"I am a 49 year old female and am currently being treated for colon cancer, stage 4. I was initially diagnosed last year, February 2007, and have been undergoing chemotherapy ever since," said Andrea Bates of Indianapolis, Ind. My initial prognosis was not good, but now is looking very good and I am thankful for that. I currently have insurance through my husband's employer and have been receiving great care, which again, I'm grateful for.
"I recently inquired about another treatment center, Cancer Treatment Centers of America, which has a lot more available options to treat my cancer that my current hospital does not provide. I was informed that because I have an HMO, I cannot pursue treatment outside my network. If I had a PPO, insurance would most likely cover the cost of me going to the Cancer Treatment Center of America though.
"Since the insurance I have is through my husband's work, we were only given two options to choose from for insurance for the 2008 year - Advantage HMO or Anthem PPO. For obvious reasons, we had to take the Advantage HMO route because it was more than half as cheap than the Anthem PPO. Why should we have to choose in the first place and why only these two types of insurances?
"But they finally did allow me to go to another hospital to have my final major surgery, and I was grateful for this since this last surgery was the one that probably ended up saving my life. I had 65 percent of my liver removed that had cancer on it.
"I don't know if the insurance company would have eventually allowed me to go to the Cancer Treatment Center of America. They might have if I would have continued to pursue it, but I guess that's part of the problem - why should I have to justify my intentions of going somewhere else where better treatment is offered that could save my life?
"It simply is not fair that we have to choose between 'affordable' healthcare versus 'not-so-affordable' healthcare and only being given limited choices of insurance plans to choose from. These choices obviously can make a difference between life and death. I'm sick to death with increasing premiums year after year and receiving less coverage, year after year."
Read stories like this every day through Election Day at: GuaranteedHealthcare
Sponsored by the California Nurses Association/National Nurses Organizing Committee
Eighty-two percent of Americans think the U.S. healthcare system should be fundamentally changed or completely rebuilt (Commonwealth Fund, Aug. 7, 2008). America's nurses know that only single-payer, improved and expanded Medicare for all will fix our broken system and the tragedy of our devastated families. HR 676, by U.S. Rep John Conyers, is the most comprehensive, cost effective way to achieve guaranteed healthcare for all.
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суббота, 10 сентября 2011 г.
Novel Drug Boosts Platelet Production, Reversing Chronic Immune Thrombocytopenic Purpura
Attacking a platelet-depleting autoimmune disease in a whole new way, an experimental drug is helping patients with immune thrombocytopenic purpura (ITP) once again produce healthy amounts of platelets -- with no major side effects.
That's the conclusion of a new, multicenter study led by Dr. James B. Bussel, professor of pediatrics at Weill Cornell Medical College, attending pediatrician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and director of the Hospital's Program for Platelet Disorders.
His team's findings appear in The New England Journal of Medicine.
The new drug, a novel protein called AMG 531, successfully boosted platelet production in patents with chronic ITP, a serious autoimmune disorder that affects more than 16,000 adult Americans, and perhaps as many children, each year.
In ITP, immune system antibodies mysteriously begin to attack and destroy blood platelet cells. In some cases, the disease goes into spontaneous remission, but for many patients it remains a chronic condition. Impaired clotting leaves many patients, especially the elderly, vulnerable to serious or fatal hemorrhage.
Up till now, ITP patients have typically turned to powerful drugs such as corticosteroids or intravenous immune globulin, which work by inhibiting platelet destruction. These drug therapies can have limited success, but they also have serious side effects. For some ITP patients splenectomy (surgical removal of the spleen) is another treatment option.
AMG 531 fights ITP in a totally different way.
"Experts have long realized that ITP not only destroys platelets, it also inhibits platelet production in the marrow," explains Dr. Bussel.
In fact, prior work in the 1990s had focused on a type of recombinant thrombopoietin, called PEG-MGDF, that researchers hoped would stimulate platelet production.
The drug did have success. "However, Dr. David Kuter at Massachusetts General Hospital showed that some patients -- and even healthy volunteers -- developed antibodies to the drug, and these antibodies cross-reacted with their own natural thrombopoietin. The result was chronic low platelet counts in people who, in many cases, had never had such problems before," Dr. Bussel says.
The trick, then, was to find a platelet-stimulating agent that avoided this dangerous immune-system response.
"Luckily, Amgen, the company that has funded this research, didn't throw in the towel," Dr. Bussel says.
The company, under the guidance of the study's senior author, Dr. Janet Nichol, eventually developed AMG 531 -- a novel protein with no structural similarity to human thrombopoietin. This dissimilarity and other features mean AMG 531 is largely ignored by the immune system.
The new, two-phase trial was led by Dr. Bussel and conducted at nine centers across the United States.
In the Phase 1 part of the study, doctors first gave six groups of four ITP patients (24 total) two subcutaneous injections of AMG 531 delivered at least two weeks apart. Depending on the group they were in, patients received anywhere from 0.2 to 10 micrograms of the drug per kilogram of body weight.
In the Phase 2 part of the trial, 21 patients were randomized to receive six weekly injections of either a harmless placebo, or AMG 531 at doses of 1, 3, or 6 micrograms per kilogram of body weight.
The Phase 1 results showed the drug to be safe, with no major adverse events attributed to AMG 531 during the treatment period. Four of a total of 41 patients did show some temporary post-treatment lowering of their platelet counts, but this later resolved.
The drug's efficacy impressed the researchers.
"We were very pleased," says Dr. Bussel. Hoping to boost platelet counts to between 50,000 to 450,000 per cubic millimeter, the researchers report that seven of 12 patients given higher doses of AMG 531 (3, 6 or 10 micrograms/kilogram) fell within that range after six weeks on the therapy.
"In fact, three of these patients saw their counts rise to over 450,000 per cubic millimeter," Dr. Bussel notes.
Platelet counts increased in treated patients in a dose-dependent fashion, with mean peak counts of 163,000, 309,000 and 746,000 per cubic millimeter for doses of 3, 6 and 10 micrograms/kilogram, respectively.
"This was a relatively small trial, so more study is needed. However, the results point to a new, effective and safe way of letting people receive an injection once a week that stimulates them to increase their platelets," Dr. Bussel says.
How does AMG 531 work? According to the researchers, the drug acts much like natural thrombopoietin, stimulating the production of platelets from their earliest stages of development within the marrow, straight through to their appearance in the bloodstream.
Based on the findings, Dr. Bussel is optimistic that ITP patients everywhere will soon have a potent new weapon against the disease.
"Further clinical trials in AMG 531 are well under way," he says, "and the next step, we hope, will be to license the compound. Then, maybe, we can begin to broaden its use to other illnesses, where boosting platelets might help the many other patients with low platelets fight disease."
Co-researchers include Dr. David J. Kuter of Massachusetts General Hospital, Boston; Dr. James N. George of the University of Oklahoma Medical Center, Oklahoma City; Drs. Robert MacMillan and Jorge Nieva, of Scripps Cancer Center, La Jolla, Calif; Dr. Louis M. Aledort of Mount Sinai Medical Center, New York City; Dr. George T. Conklin of the Diagnostic Clinic of Houston; Dr. Alan E. Lichtin, of the Cleveland Clinic Foundation; Dr. Roger M. Lyons of Hematology-Oncology Associates of South Texas, San Antonio; Dr. Jeffrey S. Wasser of DeQuattro Community Cancer Center, Manchester, Conn; Dr. Israel Wiznitzer of the Broward General Medical Center, Fort Lauderdale, Fla; and Reggie Kelly and Dr. Chien-Feng Chen, of Amgen, Thousand Oaks, Calif.
NewYork-Presbyterian Hospital
425 East 61st St., Fl. 7
New York, NY 10021
United States
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That's the conclusion of a new, multicenter study led by Dr. James B. Bussel, professor of pediatrics at Weill Cornell Medical College, attending pediatrician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and director of the Hospital's Program for Platelet Disorders.
His team's findings appear in The New England Journal of Medicine.
The new drug, a novel protein called AMG 531, successfully boosted platelet production in patents with chronic ITP, a serious autoimmune disorder that affects more than 16,000 adult Americans, and perhaps as many children, each year.
In ITP, immune system antibodies mysteriously begin to attack and destroy blood platelet cells. In some cases, the disease goes into spontaneous remission, but for many patients it remains a chronic condition. Impaired clotting leaves many patients, especially the elderly, vulnerable to serious or fatal hemorrhage.
Up till now, ITP patients have typically turned to powerful drugs such as corticosteroids or intravenous immune globulin, which work by inhibiting platelet destruction. These drug therapies can have limited success, but they also have serious side effects. For some ITP patients splenectomy (surgical removal of the spleen) is another treatment option.
AMG 531 fights ITP in a totally different way.
"Experts have long realized that ITP not only destroys platelets, it also inhibits platelet production in the marrow," explains Dr. Bussel.
In fact, prior work in the 1990s had focused on a type of recombinant thrombopoietin, called PEG-MGDF, that researchers hoped would stimulate platelet production.
The drug did have success. "However, Dr. David Kuter at Massachusetts General Hospital showed that some patients -- and even healthy volunteers -- developed antibodies to the drug, and these antibodies cross-reacted with their own natural thrombopoietin. The result was chronic low platelet counts in people who, in many cases, had never had such problems before," Dr. Bussel says.
The trick, then, was to find a platelet-stimulating agent that avoided this dangerous immune-system response.
"Luckily, Amgen, the company that has funded this research, didn't throw in the towel," Dr. Bussel says.
The company, under the guidance of the study's senior author, Dr. Janet Nichol, eventually developed AMG 531 -- a novel protein with no structural similarity to human thrombopoietin. This dissimilarity and other features mean AMG 531 is largely ignored by the immune system.
The new, two-phase trial was led by Dr. Bussel and conducted at nine centers across the United States.
In the Phase 1 part of the study, doctors first gave six groups of four ITP patients (24 total) two subcutaneous injections of AMG 531 delivered at least two weeks apart. Depending on the group they were in, patients received anywhere from 0.2 to 10 micrograms of the drug per kilogram of body weight.
In the Phase 2 part of the trial, 21 patients were randomized to receive six weekly injections of either a harmless placebo, or AMG 531 at doses of 1, 3, or 6 micrograms per kilogram of body weight.
The Phase 1 results showed the drug to be safe, with no major adverse events attributed to AMG 531 during the treatment period. Four of a total of 41 patients did show some temporary post-treatment lowering of their platelet counts, but this later resolved.
The drug's efficacy impressed the researchers.
"We were very pleased," says Dr. Bussel. Hoping to boost platelet counts to between 50,000 to 450,000 per cubic millimeter, the researchers report that seven of 12 patients given higher doses of AMG 531 (3, 6 or 10 micrograms/kilogram) fell within that range after six weeks on the therapy.
"In fact, three of these patients saw their counts rise to over 450,000 per cubic millimeter," Dr. Bussel notes.
Platelet counts increased in treated patients in a dose-dependent fashion, with mean peak counts of 163,000, 309,000 and 746,000 per cubic millimeter for doses of 3, 6 and 10 micrograms/kilogram, respectively.
"This was a relatively small trial, so more study is needed. However, the results point to a new, effective and safe way of letting people receive an injection once a week that stimulates them to increase their platelets," Dr. Bussel says.
How does AMG 531 work? According to the researchers, the drug acts much like natural thrombopoietin, stimulating the production of platelets from their earliest stages of development within the marrow, straight through to their appearance in the bloodstream.
Based on the findings, Dr. Bussel is optimistic that ITP patients everywhere will soon have a potent new weapon against the disease.
"Further clinical trials in AMG 531 are well under way," he says, "and the next step, we hope, will be to license the compound. Then, maybe, we can begin to broaden its use to other illnesses, where boosting platelets might help the many other patients with low platelets fight disease."
Co-researchers include Dr. David J. Kuter of Massachusetts General Hospital, Boston; Dr. James N. George of the University of Oklahoma Medical Center, Oklahoma City; Drs. Robert MacMillan and Jorge Nieva, of Scripps Cancer Center, La Jolla, Calif; Dr. Louis M. Aledort of Mount Sinai Medical Center, New York City; Dr. George T. Conklin of the Diagnostic Clinic of Houston; Dr. Alan E. Lichtin, of the Cleveland Clinic Foundation; Dr. Roger M. Lyons of Hematology-Oncology Associates of South Texas, San Antonio; Dr. Jeffrey S. Wasser of DeQuattro Community Cancer Center, Manchester, Conn; Dr. Israel Wiznitzer of the Broward General Medical Center, Fort Lauderdale, Fla; and Reggie Kelly and Dr. Chien-Feng Chen, of Amgen, Thousand Oaks, Calif.
NewYork-Presbyterian Hospital
425 East 61st St., Fl. 7
New York, NY 10021
United States
nyp
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Families Of Sudden Unexplained Death Victims Should Receive Comprehensive Cardiogenetic Testing
Relatives of a young person who dies suddenly should always be referred for cardiological and genetic examination in order to identify if they too are at risk of sudden death, a scientist told the annual conference of the European Society of Human Genetics. Dr. Christian van der Werf, a research fellow at the Department of Cardiogenetics, Academic Medical Centre, Amsterdam, The Netherlands said that, although his team's research showed that inherited heart disease was present in over 30% of the families of sudden unexplained death (SUD) victims, the majority of such relatives were currently not being referred for examination.
When an individual aged 1-50 years dies suddenly, autopsy reveals an inheritable heart disease in the majority of the victims. But in approximately 20% autopsy does not reveal the cause of death. "We thought that cardiological and genetic examination of surviving first degree relatives of these SUD patients might reveal an inherited heart disease", said Dr. van der Werf.
In the largest such study to date, the team looked at the outcome of first degree relative screening in 127 families who had suffered an SUD and where either there had been no autopsy (53.8%), or the autopsy did not reveal a cause of death. The average age at death of the SUD victims was only 29.8 years old.
The initial examination of the relatives consisted of taking personal and family medical history and a resting ECG. A second cardiac autopsy of the SUD victim was undertaken if tissue had been stored and was available. Additional cardiological examinations of the relatives were performed where necessary. Genetic analysis of the associated candidate gene(s) was performed in material obtained from the deceased person or in those relatives who showed clinical abnormalities.
The researchers found inherited heart disease in 36, or 32% of the families. These results meant that doctors were able to treat affected relatives and try to prevent their succumbing to sudden cardiac death. "The scale of heart disease that we found in such families underlines the necessity for general practitioners to refer first degree relatives of SUD victims to a specialised cardiogenetics department as soon as possible", said Dr. van der Werf. "Currently we estimate that only 10% of SUD families are being examined for inherited heart conditions.
The study is the second report from the registry of families who attended the Amsterdam centre's cardiogenetics department because of unexplained sudden death of a relative aged 1-50 years. The scientists intend to continue to report the yield of family screening in an increasing number of families.
"At present we are conducting a study to stimulate general practitioners and other involved physicians to request autopsy and DNA-storage for SUD patients and to refer relatives to a cardiogenetics department after a case of sudden death at young age. We hope this will lead to identification of more families at risk of sudden cardiac death, in which preventive measures then can be taken" said Dr. van der Werf.
"Relatives of young sudden death victims are often referred to cardiologists for cardiological examination. We believe relatives should instead be referred to cardiogenetics departments, where clinical geneticists, cardiologists and psychosocial workers cooperate. These professionals specialise in inherited heart diseases and their clinical and psychosocial implications, and can provide a better quality of care. Additionally, cardiologists should receive more education in inherited heart diseases. By taking these measures we can save lives and avoid further distress for families who have already suffered enough," he said.
Source:
Mary Rice
European Society of Human Genetics
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When an individual aged 1-50 years dies suddenly, autopsy reveals an inheritable heart disease in the majority of the victims. But in approximately 20% autopsy does not reveal the cause of death. "We thought that cardiological and genetic examination of surviving first degree relatives of these SUD patients might reveal an inherited heart disease", said Dr. van der Werf.
In the largest such study to date, the team looked at the outcome of first degree relative screening in 127 families who had suffered an SUD and where either there had been no autopsy (53.8%), or the autopsy did not reveal a cause of death. The average age at death of the SUD victims was only 29.8 years old.
The initial examination of the relatives consisted of taking personal and family medical history and a resting ECG. A second cardiac autopsy of the SUD victim was undertaken if tissue had been stored and was available. Additional cardiological examinations of the relatives were performed where necessary. Genetic analysis of the associated candidate gene(s) was performed in material obtained from the deceased person or in those relatives who showed clinical abnormalities.
The researchers found inherited heart disease in 36, or 32% of the families. These results meant that doctors were able to treat affected relatives and try to prevent their succumbing to sudden cardiac death. "The scale of heart disease that we found in such families underlines the necessity for general practitioners to refer first degree relatives of SUD victims to a specialised cardiogenetics department as soon as possible", said Dr. van der Werf. "Currently we estimate that only 10% of SUD families are being examined for inherited heart conditions.
The study is the second report from the registry of families who attended the Amsterdam centre's cardiogenetics department because of unexplained sudden death of a relative aged 1-50 years. The scientists intend to continue to report the yield of family screening in an increasing number of families.
"At present we are conducting a study to stimulate general practitioners and other involved physicians to request autopsy and DNA-storage for SUD patients and to refer relatives to a cardiogenetics department after a case of sudden death at young age. We hope this will lead to identification of more families at risk of sudden cardiac death, in which preventive measures then can be taken" said Dr. van der Werf.
"Relatives of young sudden death victims are often referred to cardiologists for cardiological examination. We believe relatives should instead be referred to cardiogenetics departments, where clinical geneticists, cardiologists and psychosocial workers cooperate. These professionals specialise in inherited heart diseases and their clinical and psychosocial implications, and can provide a better quality of care. Additionally, cardiologists should receive more education in inherited heart diseases. By taking these measures we can save lives and avoid further distress for families who have already suffered enough," he said.
Source:
Mary Rice
European Society of Human Genetics
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Policy Recommendations For Improving Medication Adherence
A diverse group of health care and consumer organizations released five policy recommendations this week that are designed to promote better medication adherence and improved health outcomes for patients.
The group, which includes the American College of Cardiology, GlaxoSmithKline, the National Association of Chain Drug Stores, the National Consumers League and the Pharmaceutical Research and Manufacturers of America, focused their recommendations on the areas of quality improvement, care coordination, health information technology, patient/provider education and engagement, and health services research.
Although some of the recommendations have been the subject of discussion during the ongoing health care reform debate, and in fact have been reflected in some of the proposals under consideration, the recommendations are being released with an eye toward an ongoing and consistent commitment to improving health care - and health outcomes - in America.
According to a 2005 study published in the New England Journal of Medicine, an estimated one-third to one-half of all patients in the United States do not take their medications as prescribed. The impact of this non-adherence is costly in terms of both quality of care and medical expenses. In fact, recent research including work by the New England Healthcare Institute (NEHI) and a 2004 study published in Medical Care suggested that costs resulting from non-adherence may be as high as $300 billion annually.
"Not only is poor medication adherence costly, but it also can be dangerous," said Sally Greenberg, Executive Director of National Consumers League. "Because patients don't take their medications for a variety of reasons, including side effects, misconceptions or fears about the medication, trouble with dosing, and costs such as co-pays, we need to employ a multitude of strategies to improve adherence. Our efforts are focused on identifying key opportunities to reduce barriers that keep patients from adhering to their medications."
The five recommendations were constructed, refined and finalized following a July conference with more than 40 medication adherence experts, including providers, patients, health plans, employers, and researchers. The dialogue was informed by research by the RAND Corporation, which conducted a review of the literature on medication adherence to provide an evidence-base for the discussions, and by Avalere Health, which described lessons learned from here-and-now programs to improve medication adherence.
Walid Gellad, M.D., the lead RAND researcher on this review noted that, "Poor medication adherence is an enormous public health problem. Finding solutions to this problem should be part of health reform discussions now and in the future."
Each of the recommendations is supported by specific action items to help guide its implementation. To see the full recommendations, please click here.
Quality Improvement - National quality improvement strategies should explicitly recognize medication adherence and appropriate medication use as critical components to improve health care quality and clinical outcomes.
Care Coordination - Proposals aimed at improving care coordination must recognize the important role that medications play in treating and managing illnesses.
Health Information Technology - Health information technology must improve the flow of timely and complete information between patients and providers, and enable providers and payers to identify and address gaps in patients' medication use.
Patient/Provider Education and Engagement - Strategies to improve medication adherence must fully engage patients, and patient-centered care must involve strategies to help them better understand their conditions and treatments. These efforts also must support providers in effectively communicating the importance of following treatment plans, and in providing medication support services to patients and caregivers.
Health Services Research - There is a need for additional research on medication adherence, including a focus on the effectiveness of a wider range of interventions to improve adherence, as well as an analysis of the diverse factors, behaviors, costs and consequences related to poor adherence.
"Medical adherence is a problem that should unite all providers, elected officials, pharmacists, insurers and pharmaceutical companies," said Jack Lewin, CEO of the American College of Cardiology. "Fifty percent of patients with heart disease are not taking their potentially life-saving medications, but it is our hope that recommendations like these will go a long way toward addressing this serious problem."
Source:
Tom Murphy
Chandler Chicco Agency
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The group, which includes the American College of Cardiology, GlaxoSmithKline, the National Association of Chain Drug Stores, the National Consumers League and the Pharmaceutical Research and Manufacturers of America, focused their recommendations on the areas of quality improvement, care coordination, health information technology, patient/provider education and engagement, and health services research.
Although some of the recommendations have been the subject of discussion during the ongoing health care reform debate, and in fact have been reflected in some of the proposals under consideration, the recommendations are being released with an eye toward an ongoing and consistent commitment to improving health care - and health outcomes - in America.
According to a 2005 study published in the New England Journal of Medicine, an estimated one-third to one-half of all patients in the United States do not take their medications as prescribed. The impact of this non-adherence is costly in terms of both quality of care and medical expenses. In fact, recent research including work by the New England Healthcare Institute (NEHI) and a 2004 study published in Medical Care suggested that costs resulting from non-adherence may be as high as $300 billion annually.
"Not only is poor medication adherence costly, but it also can be dangerous," said Sally Greenberg, Executive Director of National Consumers League. "Because patients don't take their medications for a variety of reasons, including side effects, misconceptions or fears about the medication, trouble with dosing, and costs such as co-pays, we need to employ a multitude of strategies to improve adherence. Our efforts are focused on identifying key opportunities to reduce barriers that keep patients from adhering to their medications."
The five recommendations were constructed, refined and finalized following a July conference with more than 40 medication adherence experts, including providers, patients, health plans, employers, and researchers. The dialogue was informed by research by the RAND Corporation, which conducted a review of the literature on medication adherence to provide an evidence-base for the discussions, and by Avalere Health, which described lessons learned from here-and-now programs to improve medication adherence.
Walid Gellad, M.D., the lead RAND researcher on this review noted that, "Poor medication adherence is an enormous public health problem. Finding solutions to this problem should be part of health reform discussions now and in the future."
Each of the recommendations is supported by specific action items to help guide its implementation. To see the full recommendations, please click here.
Quality Improvement - National quality improvement strategies should explicitly recognize medication adherence and appropriate medication use as critical components to improve health care quality and clinical outcomes.
Care Coordination - Proposals aimed at improving care coordination must recognize the important role that medications play in treating and managing illnesses.
Health Information Technology - Health information technology must improve the flow of timely and complete information between patients and providers, and enable providers and payers to identify and address gaps in patients' medication use.
Patient/Provider Education and Engagement - Strategies to improve medication adherence must fully engage patients, and patient-centered care must involve strategies to help them better understand their conditions and treatments. These efforts also must support providers in effectively communicating the importance of following treatment plans, and in providing medication support services to patients and caregivers.
Health Services Research - There is a need for additional research on medication adherence, including a focus on the effectiveness of a wider range of interventions to improve adherence, as well as an analysis of the diverse factors, behaviors, costs and consequences related to poor adherence.
"Medical adherence is a problem that should unite all providers, elected officials, pharmacists, insurers and pharmaceutical companies," said Jack Lewin, CEO of the American College of Cardiology. "Fifty percent of patients with heart disease are not taking their potentially life-saving medications, but it is our hope that recommendations like these will go a long way toward addressing this serious problem."
Source:
Tom Murphy
Chandler Chicco Agency
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Vical Begins Phase 1 Trial Of DNA Vaccine Against H5N1 Pandemic Influenza
Vical Incorporated
(Nasdaq: VICL) announced the enrollment of the first subject in its
Phase 1 trial of the company's Vaxfectin(TM)-formulated plasmid DNA (pDNA)
pandemic influenza vaccine. The double-blind, placebo-controlled trial will
evaluate safety, tolerability and immune responses in up to 60 healthy
volunteers age 18 to 45 at two U.S. clinical sites.
"We have designed a promising pandemic influenza vaccine and
demonstrated its effectiveness against a highly lethal H5N1 challenge in
ferrets, the best available animal model," said Vijay B. Samant, Vical's
President and Chief Executive Officer, "and we have now begun testing in
humans. The currently stockpiled pandemic influenza vaccines primarily
generate antibody responses against a specific strain, and have a limited
shelf life because they cannot be stored frozen. Our pDNA vaccine is
designed to provide T-cell and antibody immune responses for broad
cross-strain protection, and if frozen, would offer improved storage and
deployment. This trial is also important because it marks the first time in
humans for our Vaxfectin(TM) adjuvant, which has potential applications
with both pDNA vaccines and conventional protein-based vaccines."
Vical's vaccine contains three individual DNA plasmids encoding
consensus sequences of two highly-conserved influenza virus proteins --
nucleoprotein (NP) and ion channel protein (M2) -- plus a hemagglutinin
(HA) surface protein from the H5N1 influenza virus strain,
A/Vietnam/1203/04. The combination is designed to elicit both T-cell and
antibody immune responses against emerging strains of influenza virus that
have the potential to cause a pandemic. A monovalent pDNA vaccine encoding
only the H5 protein will also be tested. Both vaccines are formulated with
the company's Vaxfectin(TM) adjuvant, which has demonstrated effectiveness
with a variety of pDNA vaccines in multiple animal models. It has also
demonstrated dose-sparing and immune-enhancing ability with a conventional
seasonal influenza vaccine in animals.
Pandemic Influenza Vaccine Background
Vical's pandemic influenza program goal is to design a vaccine that can
be developed and manufactured quickly and safely without handling the
infectious organism, provide cross-strain protection, and be stockpiled
longer and in less restrictive conditions than conventional vaccines. Vical
systematically tested prototype vaccines using a range of viral antigens to
determine the optimum combination of conserved and variable targets. The
company then systematically tested different formulations for maximum
efficacy at the lowest possible dose. Initial virus challenge studies at
Vical with Vaxfectin(TM)-formulated vaccines encoding NP, M2 and HA
demonstrated significant protection in mice against H1N1 and H3N2 strains
of human influenza. Subsequent studies at St. Jude Children's Research
Hospital demonstrated complete protection with a single dose of the
trivalent vaccine against a lethal challenge in ferrets with the highly
pathogenic A/Vietnam/1203/04 (H5N1) influenza virus strain. Funding for the
preclinical development was provided under a previously-announced grant
from the National Institutes of Health.
"We are excited to advance our pandemic influenza DNA vaccine program
into initial human testing," said Larry R. Smith, Ph.D., Vical's Vice
President of Vaccine Research, "and to conduct our first human tests with
the novel Vaxfectin(TM) adjuvant, which was designed for pDNA vaccines but
also has demonstrated significant dose-sparing and immune-enhancing results
with the sanofi pasteur trivalent inactivated influenza vaccine in
animals."
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company's DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at vical.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected, including: whether results in mouse and ferret studies
will be predictive of results in human studies; whether Vical or others
will continue development of the pandemic influenza DNA vaccine candidate;
whether H5N1 or other strains of avian influenza will emerge as pandemic
threats; whether the company's DNA vaccine candidate will be effective in
protecting humans against H5N1 or other strains of avian influenza; whether
development of an avian influenza vaccine would lead to development of a
seasonal influenza vaccine; whether the influenza vaccine or any other
product candidates will be shown to be safe and effective; the timing,
nature and cost of clinical trials; whether Vical or its collaborative
partners will seek or gain approval to market the influenza vaccine or any
other product candidates; whether Vical or its collaborative partners will
succeed in marketing the influenza vaccine or any other product candidates;
and additional risks set forth in the company's filings with the Securities
and Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements.
Vical Incorporated
vical
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(Nasdaq: VICL) announced the enrollment of the first subject in its
Phase 1 trial of the company's Vaxfectin(TM)-formulated plasmid DNA (pDNA)
pandemic influenza vaccine. The double-blind, placebo-controlled trial will
evaluate safety, tolerability and immune responses in up to 60 healthy
volunteers age 18 to 45 at two U.S. clinical sites.
"We have designed a promising pandemic influenza vaccine and
demonstrated its effectiveness against a highly lethal H5N1 challenge in
ferrets, the best available animal model," said Vijay B. Samant, Vical's
President and Chief Executive Officer, "and we have now begun testing in
humans. The currently stockpiled pandemic influenza vaccines primarily
generate antibody responses against a specific strain, and have a limited
shelf life because they cannot be stored frozen. Our pDNA vaccine is
designed to provide T-cell and antibody immune responses for broad
cross-strain protection, and if frozen, would offer improved storage and
deployment. This trial is also important because it marks the first time in
humans for our Vaxfectin(TM) adjuvant, which has potential applications
with both pDNA vaccines and conventional protein-based vaccines."
Vical's vaccine contains three individual DNA plasmids encoding
consensus sequences of two highly-conserved influenza virus proteins --
nucleoprotein (NP) and ion channel protein (M2) -- plus a hemagglutinin
(HA) surface protein from the H5N1 influenza virus strain,
A/Vietnam/1203/04. The combination is designed to elicit both T-cell and
antibody immune responses against emerging strains of influenza virus that
have the potential to cause a pandemic. A monovalent pDNA vaccine encoding
only the H5 protein will also be tested. Both vaccines are formulated with
the company's Vaxfectin(TM) adjuvant, which has demonstrated effectiveness
with a variety of pDNA vaccines in multiple animal models. It has also
demonstrated dose-sparing and immune-enhancing ability with a conventional
seasonal influenza vaccine in animals.
Pandemic Influenza Vaccine Background
Vical's pandemic influenza program goal is to design a vaccine that can
be developed and manufactured quickly and safely without handling the
infectious organism, provide cross-strain protection, and be stockpiled
longer and in less restrictive conditions than conventional vaccines. Vical
systematically tested prototype vaccines using a range of viral antigens to
determine the optimum combination of conserved and variable targets. The
company then systematically tested different formulations for maximum
efficacy at the lowest possible dose. Initial virus challenge studies at
Vical with Vaxfectin(TM)-formulated vaccines encoding NP, M2 and HA
demonstrated significant protection in mice against H1N1 and H3N2 strains
of human influenza. Subsequent studies at St. Jude Children's Research
Hospital demonstrated complete protection with a single dose of the
trivalent vaccine against a lethal challenge in ferrets with the highly
pathogenic A/Vietnam/1203/04 (H5N1) influenza virus strain. Funding for the
preclinical development was provided under a previously-announced grant
from the National Institutes of Health.
"We are excited to advance our pandemic influenza DNA vaccine program
into initial human testing," said Larry R. Smith, Ph.D., Vical's Vice
President of Vaccine Research, "and to conduct our first human tests with
the novel Vaxfectin(TM) adjuvant, which was designed for pDNA vaccines but
also has demonstrated significant dose-sparing and immune-enhancing results
with the sanofi pasteur trivalent inactivated influenza vaccine in
animals."
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company's DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at vical.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected, including: whether results in mouse and ferret studies
will be predictive of results in human studies; whether Vical or others
will continue development of the pandemic influenza DNA vaccine candidate;
whether H5N1 or other strains of avian influenza will emerge as pandemic
threats; whether the company's DNA vaccine candidate will be effective in
protecting humans against H5N1 or other strains of avian influenza; whether
development of an avian influenza vaccine would lead to development of a
seasonal influenza vaccine; whether the influenza vaccine or any other
product candidates will be shown to be safe and effective; the timing,
nature and cost of clinical trials; whether Vical or its collaborative
partners will seek or gain approval to market the influenza vaccine or any
other product candidates; whether Vical or its collaborative partners will
succeed in marketing the influenza vaccine or any other product candidates;
and additional risks set forth in the company's filings with the Securities
and Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements.
Vical Incorporated
vical
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Toward A Less Expensive Version Of The Anti-flu Drug Tamiflu
Scientists have developed an alternative method for producing the active ingredient in Tamiflu®, the mainstay for fighting H1N1 and other forms of influenza. The new process could expand availability of the drug by reducing its cost, which now retails for as about $8 per dose. Their study is in ACS' Organic Letters, a bi-weekly journal.
Anqi Chen, Christina Chai and colleagues note that the global pandemic of H1N1 has resulted in millions of infected cases worldwide and nearly 10,000 deaths to date. Tamiflu®, also known as oseltamivir phosphate, remains the most widely used antiviral drug for the prevention and treatment of H1N1 infections as well as bird flu and seasonal influenzas. But growing demand for the drug has put pressure on the supply of shikimic acid, the raw material now used in making the drug. "As a result, chemists worldwide including ourselves have explored the possibility of using other alternative raw materials for the synthesis of the drug" said Chen and Chai, who led the research.
The scientists describe a new process for making the drug that does not use shikimic acid. They found that D-ribose, a naturally-occurring sugar produced by fermentation in large scales, potentially provides an inexpensive and abundant source of starting material for making the drug. D-ribose costs only about one-sixth as much as shikimic acid. In lab studies, the scientists demonstrated the potential use of D-ribose as an alternative source for the synthesis of Tamiflu®.
ARTICLE: "Efficient Formal Synthesis of Oseltamivir Phosphate (Tamiflu) with Inexpensive D-Ribose as the Starting Material" pubs.acs/doi/full/10.1021/ol9024716
Source: Michael Bernstein
American Chemical Society
View drug information on Tamiflu capsule.
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Anqi Chen, Christina Chai and colleagues note that the global pandemic of H1N1 has resulted in millions of infected cases worldwide and nearly 10,000 deaths to date. Tamiflu®, also known as oseltamivir phosphate, remains the most widely used antiviral drug for the prevention and treatment of H1N1 infections as well as bird flu and seasonal influenzas. But growing demand for the drug has put pressure on the supply of shikimic acid, the raw material now used in making the drug. "As a result, chemists worldwide including ourselves have explored the possibility of using other alternative raw materials for the synthesis of the drug" said Chen and Chai, who led the research.
The scientists describe a new process for making the drug that does not use shikimic acid. They found that D-ribose, a naturally-occurring sugar produced by fermentation in large scales, potentially provides an inexpensive and abundant source of starting material for making the drug. D-ribose costs only about one-sixth as much as shikimic acid. In lab studies, the scientists demonstrated the potential use of D-ribose as an alternative source for the synthesis of Tamiflu®.
ARTICLE: "Efficient Formal Synthesis of Oseltamivir Phosphate (Tamiflu) with Inexpensive D-Ribose as the Starting Material" pubs.acs/doi/full/10.1021/ol9024716
Source: Michael Bernstein
American Chemical Society
View drug information on Tamiflu capsule.
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New Health Reform Law Will Benefit All Residents Of Illinois
A group of Illinoisans were briefed yesterday about how the historic new health care law, the Patient Protection and Affordable Care Act, will make health care more affordable and accessible, and make their communities and the nation as a whole stronger and healthier.
Ron Pollack, Executive Director of the consumer health organization Families USA, joined other speakers here in outlining the vast and growing problems in our health care system that led to passage of the reform law, and how the law addresses those problems.
"Our recent history tells the tale," Pollack said. "Every year, millions of people are denied health coverage by insurance companies due to pre-existing conditions. Every year, health insurance premiums have climbed far faster than wages, making health coverage unaffordable. Every year, seniors struggle with the costs of prescription drugs, and unemployed workers have lost health coverage and been unable to afford COBRA coverage."
The new law will halt and reverse these trends, Pollack said. "Under the new law, the 2.5 million non-elderly people in Illinois who were at risk of health coverage denial because they were diagnosed with a serious health condition will have guaranteed access to coverage, regardless of their gender or health status," he said.
"With the new law, 1,163,000 uninsured Illinoisans will gain health coverage. Diseases will be caught at an earlier and more treatable stage, and these Illinoisans will live longer, more productive lives," Pollack said.
"Under the new law, our senior citizens will be able to continue to buy their prescription drugs under Medicare without the crushing burden of paying 100 percent of the price when they reach the $2,700 annual threshold, and Illinois seniors who have reached that threshold will see checks arriving this week to help cover their drug bills.
"With the new law, we won't see premiums rising five times faster than wages in Illinois, as they did from 2000 to 2009, and employers will be able to afford quality plans and be able to hire and keep good workers.
"Under the new law, young adults will be able to stay on their parents' health plans until they are 26, ensuring that they have uninterrupted access to preventive care as they finish advanced schooling and get settled in their own businesses or careers.
"These are great improvements for Illinoisans, and these improvements will make a huge difference in their health and pocketbooks," Pollack said.
Source
Families USA
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Ron Pollack, Executive Director of the consumer health organization Families USA, joined other speakers here in outlining the vast and growing problems in our health care system that led to passage of the reform law, and how the law addresses those problems.
"Our recent history tells the tale," Pollack said. "Every year, millions of people are denied health coverage by insurance companies due to pre-existing conditions. Every year, health insurance premiums have climbed far faster than wages, making health coverage unaffordable. Every year, seniors struggle with the costs of prescription drugs, and unemployed workers have lost health coverage and been unable to afford COBRA coverage."
The new law will halt and reverse these trends, Pollack said. "Under the new law, the 2.5 million non-elderly people in Illinois who were at risk of health coverage denial because they were diagnosed with a serious health condition will have guaranteed access to coverage, regardless of their gender or health status," he said.
"With the new law, 1,163,000 uninsured Illinoisans will gain health coverage. Diseases will be caught at an earlier and more treatable stage, and these Illinoisans will live longer, more productive lives," Pollack said.
"Under the new law, our senior citizens will be able to continue to buy their prescription drugs under Medicare without the crushing burden of paying 100 percent of the price when they reach the $2,700 annual threshold, and Illinois seniors who have reached that threshold will see checks arriving this week to help cover their drug bills.
"With the new law, we won't see premiums rising five times faster than wages in Illinois, as they did from 2000 to 2009, and employers will be able to afford quality plans and be able to hire and keep good workers.
"Under the new law, young adults will be able to stay on their parents' health plans until they are 26, ensuring that they have uninterrupted access to preventive care as they finish advanced schooling and get settled in their own businesses or careers.
"These are great improvements for Illinoisans, and these improvements will make a huge difference in their health and pocketbooks," Pollack said.
Source
Families USA
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Researcher's Vaccine Technology For Chlamydia: WSU Files For Patent
A Wayne State University School of Medicine researcher has developed a potential first ever vaccine for Chlamydia, the world's most prevalent sexually transmitted disease and the leading cause of new cases of blindness.
Judith Whittum-Hudson, Ph.D., professor of immunology and microbiology, internal medicine and ophthalmology, has identified three peptides that have demonstrated a vaccine effect to inoculate against Chlamydia successfully in an animal model. Those findings could soon result in a vaccine for humans.
Patent applications on the technology have been filed by Wayne State University and licensed to a start-up company.
While Chlamydia infection can be readily addressed with a regimen of antibiotics, the treatment does not prevent re-infection. Treatment with antibiotics too early after infection may interfere with the natural development of immunity to Chlamydia, Whittum-Hudson said, and significant portions of the world lack access to basic health care infrastructure that could offer treatment through antibiotics.
"There is no vaccine and the disease is widely rampant," Whittum-Hudson said. "Antibiotics, while effective in treatment, offer no protection against re-infection."
The technology developed by Dr. Whittum-Hudson consists of novel peptide immunogens selected from a random phage display library by an antibody against a Chlamydial glycolipid exoantigen, or GLXA, or peptides that correspond to antigen-binding regions of an anti-idiotypic antibody mimic of GLXA. The peptides comprising the vaccine would induce antibodies and other immune responses to the entire spectrum of genus-wide Chlamydia. Whittum-Hudson said colleagues have developed a method to encapsulate the vaccine, so that it can be delivered orally rather than through injection, a boon to developing nations that lack the infrastructure to support inoculations through needle injection.
Chlamydial infections are the leading cause of pelvic inflammatory disease (PID), because Chlamydia infects the lower genital track and then may ascend into the fallopian tubes. PID can lead to infertility, ectopic pregnancy and chronic pelvic pain. The U.S. Centers for Disease Control and Prevention estimates that in the United States 750,000 women annually experience acute PID because of Chlamydia infection, and as many as 15 percent of those women may become infertile. Because an estimated 85 percent of women infected with Chlamydia are asymptomatic, the disease can wreak its permanent damage before they even become aware of the infection. Pregnant women can pass the infection to their infants during birth, leading to eye infections, including conjunctivitis and bronchial infections.
Chlamydia trachomatis is the leading cause of infectious blindness in humans. Worldwide, according to the World Health Organization (WHO), as many as 25 percent of people infected with this form will develop permanent blindness. More than 140 million people are infected with C. trachomatis, leaving 6 million blinded in Africa, the Middle East, Asia and Latin America. At least 85 million eye infections annually are attributed to the disease, the WHO estimates. With the lack of access to basic health care in many of these regions, a vaccine would substantially reduce, if not eliminate, blindness due to Chlamydia in these areas.
A vaccine would have significant impact on health care around the world. The WHO estimates that 92 million people are infected with the sexually transmitted disease form of Chlamydia trachomatis, and the numbers continue to increase. Chlamydia trachomatis is the most commonly reported disease in the United States and has been the most prevalent of all sexually transmitted diseases reported to the CDC since 1994. The numbers of Chlamydial infections in the United States continue to rise. In 2009, the last year for which statistics are available, 1,244,180 cases of Chlamydia infection were reported to the CDC, a rate of 409.2 cases per 100,000 Americans, and a 2.8 percent increase over 2008 reported cases.
In rankings of states with the highest number of reported cases in 2009, Michigan placed 13th with 457 cases of infection for every 100,000 people. Mississippi ranked first (802.7 per 100,000) and New Hampshire ranked last (159.7 per 100,000). Some studies estimated that in the UnitedStates alone there are 4 million to 5 million new cases of Chlamydia infection annually.
Another chlamydial species, Chlamydia pneumoniae, is responsible for 10 percent to 20 percent of community-acquired pneumonia in adults. Chlamydiae also have been associated with arthritis, atherosclerosis, stroke, myocarditis, chronic obstructive pulmonary disease, late-onset Alzheimer's and temporomandibular joint disease.
Whittum-Hudson noted that animals in which the prototype vaccine has been tested showed a decrease in joint inflammation, reducing the reactive arthritis-inducing effect of disseminated Chlamydia.
She said the vaccine may require boosters delivered at various stages of life. For instance, infants or children may be vaccinated, and then receive a booster immunization as they approach sexual maturity. A booster could be administered as a patient reaches age 40 to assist in warding off potential cardiovascular effects of Chlamydia. Another booster might prove beneficial at an older age to combat the effects of Chlamydia-associated late-onset Alzheimer's disease.
Another potential benefit of the vaccine lies in the livestock and poultry industries. Cattle, sheep and some poultry can contract Chlamydia, leading to illness and the self-aborting of fetuses, and respiratory infections in poultry. A viable vaccination could save the livestock industry untold millions of dollars and protect workers in the poultry industry who can contract the disease from infected animals.
Whittum-Hudson said that while her vaccine technology shows promise, she needs to conduct further testing in animals and then in humans. A viable vaccine, she said, could become available in 10 to 15 years.
Source:
Julie O'Connor
Wayne State University - Office of the Vice President for Research
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Judith Whittum-Hudson, Ph.D., professor of immunology and microbiology, internal medicine and ophthalmology, has identified three peptides that have demonstrated a vaccine effect to inoculate against Chlamydia successfully in an animal model. Those findings could soon result in a vaccine for humans.
Patent applications on the technology have been filed by Wayne State University and licensed to a start-up company.
While Chlamydia infection can be readily addressed with a regimen of antibiotics, the treatment does not prevent re-infection. Treatment with antibiotics too early after infection may interfere with the natural development of immunity to Chlamydia, Whittum-Hudson said, and significant portions of the world lack access to basic health care infrastructure that could offer treatment through antibiotics.
"There is no vaccine and the disease is widely rampant," Whittum-Hudson said. "Antibiotics, while effective in treatment, offer no protection against re-infection."
The technology developed by Dr. Whittum-Hudson consists of novel peptide immunogens selected from a random phage display library by an antibody against a Chlamydial glycolipid exoantigen, or GLXA, or peptides that correspond to antigen-binding regions of an anti-idiotypic antibody mimic of GLXA. The peptides comprising the vaccine would induce antibodies and other immune responses to the entire spectrum of genus-wide Chlamydia. Whittum-Hudson said colleagues have developed a method to encapsulate the vaccine, so that it can be delivered orally rather than through injection, a boon to developing nations that lack the infrastructure to support inoculations through needle injection.
Chlamydial infections are the leading cause of pelvic inflammatory disease (PID), because Chlamydia infects the lower genital track and then may ascend into the fallopian tubes. PID can lead to infertility, ectopic pregnancy and chronic pelvic pain. The U.S. Centers for Disease Control and Prevention estimates that in the United States 750,000 women annually experience acute PID because of Chlamydia infection, and as many as 15 percent of those women may become infertile. Because an estimated 85 percent of women infected with Chlamydia are asymptomatic, the disease can wreak its permanent damage before they even become aware of the infection. Pregnant women can pass the infection to their infants during birth, leading to eye infections, including conjunctivitis and bronchial infections.
Chlamydia trachomatis is the leading cause of infectious blindness in humans. Worldwide, according to the World Health Organization (WHO), as many as 25 percent of people infected with this form will develop permanent blindness. More than 140 million people are infected with C. trachomatis, leaving 6 million blinded in Africa, the Middle East, Asia and Latin America. At least 85 million eye infections annually are attributed to the disease, the WHO estimates. With the lack of access to basic health care in many of these regions, a vaccine would substantially reduce, if not eliminate, blindness due to Chlamydia in these areas.
A vaccine would have significant impact on health care around the world. The WHO estimates that 92 million people are infected with the sexually transmitted disease form of Chlamydia trachomatis, and the numbers continue to increase. Chlamydia trachomatis is the most commonly reported disease in the United States and has been the most prevalent of all sexually transmitted diseases reported to the CDC since 1994. The numbers of Chlamydial infections in the United States continue to rise. In 2009, the last year for which statistics are available, 1,244,180 cases of Chlamydia infection were reported to the CDC, a rate of 409.2 cases per 100,000 Americans, and a 2.8 percent increase over 2008 reported cases.
In rankings of states with the highest number of reported cases in 2009, Michigan placed 13th with 457 cases of infection for every 100,000 people. Mississippi ranked first (802.7 per 100,000) and New Hampshire ranked last (159.7 per 100,000). Some studies estimated that in the UnitedStates alone there are 4 million to 5 million new cases of Chlamydia infection annually.
Another chlamydial species, Chlamydia pneumoniae, is responsible for 10 percent to 20 percent of community-acquired pneumonia in adults. Chlamydiae also have been associated with arthritis, atherosclerosis, stroke, myocarditis, chronic obstructive pulmonary disease, late-onset Alzheimer's and temporomandibular joint disease.
Whittum-Hudson noted that animals in which the prototype vaccine has been tested showed a decrease in joint inflammation, reducing the reactive arthritis-inducing effect of disseminated Chlamydia.
She said the vaccine may require boosters delivered at various stages of life. For instance, infants or children may be vaccinated, and then receive a booster immunization as they approach sexual maturity. A booster could be administered as a patient reaches age 40 to assist in warding off potential cardiovascular effects of Chlamydia. Another booster might prove beneficial at an older age to combat the effects of Chlamydia-associated late-onset Alzheimer's disease.
Another potential benefit of the vaccine lies in the livestock and poultry industries. Cattle, sheep and some poultry can contract Chlamydia, leading to illness and the self-aborting of fetuses, and respiratory infections in poultry. A viable vaccination could save the livestock industry untold millions of dollars and protect workers in the poultry industry who can contract the disease from infected animals.
Whittum-Hudson said that while her vaccine technology shows promise, she needs to conduct further testing in animals and then in humans. A viable vaccine, she said, could become available in 10 to 15 years.
Source:
Julie O'Connor
Wayne State University - Office of the Vice President for Research
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Hopeful Medical Industry News On Malpractice Premiums For Physicians Is Released For 2008
A newly-released 2008 Medical Economics survey focusing on malpractice premiums for physicians across the United States provides encouraging medical industry news on one of the least popular issues for healthcare providers - malpractice insurance. The actuarial research, presented to the Physician Insurers Association of America and reported by Medical Economics, is available for perusal by following the Medical Economics link.
"Malpractice premiums are certainly not the most popular topic when it comes to healthcare professionals," admits Sean Keating, Product Director for Modern Medicine, the website for doctors that offers medical industry news and an online medical library as a resource for physicians. "This report provides some encouraging medical news for the medical industry on the subject, and also helps physicians put malpractice insurance in context when it comes to the actual costs of premiums reliant on geography and medical practice areas. I think all medical practitioners in America will find it enlightening, to say the least."
Among the findings discussed in the survey is the fact that family physicians, internists, and pediatricians all paid median costs of $12,500 annually for med-mal coverage in 2007, while ob/gyns paid more than four times as much, purportedly due to their propensity to be sued. Another intriguing statistic focuses on geographic disparity - malpractice premiums continue to be higher in the East than in the South or the West, attributed to the litigious climate in the Northeast and the lack of tort reform in states such as New York and Pennsylvania.
Full details of the 2008 Medical Economics survey concerning malpractice insurance for healthcare professionals are available at medicaleconomics.modernmedicine.
About ModernMedicine
ModernMedicine is an innovative online clinical decision-support resource that provides healthcare professionals with instant answers to clinical and practice management questions from highly credible and trusted sources. Our mission is to become the leading online clinical decision-support, CME and practice management resource for healthcare professionals. ModernMedicine provides healthcare professionals with access to a robust, cross-specialty online medical library of updated content that is complemented by interactive tools and features.
ModernMedicine features current and archived content from Advanstar's award-winning journal portfolio including Medical Economics, Drug Topics, Contemporary OB-GYN and Urology Times. Covering 20 specialties from Allergy to Urology, Modern Medicine also provides reviews from more than 100 of the world's top peer-reviewed medical journals, as well as comprehensive coverage from over 50 major industry conferences and scientific sessions. Alerts and institutional updates from NIH, FDA, CDC and other government agencies are reported in real time as part of the medical resources on our healthcare professional website.
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"Malpractice premiums are certainly not the most popular topic when it comes to healthcare professionals," admits Sean Keating, Product Director for Modern Medicine, the website for doctors that offers medical industry news and an online medical library as a resource for physicians. "This report provides some encouraging medical news for the medical industry on the subject, and also helps physicians put malpractice insurance in context when it comes to the actual costs of premiums reliant on geography and medical practice areas. I think all medical practitioners in America will find it enlightening, to say the least."
Among the findings discussed in the survey is the fact that family physicians, internists, and pediatricians all paid median costs of $12,500 annually for med-mal coverage in 2007, while ob/gyns paid more than four times as much, purportedly due to their propensity to be sued. Another intriguing statistic focuses on geographic disparity - malpractice premiums continue to be higher in the East than in the South or the West, attributed to the litigious climate in the Northeast and the lack of tort reform in states such as New York and Pennsylvania.
Full details of the 2008 Medical Economics survey concerning malpractice insurance for healthcare professionals are available at medicaleconomics.modernmedicine.
About ModernMedicine
ModernMedicine is an innovative online clinical decision-support resource that provides healthcare professionals with instant answers to clinical and practice management questions from highly credible and trusted sources. Our mission is to become the leading online clinical decision-support, CME and practice management resource for healthcare professionals. ModernMedicine provides healthcare professionals with access to a robust, cross-specialty online medical library of updated content that is complemented by interactive tools and features.
ModernMedicine features current and archived content from Advanstar's award-winning journal portfolio including Medical Economics, Drug Topics, Contemporary OB-GYN and Urology Times. Covering 20 specialties from Allergy to Urology, Modern Medicine also provides reviews from more than 100 of the world's top peer-reviewed medical journals, as well as comprehensive coverage from over 50 major industry conferences and scientific sessions. Alerts and institutional updates from NIH, FDA, CDC and other government agencies are reported in real time as part of the medical resources on our healthcare professional website.
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It's Time To Get Your Flu Shot
The American College of Obstetricians and Gynecologists (ACOG) reiterated its recommendation that all women who will be pregnant during the flu season-October through mid-May-be offered influenza (flu) vaccination. According to ACOG, flu vaccination is an essential part of prenatal care that provides protection to both women and their babies. ACOG also supports the Centers for Disease Control and Prevention (CDC) recommendation that all adolescents and adults be vaccinated against the flu.
According to the CDC, roughly one-fifth of the US population is infected with the flu virus each year. Having the flu can lead to serious complications and death. Annually, an estimated 200,000 people require hospitalization and approximately 36,000 die from flu-related illness.
The flu vaccine is indicated for all adolescents and adults. Special high-risk populations should make sure to be vaccinated every year. These include pregnant women, people older than 50 and younger than 5; people of any age who have asthma, heart disease, a weakened immune system, or other chronic illnesses, and their caregivers; and health care workers.
Pregnant women are particularly susceptible to serious illness associated with the flu, and treating the flu can be risky. "The antiretroviral drugs commonly prescribed to combat the flu have not been tested for safety and efficacy in pregnancy, and their effects on the fetus are unknown. Pregnant women who are using these drugs should do so with caution. Your best bet is to avoid the flu altogether, and vaccination can help you do that," says Sarah J. Kilpatrick, MD, chair of ACOG's Committee on Obstetric Practice. "Additionally, flu vaccination during pregnancy allows the woman and the fetus to develop flu-fighting antibodies, especially important because infants from 0 to 6 months cannot be vaccinated," she adds.
Flu season usually peaks around February. Getting vaccinated early-in October or November-is ideal, but women can receive the vaccine throughout the flu season as long as supplies last. Women may be vaccinated throughout pregnancy with the inactivated vaccine (flu shot). The flu shot is also safe for breastfeeding women. Pregnant women should not use the intranasal vaccine, which is inhaled instead of injected. It is only FDA-approved for use in non-pregnant individuals ages 2-49.
The 2007-08 supplies of the flu vaccine are expected to be abundant, with as many as 132 million doses available by January. However, experts warn that not enough people are getting vaccinated, including many individuals at high risk for contracting the flu. "The CDC estimates that nearly 18 million flu shots were not used and had to be discarded last year," Dr. Kilpatrick notes. "This is a tremendous lost opportunity because the fewer people that come down with the flu, the fewer there are that can spread the flu."
ACOG urges pregnant and nonpregnant women to get vaccinated as soon as possible. The American Lung Association's "Flu Clinic Locator" can help women find facilities that are administering flu shots. Go here.
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According to the CDC, roughly one-fifth of the US population is infected with the flu virus each year. Having the flu can lead to serious complications and death. Annually, an estimated 200,000 people require hospitalization and approximately 36,000 die from flu-related illness.
The flu vaccine is indicated for all adolescents and adults. Special high-risk populations should make sure to be vaccinated every year. These include pregnant women, people older than 50 and younger than 5; people of any age who have asthma, heart disease, a weakened immune system, or other chronic illnesses, and their caregivers; and health care workers.
Pregnant women are particularly susceptible to serious illness associated with the flu, and treating the flu can be risky. "The antiretroviral drugs commonly prescribed to combat the flu have not been tested for safety and efficacy in pregnancy, and their effects on the fetus are unknown. Pregnant women who are using these drugs should do so with caution. Your best bet is to avoid the flu altogether, and vaccination can help you do that," says Sarah J. Kilpatrick, MD, chair of ACOG's Committee on Obstetric Practice. "Additionally, flu vaccination during pregnancy allows the woman and the fetus to develop flu-fighting antibodies, especially important because infants from 0 to 6 months cannot be vaccinated," she adds.
Flu season usually peaks around February. Getting vaccinated early-in October or November-is ideal, but women can receive the vaccine throughout the flu season as long as supplies last. Women may be vaccinated throughout pregnancy with the inactivated vaccine (flu shot). The flu shot is also safe for breastfeeding women. Pregnant women should not use the intranasal vaccine, which is inhaled instead of injected. It is only FDA-approved for use in non-pregnant individuals ages 2-49.
The 2007-08 supplies of the flu vaccine are expected to be abundant, with as many as 132 million doses available by January. However, experts warn that not enough people are getting vaccinated, including many individuals at high risk for contracting the flu. "The CDC estimates that nearly 18 million flu shots were not used and had to be discarded last year," Dr. Kilpatrick notes. "This is a tremendous lost opportunity because the fewer people that come down with the flu, the fewer there are that can spread the flu."
ACOG urges pregnant and nonpregnant women to get vaccinated as soon as possible. The American Lung Association's "Flu Clinic Locator" can help women find facilities that are administering flu shots. Go here.
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TAU Investigates MicroRNA And Its Role In Human Disease
Just as scientists finished sequencing the human genome, they got a new surprise. Inside the genetic pathway, where DNA produces proteins to sustain life, they found microRNA. These tiny ubiquitous molecules have opened a new research channel in biology, allowing scientists to more closely examine what causes genetic diseases, and what makes our cells tick.
"This is a pivotal mechanism for solving genetic diseases," says Dr. Noam Shomron of the Faculty of Medicine at Tel Aviv University. "It's like the Gold Rush in the 1800s - everywhere we look we find microRNAs."
Taking all this valuable information - some 700 microRNA's are now indexed -and condensing it all on a biological "DNA chip" that looks like a common scientific slide, Dr. Shomron is helping scientists the world over understand what role microRNA plays in skin, cervical and brain cancer, leukemia, HIV, depression, and schizophrenia.
A Worldwide Reach
Utilizing his basic research, Dr. Shomron developed a popular online tool that Harvard, MIT, and Yale researchers are regularly referencing to "see" what kinds of microRNAs appear in the human and other genomes. "It's like looking at the globe for first time from outer space. It's the only tool that profiles microRNA in visuals," he says.
"I am helping scientists find the microRNA fingerprint," says Dr. Shomron, who started this work at MIT. "Using the DNA chip I've built, scientists can scan all human microRNAs at the same time and associate them with various pathologies. This gives them volumes of new information about the diseases they are studying."
How It Works
Each cell in our bodies has the instructions needed for building cells identical to it encoded in its DNA. RNA is "photocopied" from DNA in the cells, and from these instructions new proteins, machines that carry out orders in the body, are built.
But somewhere along the way, the photocopied instructions of what to do can get discarded or misplaced, and this is what leads to cancer and other genetic diseases. Like mischievous "personal assistants," microRNAs connect to the photocopied message and disrupts its delivery. "Sometimes they throw out perfectly good instructions, or fail to carry out orders," says Dr. Shomron. Why they do this is the mystery that biologists everywhere want to solve. Dr. Shomron is playing no small role.
"Scientists have been trying to solve genetic diseases for many years, and God noticed we weren't vastly improving," says Dr. Shomron. This changed with the discovery of microRNAs. "When the genetic mechanism known as microRNA was described to the scientific community, we knew it would change how we studied genetic disease as we have an additional gene regulatory mechanism to look at."
Cells Behaving Badly
Scientists don't know why some breast cancer patients respond well to chemotherapy, while others do not. With the ability to provide a complete genetic profile, Dr. Shomron's research lets scientists look into a deeper layer of information about disease behavior and the potential to build specialized treatments around it. This research falls in the area known as personalized medicine.
Applications of his research can lead to understanding the effects of the environment on our cells as well. Dr. Shomron is also exploring the use of microRNA for "smart drugs" that can target individual and damaged cells.
Dr. Shomron is new to Tel Aviv University, one of 23 handpicked faculty recruited from top research institutions around the world this year. Also the academic head of BioAbroad, Dr. Shomron has made it his mission to help young and successful Israeli scientists from the U.S. return to Israel in jobs that will keep them at the top of their field.
Source:
George Hunka
American Friends of Tel Aviv University
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"This is a pivotal mechanism for solving genetic diseases," says Dr. Noam Shomron of the Faculty of Medicine at Tel Aviv University. "It's like the Gold Rush in the 1800s - everywhere we look we find microRNAs."
Taking all this valuable information - some 700 microRNA's are now indexed -and condensing it all on a biological "DNA chip" that looks like a common scientific slide, Dr. Shomron is helping scientists the world over understand what role microRNA plays in skin, cervical and brain cancer, leukemia, HIV, depression, and schizophrenia.
A Worldwide Reach
Utilizing his basic research, Dr. Shomron developed a popular online tool that Harvard, MIT, and Yale researchers are regularly referencing to "see" what kinds of microRNAs appear in the human and other genomes. "It's like looking at the globe for first time from outer space. It's the only tool that profiles microRNA in visuals," he says.
"I am helping scientists find the microRNA fingerprint," says Dr. Shomron, who started this work at MIT. "Using the DNA chip I've built, scientists can scan all human microRNAs at the same time and associate them with various pathologies. This gives them volumes of new information about the diseases they are studying."
How It Works
Each cell in our bodies has the instructions needed for building cells identical to it encoded in its DNA. RNA is "photocopied" from DNA in the cells, and from these instructions new proteins, machines that carry out orders in the body, are built.
But somewhere along the way, the photocopied instructions of what to do can get discarded or misplaced, and this is what leads to cancer and other genetic diseases. Like mischievous "personal assistants," microRNAs connect to the photocopied message and disrupts its delivery. "Sometimes they throw out perfectly good instructions, or fail to carry out orders," says Dr. Shomron. Why they do this is the mystery that biologists everywhere want to solve. Dr. Shomron is playing no small role.
"Scientists have been trying to solve genetic diseases for many years, and God noticed we weren't vastly improving," says Dr. Shomron. This changed with the discovery of microRNAs. "When the genetic mechanism known as microRNA was described to the scientific community, we knew it would change how we studied genetic disease as we have an additional gene regulatory mechanism to look at."
Cells Behaving Badly
Scientists don't know why some breast cancer patients respond well to chemotherapy, while others do not. With the ability to provide a complete genetic profile, Dr. Shomron's research lets scientists look into a deeper layer of information about disease behavior and the potential to build specialized treatments around it. This research falls in the area known as personalized medicine.
Applications of his research can lead to understanding the effects of the environment on our cells as well. Dr. Shomron is also exploring the use of microRNA for "smart drugs" that can target individual and damaged cells.
Dr. Shomron is new to Tel Aviv University, one of 23 handpicked faculty recruited from top research institutions around the world this year. Also the academic head of BioAbroad, Dr. Shomron has made it his mission to help young and successful Israeli scientists from the U.S. return to Israel in jobs that will keep them at the top of their field.
Source:
George Hunka
American Friends of Tel Aviv University
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New Report Examines Out-of-Network Charges By Some Physicians
A new report by Dyckman & Associates prepared for America's Health Insurance Plans shows that some physicians who choose not to participate in health insurance networks are charging patients fees that are several hundred - and in some cases, a thousand percent - higher than Medicare reimbursement for the same service in the same geographic area. Looking at the 30 largest states, the report found that some physicians who don't take insurance are charging patients startling fees for a wide variety of medical treatments and services.
Recently, in public policy discussions about out-of-network services, the focus has been only on how much insurers pay for these services, and the critical issue of what out-of-network physicians are charging patients has been ignored. Hearing from its members about exorbitant out-of-network charges, AHIP engaged Dyckman & Associates to gather information across the country.
What we found should cause policymakers to closely investigate this issue, including looking carefully at how these charges compare to in-network fees, as well as fees charged for similar services in other countries. For example, in one state, a physician billed a patient $6,791 for "cataract surgery with insertion of artificial lens" - over 1100% of the Medicare fee of $581. Similar examples were found in all 30 states, and there are many examples of even higher variation in charges, even though the researchers used a conservative approach to the data that excluded outliers.
While the issue of how much is appropriate for out-of-network physicians to charge has not been part of health reform discussion to date, this report demonstrates that it needs to be. No mechanism exists to protect patients who seek care out-of-network from receiving bills that are unreasonable and unaffordable.
"As policymakers pursue health care reform, we encourage them to look at how much is being charged for services, particularly since higher charges don't mean high quality of care," said AHIP President and CEO Karen Ignagni. "With the nation facing the crushing burden of rising medical costs, all stakeholders should be focusing on constructive ways to bring costs under control."
Health plans create physician networks to ensure that patients have affordable access to a wide choice of high-quality health care providers. Consumers receive savings when they visit contracted providers who have agreed to lower rates, and are generally prohibited from charging patients anything above that rate. Consumers who receive services from in-network providers also typically have lower cost sharing, which, over the decades, has saved billions of dollars in out-of-pocket costs and premiums.
Click here to view to full report: ahipresearch/ValueofProviderNetworksSurvey.html.
Source
AHIP
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Recently, in public policy discussions about out-of-network services, the focus has been only on how much insurers pay for these services, and the critical issue of what out-of-network physicians are charging patients has been ignored. Hearing from its members about exorbitant out-of-network charges, AHIP engaged Dyckman & Associates to gather information across the country.
What we found should cause policymakers to closely investigate this issue, including looking carefully at how these charges compare to in-network fees, as well as fees charged for similar services in other countries. For example, in one state, a physician billed a patient $6,791 for "cataract surgery with insertion of artificial lens" - over 1100% of the Medicare fee of $581. Similar examples were found in all 30 states, and there are many examples of even higher variation in charges, even though the researchers used a conservative approach to the data that excluded outliers.
While the issue of how much is appropriate for out-of-network physicians to charge has not been part of health reform discussion to date, this report demonstrates that it needs to be. No mechanism exists to protect patients who seek care out-of-network from receiving bills that are unreasonable and unaffordable.
"As policymakers pursue health care reform, we encourage them to look at how much is being charged for services, particularly since higher charges don't mean high quality of care," said AHIP President and CEO Karen Ignagni. "With the nation facing the crushing burden of rising medical costs, all stakeholders should be focusing on constructive ways to bring costs under control."
Health plans create physician networks to ensure that patients have affordable access to a wide choice of high-quality health care providers. Consumers receive savings when they visit contracted providers who have agreed to lower rates, and are generally prohibited from charging patients anything above that rate. Consumers who receive services from in-network providers also typically have lower cost sharing, which, over the decades, has saved billions of dollars in out-of-pocket costs and premiums.
Click here to view to full report: ahipresearch/ValueofProviderNetworksSurvey.html.
Source
AHIP
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Health Care Reform Proposals Do Not Address Problems For Insured
The Wall Street Journal on Wednesday examined how for "those millions of insured Americans who get lost in the U.S. health care system's giant maze," the "journey is frustrated by coverage limits, denied claims and impersonal service." Every major presidential candidate "has introduced a health care reform plan," but, for the "most part, these plans focus on providing coverage to the 45 million uninsured or reining in medical costs" and "do little to address the myriad hurdles insured patients often encounter when they seek care," the Journal reports.
The Journal profiled Barbara Calder, a former chef who has a rare genetic disorder called Ehlers-Danlos Syndrome, in which the connective tissue in the body disintegrates over time. According to the Journal, "although she began suspecting she had the diseases 16 months ago and had health insurance, she spent a year battling numerous roadblocks just to see a specialist who could diagnose her condition." Efforts to navigate the health care system "can be especially maddening" for patients with rare genetic diseases because few physicians "know about such diseases" and "health insurers' computer programs tend not to recognize them," the Journal reports (Carreyrou, Wall Street Journal, 11/16).
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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The Journal profiled Barbara Calder, a former chef who has a rare genetic disorder called Ehlers-Danlos Syndrome, in which the connective tissue in the body disintegrates over time. According to the Journal, "although she began suspecting she had the diseases 16 months ago and had health insurance, she spent a year battling numerous roadblocks just to see a specialist who could diagnose her condition." Efforts to navigate the health care system "can be especially maddening" for patients with rare genetic diseases because few physicians "know about such diseases" and "health insurers' computer programs tend not to recognize them," the Journal reports (Carreyrou, Wall Street Journal, 11/16).
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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Brief Video Training Dramatically Boosts Hands-Only CPR Attempts
Study participants who viewed a brief hands-only cardiopulmonary resuscitation (CPR) video were more likely to attempt CPR, and perform better quality CPR in an emergency than participants who did not view the short videos, according to research reported in Circulation: Cardiovascular Quality and Outcomes.
Each year, almost 300,000 people suffer out-of-hospital cardiac arrests in the United States. Survival rates from these events tend to be extremely low. However, research has shown that bystander CPR can double - even triple - survival from out-of-hospital cardiac arrest.
In the United States, bystanders attempt CPR only about 26 percent of the time, according to Bentley J. Bobrow, M.D., lead author of the study and clinical associate professor in the Department of Emergency Medicine in the Maricopa Medical Center in Phoenix, Arizona and the University of Arizona Emergency Medicine Research Center.
"Chest compression-only CPR, also known as hands-only CPR, has been shown in studies to be at least as effective as standard CPR with mouth-to-mouth ventilation for adult primary cardiac arrest victims," Bobrow said. "And because of its simplicity, hands-only CPR may be quicker and easier for lay rescuers to learn, remember and perform than conventional CPR."
Bobrow and colleagues conducted a study of 336 adults without recent CPR training and randomized the participants into four groups:
No training (control group of 51 participants)
Ultra brief video (UBV): watched a 60-second video (95 participants)
Brief video (BV): watched a five-minute video (99 participants)
Brief video with practice (BVP): watched an eight-minute video with a practice training session using a manikin (91 participants)
They then tested the participants' ability to perform CPR during an adult out-of-hospital cardiac arrest simulation. About half of the trained participants underwent testing immediately and half after two months. They found that nearly a quarter (23.5 percent) of the untrained group did not attempt any CPR vs. less than 1 percent (.7 percent) from all the training groups combined. Trained subjects in the immediate and delayed evaluation groups were significantly more likely to attempt CPR compared to untrained subjects.
All training groups had significantly higher median compression rates compared to the control group (62 compressions-per-minute). In the immediate testing group, the median rates of compressions-per-minute were: UBV (96), BV (95), and BVP (99.5). In the delayed testing group, the median compression rates were: UBV (94), BV (92.5) and BVP (90).
The ideal compression rate is 100 compressions per-minute, according to the American Heart Association's 2010 Guidelines for CPR and Emergency Cardiovascular Care.
All trained groups had significantly greater median compression depth compared to the untrained group (30 mm). In the immediate testing group, the median compression depths were: UBV (41 mm), BV (42 mm) and BVP (48 mm). In the delayed testing group, the media compressions depths were: UBV (43 mm), BV (42.5) and BVP (46). The ideal compression depth is 38 mm or greater.
There were no significant differences in the median compression rate and median compression depth between participants tested immediately or tested two months later.
"This is the first controlled, randomized investigation evaluating the effectiveness of ultra-brief video training for teaching hands-only CPR to the lay public," Bobrow said. "Given that the ultra-brief video training in our study is only 60 seconds, the CPR performance results are striking. "This finding has enormous public health implications because of the documented hesitancy of untrained rescuers to even attempt CPR and because it is known that any bystander resuscitation attempt improves outcomes compared to no CPR."
Co-authors are: Tyler F. Vadeboncoeur, M.D.; Daniel W. Spaite, M.D.; Jerald Potts, Ph.D.; Kurt Denninghoff, M.D.; Vatsal Chikani, M.P.H.; Paula R. Brazil, M.A.; Bob Ramsey, M.A.; and Benjamin Abella, M.D., M.Phil. Author disclosures are on the manuscript.
The American Heart Association funded the study.
Source
Circulation: Cardiovascular Quality and Outcomes (American Heart Association journal)
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Each year, almost 300,000 people suffer out-of-hospital cardiac arrests in the United States. Survival rates from these events tend to be extremely low. However, research has shown that bystander CPR can double - even triple - survival from out-of-hospital cardiac arrest.
In the United States, bystanders attempt CPR only about 26 percent of the time, according to Bentley J. Bobrow, M.D., lead author of the study and clinical associate professor in the Department of Emergency Medicine in the Maricopa Medical Center in Phoenix, Arizona and the University of Arizona Emergency Medicine Research Center.
"Chest compression-only CPR, also known as hands-only CPR, has been shown in studies to be at least as effective as standard CPR with mouth-to-mouth ventilation for adult primary cardiac arrest victims," Bobrow said. "And because of its simplicity, hands-only CPR may be quicker and easier for lay rescuers to learn, remember and perform than conventional CPR."
Bobrow and colleagues conducted a study of 336 adults without recent CPR training and randomized the participants into four groups:
No training (control group of 51 participants)
Ultra brief video (UBV): watched a 60-second video (95 participants)
Brief video (BV): watched a five-minute video (99 participants)
Brief video with practice (BVP): watched an eight-minute video with a practice training session using a manikin (91 participants)
They then tested the participants' ability to perform CPR during an adult out-of-hospital cardiac arrest simulation. About half of the trained participants underwent testing immediately and half after two months. They found that nearly a quarter (23.5 percent) of the untrained group did not attempt any CPR vs. less than 1 percent (.7 percent) from all the training groups combined. Trained subjects in the immediate and delayed evaluation groups were significantly more likely to attempt CPR compared to untrained subjects.
All training groups had significantly higher median compression rates compared to the control group (62 compressions-per-minute). In the immediate testing group, the median rates of compressions-per-minute were: UBV (96), BV (95), and BVP (99.5). In the delayed testing group, the median compression rates were: UBV (94), BV (92.5) and BVP (90).
The ideal compression rate is 100 compressions per-minute, according to the American Heart Association's 2010 Guidelines for CPR and Emergency Cardiovascular Care.
All trained groups had significantly greater median compression depth compared to the untrained group (30 mm). In the immediate testing group, the median compression depths were: UBV (41 mm), BV (42 mm) and BVP (48 mm). In the delayed testing group, the media compressions depths were: UBV (43 mm), BV (42.5) and BVP (46). The ideal compression depth is 38 mm or greater.
There were no significant differences in the median compression rate and median compression depth between participants tested immediately or tested two months later.
"This is the first controlled, randomized investigation evaluating the effectiveness of ultra-brief video training for teaching hands-only CPR to the lay public," Bobrow said. "Given that the ultra-brief video training in our study is only 60 seconds, the CPR performance results are striking. "This finding has enormous public health implications because of the documented hesitancy of untrained rescuers to even attempt CPR and because it is known that any bystander resuscitation attempt improves outcomes compared to no CPR."
Co-authors are: Tyler F. Vadeboncoeur, M.D.; Daniel W. Spaite, M.D.; Jerald Potts, Ph.D.; Kurt Denninghoff, M.D.; Vatsal Chikani, M.P.H.; Paula R. Brazil, M.A.; Bob Ramsey, M.A.; and Benjamin Abella, M.D., M.Phil. Author disclosures are on the manuscript.
The American Heart Association funded the study.
Source
Circulation: Cardiovascular Quality and Outcomes (American Heart Association journal)
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Doctors To Use Real-Time Images Of Crash Scenes To Assess Injury
As part of a new study, SUNY Upstate Medical University physicians will use traffic surveillance cameras to view motor vehicle crashes and rescue operations on Central New York highways. The real-time view of crash scenes through a camera lens may provide emergency room physicians with information that may help them provide better care to crash victims when they arrive in the emergency room.
The study-believed to be the first of its kind in the nation-is being funded by the noted U.S. economist Alfred Kahn, who survived a car crash in 2003 and spent weeks recovering from his injuries at SUNY Upstate's teaching hospital, University Hospital.
For the study, SUNY Upstate researchers will have access to nearly 20 closed-circuit video cameras installed in and around Syracuse by the New York state Department of Transportation (DOT). These cameras are monitored by the DOT's Syracuse office 24 hours a day to assess traffic conditions in the area. The cameras, controlled by DOT personnel, can pan, tilt and zoom to particular areas of the roadway. Eleven cameras cover a 12-mile stretch of Interstate 81; 8 additional cameras will be in place shortly to cover a 12-mile stretch of Interstate 690.
A special receiving antenna brings the real time images into a specially outfitted workstation located near University Hospital's trauma room. Here, medical personnel can view the crash scene and rescue efforts on a computer monitor. The technology for the workstation was provided by CXtec.
When a crash occurs, DOT personnel will alert SUNY Upstate researchers and refer them to a particular camera to view the crash. Once the image is available on the computer Researchers can begin recording the images and provide the DOT staff with instructions on whether to zoom or pan the camera.
"We think the ability to view real time images of the accident scene to see the extent of damage and the response from paramedics can provide us with a wealth of information that may help us better treat the accident victims when they arrive at the emergency room," said John McCabe, M.D., professor and chair of the Department of Emergency Medicine at SUNY Upstate.
Currently, first responders to an accident scene communicate with physicians via radio about the extent of injuries of those being transported to the hospital. They may also provide physicians with information about what the accident scene looks like and relay information about the accident from eyewitness accounts, if available.
"The information we get from the scene is what we relay on to mobilize staff and equipment in the emergency room before the patient arrives," McCabe said, "and often this information can be ambiguous."
Such was the case several years ago, when a morning rush-hour crash involving three cars occurred on Interstate 90 near Syracuse. Initial reports that 23 people were involved in the crash sent University Hospital's emergency room staff seeking to transfer existing emergency room patients to other locations and calling up extra emergency room personnel. Minutes later the report changed: only six patients were coming to the hospital.
"This is a good example of how being able to see the scene in real time and being able to communicate more closely with the emergency personnel at the scene, would have allowed our staff to better anticipate the patient needs," McCabe said. "By viewing the scene, we would have been able to see early on that many of these individuals were 'walking wounded' and were not going to be coming to the hospital."
Earlier studies done in the United States and abroad have shown that viewing photographic documentation of crash scenes, including vehicle damage, has provided benefit to physicians. Studies at East Carolina University and Albany Medical College have shown that emergency room physicians treat crash victims more aggressively when provided with photos of crash scenes. The studies also found that physicians who saw the photos noted the accidents were more severe than reports received by emergency medical personnel indicated.
Alfred Kahn originally had wanted to recognize the hospital for saving his life and directed his grateful patient donation to be used by the emergency department. When he was told that his donation would fund this study, he was elated.
"I wanted to recognize in some way the incredible care I received from University Hospital, and when I heard it was going to support this study, I thought it was a fitting way to benefit others involved in car crashes, he said. "If we can use the incredible technology we have at our disposal today in a way that can help save more lives, than supporting a project such as this is a wise investment."
Kahn is perhaps best known as the father of airline deregulation. As chairman of the Civil Aeronautics Board (1977 to 1978), he authored the United States Airline Deregulation Act of 1978, which led to lower fares and higher airline productivity. The act lifted government controls on the airline industry giving airlines more maneuverability in determining fares and service areas. Kahn also served as chairman of the New York state Public Service Commission. He currently is a senior consultant the National Economic Research Associates and the Robert Julius Thorne Professor Emeritus of Political Economy at Cornell University.
Kahn was on his way home to the Ithaca, N.Y.,-area from Saratoga Springs, N.Y., when he lost control of his the car. He recalls sitting in his overturned car suspended by his seatbelt and seeing rescue personnel outside his car window.
Kahn said he is thankful of quick action taken by everyone to save his life and put him back together. "I think that's why I am so taken by the possibilities of this study," he said. "If the technology is available to us and we can use it in a way that might provide physicians and others with an even better understanding of the accident scene and, in turn, enhance medical care to people like me, then let's do it."
250 Harrison St.
Syracuse, NY 13202
United States
universityhospital/news
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The study-believed to be the first of its kind in the nation-is being funded by the noted U.S. economist Alfred Kahn, who survived a car crash in 2003 and spent weeks recovering from his injuries at SUNY Upstate's teaching hospital, University Hospital.
For the study, SUNY Upstate researchers will have access to nearly 20 closed-circuit video cameras installed in and around Syracuse by the New York state Department of Transportation (DOT). These cameras are monitored by the DOT's Syracuse office 24 hours a day to assess traffic conditions in the area. The cameras, controlled by DOT personnel, can pan, tilt and zoom to particular areas of the roadway. Eleven cameras cover a 12-mile stretch of Interstate 81; 8 additional cameras will be in place shortly to cover a 12-mile stretch of Interstate 690.
A special receiving antenna brings the real time images into a specially outfitted workstation located near University Hospital's trauma room. Here, medical personnel can view the crash scene and rescue efforts on a computer monitor. The technology for the workstation was provided by CXtec.
When a crash occurs, DOT personnel will alert SUNY Upstate researchers and refer them to a particular camera to view the crash. Once the image is available on the computer Researchers can begin recording the images and provide the DOT staff with instructions on whether to zoom or pan the camera.
"We think the ability to view real time images of the accident scene to see the extent of damage and the response from paramedics can provide us with a wealth of information that may help us better treat the accident victims when they arrive at the emergency room," said John McCabe, M.D., professor and chair of the Department of Emergency Medicine at SUNY Upstate.
Currently, first responders to an accident scene communicate with physicians via radio about the extent of injuries of those being transported to the hospital. They may also provide physicians with information about what the accident scene looks like and relay information about the accident from eyewitness accounts, if available.
"The information we get from the scene is what we relay on to mobilize staff and equipment in the emergency room before the patient arrives," McCabe said, "and often this information can be ambiguous."
Such was the case several years ago, when a morning rush-hour crash involving three cars occurred on Interstate 90 near Syracuse. Initial reports that 23 people were involved in the crash sent University Hospital's emergency room staff seeking to transfer existing emergency room patients to other locations and calling up extra emergency room personnel. Minutes later the report changed: only six patients were coming to the hospital.
"This is a good example of how being able to see the scene in real time and being able to communicate more closely with the emergency personnel at the scene, would have allowed our staff to better anticipate the patient needs," McCabe said. "By viewing the scene, we would have been able to see early on that many of these individuals were 'walking wounded' and were not going to be coming to the hospital."
Earlier studies done in the United States and abroad have shown that viewing photographic documentation of crash scenes, including vehicle damage, has provided benefit to physicians. Studies at East Carolina University and Albany Medical College have shown that emergency room physicians treat crash victims more aggressively when provided with photos of crash scenes. The studies also found that physicians who saw the photos noted the accidents were more severe than reports received by emergency medical personnel indicated.
Alfred Kahn originally had wanted to recognize the hospital for saving his life and directed his grateful patient donation to be used by the emergency department. When he was told that his donation would fund this study, he was elated.
"I wanted to recognize in some way the incredible care I received from University Hospital, and when I heard it was going to support this study, I thought it was a fitting way to benefit others involved in car crashes, he said. "If we can use the incredible technology we have at our disposal today in a way that can help save more lives, than supporting a project such as this is a wise investment."
Kahn is perhaps best known as the father of airline deregulation. As chairman of the Civil Aeronautics Board (1977 to 1978), he authored the United States Airline Deregulation Act of 1978, which led to lower fares and higher airline productivity. The act lifted government controls on the airline industry giving airlines more maneuverability in determining fares and service areas. Kahn also served as chairman of the New York state Public Service Commission. He currently is a senior consultant the National Economic Research Associates and the Robert Julius Thorne Professor Emeritus of Political Economy at Cornell University.
Kahn was on his way home to the Ithaca, N.Y.,-area from Saratoga Springs, N.Y., when he lost control of his the car. He recalls sitting in his overturned car suspended by his seatbelt and seeing rescue personnel outside his car window.
Kahn said he is thankful of quick action taken by everyone to save his life and put him back together. "I think that's why I am so taken by the possibilities of this study," he said. "If the technology is available to us and we can use it in a way that might provide physicians and others with an even better understanding of the accident scene and, in turn, enhance medical care to people like me, then let's do it."
250 Harrison St.
Syracuse, NY 13202
United States
universityhospital/news
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Parkinsonian Tremor Caused By 'Cross Fire' From The Brain
A typical symptom of Parkinson's disease is tremor in patients. A group of scientists, including Professor Peter Tass from Forschungszentrum Julich have succeeded in demonstrating the mechanisms which cause the so-called tremor: neuron clusters in the depths of the brain drive the tremor. This discovery supports Tass' research activities aiming at developing a therapy for Parkinson's disease. A new deep brain pacemaker is to bring cells out of the diseased mode for good.
The article in the high-impact journal Europhysics Letters shows that the scientists from Forschungszentrum Julich, a member of the Helmholtz Association, are on the right track. Their new deep brain pacemaker is to help Parkinson's patients on a large scale for the first time in 2009. Communication between the networks of neurons is disturbed in people suffering from Parkinson's disease. These "fire" their stimuli at the same time thus causing the typical tremor. The frequency measured here is 5 hertz (Hz), i.e. five oscillations per second. In Germany, there are officially around 150,000 Parkinson's patients, although it is estimated that up to 450,000 people are affected.
To date, scientists have assumed that the 5-Hz rhythm deep in the brain resulted from nerve signals, which are transmitted from muscles in the limbs back to the brain. The scientific term for this response is "proprioceptive feedback". The prevailing opinion of many scientists to date, however, is that the "cross fire" is not emitted by the brain. The reason for this assumption was that the measured frequency of the "proprioceptive feedback" and the frequency in a specific core region of the brain, in the thalamus and the basal ganglia, were not completely synchronous.
With a combination of several state-of-the-art analytical processes, the team has now succeeded in demonstrating that it is not only nerve signals from the muscles as feedback that drive the diseased 5-Hz rhythm in the brain. Headed by Prof. Volker Sturm, neurosurgeons in Cologne implanted electrodes in patients for the measurements, and scientists in Saratov, Russia, recalculated the obtained data together with scientists from JГјlich. "Signals in the frequency domain of 5 Hz from the core region of the brain also drive the tremor", explained Peter Tass. "The difference: the feedback from the limbs is a fast and easy stimulus transmission. The signals from the thalamus and the basal ganglia are, however, transmitted to certain loop-like neuron pathways of the brain and spinal cord. Therefore, the dynamics are more complicated and the pathway is longer."
The JГјlich medical scientist, mathematician and physicist believes that these new findings reinforce the theoretical basis of "his" deep brain pacemaker. This device influences the disturbed neurons in the core region of the brain and effectively removes their compulsion to "fire" at the same time. Tass' new development disturbs this compulsory diseased mode by using very mild, targeted and desynchronized stimuli in different places. In this way, the rhythm becomes irregular and breaks down. Compared to conventional devices of this type, the JГјlich deep brain pacemaker puts less strain on the patient and needs less energy. Moreover, the nerve tissue is stimulated in such a way that the neurons abandon their diseased strong synaptic networks and thus forget their compulsion to develop diseased rhythms.
The pacemaker consists of two electrodes that are carefully located at the dysregulated parts of the brain. The so-called stimulator provides the electrodes with energy and signals to stimulate the neurons in the brain. This device is implanted below the collarbone under the skin and thin wires also connect it with the electrodes under the skin.
Peter Tass is head of the working group "Neuromodulation" at the Institute of Neurosciences and Biophysics - Medicine in Forschungszentrum Jülich. Together with Volker Sturm from the University of Cologne, he was awarded the Schrödinger Prize in 2005. In the following year, both were nominated for the Future Prize, which is awarded by the President of the Federal Republic of Germany.
Original publication:
D. A. Smirnov, U. B. Barnikol, T.T. Barnikol, B. P. Bezruchko, C. Hauptmann, C. BГјhrle, M. Marouf, V. Sturm, H.-J. Freund, P. A. Tass: "The generation of Parkinsonian tremor as revealed by directional coupling analysis"
Source: Erhard Lachmann
Helmholtz Association of German Research Centres
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The article in the high-impact journal Europhysics Letters shows that the scientists from Forschungszentrum Julich, a member of the Helmholtz Association, are on the right track. Their new deep brain pacemaker is to help Parkinson's patients on a large scale for the first time in 2009. Communication between the networks of neurons is disturbed in people suffering from Parkinson's disease. These "fire" their stimuli at the same time thus causing the typical tremor. The frequency measured here is 5 hertz (Hz), i.e. five oscillations per second. In Germany, there are officially around 150,000 Parkinson's patients, although it is estimated that up to 450,000 people are affected.
To date, scientists have assumed that the 5-Hz rhythm deep in the brain resulted from nerve signals, which are transmitted from muscles in the limbs back to the brain. The scientific term for this response is "proprioceptive feedback". The prevailing opinion of many scientists to date, however, is that the "cross fire" is not emitted by the brain. The reason for this assumption was that the measured frequency of the "proprioceptive feedback" and the frequency in a specific core region of the brain, in the thalamus and the basal ganglia, were not completely synchronous.
With a combination of several state-of-the-art analytical processes, the team has now succeeded in demonstrating that it is not only nerve signals from the muscles as feedback that drive the diseased 5-Hz rhythm in the brain. Headed by Prof. Volker Sturm, neurosurgeons in Cologne implanted electrodes in patients for the measurements, and scientists in Saratov, Russia, recalculated the obtained data together with scientists from JГјlich. "Signals in the frequency domain of 5 Hz from the core region of the brain also drive the tremor", explained Peter Tass. "The difference: the feedback from the limbs is a fast and easy stimulus transmission. The signals from the thalamus and the basal ganglia are, however, transmitted to certain loop-like neuron pathways of the brain and spinal cord. Therefore, the dynamics are more complicated and the pathway is longer."
The JГјlich medical scientist, mathematician and physicist believes that these new findings reinforce the theoretical basis of "his" deep brain pacemaker. This device influences the disturbed neurons in the core region of the brain and effectively removes their compulsion to "fire" at the same time. Tass' new development disturbs this compulsory diseased mode by using very mild, targeted and desynchronized stimuli in different places. In this way, the rhythm becomes irregular and breaks down. Compared to conventional devices of this type, the JГјlich deep brain pacemaker puts less strain on the patient and needs less energy. Moreover, the nerve tissue is stimulated in such a way that the neurons abandon their diseased strong synaptic networks and thus forget their compulsion to develop diseased rhythms.
The pacemaker consists of two electrodes that are carefully located at the dysregulated parts of the brain. The so-called stimulator provides the electrodes with energy and signals to stimulate the neurons in the brain. This device is implanted below the collarbone under the skin and thin wires also connect it with the electrodes under the skin.
Peter Tass is head of the working group "Neuromodulation" at the Institute of Neurosciences and Biophysics - Medicine in Forschungszentrum Jülich. Together with Volker Sturm from the University of Cologne, he was awarded the Schrödinger Prize in 2005. In the following year, both were nominated for the Future Prize, which is awarded by the President of the Federal Republic of Germany.
Original publication:
D. A. Smirnov, U. B. Barnikol, T.T. Barnikol, B. P. Bezruchko, C. Hauptmann, C. BГјhrle, M. Marouf, V. Sturm, H.-J. Freund, P. A. Tass: "The generation of Parkinsonian tremor as revealed by directional coupling analysis"
Source: Erhard Lachmann
Helmholtz Association of German Research Centres
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Amazonian Tribe Sheds Light On Causes Of Heart Disease In Developed Countries
Heart attacks and strokes the leading causes of death in the United States and other developed countries may have been rare for the vast majority of human history, suggests a study to be published in PLoS ONE on Tuesday, August 11.
"Understanding how physiological systems respond in [indigenous] populations helps us better understand conditions in countries like the United States at the beginning of the 20th century," said senior author Eileen Crimmins of the USC Davis School of Gerontology. "This also offers some insight into the worlds we evolved in."
Crimmins, lead author Michael Gurven (University of California, Santa Barbara) and an international team of scientists looked at a remote Amazonian tribe in Bolivia known as the Tsimane. They measured various predictors of heart disease such as hypertension, obesity, diet and smoking habits. (The Tsimane grow and harvest their own tobacco.)
"The Tsimane were chosen because they still live a relatively traditional lifestyle: fishing, hunting, engaged in horticulture, gathering, living in extended family clusters and without much access to modern amenities," Gurven explained. "There are other groups with similar lifestyles, but often those groups have very small population numbers. . . . The Tsimane population is large enough about 9,000 that we can study almost all of the adults over age 40."
With only limited access to medical services, half of documented deaths among the Tsimane are due to infectious or parasitic disease. About two-thirds of the population has intestinal worms, the researchers found.
"We looked at a lot of populations in both developed and developing countries, in urban and rural settings, but none live in the relatively isolated and infected conditions of the Tsimane," the researchers write.
Chronic inflammation, which may lead to damage of the arteries, is prevalent among the Tsimane. According to the study, the Tsimane also have unusually high levels of C-reactive protein, increasingly used in clinical settings to evaluate risk for cardiovascular disease.
Yet, despite these risk factors for heart attacks, the researchers found that the high levels of C-reactive protein were unrelated to risk of peripheral arterial disease (the hardening of plaque in the arteries).
In fact, peripheral arterial disease "increases with age in every investigated population except the Tsimane," according to the study. Among the Tsimane, not a single adult showed evidence for peripheral arterial disease (measured using the ankle-brachial blood pressure index).
"Neither demographic interviews nor the past 7 years of working with the Tsimane has turned up many overt cases of people dying from heart attacks," Gurven said. "The Tsimane data tell us that inflammation alone may not be destructive in terms of its effects on long-term health. However, that might only be true in the context of an active lifestyle, lean diet, and possibly (and this part is more controversial) with a history of parasitism."
The researchers note that the Tsimane may have a distinct genetic expression compared to people in developed countries. Specifically, there is overexpression of the human leukocyte antigen, which has been linked in cell studies to plaque erosion.
"We observed low levels of atherosclerosis and associated cardiovascular disease among Tsimane, suggesting that these conditions may have been rare throughout pre-industrial human history," Crimmins said. "We may not be built for the world we live in. The Tsimane are perhaps a better model for the world we are built for."
"We don't know for sure that as younger people today get older that [arterial disease] won't increase," Gurven said. "More heart disease may be on the horizon if lifestyles change rapidly."
Jung Ki Kim and Caleb Finch of the USC Davis School of Gerontology and the Andrus Gerontology Center at USC and Hillard Kaplan of the University of New Mexico also contributed to the study.
Gurven, et al., "Inflammation and infection do not promote arterial aging and cardiovascular disease risk factors among lean horticulturists," PLoS ONE 4(8): e6590.
Source: University of Southern California
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"Understanding how physiological systems respond in [indigenous] populations helps us better understand conditions in countries like the United States at the beginning of the 20th century," said senior author Eileen Crimmins of the USC Davis School of Gerontology. "This also offers some insight into the worlds we evolved in."
Crimmins, lead author Michael Gurven (University of California, Santa Barbara) and an international team of scientists looked at a remote Amazonian tribe in Bolivia known as the Tsimane. They measured various predictors of heart disease such as hypertension, obesity, diet and smoking habits. (The Tsimane grow and harvest their own tobacco.)
"The Tsimane were chosen because they still live a relatively traditional lifestyle: fishing, hunting, engaged in horticulture, gathering, living in extended family clusters and without much access to modern amenities," Gurven explained. "There are other groups with similar lifestyles, but often those groups have very small population numbers. . . . The Tsimane population is large enough about 9,000 that we can study almost all of the adults over age 40."
With only limited access to medical services, half of documented deaths among the Tsimane are due to infectious or parasitic disease. About two-thirds of the population has intestinal worms, the researchers found.
"We looked at a lot of populations in both developed and developing countries, in urban and rural settings, but none live in the relatively isolated and infected conditions of the Tsimane," the researchers write.
Chronic inflammation, which may lead to damage of the arteries, is prevalent among the Tsimane. According to the study, the Tsimane also have unusually high levels of C-reactive protein, increasingly used in clinical settings to evaluate risk for cardiovascular disease.
Yet, despite these risk factors for heart attacks, the researchers found that the high levels of C-reactive protein were unrelated to risk of peripheral arterial disease (the hardening of plaque in the arteries).
In fact, peripheral arterial disease "increases with age in every investigated population except the Tsimane," according to the study. Among the Tsimane, not a single adult showed evidence for peripheral arterial disease (measured using the ankle-brachial blood pressure index).
"Neither demographic interviews nor the past 7 years of working with the Tsimane has turned up many overt cases of people dying from heart attacks," Gurven said. "The Tsimane data tell us that inflammation alone may not be destructive in terms of its effects on long-term health. However, that might only be true in the context of an active lifestyle, lean diet, and possibly (and this part is more controversial) with a history of parasitism."
The researchers note that the Tsimane may have a distinct genetic expression compared to people in developed countries. Specifically, there is overexpression of the human leukocyte antigen, which has been linked in cell studies to plaque erosion.
"We observed low levels of atherosclerosis and associated cardiovascular disease among Tsimane, suggesting that these conditions may have been rare throughout pre-industrial human history," Crimmins said. "We may not be built for the world we live in. The Tsimane are perhaps a better model for the world we are built for."
"We don't know for sure that as younger people today get older that [arterial disease] won't increase," Gurven said. "More heart disease may be on the horizon if lifestyles change rapidly."
Jung Ki Kim and Caleb Finch of the USC Davis School of Gerontology and the Andrus Gerontology Center at USC and Hillard Kaplan of the University of New Mexico also contributed to the study.
Gurven, et al., "Inflammation and infection do not promote arterial aging and cardiovascular disease risk factors among lean horticulturists," PLoS ONE 4(8): e6590.
Source: University of Southern California
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Immunological 'Memory' In Innate Cells Protects Against Viral Infection
Researchers have demonstrated that cells of the innate immune system are capable of "memory", and of mounting rapid protection to an otherwise lethal dose of live vaccinia virus. The study, published in the Open Access journal PLoS Pathogens, challenges previous thought that only B cells and T cells can store memory to ward off future infection. The finding, by researchers from Beth Israel Deaconess Medical Center, Harvard Medical School, and Hebrew University and Duke University, has potentially significant consequences for the design of future vaccines, particularly for HIV.
Immunological "memory" is what the immune system builds to respond more effectively to pathogens (such as bacteria and viruses) that the host organism has encountered previously. Traditionally, immunological "memory" has been thought to reside within the cells of the adaptive arm of the immune system (B cells and T cells) that recognize highly specific portions of pathogens through unique receptors.
This study, lead by Dr. Geoffrey Gillard, shows that an innate population of cells, called natural killer (NK) cells form "memory" to vaccinia virus infection despite the fact that they lack the receptors of traditional "memory" cells. Transfer of "memory" NK cells into immunodeficient mice was enough to protect these mice against a normally lethal exposure to vaccinia virus. Because the NK cell population lacks the receptors that allow B and T cells to develop highly specific "memory" responses to pathogens, the study raises important questions to the manner in which "memory" NK cells are capable of recognizing virus upon a second exposure.
Understanding how innate "memory" functions will be critical for incorporating this property into more effective vaccines, particularly as part of a vaccine against HIV. The properties of NK memory, most notably the ability to respond very rapidly, may be helpful in exerting early control of HIV infection by limiting the ability of the virus to overwhelm the host immune system in the early stages of infection.
FINANCIAL DISCLOSURE: This work was supported by CHAVI, grant number AI 067854. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
COMPETING INTERESTS: The authors have declared that no competing interests exist.
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Immunological "memory" is what the immune system builds to respond more effectively to pathogens (such as bacteria and viruses) that the host organism has encountered previously. Traditionally, immunological "memory" has been thought to reside within the cells of the adaptive arm of the immune system (B cells and T cells) that recognize highly specific portions of pathogens through unique receptors.
This study, lead by Dr. Geoffrey Gillard, shows that an innate population of cells, called natural killer (NK) cells form "memory" to vaccinia virus infection despite the fact that they lack the receptors of traditional "memory" cells. Transfer of "memory" NK cells into immunodeficient mice was enough to protect these mice against a normally lethal exposure to vaccinia virus. Because the NK cell population lacks the receptors that allow B and T cells to develop highly specific "memory" responses to pathogens, the study raises important questions to the manner in which "memory" NK cells are capable of recognizing virus upon a second exposure.
Understanding how innate "memory" functions will be critical for incorporating this property into more effective vaccines, particularly as part of a vaccine against HIV. The properties of NK memory, most notably the ability to respond very rapidly, may be helpful in exerting early control of HIV infection by limiting the ability of the virus to overwhelm the host immune system in the early stages of infection.
FINANCIAL DISCLOSURE: This work was supported by CHAVI, grant number AI 067854. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
COMPETING INTERESTS: The authors have declared that no competing interests exist.
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Regular Exercise Helps Obese Youths Reduce, Reverse Risk For Heart Disease, Study Shows
Regular exercise can help obese children shrink more than just their waistlines, new research shows. The activity also can help them to reduce - and even reverse - their risk of developing cardiovascular disease, including hardening of the arteries.
The research, conducted at the University of Rostock in Germany, appears in the Nov. 7, 2006 edition of the Journal of the American College of Cardiology.
"We think the most important message is that atherosclerosis - hardening of the arteries - starts during childhood in the presence of such risk factors as obesity and sedentary lifestyle," said lead researcher Andreas Alexander Meyer, MD, a pediatrician and pediatric cardiologist at the University of Rostock Children's Hospital. "Regular exercise is one of the most important activities we can do on our own to reduce the risk and reverse the early development of atherosclerosis."
This information is vital, Dr. Meyer said, as the need continues to grow to help children protect their health without becoming dependent upon prescription medications. According to the World Health Organization, childhood obesity already is "epidemic in some areas and on the rise in others." Worldwide, an estimated 22 million children under age 5 are overweight. In some countries, including the United States, more than 30 percent of all children are considered obese.
For their study, Dr. Meyer and his colleagues defined obesity as having a body mass index (BMI) in excess of the 97th percentile for German children. BMI is determined by a mathematical formula that uses height and weight to calculate body fat.
In adults, a BMI between 18 and 24.9 is considered normal, a BMI between 25 and 29.9 is considered overweight, and a BMI of 30 or more is considered obese. Specific ranges don't exist for children, but most of the teen-agers in the University of Rostock study had BMIs ranging from 24 to 35.
Compared with normal children, the obese youths also already were showing signs of early hardening of the arteries as well as thickening of the arterial lining where atherosclerosis originates.
For the study, the researchers randomly assigned 67 obese teens to one of two groups. The first group exercised three times per week for six months. The youths participated in an hour of swimming and aqua aerobics on Mondays, 90 minutes of team sports on Wednesdays, and 60 minutes of walking on Fridays. The other teens added no exercise to their normal routines.
After six months, the researchers found that the youths who were exercising regularly had significantly improved the flexibility of their arteries, allowing the arteries to carry more oxygen-rich blood to the body when needed. The teens also had shrunk the expanded inner layer of their arteries and reduced several other risk factors for cardiovascular disease, including lowering their BMIs, cutting triglyceride and cholesterol levels, and lowering blood pressure.
Previous research has indicated that the heart-healthy benefits of exercise wear off if regular activity is discontinued, Dr. Meyer said, so encouraging all children to maintain an exercise routine is important.
"We think that 90 minutes of exercise, three times per week is the minimum children need to reduce their cardiovascular risk," Dr. Meyer said. "And it's important that children enjoy exercise, so we recommend games like soccer, football, basketball and swimming - especially for obese children.
"Low perseverance and motivation seem to be distinctive for overweight children," he said, noting his concern over the number of teens who dropped out of the six-month study. "We have intensive talks with children and their parents about their medical status and vascular changes. We let them know that it is their own decision to change their prognosis."
To help children to monitor their success, Dr. Meyer recommends regular visits to the pediatrician combined with continuous support and encouragement from parents.
Albert P. Rocchini, MD, did not participate in the research, but is a pediatric cardiologist at C.S. Mott Children's Hospital at the University of Michigan. Dr. Rocchini said he, too, is concerned about motivating overweight children, especially teen-agers, to lead healthier lives.
"That's a very difficult problem," Dr. Rocchini said. "Sometimes education helps to let them know that they aren't invincible and they do have factors that will affect them very adversely as they grow older. We want young people to understand that now is the time to start dealing with health issues before they become permanent. But it takes time to get through to them."
Studies like this help with the education process, Dr. Rocchini said, because they show how and why carrying extra weight can lead to cardiovascular disease. Not all previous studies have documented vascular changes in obese children.
"I would take this as good and bad news," Dr Rocchini said of the study. "The bad news is, (early evidence of disease) is there, but the good news is it's not fixed and permanent. There's something you can do to make it better. That's the important message to share with people."
Dr. Meyer reports no disclosures with this research. Funding comes from a University of Rostock Medical Faculty research program grant.
The American College of Cardiology is leading the way to optimal cardiovascular care and disease prevention. The College is a 34,000-member nonprofit medical society and bestows the credential Fellow of the American College of Cardiology upon physicians who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at acc/.
The American College of Cardiology (ACC) provides these news reports of clinical studies published in the Journal of the American College of Cardiology as a service to physicians, the media, the public and other interested parties. However, statements or opinions expressed in these reports reflect the view of the author(s) and do not represent official policy of the ACC unless stated so.
Contact: Amy Murphy
American College of Cardiology
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The research, conducted at the University of Rostock in Germany, appears in the Nov. 7, 2006 edition of the Journal of the American College of Cardiology.
"We think the most important message is that atherosclerosis - hardening of the arteries - starts during childhood in the presence of such risk factors as obesity and sedentary lifestyle," said lead researcher Andreas Alexander Meyer, MD, a pediatrician and pediatric cardiologist at the University of Rostock Children's Hospital. "Regular exercise is one of the most important activities we can do on our own to reduce the risk and reverse the early development of atherosclerosis."
This information is vital, Dr. Meyer said, as the need continues to grow to help children protect their health without becoming dependent upon prescription medications. According to the World Health Organization, childhood obesity already is "epidemic in some areas and on the rise in others." Worldwide, an estimated 22 million children under age 5 are overweight. In some countries, including the United States, more than 30 percent of all children are considered obese.
For their study, Dr. Meyer and his colleagues defined obesity as having a body mass index (BMI) in excess of the 97th percentile for German children. BMI is determined by a mathematical formula that uses height and weight to calculate body fat.
In adults, a BMI between 18 and 24.9 is considered normal, a BMI between 25 and 29.9 is considered overweight, and a BMI of 30 or more is considered obese. Specific ranges don't exist for children, but most of the teen-agers in the University of Rostock study had BMIs ranging from 24 to 35.
Compared with normal children, the obese youths also already were showing signs of early hardening of the arteries as well as thickening of the arterial lining where atherosclerosis originates.
For the study, the researchers randomly assigned 67 obese teens to one of two groups. The first group exercised three times per week for six months. The youths participated in an hour of swimming and aqua aerobics on Mondays, 90 minutes of team sports on Wednesdays, and 60 minutes of walking on Fridays. The other teens added no exercise to their normal routines.
After six months, the researchers found that the youths who were exercising regularly had significantly improved the flexibility of their arteries, allowing the arteries to carry more oxygen-rich blood to the body when needed. The teens also had shrunk the expanded inner layer of their arteries and reduced several other risk factors for cardiovascular disease, including lowering their BMIs, cutting triglyceride and cholesterol levels, and lowering blood pressure.
Previous research has indicated that the heart-healthy benefits of exercise wear off if regular activity is discontinued, Dr. Meyer said, so encouraging all children to maintain an exercise routine is important.
"We think that 90 minutes of exercise, three times per week is the minimum children need to reduce their cardiovascular risk," Dr. Meyer said. "And it's important that children enjoy exercise, so we recommend games like soccer, football, basketball and swimming - especially for obese children.
"Low perseverance and motivation seem to be distinctive for overweight children," he said, noting his concern over the number of teens who dropped out of the six-month study. "We have intensive talks with children and their parents about their medical status and vascular changes. We let them know that it is their own decision to change their prognosis."
To help children to monitor their success, Dr. Meyer recommends regular visits to the pediatrician combined with continuous support and encouragement from parents.
Albert P. Rocchini, MD, did not participate in the research, but is a pediatric cardiologist at C.S. Mott Children's Hospital at the University of Michigan. Dr. Rocchini said he, too, is concerned about motivating overweight children, especially teen-agers, to lead healthier lives.
"That's a very difficult problem," Dr. Rocchini said. "Sometimes education helps to let them know that they aren't invincible and they do have factors that will affect them very adversely as they grow older. We want young people to understand that now is the time to start dealing with health issues before they become permanent. But it takes time to get through to them."
Studies like this help with the education process, Dr. Rocchini said, because they show how and why carrying extra weight can lead to cardiovascular disease. Not all previous studies have documented vascular changes in obese children.
"I would take this as good and bad news," Dr Rocchini said of the study. "The bad news is, (early evidence of disease) is there, but the good news is it's not fixed and permanent. There's something you can do to make it better. That's the important message to share with people."
Dr. Meyer reports no disclosures with this research. Funding comes from a University of Rostock Medical Faculty research program grant.
The American College of Cardiology is leading the way to optimal cardiovascular care and disease prevention. The College is a 34,000-member nonprofit medical society and bestows the credential Fellow of the American College of Cardiology upon physicians who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at acc/.
The American College of Cardiology (ACC) provides these news reports of clinical studies published in the Journal of the American College of Cardiology as a service to physicians, the media, the public and other interested parties. However, statements or opinions expressed in these reports reflect the view of the author(s) and do not represent official policy of the ACC unless stated so.
Contact: Amy Murphy
American College of Cardiology
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Obama Administration Launches Food Safety Working Group Website
Responding to President Obama's directive to upgrade the nation's food safety system, the White House Food Safety Working Group, led by Agriculture Secretary Tom Vilsack and of Health and Human Services Secretary Kathleen Sebelius, launched a website to provide information about the group's activities and progress.
"The Working Group will be an important tool for gathering ideas as to how we can strengthen the food safety system to be more accountable and accessible to the public it protects, flexible enough to quickly resolve new safety challenges that emerge, and able to meet the robust needs of our rapidly changing world," said Vilsack.
"Families have enough to worry about. You shouldn't have to wonder if the food you buy at the grocery store is safe," said Sebelius. "Our Working Group is working hard to modernize our food safety system and protect the American people. The website will help ensure all Americans can share their thoughts and contribute to this important process."
The website, www.foodsafetyworkinggroup will be an important resource for people who want to learn about the current food safety network as well as stakeholders and organizations which are working to upgrade America's food safety system for the 21st century. The website features social bookmarking tools including an RSS feed and a widget that can be downloaded to help stay informed.
Last week, representatives from the White House Food Safety Working Group met and outlined principles to meet the President's goal. In the weeks to come, the Food Safety Working Group will provide additional opportunities to engage stakeholders in conversations and help shape these principles.
A comprehensive approach to an improved national food safety system links regulatory actions and public health outcomes. This approach focuses resources according to risk, applies the best available science and high quality data to the decision-making process, and strives for seamless coordination among federal agencies and their state, local and international public health partners.
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"The Working Group will be an important tool for gathering ideas as to how we can strengthen the food safety system to be more accountable and accessible to the public it protects, flexible enough to quickly resolve new safety challenges that emerge, and able to meet the robust needs of our rapidly changing world," said Vilsack.
"Families have enough to worry about. You shouldn't have to wonder if the food you buy at the grocery store is safe," said Sebelius. "Our Working Group is working hard to modernize our food safety system and protect the American people. The website will help ensure all Americans can share their thoughts and contribute to this important process."
The website, www.foodsafetyworkinggroup will be an important resource for people who want to learn about the current food safety network as well as stakeholders and organizations which are working to upgrade America's food safety system for the 21st century. The website features social bookmarking tools including an RSS feed and a widget that can be downloaded to help stay informed.
Last week, representatives from the White House Food Safety Working Group met and outlined principles to meet the President's goal. In the weeks to come, the Food Safety Working Group will provide additional opportunities to engage stakeholders in conversations and help shape these principles.
A comprehensive approach to an improved national food safety system links regulatory actions and public health outcomes. This approach focuses resources according to risk, applies the best available science and high quality data to the decision-making process, and strives for seamless coordination among federal agencies and their state, local and international public health partners.
Source
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Blue Cross And Blue Shield Of North Carolina Waives Copayments On Drugs For Chronic Conditions
Blue Cross and Blue Shield of North Carolina (BCBSNC) will waive the copayment on all generic medications that treat congestive heart failure, high blood pressure, high cholesterol and diabetes effective January 1, 2008. In addition, more than 40 brand-name drugs that treat these specific conditions will be moved into a lower-cost drug classification category to make them more affordable. It's all part of a new medication adherence program, called Medication Dedication(SM), designed to make prescription drugs more affordable and encourage members with chronic conditions to take their medications as directed.
"The failure of patients to follow medication plans is a significant problem," said Dr. Ron Smith, BCBSNC vice president of Employer Health and Pharmacy. "Medication Dedication makes it easier for our members with common chronic conditions to access affordable prescription drugs and stay on their medications."
According to the World Health Organization, only 50 percent of patients with chronic illnesses follow their physicians' long-term medication therapy recommendations. The cost of prescription drugs is often a barrier to taking medications for chronic conditions as prescribed. The Centers for Disease Control and Prevention reports that approximately 125,000 people die per year of cardiovascular problems because they did not take their medication(s) as prescribed. The problem costs an estimated $100 billion annually. By targeting these four prevalent chronic conditions, BCBSNC believes members will stay healthier and, in the long run, keep their overall medical costs down.
"We have shown that when patients can afford their medication, they take their medication," said Smith. "Applying a copayment waiver for generic drugs used to treat specific conditions is the next logical evolution in our ongoing efforts to help control health care costs."
According to the Food and Drug Administration, generic drugs are the same as their brand-name counterparts in active ingredients, dosage, safety, strength and performance. The only noticeable difference between generics and their brand-name counterparts may be the shape and color of the drug. Also, while generic drugs are just as effective as corresponding brand-name drugs, they typically cost up to 80 percent less.
BCBSNC saved members $80 million in 2006 in out-of-pocket costs when the company waived copayments on all generic drug prescriptions. Generic drugs were prescribed 58 percent of the time, up from 46.8 percent in 2004.
The Medication Dedication program is expected to run through 2009. Members only need to present their BCBSNC ID card to a network pharmacy to receive the generic copayment waiver. A list of the generic drugs that are part of this program and the brand-name medications that will move into a less-expensive drug category can be found online at bcbsnc.
About BCBSNC
Blue Cross and Blue Shield of North Carolina is a leader in delivering innovative health care products, services and information to nearly 3.6 million members, including approximately 825,000 served on behalf of other Blue Plans. For 74 years, the company has served its customers by offering health insurance at a competitive price and has served the people of North Carolina through support of community organizations, programs and events that promote good health. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association. Access BCBSNC online at bcbsnc.
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"The failure of patients to follow medication plans is a significant problem," said Dr. Ron Smith, BCBSNC vice president of Employer Health and Pharmacy. "Medication Dedication makes it easier for our members with common chronic conditions to access affordable prescription drugs and stay on their medications."
According to the World Health Organization, only 50 percent of patients with chronic illnesses follow their physicians' long-term medication therapy recommendations. The cost of prescription drugs is often a barrier to taking medications for chronic conditions as prescribed. The Centers for Disease Control and Prevention reports that approximately 125,000 people die per year of cardiovascular problems because they did not take their medication(s) as prescribed. The problem costs an estimated $100 billion annually. By targeting these four prevalent chronic conditions, BCBSNC believes members will stay healthier and, in the long run, keep their overall medical costs down.
"We have shown that when patients can afford their medication, they take their medication," said Smith. "Applying a copayment waiver for generic drugs used to treat specific conditions is the next logical evolution in our ongoing efforts to help control health care costs."
According to the Food and Drug Administration, generic drugs are the same as their brand-name counterparts in active ingredients, dosage, safety, strength and performance. The only noticeable difference between generics and their brand-name counterparts may be the shape and color of the drug. Also, while generic drugs are just as effective as corresponding brand-name drugs, they typically cost up to 80 percent less.
BCBSNC saved members $80 million in 2006 in out-of-pocket costs when the company waived copayments on all generic drug prescriptions. Generic drugs were prescribed 58 percent of the time, up from 46.8 percent in 2004.
The Medication Dedication program is expected to run through 2009. Members only need to present their BCBSNC ID card to a network pharmacy to receive the generic copayment waiver. A list of the generic drugs that are part of this program and the brand-name medications that will move into a less-expensive drug category can be found online at bcbsnc.
About BCBSNC
Blue Cross and Blue Shield of North Carolina is a leader in delivering innovative health care products, services and information to nearly 3.6 million members, including approximately 825,000 served on behalf of other Blue Plans. For 74 years, the company has served its customers by offering health insurance at a competitive price and has served the people of North Carolina through support of community organizations, programs and events that promote good health. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association. Access BCBSNC online at bcbsnc.
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Archemix Announces Strategic Alliance With Elan To Discover And Develop Aptamer Therapeutics
Archemix Corp. announced
today a multi-year, multi-product alliance with Elan Corporation, plc
(NYSE: ELN) focused on the discovery, development, and commercialization of
first-in-class aptamer therapeutics to treat autoimmune disease. The
companies will seek to develop aptamer therapeutics to IL-23, a cytokine
that has emerged as a mediator in the chronic autoimmune inflammatory
diseases, and additional protein targets. The collaboration combines
Archemix's extensive expertise in aptamer therapeutics with Elan's
experience and leadership in the development and commercialization of new
therapies for autoimmune diseases.
Under the terms of the agreement, Archemix will receive an upfront
payment of $7 million. Depending upon the number of products successfully
commercialized under the collaboration, Archemix is eligible to receive
development and sales milestones in excess of $350 million. Archemix is
also entitled to receive a royalty on any marketed products developed under
the collaboration. Other financial terms were not disclosed. Archemix also
has an option to participate in the co-development of some products that
may emerge from this collaboration.
"We selected Elan from a number of potential pharmaceutical partners
because of its demonstrated expertise in the clinical and regulatory
landscape of autoimmune disease," said Dr. Errol De Souza, President and
Chief Executive Officer of Archemix. "Our robust intellectual property
position in aptamer therapeutics uniquely positions Archemix to be a
product development engine, developing a portfolio of aptamers for both
acute and chronic disease. Aptamers are poised to become the next
generation of therapeutics, and we are extremely pleased to be working with
a company of Elan's caliber on their development."
G. Kelly Martin, Elan's President and Chief Executive Officer,
commented, "We are pleased and enthusiastic about joining forces with
Archemix to seek to further expand patient/physician treatment choice in
autoimmune diseases. By combining our strengths, this collaboration can
accelerate the development of new therapies for chronic, debilitating
diseases with continued unmet medical needs."
About Interleukin 23
Interleukin 23, or IL-23, is a cytokine that has emerged as a mediator
in chronic autoimmune inflammatory diseases such as Multiple Sclerosis,
Crohn's Disease, Psoriasis, and Rheumatoid Arthritis. Preclinical results
have demonstrated that IL-23 exerts its pro-inflammatory effects
principally at the site of inflammation. It is hypothesized that specific
blockade of IL-23 may control clinical symptoms at the level of the
inflamed tissue without generally suppressing the patient's immune system,
thus preserving the body's ability to fight infection. The current
anti-cytokine treatments for autoimmune disorders have a number of
disadvantages, including an increased risk of infection, increased chances
of developing lymphoma, renal toxicity, and limited efficacy. Archemix's
aptamers are first-in-class therapeutics for autoimmune diseases that exert
their action by specifically inhibiting IL-23 in the target tissue.
About Aptamers
Aptamers are single-stranded nucleic acids that form well-defined
three-dimensional shapes, allowing them to bind to target molecules in a
manner that is conceptually similar to antibodies. Aptamers combine the
optimal characteristics of small molecules and antibodies, including high
specificity and affinity, chemical and biological stability, low
immunogenicity, and the ability to target protein-protein interactions. In
contrast to monoclonal antibodies, aptamers are chemically synthesized
rather than biologically expressed, potentially offering a significant cost
advantage. As therapeutic agents, aptamers have demonstrated clinical
biological efficacy and typically have excellent, tunable pharmacokinetic
properties.
About Archemix Corp.
Archemix Corp. is a privately-held biopharmaceutical company based in
Cambridge, Massachusetts. The company's mission is to develop aptamers as a
class of directed therapeutics for the prevention and treatment of human
disease. Because of their unique properties and proven efficacy, aptamers
are a superior alternative to biologics and small molecules and will be a
major class of drugs for the treatment of unmet medical needs.
Archemix's aptamer expertise is complemented by a robust patent estate
comprised of over 220 issued and 230 pending patents covering the
identification, composition, and use of therapeutic aptamers. In addition
to the company's core aptamer generation technology, Archemix possesses
strong expertise in both preclinical and clinical drug development. Further
information on Archemix can be found at archemix.
Archemix Corp.
archemix
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today a multi-year, multi-product alliance with Elan Corporation, plc
(NYSE: ELN) focused on the discovery, development, and commercialization of
first-in-class aptamer therapeutics to treat autoimmune disease. The
companies will seek to develop aptamer therapeutics to IL-23, a cytokine
that has emerged as a mediator in the chronic autoimmune inflammatory
diseases, and additional protein targets. The collaboration combines
Archemix's extensive expertise in aptamer therapeutics with Elan's
experience and leadership in the development and commercialization of new
therapies for autoimmune diseases.
Under the terms of the agreement, Archemix will receive an upfront
payment of $7 million. Depending upon the number of products successfully
commercialized under the collaboration, Archemix is eligible to receive
development and sales milestones in excess of $350 million. Archemix is
also entitled to receive a royalty on any marketed products developed under
the collaboration. Other financial terms were not disclosed. Archemix also
has an option to participate in the co-development of some products that
may emerge from this collaboration.
"We selected Elan from a number of potential pharmaceutical partners
because of its demonstrated expertise in the clinical and regulatory
landscape of autoimmune disease," said Dr. Errol De Souza, President and
Chief Executive Officer of Archemix. "Our robust intellectual property
position in aptamer therapeutics uniquely positions Archemix to be a
product development engine, developing a portfolio of aptamers for both
acute and chronic disease. Aptamers are poised to become the next
generation of therapeutics, and we are extremely pleased to be working with
a company of Elan's caliber on their development."
G. Kelly Martin, Elan's President and Chief Executive Officer,
commented, "We are pleased and enthusiastic about joining forces with
Archemix to seek to further expand patient/physician treatment choice in
autoimmune diseases. By combining our strengths, this collaboration can
accelerate the development of new therapies for chronic, debilitating
diseases with continued unmet medical needs."
About Interleukin 23
Interleukin 23, or IL-23, is a cytokine that has emerged as a mediator
in chronic autoimmune inflammatory diseases such as Multiple Sclerosis,
Crohn's Disease, Psoriasis, and Rheumatoid Arthritis. Preclinical results
have demonstrated that IL-23 exerts its pro-inflammatory effects
principally at the site of inflammation. It is hypothesized that specific
blockade of IL-23 may control clinical symptoms at the level of the
inflamed tissue without generally suppressing the patient's immune system,
thus preserving the body's ability to fight infection. The current
anti-cytokine treatments for autoimmune disorders have a number of
disadvantages, including an increased risk of infection, increased chances
of developing lymphoma, renal toxicity, and limited efficacy. Archemix's
aptamers are first-in-class therapeutics for autoimmune diseases that exert
their action by specifically inhibiting IL-23 in the target tissue.
About Aptamers
Aptamers are single-stranded nucleic acids that form well-defined
three-dimensional shapes, allowing them to bind to target molecules in a
manner that is conceptually similar to antibodies. Aptamers combine the
optimal characteristics of small molecules and antibodies, including high
specificity and affinity, chemical and biological stability, low
immunogenicity, and the ability to target protein-protein interactions. In
contrast to monoclonal antibodies, aptamers are chemically synthesized
rather than biologically expressed, potentially offering a significant cost
advantage. As therapeutic agents, aptamers have demonstrated clinical
biological efficacy and typically have excellent, tunable pharmacokinetic
properties.
About Archemix Corp.
Archemix Corp. is a privately-held biopharmaceutical company based in
Cambridge, Massachusetts. The company's mission is to develop aptamers as a
class of directed therapeutics for the prevention and treatment of human
disease. Because of their unique properties and proven efficacy, aptamers
are a superior alternative to biologics and small molecules and will be a
major class of drugs for the treatment of unmet medical needs.
Archemix's aptamer expertise is complemented by a robust patent estate
comprised of over 220 issued and 230 pending patents covering the
identification, composition, and use of therapeutic aptamers. In addition
to the company's core aptamer generation technology, Archemix possesses
strong expertise in both preclinical and clinical drug development. Further
information on Archemix can be found at archemix.
Archemix Corp.
archemix
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San Francisco Chronicle Examines Political Risks In President Obama's FY 2010 Budget Proposal
President Obama "is risking his presidency on the most ambitious remake of the federal government since Ronald Reagan" with his $3.6 trillion fiscal year 2010 budget, which includes his plan to make a $634 billion down payment on health care reform, the San Francisco Chronicle reports.
According to the Chronicle, Congress for decades has been unable to address many of the issues on which Obama's budget focuses, including health care. Charles Konigsberg, chief budget counsel at the Concord Coalition, said, "This is the most ambitious budget I've ever seen in 25 years," adding, "Doing all of these [agenda items] simultaneously is an enormous task." According the Chronicle, "For liberals who fretted just a month ago that Obama was acting suspiciously centrist, his $3.6 trillion budget is a call to arms" that is "a carefully woven matrix that tackles everything from global warming to health care with new spending and taxes."
Robert Reischauer, president of the Urban Institute and former director of the Congressional Budget Office, said, "It's a terribly ambitious agenda," adding, "At 30,000 feet, covering the uninsured and moderating cost growth in health has near unanimous support, as does reducing greenhouse gases and dealing with climate change. But when pen is put to paper to specify how these goals are achieved, it inevitably involves redistributing resources and power." Julian Zelizer, a political historian at Princeton University, said addressing health care among other issues all at the same time is "a huge political risk." He added, "In 2004, we forget, Bush looked as strong as any president" until he took on one issue -- Social Security -- and failed.
While moderate Democrats "are already backing away from tax increases," Republicans "have declared war on them," the Chronicle reports. Rep. Darrell Issa (R-Calif.) said, "It's very classic redistribution of wealth," adding, "Lyndon Baines Johnson would blush to put this budget up." In an effort to garner support for the budget, liberal groups have vowed to spend up to $7 million on an advertising campaign. The Chronicle reports, "This is only a taste of the brawl that will commence when actual bills on health care" and other issues are proposed.
According to the Chronicle, "top Democratic aides conceded that Obama will need every ounce of his popularity to make his vision reality," as "even Senate Republicans who say they want to work with him on health care and energy have profound ideological differences that will be tough to bridge." In addition, "Obama's plans could also be overwhelmed by the banking mess," according to the Chronicle. The Chronicle reports that if polls are accurate, the economic recession has "altered public attitudes about government, be it the appetite for health care reform, regulation of banks or higher taxes on the wealthy" (Lochhead, San Francisco Chronicle, 3/8).
According to the Chronicle, Congress for decades has been unable to address many of the issues on which Obama's budget focuses, including health care. Charles Konigsberg, chief budget counsel at the Concord Coalition, said, "This is the most ambitious budget I've ever seen in 25 years," adding, "Doing all of these [agenda items] simultaneously is an enormous task." According the Chronicle, "For liberals who fretted just a month ago that Obama was acting suspiciously centrist, his $3.6 trillion budget is a call to arms" that is "a carefully woven matrix that tackles everything from global warming to health care with new spending and taxes."
Robert Reischauer, president of the Urban Institute and former director of the Congressional Budget Office, said, "It's a terribly ambitious agenda," adding, "At 30,000 feet, covering the uninsured and moderating cost growth in health has near unanimous support, as does reducing greenhouse gases and dealing with climate change. But when pen is put to paper to specify how these goals are achieved, it inevitably involves redistributing resources and power." Julian Zelizer, a political historian at Princeton University, said addressing health care among other issues all at the same time is "a huge political risk." He added, "In 2004, we forget, Bush looked as strong as any president" until he took on one issue -- Social Security -- and failed.
While moderate Democrats "are already backing away from tax increases," Republicans "have declared war on them," the Chronicle reports. Rep. Darrell Issa (R-Calif.) said, "It's very classic redistribution of wealth," adding, "Lyndon Baines Johnson would blush to put this budget up." In an effort to garner support for the budget, liberal groups have vowed to spend up to $7 million on an advertising campaign. The Chronicle reports, "This is only a taste of the brawl that will commence when actual bills on health care" and other issues are proposed.
According to the Chronicle, "top Democratic aides conceded that Obama will need every ounce of his popularity to make his vision reality," as "even Senate Republicans who say they want to work with him on health care and energy have profound ideological differences that will be tough to bridge." In addition, "Obama's plans could also be overwhelmed by the banking mess," according to the Chronicle. The Chronicle reports that if polls are accurate, the economic recession has "altered public attitudes about government, be it the appetite for health care reform, regulation of banks or higher taxes on the wealthy" (Lochhead, San Francisco Chronicle, 3/8).
Congress Passes, Obama Signs Continuing Resolution
The House on Friday voted 328-50 to approve a continuing resolution (H.J. Res. 38), and the Senate unanimously approved the measure by voice vote (AP/Washington Post, 3/6). Obama then signed the measure, which will fund at current levels the budgets of most Cabinet departments and federal agencies until March 11, 2009, in to law. (White House press release, 3/6).
The measure was needed because Congress has not yet approved the FY 2009 Labor-HHS-Education appropriations bill and the eight other FY 2009 appropriations bills. Since October 2008, the federal government has operated under a continuing resolution that funded most Cabinet departments and federal agencies at FY 2008 levels until March 6 (Kaiser Daily Health Policy Report, 3/2).
A vote on an omnibus appropriations bill (HR 1105) that includes the FY 2009 Labor-HHS-Education appropriations bill and the eight other unapproved FY 2009 appropriations bills would happen in the Senate at the earliest on Tuesday. The House has already approved the measure (AP/Washington Post, 3/6).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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