The higher a person’s degree of obesity, the higher their risk of stroke – regardless of race, gender and how obesity is measured, according to a new study published in Stroke: Journal of the American Heart Association.

“It has not been clear whether overweight and obesity are risk factors for stroke, especially among blacks,” said Hiroshi Yatsuya, M.D., Ph.D., study lead author and visiting associate professor at the University of Minnesota in Minneapolis. “There are also questions about which measure of excess weight (body mass index [BMI], waist circumference or waist-to-hip ratio) is most closely associated with disease risk.”

Analyzing the ARIC Study database in which subjects’ BMI, waist circumference and waist-to-hip ratio were measured at the study’s start, Yatsuya and colleagues followed 13,549 middle-aged black and white men and women in four U.S. communities from 1987 through 2005. Participants started the study free of cancer and cardiovascular disease.

During the follow-up period of about 19 years, 598 ischemic strokes occurred. The researchers calculated incidence rate – the number of new cases per 1,000 people per year – according to groups representing different degrees of obesity, using each obesity measure.

They found that incidence rates differed substantially between whites and blacks. For example, the stroke rate in the lowest BMI category was 1.2 per 1,000 person-years for white women and 4.3 per 1,000 person-years for black women. The rate in the highest BMI category was 2.2 for white women and 8.0 for black men.

“Black women had about three times higher incidence of stroke than white women in the lowest as well as in the highest BMI categories,” Yatsuya said. “But the correlation between increasing stroke incidence and increasing degree of obesity was apparent in both races and genders.”

Individuals in the highest BMI category had 1.43 to 2.12 times higher risk of stroke (varying modestly by race and sex) compared to the lowest BMI category. When waist circumference was used as a measure of obesity instead of BMI, those risk ratios ranged from 1.65 to 3.19; and 1.69 to 2.55 when waist-to-hip ratio was used. Thus, for any obesity measure, individuals in the highest category had approximately two times higher risk of stroke compared to the lowest category in each race-sex group.

“Since individuals with higher degrees of obesity tended to have higher blood pressure levels or higher diabetes prevalence, we further examined the relationship between the degree of obesity and ischemic stroke incidence by statistically adjusting for difference in blood pressure of diabetes status attributed to the degree of obesity,” Yatsuya said. “That significantly weakened the associations, suggesting these major risk factors explain much of the obesity-stroke association.”

The study re-emphasizes the need to prevent obesity in general, Yatsuya said. But, he said, clinical trials would be needed to determine whether obesity prevention or control would actually decrease stroke incidence.

Notes:

Co-authors are Aaron R. Folsom, M.D., M.P.H.; Kazumasa Yamagishi, M.D., Ph.D.; Kari E. North, Ph.D.; Frederick L. Brancati, M.D., M.H.S.; and June Stevens, Ph.D.


Author disclosures are on the manuscript.


The National Heart, Lung, and Blood Institute funded the study.

Source: Karen Astle

American Heart Association

The U.S. Food and Drug Administration and San Diego-based Ocean Harvest Inc., an outlet for salmon, tuna, and other fresh fish intended for raw consumption, and Ocean Harvest president, Minkyu Park, recently signed a consent decree of permanent injunction. The company had been selling seafood that was handled in violation of federal food safety standards.

The consent decree restrains Ocean Harvest from preparing, packing, or distributing seafood until the company complies with the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The company also cannot prepare, pack or distribute seafood until it complies with the FDA’s current Good Manufacturing Practice regulations.

HACCP is a science-based system of preventive controls for seafood safety that commercial seafood processors can use to identify and control potential food safety hazards. The FDA seafood HACCP program was designed to increase the margin of safety for U.S. consumers and to reduce illnesses to the lowest possible levels in seafood products.

“The FDA is committed to reducing health risks for consumers of seafood products,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Ocean Harvest must meet the necessary requirements to ensure that their food is safe or it will not be able to process or distribute their products.”

Ocean Harvest has an extensive history of operating under insanitary conditions and violating the seafood HACCP regulations. During the FDA’s most recent inspection of the company’s processing facility, investigators found that Ocean Harvest failed to implement adequate HACCP plans for the raw fresh fish intended for sale to sushi restaurants and failed to properly clean and sanitize equipment used to process fresh fish.

Source:

U.S. Food and Drug Administration

The Food Standards Agency (FSA) welcomes the unanimous vote on 3 October to raise the age at which bovine vertebral column (VC) is classified as specified risk material (SRM) from 24 months to 30 months. This change restores the VC SRM controls in the UK to the position pre May 2006 when the UK harmonised with EU. The proposal represents negligible risk to consumers.

The vote of the European Standing Committee on Food Chain and Animal Health (SCoFCAH) takes Europe a step closer to enabling trade in bone in carcases and part carcases from cattle up to 30 months of age without the restrictions imposed by VC SRM controls.

Before the necessary changes to the legislation which would permit this trade can be introduced, the proposal will be subject to a three month scrutiny by the European Parliament (EP). If the EP is content the Proposal should come into force in early 2008.

In advance of any change in legislation, it is important that food business operators continue to comply with current SRM and disposal legislation.

The FSA intends to use the three month EP scrutiny period to hold a public consultation on the proposal.

food

Low Levels of Vitamin D Increase Risk of Heart Disease and Death and May Account for Higher Cardiovascular Risk Among Blacks

Fiscella and Franks add to the increasing evidence that a low level of vitamin D is an independent risk factor for cardiovascular disease. And they show that the higher cardiovascular risk observed among blacks may be partly related to lower vitamin D levels, which the researchers point out are very prevalent among blacks because of lower absorption of vitamin D due to darker skin, lower dietary intake, and decreased sun exposure. Analyzing nationally representative data on more than 15,000 U.S. adults, researchers found that those with serum vitamin D, specifically 25 hydroxyvitamin D, or 25(OH)D, levels in the lowest quartile compared with those in the three higher quartiles had a 40 percent adjusted higher cardiovascular risk for death after accounting for other factors. Notably, they also found that the 38 percent higher cardiovascular mortality observed in blacks versus whites was attenuated by accounting for differences in 25(OH)D levels and fully eliminated with further adjustment for lower income. Specifically, they found that accounting for 25(OH)D levels reduced blacks’ higher risk of cardiovascular mortality by 60 percent, and inclusion of both 25(OH)D and poverty reduced the race risk to zero. The authors call for further research to determine whether vitamin D supplementation might improve cardiovascular outcomes and reduce existing racial health disparities.

Vitamin D, Race, and Cardiovascular Mortality: Findings From a National US Sample
By Kevin Fiscella, M.D., M.P.H., University of Rochester School of Medicine and Dentistry, New York, and Peter
Franks, M.D., University of California, Davis

Incidence of Hypertension Accelerating Among Rural Chinese Adults

A study out of China documents a high incidence of hypertension among rural Chinese adults, with most newly developed cases left untreated and uncontrolled. Data from a large population-based sample of 24,360 rural adults aged 35 years and older from China’s Liaoning Province show that during a follow-up period of 28 months from 2004-2006 to 2008, more than one in four adults developed hypertension. Moreover, the researchers find that the great majority of cases of incident hypertension were untreated (80 percent) and uncontrolled (98 percent). They identify predictors of incident hypertension, including several modifiable risk factors in an environment of increasing urbanization and westernization of diet and health behaviors. The authors point out that the annual hypertension incidence of 11.4 percent is higher than that previously reported in China, Canada or the United States. They conclude the increases in hypertension are probably related to rapid social changes in China and may apply to other areas of the developing world. They call for urgent public health intervention to prevent and control hypertension.

Incidence and Predictors of Hypertension Among Rural Chinese Adults: Results From Liaoning Province
By Zhaoqing Sun, M.S., et al
First Affiliated Hospital, China Medical University, Shenyang

Superficial Blood Clots not Associated With Increased Incidence of Cancer

Researchers from The Netherlands debunk the belief that superficial venous thrombophlebitis (SVTP), or superficial blood clots, are associated with concomitant cancer. Analyzing records for 250 SVTP patients from five primary care centers in Amsterdam, researchers found no increased incidence of cancer after a first episode of unprovoked SVTP. Specifically, during the two-year observation period after an episode of unprovoked SVTP, the cumulative incidence of cancer was 2 percent, compared with 2 percent in a control group of Dutch patients. Recurrent SVTP was not common in the study sample (observed only in 18 of the 250 patients), allowing no conclusion about whether repeat episodes are associated with cancer, as case reports have suggested.

Idiopathic Superficial Thrombophlebitis and the Incidence of Cancer in Primary Care Patients
By F. F. van Doormaal, M.D., et al
Academic Medical Center of Amsterdam, The Netherlands

Paucity of Evidence to Support Male Circumcision, the World’s Most Common Surgical Procedure

Although approximately 30 percent of the global male population is circumcised, this systematic review of the evidence on the safety and efficacy of circumcision for prophylactic, religious or cultural reasons finds a paucity of evidence demonstrating clinical benefit from the procedure. The eight studies included in the review did provide evidence for the efficacy of adult male circumcision in preventing HIV/AIDS acquisition in sub-Saharan African men, however the authors point out that these findings cannot necessarily be extrapolated to males in other countries. Moreover, they conclude that current evidence is unclear on the efficacy of adult circumcision in preventing sexually transmitted infections, urinary tract infections and penile cancer. The authors call for additional research to strengthen the evidence base and allow for more informed conclusions on nontherapeutic male circumcision.

Safety and Efficacy of Nontherapeutic Male Circumcision: A Systematic Review
By Caryn L. Perera, B.A., Grad. Cert. E.B.P., et al
Royal Australasian College of Surgeons, Adelaide, South Australia

Steroids Safe and Effective for Sore Throat Pain Relief, But Risks Must Be Considered

A systematic review of evidence from eight randomized controlled trials finds that steroids are effective in relieving sore throat pain in adult and pediatric patients. The review noted no serious adverse effects from the different steroids administered (dexamethasone, betamethasone, and prednisone); however, the authors point out that the benefits must be weighed against possible rare adverse drug effects and the further medicalization of a condition for which most people do not seek medical attention. They also point out that there are safe and effective over-the-counter medications to relieve sore throat pain. Notably, most patients studied also received concomitant antibiotics, and the authors point out that reducing prescription antibiotics for frequently benign upper respiratory tract infections is a public health goal. They therefore recommend further studies to establish the safety of steroid use without antibiotic coverage and the added benefits of steroids when used with regular administration of over-the-counter analgesic medications.

Steroids as Adjuvant Therapy for Acute Pharyngitis in Ambulatory Patients: A Systematic Review
By Katrin Korb, M.D., et al
University of Goettingen, Germany

Preventing Drug Errors: Physicians Disagree About How to Manage Patients’ Drug Lists

Interviews with 20 Swedish physicians revealed a diversity of opinion as to whose responsibility it is to manage a patient’s drug list to ensure drugs prescribed by different physicians do not interact negatively or cause harm. The researchers identified five different strategies used by physicians to manage this responsibility: 1) imposed responsibility, 2) responsible for own prescriptions, 3) responsible for all drugs, 4) different but shared responsibility, and 5) patient responsible for transferring drug information. They note that technical solutions, like electronic health records, alone are unlikely to be sufficient for preventing drug errors, and physicians should be made aware of variations in understanding responsibility so that health care quality can be improved.

Whose Job Is It Anyway? Swedish General Practioners’ Perception of Their Responsibility for the Patient’s Drug List
By Pia Bastholm Rahmner, et al
Stockholm County Council, Sweden

Do Physician and Patient Gender Affect how Cardiovascular Disease Risk Factors are Managed in Primary Care?

Tabenkin and colleagues look at the role sex of the physician and the patient plays in the management of cardiovascular disease risk factors. Chart audits of 4,195 patients cared for by 39 male and 19 female physicians in 30 primary care practices reveal that women physicians provide more preventive counseling for risk factors, including diet, weight loss, and physical activity. Additionally, they found that women patients, regardless of the sex of their physician, were less likely to receive drug therapy for diabetes management, including glucose-lowering medications, ACE inhibitor therapy and aspirin therapy. The authors point out, however, that the modest differences in cardiovascular disease risk factor management have little effect on the frequency with which patients meet guideline-specific goals for cardiovascular disease during a 2- 5-year period. They call for future research to explore whether the stylistic differences in cardiovascular disease risk factor management have any long-term impact on clinically relevant outcomes, such as heart attacks, strokes, heart failure and death.

Differences in Cardiovascular Disease Risk Factor Management in Primary Care by Sex of Physician and Patient
By Hava Tabenkin, M.D., M.S., L.L.B., et al
HaEmek Medical Center, Afula, Israel

Realizing the Potential of the Information Age by Considering Different Ways of Knowing

The sixth in a seven-part series of commentaries to understand health and health care With the January/February issue, Annals of Family Medicine editor Kurt Stange, M.D., Ph.D., continues his seven-part series of commentaries designed to help make sense of the problems and opportunities we face for understanding and fostering health. The series’ sixth installment explores four different ways of knowing, learning and developing. Stange asserts that our understanding of the world has become more and more fragmented as information is generated in ever-smaller segments and for increasingly narrow purposes, leaving us with limited understanding and a paucity of wisdom. He posits that researchers can realize the potential of the information age and achieve a higher level of understanding by considering other, complementary ways of knowing the phenomena under study. Using the hypothetical story of a patient with diabetes, Stange illustrates how each way of knowing, when considered together, has the potential to evolve from data to information to knowledge to understanding. He calls on readers to imagine the symbiosis, synthesis and synergy that could be created if personalized medicine were understood not just from the perspective of biomedicine, but also from systems and ecological, community and family, and person perspectives.

Ways of Knowing, Learning and Developing
By Kurt C. Stange, M.D., Ph.D.
Case Western Reserve University, Ohio

Public Health Slogans About Healthy Diet Don’t Necessarily Translate to Healthy Eating

While basic public health slogans and messages about a healthy diet may reach the lay public, this study illustrates that awareness does not necessarily translate to understanding and application in daily life. Interviews with 46 women from a Welsh working class community revealed that although the main public health messages about a healthy eating – like eating five a day and eating a balanced diet – were known by mothers and had been adopted into everyday language, the messages were being interpreted in a superficial way and appeared ineffective at achieving lasting behavior change. The authors assert that confused interpretations limit people’s ability to bring about lifestyle change. What many of the women described as a healthy diet would not satisfy official definitions, and they described many barriers to making changes, including time, money, family preferences and a desire to enhance the quality of life through the enjoyment of food. The researchers conclude that while generic slogans are useful starting points, clinicians must offer patients more personalized, detailed advice on how changes can be positively achieved and sustained.

A Question of Balance: A Qualitative Study of Mothers’ Interpretations of Dietary Recommendations
By Fiona Wood, PhD, et al
Cardiff University, Wales

Suicide Inquiry in Primary Care Sensitive and Straightforward

Noting that one-half of people who die by suicide have seen a primary care physician within a month of death, researchers from the University of Washington take a closer look at how primary care physicians inquire about suicide, recognizing the inherent challenges of suicide risk assessment given that physicians are often forced to probe for an unstated concern. The detailed qualitative analysis of 91 audio-recorded primary care visits found that most primary care physicians’ suicide inquiries were sensitive and straightforward. Researchers found that generally, physicians seamlessly wove the topic of suicide into the conversational fabric that was focused on psychosocial functioning. Additionally, they found that physicians rarely responded to the standardized patients’ denial of suicide ideation by jumping to a fresh topic. Most responded by probing for more information or by expressing supportive statements aimed at reassuring that the physician is concerned for their safety. In only a few instances (4) did physicians use language that might inhibit suicide disclosure.

Suicide Inquiry in Primary Care: Creating Context, Inquiring and Following Up
By Steven D. Vannoy, Ph.D., M.P.H., et al
University of Washington, Seattle

An Up-Close Look at New Mexico’s Successful Rural Health Extension Program

Researchers from the University of New Mexico describe a statewide program aimed at improving community health and local capacity in rural New Mexico by identifying community health priorities and linking them with resources from the University of New Mexico Health Services Center. Modeled after the Agricultural Cooperative Extension Service, the Health Extension Rural Offices (HEROs) program enables health extension agents to attend to more than just immediate, strictly medical needs by addressing underlying social determinants of disease, such as school retention, food insecurity, and local economic development through community engagement. They conclude that programs similar to HEROs could be reproduced in other cities and towns.

Health Extension in New Mexico: An Academic Health Center and the Social Determinants of Disease
By Arthur Kaufman, M.D., et al
University of New Mexico, Albuquerque

Source:
Angela Sharma

American Academy of Family Physicians

A Canadian company is betting that cryogenics research at the University of Alberta will set a new standard for stem cell
storage and preservation.

Researchers at the U of A have developed a way of cryogenically preserving blood stem cell cultures without the use of
dimethyl sulfoxide (DMSO) or other traditional cryoprotective chemicals. LifeBank Cryogenics Corp. has signed an exclusive
licensing agreement with University of Alberta to develop the research commercially.

Cryogenically preserved blood stem cells are used to treat cancers and blood disorders, and additional potential therapies
for spinal cord, cardiovascular and neurogenerative disorders, among many other ailments, are in development worldwide.

Currently, the universal method for blood stem cell cryopreservation requires the use of DMSO, which are less than ideal
because of potential toxic effects. Doctors who use cryogenically preserved cells for transfusions have ways of reducing the
toxic effects of DMSO, but these ways reduce the number of cells that survive the process, which jeopardizes the success of
the transfusions.

The U of A researchers have used computer modeling as a tool to guide biological experimentation to develop a novel method of
cryopreservation that eliminates the use of DMSO–and its toxicity–and thereby increases the retention of cells. The new
method has been demonstrated on blood stem cell cultures.

“This research definitely will have huge repercussions, not just in hematopoeic stem cell therapy, but in the whole field of
cell storage and transportation,” said Lisa Ross-Rodriguez, a U of A graduate student, who works under the joint supervision
of Dr. Dr. Locksley McGann, a biophysicist in the U of A Faculty of Medicine, and Dr. Janet Elliott, a thermodynamicist in
the U of A Faculty of Engineering.

“Often when you need cells for transplantations, you need them right away, and it is our hope that this technology will allow
much greater access to preserved healthy cells, and that should have an impact in helping to save people’s lives,”
Ross-Rodriguez said.

“Our new relationship with Lifebank is exciting because it is the final step in seeing our scientific research through from
idea to giving patients improved health or even life,” Elliott added.

The U of A researchers have presented the results of their work at international conferences. The U of A has patents pending
on this technology.

Lifebank is the only umbilical cord blood stem cell bank in Canada to be accredited by the American Association of Blood
Banks.

Contact: Ryan Smith
ryan.smithualberta
780-492-0436
University of Alberta
ualberta

HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, announced the conclusion of patient enrollment under its “ADVANCE” clinical trial.

HeartWare’s ADVANCE clinical trial is an FDA approved IDE study designed to evaluate the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The primary endpoint of the trial is survival at 180-days, defined as alive on the originally implanted device or transplanted or explanted for recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.

“We witnessed a growing enthusiasm from investigators during this study, and we are grateful for their continued support,” said HeartWare President and CEO Doug Godshall. “We also had an unexpected acceleration to the completion of the enrollment phase of the trial. During routine discussion with the FDA, we were asked to change the definition of ‘enrolled’ in our IDE protocol to include patients who were consented to enter the trial, as opposed to those who were consented and met all inclusion and none of the exclusion criteria. With two additional implants scheduled, this modification will result in 30 U.S. clinical sites implanting a total of 140 patients, making ADVANCE the largest bridge-to-transplant pivotal trial to date.”

The final implant in ADVANCE is scheduled to occur on February 25, 2010, which, if it goes forward as planned, would result in the final patient reaching the 180-day follow up by the end of August 2010. As a result, it is now anticipated that the submission to the FDA of the PMA will occur in early December rather than late December or early January as previously described.

With completion of the ADVANCE enrollment, HeartWare is seeking approval from the FDA to implant additional bridge-to-transplant patients under a Continued Access Protocol or “CAP” in any U.S. center that implanted a patient under the trial. While there is no guarantee that a CAP will be granted, the FDA has allowed CAPs following full enrollment in prior VAD trials, as it makes the technology available to patients and clinicians while also providing additional safety data for the FDA to evaluate.

Destination Therapy

To advance the clinical development of the HeartWare System, HeartWare has also submitted a protocol to the FDA for a Destination Therapy (“DT”) trial in the U.S. The Company is presently actively engaged in discussions with the FDA regarding finalization of the DT protocol. The DT trial is expected to commence in the second quarter of 2010.

About End-Stage Heart Failure

Heart failure is one of the leading causes of death in the developed world. According to the American Heart Association, congestive heart failure (CHF) afflicts approximately 5 million people in the U.S. with approximately 550,000 new cases diagnosed each year. Despite new treatment strategies for patients with end-stage heart failure, the number of patients who die with this disease is of epidemic proportion. Cardiac transplantation is currently the most effective therapy for the treatment of advanced end-stage heart failure, however, its application is limited due to the lack of available donor organs.

Over the last decade, bridging to cardiac transplantation with implantable left ventricular assist devices (LVADs) has gained wider clinical acceptance and LVADs are used to extend life expectancy for patients with end-stage heart failure who might otherwise deteriorate while awaiting a donor heart.

About HeartWare International

HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIb and Class IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD™ pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. HeartWare has received CE Marking for the HeartWare System in the European Union. The device is currently the subject of a United States clinical trial for a bridge-to-transplant indication.

HeartWare International, Inc. is a member of the Russell 2000(R) and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.

Forward-Looking Statements

This announcement contains forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the progress of clinical trials. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in the prospectus and the related prospectus supplement and any other document HeartWare files with the SEC including without limitation those described in “Item 8.01″ in HeartWare’s Form 8-K filed with the SEC on January 26, 2010.

Source: HeartWare International, Inc

Adults who begin lifting weights early in life may benefit from decreased age-related muscle loss and live independently longer, according to a report published this month by the American College of Sports Medicine.

The report, titled “Influence of Resistance Exercise on Lean Body Mass in Aging Adults: A Meta-Analysis,” was published in Medicine & Science in Sports & Exercise®, the official scientific journal of the American College of Sports Medicine. A research team with the University of Michigan compiled data from 49 studies to assemble this report. They found that older adults gain an average of 2.42 pounds of lean body mass, primarily muscle, after strength training for approximately 20 weeks.

This 2.42-pound increase counteracts the 0.4 pounds of muscle lost each year by sedentary adults over age 50. The findings suggest that aging individuals should consider beginning a strength training regimen as early as possible to maximize results and delay sarcopenia, an age-related muscle deterioration that can lead to mobility disability and loss of independence for seniors.

“The findings of this analysis are significant, given the millions of U.S. adults affected by sarcopenia,” said Mark Peterson, Ph.D., lead author of the study. “Because we have identified a robust link between resistance exercise and lean body mass, future generations of seniors who incorporate this modality may be less affected by age-related muscle loss and better able to preserve independence and quality of life.”

In addition to beginning a strength training program early in life, researchers also recommend adults consider the volume, or number of sets, of their program. The analysis suggests progression models, with gradual changes in volume and load, are appropriate to accommodate long-term growth in muscle mass.

“Our report is the first comprehensive meta-analysis to confirm a significant association between strength training volume and lean body mass increases in aging men and women,” said Dr. Peterson. “These findings suggest that, while effective for getting started, a single set of resistance exercises and/or fixed-volume programs may no longer be sufficient for individuals looking to achieve long-term changes in lean body mass.”

Researchers screened more than 5,000 references for this analysis, and 49 studies with 81 cohorts were selected for inclusion based on several criteria. The selected studies had an average participant age of at least 50 years, incorporated supervised, whole-body resistance training programs, and lasted at least eight weeks in duration.

ACSM and the Physical Activity Guidelines for Americans recommend that adults get at least 150 minutes of moderately intense physical activity each week. For more information on exercise for older adults, see the ACSM Position Stand on “Exercise and Physical Activity for Older Adults.”

Source: American College of Sports Medicine

The Cedars-Sinai Regenerative Medicine Institute has opened a new Induced Pluripotent Stem Cell (iPSC) Core Facility to produce powerful cells capable of making all tissues of the body from adult human skin cells.

One of the first to open in California, cells produced by the Cedars-Sinai core will be used in research funded by the National Institutes of Health and the California Institute for Regenerative Medicine. The cells will be critical for innovative research aimed at increasing our understanding of human diseases and genetic disorders, and the quest for new treatments.

“The opening of the Cedars-Sinai Stem Cell Core Facility underscores what an exciting time this is in regenerative medicine,” said Shlomo Melmed, MD, senior vice president of academic affairs and dean of the faculty at Cedars-Sinai. “It also is an example of Cedars-Sinai’s deep commitment to the scientific research that will be translated into tomorrow’s leading-edge treatments.”

The new facility will use the latest technology to generate induced pluripotent stem cells from a patient skin scraping. The induced pluripotent stem cells can be replicated indefinitely and have biological properties similar to embryonic stem cells. These “blank slate” cells can then be turned into any kind of differentiated cell, such as a brain cell or an eye cell or a liver cell.

lthough iPS cells were first produced only three years ago, they have quickly become valuable research tools. Clinicians can take skin cells from patients with specific life threatening diseases. Then, Regenerative Medicine Institute scientists can create iPS cells from them and then generate so-called “disease in a dish” models that enable them to more easily identify effective therapies.

“Now, for the first time, we can study human diseases by creating a laboratory specimen of afflicted cells,” said Clive Svendsen, PhD, director of the Cedars-Sinai Regenerative Medicine Institute. “We have been funded by both the National Institutes of Health and the California Institute of Regenerative Medicine to do this work which has the potential to revolutionize medicine.”

For example, the Stem Cell Core Facility already is supplying iPS cells to a five-member National Institutes of Health consortium of researchers for development of potential therapies to treat Huntington’s disease, an incurable neurodegenerative genetic disorder that affects muscle coordination and some cognitive functions, such as memory. With funding from the California Institute for Regenerative Medicine, the Cedars-Sinai core has also generated iPS cells from children with spinal muscular atrophy a lethal disease that leaves children paralyzed. These are being used to develop novel drug compounds to treat this devastating disorder, “We are very excited to launch this new core facility,” said Dhruv Sareen, PhD, the core’s new director. “It will enable exciting studies across the entire Cedars-Sinai Medical Center and we look forward to much productive collaboration.”

US researchers report that exposure to cigarette smoke inhibits innate gene expression and impairs alveolar growth in neonatal mice.

Sharon McGrath-Morrow from John Hopkin Medical Institute wrote in the American Journal of Respiratory Cell and Molecular Biology that their findings may in part explain the increased incidence of respiratory symptoms in infants and children exposed to cigarette smoke.

Infants exposed to cigarette smoke are at higher risk for sudden infant death syndrome, lower respiratory tract infections, and small airway disease, compared with infants not exposed to cigarette smoke, suggesting that perinatal life represents a period of vulnerability during which exposure to cigarette smoke may impair lung immunity and lung growth.

To investigate the effects of cigarette smoke exposure on the neonatal lung, the researchers exposed neonatal mice to cigarette smoke for the first 2 weeks of life.

Pulmonary gene-expression profiling revealed that cigarette exposure significantly inhibited type 1 and type 2 interferon pathway genes in neonatal lungs, compared with age-matched control lungs.

In addition, lung volumes at 8 weeks of age were modestly but significantly decreased in mice exposed to cigarette smoke in the neonatal period compared with age-matched controls.

The authors said, “We found that perinatal lungs are susceptible to the effects of cigarette smoke exposure. In neonatal mice, daily exposure to cigarette smoke for the first 2 weeks of life inhibited the expression of many genes in the lung that are relevant to the innate immune response.”

The team concludes: “Our murine model of cigarette smoke-induced neonatal lung injury may be useful in investigating pathways that are disrupted or altered in developing lungs exposed to cigarette smoke, and may help with understanding the overall detrimental effects of smoke exposure on developing lungs.”

ash

States that set high staffing standards for elder care in nursing homes are the only ones that come close to having enough staff nurses to prevent serious safety violations, according to a new study by a professor in the UCSF School of Nursing.

The majority of the nation’s elderly and disabled in nursing homes remain in situations where staffing is well below national recommendations for safe care, the study found. While no states have ideal nursing levels, those states with higher Medicaid reimbursements or higher mandated nursing levels have come closer to meeting the recommendations, according to the analysis published in the June issue of the journal “Health Services Research.”

The study’s initial objective was to examine the relationship between Medicaid reimbursement rates, which many states have reduced under their cost-containment efforts, and nurse staffing levels in US nursing homes, according to Charlene Harrington, PhD, RN, UCSF professor of sociology and nursing and lead author of the report.

She said previous studies have shown a direct correlation between staffing levels and higher Medicaid reimbursement for nursing homes, but this is the first to show that states with higher mandated staffing standards had substantially higher staffing as well.

“For years, families have struggled with low staffing levels in the nursing homes that care for their elderly family members, but very few studies have assessed how to change that on a broad level,” Harrington said. “This study shows that the simple step of raising the state minimum staffing ratio has a direct impact on the quality of care our seniors receive.”

Harrington based her analysis on staffing reports submitted by nursing homes to the federal government and data from multiple other sources. She examined the hours that nurses worked in nursing homes in 2002 and analyzed the data against two variables: Medicaid reimbursement rates and the range of acuity in patient care.

Medicaid pays for 67 percent of all nursing home residents in the United States, but only covers 51 percent of the $103 billion in total nursing home costs. Medicare covers 12.5 percent of those costs, private insurance pays 7 percent and consumers pay 29.5 percent.

In 2002, the average US nursing home had 15 percent fewer registered nurses per resident than nationally recommended, Harrington said. That recommendation originated in a 2001 study for the Centers for Medicare and Medicaid Services. A report by the Institute of Medicine two years later, titled “Keeping Patients Safe,” recommended that nursing homes be required to meet the levels from the 2001 study to maintain patient safety.

As expected, this study found that higher percentages of Medicaid residents correlated to lower total staffing levels, Harrington said. While it also showed that nursing homes, on average, do adjust their registered-nursing levels for the acuity of care needed, most do not increase total staffing for more acutely ill residents, which also could result in inadequate care.

Overall, nursing homes with more Medicaid residents, for-profit nursing homes, and those with a larger number of beds had fewer registered nurses and total nursing staff per patient. Nursing homes in counties with more elderly residents, more women in the workforce, and higher incomes had higher registered-nurse staffing levels.

This study found that nursing homes located in states that had increased their minimum standards for registered nursing hours had higher registered-nurse staffing levels. For example, a 10 percent increase in state minimum staffing standards would result in an increase of 1.66 hours per resident-day (or 16.6 hours for every 100 residents) in actual staffing, if all other factors remain equal, Harrington said.

“There are several possible solutions to this problem, including federal or state minimum nursing level requirements or increases in Medicaid payments,” Harrington said. “We now know that a policy change is an effective way to create an impact, and it might be an easier solution than trying to change Medicaid payments.”

An increase in Medicaid rates of $90 per day would be needed to increase the RN hours to the recommended levels, the study found, and a $50 per day increase would be needed to raise total nursing hours to the recommended levels.

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Co-authors on the study are James H. Swan, PhD, Department of Applied Gerontology, University of North Texas; and Helen Carrillo, MS, UCSF.

UCSF is a leading university that advances health worldwide by conducting advanced biomedical research, educating graduate students in the life sciences and health professions, and providing complex patient care.

Contact: Kristen Bole

University of California – San Francisco