суббота, 10 сентября 2011 г.

Critical Discovery Brings Toronto-based Researchers Closer To Creating Tailored T Cell Therapy For AIDS Patients

Researchers at Sunnybrook Health Sciences Centre have made a critical discovery in T cell development bringing immunologists one step closer to enabling the creation of tailored T cell therapy that could one day be used to treat patients with AIDS or other immune system deficiencies.



"For the first time we understand which sets of molecules are required to induce different types of T cells," says Canada Research Chair and principal investigator Dr. Juan Carlos Z--iga-Pfl-ckerr, a senior scientist at Sunnybrook Research Institute who is also a professor in the Department of Immunology at the University of Toronto.



The immune system uses two main types of T cells, alpha-beta and gamma-delta, each with unique roles in protecting us from disease. The findings show that T cell progenitors will develop into mature gamma-delta T cells despite the absence of the Notch molecule, a molecule that Z--iga-Pfl-cker's lab recently showed was essential for the early-stage development of both types of T cells.



Published today in the journal Immunity, the research is also the first to show at what developmental stage the two types of T cells become distinct lineages. The lead researcher, Maria Ciofani, a PhD student in Z--iga-Pfl-cker's lab, used precise cell isolation techniques to show which molecular cues are needed, and when for each lineage development. Collectively, the work clarifies how both T cell types can be generated in the laboratory, thereby enabling further study directed at tailoring their unique functions to specific clinical needs.



Gamma-delta T cells in particular hold exciting clinical promise for their ability to orchestrate immunity to a broad range of foreign molecules; experiments in mice have shown that gamma-delta T cell injections can eliminate cancerous tumours, although much work remains to translate this research into viable clinical therapy.



Z--iga-Pfl-cker was recently identified by the prestigious Thomson Scientific Essential Science Indicators as one of the most cited researchers in the field of immunology for his landmark December 2002 paper in Immunity, which showed how to generate T cells from stem cells in a Petri dish. In addition to enabling Z--iga-Pfl-cker's current work, this breakthrough discovery established a simple and effective way for other researchers to study T cell development, and has advanced this study in hundreds of labs around the world.







Sunnybrook Health Sciences Centre is transforming health care through the dedication of its more than 10,000 staff members who provide compassionate and innovative patient focused care. An internationally recognized leader in women's health, academic research and education and an affiliation with the University of Toronto distinguishes Sunnybrook as one of Canada's premier health sciences centres. Sunnybrook specializes in caring for newborns, adults and the elderly, treating and preventing cancer, heart problems, orthopaedic and arthritic conditions and traumatic injuries. Toronto Sunnybrook Regional Cancer Centre is the comprehensive cancer program at Sunnybrook, a Cancer Care Ontario partner and fully affiliated with the University of Toronto.



Contact:Jennifer White


Sunnybrook Health Sciences Centre


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Caps On Medical Malpractice Damages Cut Doctors' Insurance Costs

Caps on medical malpractice damages mean lower insurance premiums for doctors, according to a new review from two Alabama universities. How these caps affect patient care or costs is less certain.


"There's been substantial controversy over whether caps do what they're supposed to reduce malpractice insurance premiums," said lead author Leonard J. Nelson III, of the Cumberland School of Law at Samford University in Birmingham. "The rates of increase in malpractice insurance premiums are lower in states that have caps."


In their analysis of 10 studies conducted since 1990, Nelson and co-authors from the Lister Hill Center for Health Policy at the University of Alabama found no evidence that caps affect consumers' health insurance costs.


However, they did say there is evidence of "small-to-modest effects" of damages caps on so-called defensive medicine and some evidence that more physicians will practice in areas where there are caps. Doctors practice defensive medicine when they avoid high-risk patients or procedures to reduce their exposure to malpractice suits.


The study appears in the latest issue of The Milbank Quarterly.


In one study that examined 12 years of data, researchers found that damages caps reduced premiums for general practitioners, general surgeons and OB/GYNs by 13.4 percent, 14.3 percent and 16.9 percent, respectively, in the short term and by 40 percent to 58 percent longer term.


Lower malpractice insurance premiums for physicians indirectly help patients, said David Studdert, adjunct professor at the Harvard School of Public Health.


"If doctors' fear of litigation, stimulated in part by pricey premiums, prompts them to deliver treatments and order tests designed to cover them not improve the patient's care then the patient may suffer," Studdert said. "Lower premiums may, and probably do, reduce the incidence of such defensiveness."


Nelson said that caps might have "some good effects," but that "they can be unfair because people who are severely injured don't get adequately compensated." One effect of caps, he said, is that they discourage lawsuits.


More than half of the states have damages caps. Thirteen states and the District of Columbia never passed laws instituting caps and they were ruled unconstitutional in nine others states.


Nelson LJ, III, Morrisey MA, Kilgore ML. Damages caps in medical malpractice cases. The Milbank Quarterly 85(2), 2007.


Health Behavior News Service

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Association of American Medical Colleges Supports Hospital Agreement On Health Care Reform

AAMC (Association of American Medical Colleges) President and CEO Darrell G. Kirch, M.D., issued the following statement on the agreement reached by the hospital community, the Obama administration, and the Senate Finance Committee in support of health care reform:


"The AAMC strongly supports the agreement announced today and believes it moves our nation closer to achieving meaningful health care reform. U.S. teaching hospitals provide 71 percent of all hospital-based charity care and are often the only source of specialized services in their communities. We greatly appreciate the thoughtful approach this agreement takes to guarantee that the safety net remains intact during the transition to a better system.


This accord helps to fulfill two key principles that the AAMC established for health care reform last year, namely that all Americans should have health care coverage, and that existing safety net mechanisms be supported and preserved until new ones are in place. By voluntarily accepting reduced market increases in hospital payments over the next decade, hospitals will contribute $100 billion toward the funding needed to provide all Americans with health insurance. We also are pleased that this agreement takes appropriate steps to ensure that new coverage mechanisms are in place before any reductions are made to Disproportionate Share payments. Congress and the administration will need to continually evaluate the effects of coverage expansion before making any cuts that could jeopardize the safety net for the uninsured and underinsured.


The nation's teaching hospitals are working hard to help expand access to health care while maintaining an environment where clinical care, discovery, and the training of the next generation of health professionals can occur-and will continue to make sacrifices as long as patient care comes first. As the Obama administration and Congress move forward with health care legislation, the AAMC and its members stand ready to make the positive changes needed for successful reform."


Source

Association of American Medical Colleges

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Bypass Procedure Used During Infant Heart Surgery Does Not Impair Later Neurological Outcomes

Congenital heart defects (CHD) are the most common birth defects in humans, affecting 8 per 1000 live births with one-third of affected children requiring intervention in early infancy. Increasing numbers of survivors combined with developmental expectations for independence, behavioral self-regulation and academic achievement have led to a growing identification of neurobehavioral symptoms in some survivors. A study now suggests that a cooling technique often used in heart operations does not impair neurological outcomes.


Congenital heart disease and its treatment were originally thought to potentially increase neurologic injury in these patients. The technique of deep hypothermic circulatory arrest (DHCA) is used in order to repair these congenital cardiac defects by providing a bloodless surgical field, which may facilitate completion of the best physiologic repair, and decrease the duration of blood exposure to the bypass circuit. However, it involves a period of reduced blood flow in the brain. Cooling is a protective mechanism to reduce metabolism of the brain and other organs during periods of low blood flow.


Stephanie Fuller, M.D., a cardiothoracic surgeon at The Children's Hospital of Philadelphia, presented these research findings yesterday in the prestigious J. Maxwell Chamberlain Lecture at the annual meeting of the Society of Thoracic Surgeons in Fort Lauderdale, Fla. According to the study, DHCA does not impair language skills, attention, and other neurocognitive abilities in school-age children.


Dr. Fuller and colleagues from Children's Hospital and the University of Washington assessed the use of DHCA as a predictor of neurodevelopmental outcomes in children who had cardiac surgery as infants. The infants were enrolled in a prospective study of apolipoprotein-E (APOE) polymorphisms and neurodevelopmental outcome after cardiac surgery and underwent formal neurodevelopmental testing at four years of age.


Neurodevelopmental testing was completed in 238 out of 307 eligible patients. The surgeons used DHCA in 92 of those infants as deemed necessary to provide better operative exposure with a bloodless and less cluttered surgical field and therefore a shorter total cardiopulmonary support time. Use of DHCA was not predictive of worse performance for any neurodevelopmental outcome. Significant predictors of worse outcome included lower socioeconomic status, preoperative mechanical ventilation and babies that were younger and smaller at the time of first operation. Neurodevelopmental assessment included cognition, language skills, attention, impulsivity, executive function, social competence, and visual-motor and fine-motor skills.


"Selective use of DHCA during cardiac surgery in infancy may facilitate operative repair and is not associated with impaired neurodevelopmental outcomes," said Dr. Fuller. "Despite added risk factors, the selective use of DHCA during infancy for repair of congenital heart disease without an obstruction in the aorta was not predictive of worse performance at four years of age."


Dr. Fuller added "use of DHCA as a support technique during cardiac surgery in infancy has many advantages; it is not necessary to sacrifice these advantages merely to avoid use of DHCA. Our study adds to the growing literature showing no adverse influence of limited periods of DHCA. New support techniques must be carefully evaluated prior to wide-spread acceptance to confirm they are not inferior to conventional management strategies."



Source

The Children's Hospital of Philadelphia

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Average Annual Deductible For Individual Employer-Sponsored PPO Now Over $1,000, According To Survey

The increasing cost of health care in the U.S. has prompted more U.S. employers to shift a larger portion of the expenses to their workers, pushing the average annual PPO deductible in 2008 for a single worker to more than $1,000, according to a study released on Wednesday by Mercer , the Los Angeles Times reports (Girion, Los Angeles Times, 11/20). The study was based on an annual survey of about 2,900 businesses nationwide that had at least 10 employees (Boulton, Milwaukee Journal Sentinel, 11/19).

The study found that the mean deductible for a traditional health plan increased from $859 last year to $1,001 this year, an increase of about 17%, because a large number of employers, especially those with fewer than 500 workers, raised their deductibles (Rubenstein, Wall Street Journal, 11/20). The study found that nearly half of all employers nationwide in 2000 offered health plans that did not require workers to pay a deductible, but in 2008, four in five businesses required a deductible, in addition to an average monthly premium of $124 for individuals under PPO plans (Raabe, Denver Post, 11/20). According to the Journal, from 2000 to 2007 the median deductible had stayed consistent at $500. Deductibles typically are raised in increments of $500, $1,000 or $1,500 (Wall Street Journal, 11/20).

The Denver Post reports that businesses have been able to maintain their annual cost increases at about 6% over the last four years by charging employees higher monthly premiums and deductibles. Health benefit costs for U.S. employees averaged $8,482 per employee, an increase of 6.3% on average, according to the Post (Denver Post, 11/20). Blaine Bos, the chief analyst for the survey, said, "Raising the deductible has become the fallback for employers faced with cost increases they can't handle," adding, "It's the easiest way to reduce cost without taking more out of every employee's paycheck" (Yee, Minneapolis Star Tribune, 11/19).

Laura Baker, a consultant for Mercer, said that companies are expecting further increases in 2009. "Historically, downturns in the economy have often correlated with higher medical trends," Baker said (Los Angeles Times, 11/20). However, Chris Watts, head of Mercer's health and benefits consulting office in Denver, said, "But these are different times, and history may not repeat itself," adding, "Higher employee cost-sharing -- like a $1,000 deductible -- could prevent that spike in utilization that we've seen in other recessions" (Denver Post, 11/20).

Small Businesses Experience Biggest Deductible Increases
A separate employer survey by the Kaiser Family Foundation and the Health Research and Education Trust found that businesses with three to 199 workers had experienced the largest increase in deductibles, with at least one in three workers paying a minimum of $1,000 for single PPO coverage (Los Angeles Times, 11/20). The study also projected potential increases in employee deductibles, copayments and other fees in 2009, the Raleigh News & Observer reports (Wolf, Raleigh News & Observer, 11/20).

Survey co-author Gary Claxton, a Kaiser Family Foundation vice president and director of the Foundation's Health Care Marketplace Project -- said deductibles likely would continue to increase over the next couple of years. "When unemployment goes up, workers just have less ability to push for good benefits," he said (Wall Street Journal, 11/20). He said that a deductible "discourages people from using services," adding, "The more cost-sharing there is, the more it's going to be discouraged. And when they are already worried economically, that's got to amplify the effect" (Los Angeles Times, 11/20).


The Mercer study is available online.


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


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Video Camera That Records At The Speed Of Thought

European researchers who created an ultra-fast, extremely high-resolution video camera have enabled dozens of medical applications, including one scenario that can record 'thought' processes travelling along neurons. This is ingenious science.


The Megaframe project scored a staggering number of breakthroughs to create the world's first 1024 pixel, photon-resolution, million-frame-per-second CMOS camera that puts Europe firmly in the lead for ultra-high speed video cameras.


Their work has pushed the boundaries of CMOS (a type of semiconductor) miniaturisation and sophistication. But it is in the application of their technology that the most stunning impacts of the Megaframe project will be seen, particularly in medical applications.


That is because the camera can detect a single photon at a million times a second, and so it can record molecular processes in unprecedented detail. "We need this sort of detail because biomedical scientists are studying processes at the intra-cellular and molecular levels," underlines Edoardo Charbon, coordinator of the EU-funded Megaframe project.


Ingenious


Scientists have developed extremely ingenious ways to infer or deduce what is happening at the molecular level, and Megaframe could make that process even more detailed. Essentially, scientists use a variety of emissive materials to see what is happening in microscopic biomedical processes.


Take Fluorescence Lifetime Imaging Microscopy (FLIM). Here, a fluorescent material is introduced to the area of interest. Fluorescence has some interesting properties, for example a particular spectrum of emission and a rate of decay.


One particular fluorophore, Oregon Green Bapta (OGB-1), decays at a rate proportionate to the presence of calcium. Interestingly, calcium is an important indicator of neuron activity.


"So it is possible, for example, to go inside neurons and look at their ion channels. These are the channels that allow neurons to communicate with other neurons. And you can basically see the amount of calcium that is present. You can probe optically how neurons communicate with other neurons just by looking at the concentrations of calcium in real time," explains Charbon.


So scientists can use the OGB-1 to indicate the presence and concentration of calcium, and the whole process can be recorded in ultra-fine detail thanks to single-photon detectors, such as the ones present in the Megaframe camera. The camera is recording at the speed of thought.


"Biomedical scientists could in principle use this microscopic information about calcium to learn about macroscopic conditions like Parkinson's, or Alzheimer's or epilepsy," Charbon stresses.


But that's just the beginning. Megaframe could have a significant impact on any medical science that uses visible light emissive scanning technologies like FLIM. But it can even have an impact where visible light is not present.


Other apps


Other applications currently under exploration by Megaframe include intracellular DNA sequencing and proteomics, two huge areas for drug discovery, as well as basic scientific research for gene sequencing and protein-folding.


"For example, the camera could be used to detect and display the impact of certain drugs, or certain combinations of drugs, in animal or human models," Charbon says, adding that they are currently looking at oligonucleotides, which are "very short sequences of DNA mounted directly onto the detectors for labelled and label-free monitoring of the hybridisation process."


Other areas where Megaframe's work could boost research results include cell membrane scanning, to discover what bacteria or other material are present, and this research could be extended to look at issues like water purity, and waterborne bacteria.


Exploring further potential


Another very promising technique is the combination of fluorescence imaging with MRI, or magnetic resonance imaging. "In MRI you need very strong magnetic fields in the cavity where you are performing the imaging, up to 10 Tesla, but conventional fluorescence technology won't work in these conditions," says Charbon.


But Megaframe's choice of photo detector the Single-Photon Avalanche Diode (SPAD) have been tested successfully in fields up to 9.4 Tesla, he reveals.


"Thus, it can be envisaged to have a system where fluorescence-enhanced imaging and functional MRI may be used simultaneously," Charbon enthuses. "This is very useful in a number of biomedical applications, where one wants to monitor the correlation between the presence of certain molecules in organs, such as the brain, and their function."



Again, pharmacology could benefit from this technique enormously, as well as epidemiological research.


"Our preliminary tests were conducted in an animal MRI, which in general has much higher fields than a human MRI. Human MRI tests will follow," reveals Charbon, adding that the technique has been tested with other SPAD-based microsensors and has yielded good results.


"Even though we have not tested it with the Megaframe chip, it is a guaranteed success because the technology is in principle the same," Charbon predicts.


The Megaframe project has just begun to explore the potential for their camera in biomedical applications, and the list just keeps on growing as their research continues. And that is just in the biomedical field. There are dozens of potential applications in fields as diverse as high-energy physics, entertainment and automotive diagnostics.


The Megaframe project received funding from the FET-Open scheme of the EU's Sixth Framework Programme for research.


This is the second of a three-part special feature on the Megaframe project appearing on ICT Results.


Source: ICT Results

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Putting A Bull's-Eye On The Flu: Science Paper Details Influenza's Structure For Future Drug Targeting

Beating the flu has always been tough, but it has gotten even more difficult in recent years. Two of the four antiviral drugs used to treat a nasty case of the influenza A virus no longer work.



Fortunately, scientists at the National High Magnetic Field Laboratory and Institute of Molecular Biophysics at Florida State University and researchers at Brigham Young University in Utah are close to understanding why these drugs have become less effective - and how new drugs might take their place. Their findings appear this week in the journal Science.



"Resistance to drugs is a fundamental problem that develops from their misuse, overuse and underuse," said Timothy A. Cross, the Earl Frieden Professor of Chemistry and Biochemistry at Florida State and director of the Magnet Lab's Nuclear Magnetic Resonance Program, as well as one of the Science article's senior authors. Compounding the problem is that "the development of new drugs to take their place is a decade-long process with infrequent success."



The two drugs no longer recommended by the U.S. Centers for Disease Control - amantadine (brand names Symadine and Symmetrel) and rimantadine (Flumadine) - have been used to fight the flu since 1969. For decades, they worked by preventing an essential protein function during viral infection of healthy cells. The protein, called the M2 channel, plays a key role in the virus' ability to reproduce. But the M2 channel mutated just enough to allow the virus to resist both drugs.



"Our work provides a blueprint on how protons are moved through a passageway inside the M2 channel," said Huan-Xiang Zhou, an FSU physics professor and the other senior co-author of the Science article. Interfering with that passageway is "an obvious route for drug development."



To study the M2 channel, researchers enlisted the help of one of the magnet lab's crown jewels: the 900-megahertz, nuclear magnetic resonance magnet. The 40-ton magnet was used to map the protein's structure by giving it the equivalent of an MRI scan. The detailed images allowed the research groups of Cross and Zhou to chart the tiniest, previously unknown aspects of the protein's atomic structure.



"Now that we have a much more refined view of M2 - going all the way down to the atomic level, the level that includes protons going through the channel - we can draw conclusions about how to block it," said David Busath, a biophysicist at Brigham Young University and a co-author of the Science paper.



Busath and his team have already begun screening millions of compounds, looking for drugs that will bind to the channel and block its reproductive role.



And FSU "has been awarded two patents for drug screening," Cross said. "We'll continue to use the 900-megahertz magnet for these drug-screening activities."



As to why the longtime flu drugs have become ineffective, the massive misuse of amantadine in poultry may have played a role, Cross said.



In the West, amantadine can only be given to humans. But starting in 2005, the Chinese began feeding it to chickens and other poultry to prevent them from getting avian flu. In all, China administered 2.6 billion doses of amantadine to its domestic birds.



"It's terrible to utilize these miracle drugs that can save thousands, if not millions, of lives and dramatically reduce hospitalizations in that fashion," Cross said.



The flu project headed up by Cross, Zhou and Busath is paid for by a 10-year, multimillion-dollar grant from the National Institutes of Health. Additional contributors to the Science article are lead author Mukesh Sharma, Myunggi Yi, Hao Dong and Huajun Qin, all of FSU, and Emily Peterson of BYU.



The National High Magnetic Field Laboratory develops and operates state-of-the-art, high-magnetic-field facilities that faculty and visiting scientists and engineers use for research. The laboratory is sponsored by the National Science Foundation and the state of Florida. To learn more, visit here.

Source:

Florida State University

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"Culture Of Medicine," Not Fear Of Malpractice, Prompts Physicians To Withhold Information About Medical Errors From Patients, Study Says

Physicians often fail to inform patients about medical errors because of the "culture of medicine," rather than because of concerns about malpractice lawsuits, according to a study published on Monday in the Archives of Internal Medicine, the Seattle Times reports. For the study, researchers from the University of Washington surveyed 1,404 surgeons and general practitioners in Canada, which limits medical liability and discourages malpractice lawsuits, and 1,233 surgeons and general practitioners in Washington and Missouri, two states considered to have high malpractice insurance costs. Researchers asked survey participants to respond to specific scenarios in which they had committed medical errors. According to the study, Canadian and U.S. respondents were significantly less likely to inform patients about serious medical errors when patients were unlikely to find the mistakes on their own, and their decisions on whether to inform patients about errors were not affected by concerns about malpractice lawsuits. More than half of respondents said that they would inform patients about adverse events but would not inform them that the problems resulted from medical errors, and only one-third said that they would apologize, the study finds. Study authors Eric Larson, a former medical director at the UW Medical Center and current head of Group Health's Center for Health Studies, and Thomas Gallagher, a UW internal medicine physician, said that physicians learn a "culture of perfectionism" in medical school that discourages the disclosure of medical errors. Larson said, "This code of silence, this conspiracy of silence does not work for reducing errors," adding, "What we know now is it does nobody any good to bury a mistake or cover up a mistake; you can't correct what led to the mistake unless you deal with it explicitly" (Ostrom, Seattle Times, 8/17).

An abstract of the study is available online.


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


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Novartis Plans 30% Increase In US Supplies Of Fluvirin Influenza Vaccines And Delivery Of 40 Million Doses For 2007/2008 Season

Novartis Vaccines, the second largest supplier of influenza vaccines in the US, plans to produce approximately 40 million doses of its Fluvirin vaccine for distribution in the US during the upcoming 2007/08 influenza season - a 30% increase in supply from Novartis compared to the previous influenza season.



Based on accelerated production plans, approximately half of these doses are planned for delivery by the end of September, with all doses expected to be delivered by the end of October. The exact timing of deliveries will depend on the release of doses by the US Food and Drug Administration. As in the past, Novartis will ensure a continuous supply of vaccines for the upcoming influenza season.



"Providing a reliable and timely supply of flu vaccines is a top priority for Novartis in supporting US public health goals of increasing vaccination rates among the growing number of people at risk and recommended for vaccination," said Rajiv De Silva, President of Novartis Vaccines in the US.



"The early availability of Novartis influenza vaccines will enable healthcare providers to open additional clinics early in the season, a period when vaccination is most often requested," De Silva said.



Fluvirin contains the recommended virus strains


Influenza vaccines are updated each year to address changes in the viruses. Traditional "flu shots" are made from viruses that have been inactivated (killed), while nasally delivered vaccines are made with live attenuated influenza viruses.



Fluvirin contains the three influenza virus strains identified in the annual public health expert assessment for the 2007-2008 season in the US, which are the following:


-- A/Solomon Islands/3/2006 (H1N1)-like virus


-- A/Wisconsin/67/2005 (H3N2)-like virus


-- B/Malaysia/2506/2004-like virus



Novartis was the first to provide injectable influenza vaccines to the US for the previous year, having fulfilled and surpassed its overall supply commitment for the 2006-2007 season.



An early and reliable availability of vaccine supplies is important to support public health officials and generate confidence that vaccines will be available to protect more of the population.



Vaccines help prevent influenza-related deaths and hospitalizations


In an average year in the US, influenza causes more than 200,000 hospitalizations and kills approximately 36,000 people, primarily in people over age 65. Among elderly nursing home residents, the flu shot can help prevent cases and deaths from the flu. When combined with pneumonia, these diseases are the seventh leading cause of death in the US, killing more people than any other infectious diseases.
















The annual direct medical costs of influenza are estimated at USD 3 billion to USD 5 billion. Total direct and indirect costs, including lost work days, of a severe flu epidemic could be as high as USD 12 billion to USD 14 billion.



Influenza vaccination is the most effective way to prevent influenza, which is a contagious disease caused by a virus that affects the respiratory tract. The results are often a cough, sore throat, runny or stuffy nose as well as fever, headache, extreme tiredness and muscle aches. An infection can also lead to complications such as bacterial pneumonia, dehydration and worsening of chronic medical conditions, including congestive heart failure, asthma or diabetes. Children may get sinus problems and ear infections.



Influenza vaccination not only helps to decrease the risk of influenza and its complications for the vaccine recipient but can also reduce the risk of the virus spreading to those who come in contact with vaccinated people.



Although the flu season can begin earlier, it usually starts in December, peaks in January or February, and continues through March. According to the US Centers for Disease Control and Prevention (CDC), the primary months for vaccinations are October and November, but earlier vaccinations are recommended as well as vaccinations in December or later for those not vaccinated earlier.


Safety information


The most common side effect of vaccination with Fluvirin vaccine is soreness at the injection site. Less common side effects include fever, malaise, myalgia and allergic reactions. Fluvirin vaccine should not be administered to anyone with a history of hypersensitivity to any component of the vaccine, including eggs, egg products or thimerosal. As is the case with most drugs and vaccines, there is a chance that a serious allergic reaction, serious illness or even death could occur as a result of vaccination with Fluvirin vaccine. Generally, persons should not be vaccinated during an acute febrile illness. Vaccination should be delayed in persons with an active, unstable neurological disorder, but should be considered when the disorder has been stabilized. The occurrence of any neurological symptoms or signs following administration of any vaccine is a contraindication to further use. Fluvirin vaccine is not indicated for use in children under four years of age. Persons should consult with their healthcare providers if they are pregnant and/or are taking other medications. Fluvirin vaccine may not protect 100% of individuals who are susceptible to influenza. Before administering Fluvirin vaccine, please see full prescribing information.



Disclaimer


This release contains certain forward-looking statements, relating to the Novartis Group's business, which can be identified by the use of forward-looking terminology such as "plans," "would," "will," "expected," "will," "can," "may," "recommended," "should," "could" or similar expressions, or by express or implied discussions regarding future sales of, and business operations relating, but not limited, to the manufacture, distribution, commercialization and sale of, Fluvirin. Such forward-looking statements reflect current views of Novartis regarding future events and involve certain known and unknown risks, uncertainties and other factors that may cause actual results with Fluvirin to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that sales or supply of Fluvirin will reach any particular level of sales. In particular, management's expectations regarding Fluvirin could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including additional analysis of existing clinical data and new clinical data; competition in general; the ability of Novartis to obtain or maintain patent or other proprietary intellectual property protection; increased government, industry, and general public pricing pressures; and other risks and factors referred to in the Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.



About Novartis


Novartis Vaccines and Diagnostics is a division of Novartis focused on the development of preventive treatments. The division has two businesses: Novartis Vaccines and Chiron. Novartis Vaccines is the world's fifth-largest vaccines manufacturer and second-largest supplier of flu vaccines in the US. The division's products also include meningococcal, pediatric and travel vaccines. Chiron, the blood testing and molecular diagnostics business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools that protect the world's blood supply.



Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world.


Novartis

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Nanoemulsion Vaccines Show Increasing Promise

A novel technique for vaccinating against a variety of infectious diseases using an oil-based emulsion placed in the nose, rather than needles has proved able to produce a strong immune response against smallpox and HIV in two new studies.


The results build on previous success in animal studies with a nasal nanoemulsion vaccine for influenza, reported by University of Michigan researchers in 2003.


Nanoemulsion vaccines developed at the Michigan Nanotechnology Institute for Medicine and the Biological Sciences at U-M are based on a mixture of soybean oil, alcohol, water and detergents emulsified into ultra-small particles smaller than 400 nanometers wide, or 1/200th the width of a human hair. These are combined with part or all of the disease-causing microbe to trigger the body's immune response.


A team led by U-M scientist James Baker Jr., M.D., the institute's director, pioneered the technology, for which a patent was recently awarded to U-M.


"The two studies show the nanoemulsion platform is capable of developing vaccines from very diverse materials. We used whole virus in the smallpox vaccine. In the HIV vaccine, we used a single protein. We were able to promote an immune response using either source," says Baker.


The technology is licensed to NanoBio Corp., an Ann Arbor-based biotech company which Baker founded in 2000 and in which he has a financial interest. Baker is the Ruth Dow Doan Professor of internal medicine and Allergy Division chief at the U-M Medical School.


The surface tension of the nanoparticles disrupts membranes and destroys microbes but does not harm most human cells due to their location within body tissues. Nanoemulsion vaccines are highly effective at penetrating the mucous membranes in the nose and initiating strong and protective types of immune response, Baker says. U-M researchers are also exploring nasal nanoemulsion vaccines to protect against bioterrorism agents and hepatitis B.


Potential for a better smallpox vaccine


The smallpox results, which appear in the February issue of Clinical Vaccine Immunology, could lead to an effective human vaccine against smallpox that is safer than the present live vaccinia virus vaccine because it would use nanoemulsion killed vaccinia virus, says Baker.


Anna U. Bielinska, Ph.D., a research assistant professor in internal medicine at the U-M Medical School, and others on Baker's research team developed a killed-vaccinia virus nanoemulsion vaccine which they placed in the noses of mice to trigger an immune response. They found the vaccine produced both mucosal and antibody immunity, as well as Th1 cellular immunity, an important measure of protective immunity.















When the mice were exposed to live vaccinia virus to test the vaccine's protective effect, all of them survived, while none of the unvaccinated control mice did. The researchers conclude that the nanoemulsion vaccinia vaccine offers protection equal to that of the existing vaccine, without the risk of using a live virus or the need for an inflammatory adjuvant such as alum hydroxide.


"We found that the nanoemulsion vaccine could inactivate and kill the virus and then subsequently induce immunity to the virus that includes cellular immunity, antibody immunity and mucosal immunity," Baker says.


In antibody immunity, antibodies bind invading microbes as they circulate through the body. In cellular immunity, the immune system attacks invaders inside infected cells. There is growing interest in vaccines that induce mucosal immunity, in which the immune system stops and kills the invader in mucous membranes before it enters body systems.


A National Institutes of Health program, the Great Lakes Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases, funded the research. If the federal government conducts further studies and finds the nanoemulsion smallpox vaccine effective in people, it could be a safer way to protect citizens and health care workers in the event of a bioterrorism attack involving smallpox, Baker says.


That would allay concerns about the current vaccine's safety which arose in 2002. On the eve of the Iraq War, the Bush administration proposed a voluntary program to vaccinate military personnel and 500,000 health care workers with the existing vaccine to prepare for the possible use of smallpox virus as a biological weapon.


Relatively few health care workers volunteered to get the vaccine, amid concerns that the live vaccinia virus used in the vaccine can be transmitted to other people for a time and can pose a serious risk to people with weakened immune systems and certain skin conditions. As of mid-2007, more than 1.2 million military personnel received smallpox shots. Small percentages of those vaccinated subsequently have had heart and neurological adverse effects.


Early HIV study tests mucosal immunity


Baker's team has published results from a preliminary test of a nanoemulsion vaccine's effectiveness against HIV in the February issue of AIDS Research Human Retroviruses.


It is becoming widely acknowledged that standard approaches to vaccines against HIV have not worked. Baker says the HIV nanoemulsion vaccine tested in the noses of mice in the study represents "a different approach in the way it produces immunity and the type of immunity produced."


Vaccines administered in the nose are also able to induce mucosal immunity in the genital mucosa. Evidence is growing that HIV virus can infect the mucosal immune system.


"Therefore, developing mucosal immunity may be very important for protection against HIV," Baker says, adding that previous vaccine approaches have not aimed to do that.


In the study, the nanoemulsion HIV vaccine showed it was able to induce mucosal immunity, cellular immunity and neutralizing antibody to various isolates of HIV virus. A protein used by the team, gp120, is one of the major binding proteins under study in other HIV vaccine approaches.


"This was an exploratory study to see if further research is warranted," Baker says. His team plans further research to test the concept in animal models, potentially with whole viral vaccines or ones with multiple protein components.


For more on the Michigan Nanotechnology Institute for Medicine and the Biological Sciences, visit
med.umich.edu


The smallpox study appears in Clinical Vaccine Immunology, Vol. 15(2), Feb. 2008.


The study was funded by the National Institute of Allergy and Infectious Diseases, through the Great Lakes Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases.
In addition to Bielinska and Baker, other University of Michigan authors include Alexander A. Chepurnov, Jeffrey J. Landers, Katarzyna W. Janczak, Tatiana S. Chepurnova and Gary D. Luker.


The HIV study results appear in AIDS Research Human Retroviruses, Vol. 24, Feb. 2008.


The study was funded by the Michigan Nanotechnology Institute for Medicine and the Biological Sciences, the Ruth Dow Doan Endowment and the Burroughs Welcome Fund.


In addition to Baker, authors include Anna U. Bielinska, Katarzyna W. Janczak, Jeffrey J. Landers and David M. Markovitz of the U-M Medical School and David C. Montefiori of the Duke University Medical Center.


A patent has been granted and assigned to U-M for the nanoemulsion vaccine technique, which has been exclusively licensed to NanoBio Corp., an Ann Arbor based biotech company in which Baker has a financial interest.


University of Michigan Health System

2901 Hubbard St., Ste. 2400

Ann Arbor, MI 48109-2435

United States

med.umich.edu


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First Patient Enrolled In CYPRESS, A Dual Antiplatelet Therapy Trial With The CYPHER(R) Sirolimus-Eluting Coronary Stent

Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced today that the first patient has been enrolled in the CYPRESS study, which will assess clinical outcomes in a broad range of patients with coronary artery disease who take dual anti-platelet therapy after receiving a CYPHER® Sirolimus-eluting Coronary Stent. The procedure was performed by Patrick Flaherty, D.O., Arkansas Heart Hospital in Little Rock, AK.


CYPRESS will provide data to support the clinical evaluation of the company's new NEVO™ Sirolimus-eluting Coronary Stent in the NEVO III trial, a non-randomized, single-arm trial evaluating the clinical outcomes of NEVO™ in approximately 1,200 patients in the United States and Canada. NEVO™ is the first drug-eluting stent utilizing RES TECHNOLOGY™, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. Products using RES TECHNOLOGY™ are under development and are not approved or available for sale in any market.


"While the original clinical trials of the CYPHER® Stent have demonstrated sustained efficacy and similar safety to bare-metal stents through five years of follow-up, many technical improvements in percutaneous coronary interventions and concomitant therapy may lead to even better outcomes with the world's most studied drug-eluting stent," said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation.


Dr. Rogers continued, "CYPRESS will be used to support our pre-market approval application in the U.S. for NEVO™, which we believe has the potential to return Cordis to global leadership in the drug-eluting stent market."


CYPRESS will enroll an estimated 2,000 patients at approximately 200 centers throughout the U.S. The patients in this study will represent a variety of coronary artery disease cases including those considered 'complex' due to multi-vessel disease.


In addition, clinical data from CYPRESS (CYPherR for Evaluating Sustained Safety) will contribute to the approximately 20,000-patient independent Dual Antiplatelet Therapy (DAPT) Study, a unique collaboration amongst the U.S. Food and Drug Administration, drug and device manufacturers and Harvard Clinical Research Institute. The DAPT Study concept was developed by a group of stent manufacturers and manufacturers of antiplatelet medications who came together to address a FDA request for this post-market study. The Harvard Clinical Research Institute is responsible for the scientific conduct and independent analysis of the overall study.


The CYPRESS trial is divided into two phases. In Phase I, patients will receive the CYPHER® Stent and receive 12-months of dual antiplatelet therapy with a thienopyridine - clopidogrel or prasugrel - and aspirin. The primary endpoint of this portion of the trial is target lesion failure at 12-months.


In Phase II, patients treated with 12-months of dual antiplatelet therapy from Phase I, who remain free from death, heart attack, stroke, the need for another procedure (revascularization), stent thrombosis and major bleeding are then eligible for randomization to either placebo or an additional 18-months of thienopyridine therapy. All patients in Phase II will continue aspirin therapy. The primary endpoints of Phase II are rates of Major Adverse Coronary and Cerebrovascular Events, also known as MACCE, stent thrombosis and bleeding.


"There continues to be debate among clinicians as to the optimal duration of dual antiplatelet therapy and the results from CYPRESS will add important information to our understanding of the role of dual antiplatelet therapy in patients who receive a CYPHER® Stent," said Daniel I. Simon, M.D., Principal Investigator of both CYPRESS and NEVO III. Dr. Simon is Director, Harrington-McLaughlin Heart & Vascular Institute at University Hospitals Case Medical Center in Cleveland, Ohio. Co-Principal Investigator of both trials is David Kandzari, M.D., Scripps Clinic, San Diego, CA. Drs. Simon and Kandzari are compensated for their time as Principal Investigators.


The DAPT Study is an independent, large-scale study in size and scope intended to compare two durations (12 months and 30 months) of dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication to reduce the risk of blood clots) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of coronary stents.


The course of anti-platelet therapy for the CYPHER® Stent used in the pivotal clinical study supporting its approval was three months. In late 2006, however, the company announced its support of the recommendations of the percutaneous coronary revascularization guidelines from the American Heart Association, the American College of Cardiology and The Society for Cardiovascular Angiography and Interventions which recommend up to 12 months of aspirin and clopidogrel for patients who are considered to be at low risk for bleeding complications.


About the CYPHER® Stent


The CYPHER® Stent has been chosen by cardiologists worldwide to treat more than three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 200 randomized and nonrandomized studies that examine the performance of the CYPHER® Stent in a broad range of patients. A number of these studies have data now out to seven years.


For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at cypherstent.


About RES TECHNOLOGY™


RES TECHNOLOGY™ is a stent design that incorporates in the stent struts hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75 percent bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents have 100 percent of their surfaces coated with drug and polymer and the polymer is never fully bioabsorbed.


Products using RES TECHNOLOGY™ are under development and are not approved or available for sale in any market.


More information about RES TECHNOLOGY™ can be found at res-technology.


Source

Cordis Corporation

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Small Businesses, Under Increased Pressure, Deepening Cuts To Health Coverage

The New York Times on Tuesday examined how the recession has "accelerated the pressure on small-business owners to pinch every penny, and many feel they have few options but to go after employee health coverage." According to the Times, "Even before the recession, owners of the smallest businesses had struggled to absorb the inexorable annual rise in health premiums."

The Times reports, "Surveys suggest that rising premiums have prompted more than half of small businesses to reduce benefits, raise deductibles or require workers to shoulder a larger share of an ever more expensive pie." The number of companies with fewer than 10 workers that offer health insurance has declined by 16% since 2001, with 49% of the smallest companies now offering benefits, according to a survey released by the Kaiser Family Foundation and the Health Research and Education Trust. In addition, employees of firms with fewer than 25 workers are now twice as likely to be without health insurance compared with workers in larger companies, according to the Employee Benefits Research Institute. Among small-business employees who do have health coverage, the number with high deductibles has more than doubled in the past two years, according to the Times.

According to the Times, several states have introduced programs "to lighten the health care burden on small businesses through tax credits, pooling mechanisms and insurance regulation." In addition, President Obama during his campaign advocated for federal tax credits to help small business provide health coverage. Obama also said he would consider taxing "all but the smallest businesses" if they did not contribute to their workers' health coverage, according to the Times (Sack, New York Times, 2/3).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


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Switzerland To Purchase GSK's H5N1 Vaccine For Pre-pandemic Use

GlaxoSmithKline (plc) today announced that a supply contract has been signed by the Swiss Federal Office of Public Health and GlaxoSmithKline for 8 million doses of GSK's H5N1 antigen influenza vaccine and its proprietary adjuvant for pre-pandemic use. The order provides enough doses, one per head of the entire Swiss population, to help prepare the immune system against the threat of a human influenza pandemic and is the first national programme to do so. Supply and stockpiling of the pre-pandemic vaccine is expected in early 2007 once the Swiss regulatory agency, Swissmedic, has reviewed and approved GSK's regulatory file.


Andrew Witty, President Pharmaceuticals Europe said: "This is the first major contract that GSK has signed for its candidate H5N1 vaccine. The Swiss Government have adopted a comprehensive strategy to help protect their population. Our vaccine, which has already demonstrated strong immunogenicity at the lowest dose seen with a split cell vaccine, provides an attractive option for Governments currently considering how best to combat the threat of a flu pandemic. We continue to work with Governments across Europeon their pandemic plans and are on track to file our adjuvanted H5N1 vaccine with the European regulators by the end of 2006."


In the event of an influenza pandemic further immunisation with a vaccine appropriate to the actual pandemic would be needed for full protection. To this end the supply contract also provides for an advance purchase agreement for 7.5 million doses of a GSK pandemic vaccine which will be manufactured once a pandemic strain is identified by the WHO.


In July GSK announced that its candidate H5N1 vaccine enabled over 80% of subjects who received 3.75ug of antigen (the lowest dose tested in the study) to demonstrate a strong immune response. Oncea pandemic has been declared by WHO and the final pandemic strain identified, it is hoped that the immunity developed in response to H5N1 vaccine will prepare the immune system against the threat of an actual pandemic virus.


The GSK H5N1 and pandemic vaccines are administered with a proprietary adjuvant, an extra ingredient in the vaccine formulation which is designed to increase the immunogenicity of the vaccine as well as potentially offering protection against variant virus strains (commonly called drift strains).


About GSK


GSK continues to be committed to doing all it can to support governments and health authorities around the world in planning to respond to a global influenza pandemic prior to its outbreak and in the event one is officially declared. GSK has made substantial progress in its vaccine development programme and continues to investigate ways to further improve our pre-pandemic and pandemic vaccine strategies. To this end more than $2 billion has already been invested in developing a vaccine to combat avian flu, increasing the production capacity for influenza vaccines and GSK's anti-viral flu treatment Relenza, in addition to ensuring the continuity of critical business operations and processes"


GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at gsk.


GlaxoSmithKline

gsk


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New Insights Could Lead To A Better Pneumococcal Vaccine

The discovery of a previously unknown mechanism of immunity may lead to a better way to protect vulnerable children and adults against Streptococcus
pneumoniae (pneumococcal) infection. These are the conclusions by researchers from Children's Hospital Boston, the Harvard School of Public Health
(HSPH), the University of Bristol, United Kingdom, the University of Pittsburgh, GГ¶teborg University, Sweden, and the Cambridge Health Alliance,
Cambridge Massachusetts.



The findings, now published in the open-access journal PLoS Pathogens, may aid the development of novel pneumococcal vaccines that would be less
expensive and cover a greater number of known pneumococcal strains than that currently available.



Pneumococcus causes serious infections in children and the elderly, including pneumonia and meningitis (inflammation of the brain). Since 2000, U.S.
infants have been routinely immunized against pneumococcus, but most developing countries (where nearly one million children die from pneumococcal
infections annually) cannot afford the existing vaccine.



Richard Malley, MD, of Children's Division of Infectious Diseases, and Marc Lipsitch, D. Phil., of the HSPH have been studying how natural immunity
against pneumococcus develops, and have shown that in addition to antibodies, T-cells can provide broad protection against this pathogen. In this new
study, Malley and Lipsitch identify the specific protective T-cells - so-called TH17 cells - and show that they protect against infection by
releasing IL-17, a protein that enables human blood cells to kill pneumococcus in the nose more efficiently. This is significant, since colonizing a
person's nose is the first necessary step of infection.



Researchers knew that as children get older, they carry pneumococcus in the nose for shorter periods of time and have less risk of disease, but it
hadn't been known how this resistance develops. Malley, Lipsitch and their colleagues now show that adults and older children, but not newborn
babies, have TH17 cells that target pneumococci, suggesting that exposure to pneumococcus normally leads to production of these cells. In mice, they
show directly that exposure to pneumococcus triggers the development of these T cells and shortens the duration of nasal carriage of the pathogen.



The investigators also describe an efficient way of measuring TH17 cells, which could help determine whether a new vaccine is rallying an effective
response.



"We are now evaluating vaccine candidates and changing them so they not only induce antibodies, but also induce this specific type of immunity,"
says Malley. "A vaccine that induces both protective antibodies and T-cell immunity to pneumococcus may be a very effective way to protect against
this potentially devastating disease."




"Interleukin-17A Mediates Acquired Immunity to Pneumococcal Colonization."
Lu Y-J, Gross J, Bogaert D, Finn A, Bagrade L, et al. (2008)

PLoS Pathog 4(9): e1000159. doi:10.1371/journal.ppat.1000159

Click here to view article online.




About PLoS Pathogens



PLoS Pathogens publishes outstanding original articles that significantly advance the understanding of pathogens and how they
interact with their host organisms. All works published in PLoS Pathogens are open access. Everything is immediately available subject only to the
condition that the original authorship and source are properly attributed. Copyright is retained by the authors. The Public Library of Science uses
the Creative Commons Attribution License.

PLoS Pathogens



About the Public Library of Science



The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical
literature a freely available public resource.

Public Library of Science

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Social Security Disability Insurance Recipients Need Better Understanding Of Pros And Cons Of New Debit Card, Allsup Says (USA)

Starting next month Social Security Disability Insurance recipients in some states will have the option of receiving their benefit payments electronically on a debit card, rather than via a paper check. However, eligible individuals - many of whom are "unbanked" - should have a clear understanding of the pros and cons of opting for the debit card, particularly the financial ramifications, according to Allsup, which represents tens of thousands of people in the Social Security Disability Insurance (SSDI) process each year. It also offers services that support the financial and health well-being of individuals with disabilities.



"Before signing on to or totally dismissing the idea of the debit card program, potential cardholders should look at how they are likely to use a card," said Paul Gada, personal financial planning director of the Allsup Disability Life Planning Center. "For some, the card may make sense. For others, they may realize after looking at their spending habits that getting a bank account may really be the best option. And there will be others that will always operate with cash only, regardless of the drawbacks it presents."



The debit card program, called Direct Express, is run by the U.S. Treasury Department through Comerica Bank with the intent to encourage Social Security recipients who do not have a bank account to elect to have their benefits loaded electronically onto a debit card. The Direct Express program will be introduced this spring in Arkansas, Louisiana, Oklahoma and Texas before being phased in across the nation during the summer.



The cost savings for the government could be significant, based on estimates from the Treasury's Financial Management Service. For example, it cost 89 cents for the government to issue a paper check in 2006 compared with 9 cents to process an electronic payment. As a result, if the 4 million recipients of Social Security, SSDI and Supplemental Security Income (SSI) who don't have bank accounts were to sign up for the debit card, the savings could be $44 million annually.


Having monthly benefits electronically deposited onto debit cards also has its advantages for recipients, most notably convenience and security. In the case of individuals with disabilities who may have limited mobility, for example, having the debit card would mean that they would not have to make a special trip to cash their SSDI award or be concerned if they were hospitalized or otherwise unable to retrieve their benefit payment when it was due to arrive. Additionally, funds on the card are FDIC insured, just like money in a bank account, so the money is fully protected if the card is lost or stolen; though a card replacement fee will be assessed the second time a card needs to be replaced in any given year.



Evaluating the Costs



While cost savings for the government - and taxpayers - are obvious, the cost savings may not be as clear-cut for debit-card recipients. They might end up paying even more in transaction fees than the average $6 to have a paper check cashed, especially if they don't pay attention to how they're using the debit card.
















Among the questions Gada recommends potential cardholders consider before signing up for a debit card include:



- How accessible to you is an ATM in the Comerica network?

- How often would you make ATM withdrawals and would those ATM withdrawals be at in- or out-of-network ATMs?

- How often would you use the electronic bill payment feature?

- Will the companies you are paying electronically charge you a fee for electronic payment?

- Is there a bank in your area that could provide you with a more cost-effective solution for the features you want, such as ATM, electronic bill pay or direct debit?

- If you are concerned about opening a bank account, why is that and have you spoken with a local bank to see if they can help alleviate your concerns?



Social Security recipients participating in the Direct Express program are allowed one free ATM cash withdrawal per month from a designated ATM. They are assessed a 90-cent fee for each additional ATM withdrawal. Cardholders may be charged an additional "surcharge fee" by ATM owners outside of the Comerica Bank network, which issues the debit cards. Additionally, program participants have access to online bill payment for a fee of 50 cents per online bill payment and can receive a paper statement for a 75-cent monthly fee.



Gada advises potential cardholders to consider how they would use the debit card, looking at the trade-off between potential costs and benefits. For example, rather than having to pay for a cashier check or carry large amounts of cash and pay bills in person, incurring a small transaction fee for electronic bill payment may be worth it, particularly for individuals who have a difficult time getting around. However, he noted, individuals should check to see if the organization they are paying will assess an additional charge for accepting electronic bill payment.



On the other hand, individuals who are going to head for an ATM every time they need cash will find transaction fees quickly adding up to little added value.



"In these cases, it's time to seriously consider what is preventing you from getting an account at your local bank, because that probably would be your best option," said Gada. "Many banks offer no minimum balance checking accounts where you can have your Social Security benefits direct deposited and electronically pay bills or use their ATMs at no additional charge."



Overcoming Banking Barriers



One of the reasons that some Social Security recipients continue to insist on paper checks is the fear that their bank accounts could be attached by creditors. However, under federal law, Social Security benefit payments are protected from attachment, meaning creditors do not have the right to take these funds from a recipient's bank account. The same rules will apply to funds placed on Direct Express debit cards. There are a few explicit exceptions to the rules guarding against attachment of Social Security benefits. For example, Social Security funds can be taken to pay child support or alimony payments the individual owes.



"At any given time, there are likely millions of dollars in Social Security payments that are at risk because people on fixed incomes got into debt or are having a dispute with a creditor," said Gada. "Unfortunately, they are acting on inaccurate information that has them afraid to put their money into bank accounts where it can be protected and they can be afforded other benefits of being banked."



About Allsup



Allsup is the nation's premier Social Security Disability Insurance representation company. Since 1984, Allsup has helped more than 100,000 people with disabilities receive their entitled disability benefits. Today, the company has 500 professionals focused on helping individuals and their family's nationwide gain the financial and health benefits they deserve.

allsup

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Researchers make headway in mystery of migraines

Scientists at the MUHC have made progress in understanding what causes migraines. The research, published in the new issue of the Proceedings of National Academy of Sciences (PNAS), reveals how gene mutations known to cause a form of inherited migraine--the kind that cause debilitating headaches and light flashes known as auras--target a cellular process involved in brain cell communication.


"A number of mutations have been shown to result in familial migraines," says Dr. Rhoda Blostein--a medical scientist at the Research Institute of the MUHC, professor in the Department of Medicine and Biochemistry at McGill University, and author of the new study. "Discovering genetic mutations that cause disease is important, but in order to develop treatments we must understand what these mutations do." By engineering several genetic mutations known to cause inherited migraines (type 2), and incorporating them into human cells, Dr. Blostein and her team showed several genotypes damage the operation of a tiny cellular mechanism commonly known as the Sodium Pump (Sodium/Potassium ATPase enzyme).


"Much of what happens in your brain--from memory to basic movement--is the result of the transmission of electrical impulses along nerve cells," says Dr. Blostein. "This is a basic process by which our brain cells communicate." By expelling sodium from the cell, and drawing potassium from outside, the sodium pump maintains a gradient of potassium, which is critical for the propagation of electrical signals along nerve cells. Like an air conditioner in the heat of summer, the sodium pump is a massive energy hog, consuming around 30% of the energy produced by the cell in order to perform this vital cellular process.


Of particular interest in this study is that some mutations cause migraines by reducing sodium pump efficiency--akin to reducing the power supply. "This is the first time that a genetic mutation of the sodium pump has been shown to cause disease by changing the properties of this biochemical process, rather than completely turning it off," notes Dr. Blostein. This new understanding of how genetic mutations cause migraines takes us one step closer to the development of improved treatments, providing hope to millions of migraine sufferers.


This study was funded by the Canadian Institutes of Health Research (CIHR).


The Research Institute of the McGill University Health Centre (RI MUHC) is a world-renowned biomedical and health-care hospital research centre. Located in Montreal, Quebec, the institute is the research arm of the MUHC, a university health center affiliated with the Faculty of Medicine at McGill University. The institute supports over 500 researchers, nearly 1000 graduate and post-doctoral students and operates more than 300 laboratories devoted to a broad spectrum of fundamental and clinical research. The Research Institute operates at the forefront of knowledge, innovation and technology and is inextricably linked to the clinical programs of the MUHC, ensuring that patients benefit directly from the latest research-based knowledge. For further details visit: www.muhc/research.


The McGill University Health Centre (MUHC) is a comprehensive academic health institution with an international reputation for excellence in clinical programs, research and teaching. The MUHC is a merger of five teaching hospitals affiliated with the Faculty of Medicine at McGill University--the Montreal Children's, Montreal General, Royal Victoria, and Montreal Neurological Hospitals, as well as the Montreal Chest Institute. Building on the tradition of medical leadership of the founding hospitals, the goal of the MUHC is to provide patient care based on the most advanced knowledge in the health care field, and to contribute to the development of new knowledge.


Ian Popple

ian.popplemuhc.mcgill

514-843-1560

McGill University

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Doctors Give Massachusetts Health Reform A Failing Grade - Poor Early Outcomes Raise Red Flags, Only Private Insurers Profit

Over 250 Massachusetts doctors have signed an open letter to the country warning that the health reform model enacted by Massachusetts is failing and that a single payer program is the only alternative.


"It is urgent that the rest of the country know that Massachusetts is a living laboratory for the health care reforms being pushed in California and by the Obama/Clinton/Edwards campaigns. Right now the Gov. Romney/Massachusetts' plan gets a failing grade on the ground," said Dr.Rachel Nardin, Assistant Professor of neurology at Harvard Medical School.


An Open Letter to the Nation from Massachusetts Physicians: Early Outcomes from Massachusetts' Health Care Reform


We write to alert colleagues and the nation to the disturbing early outcomes of Massachusetts' widely-heralded approach to health care reform. Although we wish that the current reform could secure health insurance for all, its failings reinforce our conviction that only a single payer program can assure patients the care they need.


In 2006, our state enacted a law designed to extend health coverage to virtually all state residents. Political leaders in other states as well as several Democratic presidential candidates have embraced this model.


Massachusetts' law mandates that uninsured individuals must purchase private insurance or pay a fine. The law established a new state agency to ensure that affordable plans were available; offered low income residents subsidies to help them buy coverage; and expanded Medicaid coverage for the very poor. (Immigrants are mostly excluded from these subsidized programs.) Moneys that previously funded free care for the uninsured were shifted to the new insurance program, along with revenues from new fines on employers who fail to offer health benefits to their workers. In addition, the federal government provided extra funds for the program's first two years.


Starting January 1, 2008 Massachusetts residents face fines if they cannot offer proof of insurance. Yet as of December 1, 2007 only 37% of the 657,000 uninsured had gained coverage under the new program. These individuals often feel well served by the reform in that they now have health insurance. However, 79% of these newly insured individuals are very poor people enrolled in Medicaid or similar free plans. Virtually all of them were previously eligible for completely free care funded by the state, but face co-payments under the new plan. In effect, public funds for care of the poor that previously flowed directly to hospitals and clinics now flow through insurers with their higher administrative costs.


Among the near poor uninsured (who are eligible for partial premium subsidies) only 16% had enrolled in the new coverage. And barely 7% of the uninsured individuals with incomes too high to qualify for subsidies had enrolled according to the official state figures. Few can afford premiums for even the skimpiest coverage; the lowest cost plan offered for a couple in their fifties costs $8,200 annually, and carries a $2,000 per person deductible.


Moreover, the state's cost for subsidies is running $147 million over the $472 million budgeted for fiscal year 2007. Meanwhile, collections from fines on employers who fail to provide coverage are 80% below the original projections. The funding gap will widen in future years as health care costs escalate and insurers raise premiums. Already, state officials speak of making up the shortfall by forcing patients to pay sharply higher co-pays and deductibles, and by slashing funds promised to safety net hospitals.


While patients, the state and safety net providers struggle, private insurers have prospered under the new law, and the costs of bureaucracy have risen. Blue Cross, the state's largest insurer, is reaping a surplus of more than $1 million each day, and awarded its chairman a $16.4 million retirement bonus even as he continues to draw a $3 million salary. All of the major insurers in our state continue to charge overhead costs five times higher than Medicare and eleven-fold higher than Canada's single payer system. Moreover, the new state agency that brokers private coverage adds its own surcharge of 4.5% to each policy it sells.


A single payer program could save Massachusetts more than $9 billion annually on health care bureaucracy, making universal coverage affordable. But because the 2006 law deepened our dependence on private insurance, it can only add coverage by adding costs. Though politically feasible, this approach is already proving fiscally unsustainable. The next economic downturn will push up the number of uninsured just as the tax revenues needed to fund subsidies fall.



The lesson from Massachusetts is that we still need real health care reform: single payer, non-profit national health insurance.


California Nurses Association

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Study Finds Regional Nuclear Conflict Would Create Near-Global Ozone Hole, Impacting Human Health And Ecosystems

A limited nuclear weapons exchange between Pakistan and India using their current arsenals could create a near-global ozone hole, triggering human health problems and wreaking environmental havoc for at least a decade, according to a study led by the University of Colorado at Boulder.



The computer-modeling study showed a nuclear war between the two countries involving 50 Hiroshima-sized nuclear devices on each side would cause massive urban fires and loft as much as 5 million metric tons of soot about 50 miles into the stratosphere, said CU-Boulder Research Associate Michael Mills, chief study author. The soot would absorb enough solar radiation to heat surrounding gases, setting in motion a series of chemical reactions that would break down the stratospheric ozone layer protecting Earth from harmful ultraviolet radiation, said Mills.



"We would see a dramatic drop in ozone levels that would persist for many years," said Mills of CU-Boulder's Laboratory for Atmospheric and Space Physics. "At mid- latitudes the ozone decrease would be up to 40 percent, which could have huge effects on human health and on terrestrial, aquatic and marine ecosystems."



A paper on the subject, titled "Massive Global Ozone Loss Predicted Following A Regional Nuclear Conflict," appeared the week of April 7 in the Proceedings of the National Academy of Sciences. Co-authors on the study include CU-Boulder Professor Brian Toon, UCLA Professor Richard Turco and National Center for Atmospheric Research scientists Douglas Kinnison and Rolando Garcia.



According to the computer simulations, fires ignited in large cities by nuclear explosions would send several million metric tons of soot into the upper stratosphere, which would be heated by massive smoke injections. Higher temperatures would accelerate catalytic reaction cycles in the stratosphere, particularly reactions of nitrogen oxide gases known collectively as NOx that destroy ozone, Mills said.



In addition to ozone losses of 25 percent to 40 percent at mid-latitudes, the models show a 50 percent to 70 percent ozone loss at northern high latitudes, said Mills. "The models show this magnitude of ozone loss would persist for five years, and we would see substantial losses continuing for at least another five years," he said.



The ozone losses predicted in the study are much larger than losses estimated in previous "nuclear winter" and "ultraviolet spring" scenario calculations following nuclear conflicts, said Toon, chair of CU-Boulder's oceanic and atmospheric sciences department. A 1985 National Research Council Report predicted a global nuclear exchange involving thousands of megatons of explosions, rather than the 1.5 megatons assumed in the PNAS study, would deplete only 17 percent of the Northern Hemisphere's stratospheric ozone, which would recover by half in three years.



"The missing piece back then was that the models at the time could not account for the rise of the smoke plume and consequent heating of the stratosphere," said Toon. "The big surprise is that this study demonstrates that a small-scale, regional nuclear conflict is capable of triggering ozone losses even larger than losses that were predicted following a full-scale nuclear war."



Human health ailments like cataracts and skin cancer, as well as damage to plants, animals and ecosystems at mid-latitudes would likely rise sharply as ozone levels decreased and allowed more harmful UV light to reach Earth, according to the PNAS study. "By adopting the Montreal Protocol in 1987, society demonstrated it was unwilling to tolerate a small percentage of ozone loss because of serious health risks," said Toon. "But ozone loss from a limited nuclear exchange would be more than an order of magnitude larger than ozone loss from the release of gases like CFCs."



UV radiation has been shown to be particularly damaging to inhabitants of aquatic ecosystems, including amphibians, shrimp, fish and phytoplankton, said Mills. "Most organisms can do little to avoid UV exposure, so one of the big unanswered questions is how the biota would respond to these big UV increases triggered by a nuclear exchange."



The team used a cluster of computer processors at LASP to run three separate 10-year simulations -- each more than 300 hours long -- linking the urban fire nuclear scenario to climate and atmospheric chemistry processes. The team coupled NCAR's Whole Atmosphere Community Climate Model 3 with the Community Aerosol and Radiation Model for Atmospheres developed by CU-Boulder and NASA Ames.



Two 2006 studies led by Toon and involving UCLA and Rutgers University showed that such a small-scale regional nuclear war could produce as many fatalities as all of World War II and disrupt global climate for a decade or more. Of the eight nations known to possess nuclear weapons, even those with the smallest nuclear arsenals, like Pakistan and India, are believed to have 50 or more Hiroshima-sized weapons.



In addition, about 40 countries possess enough plutonium, uranium or a combination of both to construct substantial nuclear arsenals, said Toon. A nuclear exchange involving 100 15-kiloton, Hiroshima-type weapons is only 0.03 percent of the total explosive power of the world's nuclear arsenal, he said.



"We hope other research groups repeat our calculations and undertake their own scientific studies on this issue," said Toon. "The world has become a far more dangerous place when the actions of two countries on the other side of the world could have such a drastic impact on the planet." The study was funded by CU-Boulder.







Click here to access a podcast with Mills on the Web.



Source: Michael Mills


University of Colorado at Boulder


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Medical Record Adoption In Hospitals Sped By Key Medical Centers, Says Management Insights Study

Persuading influential medical centers to adopt electronic medical records helps speed adoption by their neighboring hospitals, according to the Management Insights feature in the current issue of Management Science, a flagship journal of the Institute for Operations Research and the Management Sciences (INFORMS®).



"Social Contagion and Information Technology Diffusion: The Adoption of Electronic Medical Records in U.S. Hospitals" is by Corey M. Angst and Ken Kelley of the University of Notre Dame; Ritu Agarwal of the University of Maryland; and V. Sambamurthy of Michigan State University.



Management Insights, a regular feature of the journal, is a digest of important research in business, management, operations research, and management science. It appears in every issue of the monthly journal.



The call for electronic medical records extends back to the Clinton and Bush administrations. In a State of the Union Address, President George W. Bush called for broad adoption of electronic medical records by the middle of this decade. Last year, President Barack Obama signed into law HR 1, the American Recovery and Reinvestment Act, which allocates $19.2 billion in funding to support the adoption and use of health information technology to reduce clerical errors and costs in health care.



The authors of this study asked what mechanisms influence the swift and successful diffusion of technological innovations at hospitals. They use a "social contagion" model to study the diffusion of electronic medical records in the population of U.S. hospitals; hospitals have mutual influence on each other for information technology adoption.



The authors look at 20 years of data from almost 4,000 U.S. hospitals and write that diffusion is accelerated if specific attention is given to increasing adoption among well-known, larger, older hospitals in densely populated geographic regions. Their insight for management is that targeting specific influential institutions for a new technology can vastly increase its rate of adoption.



The other Insights in the current issue are:
The Lean and Hungry or Fat and Content? Entrepreneurs' Wealth and Start-Up Performance by Hans K. Hvide, Jarle Moen
Strategic Entry Before Demand Takes Off by Qiaowei Shen, J. Miguel Villas-Boas
Optimal Choice and Beliefs with Ex Ante Savoring and Ex Post Disappointment by Christian Gollier, Alexander Muermann
Optimal Flexibility Configurations in Newsvendor Networks: Going Beyond Chaining and Pairing by Achal Bassamboo, Ramandeep S. Randhawa, Jan A. Van Mieghem
Model of Migration and Use of Platforms: Role of Hierarchy, Current Generation, and Complementarities in Consumer Settings by Xin Xu, Viswanath Venkatesh, Kar Yan Tam, Se-Joon Hong
Incentives in New Product Development Projects and the Role of Target Costing by Jurgen Mihm
Joint Dynamic Pricing of Multiple Perishable Products Under Consumer Choice by YalcД±n Akcay, Harihara Prasad Natarajan, Susan H. Xu
Optimal Control and Equilibrium Behavior of Production-Inventory Systems by Owen Q. Wu, Hong Chen
Improving Supply Chain Performance and Managing Risk Under Weather-Related Demand Uncertainty by Frank Youhua Chen, Candace Arai Yano
Management Economics in a Large Retail Company by W. Stanley Siebert, Nikolay Zubanov

Source:

Barry List

Institute for Operations Research and the Management Sciences

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Ongoing Support Needed For Medical Practices To Process Electronic Medicare Claims, Australia

AMA President, Dr Andrew Pesce, said today that the increase in electronic Medicare rebate claiming announced by the Government is a good case to introduce ongoing financial support to assist medical practices cover the administrative costs associated with electronic claiming.



Dr Pesce said Medicare Easyclaim had effectively shifted the administrative burden of electronic Medicare claims from Medicare Australia to private medical practice - but with no ongoing compensation for the shift in responsibility for administering the system.



"The AMA is pleased that Minister Bowen has today recognised the considerable work that medical practices are now doing on behalf of Medicare offices around Australia," Dr Pesce said.



"Medical practices are contributing to significant savings in administration costs for the Government.



"The Transitional Support Package has provided the impetus to almost double the number of participating medical providers and the number of electronic claims made since April this year, but the Package expires on 31 December.



"The AMA is concerned that medical practices will now have no incentive to sign up to or continue with Medicare Easyclaim because there will be no compensation for the costs and extra work involved in doing the work of Medicare Australia.



"The AMA wrote to Ministers Roxon and Bowen in October calling for a new ongoing payment for medical practices for each claim for Medicare benefits they lodge electronically on behalf of patients.



"This was followed up with a repeat call to Minister Roxon from the AMA and other medical groups last month.



"But we have heard nothing.



"We are seeking a process that is consistent with the Government approach to pharmacies, whereby pharmacies receive a 40-cent payment for each prescription they process using PBS Online.



"This would ensure a continued increase in electronic Medicare claiming, and it would allow doctors to be able to continue to provide electronic claiming in their practices.



"It would also provide convenience for patients and create further administrative efficiencies for the Government," Dr Pesce said.


Source
Australian Medical Association


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Mechanism Alerts Neighbors To Amplify Immune Response

New research reveals a clever strategy that enables a host organism to outsmart an invading bacterium by counteracting its efforts to suppress the innate immune response. The study, published by Cell Press in the November 24th issue of the journal Immunity, describes a mechanism by which an infected cell can quickly alert unsuspecting (and uninfected) neighboring cells that can join the fight, amplify the immune response and defeat the invader.



The pathogen Shigella flexneri invades the cells that line the gut and causes Shigellosis, a disorder characterized by diarrhea and sometimes even death in humans. S. flexneri subverts the normal immune response of the host by interfering with the ability of the infected cell to secrete chemicals called chemokines that stimulate inflammation. Inflammation is a complex response to pathogens that attracts white blood cells to destroy the bacteria. Despite the documented ability of S. flexneri to suppress inflammation in infected cells, intestinal cells do secrete large amounts of chemokines and exhibit substantial inflammation during Shigellosis.



Professor CГ©cile Arrieumerlou from the University of Basel in Switzerland led a study designed to investigate the molecular mechanisms that control inflammation during bacterial infection. Using a sophisticated microscopic technique that allowed analysis of S. flexneri infection at the single cell level, the researchers discovered that activation of proinflammatory signaling pathways is propagated from infected cells to adjacent uninfected cells, leading to chemokine secretion from the bystander cells. "We found that this mechanism was mediated by specialized intercellular connections called gap junctions that allowed the infected cells to communicate with neighboring uninfected cells," explains Prof. Arrieumerlou.



Taken together, the results show that even when the immune response is suppressed in the infected cell, alerted bystanders can amplify the inflammatory response. "We have identified a novel mechanism of cell to cell communication that amplifies the immune response against bacterial infection by rapidly spreading signals via gap junctions to yet uninfected cells," concludes Prof. Arrieumerlou. "This mechanism enables the host to circumvent the immunosuppressive activity of bacteria and to massively amplify inflammation during bacterial infection."



Source:

Elisabeth (Lisa) Lyons

Cell Press

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High Tech Help To Prevent Further Heart Disease

Thanks to an innovative new project being developed by Central Queensland University with funding from MBF Foundation, heart surgery patients around the country could soon have access to rehabilitation services in the comfort of their own home rather than having to travel to special outpatient clinics.



Researchers at the University's Rockhampton campus are developing an on-line outpatient rehabilitation service for people who have had heart surgery to see if it improves health outcomes by reducing the risk of heart problems recurring.



Study leader, Professor Kerry Mummery, said post-surgery monitoring and counselling is very important to ensure that patients who have undergone heart operations change the lifestyle factors that contributed to their illness, such as too little physical activity and poor diet.



"Currently patients have to make regular follow up visits to special hospital outpatient facilities or private clinics for these services," said Professor Mummery. "Those who live in the bush or outlying areas throughout Queensland can't make it because they live too far away. Others choose not to go or drop out after one or two visits."



Researchers believe that delivering rehabilitation services directly to patients in an easy-to-use interactive format will overcome many of the barriers.



Chair of MBF Foundation's Steering Committee, Dr Christine Bennett, said that this easy access, high quality rehabilitation service can deliver better community health outcomes by guiding patients to make healthy and positive lifestyle changes that will contribute to their recovery and ongoing wellbeing.






The MBF Foundation is a charitable institution set up by MBF to support and manage important health initiatives for the community using a portion of MBF Group's investment income each year. Projects undertaken encompass three key areas - wellness and obesity, supporting healthy ageing and keeping healthcare affordable.



Contact: Jackie Crossman


Research Australia


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