for Integrative Medicine (NccIM) in Preventive Medicine. The purpose of the coordinating center, which ACPM will call the Integrative Medicine in Preventive Medicine Education (IMPriME) Coordinating Center, is to provide technical support for Preventive Medicine Residency and other health professions training programs interested in incorporating evidence-based integrative medicine content into their training. Under a companion funding announcement, 12 Preventive Medicine Residencies have been funded as Integrative Medicine Programs (IMPs) to develop and incorporate integrative medicine curricula and teaching into their residency training programs. These IMPs will coordinate their activities through the NccIM.

The centerpiece of ACPM's approach to the NccIM is to create, convene, administer and sustain a Community of Learning for integrative medicine and preventive medicine that includes partners in Preventive Medicine training, primary care, other health professions such as nursing, dentistry, and pharmacy, and complementary and alternative medicine (CAM) practitioners from a wide variety of practice modalities. The learning community will form the basis for sharing practices, creating and validating evaluation instruments, and disseminating shared experiences to the wider integrative medicine, Preventive Medicine, primary care, other health professions, and CAM practitioner audiences. With its strong focus on primary prevention, health promotion, team-based interprofessional care, and a whole-system perspective, ACPM has a natural alignment with the core values of integrative care. These connections have drawn the support and participation of many leading multidisciplinary, complementary, and integrative health practice and educator organizations into a robust partnership developed for the NccIM. ACPM has assembled a robust team of steering committee members representing Preventive Medicine, primary care, and the integrative medicine/CAM community, as well as faculty experts in specific integrative medicine/CAM disciplines to serve as peer mentors to trainees and program faculty for IM research, faculty development, and curriculum implementation.

"ACPM is thrilled to have been selected by HRSA to create and manage this critically important center," said ACPM Executive Director, Michael Barry. "With our focus on evidence-based interventions to prevent disease and promote health, healthy lifestyles, and systems-based approaches to health care, and our longstanding relationship with and commitment to Preventive Medicine Residency training programs, I believe ACPM is uniquely qualified to lead this effort."

Released: 10/09/12

ImaginAb and Lundbeck to Collaborate in Neurodegeneration

Collaboration around CNS imaging with biologics

ImaginAb, Inc, a clinical-stage company developing in vivo molecular imaging agents based on antibody fragment technology, today announced that it has entered into a collaboration and commercialization agreement with H. Lundbeck A/S. Under the terms of the agreement, ImaginAb and Lundbeck will collaborate around a novel central nervous system (CNS) target in order to explore the use of re-engineered antibodies to accelerate the blood-brain barrier (BBB) transport of biologics.

"This collaboration represents a great opportunity for both companies to explore an increasingly important intersection between therapeutic and diagnostic medicine," said Dr. Christian Behrenbruch, Chief Executive Officer of ImaginAb. "Given the worrying number of recent failures of late-stage biologics programs, including for neurodegenerative applications, there is a critical need to explore new ways of integrating diagnostic and therapeutic strategies to de-risk development."

Under the terms of the agreement, the parties will collaborate to concurrently develop biologics with improved BBB transport and imaging agents that are capable of quantitating kinetics and targeting efficacy. The agreement also includes an option for Lundbeck to commercialize the results of the collaboration for both diagnostic and therapeutic uses.

"Molecular imaging has become a prevalent aspect of developing new CNS products, both during product development and for clinical management of disease, and we are pleased to be working with ImaginAb to explore this exciting opportunity," commented Dr. Jeffrey Stavenhagen, Head of Biologics for Lundbeck.

Released: 10/09/12

People with Paralysis Can Walk

Huntington Memorial Hospital announced today that it has become the first hospital in Southern California – and only the third in the 11 western states – to offer an incredible new technology that enables people with lower-extremity paralysis or weakness to stand and walk.

“What we are witnessing is truly the best of what science, engineering and medicine have to offer,” said Sunil Hegde, MD, medical director of the hospital’s Outpatient Rehabilitation Center. “Together we are helping people rethink current physical limitations and achieve the remarkable.”

Patients are able to walk with the assistance of Ekso, a ready-to-wear, battery-powered bionic suit – or exoskeleton – that is strapped over the user’s clothing. With the patient providing the balance and proper body positioning, Ekso allows patients to walk while a physical therapist uses the control pad to program the desired walking parameters, such as step length and speed, as well as control when the Ekso stands, sits and takes a step. It is powered by two high-capacity lithium batteries, which drive the hip and knee motors.

“With the aid of the Ekso remote control, one of our physical therapists helps teach the patient when to take a step, how to position their body for proper balance, and how to shift their weight in preparation to take another step,” said Dr. Hedge. “The physical therapist also has the ability to modify the walking pattern – step speed and length – as the patient progresses.”

Ekso can be adjusted to fit most people between 5’2” and 6’2” who weigh 220 pounds or less. The user needs arm function and adequate upper extremity strength to manage crutches or a walker. An experienced user can transfer to/from their wheelchair and put on or off the Ekso in less than five minutes. The torso and leg straps are designed to enable the user/patient to easily get in and out of the device with no or minimal assistance. The learning curve is user specific, and usually individuals begin using a walker and progress to crutches.

The addition of the Ekso technology to Huntington Hospital’s Outpatient Rehabilitation Center was made possible through the generosity of a challenge gift from donors Carol and Harry Tsao and Renata and Talmadge O’Neill. They made their donation in honor of their families’ philanthropic legacies. Tsao and Talmadge are co-founders of Mezi Media and are investors in Ekso Bionics.

So as to encourage other people to support these much-needed services, Tsao and Talmadge have agreed to match dollar for dollar other community donations to the hospital’s neuroscience program. “We are deeply grateful to these wonderful families for their support of important and life-changing care within our walls,” said Dr. Hedge.

“While this technology is currently used only in rehabilitation centers, we join with Ekso in looking forward to the day when people will be able to utilize this technology on the sidewalks or in shopping malls,” continued Dr. Hedge. “Since the robotic suit is self-contained robotic and not tethered to a power supply, why not dream big?”

Released: 10/05/12

The International Academy of Compounding Pharmacists Responds to Meningitis Outbreak

The International Academy of Compounding Pharmacists (IACP) on behalf of its 2,700 member compounding pharmacists, technicians and student pharmacists, responds today to the tragic situation involving a Massachusetts compounding pharmacy. As pharmacists who care deeply about their patients, this situation causes the Academy and its entire membership great concern and empathy on behalf of all of the individuals involved.

As the investigation continues by the Centers for Disease Control (CDC), the Food and Drug Administration (FDA), and the Boards of Pharmacy in the six states in which clinical cases of fungal meningitis have occurred, IACP believes it is important to clarify the role and nature of compounding pharmacy.

Key Points:

How common is pharmacy compounding?

Compounding is a traditional part of pharmacy practice. It involves the preparation of medications on prescription by physicians and other authorized prescribers who meet unique patient healthcare needs that cannot be met with commercially manufactured and marketed drug products. This might include providing different strengths, preparing a drug with different non-active excipients for which a patient may have an allergy, or creating dosage forms which are more palatable for a patient.
Of the approximately 56,000 community-based pharmacies, more than half provide some level of basic compounding services to local patients and physicians. IACP estimates that there are 7,500 pharmacies in the United States that specialize in advanced compounding services of which approximately 3,000 provide sterile compounding. It is estimated that one to three percent of all prescriptions dispensed in the United States are compounded on prescriptions for individual patients.
The value of compounding pharmacy to the healthcare system has grown recently as pharmacists have worked with local physicians, hospitals and medical clinics to address the ongoing shortage of critical manufactured medications. As the number of medicines previously available through manufacturers have gone into backorder or long-term shortage status due to manufacturing problems, compounding pharmacists have been able to access the raw drug ingredients and collaborate to provide those medicines until manufacturing supply has been revived.

Is Compounding Pharmacy Regulated?

All compounding pharmacists and pharmacies are subject to governmental oversight by three distinct regulatory bodies: their individual State Boards of Pharmacy for adherence to practice requirements, the Food & Drug Administration (FDA) for the integrity of the drugs and Active Pharmaceutical Ingredients (APIs) which they order, store and use; and, by the Drug Enforcement Administration (DEA) for their handling of controlled substances used in the preparation of compounded medications.
In addition to government regulation, adherence to United States Pharmacopeia USP <797> standards for the compounding of sterile medications is expected. USP <797> is a national standard for the process, testing, and verification of any medication prepared for administration to patients. These standards are included as a requirement in many state regulations in addition to being a professional standard.
The pharmacy profession has an accrediting body – the Pharmacy Compounding Accreditation Board (PCAB) – which provides an additional level of quality assurance recognition for sterile and non-sterile compounded preparations. Pharmacies with PCAB accreditation status have demonstrated that their policies and processes meet the highest possible quality standards. New England Compounding Center is not a current PCAB accredited pharmacy.

Was this pharmacy – NECC – compliant with state and federal laws?

Given the nature of the ongoing investigation, the first priority for all parties must be the identification and prompt treatment of any additional patients who may be at risk from medications compounded by New England Compounding Center (NECC). IACP is not aware of any specific violations of state and federal law by NECC at this time. The Academy will be working closely with regulatory authorities in any manner they deem necessary to assist in determining whether or not the pharmacy in question failed to meet legal and professional standards of practice.

How can a physician, hospital or clinic know that the compounding pharmacy they work with is reliable?

IACP has developed a comprehensive tool for the medical community to help assess and select a compounding pharmacy. The objective of IACP's Compounding Pharmacy Assessment Questionnaire (CPAQ) is to aid compounding pharmacists have a meaningful discussion with hospitals and practitioners regarding pharmacy compounding and to raise awareness of the stringent policies and procedures employed in compounding.
IACP's CPAQ document emphasizes the importance of verifying licensure status, accreditation status, and face-to-face consultation between medical practitioners and the compounding pharmacists with whom they wish to establish a relationship.
IACP is not aware of whether or not any of the facilities which purchased medications from New England Compounding Center pursued the due diligence the Academy recommends.

Released: 10/04/12

NFL Pro Bowler E.J. Henderson Supports Concussion Program

Amarantus BioSciences Inc, a biotechnology company developing new treatments for brain-related disorders including Parkinson's disease and Traumatic Brain Injuries (TBI) centered on its unique proprietary anti-apoptotic therapeutic protein known as MANF, today announced the commitment by former Minnesota Vikings Pro Bowl linebacker E.J. Henderson to support the further development of Amarantus' TBI research collaboration with Banyan Biomarkers. Mr. Henderson will be working alongside NFL veterans Jack Brewer and Corey Chavous to raise awareness and broaden the support base for the Amarantus-Banyan research collaboration by utilizing the Coalition for Concussion Treatment (#C4CT) awareness campaign on Twitter, led by Brewer Sports International.

"Concussions and their long-term side effects are a huge problem for NFL players and alumni," said Mr. Henderson. "I have been following Amarantus since they announced their collaboration with Banyan last November, and I was impressed with the initial success achieved this summer. As a result, I've decided to become actively involved with Amarantus in order to help bring their research to the forefront in the mainstream media. I believe these types of advances in scientific research can ultimately help current NFL players and NFL alumni who are at an unusually high risk of developing long-term side effects from multiple concussions."

ESPN reported in June that NFL players were at an unusually high risk of developing neurodegenerative diseases such as Parkinson's disease due to the traumatic impact of multiple concussions and sub-concussive hits. Former NFL players such as Messrs. Henderson, Brewer and Chavous have become significantly more active in seeking solutions to these chronic problems by looking to pool NFL players' collective influence to help research potential medical treatments.

"NFL players are well aware of the risks associated with their sport, being directly affected by Traumatic Brain Injuries on a daily basis. Many are taking an active role in supporting pertinent and relevant scientific research such as the research undertaken here at Amarantus," said Gerald Commissiong, President & CEO of Amarantus and former professional football player with the Calgary Stampeders of the Canadian Football League. "E.J. Henderson understands the potential value and long-term benefits that our research effort could have for football players and their families. The awareness generated by the support of known athletes for our program should contribute to Amarantus' growth, allowing us to attract capital to pursue our mission of developing new treatments for patients with brain disorders such as Parkinson's and TBI."

In June 2012, Amarantus announced positive data for its Traumatic Brain Injury collaboration with Banyan Biomarkers. The research was supported by a research grant by Brewer Sports International. Amarantus and Banyan are currently working on the design of the next phase of testing MANF as a disease-modifying treatment for Traumatic Brain Injury.

Released: 10/02/12

Published Study Indicates Effectiveness of Brain Training for Chemobrain

A new clinical study, published in Breast Cancer Research and Treatment, shows that breast cancer survivors who experience "chemobrain"—cognitive problems that arise during and after cancer treatment—may finally have a valid treatment option: computerized brain training. In the study, breast cancer survivors who used a specific set of Posit Science's brain training exercises showed significant improvements in memory, brain speed, anxiety, depression, and health-related quality of life.

"Cancer-related cognitive impairment can inhibit full recovery from cancer," said Diane Von Ah, PhD, RN the study's lead author and assistant professor at the Indiana University School of Nursing and a researcher at the Indiana University Melvin and Bren Simon Cancer Center in Indianapolis. "Many breast cancer survivors report difficulty with basic cognitive abilities, like word-finding, memory, and multi-tasking. These problems in turn affect self-confidence, mood, and more. As a result, some cancer survivors have a long road ahead of them even after their cancer is gone. Their cognitive problems make it difficult for them to meet family and work responsibilities and life goals."

Recent research has confirmed that chemobrain, which scientists refer to as "cancer-related cognitive impairment," affects anywhere from 20 percent to 75 percent of breast cancer survivors who undergo chemotherapy. Symptoms can last up to ten years after drug or radiation therapies have ceased. Until now, there have been no evidence-based treatment options for this problem.

The results of this study offer hope that this may become the first evidence-based treatment option for breast cancer survivors who report cognitive concerns. "It is exciting that the computerized brain training program improved both memory and information processing speed," Dr. Von Ah said. "Our next step is to conduct a larger study to duplicate our results, especially to see if our results hold in subgroups of breast cancer survivors."

In the study, eighty-two breast cancer survivors took part in a randomized, blinded, controlled trial comparing two types of cognitive training—computerized brain speed training from Posit Science and a classroom memory training course—to a control group that did no cognitive training. Researchers measured cognitive function before, immediately after and two months after completing training. The Posit Science training group showed significant improvements in memory, speed, depression, fatigue, and health-related quality of life, all of which were maintained at the two-month follow-up visit, with anxiety symptoms improving specifically at the follow-up visit. The classroom memory training group showed improvements in self-rated cognitive function, with additional benefits in memory and anxiety documented at the follow-up visit.

"One surprise was how much people liked the brain training exercises," noted Dr. Von Ah. "Often getting patients to use rehab programs that will help them can be difficult due to their busy lifestyles, but people enjoyed the challenge and the interactivity of the exercises."

The Posit Science brain training exercises used in the study focused on processing speed, divided attention, attentional speed, sustained attention, and rapid visual search and memory tasks. They are available online at BrainHQ.com. Each exercise uses an intelligent algorithm to constantly adjust, so that each user has a unique journey through the program and experiences maximum benefit. "We're excited that our brain training exercises have been shown to improve cognitive function for people with chemobrain," said renowned neuroscientist, Michael Merzenich, PhD, Co-Founder and Chief Scientific Officer of Posit Science and professor emeritus of the University of California San Francisco. "We believe our cognitive training has the potential to help millions of people think faster, focus better, and remember more, for a better life. This study adds to the scientific and clinical research indicating the effectiveness of our programs for a broad spectrum of the population."