The Los Angeles Times on Thursday, in the third installment of a three-part series on the U.S. health insurance system, examined how physicians and "hospital executives say collecting payments from insurers has become an expensive headache that is driving up the nation's health care costs." According to the Times, "Billing disputes and protracted payment delays are one consequence of a massive consolidation among health insurers that has created de facto monopolies in much of the country." Four insurance companies cover nearly half of all privately insured U.S. residents, leaving doctors and hospitals "little negotiating power and few options when an insurer rejects a bill," the Times reports. As a result, some physicians have dropped out of insurance networks, turned away new patients, created cash-only practices or left the business entirely.
According to the Times, "Arcane and ever-changing coverage rules are a leading cause of fee disputes," and medical professionals and staff are "spending more and more time haggling with insures over claims or obtaining advance approval for treatments." Patients are "often dragged into the financial tug of war" when doctors try to recover unpaid balances from them after insurers reject or reduce claims, the Times reports. Thousand of physicians across the U.S. are involved in class-action lawsuits alleging that the nation's largest insurers are involved in a "conspiracy ... to deny, delay and diminish payments to health care providers."
Patients' rights groups and some state regulators also are pushing to overhaul the system insurers use to set out-of-network payment rates. The insurance industry has invested billions of dollars to develop claims processing software that can identify inflated charges, errors or inconsistencies. According to the Times, "Because most physicians use paper billing records, many say that challenging the insurers is like going into a gunfight with a butter knife." The Times reports, "To even the odds, some doctors, clinics and hospitals are investing in software of their own or outsourcing their billing to national companies that aim to pool enough providers to match the insurance industry's muscle" (Costello et al., Los Angeles Times, 10/23).
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.В All rights reserved.
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A Molecular Search For Happier Skin
Leeds scientists are using the most sophisticated techniques to tackle a question almost as old as mankind itself - what makes skin feel good, and why?
The research is coordinated at the University of Leeds by Professor Peter Olmsted of the School of Physics and Astronomy, who is bringing atomic force microscopy, computer simulation and theoretical physics to bear on the problem, within a larger collaborative project led by Dr Massimo Noro at Unilever R&D Port Sunlight. The aim is to design better skin products that appeal to consumers by working well - and making them feel good too.
Prof Olmsted, whose research expertise is in soft condensed matter such as polymers and liquid crystals, will examine the properties of the lipid bilayers that are found in the stratum corneum membrane, the outermost layer of skin which is just 50-100 microns thick - about a tenth of the thickness of a sheet of paper.
"Essentially our work is an attempt to understand in scientific terms what 'feeling good' means," says Professor Peter Olmsted.
The Leeds team, which also includes Dr Simon Connell, will concentrate on understanding how the extremely complex composite structure of skin gives it its unique properties of strength and elasticity. Scientists will be able to construct a profile of the skin lipids that is accurate up to a millionth of a millimetre.
The team will use this information to carry out experiments and make theoretical calculations that model how skin behaves at a molecular level to the ingredients of personal care products, from simple water molecules to complex oils.
"In examining the science of these membranes we hope to come up with design rules for products that work better and are more appealing to the person who is using them," adds Professor Olmsted.
"It's about caring for the natural barrier which is the skin surface. We will be testing the various ingredients used in these products to see what effects they have. We wish to link these effects to the science of the mechanics and permeability of complex membranes."
As skin grows from the inside of the body towards the outside, cells are pushed to the surface layers of the skin. They over-express certain proteins that form mechanical "bricks", held together by a "mortar" made of special lipid molecules called ceramides, in a form that only exists in skin. The research group is interested in how the special features of these molecules contribute to the elastic, strong, and supple object that is skin.
"In examining the science of these membranes we hope to come up with design rules for products that work better and are more appealing to the person who is using them," says Professor Olmsted.
And Prof Olmsted is philosophical about why this has not been the focus of research in the past: " A lot of work has been done but there is an awful lot further to go, because this is a very complicated system to understand and, from my own personal point of view, contains a host of scientifically interesting questions."
The project is funded by regional development agency Yorkshire Forward and Unilever R&D. A further award of ВЈ2 million has recently been made which also involves the University of Bradford and the University of Hull.
Source:
Clare Ryan
University of Leeds
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The research is coordinated at the University of Leeds by Professor Peter Olmsted of the School of Physics and Astronomy, who is bringing atomic force microscopy, computer simulation and theoretical physics to bear on the problem, within a larger collaborative project led by Dr Massimo Noro at Unilever R&D Port Sunlight. The aim is to design better skin products that appeal to consumers by working well - and making them feel good too.
Prof Olmsted, whose research expertise is in soft condensed matter such as polymers and liquid crystals, will examine the properties of the lipid bilayers that are found in the stratum corneum membrane, the outermost layer of skin which is just 50-100 microns thick - about a tenth of the thickness of a sheet of paper.
"Essentially our work is an attempt to understand in scientific terms what 'feeling good' means," says Professor Peter Olmsted.
The Leeds team, which also includes Dr Simon Connell, will concentrate on understanding how the extremely complex composite structure of skin gives it its unique properties of strength and elasticity. Scientists will be able to construct a profile of the skin lipids that is accurate up to a millionth of a millimetre.
The team will use this information to carry out experiments and make theoretical calculations that model how skin behaves at a molecular level to the ingredients of personal care products, from simple water molecules to complex oils.
"In examining the science of these membranes we hope to come up with design rules for products that work better and are more appealing to the person who is using them," adds Professor Olmsted.
"It's about caring for the natural barrier which is the skin surface. We will be testing the various ingredients used in these products to see what effects they have. We wish to link these effects to the science of the mechanics and permeability of complex membranes."
As skin grows from the inside of the body towards the outside, cells are pushed to the surface layers of the skin. They over-express certain proteins that form mechanical "bricks", held together by a "mortar" made of special lipid molecules called ceramides, in a form that only exists in skin. The research group is interested in how the special features of these molecules contribute to the elastic, strong, and supple object that is skin.
"In examining the science of these membranes we hope to come up with design rules for products that work better and are more appealing to the person who is using them," says Professor Olmsted.
And Prof Olmsted is philosophical about why this has not been the focus of research in the past: " A lot of work has been done but there is an awful lot further to go, because this is a very complicated system to understand and, from my own personal point of view, contains a host of scientifically interesting questions."
The project is funded by regional development agency Yorkshire Forward and Unilever R&D. A further award of ВЈ2 million has recently been made which also involves the University of Bradford and the University of Hull.
Source:
Clare Ryan
University of Leeds
Buy Triamcinolone Without Prescription
Nationwide Medical/Surgical Announces They Will Carry Flu Vaccine
Nationwide Medical/Surgical has recently announced they will carry the Flu Vaccine for the 2009-2010 flu season. They will carry flu vaccines made by several manufacturers in several different formats including 10-dose vials and pre-filled syringes. The 2007-2008 flu season was allegedly the worst year of the last four for adult deaths by flu and pneumonia. In an effort to prevent more deaths, Nationwide Medical/Surgical will participate in supplying the flu vaccine to the medical community.
The flu shot is made up of inactive flu virus (that has already been killed) and is administered through the arm. The CDC determines what strains are included the new vaccine. Certain flu vaccines are approved for children 6 months old to 36 months old while other vaccines may be administered to children 4 years old and adults. Nationwide Medical/Surgical typically begins to ship out the flu vaccine to customers in the middle of August and the vaccine is available for purchase through December and beyond. Nationwide Medical/Surgical offers competitive pricing and exemplary service.
To find out more about how to order the vaccines, visit nationwidemedical/ . Not only can you find information about how to order the flu vaccine, but you can also access their vast inventory of other medications and medical supplies.
Nationwide Medical/Surgical
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The flu shot is made up of inactive flu virus (that has already been killed) and is administered through the arm. The CDC determines what strains are included the new vaccine. Certain flu vaccines are approved for children 6 months old to 36 months old while other vaccines may be administered to children 4 years old and adults. Nationwide Medical/Surgical typically begins to ship out the flu vaccine to customers in the middle of August and the vaccine is available for purchase through December and beyond. Nationwide Medical/Surgical offers competitive pricing and exemplary service.
To find out more about how to order the vaccines, visit nationwidemedical/ . Not only can you find information about how to order the flu vaccine, but you can also access their vast inventory of other medications and medical supplies.
Nationwide Medical/Surgical
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Report Examines Effects Of Linking Amount Of Health Ins. Federal Subsidy To Federal Poverty Level; GAO Analyzes Challenges Of Financing Health Care
"Effect of Tying Eligibility for Health Insurance Subsidies to the Federal Poverty Level," Kaiser Family Foundation: The brief, which is part of Kaiser Family Foundation's Snapshots: Health Care Costs online series, examined the effects of determining eligibility for health insurance subsidies by comparing an individual's income with the federal poverty level. The report notes that as health care costs and premiums rise faster than the poverty level -- which they have historically done -- tying eligibility to the poverty level might not provide a consistent level of protection against rising costs (Kaiser Family Foundation release, 2/15).
"Health Care Spending: Public Payers Face Burden of Entitlement Program Growth, While All Payers Face Rising Prices and Increasing Use of Services," Government Accountability Office: The testimony examined how spending on public health insurance programs such as Medicare and Medicaid affects the federal budget. It discusses the long-term outlook of federal solvency, federal health care spending increases and causes, and challenges policymakers face in curbing health care spending growth (Government Accountability Office, "Health Care Spending: Public Payers Face Burden of Entitlement Program Growth, While All Payers Face Rising Prices and Increasing Use of Services," 2/15).
"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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"Health Care Spending: Public Payers Face Burden of Entitlement Program Growth, While All Payers Face Rising Prices and Increasing Use of Services," Government Accountability Office: The testimony examined how spending on public health insurance programs such as Medicare and Medicaid affects the federal budget. It discusses the long-term outlook of federal solvency, federal health care spending increases and causes, and challenges policymakers face in curbing health care spending growth (Government Accountability Office, "Health Care Spending: Public Payers Face Burden of Entitlement Program Growth, While All Payers Face Rising Prices and Increasing Use of Services," 2/15).
"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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Independent Analysis of Malpractice Debate Calls Clash Between Doctors and Lawyers a Red Herring, USA
Study Faults US Malpractice System for Skyrocketing Malpractice Costs -
Tired of the war mongering between doctors and lawyers groups accusing each other of being responsible for rapidly rising
malpractice costs, the independent nonprofit group CodeBlueNow! today issued a Malpractice Fact Sheet that describes the
current debate over medical malpractice and damage caps. According to CodeBlueNow!'s analysis, the real malpractice "crisis"
is about fundamental flaws in the American malpractice system.
The CodeBlueNow! Malpractice Fact Sheet can be found online at codebluenow/pdf/malpractice-facts.
"The problem with the current debate is that neither the doctors nor the lawyers in the current debate speak for the citizen
consumer," says Kathleen O'Connor, Founder and CEO of CodeBlueNow!. "When consumers become victims of unavoidable or
avoidable medical error, they need to be compensated for medical expenses, wage loss and other direct damages in a fair,
efficient and timely manner. It's our malpractice system and its reliance on fault that are responsible for increasing damage
awards and costly defensive medicine on the part of physicians."
The American malpractice system relies on fault. It requires the injured victim and their attorney to allege fault and to
accuse the medical provider of substandard medicine. The system requires the medical provider and their attorney to defend
against these charges -- which, in turn, motivates the provider to conceal rather than document mistakes -- and to practice
defensive medicine. Having providers conceal their errors is antithetical to quality improvement programs, which require the
diligent identification of individual and system errors to establish proper corrective actions. The provider's practice of
defensive medicine is not only costly; it exposes patients to medically unnecessary treatment.
Troyen Brennan, professor of Medicine, Law and Public Health at Harvard, and others who have studied the performance of the
medical malpractice system with respect to these consumer objectives, have found the American malpractice system to be
woefully inadequate. The majority of malpractice system dollars do not go to victims of medical error, but to plaintiff and
defense attorneys, insurers, expert witnesses, and so forth. Brennan's studies also show that the vast majority of medical
error victims do not file medical malpractice suits. Finally, the small minority that do sue and receive compensation are
likely to be victims of actual medical error, although the system does sometimes reward individuals who are not in fact
victims.
"There is no evidence that the American fault-based system motivates healthcare providers to practice better medicine. A
no-fault based medical injury compensation system modeled after the American workers compensation system or New Zealand's
governmental medical injury compensation program seems to require greater attention in the current debate. They are far more
advantageous to citizen consumers who become medical injury victims. These individuals are not looking for someone to blame
following suffering of medical injury, they are simply looking for appropriate compensation," O'Connor stresses.
The Malpractice Fact Sheet is the second in a series. The first was on the Medicare Prescription Drug Bill. Coming next is
Medicaid. All Fact Sheets are available for downloading from the CodeBlueNow! website: codebluenow/news.html#factsheets
About CodeBlueNow!
CodeBlueNow! is a non-partisan, national 501(c)3 non-profit organization that is mobilizing grassroots efforts to transform
the financing, delivery and management of the American health care system, by assuring that the public has a voice in shaping
health care policy. The organization has grown from 30 people in October 2003 to having thousands of supporters in 46 states
and an online radio show. More information is online at: codebluenow.
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Tired of the war mongering between doctors and lawyers groups accusing each other of being responsible for rapidly rising
malpractice costs, the independent nonprofit group CodeBlueNow! today issued a Malpractice Fact Sheet that describes the
current debate over medical malpractice and damage caps. According to CodeBlueNow!'s analysis, the real malpractice "crisis"
is about fundamental flaws in the American malpractice system.
The CodeBlueNow! Malpractice Fact Sheet can be found online at codebluenow/pdf/malpractice-facts.
"The problem with the current debate is that neither the doctors nor the lawyers in the current debate speak for the citizen
consumer," says Kathleen O'Connor, Founder and CEO of CodeBlueNow!. "When consumers become victims of unavoidable or
avoidable medical error, they need to be compensated for medical expenses, wage loss and other direct damages in a fair,
efficient and timely manner. It's our malpractice system and its reliance on fault that are responsible for increasing damage
awards and costly defensive medicine on the part of physicians."
The American malpractice system relies on fault. It requires the injured victim and their attorney to allege fault and to
accuse the medical provider of substandard medicine. The system requires the medical provider and their attorney to defend
against these charges -- which, in turn, motivates the provider to conceal rather than document mistakes -- and to practice
defensive medicine. Having providers conceal their errors is antithetical to quality improvement programs, which require the
diligent identification of individual and system errors to establish proper corrective actions. The provider's practice of
defensive medicine is not only costly; it exposes patients to medically unnecessary treatment.
Troyen Brennan, professor of Medicine, Law and Public Health at Harvard, and others who have studied the performance of the
medical malpractice system with respect to these consumer objectives, have found the American malpractice system to be
woefully inadequate. The majority of malpractice system dollars do not go to victims of medical error, but to plaintiff and
defense attorneys, insurers, expert witnesses, and so forth. Brennan's studies also show that the vast majority of medical
error victims do not file medical malpractice suits. Finally, the small minority that do sue and receive compensation are
likely to be victims of actual medical error, although the system does sometimes reward individuals who are not in fact
victims.
"There is no evidence that the American fault-based system motivates healthcare providers to practice better medicine. A
no-fault based medical injury compensation system modeled after the American workers compensation system or New Zealand's
governmental medical injury compensation program seems to require greater attention in the current debate. They are far more
advantageous to citizen consumers who become medical injury victims. These individuals are not looking for someone to blame
following suffering of medical injury, they are simply looking for appropriate compensation," O'Connor stresses.
The Malpractice Fact Sheet is the second in a series. The first was on the Medicare Prescription Drug Bill. Coming next is
Medicaid. All Fact Sheets are available for downloading from the CodeBlueNow! website: codebluenow/news.html#factsheets
About CodeBlueNow!
CodeBlueNow! is a non-partisan, national 501(c)3 non-profit organization that is mobilizing grassroots efforts to transform
the financing, delivery and management of the American health care system, by assuring that the public has a voice in shaping
health care policy. The organization has grown from 30 people in October 2003 to having thousands of supporters in 46 states
and an online radio show. More information is online at: codebluenow.
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Autism Research: For Measuring And Analyzing Child Behavior, NSF Awards $10M To Develop Computing Techniques
A team led by the Georgia Institute of Technology has received a $10 million "Expeditions in Computing" award from the National Science Foundation (NSF) to develop novel computing techniques for measuring and analyzing the behavior of children.
These technologies will be used to enable new approaches for identifying children at risk for autism and other developmental delays. In addition, these methods may potentially improve the delivery and evaluation of treatment.
The award -- one of only 10 given out by the NSF since 2008 -- provides up to $2 million in funding each year for five years and is designed to push boundaries in computer science. This project will push the limits by catalyzing a new scientific discipline called computational behavioral science, which will draw equally from computer science and psychology to transform the study of human behavior.
"There is a great deal of creativity in the computer science research community today," said Deborah Crawford, acting assistant director of Computer and Information Science and Engineering at NSF. "Our intentions with the Expeditions in Computing program are to stimulate and use that creativity to expand the horizons of computing. For example, several of the projects will be exploring new computational approaches to some of the most vexing problems we face in the science and engineering enterprise as well as in the larger society."
Autism affects one of every 110 children in the United States and the long-term outcomes for a child who is at risk for autism can be significantly improved if the child is treated at an early age. As a result, it is widely accepted that all children should be screened for developmental delays as early in life as possible.
"Direct observation of a child by highly trained specialists is an important step in assessing risk for developmental disorders, but such an approach cannot be easily scaled to the large number of individuals needing evaluation and treatment," said the project's lead principal investigator James Rehg, a professor in Georgia Tech's School of Interactive Computing.
For this project, the researchers will design vision, speech and wearable sensor technologies to analyze child behavior. Data will be collected from interactions between caregivers and children, children playing and socializing in a daycare environment, and clinicians interacting with children during individual therapy sessions. Multiple sensing technologies are necessary to obtain a comprehensive and integrated portrait of expressed behavior.
"People use eye gaze, hand gestures, facial expressions, and tone of voice to convey engagement and regulate social interactions," said co-principal investigator Gregory Abowd, a professor in the School of Interactive Computing at Georgia Tech. "In addition, physiological responses, such as increased heart rate, can impact the expression of these behaviors."
Cameras and microphones will provide an inexpensive and noninvasive way to measure eye gaze and facial and body expressions, along with speech and non-speech utterances. Wearable sensors will measure physiological variables such as heart rate and skin conductivity, which contain important clues about levels of internal stress and arousal that are linked to behavior.
The research team will also develop capabilities for synchronizing the signals from the microphones, cameras and on-body sensors. By developing and using models of social interactions, the researchers will analyze the sensor data to quantify engagement.
As part of this award, the researchers will use a behavioral screening instrument called Rapid-ABC, which is currently under development by Abowd, Emory University School of Medicine assistant professor of psychiatry Opal Ousley, and Georgia Tech School of Interactive Computing senior research scientist Rosa Arriaga. The researchers intend to utilize the information gathered from the microphones, cameras and on-body sensors to automate some of the scoring for the Rapid-ABC test.
"We hope that by incorporating this screening protocol into well-child doctor visits for children less than two years old, we can reduce the average age of autism diagnosis, which is currently about four years old," explained Arriaga.
In the future, the researchers hope to expand their work beyond autism to other developmental disorders and the general study of child behavior.
"While autism is our focus right now, this project addresses general social, communicative and repetitive behaviors, so the technologies we develop will have applicability to other childhood disorders, such as Down syndrome or attention deficit hyperactivity disorder," added Rehg.
In addition to Georgia Tech, this project includes investigators and collaborators at Boston University, Carnegie Mellon, the Emory Autism Center, the Marcus Autism Center -- an affiliate of Children's Healthcare of Atlanta, the Massachusetts Institute of Technology, the University of Illinois at Urbana-Champaign, the University of Pittsburgh, and the University of Southern California. Outreach activities include collaborations with the Atlanta Autism Consortium and major autism research centers in Atlanta, Boston, Pittsburgh, Urbana Champaign and Los Angeles.
Other Georgia Tech participants include co-principal investigators Mark Clements, a professor in the School of Electrical and Computer Engineering, and Agata Rozga, a research scientist in the School of Interactive Computing; as well as School of Interactive Computing postdoctoral fellow Mario Romero.
Source:
Abby Vogel Robinson
Georgia Institute of Technology Research News
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These technologies will be used to enable new approaches for identifying children at risk for autism and other developmental delays. In addition, these methods may potentially improve the delivery and evaluation of treatment.
The award -- one of only 10 given out by the NSF since 2008 -- provides up to $2 million in funding each year for five years and is designed to push boundaries in computer science. This project will push the limits by catalyzing a new scientific discipline called computational behavioral science, which will draw equally from computer science and psychology to transform the study of human behavior.
"There is a great deal of creativity in the computer science research community today," said Deborah Crawford, acting assistant director of Computer and Information Science and Engineering at NSF. "Our intentions with the Expeditions in Computing program are to stimulate and use that creativity to expand the horizons of computing. For example, several of the projects will be exploring new computational approaches to some of the most vexing problems we face in the science and engineering enterprise as well as in the larger society."
Autism affects one of every 110 children in the United States and the long-term outcomes for a child who is at risk for autism can be significantly improved if the child is treated at an early age. As a result, it is widely accepted that all children should be screened for developmental delays as early in life as possible.
"Direct observation of a child by highly trained specialists is an important step in assessing risk for developmental disorders, but such an approach cannot be easily scaled to the large number of individuals needing evaluation and treatment," said the project's lead principal investigator James Rehg, a professor in Georgia Tech's School of Interactive Computing.
For this project, the researchers will design vision, speech and wearable sensor technologies to analyze child behavior. Data will be collected from interactions between caregivers and children, children playing and socializing in a daycare environment, and clinicians interacting with children during individual therapy sessions. Multiple sensing technologies are necessary to obtain a comprehensive and integrated portrait of expressed behavior.
"People use eye gaze, hand gestures, facial expressions, and tone of voice to convey engagement and regulate social interactions," said co-principal investigator Gregory Abowd, a professor in the School of Interactive Computing at Georgia Tech. "In addition, physiological responses, such as increased heart rate, can impact the expression of these behaviors."
Cameras and microphones will provide an inexpensive and noninvasive way to measure eye gaze and facial and body expressions, along with speech and non-speech utterances. Wearable sensors will measure physiological variables such as heart rate and skin conductivity, which contain important clues about levels of internal stress and arousal that are linked to behavior.
The research team will also develop capabilities for synchronizing the signals from the microphones, cameras and on-body sensors. By developing and using models of social interactions, the researchers will analyze the sensor data to quantify engagement.
As part of this award, the researchers will use a behavioral screening instrument called Rapid-ABC, which is currently under development by Abowd, Emory University School of Medicine assistant professor of psychiatry Opal Ousley, and Georgia Tech School of Interactive Computing senior research scientist Rosa Arriaga. The researchers intend to utilize the information gathered from the microphones, cameras and on-body sensors to automate some of the scoring for the Rapid-ABC test.
"We hope that by incorporating this screening protocol into well-child doctor visits for children less than two years old, we can reduce the average age of autism diagnosis, which is currently about four years old," explained Arriaga.
In the future, the researchers hope to expand their work beyond autism to other developmental disorders and the general study of child behavior.
"While autism is our focus right now, this project addresses general social, communicative and repetitive behaviors, so the technologies we develop will have applicability to other childhood disorders, such as Down syndrome or attention deficit hyperactivity disorder," added Rehg.
In addition to Georgia Tech, this project includes investigators and collaborators at Boston University, Carnegie Mellon, the Emory Autism Center, the Marcus Autism Center -- an affiliate of Children's Healthcare of Atlanta, the Massachusetts Institute of Technology, the University of Illinois at Urbana-Champaign, the University of Pittsburgh, and the University of Southern California. Outreach activities include collaborations with the Atlanta Autism Consortium and major autism research centers in Atlanta, Boston, Pittsburgh, Urbana Champaign and Los Angeles.
Other Georgia Tech participants include co-principal investigators Mark Clements, a professor in the School of Electrical and Computer Engineering, and Agata Rozga, a research scientist in the School of Interactive Computing; as well as School of Interactive Computing postdoctoral fellow Mario Romero.
Source:
Abby Vogel Robinson
Georgia Institute of Technology Research News
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Current Thinking Regarding AIDS Challenged By Researchers At Tulane National Primate Research Center
A sudden loss of T cells -- white blood cells crucial to the immune system -- is not the trigger for the onset of AIDS, according to a study published in the September 2007 issue of the Journal of Immunology by a team of researchers at Tulane National Primate Research Center.
The study, "Acute Loss of Intestinal CD4+ T Cells is Not Predictive of Simian Immunodeficiency Virus Virulence," challenges current thinking regarding AIDS, namely that a sudden, acute loss of T cells is considered to be sufficient to predict progression to the disease's last stages -- final collapse of the immune system and death. The team, led by Ivona V. Pandrea and Cristian Apetrei of Tulane University, states that although a severe acute depletion of T cells (white blood cells that provide continuing immunity to infection) was previously considered to trigger progression to full-blown AIDS in humans, some non-human primates infected with simian immunodeficiency virus (SIV) do not develop AIDS after such a depletion. African green monkeys infected with SIV, for example, were found to recover even after a period of severe T cell depletion.
Two companion papers in the Journal of Immunology by researchers from the University of Pennsylvania and Southwestern University of Dallas came to the same conclusions in their studies of sooty mangabeys.
Another major question raised by the study is why monkeys with SIV, unlike HIV-positive humans, are generally resistant to progression to AIDS after infection with the virus. The answer, the authors propose, is that thousands of years of host/virus co-adaptation has enabled monkeys, the natural hosts of SIV, to effectively limit T cell immune activation and apoptosis, a mechanism that leads to progression of the disease. By contrast, humans, who were introduced to the virus relatively recently, have not had the opportunity to develop such protective adaptations.
The authors also suggested that approaches to control immune system activation and resultant cell death should be considered for use in addition to currently available therapies to slow progression of the disease in HIV-infected individuals.
Source: Arthur Nead
Tulane University
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The study, "Acute Loss of Intestinal CD4+ T Cells is Not Predictive of Simian Immunodeficiency Virus Virulence," challenges current thinking regarding AIDS, namely that a sudden, acute loss of T cells is considered to be sufficient to predict progression to the disease's last stages -- final collapse of the immune system and death. The team, led by Ivona V. Pandrea and Cristian Apetrei of Tulane University, states that although a severe acute depletion of T cells (white blood cells that provide continuing immunity to infection) was previously considered to trigger progression to full-blown AIDS in humans, some non-human primates infected with simian immunodeficiency virus (SIV) do not develop AIDS after such a depletion. African green monkeys infected with SIV, for example, were found to recover even after a period of severe T cell depletion.
Two companion papers in the Journal of Immunology by researchers from the University of Pennsylvania and Southwestern University of Dallas came to the same conclusions in their studies of sooty mangabeys.
Another major question raised by the study is why monkeys with SIV, unlike HIV-positive humans, are generally resistant to progression to AIDS after infection with the virus. The answer, the authors propose, is that thousands of years of host/virus co-adaptation has enabled monkeys, the natural hosts of SIV, to effectively limit T cell immune activation and apoptosis, a mechanism that leads to progression of the disease. By contrast, humans, who were introduced to the virus relatively recently, have not had the opportunity to develop such protective adaptations.
The authors also suggested that approaches to control immune system activation and resultant cell death should be considered for use in addition to currently available therapies to slow progression of the disease in HIV-infected individuals.
Source: Arthur Nead
Tulane University
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Kaiser Daily Health Policy Report Feature Highlights Recent Blog Entries
While mainstream news coverage is still a primary source of information for the latest in policy debates and the health care marketplace, online blogs have become a significant part of the media landscape, often presenting new perspectives on policy issues and drawing attention to under-reported topics. To provide complete coverage of health policy issues, the Kaiser Daily Health Policy Report offers readers a window into the world of blogs in a new roundup of health policy-related blog posts. "Blog Watch," published on Tuesdays and Fridays, tracks a wide range of blogs, providing a brief description and relevant links for highlighted posts.
Elizabeth Edwards of the Center for American Progress' Action Fund Wonk Room blog and Jonathan Cohn from The New Republic's The Plank discuss problems with the individual insurance market in reaction to a Los Angeles Times column, which reported that three insurers are charging men and women different rates for individual policies in California.
Congressional Budget Office Director Peter Orszag discusses a new CBO report that estimates savings for S 1695, a bill that would create a regulatory pathway for the approval of generic versions of biotechnology drugs. Sen. Mike Enzi (R-Wyo.) on The Hill's Congress Blog also discusses the report.
Jaan Sidorov from the Disease Management Care Blog hosted the most recent edition of Health Wonk Review, a biweekly compendium of more than two dozen health policy, infrastructure, insurance, technology and managed care bloggers. A different participant's blog hosts each issue.
Merrill Goozner of Gooz News and Bob Laszewski of Health Care Policy and Marketplace Review critique a recent Wall Street Journal opinion piece about legislation that would reduce funds for Medicare Advantage plans. Conn Carroll from the Heritage Foundation's The Foundry blog also weighs in on MA.
HHS Secretary Mike Leavitt completes a series of posts where he examined challenges facing lawmakers addressing fiscal concerns in the Medicare program (here, here and here.) Leavitt will submit the posts as minutes to the annual spring Medicare Trustee's meeting.
Maggie Mahar from the Health Beat Blog discusses why she thinks progressives should spend more time talking about ways to slow the growth of health care costs.
Brian Rosman from Health Care For All's A Healthy Blog posts a debate from the blog's comment section between Paul Levy, president of Beth Israel Deaconess Medical Center, and Charlie Baker, CEO of Harvard Pilgrim Health Care, about a plan in Massachusetts to publicly post hospital cost data.
Health Populi's Jane Sarasohn-Kahn discusses results from a Deloitte survey that finds three out of four patients would like to customize their health plan by choosing benefits.
Joanne Kenen from The New America Foundation's New Health Dialogue writes that price transparency is valuable but says that without comparative effectiveness data, health information technology and reimbursement changes, "we're just looking at one apple when we need to be checking the whole bushel."
Supraspinatus discusses results of an American Medical Association survey that found few patients use online rating sites to choose their physicians. Supraspinatus says that although a small percentage of patients currently use these services, the growth in use is so fast that "we will get to one-third [of patients using rating sites] long before 2010."
NewTalk hosts an online forum with health policy experts on chronic disease and health care reform.
Joe Paduda from Managed Care Matters makes predictions about possible health legislation if Democrats make gains in the 2008 election.
Theo Francis from the Wall Street Journal's Health Blog reports on a new service from Data Advantage that assigns different weights to measures of quality, affordability, efficiency and patient satisfaction to make a Hospital Value Index.
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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Elizabeth Edwards of the Center for American Progress' Action Fund Wonk Room blog and Jonathan Cohn from The New Republic's The Plank discuss problems with the individual insurance market in reaction to a Los Angeles Times column, which reported that three insurers are charging men and women different rates for individual policies in California.
Congressional Budget Office Director Peter Orszag discusses a new CBO report that estimates savings for S 1695, a bill that would create a regulatory pathway for the approval of generic versions of biotechnology drugs. Sen. Mike Enzi (R-Wyo.) on The Hill's Congress Blog also discusses the report.
Jaan Sidorov from the Disease Management Care Blog hosted the most recent edition of Health Wonk Review, a biweekly compendium of more than two dozen health policy, infrastructure, insurance, technology and managed care bloggers. A different participant's blog hosts each issue.
Merrill Goozner of Gooz News and Bob Laszewski of Health Care Policy and Marketplace Review critique a recent Wall Street Journal opinion piece about legislation that would reduce funds for Medicare Advantage plans. Conn Carroll from the Heritage Foundation's The Foundry blog also weighs in on MA.
HHS Secretary Mike Leavitt completes a series of posts where he examined challenges facing lawmakers addressing fiscal concerns in the Medicare program (here, here and here.) Leavitt will submit the posts as minutes to the annual spring Medicare Trustee's meeting.
Maggie Mahar from the Health Beat Blog discusses why she thinks progressives should spend more time talking about ways to slow the growth of health care costs.
Brian Rosman from Health Care For All's A Healthy Blog posts a debate from the blog's comment section between Paul Levy, president of Beth Israel Deaconess Medical Center, and Charlie Baker, CEO of Harvard Pilgrim Health Care, about a plan in Massachusetts to publicly post hospital cost data.
Health Populi's Jane Sarasohn-Kahn discusses results from a Deloitte survey that finds three out of four patients would like to customize their health plan by choosing benefits.
Joanne Kenen from The New America Foundation's New Health Dialogue writes that price transparency is valuable but says that without comparative effectiveness data, health information technology and reimbursement changes, "we're just looking at one apple when we need to be checking the whole bushel."
Supraspinatus discusses results of an American Medical Association survey that found few patients use online rating sites to choose their physicians. Supraspinatus says that although a small percentage of patients currently use these services, the growth in use is so fast that "we will get to one-third [of patients using rating sites] long before 2010."
NewTalk hosts an online forum with health policy experts on chronic disease and health care reform.
Joe Paduda from Managed Care Matters makes predictions about possible health legislation if Democrats make gains in the 2008 election.
Theo Francis from the Wall Street Journal's Health Blog reports on a new service from Data Advantage that assigns different weights to measures of quality, affordability, efficiency and patient satisfaction to make a Hospital Value Index.
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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COPD May Be A Problem With Autoimmunity
Moderate to severe chronic obstructive pulmonary disease (COPD) may be an auto-immunity problem, according to researchers in Spain, who studied the presence of auto-antibodies in patients with COPD and compared them to levels of control subjects. They found that a significant number of patients with COPD had significant levels of auto-antibodies circulating in their blood, about 5 to 10 times the level in controls.
The findings were published online ahead of the print edition of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine.
"We showed that between one third and one quarter of patients with clinically stable COPD present abnormal levels of circulating auto-antibodies in the blood," said Jaume Sauleda M.D., coordinator of respiratory medicine department, Hospital Universitari Son Dureta, Palma Mallorca, Spain. "Our findings provide further support for the hypothesis that the pathogenesis of COPD involves an auto-immune component."
The researchers recruited 328 patients with clinically stable COPD three months after hospitalization for the first time with an exacerbation of the disease at nine participating hospitals in Spain, and 67 healthy volunteers from primary care clinics, blood donors and hospital workers. They collected information on current and past smoking habits, comorbidities, and data such as body mass index, degree of dyspnea and six-minute walk distance. They tested lung function with spirometry.
They then took blood samples and tested the blood for antinuclear antibodies (ANA), anti-tissue antibodies (AT) including mitochondrial (AMA), liver-kidney microsomal (LKM), smoothmuscle (SMA), and parietal gastric cell (PGC) antibodies. The serum levels of C-reactive protein were also tested in patients.
"We wanted to quantify the levels of auto-antibodies in COPD with respect to the patients' lung function and disease severity. By doing so, we hoped to determine whether in fact COPD had an auto-immune aspect," said Dr. Sauleda. "COPD is the fourth-leading cause of death in the world, and is becoming increasingly common in the developing world as generations of heavy smokers age. Understanding its pathogenesis is key to developing effective treatments that go beyond symptom palliation."
The researchers found that, overall, 34 percent of COPD patients had abnormally high levels of ANA titer-a prevalence 11 times higher than seen in the control group, and 7 times higher than reported in healthy subjects in previous studies. Furthermore, 26 percent of the patients were positive for AT, a prevalence 4.5 times higher than in the controls, and 4 times higher than reported in healthy subjects in other studies.
Patients with AT tended to be younger and active smokers, and the level of these auto-antibodies was related to impairment of lung function. There were no other associations between auto-antibodies and other patient characteristics.
The much higher prevalence of auto-antibodies in COPD patients has several implications and possible explanations. Other studies have found that patients with "severe bronchitis" (which would probably be characterized as COPD today) had high levels of circulating ANA, and these results confirm those earlier findings. Recent reports have also suggested that circulating antibodies are directed against components of the lung matrix and epithelium in patients with COPD.
"We can only speculate on the mechanisms underlying the observed associations," said Dr. Sauleda. "The prevalence of ANA and AT may be non-specific markers of an ongoing auto-immune response or may be directly involved in the pathogenesis of the disease. However, these alternatives are not mutually exclusive. "Future longitudinal studies in general population evaluating the relationships between these auto-antibodies and lung function during several years can help us to unravel this issue."
Dr. Sauleda continued, "If future research confirms the suspected auto-immune component of COPD, it raises the possibility of future clinical trials evaluating possible new therapies for this disease, for instance, immunomodulators."
Source:
American Thoracic Society
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The findings were published online ahead of the print edition of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine.
"We showed that between one third and one quarter of patients with clinically stable COPD present abnormal levels of circulating auto-antibodies in the blood," said Jaume Sauleda M.D., coordinator of respiratory medicine department, Hospital Universitari Son Dureta, Palma Mallorca, Spain. "Our findings provide further support for the hypothesis that the pathogenesis of COPD involves an auto-immune component."
The researchers recruited 328 patients with clinically stable COPD three months after hospitalization for the first time with an exacerbation of the disease at nine participating hospitals in Spain, and 67 healthy volunteers from primary care clinics, blood donors and hospital workers. They collected information on current and past smoking habits, comorbidities, and data such as body mass index, degree of dyspnea and six-minute walk distance. They tested lung function with spirometry.
They then took blood samples and tested the blood for antinuclear antibodies (ANA), anti-tissue antibodies (AT) including mitochondrial (AMA), liver-kidney microsomal (LKM), smoothmuscle (SMA), and parietal gastric cell (PGC) antibodies. The serum levels of C-reactive protein were also tested in patients.
"We wanted to quantify the levels of auto-antibodies in COPD with respect to the patients' lung function and disease severity. By doing so, we hoped to determine whether in fact COPD had an auto-immune aspect," said Dr. Sauleda. "COPD is the fourth-leading cause of death in the world, and is becoming increasingly common in the developing world as generations of heavy smokers age. Understanding its pathogenesis is key to developing effective treatments that go beyond symptom palliation."
The researchers found that, overall, 34 percent of COPD patients had abnormally high levels of ANA titer-a prevalence 11 times higher than seen in the control group, and 7 times higher than reported in healthy subjects in previous studies. Furthermore, 26 percent of the patients were positive for AT, a prevalence 4.5 times higher than in the controls, and 4 times higher than reported in healthy subjects in other studies.
Patients with AT tended to be younger and active smokers, and the level of these auto-antibodies was related to impairment of lung function. There were no other associations between auto-antibodies and other patient characteristics.
The much higher prevalence of auto-antibodies in COPD patients has several implications and possible explanations. Other studies have found that patients with "severe bronchitis" (which would probably be characterized as COPD today) had high levels of circulating ANA, and these results confirm those earlier findings. Recent reports have also suggested that circulating antibodies are directed against components of the lung matrix and epithelium in patients with COPD.
"We can only speculate on the mechanisms underlying the observed associations," said Dr. Sauleda. "The prevalence of ANA and AT may be non-specific markers of an ongoing auto-immune response or may be directly involved in the pathogenesis of the disease. However, these alternatives are not mutually exclusive. "Future longitudinal studies in general population evaluating the relationships between these auto-antibodies and lung function during several years can help us to unravel this issue."
Dr. Sauleda continued, "If future research confirms the suspected auto-immune component of COPD, it raises the possibility of future clinical trials evaluating possible new therapies for this disease, for instance, immunomodulators."
Source:
American Thoracic Society
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Wall Street Journal Letter To The Editor Disputes Claims About Massachusetts Health Insurance Law
In a Jan. 31, 2007, Wall Street Journal opinion piece "condemning Massachusetts's landmark effort to insure our citizens," Shikha Dalmia, a senior analyst at the Reason Foundation, could not "wait (for the facts) to render a verdict" on the state's health insurance law, Jon Kingsdale, executive director for the Massachusetts Health Insurance Connector Authority, writes in a Journal letter to the editor.
Kingsdale writes, "Dalmia claims that spending for our subsidized plan will cost 85% 'more than originally projected' during the next fiscal year," but the "governor's budget proposal calls for $869 million," and the "original estimate by the conference committee that wrote the legislation in 2006 pegged it at $725 million," adding, "That's 20%, not 85%." In addition, Kingsdale writes that while Dalmia "claims that inflated demand combined with onerous regulations triggered premium increases of 12%" for 2008, "premiums had been rising 12% or so prior to reform," and the state is "expecting that trend to moderate" under the health insurance law.
He continues, "As of July 1, 2007, the typical uninsured individual in Massachusetts could buy a policy that covered twice as much for half the premium as that person could have bought before reform," which is "one example of how we are helping to control costs, not increase them." Kingsdale also addresses Dalmia's claim "that the cheapest plan available to a couple in their 50s" costs $8,200. He writes that the coverage is "actually much less, and when the couple takes advantage of reform to buy it with pre-tax dollars, the price is nearer to one-half" of Dalmia's "assertion."
Kingsdale concludes, "Across the country, more and more people are going without health insurance every day," but in "just 18 months, Massachusetts has newly enrolled over 300,000." He adds, "Now there's a fact. And better yet, this one is true" (Kingsdale, Wall Street Journal, 2/7).
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© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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Kingsdale writes, "Dalmia claims that spending for our subsidized plan will cost 85% 'more than originally projected' during the next fiscal year," but the "governor's budget proposal calls for $869 million," and the "original estimate by the conference committee that wrote the legislation in 2006 pegged it at $725 million," adding, "That's 20%, not 85%." In addition, Kingsdale writes that while Dalmia "claims that inflated demand combined with onerous regulations triggered premium increases of 12%" for 2008, "premiums had been rising 12% or so prior to reform," and the state is "expecting that trend to moderate" under the health insurance law.
He continues, "As of July 1, 2007, the typical uninsured individual in Massachusetts could buy a policy that covered twice as much for half the premium as that person could have bought before reform," which is "one example of how we are helping to control costs, not increase them." Kingsdale also addresses Dalmia's claim "that the cheapest plan available to a couple in their 50s" costs $8,200. He writes that the coverage is "actually much less, and when the couple takes advantage of reform to buy it with pre-tax dollars, the price is nearer to one-half" of Dalmia's "assertion."
Kingsdale concludes, "Across the country, more and more people are going without health insurance every day," but in "just 18 months, Massachusetts has newly enrolled over 300,000." He adds, "Now there's a fact. And better yet, this one is true" (Kingsdale, Wall Street Journal, 2/7).
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© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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Pure Protein Announces Soluble Class II HLA Technology Breakthrough
Pure Protein, L.L.C., a biopharmaceutical company specializing in diagnostic and therapeutic reagents for use in immunology research and development, has announced that Chief Scientist William Hildebrand, Ph.D., and his team, have developed soluble Class II human leukocyte antigens (HLA). This represents a significant technology breakthrough that can dramatically impact multiple pharmaceutical and medical sectors and has enormous market potential. Autoimmune disease is a key area of interest for HLA research and product development.
Molecular Fingerprints for the Immune System
HLA Class II proteins beneficially serve as molecular fingerprints for the immune system and direct immune responses to attack infections. But they are also responsible for initiating the rejection of transplanted organs and tissues, as well as deleterious autoimmune responses.
Each person's unique set of Class II HLA molecules provides a diverse immune response to infections. While diversity is advantageous in regards to maintaining good health, it makes studying and treating this system a challenging task. Pure Protein is now able to provide a solution through its native Class II HLA proteins to characterize and modulate human immune responses.
Pure Protein is now producing highly purified Class II HLA proteins through its patent-pending methodology. Large quantities of soluble HLA (sHLA) protein from human cell lines are available for use in transplantation, drug target discovery and bio-therapeutic development. The company's soluble HLA (sHLA) production method generates pure, single species antigens with correct cellular processing, enabling powerful insight into the workings of diseased cells and the body's response to them.
Competing HLA production methods involve destruction of the cells followed by extensive yet inefficient purification steps that do not yield highly purified protein. Pure Protein's sHLA preparations are comprised of single specificity proteins without any other components of the cell. Because the company uses a recombinant form of HLA that requires minimal downstream purification, the protein can be produced in large quantities (tens of milligrams) with high purity and specificity. This breakthrough in production will facilitate the use of HLA in therapeutic areas requiring significant clinical validation.
Market Potential and Business Development
William C. Strieber, Executive Vice President of Pure Protein, said, "Our development of an efficient way to produce soluble Class II gives Pure Protein an extraordinary opportunity to create many new avenues to the diagnosis and treatment of autoimmunity, infectious diseases, cancer and transplantation related maladies. We look forward to the new collaborations the company is building to take full advantage of the leading-edge, superior technology that we can provide market leaders."
Pure Protein's soluble Class II HLA molecules address multiple unmet needs from which a broad variety of products can be developed for several multi-billion dollar markets. The global market for autoimmune disease treatments is estimated to be at $37.84 billion in 2009, and is growing at a CAGR of $12.7% from 2009 to 2014 to reach an estimated $68.81 billion in 2014.1 The US tissue and organ clinical transplantation market is expected to grow to $5.25 billion by 2012.2 In infectious diseases therapeutics (non-antibiotic), the US market was $13.5 billion in 2005 and will likely double over the next 5 years.3 Growing at a CAGR of 12.3%, the global market for cancer drugs is expected to exceed $78 billion by 2012. Cancer vaccines and antiangiogenics will record the fastest growth rate. Drug manufacturers are now focused on developing target therapies. These drugs attack target cells and thus limit the severity of side effects.4
References:
1. Research and Markets Report, "Autoimmune Treatment (2009 - 2014)," September 10, 2009.
2. Global Industry Analysts, Inc., "Organ and Tissue Transplantation: A Global Strategic Business Report," February 2008.
3. Insight Pharma Reports, "Infectious Diseases - R and D Challenges and Market Drivers," September 2006.
4. RNCOS, "Global Cancer Treatment Forecast to 2012," August 2008.
Source
Pure Protein, L.L.C.
Emergent Technologies, Inc.
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Molecular Fingerprints for the Immune System
HLA Class II proteins beneficially serve as molecular fingerprints for the immune system and direct immune responses to attack infections. But they are also responsible for initiating the rejection of transplanted organs and tissues, as well as deleterious autoimmune responses.
Each person's unique set of Class II HLA molecules provides a diverse immune response to infections. While diversity is advantageous in regards to maintaining good health, it makes studying and treating this system a challenging task. Pure Protein is now able to provide a solution through its native Class II HLA proteins to characterize and modulate human immune responses.
Pure Protein is now producing highly purified Class II HLA proteins through its patent-pending methodology. Large quantities of soluble HLA (sHLA) protein from human cell lines are available for use in transplantation, drug target discovery and bio-therapeutic development. The company's soluble HLA (sHLA) production method generates pure, single species antigens with correct cellular processing, enabling powerful insight into the workings of diseased cells and the body's response to them.
Competing HLA production methods involve destruction of the cells followed by extensive yet inefficient purification steps that do not yield highly purified protein. Pure Protein's sHLA preparations are comprised of single specificity proteins without any other components of the cell. Because the company uses a recombinant form of HLA that requires minimal downstream purification, the protein can be produced in large quantities (tens of milligrams) with high purity and specificity. This breakthrough in production will facilitate the use of HLA in therapeutic areas requiring significant clinical validation.
Market Potential and Business Development
William C. Strieber, Executive Vice President of Pure Protein, said, "Our development of an efficient way to produce soluble Class II gives Pure Protein an extraordinary opportunity to create many new avenues to the diagnosis and treatment of autoimmunity, infectious diseases, cancer and transplantation related maladies. We look forward to the new collaborations the company is building to take full advantage of the leading-edge, superior technology that we can provide market leaders."
Pure Protein's soluble Class II HLA molecules address multiple unmet needs from which a broad variety of products can be developed for several multi-billion dollar markets. The global market for autoimmune disease treatments is estimated to be at $37.84 billion in 2009, and is growing at a CAGR of $12.7% from 2009 to 2014 to reach an estimated $68.81 billion in 2014.1 The US tissue and organ clinical transplantation market is expected to grow to $5.25 billion by 2012.2 In infectious diseases therapeutics (non-antibiotic), the US market was $13.5 billion in 2005 and will likely double over the next 5 years.3 Growing at a CAGR of 12.3%, the global market for cancer drugs is expected to exceed $78 billion by 2012. Cancer vaccines and antiangiogenics will record the fastest growth rate. Drug manufacturers are now focused on developing target therapies. These drugs attack target cells and thus limit the severity of side effects.4
References:
1. Research and Markets Report, "Autoimmune Treatment (2009 - 2014)," September 10, 2009.
2. Global Industry Analysts, Inc., "Organ and Tissue Transplantation: A Global Strategic Business Report," February 2008.
3. Insight Pharma Reports, "Infectious Diseases - R and D Challenges and Market Drivers," September 2006.
4. RNCOS, "Global Cancer Treatment Forecast to 2012," August 2008.
Source
Pure Protein, L.L.C.
Emergent Technologies, Inc.
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Veterinarians At Increased Risk Of Avian Influenza Virus Infection
Veterinarians who work with birds are at increased risk for infection with avian influenza virus and should be among those with priority access to pandemic influenza vaccines and antivirals, according to a study conducted by researchers in the University of Iowa College of Public Health.
The investigators, led by Kendall Myers, a doctoral student in occupational and environmental health, and Gregory Gray, M.D., UI professor of epidemiology, examined blood samples from a group of U.S. veterinarians for evidence of previous avian influenza virus infection. The veterinarians all had occupational exposure to live chickens, ducks, turkeys, geese or quail.
The study showed that, compared with the control group, the veterinarians who worked with birds had significantly higher levels of antibodies in their blood against the H5, H6 and H7 avian virus strains, indicating previous infections with these viruses. The infections were likely due to the mild forms of avian influenza virus that have occasionally circulated among wild and domestic birds in the United States, according to the researchers. The greatest risk factor for infection reported by veterinarians was examining birds known to be sick with influenza.
"Veterinarians and others with frequent and close contact to infected birds may be among the first to be infected with a pandemic strain of influenza," Myers said. "They have the potential to spread the illness to their families and communities. Because of this, we suggest that veterinarians should be considered for inclusion on priority access lists for pandemic influenza vaccines and antivirals."
Birds are the source of all influenza viruses in all other species, the authors noted in their study, and a better understanding of interspecies transmission of avian influenza is a crucial component in efforts to minimize the effects of the next pandemic. Health authorities worldwide are closely monitoring the H5N1 virus strain that emerged in Asia as a possible source of a pandemic.
"While these avian influenza virus infections in veterinarians were likely mild or subclinical, the story might be very different should aggressive avian influenza strains enter the United States like the H5N1 strains infecting domestic birds in Asia," Gray said. "As federal officials continue to plan for a pandemic event, it is increasingly important to identify the best ways to protect veterinarians and other agricultural workers most at risk for zoonotic diseases."
The study is published in the July 1 issue of the journal Clinical Infectious Diseases, now available online at journals.uchicago.edu/CID/home.html.
STORY SOURCE: The University of Iowa College of Public Health Office of Communications, 4257 Westlawn, Iowa City, Iowa 52242
Contact: Debra Venzke
University of Iowa
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The investigators, led by Kendall Myers, a doctoral student in occupational and environmental health, and Gregory Gray, M.D., UI professor of epidemiology, examined blood samples from a group of U.S. veterinarians for evidence of previous avian influenza virus infection. The veterinarians all had occupational exposure to live chickens, ducks, turkeys, geese or quail.
The study showed that, compared with the control group, the veterinarians who worked with birds had significantly higher levels of antibodies in their blood against the H5, H6 and H7 avian virus strains, indicating previous infections with these viruses. The infections were likely due to the mild forms of avian influenza virus that have occasionally circulated among wild and domestic birds in the United States, according to the researchers. The greatest risk factor for infection reported by veterinarians was examining birds known to be sick with influenza.
"Veterinarians and others with frequent and close contact to infected birds may be among the first to be infected with a pandemic strain of influenza," Myers said. "They have the potential to spread the illness to their families and communities. Because of this, we suggest that veterinarians should be considered for inclusion on priority access lists for pandemic influenza vaccines and antivirals."
Birds are the source of all influenza viruses in all other species, the authors noted in their study, and a better understanding of interspecies transmission of avian influenza is a crucial component in efforts to minimize the effects of the next pandemic. Health authorities worldwide are closely monitoring the H5N1 virus strain that emerged in Asia as a possible source of a pandemic.
"While these avian influenza virus infections in veterinarians were likely mild or subclinical, the story might be very different should aggressive avian influenza strains enter the United States like the H5N1 strains infecting domestic birds in Asia," Gray said. "As federal officials continue to plan for a pandemic event, it is increasingly important to identify the best ways to protect veterinarians and other agricultural workers most at risk for zoonotic diseases."
The study is published in the July 1 issue of the journal Clinical Infectious Diseases, now available online at journals.uchicago.edu/CID/home.html.
STORY SOURCE: The University of Iowa College of Public Health Office of Communications, 4257 Westlawn, Iowa City, Iowa 52242
Contact: Debra Venzke
University of Iowa
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Social Stress Leads To Atherosclerosis
Studies on genetically engineered mice show that social stress activates the immune system and accelerates the development of atherosclerosis. Commonly used drugs to reduce blood pressure, however, may stop this process. This is the conclusion of a thesis presented at the University of Gothenburg, Sweden.
Several large studies have clearly shown that there is a correlation between psychosocial stress and the risk of developing cardiovascular disease. However, little is known about why this is the case.
"The aim of my thesis was to study the underlying mechanisms by which stress leads to atherosclerosis and subsequent cardiovascular disease", explains Evelina Bernberg, researcher at the Department of Molecular and Clinical Medicine, at the Sahlgrenska Academy.
The study has been conducted using mice that have been genetically modified to spontaneously develop atherosclerosis. Using mice as experimental animals allows the scientists to study cause and effect relationships in a controlled situation.
"We found that situations that disrupt the social environment in which the mice normally live increased atherosclerosis, while more physical forms of stress did not", explains Evelina Bernberg.
The scientists discovered that social stress increased blood levels of different markers of inflammation - which previously have been shown to accelerate the development of atherosclerosis.
"When the sympathetic nervous system is activated, adrenalin is released and this increases the heart rate. We also found some evidence that the sympathetic nervous system is responsible for the release of these inflammatory markers", Evelina Bernberg relates.
This release could be reduced by commonly used blood pressure medication, beta-blockers. The same beta-blockers also reduced atherosclerosis and the release of inflammatory markers in unstressed mice, showing that the sympathetic nervous system plays an important role in the development of atherosclerosis.
"Our studies suggest that social stress that activates the immune system is also the type of stress that can lead to the development of atherosclerosis, but we need to confirm whether our studies on gene-modified mice also reflect the situation in humans. It is possible that commonly used beta-blockers to a certain extent may prevent stress from leading to atherosclerosis", says Evelina Bernberg.
ATHEROSCLEROSIS
Atherosclerosis is initiated when cholesterol enters the blood vessel wall and atherosclerotic plaques are formed. Atherosclerosis is the major underlying cause of cardiovascular disease, such as angina, myocardial infarction and stroke. Diseases related to atherosclerosis cause 40-50% of deaths in Sweden.
The thesis has been successfully defended.
Source:
Evelina Bernberg
University of Gothenburg
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Several large studies have clearly shown that there is a correlation between psychosocial stress and the risk of developing cardiovascular disease. However, little is known about why this is the case.
"The aim of my thesis was to study the underlying mechanisms by which stress leads to atherosclerosis and subsequent cardiovascular disease", explains Evelina Bernberg, researcher at the Department of Molecular and Clinical Medicine, at the Sahlgrenska Academy.
The study has been conducted using mice that have been genetically modified to spontaneously develop atherosclerosis. Using mice as experimental animals allows the scientists to study cause and effect relationships in a controlled situation.
"We found that situations that disrupt the social environment in which the mice normally live increased atherosclerosis, while more physical forms of stress did not", explains Evelina Bernberg.
The scientists discovered that social stress increased blood levels of different markers of inflammation - which previously have been shown to accelerate the development of atherosclerosis.
"When the sympathetic nervous system is activated, adrenalin is released and this increases the heart rate. We also found some evidence that the sympathetic nervous system is responsible for the release of these inflammatory markers", Evelina Bernberg relates.
This release could be reduced by commonly used blood pressure medication, beta-blockers. The same beta-blockers also reduced atherosclerosis and the release of inflammatory markers in unstressed mice, showing that the sympathetic nervous system plays an important role in the development of atherosclerosis.
"Our studies suggest that social stress that activates the immune system is also the type of stress that can lead to the development of atherosclerosis, but we need to confirm whether our studies on gene-modified mice also reflect the situation in humans. It is possible that commonly used beta-blockers to a certain extent may prevent stress from leading to atherosclerosis", says Evelina Bernberg.
ATHEROSCLEROSIS
Atherosclerosis is initiated when cholesterol enters the blood vessel wall and atherosclerotic plaques are formed. Atherosclerosis is the major underlying cause of cardiovascular disease, such as angina, myocardial infarction and stroke. Diseases related to atherosclerosis cause 40-50% of deaths in Sweden.
The thesis has been successfully defended.
Source:
Evelina Bernberg
University of Gothenburg
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TAU Develops New Medical Management Tool To Combat Swine Flu, Viral Outbreaks
As swine flu spreads across America, good data can make all the difference in controlling it.
Who needs to get antiviral medications first? Who can wait? When should counties and states shut down airports, schools, and highways? When should they tell people to stay home from school and work?
As America - and the world - braces for the worst, a team of Tel Aviv University mathematicians says it may have a solution that can save both time and lives. Prof. Lewi Stone and his colleagues at TAU's Department of Life Sciences are creating a statistical tool which, they believe, has the power to macro- and micromanage pandemic influenza outbreaks.
Their secret weapon is the most extensive database in the world dealing with influenza outbreaks. "We've accessed a veritable gold-mine of data, collected over 10 years in Israel by a large network of hospital and medical clinics," says Prof. Stone. "It gives us a country-wide picture of what a seasonal flu is like and how much worse it would be if there were a swine flu pandemic.
The best data in the world
Two American teams tried to predict what would happen to the swine flu when it started infecting Americans, with limited success. The Israeli team believes that their approach - a set of modeling tools modular in design - will be more successful. One reason is their impressive data set. Another is the modular way the model is conceived: The models are complicated when the existing data is good, simpler when key variables are missing.
"Based on our study of influenza outbreaks in Israel," says Dr. Amit Huppert of the Gertner Institute at Israel's Tel Hashomer Hospital, who is collaborating on the research, "we can estimate the rate at which the virus spreads in towns with a very young population. These communities are especially at risk. Communities in the U.S. with a high population of children can be advised to stock up on anti-virals."
"It's taken a lot of work to remove the 'noise' from the data set in a careful way," says Prof. Stone. Some doctors misclassified other respiratory illnesses as the flu, or perpetrated other doctors' reporting errors.
Finetuning for the worst
The TAU researchers also took into account that the swine flu will attack more people than an annual seasonal flu, because most people have only limited immunity to the new H1N1 swine flu. These factors are worked into the model so that communities, hospitals and bodies like the United Nations or the Center for Disease Control can make better decisions in planning.
Prof. Stone believes that we haven't seen the worst of the swine flu yet. "The pandemic, if it's like the previous one, will come in waves," he says. "The first wave is the weaker one and rather wimpy. It's not very dangerous. We still have to brace ourselves for the worst.
"Our model provides guidance for complex decisions such as whether to close airports, schools, and travel routes, and how to distribute Tamiflu," Prof. Stone continues. "It could be applied to very small populations as well as populations as large as 6 to 10 million people and more."
Funded by Epiwork, a European Union project, the Tel Aviv University team - which also includes Dr. Haggai Katriel, Uri Roll, Oren Barnea and Rami Yaari, all from TAU's Faculty of Life Sciences - hopes to have a commercial version of the model available in three years. Prof. Stone, one of the project's managers, is a world expert in managing childhood epidemics like measles and mumps, and published a landmark study on his work two years ago in Nature.
The new Tel Aviv University model might also be used to understand bio-terror attacks, should such a catastrophic event take place.
Source:
George Hunka
American Friends of Tel Aviv University
View drug information on Tamiflu capsule.
Buy Tetracycline Without Prescription
Who needs to get antiviral medications first? Who can wait? When should counties and states shut down airports, schools, and highways? When should they tell people to stay home from school and work?
As America - and the world - braces for the worst, a team of Tel Aviv University mathematicians says it may have a solution that can save both time and lives. Prof. Lewi Stone and his colleagues at TAU's Department of Life Sciences are creating a statistical tool which, they believe, has the power to macro- and micromanage pandemic influenza outbreaks.
Their secret weapon is the most extensive database in the world dealing with influenza outbreaks. "We've accessed a veritable gold-mine of data, collected over 10 years in Israel by a large network of hospital and medical clinics," says Prof. Stone. "It gives us a country-wide picture of what a seasonal flu is like and how much worse it would be if there were a swine flu pandemic.
The best data in the world
Two American teams tried to predict what would happen to the swine flu when it started infecting Americans, with limited success. The Israeli team believes that their approach - a set of modeling tools modular in design - will be more successful. One reason is their impressive data set. Another is the modular way the model is conceived: The models are complicated when the existing data is good, simpler when key variables are missing.
"Based on our study of influenza outbreaks in Israel," says Dr. Amit Huppert of the Gertner Institute at Israel's Tel Hashomer Hospital, who is collaborating on the research, "we can estimate the rate at which the virus spreads in towns with a very young population. These communities are especially at risk. Communities in the U.S. with a high population of children can be advised to stock up on anti-virals."
"It's taken a lot of work to remove the 'noise' from the data set in a careful way," says Prof. Stone. Some doctors misclassified other respiratory illnesses as the flu, or perpetrated other doctors' reporting errors.
Finetuning for the worst
The TAU researchers also took into account that the swine flu will attack more people than an annual seasonal flu, because most people have only limited immunity to the new H1N1 swine flu. These factors are worked into the model so that communities, hospitals and bodies like the United Nations or the Center for Disease Control can make better decisions in planning.
Prof. Stone believes that we haven't seen the worst of the swine flu yet. "The pandemic, if it's like the previous one, will come in waves," he says. "The first wave is the weaker one and rather wimpy. It's not very dangerous. We still have to brace ourselves for the worst.
"Our model provides guidance for complex decisions such as whether to close airports, schools, and travel routes, and how to distribute Tamiflu," Prof. Stone continues. "It could be applied to very small populations as well as populations as large as 6 to 10 million people and more."
Funded by Epiwork, a European Union project, the Tel Aviv University team - which also includes Dr. Haggai Katriel, Uri Roll, Oren Barnea and Rami Yaari, all from TAU's Faculty of Life Sciences - hopes to have a commercial version of the model available in three years. Prof. Stone, one of the project's managers, is a world expert in managing childhood epidemics like measles and mumps, and published a landmark study on his work two years ago in Nature.
The new Tel Aviv University model might also be used to understand bio-terror attacks, should such a catastrophic event take place.
Source:
George Hunka
American Friends of Tel Aviv University
View drug information on Tamiflu capsule.
Buy Tetracycline Without Prescription
About 11% Of Children Lack Health Insurance, Report Finds
About 11% of U.S. children lack health insurance, according to the 18th annual "Kids Count" report released on Wednesday by the Annie E. Casey Foundation, the San Francisco Chronicle reports. The report measured the progress of each state since 2000 in 10 areas -- infant mortality rates, teenage birth and mortality rates, child mortality rates, rates of low-birthweight infants, and child poverty rates -- based on Census Bureau data from 2004 or 2005, the most recent information available (Franko, San Francisco Chronicle, 7/25). In addition, the report ranked states in each area, as well as overall (AP/Winston-Salem Journal, 7/25).
The report found that Minnesota, New Hampshire and Connecticut ranked the highest overall and that Alabama, Louisiana and Mississippi ranked the lowest (Smith, Richmond Times-Dispatch, 7/25). According to the report, the national infant mortality rate decreased to 6.8 per 1,000 live births in 2004 from 6.9 per 1,000 in 2000 (Fitzpatrick, Providence Journal, 7/25). The report also found that the national birth rate among teens ages 15 to 19 decreased to 41 per 1,000 in 2004 from 48 per 1,000 in 2000 and that the mortality rate among teens ages 15 to 19 decreased to 66 per 100,000 in 2004 from 67 per 100,000 in 2000 (Crawford, Arizona Republic, 7/25).
Elizabeth Hudgins, senior director of policy research at Action for Children North Carolina, said that states "need to think creatively about strategies to make sure children get what they need," adding that the report "really provides some guidance in moving forward" (AP/Winston-Salem Journal, 7/25).
The report 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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The report found that Minnesota, New Hampshire and Connecticut ranked the highest overall and that Alabama, Louisiana and Mississippi ranked the lowest (Smith, Richmond Times-Dispatch, 7/25). According to the report, the national infant mortality rate decreased to 6.8 per 1,000 live births in 2004 from 6.9 per 1,000 in 2000 (Fitzpatrick, Providence Journal, 7/25). The report also found that the national birth rate among teens ages 15 to 19 decreased to 41 per 1,000 in 2004 from 48 per 1,000 in 2000 and that the mortality rate among teens ages 15 to 19 decreased to 66 per 100,000 in 2004 from 67 per 100,000 in 2000 (Crawford, Arizona Republic, 7/25).
Elizabeth Hudgins, senior director of policy research at Action for Children North Carolina, said that states "need to think creatively about strategies to make sure children get what they need," adding that the report "really provides some guidance in moving forward" (AP/Winston-Salem Journal, 7/25).
The report 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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New Analyses Of Data From RE-LY Trial, Involving Oral Anticoagulant Pradaxa, To Be Presented At American Heart Association's Scientific Sessions
Results of two pre-specified sub-study analyses of the 18,113 patient RE-LY® trial,(1) involving the newly approved oral anticoagulant Pradaxa® (dabigatran etexilate mesylate) capsules,(2) will be presented at the American Heart Association's Annual Scientific Sessions on Monday, November 15, 2010. The analyses assessed the prognostic value of two separate biomarkers (D-dimer and NT-proBNP) for predicting cardiovascular events in patients with non-valvular atrial fibrillation (AFib).(3,4)
RE-LY® was a global, Phase III, randomized trial, which investigated whether PRADAXA was as effective as well-controlled warfarin (open label) for stroke prevention in patients with non-valvular atrial fibrillation.(1) The study provided the basis for the U.S. Food and Drug Administration's (FDA) recent approval of PRADAXA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.(2)
Well-controlled warfarin, defined as INR 2.0 - 3.0, has been shown to reduce the risk of stroke in patients with non-valvular atrial fibrillation.(5) Results of the RE-LY® trial demonstrated PRADAXA 150mg taken twice daily significantly reduced stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin.(2) PRADAXA 150mg taken twice daily also significantly reduced both ischemic and hemorrhagic strokes compared to warfarin.(2)
PRADAXA is the only approved oral anticoagulant that has been shown to significantly reduce the risk of stroke compared to warfarin(2) and is the first oral anticoagulant to be approved in the U.S. in more than 50 years. PRADAXA is now available in more than 35,000 pharmacies nationwide.
About RE-LY®
RE-LY® was a global, Phase III, randomized trial(1) of 18,113 patients(1) enrolled in 951 centers in 44 countries,(6) investigating whether PRADAXA (two blinded doses) was as effective as well-controlled warfarin INR 2.0 - 3.0 (open label) for stroke prevention.(1) Patients with non-valvular AFib and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, age greater than or equal to 75 years, age greater than or equal to 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension)(6) were enrolled in the study for two years with a minimum follow-up period of one year.(1)
The RE-LY® trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) clinical trial protocol,(1) which has been used in the previous trials of anticoagulation for stroke prevention in patients with AFib.(1) A PROBE design may reflect the differences in the management of warfarin and PRADAXA in clinical practice.(1)
The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.(1) Safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction and other adverse events.(1)
In the RE-LY® trial, all clinical outcomes were adjudicated in a blinded manner to minimize bias in assessment of outcomes for each treatment.(1)
About Atrial Fibrillation and Stroke
Atrial fibrillation, characterized by an irregular heartbeat,(7) can cause blood clots to form in the heart that can travel to the brain and cause a stroke.(7) An estimated 2.3 million Americans are living with AFib,(8) and the prevalence is expected to increase to 5.6 million by 2050.(8) A large managed care database study showed that non-valvular atrial fibrillation represents approximately 95 percent of all atrial fibrillation cases in the U.S.(8) Atrial fibrillation increases the risk of stroke nearly five times(9) and is associated with up to 15 percent of all strokes in the U.S.(9) Strokes associated with AFib can be about twice as likely to be fatal(10) or severely disabling as non-AFib strokes.(11) Atrial fibrillation imposes a substantial economic burden to the healthcare system,(12) specifically the high costs associated with stroke.(13)
About Pradaxa® (dabigatran etexilate) Capsules
Indications and Usage
PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
CONTRAINDICATIONS
PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.
WARNINGS AND PRECAUTIONS
Risk of Bleeding
PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.
Risk factors for bleeding include:
-- Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).
-- Labor and delivery
Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.
Temporary Discontinuation of PRADAXA
Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke. Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.
Effect of P-gp Inducers and Inhibitors on PRADAXA Exposure
The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided. P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments. These results should not be extrapolated to other P-gp inhibitors.
ADVERSE REACTIONS
In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal events. PRADAXA 150 mg resulted in a higher rate of major gastrointestinal (GI) bleeds and any GI bleeds compared to warfarin. In patients greater than or equal to 75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were commonly dyspepsia (including abdominal pain, upper abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, gastritis, and GI ulcer). Drug hypersensitivity reactions were reported in Buy Prograf Without Prescription
RE-LY® was a global, Phase III, randomized trial, which investigated whether PRADAXA was as effective as well-controlled warfarin (open label) for stroke prevention in patients with non-valvular atrial fibrillation.(1) The study provided the basis for the U.S. Food and Drug Administration's (FDA) recent approval of PRADAXA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.(2)
Well-controlled warfarin, defined as INR 2.0 - 3.0, has been shown to reduce the risk of stroke in patients with non-valvular atrial fibrillation.(5) Results of the RE-LY® trial demonstrated PRADAXA 150mg taken twice daily significantly reduced stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin.(2) PRADAXA 150mg taken twice daily also significantly reduced both ischemic and hemorrhagic strokes compared to warfarin.(2)
PRADAXA is the only approved oral anticoagulant that has been shown to significantly reduce the risk of stroke compared to warfarin(2) and is the first oral anticoagulant to be approved in the U.S. in more than 50 years. PRADAXA is now available in more than 35,000 pharmacies nationwide.
About RE-LY®
RE-LY® was a global, Phase III, randomized trial(1) of 18,113 patients(1) enrolled in 951 centers in 44 countries,(6) investigating whether PRADAXA (two blinded doses) was as effective as well-controlled warfarin INR 2.0 - 3.0 (open label) for stroke prevention.(1) Patients with non-valvular AFib and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, age greater than or equal to 75 years, age greater than or equal to 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension)(6) were enrolled in the study for two years with a minimum follow-up period of one year.(1)
The RE-LY® trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) clinical trial protocol,(1) which has been used in the previous trials of anticoagulation for stroke prevention in patients with AFib.(1) A PROBE design may reflect the differences in the management of warfarin and PRADAXA in clinical practice.(1)
The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.(1) Safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction and other adverse events.(1)
In the RE-LY® trial, all clinical outcomes were adjudicated in a blinded manner to minimize bias in assessment of outcomes for each treatment.(1)
About Atrial Fibrillation and Stroke
Atrial fibrillation, characterized by an irregular heartbeat,(7) can cause blood clots to form in the heart that can travel to the brain and cause a stroke.(7) An estimated 2.3 million Americans are living with AFib,(8) and the prevalence is expected to increase to 5.6 million by 2050.(8) A large managed care database study showed that non-valvular atrial fibrillation represents approximately 95 percent of all atrial fibrillation cases in the U.S.(8) Atrial fibrillation increases the risk of stroke nearly five times(9) and is associated with up to 15 percent of all strokes in the U.S.(9) Strokes associated with AFib can be about twice as likely to be fatal(10) or severely disabling as non-AFib strokes.(11) Atrial fibrillation imposes a substantial economic burden to the healthcare system,(12) specifically the high costs associated with stroke.(13)
About Pradaxa® (dabigatran etexilate) Capsules
Indications and Usage
PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
CONTRAINDICATIONS
PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.
WARNINGS AND PRECAUTIONS
Risk of Bleeding
PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.
Risk factors for bleeding include:
-- Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).
-- Labor and delivery
Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.
Temporary Discontinuation of PRADAXA
Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke. Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.
Effect of P-gp Inducers and Inhibitors on PRADAXA Exposure
The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided. P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments. These results should not be extrapolated to other P-gp inhibitors.
ADVERSE REACTIONS
In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal events. PRADAXA 150 mg resulted in a higher rate of major gastrointestinal (GI) bleeds and any GI bleeds compared to warfarin. In patients greater than or equal to 75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were commonly dyspepsia (including abdominal pain, upper abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, gastritis, and GI ulcer). Drug hypersensitivity reactions were reported in Buy Prograf Without Prescription
Researchers Stop Muscle Weakness Caused By Myasthenia Gravis
Severe muscle weakness caused by myasthenia gravis a highly debilitating autoimmune disorder can be prevented or reversed by blocking a key step in the immune response that brings on the disease, researchers at the Saint Louis University School of Medicine have found.
Myasthenia gravis, which affects about 120,000 Americans, is caused when the immune system produces antibodies that attack and damage acetylcholine receptors, which are mechanisms that play a key role in transmitting the electrical impulses that cause muscles to move and contract.
The immune response at the heart of this process is called a complement cascade a complex chain of chemical reactions in which proteins bind together to attack a cell by punching a hole in it. When acetylcholine receptors are damaged in this way, muscle movement is severely impaired.
Using an animal model, the SLU scientists found they could prevent muscle weakness, or restore muscle strength, caused by myasthenia gravis by stopping the complement cascade at a step called C5 before the series of chemical reactions had finished. They did this by administering an anti C5 agent, which targets one of the proteins involved in the cascade and thus stops the process.
The researchers' findings are published in a recent edition of the Journal of Immunology.
Henry J. Kaminski, M.D., professor and chairman of the department of neurology and psychiatry at the Saint Louis University School of Medicine, one of the study's authors, said the findings are promising enough that human clinical trials involving the anti C5 agent called eculizumab are likely within a year.
"We believe this therapeutic approach has strong potential for improving the lives of patients with myasthenia gravis," Kaminski said. "And if it proves successful there, it could also one day help us find new therapies for other auto-immune disorders, such as rheumatoid arthritis and lupus."
Myasthenia gravis affects roughly 400 per 1 million people. The severe muscle weakness caused by the disease brings a host of other complications, including difficulty breathing, difficulty chewing and swallowing, slurred speech, droopy eyelids and blurred or double vision. By preventing or reversing the muscle weakness, the other symptoms are prevented or reversed as well.
Myasthenia gravis can't be cured, but it is sometimes be treated with surgery to remove the thymus (which plays a role in the immune system) or with various drugs. Surgery often doesn't bring relief, however, and the medications typically decrease in effectiveness over time or, in the case of immunosupressants and corticosteriods, have severe side effects.
In addition to Kaminski, the study's authors include Yuefang Zhou, Ph.D., and Bendi Gong, Ph.D., both of Saint Louis University; M. Edward Medof, M.D., and Feng Lin, Ph.D., both of the Institute of Pathology at Case Western Reserve University in Cleveland; and Russell Rother, Ph.D., of Alexion Pharmaceuticals in Cheshire, Conn.
The research was supported by grants from the National Institutes of Health.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
Saint Louis University Medical Center
St. Louis, MO 63103
United States
Saint Louis University Medical Center
Buy Cystone Without Prescription
Myasthenia gravis, which affects about 120,000 Americans, is caused when the immune system produces antibodies that attack and damage acetylcholine receptors, which are mechanisms that play a key role in transmitting the electrical impulses that cause muscles to move and contract.
The immune response at the heart of this process is called a complement cascade a complex chain of chemical reactions in which proteins bind together to attack a cell by punching a hole in it. When acetylcholine receptors are damaged in this way, muscle movement is severely impaired.
Using an animal model, the SLU scientists found they could prevent muscle weakness, or restore muscle strength, caused by myasthenia gravis by stopping the complement cascade at a step called C5 before the series of chemical reactions had finished. They did this by administering an anti C5 agent, which targets one of the proteins involved in the cascade and thus stops the process.
The researchers' findings are published in a recent edition of the Journal of Immunology.
Henry J. Kaminski, M.D., professor and chairman of the department of neurology and psychiatry at the Saint Louis University School of Medicine, one of the study's authors, said the findings are promising enough that human clinical trials involving the anti C5 agent called eculizumab are likely within a year.
"We believe this therapeutic approach has strong potential for improving the lives of patients with myasthenia gravis," Kaminski said. "And if it proves successful there, it could also one day help us find new therapies for other auto-immune disorders, such as rheumatoid arthritis and lupus."
Myasthenia gravis affects roughly 400 per 1 million people. The severe muscle weakness caused by the disease brings a host of other complications, including difficulty breathing, difficulty chewing and swallowing, slurred speech, droopy eyelids and blurred or double vision. By preventing or reversing the muscle weakness, the other symptoms are prevented or reversed as well.
Myasthenia gravis can't be cured, but it is sometimes be treated with surgery to remove the thymus (which plays a role in the immune system) or with various drugs. Surgery often doesn't bring relief, however, and the medications typically decrease in effectiveness over time or, in the case of immunosupressants and corticosteriods, have severe side effects.
In addition to Kaminski, the study's authors include Yuefang Zhou, Ph.D., and Bendi Gong, Ph.D., both of Saint Louis University; M. Edward Medof, M.D., and Feng Lin, Ph.D., both of the Institute of Pathology at Case Western Reserve University in Cleveland; and Russell Rother, Ph.D., of Alexion Pharmaceuticals in Cheshire, Conn.
The research was supported by grants from the National Institutes of Health.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
Saint Louis University Medical Center
St. Louis, MO 63103
United States
Saint Louis University Medical Center
Buy Cystone Without Prescription
American Heart Association Enhances ELearning For Emergency Cardiovascular Care (ECC)
For many years, American Heart
Association research has supported education and training programs for
Emergency Cardiovascular Care (ECC) that save thousands of lives each year.
Now, healthcare providers have more ways to access the American Heart
Association's research-based ECC programs, as the organization introduces a
significantly expanded eLearning program. That means more people, taking
more courses, and saving more lives.
The expansion of the ECC Web-based eLearning offerings takes advantage
of advances in technology and instructional design to deliver certain
courses in a format that maximizes flexibility and consistency, while also
saving participants time and money. The new eLearning offerings include a
mix of online-only and "blended" courses -- which include basic online
instruction with required hands-on training and assessment -- depending on
the assessment and certification required. For example, courses involving
strictly cognitive learning can be completed as eLearning modules online.
Programs that rely heavily on effective CPR require skills practice and
testing, and will need to be scheduled with an authorized American Heart
Association Training Center.
Prior to this expansion, the American Heart Association's ECC program
provided training through traditional instructor-led classroom courses,
"micro-simulation" instruction using computerized manikins, and a limited
mix of stand-alone online modules and blended courses. The new eLearning
courses add to these offerings and help further the American Heart
Association's commitment to develop learning programs that cover the entire
educational spectrum through the most effective, research-based teaching
methodologies available, no matter the delivery format.
"Changes in technology and a greater general acceptance of eLearning
have made this the right time for the American Heart Association to enhance
its eLearning programs for emergency cardiovascular care training," said
William W. Hammill, M.D., Director of Cardiopulmonary and Vascular Services
for Martha Jefferson Hospital, and chair, American Heart Association ECC
First Aid Task Force. "Now, healthcare providers will not only have access
to traditional instructor-led classroom courses to complete their training
requirements, but they will also have a greater array of options to
complete certain courses when their schedules allow, without being tied to
a specific classroom at a specific time. The convenience and cost savings
associated with eLearning programs will make them an invaluable component
of a full spectrum of educational and training options."
The eLearning course lineup includes the following options:
Stand-alone online courses
-- Basic ECG Rhythm Recognition, called Learn Rhythm - Adult, which covers
basic heart rhythms, arrhythmias and rhythm recognition, and which is
an excellent educational tool for healthcare workers holding Basic Life
Support certification who seek to take Advanced Life Support (course
available soon online)
-- Stroke Prehospital Care Online, which will cover risk factors,
diagnosis, assessment and management of potential strokes
Blended courses
-- The AHA Healthcare Provider Course, HeartCode(TM) BLS Anywhere (course
available soon online)
-- BLS Healthcare Provider (HCP) Online Renewal
-- Heartsaver(R) First Aid Online
-- Heartsaver(R) First Aid Online With CPR and AED Renewal
The American Heart Association's ECC eLearning initiative corresponds
with research by the American Society for Training and Development that
shows the use of technology-based training delivery methods increased by
nearly five-fold between 1999 and 2005. In addition, research by the
healthcare compliance company HCPro, Inc. indicated that education and
human resource leaders at 34 of the nation's largest multi-facility
healthcare systems viewed online instruction as an extremely effective,
convenient and time-efficient training method. The reasons for such a
positive view are that eLearning helps overcome many barriers that prevent
people from completing required training, such as inflexible schedules,
difficulty in attending training sessions or unease in traditional
classroom environments.
The new ECC eLearning modules fulfill a wide range of learning needs,
including preparing for success in a traditional classroom course, updating
professional skills and preparing for a medical emergency, following
through on a commitment to ongoing training, and earning CE credit or
achieving certification. While the first eLearning courses are primarily
targeted to healthcare providers who need to keep their skills current,
ultimately there will be more courses directed toward the general public,
reflecting the American Heart Association's commitment to teach lifesaving
skills to a greater number of people.
"Being able to reach so many more people through these expanded
eLearning programs will be a critical factor in meeting the American Heart
Association's goal of training 20 million people in emergency
cardiovascular care by 2010," said Dr. Hammill. "Combining the
research-based nature of our courses with the convenience and flexibility
of eLearning can help improve outcomes for patients, which ultimately is
the goal of our emergency cardiovascular care training."
About the American Heart Association
Founded in 1924, the American Heart Association today is the nation's
oldest and largest voluntary health organization dedicated to reducing
disability and death from diseases of the heart and stroke. These diseases,
America's No. 1 and No. 3 killers, and all other cardiovascular diseases
claim over 870,000 lives a year. In fiscal year 2005-06 the association
invested over $543 million in research, professional and public education,
advocacy and community service programs to help all Americans live longer,
healthier lives.
American Heart Association
onlineaha
Buy Cleocin Without Prescription
Association research has supported education and training programs for
Emergency Cardiovascular Care (ECC) that save thousands of lives each year.
Now, healthcare providers have more ways to access the American Heart
Association's research-based ECC programs, as the organization introduces a
significantly expanded eLearning program. That means more people, taking
more courses, and saving more lives.
The expansion of the ECC Web-based eLearning offerings takes advantage
of advances in technology and instructional design to deliver certain
courses in a format that maximizes flexibility and consistency, while also
saving participants time and money. The new eLearning offerings include a
mix of online-only and "blended" courses -- which include basic online
instruction with required hands-on training and assessment -- depending on
the assessment and certification required. For example, courses involving
strictly cognitive learning can be completed as eLearning modules online.
Programs that rely heavily on effective CPR require skills practice and
testing, and will need to be scheduled with an authorized American Heart
Association Training Center.
Prior to this expansion, the American Heart Association's ECC program
provided training through traditional instructor-led classroom courses,
"micro-simulation" instruction using computerized manikins, and a limited
mix of stand-alone online modules and blended courses. The new eLearning
courses add to these offerings and help further the American Heart
Association's commitment to develop learning programs that cover the entire
educational spectrum through the most effective, research-based teaching
methodologies available, no matter the delivery format.
"Changes in technology and a greater general acceptance of eLearning
have made this the right time for the American Heart Association to enhance
its eLearning programs for emergency cardiovascular care training," said
William W. Hammill, M.D., Director of Cardiopulmonary and Vascular Services
for Martha Jefferson Hospital, and chair, American Heart Association ECC
First Aid Task Force. "Now, healthcare providers will not only have access
to traditional instructor-led classroom courses to complete their training
requirements, but they will also have a greater array of options to
complete certain courses when their schedules allow, without being tied to
a specific classroom at a specific time. The convenience and cost savings
associated with eLearning programs will make them an invaluable component
of a full spectrum of educational and training options."
The eLearning course lineup includes the following options:
Stand-alone online courses
-- Basic ECG Rhythm Recognition, called Learn Rhythm - Adult, which covers
basic heart rhythms, arrhythmias and rhythm recognition, and which is
an excellent educational tool for healthcare workers holding Basic Life
Support certification who seek to take Advanced Life Support (course
available soon online)
-- Stroke Prehospital Care Online, which will cover risk factors,
diagnosis, assessment and management of potential strokes
Blended courses
-- The AHA Healthcare Provider Course, HeartCode(TM) BLS Anywhere (course
available soon online)
-- BLS Healthcare Provider (HCP) Online Renewal
-- Heartsaver(R) First Aid Online
-- Heartsaver(R) First Aid Online With CPR and AED Renewal
The American Heart Association's ECC eLearning initiative corresponds
with research by the American Society for Training and Development that
shows the use of technology-based training delivery methods increased by
nearly five-fold between 1999 and 2005. In addition, research by the
healthcare compliance company HCPro, Inc. indicated that education and
human resource leaders at 34 of the nation's largest multi-facility
healthcare systems viewed online instruction as an extremely effective,
convenient and time-efficient training method. The reasons for such a
positive view are that eLearning helps overcome many barriers that prevent
people from completing required training, such as inflexible schedules,
difficulty in attending training sessions or unease in traditional
classroom environments.
The new ECC eLearning modules fulfill a wide range of learning needs,
including preparing for success in a traditional classroom course, updating
professional skills and preparing for a medical emergency, following
through on a commitment to ongoing training, and earning CE credit or
achieving certification. While the first eLearning courses are primarily
targeted to healthcare providers who need to keep their skills current,
ultimately there will be more courses directed toward the general public,
reflecting the American Heart Association's commitment to teach lifesaving
skills to a greater number of people.
"Being able to reach so many more people through these expanded
eLearning programs will be a critical factor in meeting the American Heart
Association's goal of training 20 million people in emergency
cardiovascular care by 2010," said Dr. Hammill. "Combining the
research-based nature of our courses with the convenience and flexibility
of eLearning can help improve outcomes for patients, which ultimately is
the goal of our emergency cardiovascular care training."
About the American Heart Association
Founded in 1924, the American Heart Association today is the nation's
oldest and largest voluntary health organization dedicated to reducing
disability and death from diseases of the heart and stroke. These diseases,
America's No. 1 and No. 3 killers, and all other cardiovascular diseases
claim over 870,000 lives a year. In fiscal year 2005-06 the association
invested over $543 million in research, professional and public education,
advocacy and community service programs to help all Americans live longer,
healthier lives.
American Heart Association
onlineaha
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Early Exposure To Pets Does Not Increase Children's Risk Of Allergies
A new study published in the journal Clinical & Experimental Allergy reveals that keeping a dog or cat in the home does not increase children's risk of becoming allergic to the pets.
Parents of young children frequently want to know whether keeping a dog or cat in their home will increase the risk of their children becoming allergic to their pets.
Led by Ganesa Wegienka, MS, PhD, of the Department of Public Health Sciences, Henry Ford Hospital, researchers followed a group of children from birth until they reached adulthood. Periodic contact was made with the parents and the children to collect information about exposure to cats and dogs.
At age 18 years, 565 study participants supplied blood samples to the researchers, who measured antibodies to dog and cat allergens in the samples.
Results found that being exposed to the specific animal in the first year of life was the most important exposure period, and the exposure appeared protective in some groups.
Young men whose families had kept an indoor dog during their first year of life had about half the risk of becoming sensitized to dogs compared to those whose families did not keep a dog in the first year of life.
Both men and women were about half as likely to be sensitized to cats if they had lived with a cat in the first year of life, compared to those who did not live with cats.
"This research provides further evidence that experiences in the first year of life are associated with health status later in life, and that early life pet exposure does not put most children at risk of being sensitized to these animals later in life," Wegienka concludes.
Full citation:
"Lifetime dog and cat exposure and dog- and cat-specific sensitization at age 18 years"
Wegienka et al.
Clinical & Experimental Allergy
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Parents of young children frequently want to know whether keeping a dog or cat in their home will increase the risk of their children becoming allergic to their pets.
Led by Ganesa Wegienka, MS, PhD, of the Department of Public Health Sciences, Henry Ford Hospital, researchers followed a group of children from birth until they reached adulthood. Periodic contact was made with the parents and the children to collect information about exposure to cats and dogs.
At age 18 years, 565 study participants supplied blood samples to the researchers, who measured antibodies to dog and cat allergens in the samples.
Results found that being exposed to the specific animal in the first year of life was the most important exposure period, and the exposure appeared protective in some groups.
Young men whose families had kept an indoor dog during their first year of life had about half the risk of becoming sensitized to dogs compared to those whose families did not keep a dog in the first year of life.
Both men and women were about half as likely to be sensitized to cats if they had lived with a cat in the first year of life, compared to those who did not live with cats.
"This research provides further evidence that experiences in the first year of life are associated with health status later in life, and that early life pet exposure does not put most children at risk of being sensitized to these animals later in life," Wegienka concludes.
Full citation:
"Lifetime dog and cat exposure and dog- and cat-specific sensitization at age 18 years"
Wegienka et al.
Clinical & Experimental Allergy
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FDA Petitioned By Nonagenarian Researcher To Ban Trans Fats
I request to ban trans fats from the American diet."
Thus begins a 3,000-word petition to the Food and Drug Administration, the work of a man on a dogged, decades-old crusade to eradicate trans fats from food.
Fred Kummerow, a 94-year-old University of Illinois veterinary biosciences professor emeritus who still conducts research on the health effects of trans fats in the diet, filed the petition with the FDA last month. The petition is now posted on the FDA Web site, and public comments are invited. (See below for information on viewing the petition and making a comment.)
"Everybody should read my petition because it will scare the hell out of them," Kummerow said.
Trans fats contribute to the two main causes of heart disease: blood clots in the coronary arteries that can lead to sudden death from a heart attack, and atherosclerosis, the buildup of plaque in the arteries that interferes with blood flow, he said. Trans fats are also known to increase low-density lipoproteins (LDLs) in the blood and to spur inflammation, both of which contribute to heart disease.
Trans fats displace the essential fatty acids linoleic acid (omega-6) and linolenic acid (omega-3), which the body needs for a variety of functions. Kummerow's own research, published last month in the journal Atherosclerosis, found that trans fats also interfere with the function of a key enzyme essential to blood flow regulation.
An earlier study from Kummerow's lab found that pregnant sows fed a diet that included trans fats passed significant quantities of the trans fats to their offspring during nursing. The piglets' plasma levels of trans fats increased from 5 percent three days after birth to 15.3 percent at 6 weeks of age.
Kummerow believes the FDA's requirement (begun in 2006) that trans fats be included on food labels is inadequate and misleading. Anything less than one-half gram of trans fats per serving can be listed as zero grams. This means that people are getting the mistaken impression that their food is trans fat-free, he said.
Although Kummerow began publishing on trans fats in 1957, his efforts against trans fats in food began in earnest in 1968, when he urged the American Heart Association to ask the Institute of Shortening and Edible Oils to have its members decrease the amount of trans fatty acids in shortenings and margarines, replacing them with essential fatty acids.
"Even then, there was strong evidence that trans fatty acids increased plasma cholesterol levels," Kummerow said.
The food oil industry reluctantly agreed to lower the trans fatty acid content and increase essential fatty acids in its products. That change coincided with a dramatic decline in coronary heart disease mortality after 1968. Kummerow believes the decline in the dietary intake of trans fats and the increase in linoleic acid could explain at least part of the reduction in mortality due to heart disease.
To reinforce his message, Kummerow keeps in his lab a sample of human arteries that are clogged with atherosclerotic plaque. Another unfortunate characteristic of trans fats is that they cause cells to increase calcium in the blood, which builds up in and narrows the arteries, the main symptom of atherosclerosis.
Atherosclerosis makes the arteries "look like old scrub boards," Kummerow said. "They look corrugated. This corrugation builds up to the point where it will stop blood flow."
Kummerow's petition was filed Aug. 7, 2009. The FDA has 180 days to respond.
"According to American Heart Association data, nearly 2,400 Americans die of heart disease each day," Kummerow said. "This statistic shows the importance of a quick response."
To view and comment on the petition, visit regulations. Under "Enter Keyword or ID," type the petition docket number: "2009-P-0382" and click on the "Search" button. Once you get the results, scroll down the right-hand column and click on "Submit a Comment." Enter your information on the left and write your comment in the box on the right.
The full petition is also available at news.illinois.edu/WebsandThumbs/kummerow,fred/FDA-petition.pdf
Source:
Diana Yates
University of Illinois at Urbana-Champaign
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Thus begins a 3,000-word petition to the Food and Drug Administration, the work of a man on a dogged, decades-old crusade to eradicate trans fats from food.
Fred Kummerow, a 94-year-old University of Illinois veterinary biosciences professor emeritus who still conducts research on the health effects of trans fats in the diet, filed the petition with the FDA last month. The petition is now posted on the FDA Web site, and public comments are invited. (See below for information on viewing the petition and making a comment.)
"Everybody should read my petition because it will scare the hell out of them," Kummerow said.
Trans fats contribute to the two main causes of heart disease: blood clots in the coronary arteries that can lead to sudden death from a heart attack, and atherosclerosis, the buildup of plaque in the arteries that interferes with blood flow, he said. Trans fats are also known to increase low-density lipoproteins (LDLs) in the blood and to spur inflammation, both of which contribute to heart disease.
Trans fats displace the essential fatty acids linoleic acid (omega-6) and linolenic acid (omega-3), which the body needs for a variety of functions. Kummerow's own research, published last month in the journal Atherosclerosis, found that trans fats also interfere with the function of a key enzyme essential to blood flow regulation.
An earlier study from Kummerow's lab found that pregnant sows fed a diet that included trans fats passed significant quantities of the trans fats to their offspring during nursing. The piglets' plasma levels of trans fats increased from 5 percent three days after birth to 15.3 percent at 6 weeks of age.
Kummerow believes the FDA's requirement (begun in 2006) that trans fats be included on food labels is inadequate and misleading. Anything less than one-half gram of trans fats per serving can be listed as zero grams. This means that people are getting the mistaken impression that their food is trans fat-free, he said.
Although Kummerow began publishing on trans fats in 1957, his efforts against trans fats in food began in earnest in 1968, when he urged the American Heart Association to ask the Institute of Shortening and Edible Oils to have its members decrease the amount of trans fatty acids in shortenings and margarines, replacing them with essential fatty acids.
"Even then, there was strong evidence that trans fatty acids increased plasma cholesterol levels," Kummerow said.
The food oil industry reluctantly agreed to lower the trans fatty acid content and increase essential fatty acids in its products. That change coincided with a dramatic decline in coronary heart disease mortality after 1968. Kummerow believes the decline in the dietary intake of trans fats and the increase in linoleic acid could explain at least part of the reduction in mortality due to heart disease.
To reinforce his message, Kummerow keeps in his lab a sample of human arteries that are clogged with atherosclerotic plaque. Another unfortunate characteristic of trans fats is that they cause cells to increase calcium in the blood, which builds up in and narrows the arteries, the main symptom of atherosclerosis.
Atherosclerosis makes the arteries "look like old scrub boards," Kummerow said. "They look corrugated. This corrugation builds up to the point where it will stop blood flow."
Kummerow's petition was filed Aug. 7, 2009. The FDA has 180 days to respond.
"According to American Heart Association data, nearly 2,400 Americans die of heart disease each day," Kummerow said. "This statistic shows the importance of a quick response."
To view and comment on the petition, visit regulations. Under "Enter Keyword or ID," type the petition docket number: "2009-P-0382" and click on the "Search" button. Once you get the results, scroll down the right-hand column and click on "Submit a Comment." Enter your information on the left and write your comment in the box on the right.
The full petition is also available at news.illinois.edu/WebsandThumbs/kummerow,fred/FDA-petition.pdf
Source:
Diana Yates
University of Illinois at Urbana-Champaign
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US Kids Given More Psychotropic Drugs
A new international study found that children in the US were up to three times more likely to be given psychotropic drugs as kids in Germany and The
Netherlands; and the researchers suggested this was because of differences in policies on drug advertising, drug classication, and cultural beliefs about
using drugs to treat children's emotional and behavioural problems.
The population-based study is published in the open access journal Child and Adolescent Psychiatry and Mental Health and was the work of lead
researcher Dr Julie M Zito of the School of Pharmacy, University of Maryland, Baltimore, US, and colleagues from the US, Germany and The Netherlands.
There is much controversy over different country practices (and between the US and Western Europe in particular) in the use of antidepressants, like Prozac, and stimulants, like Ritalin, to treat children with behavioural and emotional problems.
For the study the researchers looked at administrative claims from major health insurance schemes made in 2000 in the United
States, Germany and The the Netherlands, for use by nearly 6,000 children from 0 to 19 years of age. The key measure was the annual prevalence of psychotropic medication, which they defined as the "dispensing of 1 or more prescriptions for a
psychotropic drug during the study year (2000) per 100 enrolled youth".
Zito and colleagues found that:
The annual prevalence of any psychotropic medication for children aged 0 to 19 years was significantly greater in the US (6.7 per cent) than in
the Netherlands (2.9 per cent) and in Germany (2.0 per cent).
Prevalence of antidepressants and stimulants was 3 or more times greater in the US than in The Netherlands and Germany.
Prevalence of antipsychotics was 1.5 to 2.2 times greater in the US than in The Netherlands and Germany.
Atypical antipsychotics represented only 5 per cent of antipsychotic use in Germany, but 48 per cent in The Netherlands and 66 per cent in the
US.
Less commonly prescribed drugs such as alpha agonists, lithium and antiparkinsonian agents, were more prevalent among US kids followed by much rarer use
(less than 0.05 per cent) among Dutch and German children.
Though rarely used, anxiolytics were twice as common in Dutch as in US and German kids.
Prescription hypnotics were half as common as anxiolytics in Dutch and US kids and very uncommon in German.
Using more than one drug at a time was far more common among the US kids (19.2 per cent prevalence); in fact it was more than double that of Dutch and
three times that of German kids.
The authors concluded that:
"Prominent differences in psychotropic medication treatment patterns exist between youth in the US and Western Europe and within Western Europe."
They suggested that:
"Differences in policies regarding direct to consumer drug advertising, government regulatory restrictions, reimbursement policies, as well as diagnostic
classification systems, and cultural beliefs regarding the role of medication for emotional and behavioral treatment are likely to account for these
differences."
"A three-country comparison of psychotropic medication prevalence in youth."
Zito JM, Safer DJ, de Jong-van den Berg LTW, Janhsen K, Fegert JM, Gardner JF, Glaeske G, Valluri SC.
Child and Adolescent Psychiatry and Mental Health 2008, 2:26 (25 September 2008).
Click here for Abstract.
Source: Journal article.
: Catharine Paddock, PhD
View drug information on Prozac Weekly; Ritalin LA.
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Netherlands; and the researchers suggested this was because of differences in policies on drug advertising, drug classication, and cultural beliefs about
using drugs to treat children's emotional and behavioural problems.
The population-based study is published in the open access journal Child and Adolescent Psychiatry and Mental Health and was the work of lead
researcher Dr Julie M Zito of the School of Pharmacy, University of Maryland, Baltimore, US, and colleagues from the US, Germany and The Netherlands.
There is much controversy over different country practices (and between the US and Western Europe in particular) in the use of antidepressants, like Prozac, and stimulants, like Ritalin, to treat children with behavioural and emotional problems.
For the study the researchers looked at administrative claims from major health insurance schemes made in 2000 in the United
States, Germany and The the Netherlands, for use by nearly 6,000 children from 0 to 19 years of age. The key measure was the annual prevalence of psychotropic medication, which they defined as the "dispensing of 1 or more prescriptions for a
psychotropic drug during the study year (2000) per 100 enrolled youth".
Zito and colleagues found that:
The annual prevalence of any psychotropic medication for children aged 0 to 19 years was significantly greater in the US (6.7 per cent) than in
the Netherlands (2.9 per cent) and in Germany (2.0 per cent).
Prevalence of antidepressants and stimulants was 3 or more times greater in the US than in The Netherlands and Germany.
Prevalence of antipsychotics was 1.5 to 2.2 times greater in the US than in The Netherlands and Germany.
Atypical antipsychotics represented only 5 per cent of antipsychotic use in Germany, but 48 per cent in The Netherlands and 66 per cent in the
US.
Less commonly prescribed drugs such as alpha agonists, lithium and antiparkinsonian agents, were more prevalent among US kids followed by much rarer use
(less than 0.05 per cent) among Dutch and German children.
Though rarely used, anxiolytics were twice as common in Dutch as in US and German kids.
Prescription hypnotics were half as common as anxiolytics in Dutch and US kids and very uncommon in German.
Using more than one drug at a time was far more common among the US kids (19.2 per cent prevalence); in fact it was more than double that of Dutch and
three times that of German kids.
The authors concluded that:
"Prominent differences in psychotropic medication treatment patterns exist between youth in the US and Western Europe and within Western Europe."
They suggested that:
"Differences in policies regarding direct to consumer drug advertising, government regulatory restrictions, reimbursement policies, as well as diagnostic
classification systems, and cultural beliefs regarding the role of medication for emotional and behavioral treatment are likely to account for these
differences."
"A three-country comparison of psychotropic medication prevalence in youth."
Zito JM, Safer DJ, de Jong-van den Berg LTW, Janhsen K, Fegert JM, Gardner JF, Glaeske G, Valluri SC.
Child and Adolescent Psychiatry and Mental Health 2008, 2:26 (25 September 2008).
Click here for Abstract.
Source: Journal article.
: Catharine Paddock, PhD
View drug information on Prozac Weekly; Ritalin LA.
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News From The Journal Of Clinical Investigation June 20, 2008
Overcoming resistance to a cancer drug
Drugs that target members of the EGFR family of proteins have proven effective for the treatment of certain types of cancer, including breast cancer. However, in a large number of patients for whom the treatment initially works well, the tumor recurs and is resistant to the effects of the drug. New insight into the mechanisms of tumor resistance to a drug known as gefitinib, which targets EGFR, has now been provided by a team of researchers at Vanderbilt University Medical Center, Nashville, and Massachusetts General Hospital Cancer Center, Charlestown. As discussed by both the authors and, in an accompanying commentary, Mark Greene and Qiang Wang, at the University of Pennsylvania Medical Center, Philadelphia, these observations help us understand why tumors become resistant to the effects of EGFR-targeted drugs, information that is essential if more effective therapies are to be developed.
The team, led by Carlos Arteaga and Jeffrey Engelman, generated cancer cells resistant to the effects of gefitinib and found that these cells were constantly sending signals from a protein on their surface known as IGF1R. This meant that two proteins known as IRS-1 and PI3K were always associated. If this association was disrupted then the cells once again became susceptible to the effects of gefitinib. Further analysis showed that if mice with a human tumor were treated with gefitinib and a drug inhibiting IGF1R their tumors did not recur, whereas neither drug alone could prevent tumor recurrence. The authors therefore suggest that drug combinations that target both EGFR and IGF1R might be of benefit to individuals with cancers that are responsive to EGFR-targeted therapies.
TITLE: Acquired resistance to EGFR tyrosine kinase inhibitors in cancer cells is mediated by loss of IGF-binding proteins
AUTHOR CONTACT:
Carlos L. Arteaga
Vanderbilt University Medical Center, Nashville, Tennessee, USA
Jeffrey A. Engelman
Massachusetts General Hospital Cancer Center, Harvard Medical School, Charlestown, Massachusetts, USA.
View the PDF of this article at: https://www.the-jci/article.php?id=34588
ACCOMPANYING COMMENTARY
TITLE: Mechanisms of resistance to ErbB-targeted cancer therapeutics
AUTHOR CONTACT:
Mark I. Greene
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
View the PDF of this article at: https://www.the-jci/article.php?id=36260
How an anticancer drug dampens the immune system
Drugs known as HDAC inhibitors, which have antitumor activity and can be used to treat some forms of skin cancer and some types of leukemia, are also known to have anti-inflammatory properties, but the mechanisms by which they modulate the immune system have not been determined. New data, generated by Pavan Reddy and colleagues, at the University of Michigan Cancer Center, Ann Arbor, have now indicated one mechanism by which HDAC inhibitors modulate the mouse and human immune system and the information gained has been used to develop an approach to protect mice from graft-versus-host disease after bone marrow transplantation.
In the study, two different HDAC inhibitors were shown to prevent mouse and human immune cells known as dendritic cells (DCs) from initiating proinflammatory immune responses in vitro. Further, if DCs treated ex vivo with HDAC inhibitors were injected into mice after they had received a bone marrow transplant, the incidence and severity of graft-versus-host disease was dramatically reduced. Detailed analysis revealed that the HDAC inhibitors mediated their effects by inducing DCs to express more of a molecule known as IDO, which is a suppressor of DC function. The authors therefore hope that their data provide support for studies to determine whether HDAC inhibitors might be of benefit to individuals receiving bone marrow transplants and to those with other immune-mediated diseases.
TITLE: Histone deacetylase inhibition modulates indoleamine 2,3-dioxygenase-dependent DC functions and regulates experimental graft-versus-host disease in mice
AUTHOR CONTACT:
Pavan Reddy
University of Michigan Cancer Center, Ann Arbor, Michigan, USA.
View the PDF of this article at: https://www.the-jci/article.php?id=34712
A prickly problem: hedgehog signaling in the blood vessels of the heart
New data, generated by David Ornitz and colleagues, at Washington University School of Medicine, St. Louis, have indicated a crucial role for signaling pathways that involve the protein sonic hedgehog in maintaining the blood vessels that supply the mouse heart and keep it beating. These data have implications for drug development as they suggest that antagonists of hedgehog signaling pathways, such as those being developed as anticancer therapeutics, might have unwanted side effects.
In the study, mice lacking the ability to mediate hedgehog signaling in cells that form part of the blood vessels that supply the heart were found to die of heart failure. This was because in the absence of hedgehog signaling the blood vessels of the heart were lost, meaning that the heart cells were no longer supplied with enough oxygen and died. Although these data indicate a need for caution when developing clinical antagonists of hedgehog signaling, it is possible that the degree of inhibition needed to have a clinical effect on tumor development might not have the effect on blood vessels of the heart that completely eliminating expression of the protein does.
TITLE: Hedgehog signaling is critical for maintenance of the adult coronary vasculature in mice
AUTHOR CONTACT:
David M. Ornitz
Washington University School of Medicine, St. Louis, Missouri, USA.
View the PDF of this article at: https://www.the-jci/article.php?id=34561
Immune cells cause inflammation by destroying an anti-inflammatory protein
Among the first cells of the immune system to respond to microorganisms that invade our body are neutrophils. Although neutrophils are considered the "good guys" in such circumstances, they also contribute to the noninfectious chronic inflammation that underlies various diseases, including autoimmune diseases such as rheumatoid arthritis. One mechanism by which neutrophils protect us is to internalize microorganisms and destroy them using proteins known as neutrophil serine proteases (NSPs), but whether NSPs have a role in noninfectious chronic inflammation has not been clearly determined. However, using mice lacking two very similar NSPs, PR3 and NE, a team of researchers at the Max-Planck-Institute of Neurobiology, Germany, have now shown that these two NSPs have a crucial role in one form of noninfectious chronic inflammation. Detailed analysis revealed that PR3 and NE destroy an anti-inflammatory molecule known as PGRN and in this way help to promote inflammation in the absence of invading microorganisms. The authors therefore suggest that these data provide rationale for considering inhibitors of NSPs as anti-inflammatory drugs.
TITLE: Proteinase 3 and neutrophil elastase enhance inflammation in mice by inactivating antiinflammatory progranulin
AUTHOR CONTACT:
Kai Kessenbrock
Max-Planck-Institute of Neurobiology, Martinsried, Germany.
Dieter E. Jenne
Max-Planck-Institute of Neurobiology, Martinsried, Germany.
View the PDF of this article at: https://www.the-jci/article.php?id=34694
Source: Karen Honey
Journal of Clinical Investigation
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Drugs that target members of the EGFR family of proteins have proven effective for the treatment of certain types of cancer, including breast cancer. However, in a large number of patients for whom the treatment initially works well, the tumor recurs and is resistant to the effects of the drug. New insight into the mechanisms of tumor resistance to a drug known as gefitinib, which targets EGFR, has now been provided by a team of researchers at Vanderbilt University Medical Center, Nashville, and Massachusetts General Hospital Cancer Center, Charlestown. As discussed by both the authors and, in an accompanying commentary, Mark Greene and Qiang Wang, at the University of Pennsylvania Medical Center, Philadelphia, these observations help us understand why tumors become resistant to the effects of EGFR-targeted drugs, information that is essential if more effective therapies are to be developed.
The team, led by Carlos Arteaga and Jeffrey Engelman, generated cancer cells resistant to the effects of gefitinib and found that these cells were constantly sending signals from a protein on their surface known as IGF1R. This meant that two proteins known as IRS-1 and PI3K were always associated. If this association was disrupted then the cells once again became susceptible to the effects of gefitinib. Further analysis showed that if mice with a human tumor were treated with gefitinib and a drug inhibiting IGF1R their tumors did not recur, whereas neither drug alone could prevent tumor recurrence. The authors therefore suggest that drug combinations that target both EGFR and IGF1R might be of benefit to individuals with cancers that are responsive to EGFR-targeted therapies.
TITLE: Acquired resistance to EGFR tyrosine kinase inhibitors in cancer cells is mediated by loss of IGF-binding proteins
AUTHOR CONTACT:
Carlos L. Arteaga
Vanderbilt University Medical Center, Nashville, Tennessee, USA
Jeffrey A. Engelman
Massachusetts General Hospital Cancer Center, Harvard Medical School, Charlestown, Massachusetts, USA.
View the PDF of this article at: https://www.the-jci/article.php?id=34588
ACCOMPANYING COMMENTARY
TITLE: Mechanisms of resistance to ErbB-targeted cancer therapeutics
AUTHOR CONTACT:
Mark I. Greene
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
View the PDF of this article at: https://www.the-jci/article.php?id=36260
How an anticancer drug dampens the immune system
Drugs known as HDAC inhibitors, which have antitumor activity and can be used to treat some forms of skin cancer and some types of leukemia, are also known to have anti-inflammatory properties, but the mechanisms by which they modulate the immune system have not been determined. New data, generated by Pavan Reddy and colleagues, at the University of Michigan Cancer Center, Ann Arbor, have now indicated one mechanism by which HDAC inhibitors modulate the mouse and human immune system and the information gained has been used to develop an approach to protect mice from graft-versus-host disease after bone marrow transplantation.
In the study, two different HDAC inhibitors were shown to prevent mouse and human immune cells known as dendritic cells (DCs) from initiating proinflammatory immune responses in vitro. Further, if DCs treated ex vivo with HDAC inhibitors were injected into mice after they had received a bone marrow transplant, the incidence and severity of graft-versus-host disease was dramatically reduced. Detailed analysis revealed that the HDAC inhibitors mediated their effects by inducing DCs to express more of a molecule known as IDO, which is a suppressor of DC function. The authors therefore hope that their data provide support for studies to determine whether HDAC inhibitors might be of benefit to individuals receiving bone marrow transplants and to those with other immune-mediated diseases.
TITLE: Histone deacetylase inhibition modulates indoleamine 2,3-dioxygenase-dependent DC functions and regulates experimental graft-versus-host disease in mice
AUTHOR CONTACT:
Pavan Reddy
University of Michigan Cancer Center, Ann Arbor, Michigan, USA.
View the PDF of this article at: https://www.the-jci/article.php?id=34712
A prickly problem: hedgehog signaling in the blood vessels of the heart
New data, generated by David Ornitz and colleagues, at Washington University School of Medicine, St. Louis, have indicated a crucial role for signaling pathways that involve the protein sonic hedgehog in maintaining the blood vessels that supply the mouse heart and keep it beating. These data have implications for drug development as they suggest that antagonists of hedgehog signaling pathways, such as those being developed as anticancer therapeutics, might have unwanted side effects.
In the study, mice lacking the ability to mediate hedgehog signaling in cells that form part of the blood vessels that supply the heart were found to die of heart failure. This was because in the absence of hedgehog signaling the blood vessels of the heart were lost, meaning that the heart cells were no longer supplied with enough oxygen and died. Although these data indicate a need for caution when developing clinical antagonists of hedgehog signaling, it is possible that the degree of inhibition needed to have a clinical effect on tumor development might not have the effect on blood vessels of the heart that completely eliminating expression of the protein does.
TITLE: Hedgehog signaling is critical for maintenance of the adult coronary vasculature in mice
AUTHOR CONTACT:
David M. Ornitz
Washington University School of Medicine, St. Louis, Missouri, USA.
View the PDF of this article at: https://www.the-jci/article.php?id=34561
Immune cells cause inflammation by destroying an anti-inflammatory protein
Among the first cells of the immune system to respond to microorganisms that invade our body are neutrophils. Although neutrophils are considered the "good guys" in such circumstances, they also contribute to the noninfectious chronic inflammation that underlies various diseases, including autoimmune diseases such as rheumatoid arthritis. One mechanism by which neutrophils protect us is to internalize microorganisms and destroy them using proteins known as neutrophil serine proteases (NSPs), but whether NSPs have a role in noninfectious chronic inflammation has not been clearly determined. However, using mice lacking two very similar NSPs, PR3 and NE, a team of researchers at the Max-Planck-Institute of Neurobiology, Germany, have now shown that these two NSPs have a crucial role in one form of noninfectious chronic inflammation. Detailed analysis revealed that PR3 and NE destroy an anti-inflammatory molecule known as PGRN and in this way help to promote inflammation in the absence of invading microorganisms. The authors therefore suggest that these data provide rationale for considering inhibitors of NSPs as anti-inflammatory drugs.
TITLE: Proteinase 3 and neutrophil elastase enhance inflammation in mice by inactivating antiinflammatory progranulin
AUTHOR CONTACT:
Kai Kessenbrock
Max-Planck-Institute of Neurobiology, Martinsried, Germany.
Dieter E. Jenne
Max-Planck-Institute of Neurobiology, Martinsried, Germany.
View the PDF of this article at: https://www.the-jci/article.php?id=34694
Source: Karen Honey
Journal of Clinical Investigation
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MedPAC Chair Discusses Challenges In Interview With The Hill
The Hill on Friday published an interview with Glenn Hackbarth, chair of the Medicare Payment Advisory Commission, who discussed problems with the long-term financial stability of Medicare, reimbursements for private Medicare Advantage plans and physician reimbursements, among other issues. According to Hackbarth, problems with long-term financial stability are the "biggest" threat to Medicare, and, although "people pay lip service to it at times," no one "is really addressing the issue in a substantive way." He added that MedPAC is "really concerned about the lack of attention" to the issue because the longer the U.S. waits to address the problems, "the more difficult" the problems will become.
Hackbarth also said that health care has become a "very prominent" issue in the current presidential campaign. "It'll be interesting to see whether we are prepared to actually do something. Difficult choices will be required and a lot of consensus building required," he said.
In addition, Hackbarth said that MedPAC supports the "basic idea" of MA, which "is to offer beneficiaries the opportunity to enroll in private health plans," but does "think that private plans ought to be ... paid the same amount" as traditional Medicare "would have spent on behalf of the same beneficiaries." Hackbarth added that the "flaw" in MA "is the (payment) benchmarks that are set for the plans" because "those benchmarks are not market-set prices," but "prices that were set by Congress as part of a political process."
Hackbarth also discussed efforts to revise the "sustainable growth rate" formula used to determine Medicare physician reimbursements. According to Hackbarth, the problem with the formula "is the budget baseline created by the SGR mechanism," which "is so low relative to current payments that it's really a barrier to trying to do something sensible to reform physician payments" (Young, The Hill, 9/21).
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© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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Hackbarth also said that health care has become a "very prominent" issue in the current presidential campaign. "It'll be interesting to see whether we are prepared to actually do something. Difficult choices will be required and a lot of consensus building required," he said.
In addition, Hackbarth said that MedPAC supports the "basic idea" of MA, which "is to offer beneficiaries the opportunity to enroll in private health plans," but does "think that private plans ought to be ... paid the same amount" as traditional Medicare "would have spent on behalf of the same beneficiaries." Hackbarth added that the "flaw" in MA "is the (payment) benchmarks that are set for the plans" because "those benchmarks are not market-set prices," but "prices that were set by Congress as part of a political process."
Hackbarth also discussed efforts to revise the "sustainable growth rate" formula used to determine Medicare physician reimbursements. According to Hackbarth, the problem with the formula "is the budget baseline created by the SGR mechanism," which "is so low relative to current payments that it's really a barrier to trying to do something sensible to reform physician payments" (Young, The Hill, 9/21).
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© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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World's First Dedicated HIV Neutralizing Antibody Center Launched By Scripps Research Institute And IAVI
The Scripps Research Institute, one of the world's largest independent, non-profit biomedical research organizations, and the International AIDS Vaccine Initiative (IAVI), the world's only global non-profit organization focused solely on AIDS vaccine development, today announced the establishment of a new research center dedicated exclusively to solving the most pressing challenge facing AIDS vaccine researchers today. Located at The Scripps Research Institute and linked to a network of research institutions in Africa, Asia, Europe and the U.S., the center will develop vaccine candidates devised to elicit broadly neutralizing antibodies against HIV, which are almost certainly essential to preventing infection by the virus.
"The world needs an AIDS vaccine to turn the tide on this devastating pandemic. Scripps Research is delighted to partner with IAVI to establish the world's first center dedicated to tackling the toughest challenge facing AIDS vaccine researchers today," said Richard A. Lerner, M.D., President of The Scripps Research Institute. "We are confident that this center will facilitate more productive exchanges among researchers and stimulate new ideas that will help to accelerate AIDS vaccine science."
Under a five-year supplemental agreement extending the existing collaboration between IAVI and Scripps Research, IAVI will invest $30 million to support the creation of the world's only HIV Neutralizing Antibody Center comprised of multidisciplinary scientific teams, including IAVI scientists, focused on designing vaccines to prevent HIV infection. The first brick-and-mortar institution of its kind, the center at Scripps Research will bring together a critical mass of structural biologists, virologists, chemists, immunologists and computational biologists who will work daily side-by-side to tease out how to generate broadly neutralizing antibodies against HIV.
This new center will link to an expanded international scientific Consortium, which was created and is currently project managed by IAVI and known as the Neutralizing Antibody Consortium or NAC. The center and broader NAC will collaborate closely with many levels of IAVI's research program. For example, leading concepts identified by the NAC scientists will be rapidly translated into clinical candidates for human testing at IAVI's AIDS Vaccine Development Laboratory in New York.
"Collaboration is essential to making things happen, so the more we bring people together to promote scientific interaction, the more rapid our progress will be toward the creation of an effective AIDS vaccine," said Dennis Burton, Ph.D., Professor in The Scripps Research Institute Department of Immunology and Microbial Science and Scientific Director of IAVI's NAC. "This reinvigorated approach will also make it easier for us to recruit and mentor the young scientists who represent the future of HIV/AIDS vaccine research. And it will also mean that our scientists will spend less time traveling and attending meetings and more time focused on how to solve the problem of how to generate neutralizing antibodies against HIV."
The scientific community has made solid advances in the HIV antibody field over the past few years. Researchers have successfully crystallized several broadly neutralizing antibodies to HIV, determined their structures down to the atomic level, and used this information to get a handle on how each disables HIV. They are now applying what they have learned to develop immunogens that, when delivered as vaccines, will reliably induce these antibodies in all people - with the goal of preventing HIV infection.
"Finding a way to elicit neutralizing antibodies against HIV is the biggest challenge facing AIDS vaccine researchers today. IAVI is establishing the HIV Neutralizing Antibody Center at The Scripps Research Institute and expanding our Consortium to ensure that the best minds and institutions are dedicated to solving this problem," said Dr. Seth Berkley, President and CEO of IAVI. "We are excited and hopeful that this collaboration will help to bring us closer to developing a vaccine that will help end the AIDS pandemic."
"Our existing partnership with IAVI, and this additional funding, will allow us to expand our own efforts and to take a more focused approach to the extremely difficult but vital task of finding an effective antibody-inducing component for an AIDS vaccine," said Burton who is renowned for his work on antibodies and antibody responses to HIV. "We believe that the center will coordinate, support and streamline the work being done around the world in laboratories associated with the NAC."
IAVI created the NAC six years ago to address a neglected area of AIDS vaccine research and development. Its purpose was to focus attention on the potential of neutralizing antibodies at a time when vaccine candidates in preclinical and clinical testing were devised almost exclusively to elicit cell-mediated immune (CMI) responses. Most existing vaccines against other diseases work by eliciting neutralizing antibodies.
The NAC is part of a global AIDS vaccine discovery program that extends to Africa, Asia and Europe. Current members of the Consortium include IAVI, The Scripps Research Institute, Academia Sinica, Cornell University, the Dana-Farber Cancer Institute, the Children's Hospital of Philadelphia, the Karolinska Institute, Harvard Medical School, the Indian Institute of Science, Oxford University, the Institute for Research in Biomedicine, the International Centre for Genetic Engineering and Biotechnology, the University of Pennsylvania, the University of Washington, the University of Wisconsin and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.
"The HIV vaccine neutralizing antibody problem is solvable, and its solution is a prerequisite for a successful AIDS vaccine," said Dr. Wayne Koff, IAVI Senior Vice President, Research and Development. "By establishing this center of multidisciplinary experts at Scripps, we expect to solve the problem and accelerate the development of a safe and effective AIDS vaccine."
About The Scripps Research Institute
The Scripps Research Institute is one of the world's largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus by 2009. For more information, please visit scripps.edu.
About IAVI
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI's financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health, The John D. Evans Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust, The Rockefeller Foundation, The Starr Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, India, Ireland, The Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Bristol-Myers Squibb, Continental Airlines, Google Inc., Henry Schein, Inc., Merck & Co., Inc. and Pfizer Inc; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There's A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world. For more information, see iavi/.
Source: Rachel Steinhardt
International AIDS Vaccine Initiative
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"The world needs an AIDS vaccine to turn the tide on this devastating pandemic. Scripps Research is delighted to partner with IAVI to establish the world's first center dedicated to tackling the toughest challenge facing AIDS vaccine researchers today," said Richard A. Lerner, M.D., President of The Scripps Research Institute. "We are confident that this center will facilitate more productive exchanges among researchers and stimulate new ideas that will help to accelerate AIDS vaccine science."
Under a five-year supplemental agreement extending the existing collaboration between IAVI and Scripps Research, IAVI will invest $30 million to support the creation of the world's only HIV Neutralizing Antibody Center comprised of multidisciplinary scientific teams, including IAVI scientists, focused on designing vaccines to prevent HIV infection. The first brick-and-mortar institution of its kind, the center at Scripps Research will bring together a critical mass of structural biologists, virologists, chemists, immunologists and computational biologists who will work daily side-by-side to tease out how to generate broadly neutralizing antibodies against HIV.
This new center will link to an expanded international scientific Consortium, which was created and is currently project managed by IAVI and known as the Neutralizing Antibody Consortium or NAC. The center and broader NAC will collaborate closely with many levels of IAVI's research program. For example, leading concepts identified by the NAC scientists will be rapidly translated into clinical candidates for human testing at IAVI's AIDS Vaccine Development Laboratory in New York.
"Collaboration is essential to making things happen, so the more we bring people together to promote scientific interaction, the more rapid our progress will be toward the creation of an effective AIDS vaccine," said Dennis Burton, Ph.D., Professor in The Scripps Research Institute Department of Immunology and Microbial Science and Scientific Director of IAVI's NAC. "This reinvigorated approach will also make it easier for us to recruit and mentor the young scientists who represent the future of HIV/AIDS vaccine research. And it will also mean that our scientists will spend less time traveling and attending meetings and more time focused on how to solve the problem of how to generate neutralizing antibodies against HIV."
The scientific community has made solid advances in the HIV antibody field over the past few years. Researchers have successfully crystallized several broadly neutralizing antibodies to HIV, determined their structures down to the atomic level, and used this information to get a handle on how each disables HIV. They are now applying what they have learned to develop immunogens that, when delivered as vaccines, will reliably induce these antibodies in all people - with the goal of preventing HIV infection.
"Finding a way to elicit neutralizing antibodies against HIV is the biggest challenge facing AIDS vaccine researchers today. IAVI is establishing the HIV Neutralizing Antibody Center at The Scripps Research Institute and expanding our Consortium to ensure that the best minds and institutions are dedicated to solving this problem," said Dr. Seth Berkley, President and CEO of IAVI. "We are excited and hopeful that this collaboration will help to bring us closer to developing a vaccine that will help end the AIDS pandemic."
"Our existing partnership with IAVI, and this additional funding, will allow us to expand our own efforts and to take a more focused approach to the extremely difficult but vital task of finding an effective antibody-inducing component for an AIDS vaccine," said Burton who is renowned for his work on antibodies and antibody responses to HIV. "We believe that the center will coordinate, support and streamline the work being done around the world in laboratories associated with the NAC."
IAVI created the NAC six years ago to address a neglected area of AIDS vaccine research and development. Its purpose was to focus attention on the potential of neutralizing antibodies at a time when vaccine candidates in preclinical and clinical testing were devised almost exclusively to elicit cell-mediated immune (CMI) responses. Most existing vaccines against other diseases work by eliciting neutralizing antibodies.
The NAC is part of a global AIDS vaccine discovery program that extends to Africa, Asia and Europe. Current members of the Consortium include IAVI, The Scripps Research Institute, Academia Sinica, Cornell University, the Dana-Farber Cancer Institute, the Children's Hospital of Philadelphia, the Karolinska Institute, Harvard Medical School, the Indian Institute of Science, Oxford University, the Institute for Research in Biomedicine, the International Centre for Genetic Engineering and Biotechnology, the University of Pennsylvania, the University of Washington, the University of Wisconsin and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.
"The HIV vaccine neutralizing antibody problem is solvable, and its solution is a prerequisite for a successful AIDS vaccine," said Dr. Wayne Koff, IAVI Senior Vice President, Research and Development. "By establishing this center of multidisciplinary experts at Scripps, we expect to solve the problem and accelerate the development of a safe and effective AIDS vaccine."
About The Scripps Research Institute
The Scripps Research Institute is one of the world's largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus by 2009. For more information, please visit scripps.edu.
About IAVI
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI's financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health, The John D. Evans Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust, The Rockefeller Foundation, The Starr Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, India, Ireland, The Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Bristol-Myers Squibb, Continental Airlines, Google Inc., Henry Schein, Inc., Merck & Co., Inc. and Pfizer Inc; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There's A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world. For more information, see iavi/.
Source: Rachel Steinhardt
International AIDS Vaccine Initiative
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