Researchers in Hong Kong report that testing patient blood for DNA from Epstein-Barr virus (EBV) during treatment for nasopharyngeal carcinoma effectively predicts clinical outcome. A biomarker test like this, when perfected, could identify patients whose treatment could be intensified after a month or so of standard therapy as well as those who might benefit from lighter treatment.
The study, presented at the American Association for Cancer Research Molecular Diagnostics in Cancer Therapeutic Development meeting held here September 22-25, highlights the strong link between the virus and this cancer, which is common in Southern China and also develops in Chinese immigrants It further suggests that genetic levels of EBV should be assessed before and during treatment, not just after therapy, as it is now.
"We found that patients with undetectable EBV DNA mid-course through treatment had a greatly reduced risk of developing cancer recurrence two years after treatment, compared with patients with detectable EBV DNA," said the study's senior investigator, Anthony Chan, M.D., director of the Cancer Center at the Chinese University of Hong Kong.
Although EBV is associated with nasopharynx cancer, which develops in the upper area of the throat, a causal relationship hasn't been established, Chan says. Still, cancer cells contain EBV genetic material, which leaks into the bloodstream and can be detected using DNA tests. "That means a larger number of nasopharynx cancer cells in the body would give rise to a larger amount of EBV genetic material in the blood circulation, and so the EBV DNA level is a marker of the extent of cancer."
Researchers know that the amount of EBV DNA found after treatment is a recognized prognostic marker of survival because residual detectable EBV DNA "implies incomplete killing of cancer and thus a poor prognosis," Chan said. The question the researchers investigated is whether there is a way to identify patients with such a viral load before treatment is finished so that more aggressive therapy might be instituted.
"We need to know what to do for those patients with residual EBV. These patients usually do not have clinical evidence of cancer at that point and the residual cancer burden is at a microscopic level. Any extra treatment would be for undetectable cancer, and we need to prove that such treatment has an impact on improving survival," Chan said.
In this study, researchers tested 108 patients with advanced stage cancer for EBV DNA before the start of treatment, after a month of therapy, and then within three months after completion of treatment, and matched these levels to outcomes two-years later. They found that 94 percent of patients had detectable EBV DNA before therapy, but that it became undetectable in 54 percent of patients midway through treatment. The 42 percent of patients who had both low pretreatment and undetectable four-week viral levels constituted a "good risk group" because their recurrence rate was only nine percent.
Conversely, they found that levels detected after four weeks of treatment correlated with detectable post-treatment amounts, with an almost threefold greater risk of cancer recurrence and threefold higher risk of distant metastasis at two years.
"It is possible to test for EBV DNA levels at any time point, so based on further validation studies, we may be able to use biomarker levels at several time points to guide clinical therapy," Chan said.
The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes nearly 27,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication and its sixth major journal, Cancer Prevention Research, is the only journal worldwide dedicated exclusively to cancer prevention, from preclinical research to clinical trials. The AACR also publishes CR, a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. CR provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.
Source: Jeremy Moore
American Association for Cancer Research
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четверг, 8 сентября 2011 г.
Novel Study Proves That Good Fences Make Good Neighbors
In the last century, more than 100 million people have perished in violent conflict, very often because of local clashes between ethnically or culturally distinct groups. In a novel study this week in Science, researchers report on a mathematical model that can predict where ethnic conflict will erupt.
The study, conducted by scientists at the New England Complex Systems Institute (NECSI) and Brandeis University, can be applied to many areas and its predictions were tested on distinct ethnic groups in India and the former Yugoslavia. The researchers applied a model of global pattern formation that differentiates regions by culture. They discovered that heterogeneous areas with poorly-defined boundaries were prone to ethnic conflict.
The research asserts that in highly mixed regions, groups of the same type are not large enough to sway collective behavior toward claiming any particular public space; likewise, well-segregated groups are protected by clear boundaries identifying their space. However, the study concludes that "partial separation with poorly defined boundaries fosters conflict."
In essence, as poet Robert Frost wrote in a well-known poem, "good fences make good neighbors." Well-defined borders help prevent ethnic tension.
"Our research shows that violence takes place when an ethnic group is large enough to impose cultural norms on public spaces, but not large enough to prevent those norms from being broken," said Brandeis researcher Dr. May Lim. "Usually this occurs in places where boundaries between groups are unclear."
Reflecting an emerging direction in science applied to social policy, the study applies the scientific principles of pattern formation -- which are used to describe, for example, how chemicals separate by type or phase -- to the huge social problem of ethnic conflict. The researchers discovered that ethnic violence occurs in certain predictable patterns, just as do other collective behaviors in physical, biological, and social complex systems.
"The concept of pattern formation, while it may have been originally developed to understand chemical systems, is really a scientific model of collective behaviors, in which you look at those aspects that control overall behavior," said co-author and NECSI president Yaneer Bar-Yam.
"This study provides an indication of where regions may run into trouble, and how to avoid conflict, said Bar-Yam, adding, "this research reflects a tremendous opportunity for us to address a wide range of social concerns with new scientific tools."
Source: Laura Gardner
Brandeis University
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The study, conducted by scientists at the New England Complex Systems Institute (NECSI) and Brandeis University, can be applied to many areas and its predictions were tested on distinct ethnic groups in India and the former Yugoslavia. The researchers applied a model of global pattern formation that differentiates regions by culture. They discovered that heterogeneous areas with poorly-defined boundaries were prone to ethnic conflict.
The research asserts that in highly mixed regions, groups of the same type are not large enough to sway collective behavior toward claiming any particular public space; likewise, well-segregated groups are protected by clear boundaries identifying their space. However, the study concludes that "partial separation with poorly defined boundaries fosters conflict."
In essence, as poet Robert Frost wrote in a well-known poem, "good fences make good neighbors." Well-defined borders help prevent ethnic tension.
"Our research shows that violence takes place when an ethnic group is large enough to impose cultural norms on public spaces, but not large enough to prevent those norms from being broken," said Brandeis researcher Dr. May Lim. "Usually this occurs in places where boundaries between groups are unclear."
Reflecting an emerging direction in science applied to social policy, the study applies the scientific principles of pattern formation -- which are used to describe, for example, how chemicals separate by type or phase -- to the huge social problem of ethnic conflict. The researchers discovered that ethnic violence occurs in certain predictable patterns, just as do other collective behaviors in physical, biological, and social complex systems.
"The concept of pattern formation, while it may have been originally developed to understand chemical systems, is really a scientific model of collective behaviors, in which you look at those aspects that control overall behavior," said co-author and NECSI president Yaneer Bar-Yam.
"This study provides an indication of where regions may run into trouble, and how to avoid conflict, said Bar-Yam, adding, "this research reflects a tremendous opportunity for us to address a wide range of social concerns with new scientific tools."
Source: Laura Gardner
Brandeis University
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Nationwide Vaccine and Treatment Units Strengthened and Expanded, US
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded eight contracts to strengthen and expand its nationwide group of institutions conducting clinical trials of promising candidate vaccines and therapies for infectious diseases. In addition to increasing the number of sites from seven to eight, NIAID expects the Vaccine and Treatment Evaluation Units (VTEUs) to carry out more clinical trials in larger populations and to safely test vaccines in specific vulnerable populations, such as infants and the elderly. Moreover, all the VTEUs will have inpatient beds for isolating volunteers who participate in the testing of vaccines containing weakened versions of live microbes, making it easier to conduct such trials quickly.
Each VTEU will receive approximately $23.7 million over seven years. The combined capabilities of these research facilities -- located in Atlanta, Baltimore, Cincinnati, Houston, Iowa City, Nashville, Seattle and St. Louis -- will enhance NIAID's ability to direct clinical research to quickly respond to emerging public health needs.
"In more than four decades of research, the VTEUs have conducted hundreds of clinical trials of investigational vaccines and therapeutics for a variety of infectious diseases of public health concern, and many of these trials have contributed to the licensure of products," says NIAID Director Anthony S. Fauci, M.D. "We expect this success to continue, as each VTEU has exceptional expertise and experience in vaccinology and an impressive capacity to recruit volunteers from diverse populations in its community."
Established in 1962, the VTEUs are a national resource for vaccine development. VTEU investigators have tested and advanced vaccines for many diseases, including influenza, pneumonia, whooping cough, Haemophilus influenzae infection, cytomegalovirus infection, malaria, smallpox, anthrax and tularemia. Childhood vaccines and combination vaccines -- the delivery of several vaccines through one inoculation -- have been and remain an important part of the VTEUs' research goals. The first trial of an edible vaccine was conducted by VTEU researchers, and other novel vaccine delivery systems have been extensively tested by this select group of medical research facilities. For example, one VTEU demonstrated that consuming genetically engineered potatoes could stimulate an immune response against Escherichia coli in humans, and six VTEUs enrolled young children in a successful Phase III trial of FluMist, an influenza vaccine delivered through a nasal spray.
An important strength of the VTEUs is their ability to enroll large numbers of volunteers into trials rapidly and vaccinate them in a manner that is safe, effective and quick to yield results. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. For example, the VTEUs conducted multiple studies in 2005 and 2006 of a vaccine for a strain of H5N1 avian influenza virus to determine the most effective dose. Those studies led to the licensure of the first vaccine approved by the U.S. Food and Drug Administration (FDA) against an H5N1 influenza virus. The units also swiftly initiated a large-scale trial to evaluate the seasonal influenza vaccine Fluarix for use in healthy adults in the United States. The trial demonstrated the vaccine's safety and ability to generate an immune response and ultimately led to its expedited approval by FDA in August 2005 -- less than a year after the trial began. This approval helped reduce the impact of future delays or shortages of seasonal influenza vaccines in the United States.
The selected VTEU sites and principal investigators (PIs) are as follows.
Baylor College of Medicine
Houston, Texas
PI: Wendy A. Keitel, M.D.
Children's Hospital Medical Center
Cincinnati, Ohio
PI: David I. Bernstein, M.D., M.A.
Emory University
Atlanta, Georgia
PI: Mark J. Mulligan, M.D.
Group Health Cooperative
Seattle, Washington
PI: Lisa A. Jackson, M.D., M.P.H.
Saint Louis University
St. Louis, Missouri
PI: Robert B. Belshe, M.D.
University of Iowa
Iowa City, Iowa
PI: Patricia L. Winokur, M.D.
University of Maryland
Baltimore, Maryland
PI: Karen L. Kotloff, M.D.
Vanderbilt University
Nashville, Tennessee
PI: Kathryn M. Edwards, M.D.
NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.
News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at niaid.nih/.
Source: Laura Sivitz
NIH/National Institute of Allergy and Infectious Diseases
View drug information on FluMist.
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Each VTEU will receive approximately $23.7 million over seven years. The combined capabilities of these research facilities -- located in Atlanta, Baltimore, Cincinnati, Houston, Iowa City, Nashville, Seattle and St. Louis -- will enhance NIAID's ability to direct clinical research to quickly respond to emerging public health needs.
"In more than four decades of research, the VTEUs have conducted hundreds of clinical trials of investigational vaccines and therapeutics for a variety of infectious diseases of public health concern, and many of these trials have contributed to the licensure of products," says NIAID Director Anthony S. Fauci, M.D. "We expect this success to continue, as each VTEU has exceptional expertise and experience in vaccinology and an impressive capacity to recruit volunteers from diverse populations in its community."
Established in 1962, the VTEUs are a national resource for vaccine development. VTEU investigators have tested and advanced vaccines for many diseases, including influenza, pneumonia, whooping cough, Haemophilus influenzae infection, cytomegalovirus infection, malaria, smallpox, anthrax and tularemia. Childhood vaccines and combination vaccines -- the delivery of several vaccines through one inoculation -- have been and remain an important part of the VTEUs' research goals. The first trial of an edible vaccine was conducted by VTEU researchers, and other novel vaccine delivery systems have been extensively tested by this select group of medical research facilities. For example, one VTEU demonstrated that consuming genetically engineered potatoes could stimulate an immune response against Escherichia coli in humans, and six VTEUs enrolled young children in a successful Phase III trial of FluMist, an influenza vaccine delivered through a nasal spray.
An important strength of the VTEUs is their ability to enroll large numbers of volunteers into trials rapidly and vaccinate them in a manner that is safe, effective and quick to yield results. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. For example, the VTEUs conducted multiple studies in 2005 and 2006 of a vaccine for a strain of H5N1 avian influenza virus to determine the most effective dose. Those studies led to the licensure of the first vaccine approved by the U.S. Food and Drug Administration (FDA) against an H5N1 influenza virus. The units also swiftly initiated a large-scale trial to evaluate the seasonal influenza vaccine Fluarix for use in healthy adults in the United States. The trial demonstrated the vaccine's safety and ability to generate an immune response and ultimately led to its expedited approval by FDA in August 2005 -- less than a year after the trial began. This approval helped reduce the impact of future delays or shortages of seasonal influenza vaccines in the United States.
The selected VTEU sites and principal investigators (PIs) are as follows.
Baylor College of Medicine
Houston, Texas
PI: Wendy A. Keitel, M.D.
Children's Hospital Medical Center
Cincinnati, Ohio
PI: David I. Bernstein, M.D., M.A.
Emory University
Atlanta, Georgia
PI: Mark J. Mulligan, M.D.
Group Health Cooperative
Seattle, Washington
PI: Lisa A. Jackson, M.D., M.P.H.
Saint Louis University
St. Louis, Missouri
PI: Robert B. Belshe, M.D.
University of Iowa
Iowa City, Iowa
PI: Patricia L. Winokur, M.D.
University of Maryland
Baltimore, Maryland
PI: Karen L. Kotloff, M.D.
Vanderbilt University
Nashville, Tennessee
PI: Kathryn M. Edwards, M.D.
NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.
News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at niaid.nih/.
Source: Laura Sivitz
NIH/National Institute of Allergy and Infectious Diseases
View drug information on FluMist.
Buy Diamox Without Prescription
Turmeric Might Be "The Right Spice" To Fight Colon Cancer And Inflamation
Turmeric, a bright yellow spice from south Asia belonging to the ginger family, is the main ingredient in curries - and ancient wisdom suggests that it's also good for your health. Taking this wisdom to the laboratory, Tel Aviv University researchers have discovered that turmeric's active ingredient called curcumin amplifies the therapeutic activity of highly toxic anti-inflammatory drugs used to fight colon cancer when used at high doses.
Dr. Shahar Lev-Ari of Tel Aviv University's School of Public Health at the Sackler Faculty of Medicine and his colleagues have found that curcumin can fight cancer when used in combination with a popular anti-inflammatory drug, alleviating the inflammatory response caused when cancer takes root in the body. A treatment based on this finding has already had promising results in human clinical trials.
"Although more testing will be needed before a possible new drug treatment is developed," says Dr. Lev-Ari, "one could combine curcumin with a lower dose of a cancer anti-inflammatory drug, to better fight colon cancer." The results of the new study have been published in the journal Therapeutic Advances in Gastroenterology.
Alleviating unwanted side effects
Research in the last few decades has shown that cancer is linked to inflammation. Several lines of evidence demonstrate that chronic inflammation in the stomach can cause gastric cancer and that inflammation in the liver from hepatitis can lead to liver cancer.
Dr. Lev-Ari and his colleagues found that Celecoxib, a popular anti-inflammatory drug commonly used to treat arthritis, also inhibits proliferation of colon cancer in laboratory settings. Curcumin increases the anti-cancer and anti-inflammatory effects of Celecoxib while reducing its dose, thus reducing its toxic side-effects, including the rate of heart attack and stroke.
The effect of using a curcumin concentrate to improve the effects of cancer drugs was first proposed by Dr. Lev-Ari when he was a graduate student at Tel Aviv University's Sackler Faculty of Medicine under the supervision of Prof. Nadir Arber and Prof. Dov Lichtenberg.
Both co-supervisors were eager to test the possible health benefits described in folk medicine but were looking for hard evidence. "We would like to use this treatment for patients with all types of cancers," says Prof. Arber. "It has the promise of being an important life-extending therapy, particularly for non-curable pancreatic cancer, suggested by the very promising results we achieved for 20 pancreatic cancer patients."
Putting shelved cancer drugs back into circulation
Previous in vitro and in vivo experiments conducted by the Tel Aviv University team show that curcumin inhibits an enzyme known as COX-2 (cyclooxygenase-2), believed to cause inflammation. The team's research demonstrates that curcumin neutralizes oxygen free radicals, which are believed to play an important role in carcinogenesis.
These effects may be the basis for drug treatment of both inflammation and cancer through the combination of curcumin and Celecoxib. And it may also help return previously shelved potent anticancer drugs - taken out of use due to high toxicity - back to the market under lower dosage indications.
Source:
George Hunka
American Friends of Tel Aviv University
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Dr. Shahar Lev-Ari of Tel Aviv University's School of Public Health at the Sackler Faculty of Medicine and his colleagues have found that curcumin can fight cancer when used in combination with a popular anti-inflammatory drug, alleviating the inflammatory response caused when cancer takes root in the body. A treatment based on this finding has already had promising results in human clinical trials.
"Although more testing will be needed before a possible new drug treatment is developed," says Dr. Lev-Ari, "one could combine curcumin with a lower dose of a cancer anti-inflammatory drug, to better fight colon cancer." The results of the new study have been published in the journal Therapeutic Advances in Gastroenterology.
Alleviating unwanted side effects
Research in the last few decades has shown that cancer is linked to inflammation. Several lines of evidence demonstrate that chronic inflammation in the stomach can cause gastric cancer and that inflammation in the liver from hepatitis can lead to liver cancer.
Dr. Lev-Ari and his colleagues found that Celecoxib, a popular anti-inflammatory drug commonly used to treat arthritis, also inhibits proliferation of colon cancer in laboratory settings. Curcumin increases the anti-cancer and anti-inflammatory effects of Celecoxib while reducing its dose, thus reducing its toxic side-effects, including the rate of heart attack and stroke.
The effect of using a curcumin concentrate to improve the effects of cancer drugs was first proposed by Dr. Lev-Ari when he was a graduate student at Tel Aviv University's Sackler Faculty of Medicine under the supervision of Prof. Nadir Arber and Prof. Dov Lichtenberg.
Both co-supervisors were eager to test the possible health benefits described in folk medicine but were looking for hard evidence. "We would like to use this treatment for patients with all types of cancers," says Prof. Arber. "It has the promise of being an important life-extending therapy, particularly for non-curable pancreatic cancer, suggested by the very promising results we achieved for 20 pancreatic cancer patients."
Putting shelved cancer drugs back into circulation
Previous in vitro and in vivo experiments conducted by the Tel Aviv University team show that curcumin inhibits an enzyme known as COX-2 (cyclooxygenase-2), believed to cause inflammation. The team's research demonstrates that curcumin neutralizes oxygen free radicals, which are believed to play an important role in carcinogenesis.
These effects may be the basis for drug treatment of both inflammation and cancer through the combination of curcumin and Celecoxib. And it may also help return previously shelved potent anticancer drugs - taken out of use due to high toxicity - back to the market under lower dosage indications.
Source:
George Hunka
American Friends of Tel Aviv University
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Massachusetts Group Launches Campaign To Regulate Drug Maker Marketing
The newly formed Massachusetts Prescription Reform Coalition on Thursday announced an effort to curb pharmaceutical industry marketing in an attempt to bring down drug costs and health spending, the Boston Globe reports. The group contends that rapid drug spending growth is putting Massachusetts' health care law in jeopardy and hindering other initiatives to expand health insurance in the state.
The coalition has three objectives:
Prohibit gifts from drug makers to health care professionals who prescribe drugs;
Ban data-mining; and
Create a drug education program to provide unbiased information to physicians.The coalition was created by Health Care for All, and its members include AARP, the Massachusetts Public Interest Research Group, the American Heart Association, the American Stroke Association, Blue Cross and Blue Shield of Massachusetts and Neighborhood Health Plan.
Stephen Mulloney, director of policy and public affairs for the Massachusetts Biotechnology Council, said, "This campaign seems to be less about good public policy and more about animosity toward the biopharmaceutical industry." He added that the coalition's efforts could hurt some Massachusetts biotech companies (Krasner, Boston Globe, 1/17).
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 coalition has three objectives:
Prohibit gifts from drug makers to health care professionals who prescribe drugs;
Ban data-mining; and
Create a drug education program to provide unbiased information to physicians.The coalition was created by Health Care for All, and its members include AARP, the Massachusetts Public Interest Research Group, the American Heart Association, the American Stroke Association, Blue Cross and Blue Shield of Massachusetts and Neighborhood Health Plan.
Stephen Mulloney, director of policy and public affairs for the Massachusetts Biotechnology Council, said, "This campaign seems to be less about good public policy and more about animosity toward the biopharmaceutical industry." He added that the coalition's efforts could hurt some Massachusetts biotech companies (Krasner, Boston Globe, 1/17).
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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VA Medical Imaging Reaches Record Level
VistA Imaging, the medical and health care imaging system used in Department of Veterans Affairs (VA) medical centers, attained over one billion stored images in January this year, according to the department.
"Using this technology, VA has established an unprecedented number of medical images in its database, allowing VA physicians immediate access to patient records regardless of their location," said Dr. Gerald Cross, VA's acting under secretary for health, said. "Our Veterans don't have to wait for hospital staff to find x-rays or make comparisons between a patient's past and current records."
The imaging system captures clinical images, scanned documents, motion video and other non-text data, and makes them part of the patient's electronic record.
In the course of serving 1.2 million patients a month, VA stores 20-25 million images in the VistA Imaging system. In 2009, a total of 290 million are expected to be stored. Storage space used today is approximately one pedabyte -- one million gigabytes.
Using digital images makes remote diagnosis and treatment possible and permits in-home monitoring of some patients' conditions. It eliminates travel for patients needing follow-up care and makes services available in medically underserved areas.
Storing images on magnetic and optical disks provides both long-term access and recovery in disasters. Following Hurricane Katrina in 2006, 5.4 million VA images -- nearly 100 percent -- were recovered from VistA Imaging at the New Orleans VA Medical Center, even though the optical servers had been underwater. These images could be viewed remotely from any VA site and that capability enabled VA to continue providing treatment to Veterans displaced by Katrina when they visited another VA facility.
VistA Imaging first became operational in 1990 at the Washington, D.C., VA Medical Center to handle radiology, and in 1999, VA spread its use to all VA medical centers. The system and its leadership have been recognized with awards and published articles since 1993.
More than 7.8 million Veterans are enrolled in the VA health care system.
Source: U.S. Department of Veterans Affairs
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"Using this technology, VA has established an unprecedented number of medical images in its database, allowing VA physicians immediate access to patient records regardless of their location," said Dr. Gerald Cross, VA's acting under secretary for health, said. "Our Veterans don't have to wait for hospital staff to find x-rays or make comparisons between a patient's past and current records."
The imaging system captures clinical images, scanned documents, motion video and other non-text data, and makes them part of the patient's electronic record.
In the course of serving 1.2 million patients a month, VA stores 20-25 million images in the VistA Imaging system. In 2009, a total of 290 million are expected to be stored. Storage space used today is approximately one pedabyte -- one million gigabytes.
Using digital images makes remote diagnosis and treatment possible and permits in-home monitoring of some patients' conditions. It eliminates travel for patients needing follow-up care and makes services available in medically underserved areas.
Storing images on magnetic and optical disks provides both long-term access and recovery in disasters. Following Hurricane Katrina in 2006, 5.4 million VA images -- nearly 100 percent -- were recovered from VistA Imaging at the New Orleans VA Medical Center, even though the optical servers had been underwater. These images could be viewed remotely from any VA site and that capability enabled VA to continue providing treatment to Veterans displaced by Katrina when they visited another VA facility.
VistA Imaging first became operational in 1990 at the Washington, D.C., VA Medical Center to handle radiology, and in 1999, VA spread its use to all VA medical centers. The system and its leadership have been recognized with awards and published articles since 1993.
More than 7.8 million Veterans are enrolled in the VA health care system.
Source: U.S. Department of Veterans Affairs
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Cholera Outbreaks Predicted by Mathematical Model
A mathematical model of disease cycles developed at the University of Michigan shows promise for predicting cholera outbreaks.
Speaking in a symposium titled "New Vistas in the Mathematics of Ecology and Evolution" at the annual meeting of the American Association for the Advancement of Science in San Francisco, theoretical ecologist Mercedes Pascual discussed how models that she and coworkers have developed can aid short-term forecasting of infectious diseases, such as cholera, and inform decisions about vaccination and other disease-prevention strategies.
In research done over the past seven years, Pascual and colleagues have found evidence that a phenomenon known as the El Nino-Southern Oscillation (ENSO), a major source of climate variability from year to year, influences cycles of cholera in Bangladesh. They also showed that the coupling between climate variability and cholera cycles has become stronger in recent decades.
Now, Pascual is examining the feasibility of using a model developed during that work as an early warning system.
"The question we asked was whether, using data from 1966 to 2000, we could have predicted cholera outbreaks over the past five years," said Pascual, an associate professor of ecology and evolutionary biology. "We also wanted to know whether incorporating ENSO into the model would improve the accuracy of our predictions." The challenge for the model was particularly interesting because the past five years were atypical, with fewer cholera cases than usual and no strong climate anomalies. However, the model performed well, Pascual said.
"Our results showed that for the past five years, we would have done fairly well predicting cholera cases one year ahead, and that the model that uses ENSO makes prediction even more accurate."
Cholera, a serious health problem in many parts of the world, results from a bacterial infection. The bacterium takes up residence in the intestines, causing vomiting and diarrhea, which can lead to severe dehydration and death if patients are not promptly treated.
For more information:
Mercedes Pascua
American Association for the Advancement of Science
Contact: Nancy Ross-Flanigan
University of Michigan
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Speaking in a symposium titled "New Vistas in the Mathematics of Ecology and Evolution" at the annual meeting of the American Association for the Advancement of Science in San Francisco, theoretical ecologist Mercedes Pascual discussed how models that she and coworkers have developed can aid short-term forecasting of infectious diseases, such as cholera, and inform decisions about vaccination and other disease-prevention strategies.
In research done over the past seven years, Pascual and colleagues have found evidence that a phenomenon known as the El Nino-Southern Oscillation (ENSO), a major source of climate variability from year to year, influences cycles of cholera in Bangladesh. They also showed that the coupling between climate variability and cholera cycles has become stronger in recent decades.
Now, Pascual is examining the feasibility of using a model developed during that work as an early warning system.
"The question we asked was whether, using data from 1966 to 2000, we could have predicted cholera outbreaks over the past five years," said Pascual, an associate professor of ecology and evolutionary biology. "We also wanted to know whether incorporating ENSO into the model would improve the accuracy of our predictions." The challenge for the model was particularly interesting because the past five years were atypical, with fewer cholera cases than usual and no strong climate anomalies. However, the model performed well, Pascual said.
"Our results showed that for the past five years, we would have done fairly well predicting cholera cases one year ahead, and that the model that uses ENSO makes prediction even more accurate."
Cholera, a serious health problem in many parts of the world, results from a bacterial infection. The bacterium takes up residence in the intestines, causing vomiting and diarrhea, which can lead to severe dehydration and death if patients are not promptly treated.
For more information:
Mercedes Pascua
American Association for the Advancement of Science
Contact: Nancy Ross-Flanigan
University of Michigan
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Improved Imaging For Identifying Breast Cancer In Overweight Women
Increasing the ability to identify sentinel nodes - the very first lymph nodes that trap cancer cells draining away from a breast lesion site - has a major impact in the treatment and outcome of breast cancer patients, possibly eliminating the need for unnecessary and painful surgery. Researchers found that using SPECT/CT imaging aids in sentinel node identification - especially for overweight or obese women, according to a report in the February issue of the Journal of Nuclear Medicine.
Lymphoscintigraphy (a commonly performed nuclear medicine procedure that makes the lymphatic system visible to specialized cameras) - used with single photon emission computed tomography (SPECT)/computed tomography (CT) imaging - boosted sentinel node identification not only for the general population but also for those who were overweight. "The addition of SPECT/CT with lymphoscintigraphy enhanced sentinel node identification in overweight patients with breast cancer," noted Hedva Lerman, vice chair of the nuclear medicine department at Tel-Aviv Sourasky Medical Center in Israel. Failure to identify sentinel nodes is more frequent in overweight or obese patients, and improved techniques are needed to guide surgeons to their location, said the co-author of "Improved Sentinel Node Identification by SPECT/CT in Overweight Patients With Breast Cancer." She explained, "While the identification of the sentinel node is an important part of surgical management approaches in breast cancer, obesity is a significant factor in why it fails and inevitably leads to occasional - and unnecessary - full axillary lymph node dissection (a more complex surgery that removes all lymph nodes in the armpit region)."
Breast cancer is the second leading cause of cancer death in this country, with women having a 1 in 8 chance of developing it during their lives. When breast cancer is suspected, women may undergo sentinel node biopsy, a minimally invasive surgical procedure used to determine whether breast cancer has spread to lymph glands under the arm, said Lerman. The biopsy requires the removal of only a few first draining lymph nodes for close review, and the lack of cancer cells in these nodes could eliminate the need for removing additional lymph nodes. Identifying the sentinel node before this surgery is key; by removing and examining it, a doctor can determine if breast cancer has spread. "Accurate staging of newly diagnosed patients with breast cancer is of major importance for optimizing breast cancer patients' treatment," said Lerman. Knowing whether the cancer has spread helps determine the stage and approach to treatment, she noted. "Performing lymphoscintigraphy by using SPECT/CT allows detection of sentinel nodes preoperatively in more patients, thus reducing the rate of failure to identify these nodes, especially in overweight patients," said Lerman. She added, "It also provides a more precise anatomical localization of the nodes prior to surgery, thus facilitating the surgical procedure."
In this study, Israeli researchers calculated their subjects' body mass indexes and evaluated 220 women with invasive breast cancer by identifying sentinel nodes in three ways: using an intraoperative blue dye technique, lymphoscintigraphy (pre-operative two-dimensional imaging) and SPECT/CT lymphoscintigraphy. Researchers found that SPECT/CT lymphoscintigraphy also discovered sentinel nodes that were not identified with the intraoperative blue dye technique in a significant number of patients. "As the number of integrated hybrid SPECT/CT systems evolves, our results hopefully will encourage the use of lymphoscintigraphic SPECT/CT in other centers," said Lerman. "Data will continue to be collected in identifying sentinel nodes in 'problematic' subgroups of patients with breast cancer and in those with other solid tumors where nodal staging is indicated," she said.
"Improved Sentinel Node Identification by SPECT/CT in Overweight Patients With Breast Cancer" appears in the February issue of the Journal of Nuclear Medicine, which is published by SNM, the leading international molecular imaging and nuclear medicine association. Additional co-authors include Gennady Lievshitz, the nuclear medicine department at Tel-Aviv Sourasky Medical Center; Osnat Zak, GE Healthcare in Haifa, Israel; Ur Metser and Einat Even-Sapir, both with the nuclear medicine department at Tel-Aviv Sourasky Medical Center and the Sackler Faculty of Medicine at Tel-Aviv University; and Shlomo Schneebaum, the Sackler Faculty of Medicine at Tel-Aviv University and the Department of Radio-Isotope Guided Surgery Unit of Surgery A, Tel-Aviv Sourasky Medical Center.
About SNM - Advancing Molecular Imaging and Therapy
SNM is an international scientific and professional organization of more than 16,000 members dedicated to promoting the science, technology and practical applications of molecular and nuclear imaging to diagnose, manage and treat diseases in women, men and children. Founded more than 50 years ago, SNM continues to provide essential resources for health care practitioners and patients; publish the most prominent peer-reviewed journal in the field (the Journal of Nuclear Medicine); host the premier annual meeting for medical imaging; sponsor research grants, fellowships and awards; and train physicians, technologists, scientists, physicists, chemists and radiopharmacists in state-of-the-art imaging procedures and advances. SNM members have introduced - and continue to explore - biological and technological innovations in medicine that noninvasively investigate the molecular basis of diseases, benefiting countless generations of patients. SNM is based in Reston, Va.; additional information can be found online at snm/.
Contact: Maryann Verrillo
Society of Nuclear Medicine
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Lymphoscintigraphy (a commonly performed nuclear medicine procedure that makes the lymphatic system visible to specialized cameras) - used with single photon emission computed tomography (SPECT)/computed tomography (CT) imaging - boosted sentinel node identification not only for the general population but also for those who were overweight. "The addition of SPECT/CT with lymphoscintigraphy enhanced sentinel node identification in overweight patients with breast cancer," noted Hedva Lerman, vice chair of the nuclear medicine department at Tel-Aviv Sourasky Medical Center in Israel. Failure to identify sentinel nodes is more frequent in overweight or obese patients, and improved techniques are needed to guide surgeons to their location, said the co-author of "Improved Sentinel Node Identification by SPECT/CT in Overweight Patients With Breast Cancer." She explained, "While the identification of the sentinel node is an important part of surgical management approaches in breast cancer, obesity is a significant factor in why it fails and inevitably leads to occasional - and unnecessary - full axillary lymph node dissection (a more complex surgery that removes all lymph nodes in the armpit region)."
Breast cancer is the second leading cause of cancer death in this country, with women having a 1 in 8 chance of developing it during their lives. When breast cancer is suspected, women may undergo sentinel node biopsy, a minimally invasive surgical procedure used to determine whether breast cancer has spread to lymph glands under the arm, said Lerman. The biopsy requires the removal of only a few first draining lymph nodes for close review, and the lack of cancer cells in these nodes could eliminate the need for removing additional lymph nodes. Identifying the sentinel node before this surgery is key; by removing and examining it, a doctor can determine if breast cancer has spread. "Accurate staging of newly diagnosed patients with breast cancer is of major importance for optimizing breast cancer patients' treatment," said Lerman. Knowing whether the cancer has spread helps determine the stage and approach to treatment, she noted. "Performing lymphoscintigraphy by using SPECT/CT allows detection of sentinel nodes preoperatively in more patients, thus reducing the rate of failure to identify these nodes, especially in overweight patients," said Lerman. She added, "It also provides a more precise anatomical localization of the nodes prior to surgery, thus facilitating the surgical procedure."
In this study, Israeli researchers calculated their subjects' body mass indexes and evaluated 220 women with invasive breast cancer by identifying sentinel nodes in three ways: using an intraoperative blue dye technique, lymphoscintigraphy (pre-operative two-dimensional imaging) and SPECT/CT lymphoscintigraphy. Researchers found that SPECT/CT lymphoscintigraphy also discovered sentinel nodes that were not identified with the intraoperative blue dye technique in a significant number of patients. "As the number of integrated hybrid SPECT/CT systems evolves, our results hopefully will encourage the use of lymphoscintigraphic SPECT/CT in other centers," said Lerman. "Data will continue to be collected in identifying sentinel nodes in 'problematic' subgroups of patients with breast cancer and in those with other solid tumors where nodal staging is indicated," she said.
"Improved Sentinel Node Identification by SPECT/CT in Overweight Patients With Breast Cancer" appears in the February issue of the Journal of Nuclear Medicine, which is published by SNM, the leading international molecular imaging and nuclear medicine association. Additional co-authors include Gennady Lievshitz, the nuclear medicine department at Tel-Aviv Sourasky Medical Center; Osnat Zak, GE Healthcare in Haifa, Israel; Ur Metser and Einat Even-Sapir, both with the nuclear medicine department at Tel-Aviv Sourasky Medical Center and the Sackler Faculty of Medicine at Tel-Aviv University; and Shlomo Schneebaum, the Sackler Faculty of Medicine at Tel-Aviv University and the Department of Radio-Isotope Guided Surgery Unit of Surgery A, Tel-Aviv Sourasky Medical Center.
About SNM - Advancing Molecular Imaging and Therapy
SNM is an international scientific and professional organization of more than 16,000 members dedicated to promoting the science, technology and practical applications of molecular and nuclear imaging to diagnose, manage and treat diseases in women, men and children. Founded more than 50 years ago, SNM continues to provide essential resources for health care practitioners and patients; publish the most prominent peer-reviewed journal in the field (the Journal of Nuclear Medicine); host the premier annual meeting for medical imaging; sponsor research grants, fellowships and awards; and train physicians, technologists, scientists, physicists, chemists and radiopharmacists in state-of-the-art imaging procedures and advances. SNM members have introduced - and continue to explore - biological and technological innovations in medicine that noninvasively investigate the molecular basis of diseases, benefiting countless generations of patients. SNM is based in Reston, Va.; additional information can be found online at snm/.
Contact: Maryann Verrillo
Society of Nuclear Medicine
Buy Anti-Bacterial Face Mask Without Prescription
How Blast Waves May Cause Human Brain Injury Even Without Direct Head Impacts
New research on the effects of blast waves could lead to an enhanced understanding of head injuries and improved military helmet design.
Using numerical hydrodynamic computer simulations, Lawrence Livermore scientists Willy Moss and Michael King, along with University of Rochester colleague Eric Blackman, have discovered that nonlethal blasts can induce enough skull flexure to generate potentially damaging loads in the brain, even without direct head impact.
Traumatic brain injury (TBI) results from mechanical loads in the brain, often without skull fracture, and causes complex, long-lasting symptoms.
TBI in civilians is usually caused by direct head impacts resulting from motor vehicle and sports accidents. TBI also has emerged among military combat personnel exposed to blast waves. As modern body armor has substantially reduced soldier fatalities from explosive attacks, the lower mortality rates have revealed the high prevalence of TBI.
There has been extensive research on how head impacts, for example from automobile accidents, cause traumatic brain injury. But TBIs resulting from blast waves without head impacts have not been well understood.
To tackle this puzzle, the team used three-dimensional hydrodynamic simulations to prove that direct action of the blast wave on the head causes skull flexure, producing mechanical loads in brain tissue comparable to those in an injury-inducing impact, even at nonlethal blast pressures as low as 1 bar above atmospheric pressure.
In particular, the team showed that blast waves affect the brain very differently from direct impacts.
The primary source of injury from direct impacts is the force resulting from the bulk acceleration of the head. In contrast, a blast wave squeezes the skull, creating pressures as large as an injury-inducing impact and pressure gradients in the brain that are much larger. This occurs even when the bulk head accelerations induced by a blast wave are much smaller than from a direct impact.
"The blast wave sweeps over the skull like a rolling pin going over dough," said King, LLNL co-principal investigator.
Although the simulations show that the skull is deformed only about 50 microns (the width of a human hair), "this is large enough to generate potentially damaging loads in the brain," according to Moss.
Because blast waves and direct impact affect the head in fundamentally different ways, armor systems that are designed to protect soldiers from impacts and projectiles may not be optimal for blast wave protection.
The team studied how helmets and their suspension systems influence the blast-induced mechanical loads in the brain.
They looked at two common systems: a nylon web system formerly used in the Personnel Armor Systems Ground Troops infantry helmet and viscoelastic foam pads like those in advanced combat helmets. Both helmets were modeled as hemi-ellipsoidal Kevlar shells.
In the first case, the 1.3 centimeter gap between the webbing and the shell allows the blast wave to "wash" under the helmet. In this case, the blast wave is focused by the shape of the helmet and the pressures under the helmet exceed those outside, so the helmet doesn't prevent the rippling deformation of the skull and pressure gradients in the brain.
In the second case, this "under wash" effect is mostly prevented by the presence of the foam pads, but under blast loading, the pads can become stiffer so that the blast wave-induced motion or deformation of the helmet is transferred to the skull. This can result in dangerous loads in the brain.
"The possibility that blasts may contribute to traumatic brain injury has implications for injury diagnosis and improved armor design," Moss said.
Blackman added, "By comparing the effect of blasts on the head with the effect of head impacts we'd be able to make some sense of the distinct mechanisms of injury, the damage a solider might incur, and how a helmet might be designed to minimize both."
The research appears online Aug. 26 in Physical Review Letters.
Source:
Anne Stark
DOE/Lawrence Livermore National Laboratory
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Using numerical hydrodynamic computer simulations, Lawrence Livermore scientists Willy Moss and Michael King, along with University of Rochester colleague Eric Blackman, have discovered that nonlethal blasts can induce enough skull flexure to generate potentially damaging loads in the brain, even without direct head impact.
Traumatic brain injury (TBI) results from mechanical loads in the brain, often without skull fracture, and causes complex, long-lasting symptoms.
TBI in civilians is usually caused by direct head impacts resulting from motor vehicle and sports accidents. TBI also has emerged among military combat personnel exposed to blast waves. As modern body armor has substantially reduced soldier fatalities from explosive attacks, the lower mortality rates have revealed the high prevalence of TBI.
There has been extensive research on how head impacts, for example from automobile accidents, cause traumatic brain injury. But TBIs resulting from blast waves without head impacts have not been well understood.
To tackle this puzzle, the team used three-dimensional hydrodynamic simulations to prove that direct action of the blast wave on the head causes skull flexure, producing mechanical loads in brain tissue comparable to those in an injury-inducing impact, even at nonlethal blast pressures as low as 1 bar above atmospheric pressure.
In particular, the team showed that blast waves affect the brain very differently from direct impacts.
The primary source of injury from direct impacts is the force resulting from the bulk acceleration of the head. In contrast, a blast wave squeezes the skull, creating pressures as large as an injury-inducing impact and pressure gradients in the brain that are much larger. This occurs even when the bulk head accelerations induced by a blast wave are much smaller than from a direct impact.
"The blast wave sweeps over the skull like a rolling pin going over dough," said King, LLNL co-principal investigator.
Although the simulations show that the skull is deformed only about 50 microns (the width of a human hair), "this is large enough to generate potentially damaging loads in the brain," according to Moss.
Because blast waves and direct impact affect the head in fundamentally different ways, armor systems that are designed to protect soldiers from impacts and projectiles may not be optimal for blast wave protection.
The team studied how helmets and their suspension systems influence the blast-induced mechanical loads in the brain.
They looked at two common systems: a nylon web system formerly used in the Personnel Armor Systems Ground Troops infantry helmet and viscoelastic foam pads like those in advanced combat helmets. Both helmets were modeled as hemi-ellipsoidal Kevlar shells.
In the first case, the 1.3 centimeter gap between the webbing and the shell allows the blast wave to "wash" under the helmet. In this case, the blast wave is focused by the shape of the helmet and the pressures under the helmet exceed those outside, so the helmet doesn't prevent the rippling deformation of the skull and pressure gradients in the brain.
In the second case, this "under wash" effect is mostly prevented by the presence of the foam pads, but under blast loading, the pads can become stiffer so that the blast wave-induced motion or deformation of the helmet is transferred to the skull. This can result in dangerous loads in the brain.
"The possibility that blasts may contribute to traumatic brain injury has implications for injury diagnosis and improved armor design," Moss said.
Blackman added, "By comparing the effect of blasts on the head with the effect of head impacts we'd be able to make some sense of the distinct mechanisms of injury, the damage a solider might incur, and how a helmet might be designed to minimize both."
The research appears online Aug. 26 in Physical Review Letters.
Source:
Anne Stark
DOE/Lawrence Livermore National Laboratory
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Academic Health Centers Should Take Lead In Promoting The Sharing Of Biomedical Research Data
Academic health centers (AHCs) have a critical role in enabling, encouraging, and rewarding the sharing of biomedical research data, say a team of
academics in this week's PLoS Medicine. "The leaders of medical schools and academic-affiliated hospitals," they say "can play a unique role in
supporting this transformation of the research enterprise."
Rebecca Crowley (University of Pittsburgh Medical School, USA) and colleagues argue that despite the anticipated benefits of data sharing, such
sharing has "yet to be widely adopted in biomedicine" and they urge AHCs to take a leadership role. "Through their interwoven roles in education,
research, and policy, AHCs can lead the development of best practices for establishing a data sharing culture."
The authors lay out 7 recommendations for AHCs to encourage data sharing:
- Commit to sharing research data as openly as possible, given privacy constraints, and streamline policies and procedures relating to
institutional review boards (research ethics committees), technology transfer, and information technology
- Recognize data sharing contributions in staff hiring and promotion decisions
- Educate trainees and current investigators on responsible data sharing
- Encourage data sharing practices as part of publication policies
- Encourage data sharing plans as part of funding policies
- Fund the costs of data sharing, support for data repositories, adoption of sharing infrastructure and metrics, and research into best practices
through federal grants and AHC funds
- Publish experiences in data sharing to facilitate the exchange of best practices.
"Academic health centers will benefit by leading the transition towards a culture of biomedical data sharing," conclude the authors. "More widespread
awareness of these benefits can motivate key stakeholders to take concrete steps to enable, inspire, and reward data sharing within and beyond their
institutions."
Towards a data sharing culture: Recommendations for leadership from academic health centers.
Piwowar HA, Becich MJ, Bilofsky H, Crowley RS (2008)
PLoS Med 5(9): e183. doi:10.1371/journal.pmed.0050183
Click here to view article online.
About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of
human health and disease, together with commentary and analysis of important global health issues.
PLoS Medicine
About the Public Library of Science
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical
literature a freely available public resource.
Public Library of Science
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academics in this week's PLoS Medicine. "The leaders of medical schools and academic-affiliated hospitals," they say "can play a unique role in
supporting this transformation of the research enterprise."
Rebecca Crowley (University of Pittsburgh Medical School, USA) and colleagues argue that despite the anticipated benefits of data sharing, such
sharing has "yet to be widely adopted in biomedicine" and they urge AHCs to take a leadership role. "Through their interwoven roles in education,
research, and policy, AHCs can lead the development of best practices for establishing a data sharing culture."
The authors lay out 7 recommendations for AHCs to encourage data sharing:
- Commit to sharing research data as openly as possible, given privacy constraints, and streamline policies and procedures relating to
institutional review boards (research ethics committees), technology transfer, and information technology
- Recognize data sharing contributions in staff hiring and promotion decisions
- Educate trainees and current investigators on responsible data sharing
- Encourage data sharing practices as part of publication policies
- Encourage data sharing plans as part of funding policies
- Fund the costs of data sharing, support for data repositories, adoption of sharing infrastructure and metrics, and research into best practices
through federal grants and AHC funds
- Publish experiences in data sharing to facilitate the exchange of best practices.
"Academic health centers will benefit by leading the transition towards a culture of biomedical data sharing," conclude the authors. "More widespread
awareness of these benefits can motivate key stakeholders to take concrete steps to enable, inspire, and reward data sharing within and beyond their
institutions."
Towards a data sharing culture: Recommendations for leadership from academic health centers.
Piwowar HA, Becich MJ, Bilofsky H, Crowley RS (2008)
PLoS Med 5(9): e183. doi:10.1371/journal.pmed.0050183
Click here to view article online.
About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of
human health and disease, together with commentary and analysis of important global health issues.
PLoS Medicine
About the Public Library of Science
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical
literature a freely available public resource.
Public Library of Science
Buy Trecator SC Without Prescription
Counseling Via Web- And Phone Effective For Smoking Cessation With Chantix
A randomized trial compared three ways to deliver a behavioral smoking cessation program using varenicline (Chantix®): by phone, Web, or both. Although phone counseling had greater treatment advantage for early cessation and appeared to increase medication adherence, abstinence outcomes did not differ at six months. The findings suggest the three programs are all effective treatment options when combined with varenicline. Nonprofit scientific research institute SRI International, Group Health Research Institute, and Free & Clear, Inc. conducted the trial, published in the May 2010 American Journal of Preventive Medicine.
Proactive telephone behavioral counseling and Web-based services are popular tools for smoking cessation. Although both phone- and Web-based services are known to be effective, previous studies have not examined whether combining these services improves outcomes over either method alone. The trial aimed to determine the relative effectiveness of a widely used smoking cessation program (Free & Clear Quit For Life® Program) delivered in three ways: standard proactive telephone behavioral counseling, Web-based delivery, and a program that combined the two.
The trial was among the first "real-world" examinations of varenicline use since the original phase III studies that the manufacturer sponsored. The researchers tracked more than 1,200 Group Health adult patients who received behavioral therapy and varenicline to quit smoking. All participants received 12 weeks of varenicline, printed guides, a 5у€ќ¶ minute orientation call, and access to a toll-free phone number for support as needed.
"Our findings provide important data regarding the real-world use of varenicline and show that a supportive treatment philosophy along with individualized information matter most for long-term smoking cessation success," said Gary Swan, PhD, director of the Center for Health Sciences at SRI International and lead author of the study. "Any of the programs shows promise as a counseling tool when used in combination with varenicline."
Varenicline is a non-nicotine prescription medicine specifically developed to help adults 18 and older quit smoking. It targets nicotine receptors in the brain, attaches to them, and blocks nicotine from reaching them. Based on the observed smoking abstinence outcomes, researchers found that data obtained in real-world behavioral therapy settings are comparable to those from the varenicline phase III clinical trials. Gastrointestinal disturbances and abnormal dreams were the most common varenicline side effects, similar to the proportion of study participants reporting side effects in the phase III trials. No serious neuro-psychiatric incidents attributable to varenicline use occurred during the trial.
Notes:
Co-authors were Group Health Research Institute Senior Investigator Jennifer B. McClure, PhD, and Associate Investigator Sheryl L. Catz, PhD; Project Manager Julie Richards, MPH; and Affiliate Investigators Susan M. Zbikowski, PhD, and Timothy A. McAfee, MD, MPH, both of Free & Clear; Mona Deprey, MS, of Free & Clear; and Lisa M. Jack, MA, and Harold S. Javitz, PhD, of SRI International.
The project described is registered at clinicaltrials (NCT00301145). It was 97.85 percent funded ($3.3 million) by the National Cancer Institute (Grant R01CA071358). Pfizer Inc. provided study medication and nominal support (2.15%) for recruiting participants ($72,000).
Source:
Rebecca Hughes
Group Health Research Institute
View drug information on Chantix.
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Proactive telephone behavioral counseling and Web-based services are popular tools for smoking cessation. Although both phone- and Web-based services are known to be effective, previous studies have not examined whether combining these services improves outcomes over either method alone. The trial aimed to determine the relative effectiveness of a widely used smoking cessation program (Free & Clear Quit For Life® Program) delivered in three ways: standard proactive telephone behavioral counseling, Web-based delivery, and a program that combined the two.
The trial was among the first "real-world" examinations of varenicline use since the original phase III studies that the manufacturer sponsored. The researchers tracked more than 1,200 Group Health adult patients who received behavioral therapy and varenicline to quit smoking. All participants received 12 weeks of varenicline, printed guides, a 5у€ќ¶ minute orientation call, and access to a toll-free phone number for support as needed.
"Our findings provide important data regarding the real-world use of varenicline and show that a supportive treatment philosophy along with individualized information matter most for long-term smoking cessation success," said Gary Swan, PhD, director of the Center for Health Sciences at SRI International and lead author of the study. "Any of the programs shows promise as a counseling tool when used in combination with varenicline."
Varenicline is a non-nicotine prescription medicine specifically developed to help adults 18 and older quit smoking. It targets nicotine receptors in the brain, attaches to them, and blocks nicotine from reaching them. Based on the observed smoking abstinence outcomes, researchers found that data obtained in real-world behavioral therapy settings are comparable to those from the varenicline phase III clinical trials. Gastrointestinal disturbances and abnormal dreams were the most common varenicline side effects, similar to the proportion of study participants reporting side effects in the phase III trials. No serious neuro-psychiatric incidents attributable to varenicline use occurred during the trial.
Notes:
Co-authors were Group Health Research Institute Senior Investigator Jennifer B. McClure, PhD, and Associate Investigator Sheryl L. Catz, PhD; Project Manager Julie Richards, MPH; and Affiliate Investigators Susan M. Zbikowski, PhD, and Timothy A. McAfee, MD, MPH, both of Free & Clear; Mona Deprey, MS, of Free & Clear; and Lisa M. Jack, MA, and Harold S. Javitz, PhD, of SRI International.
The project described is registered at clinicaltrials (NCT00301145). It was 97.85 percent funded ($3.3 million) by the National Cancer Institute (Grant R01CA071358). Pfizer Inc. provided study medication and nominal support (2.15%) for recruiting participants ($72,000).
Source:
Rebecca Hughes
Group Health Research Institute
View drug information on Chantix.
Buy Valtrex Without Prescription
Over The Counter Statin Treatment Could Help Stem The Cardiovascular Disease Epidemic
Making statin treatment available without a prescription could help the fight against heart disease, says Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Director of the Zena and Michael A. Wiener Cardiovascular Institute and the Marie-JosГ©e and Henry R. Kravis Center for Cardiovascular Health at The Mount Sinai Medical Center.
Writing in the September 1 edition of The American Journal of Cardiology, Dr. Fuster notes that a nonprescription statin program could provide patients with a tool of proved benefit in cardiovascular risk prevention. Educating the public and encouraging patient involvement in their own health care has repeatedly shown to be an effective means of improving disease prevention.
"There could be an enormous health benefit to making nonprescription statins available and enhancing patients' involvement in their own care," said Dr. Fuster, who has served as president of the World Heart Federation.
Dr. Fuster's recommendation comes at a time when heart disease is reaching epidemic proportions in the United States and remains the leading cause of death in this country. Cholesterol is a primary risk factor for heart disease. The number of Americans estimated to have coronary heart disease is expected to more than double by 2050, according to the editorial.
"Even though statins have been available for 20 years, and have proven to be safe and effective in lowering cholesterol, many patients throughout the world still do not get this treatment," said Dr. Fuster. "We have made only limited progress tackling coronary heart disease, and we need additional approaches to prevent this epidemic from continuing."
Several studies have found that any reduction in low density lipoprotein (LDL) cholesterol levels results in coronary heart disease risk reduction. Research has also shown that taking statins can reduce LDL levels by as much as 24% and that when patients are introduced to cholesterol-lowering therapies, they become motivated to learn about other lifestyle modifications that can help keep lipid levels under control, such as diet and exercise.
There are more than 23 million people in the U.S. without coronary heart disease but with risk factors for developing the disease. A significant proportion of these patients are candidates for lipid-lowering therapy and could benefit by taking statin drugs, but are currently not on treatment, said Dr. Fuster. It is this moderate risk population that could directly benefit from the greater access and education a nonprescription statin would provide.
Dr. Fuster notes in his editorial that any proposal for nonprescription statins is an opportunity to educate the public about how to protect themselves from heart disease. Any over-the-counter statin therapy should be accompanied by lifestyle changes, including eating a heart-healthy diet, exercising, enrolling in a smoking cessation program, getting cholesterol tests, and discussing cholesterol management with physicians, he explained. "To realize this potential," Dr. Fuster said, "sponsors of nonprescription statin proposals must continue the development of improved product labeling and educational messages and to demonstrate their effectiveness in driving appropriate consumer behavior."
About The Mount Sinai Medical Center
The Mount Sinai Medical Center, located in New York City, consists of The Mount Sinai Hospital, a tertiary care facility known for excellence in patient care and Mount Sinai School of Medicine, a leader in medical research and in the education of tomorrow's physicians by internationally known faculty. Founded in 1852, The Mount Sinai Hospital is one of the oldest voluntary teaching hospitals in the country and in 1963, the Hospital created Mount Sinai School of Medicine, beginning a close collaboration that has made Mount Sinai one of the leading academic medical center in the country. Today, the patients of Mount Sinai benefit as teams of physicians and scientists work together to rapidly translate laboratory research to new patient treatments. Many of the groundbreaking approaches that result from these collaborations are initially available at only a handful of facilities in the country some, only at Mount Sinai. These advances make Mount Sinai the first choice for patients with complex medical and surgical needs.
Mount Sinai Medical Center
One Gustave Levy Place
New York, NY 10029
United States
Mount Sinai Medical Center
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Writing in the September 1 edition of The American Journal of Cardiology, Dr. Fuster notes that a nonprescription statin program could provide patients with a tool of proved benefit in cardiovascular risk prevention. Educating the public and encouraging patient involvement in their own health care has repeatedly shown to be an effective means of improving disease prevention.
"There could be an enormous health benefit to making nonprescription statins available and enhancing patients' involvement in their own care," said Dr. Fuster, who has served as president of the World Heart Federation.
Dr. Fuster's recommendation comes at a time when heart disease is reaching epidemic proportions in the United States and remains the leading cause of death in this country. Cholesterol is a primary risk factor for heart disease. The number of Americans estimated to have coronary heart disease is expected to more than double by 2050, according to the editorial.
"Even though statins have been available for 20 years, and have proven to be safe and effective in lowering cholesterol, many patients throughout the world still do not get this treatment," said Dr. Fuster. "We have made only limited progress tackling coronary heart disease, and we need additional approaches to prevent this epidemic from continuing."
Several studies have found that any reduction in low density lipoprotein (LDL) cholesterol levels results in coronary heart disease risk reduction. Research has also shown that taking statins can reduce LDL levels by as much as 24% and that when patients are introduced to cholesterol-lowering therapies, they become motivated to learn about other lifestyle modifications that can help keep lipid levels under control, such as diet and exercise.
There are more than 23 million people in the U.S. without coronary heart disease but with risk factors for developing the disease. A significant proportion of these patients are candidates for lipid-lowering therapy and could benefit by taking statin drugs, but are currently not on treatment, said Dr. Fuster. It is this moderate risk population that could directly benefit from the greater access and education a nonprescription statin would provide.
Dr. Fuster notes in his editorial that any proposal for nonprescription statins is an opportunity to educate the public about how to protect themselves from heart disease. Any over-the-counter statin therapy should be accompanied by lifestyle changes, including eating a heart-healthy diet, exercising, enrolling in a smoking cessation program, getting cholesterol tests, and discussing cholesterol management with physicians, he explained. "To realize this potential," Dr. Fuster said, "sponsors of nonprescription statin proposals must continue the development of improved product labeling and educational messages and to demonstrate their effectiveness in driving appropriate consumer behavior."
About The Mount Sinai Medical Center
The Mount Sinai Medical Center, located in New York City, consists of The Mount Sinai Hospital, a tertiary care facility known for excellence in patient care and Mount Sinai School of Medicine, a leader in medical research and in the education of tomorrow's physicians by internationally known faculty. Founded in 1852, The Mount Sinai Hospital is one of the oldest voluntary teaching hospitals in the country and in 1963, the Hospital created Mount Sinai School of Medicine, beginning a close collaboration that has made Mount Sinai one of the leading academic medical center in the country. Today, the patients of Mount Sinai benefit as teams of physicians and scientists work together to rapidly translate laboratory research to new patient treatments. Many of the groundbreaking approaches that result from these collaborations are initially available at only a handful of facilities in the country some, only at Mount Sinai. These advances make Mount Sinai the first choice for patients with complex medical and surgical needs.
Mount Sinai Medical Center
One Gustave Levy Place
New York, NY 10029
United States
Mount Sinai Medical Center
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MRC Scientists Announce Advance In Understanding Body's Natural Defences
Medical Research Council (MRC) scientists at the University of Leicester have made a new advance in understanding how the body fights certain types of cancer and other disease such as Lupus and rheumatoid arthritis.
Dr Melania Capasso, one of the authors of the study, described the findings as being 'very significant'.
"We showed that a newly discovered protein, HVCN1, regulates antibody production through modulation of intracellular oxidation. In the absence of HVCN1, the immune response is blunted. These findings are very novel and significantly contribute to our understanding of how the organism mounts an immune response.
"The findings are very significant for the immunology field and help elucidate the contribution of natural oxidants such as reactive oxygen species to B cell activation and represent the rationale for using HVCN1 as a target for therapies where activation of B cell needs to be diminished."
Dr Capasso said the findings could be useful for the treatment of some types of B cell lymphoma and the treatment of autoimmune diseases such as Lupus (and rheumatoid arthritis.
Source: Leicester University
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Dr Melania Capasso, one of the authors of the study, described the findings as being 'very significant'.
"We showed that a newly discovered protein, HVCN1, regulates antibody production through modulation of intracellular oxidation. In the absence of HVCN1, the immune response is blunted. These findings are very novel and significantly contribute to our understanding of how the organism mounts an immune response.
"The findings are very significant for the immunology field and help elucidate the contribution of natural oxidants such as reactive oxygen species to B cell activation and represent the rationale for using HVCN1 as a target for therapies where activation of B cell needs to be diminished."
Dr Capasso said the findings could be useful for the treatment of some types of B cell lymphoma and the treatment of autoimmune diseases such as Lupus (and rheumatoid arthritis.
Source: Leicester University
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Health Insurance Proposal Announced By President Bush In State Of The Union Address Would Expand Coverage, HHS Secretary Says
The health care proposals promoted by President Bush in his State of the Union address on Tuesday would make it easier for states to expand health insurance coverage by redistributing federal funding and make it more affordable for the uninsured to purchase private health insurance, HHS Secretary Mike Leavitt said Wednesday, CQ HealthBeat reports. "The president made clear in the State of the Union last night that he intends to pursue a policy that would work with the states in partnership with the medical community to develop plans for access for every citizen in those states," Leavitt said. He said the two health care proposals Bush announced are part of a strategy to expand health insurance coverage. Leavitt said the first step is reauthorization of SCHIP, which will expire this year. The second part of the administration's strategy is ensuring that a "basic insurance plan" is available in every state, Leavitt said (Armstrong, CQ HealthBeat, 1/24). Bush in the State of the Union proposed redirecting portions of existing federal funding to create "Affordable Choices" grants that would give states more flexibility to expand health insurance (Kaiser Daily Health Policy Report, 1/24). CQ HealthBeat reports that the proposal would potentially redirect about $30 billion in federal Medicare and Medicaid funding currently designated for disproportionate share hospitals -- facilities that treat a large number of uninsured and indigent patients -- and capital funds. Leavitt said that no final decisions have been made on which portions of funding would be affected or what amounts. "We're not making any specific proposal on a number," he said, adding, "You won't see any specific fund mentioned. You won't see any specific amount."
Tax Proposal
Another component of Bush's health care proposal, also announced in recent days, would offer a federal tax deduction of $7,500 for individuals and $15,000 for families who obtain health insurance on their own or through an employer, regardless of the cost of the coverage (CQ HealthBeat, 1/24). The proposal would for the first time levy a tax on the value of employer-sponsored health insurance in some cases. Currently, most employees are not taxed on the value of their employer-sponsored health insurance. Under the proposal, individuals and families with employer-sponsored health insurance plans worth more than the proposed allowable deductions would pay taxes on the difference. The deduction would be available to all individuals and families who purchase health insurance, regardless of the value of their policies or whether they itemize deductions on their tax returns. For U.S. residents who receive employer-based health insurance, the deduction would be offset by the cost of their coverage. The proposal would pose no net cost to the government over 10 years, according to the administration (Kaiser Daily Health Policy Report, 1/24). Leavitt said, "The goal here is to make certain that every person has access to an affordable basic insurance policy, and there are some very significant roadblocks right now," adding, "The states can solve most of them, but they can't solve the tax problem." Leavitt said that administration officials also have considered a proposal that would offer a tax credit rather than a tax deduction for purchasing health insurance. Department of the Treasury officials also said they had considered a tax credit proposal (CQ HealthBeat, 1/24).
Impact on Employer-Sponsored Coverage
Some analysts and critics have raised concerns that Bush's tax proposal could "create an incentive for employers to get out of the business of offering health care to workers, further eroding employment-based coverage," Dow Jones reports (Gerencher, Dow Jones, 1/24). Leavitt said on Wednesday that the proposal will "absolutely not" have a negative effect on employer-sponsored health insurance, adding, "I do not see employers leaving the employment-based system." Joel Kaplan, White House deputy chief of staff for policy, on Tuesday said the tax proposal potentially could lead more employers to stop offering health insurance benefits but that the tax deductions would give employees new means to "buy insurance in the individual market that they can't now" (Zhang/Lueck, Wall Street Journal, 1/25). Currently, about 175 million U.S. residents have employer-sponsored health insurance and more than 17 million purchase health insurance on their own, according to Karen Ignagni, president of America's Health Insurance Plans (Salt Lake Tribune, 1/24). Sixty-one percent of employers offered health insurance to employees in 2006, compared with 69% in 2000, according to a survey by the Kaiser Family Foundation and Health Research and Educational Trust. Fewer than 50% of companies with three to nine employees offer health insurance.
Comments on Employer-Sponsored Coverage
Steve Wojcik, vice president of public policy for the National Business Group on Health, said, "We would be very cautious about this approach, but we still want to see more details," adding, "Outside of the Medicare program, [employer-sponsored health insurance] is the second most popular way people have coverage, and we don't want to do anything that would damage that" (Dow Jones, 1/24). Neil Trautwein, vice president of the National Retail Federation, said, "The fear is that if it becomes more attractive for people to decline employer coverage and buy on the open market, then you could get great spirals in the employer plans." He added, "I'm not convinced we should take away one of the pillars that has been supporting the health care system." Nina Owcharenko, a senior policy analyst for health care at the Heritage Foundation, said, "It's not removing the employer system. It's not keeping the individual market as it is," adding, "The overall impact is combining the tax code with state innovations. The end goal will be to increase the number of people who have private insurance" (Wall Street Journal, 1/25). Tom Billet, a senior consultant at Watson Wyatt, said employers would continue to offer health insurance benefits, adding, "I think they're interested in giving their people quality, affordable health care coverage" (Dow Jones, 1/24). Larry Glasscock, chair and CEO of WellPoint, said, "We need to be very cautious if we change the deductibility of the benefits that are offered" (Lee, Indianapolis Star, 1/25).
Comments on the Individual Insurance Market
Another concern raised by critics and analysts is that the non-group insurance market "needs an overhaul if it's expected to work for people who need coverage the most -- the uninsured, low-income families and those who are older and sicker," according to Dow Jones. Dow Jones reports that families and individuals who purchase health insurance on their own generally pay higher premiums and face more restrictions on coverage for pre-existing medical conditions. Billet said, "The major drawback here is that the individual insurance market is badly broken and this proposal doesn't deal with it at all," adding, "Does it put more money into the system? Yes. But it doesn't address the problem" (Dow Jones, 1/24). Karen Davis, president of the Commonwealth Fund, said of the proposal, "What it does is favor individual insurance," adding, "The question is, should you try to undermine employer coverage? Employer coverage has lower administrative costs and it covers everybody in a firm, not just those who are healthy enough to pass a medical exam." Robert Reischauer, president of the Urban Institute, said, "We're tilting the playing field toward this very flawed market" (Lee/Montgomery, Washington Post, 1/25). Owcharenko said, "This is trying to find a way to make sure there's a market for an individual so they can buy health insurance. Both can co-exist" (Wall Street Journal, 1/25). Ignagni said, "We strongly support a level playing field in which individuals can purchase health care coverage with pretax dollars" (Fox, Reuters, 1/24).
Additional Comments
Former CMS Administrator Mark McClellan said Bush's tax proposal "gives everyone a strong incentive to search for less costly health care." Former CMS Administrator Thomas Scully said, "It's breaking the ice to where the real source of revenue is and redistributing it from overinsured people to poor people. ... The concept is a huge step in the right direction" (Washington Post, 1/25). Diane Rowland, executive vice president of the Kaiser Family Foundation and executive director of the Kaiser Commission on Medicaid and the Uninsured, said, "Our 46 million uninsured predominantly have low incomes. Forty-three percent are below level where they have any tax liability." Rowland added, "The question is really who among the uninsured benefits from this program" (Fox, Reuters, 1/24).
Auto Industry
In related news, Kaplan and other White House officials said they hope Bush's recent domestic proposals, including his health care plan, "will boost the ailing American auto industry," the Wall Street Journal reports. David Cole, head of the Center for Automotive Research, said, "In general, anything that can reduce the cost of health care is positive for the industry." However, Bush's tax proposal "could hurt some employees -- like auto workers -- who get especially generous health benefits from their employers," according to the Journal. Alan Reuther, legislative director for the United Auto Workers, said the proposal could encourage younger, healthier workers to opt out of employer-sponsored health insurance, creating an older, sicker membership (McKinnon/Spector, Wall Street Journal, 1/25). UAW and other unions could raise "tough opposition" to the proposal, the Detroit Free Press reports. AFL-CIO President John Sweeney said the proposal "only pretends to address our nation's health care crisis, and actually would make it worse" (Collier, Detroit Free Press, 1/25).
Employer Movement
In other coverage, the New York Times on Thursday examined how some employers -- "straining under runaway costs for providing health insurance" -- now "see the time as ripe for starting to overhaul the system." According to the Times, some employers and health care industry executives would support expansion of SCHIP as a "starting point." Supporters of this approach would "work up from there" with expansion of health insurance for uninsured college students, followed by uninsured families with annual incomes that are high enough to purchase insurance if coverage "became mandatory and if a market for affordable personal policies was created," the Times reports (Freudenheim, New York Times, 1/25).
Additional Coverage
Newspapers on Thursday published the following articles on President Bush's State of the Union address and proposed health plan:"Bush's Gambit on Health Insurance" (Trumbull/Lamb, Christian Science Monitor, 1/25).
"Reaction to Bush's Health Plan Is Mixed" (Karash/Stafford, Kansas City Star, 1/25).
"Health Proposal Gives and Takes" (Hennessy-Fiske/Alonso-Zaldivar, Los Angeles Times, 1/25).
"Attention to Health Benefits Is Welcome" (Von Bergen, Philadelphia Inquirer, 1/25).
"Parsing Bush's Words" (Beckel/Thomas, USA Today, 1/25).
Broadcast Coverage
Al Hubbard, Director of the National Economic Council, is scheduled to discuss Bush's health care proposals in an "Ask the White House" chat on Friday at 4:30 p.m. ET. Questions can be submitted online. A transcript will be available online after the chat. In addition, several broadcast programs reported on Bush's proposals:APM's "Marketplace": The segment includes comments from Kai Ryssdal, "Marketplace" host, and Helen Palmer, "Marketplace" health correspondent (Ryssdal, "Marketplace," APM, 1/24). In addition, "Marketplace" included a commentary by Robert Reich, a professor of public policy at the University of California-Berkeley and former secretary of labor. Audio and a transcript of the first segment are available online. Audio and a transcript of the commentary also are available online.
CSPAN's "Washington Journal": Guests on the program included Rep. Nathan Deal (R-Ga.), ranking member of the Health Subcommittee ("Washington Journal," CSPAN, 1/24). The segment is available online.
NPR's "Morning Edition": The segment includes comments from Peter Orszag, chief of the Congressional Budget Office; Senate Budget Committee Chair Kent Conrad (D-N.D.); and Mario Diaz-Balart (R-Fla.) (Seabrook, "Morning Edition," NPR, 1/25). The segment is available online.
WBUR's "Here and Now": The segment includes comments from Gail Chaddock, a reporter for the Christian Science Monitor, and Julian Zelizer, a professor of history at Boston University ("Here and Now," WBUR, 1/24). The segment is available online.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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Michigan Lawmakers Introduce Bills Package To Expand Access To Health Care To State's Uninsured
Michigan lawmakers introduced health reform packages this week, the Detroit News reports. On Thursday, state senators introduced a bipartisan package of health care bills aimed at expanding health insurance coverage to the state's 1.2 million uninsured residents. The package, named MI Health, would establish two state health plans that provide the residents with more affordable and accessible coverage options.
MI Access would expand the state Medicaid program to include residents with annual incomes under 200% of the federal poverty level, and beneficiaries would contribute copayments for services and medications. MI Coverage would provide subsidized coverage options for residents with annual incomes at 200% to 300% of the poverty level. Fees for residents under MI Coverage would be set according to their health levels and habits (Bouffard, Detroit News, 5/14).
The proposed legislation package also would create a state fund that pays for insurance claims exceeding $25,000, or up to $250,000 per year, with health plans making contributions to the fund. In addition, the package proposes to bar commercial insurers from rejecting coverage for applicants with chronic conditions or increasing their premiums if they have been previously diagnosed with a chronic condition (Anstett, Detroit Free Press, 5/15).
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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MI Access would expand the state Medicaid program to include residents with annual incomes under 200% of the federal poverty level, and beneficiaries would contribute copayments for services and medications. MI Coverage would provide subsidized coverage options for residents with annual incomes at 200% to 300% of the poverty level. Fees for residents under MI Coverage would be set according to their health levels and habits (Bouffard, Detroit News, 5/14).
The proposed legislation package also would create a state fund that pays for insurance claims exceeding $25,000, or up to $250,000 per year, with health plans making contributions to the fund. In addition, the package proposes to bar commercial insurers from rejecting coverage for applicants with chronic conditions or increasing their premiums if they have been previously diagnosed with a chronic condition (Anstett, Detroit Free Press, 5/15).
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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Mayo Clinic Health Letter Highlights Leukemia Diagnosis And Treatment -- It's Improving Dramatically
In the past decade, researchers have made dramatic strides in understanding and treating leukemia, according to the April issue of Mayo Clinic Health Letter.
Leukemia encompasses several types of cancer of the bone marrow and blood. While often associated with children and young adults, leukemia most commonly occurs in adults over age 60. With chronic lymphocytic leukemia (CLL), the most common type, the average age at diagnosis is 70.
Highlights from the information in Mayo Clinic Health Letter include:
More effective treatments: As recently as the 1990s, only about 55 percent of those with CLL had any response to the drugs used to treat the disease. Only 2 percent of patients went into complete remission. Today, drug combinations used to treat the disease result in a 91 to 95 percent response rate and about 41 to 70 percent rate of complete response.
Easier diagnosis: CLL often progresses slowly and may be present for years without signs or symptoms. For most people, the first sign of CLL is an elevated white blood cell count found in a routine blood test. In the past, a bone marrow biopsy was the only way to confirm a diagnosis. That's changed. Today, for about 90 percent of those with CLL, a blood test called flow cytometry can identify the presence of cancerous blood cells.
More informative diagnosis: Recently, advances in diagnostic tests help provide more information. An array of blood tests looks for specific genes, chromosomes or proteins of cancerous cells that help predict the aggressiveness of the cancer. A disease classified as high risk suggests that treatment will be needed in two to five years; low risk indicates treatment may not be needed for decades. Most patients are diagnosed with CLL at an early stage of the disease and don't need immediate treatment for cancer.
Research into all forms of leukemia continues to advance rapidly. Because therapies are changing quickly, it's wise to seek leukemia treatment from doctors and medical centers that specialize in the disease.
Source
Mayo Clinic
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Leukemia encompasses several types of cancer of the bone marrow and blood. While often associated with children and young adults, leukemia most commonly occurs in adults over age 60. With chronic lymphocytic leukemia (CLL), the most common type, the average age at diagnosis is 70.
Highlights from the information in Mayo Clinic Health Letter include:
More effective treatments: As recently as the 1990s, only about 55 percent of those with CLL had any response to the drugs used to treat the disease. Only 2 percent of patients went into complete remission. Today, drug combinations used to treat the disease result in a 91 to 95 percent response rate and about 41 to 70 percent rate of complete response.
Easier diagnosis: CLL often progresses slowly and may be present for years without signs or symptoms. For most people, the first sign of CLL is an elevated white blood cell count found in a routine blood test. In the past, a bone marrow biopsy was the only way to confirm a diagnosis. That's changed. Today, for about 90 percent of those with CLL, a blood test called flow cytometry can identify the presence of cancerous blood cells.
More informative diagnosis: Recently, advances in diagnostic tests help provide more information. An array of blood tests looks for specific genes, chromosomes or proteins of cancerous cells that help predict the aggressiveness of the cancer. A disease classified as high risk suggests that treatment will be needed in two to five years; low risk indicates treatment may not be needed for decades. Most patients are diagnosed with CLL at an early stage of the disease and don't need immediate treatment for cancer.
Research into all forms of leukemia continues to advance rapidly. Because therapies are changing quickly, it's wise to seek leukemia treatment from doctors and medical centers that specialize in the disease.
Source
Mayo Clinic
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Third Global Vaccine Congress In Singapore To Also Feature Virtual Component
Elsevier, a leading publisher of scientific, technical and medical information products and services, has announced, that its journal Vaccine, the most comprehensive and pre-eminent journal for those interested in vaccines and vaccination, will organize the 3rd Vaccine Global Congress from 4-6 October, 2009, in Singapore. For people who cannot attend the congress in Singapore, Elsevier is organizing a Vaccine Virtual counterpart. This truly interactive event will allow people to sample the high-quality content and networking opportunities that the congress and exhibition provide from their desk.
Following the successful Second Vaccine Congress held in Boston last year, the meeting in Singapore will again serve as an authoritative international interface between academics in research and development, regulatory and governmental agencies, charities, and health and industry professionals.
The 3rd Vaccine Global Congress is organized in collaboration with the International Society for Vaccines (isv-online/). At the congress, both GSK and Novartis will present their latest data on H1N1 flu vaccine research. To supplement a number of invited keynote speakers, multiple oral and poster presentations have been selected to cover all facets of vaccinology, including: human vaccines for infectious and non-infectious diseases, veterinary vaccines, adjuvants, drug delivery, production, safety and regulatory aspects.
In addition, Elsevier is offering a taste of the 3rd Vaccine Global Congress by video broadcasting live and on-demand keynote presentations and related Q&A, scheduled on the 5th and 7th of October, respectively. Virtual delegates will be able to attend presentations from top international speakers, submit questions in real time, network and chat with their online peers, and navigate the show via a virtual fully interactive platform. Registration for the Vaccine Virtual Congress (vaccinecongress/) is free for the first 250 registrants.
"The Vaccine Congress is again featuring a high diversity of talks", stated Floris de Hon, Executive Publisher of Vaccine. "Following the success of last year's virtual congress, I am confident that this year's event will provide delegates with an excellent environment to access high quality content, assisting in accelerating progress in the development of vaccines".
Source:
Anna Hogrebe
Elsevier
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Following the successful Second Vaccine Congress held in Boston last year, the meeting in Singapore will again serve as an authoritative international interface between academics in research and development, regulatory and governmental agencies, charities, and health and industry professionals.
The 3rd Vaccine Global Congress is organized in collaboration with the International Society for Vaccines (isv-online/). At the congress, both GSK and Novartis will present their latest data on H1N1 flu vaccine research. To supplement a number of invited keynote speakers, multiple oral and poster presentations have been selected to cover all facets of vaccinology, including: human vaccines for infectious and non-infectious diseases, veterinary vaccines, adjuvants, drug delivery, production, safety and regulatory aspects.
In addition, Elsevier is offering a taste of the 3rd Vaccine Global Congress by video broadcasting live and on-demand keynote presentations and related Q&A, scheduled on the 5th and 7th of October, respectively. Virtual delegates will be able to attend presentations from top international speakers, submit questions in real time, network and chat with their online peers, and navigate the show via a virtual fully interactive platform. Registration for the Vaccine Virtual Congress (vaccinecongress/) is free for the first 250 registrants.
"The Vaccine Congress is again featuring a high diversity of talks", stated Floris de Hon, Executive Publisher of Vaccine. "Following the success of last year's virtual congress, I am confident that this year's event will provide delegates with an excellent environment to access high quality content, assisting in accelerating progress in the development of vaccines".
Source:
Anna Hogrebe
Elsevier
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Merck And Sanofi Pasteur Initiate Phase III Study In The United States Of Pediatric Combination Vaccine To Help Prevent Six Infectious Diseases
Merck (NYSE: MRK) (known outside the United States and Canada as MSD) and Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN, NYSE: SNY), announced today the initiation of a Phase III clinical program to evaluate the safety and immunogenicity of an investigational pediatric hexavalent combination vaccine1. This combination vaccine is designed to help protect against six potentially serious diseases: diphtheria, tetanus, whooping cough (Bordetella pertussis), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b, and hepatitis B.
The investigational vaccine is a combination of select components: DTaP5-IPV-Hib-HepB; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine. The vaccine is being developed as part of a partnership between Merck and Sanofi Pasteur that focuses on the development of pediatric combination vaccines.
"Combination vaccines simplify the childhood immunization schedule and may improve coverage, on time vaccination and reduce the number of injections for children," said Gary S. Marshall, M.D., professor of pediatrics, University of Louisville School of Medicine.
The Phase III clinical program will begin in the United States with a randomized, open-label, active-comparator controlled clinical trial that will involve approximately 1,440 infants at multiple centers. The primary study objectives are to assess the safety and immunogenicity of the investigational hexavalent combination vaccine when given at 2, 4, and 6 months of age concomitantly with Prevnar 13TM Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) and ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent). The clinical program is expected to begin in Europe this year. For more information on this study, please visit here.
The Phase III program was initiated following results from a Phase IIb clinical trial of
459 children that assessed the safety and immunogenicity of the investigational combination vaccine.
"Based on the results of Phase II trials, we are pleased to move this investigational hexavalent combination vaccine to a late-stage clinical program," said Michel DeWilde, Ph.D., senior vice president, Research and Development, Sanofi Pasteur. "We partnered with Merck to draw on the companies' combined leadership, experience and expertise in the development, manufacturing and marketing of pediatric combination vaccines."
In the United States, the Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and American Academy of Family Physicians (AAFP) generally recommend the use of combination vaccines instead of individual injections, considering the potential for improved vaccination coverage.
"The need to consolidate vaccinations for infants will become increasingly important as the number of diseases that vaccines help prevent continues to increase," said Tony Ford-Hutchinson, Ph.D., senior vice president, Vaccines Research, Merck. "The development of a hexavalent combination vaccine is complex. The ability to share expertise and capabilities with our partner Sanofi Pasteur is fundamental in reaching our shared goal of developing new combination vaccines that may improve vaccination rates of children."
1. Known as V419 on the Merck pipeline chart and DTP-HepB-Polio-Hib Pediatric hexavalent vaccine on the sanofi-aventis and Sanofi-Pasteur pipeline charts.
Source:
Merck
sanofi-aventis
View drug information on Prevnar 13; Rotateq.
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The investigational vaccine is a combination of select components: DTaP5-IPV-Hib-HepB; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine. The vaccine is being developed as part of a partnership between Merck and Sanofi Pasteur that focuses on the development of pediatric combination vaccines.
"Combination vaccines simplify the childhood immunization schedule and may improve coverage, on time vaccination and reduce the number of injections for children," said Gary S. Marshall, M.D., professor of pediatrics, University of Louisville School of Medicine.
The Phase III clinical program will begin in the United States with a randomized, open-label, active-comparator controlled clinical trial that will involve approximately 1,440 infants at multiple centers. The primary study objectives are to assess the safety and immunogenicity of the investigational hexavalent combination vaccine when given at 2, 4, and 6 months of age concomitantly with Prevnar 13TM Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) and ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent). The clinical program is expected to begin in Europe this year. For more information on this study, please visit here.
The Phase III program was initiated following results from a Phase IIb clinical trial of
459 children that assessed the safety and immunogenicity of the investigational combination vaccine.
"Based on the results of Phase II trials, we are pleased to move this investigational hexavalent combination vaccine to a late-stage clinical program," said Michel DeWilde, Ph.D., senior vice president, Research and Development, Sanofi Pasteur. "We partnered with Merck to draw on the companies' combined leadership, experience and expertise in the development, manufacturing and marketing of pediatric combination vaccines."
In the United States, the Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and American Academy of Family Physicians (AAFP) generally recommend the use of combination vaccines instead of individual injections, considering the potential for improved vaccination coverage.
"The need to consolidate vaccinations for infants will become increasingly important as the number of diseases that vaccines help prevent continues to increase," said Tony Ford-Hutchinson, Ph.D., senior vice president, Vaccines Research, Merck. "The development of a hexavalent combination vaccine is complex. The ability to share expertise and capabilities with our partner Sanofi Pasteur is fundamental in reaching our shared goal of developing new combination vaccines that may improve vaccination rates of children."
1. Known as V419 on the Merck pipeline chart and DTP-HepB-Polio-Hib Pediatric hexavalent vaccine on the sanofi-aventis and Sanofi-Pasteur pipeline charts.
Source:
Merck
sanofi-aventis
View drug information on Prevnar 13; Rotateq.
Buy Urispas Without Prescription
Health Affairs Reports Discuss Barriers, Advantages, Costs of Implementing Health Information Technology Systems
Several newspapers on Thursday addressed three studies and one editorial on health care information technology published Wednesday in the September/October edition of... Health Affairs. Summaries appear below.
Cost Effectiveness: Implementation of a nationwide electronic health records network would take about 15 years and cost hospitals about $98 billion and physicians about $17 billion, according to a study by Richard Hillestad and colleagues at RAND, the AP/Las Vegas Sun reports (Neergaard, AP/Las Vegas Sun, 9/14). Over the 15-year period, the average annual cost to hospitals would be $6.5 billion and the average annual cost to physicians would be $1.1 billion (CQ HealthBeat [1], 9/14). However, if 90% of providers adopted such a network, annual savings would total $81 billion, including $77 billion from improved efficiency and $4 billion from reduced medical errors, the study found (AP/Las Vegas Sun, 9/14). The study estimates that an EHR network would reduce adverse drug events in inpatient hospital settings by 200,000 annually and reduce such events in ambulatory settings by two million annually, saving $1 billion annually in hospitals and $3.5 billion in ambulatory settings. For hospitals, about 60% of these savings would be from reduced adverse drug events in patients ages 65 and older, while 40% of savings to ambulatory practices from reduced medication errors would be in patients 65 and older (CQ HealthBeat [1], 9/14). In addition, the study estimates that a national EHR network would save Medicare about $23 billion annually and save private insurers about $31 billion annually. The study projects that the estimated total annual savings of $81 billion would double if providers followed all checkup reminders and other prompts from the system (AP/Las Vegas Sun, 9/14). Currently, about 20% to 25% of hospitals and 15% to 20% of physician offices have EHR systems, according to the study (CQ HealthBeat [1], 9/14).
An abstract of the study is available online.
Editorial: RAND's projections are based on "a disturbing array of unproven assumptions [and] wishful thinking," David Himmelstein and Steffie Woolhandler of Harvard Medical School write in a commentary piece accompanying the RAND study (AP/Las Vegas Sun, 9/14). Although EHR technology has progressed over the past three decades, "computers don't offer the panaceas that politicians hope for and computer firms are peddling," they wrote (Trehan, Reuters/Boston Globe, 9/15).
An abstract of the commentary is available online.
Small Practices: Physician practices spent an average of about $44,000 per full-time equivalent provider to implement an EHR system and about $8,500 per provider to maintain the system, according to a study of 14 solo and small group practices with EHR systems. On average, the practices recouped the costs of the systems through business savings within two and a half years, although "some practices didn't recoup the investments for years," the AP/Sun reports. The study was led by researchers at the University of California-San Francisco (AP/Las Vegas Sun, 9/14).
An abstract of the study is available online.
Group Practices: About 14.1% of group practices use an EHR system, according to a nationwide survey conducted by researchers at the Medical Group Management Association Center for Research and the University of Minnesota School of Public Health and funded by the Agency for Healthcare Research and Quality. The percentage of practices with EHR systems increased as the size of the group practices increased, the survey found. About 12.5% of practices with five or fewer full-time equivalent physicians reported use of an EHR system, compared with 15.2% for practices with six to 10 FTE physicians, 18.9% for practices with 11 to 20 FTE physicians and 19.5% for groups with 20 or more FTE physicians, according to the survey. The average cost of purchasing and implementing an EHR system was $32,606 per FTE physician, with monthly maintenance costs of $1,500 per FTE physician, the survey found. In addition, the average cost of EHR system implementation was about 25% higher than initial vendor estimates, the survey found (CQ HealthBeat [2], 9/14).
An abstract of the study is available online.
Cost Effectiveness: Implementation of a nationwide electronic health records network would take about 15 years and cost hospitals about $98 billion and physicians about $17 billion, according to a study by Richard Hillestad and colleagues at RAND, the AP/Las Vegas Sun reports (Neergaard, AP/Las Vegas Sun, 9/14). Over the 15-year period, the average annual cost to hospitals would be $6.5 billion and the average annual cost to physicians would be $1.1 billion (CQ HealthBeat [1], 9/14). However, if 90% of providers adopted such a network, annual savings would total $81 billion, including $77 billion from improved efficiency and $4 billion from reduced medical errors, the study found (AP/Las Vegas Sun, 9/14). The study estimates that an EHR network would reduce adverse drug events in inpatient hospital settings by 200,000 annually and reduce such events in ambulatory settings by two million annually, saving $1 billion annually in hospitals and $3.5 billion in ambulatory settings. For hospitals, about 60% of these savings would be from reduced adverse drug events in patients ages 65 and older, while 40% of savings to ambulatory practices from reduced medication errors would be in patients 65 and older (CQ HealthBeat [1], 9/14). In addition, the study estimates that a national EHR network would save Medicare about $23 billion annually and save private insurers about $31 billion annually. The study projects that the estimated total annual savings of $81 billion would double if providers followed all checkup reminders and other prompts from the system (AP/Las Vegas Sun, 9/14). Currently, about 20% to 25% of hospitals and 15% to 20% of physician offices have EHR systems, according to the study (CQ HealthBeat [1], 9/14).
An abstract of the study is available online.
Editorial: RAND's projections are based on "a disturbing array of unproven assumptions [and] wishful thinking," David Himmelstein and Steffie Woolhandler of Harvard Medical School write in a commentary piece accompanying the RAND study (AP/Las Vegas Sun, 9/14). Although EHR technology has progressed over the past three decades, "computers don't offer the panaceas that politicians hope for and computer firms are peddling," they wrote (Trehan, Reuters/Boston Globe, 9/15).
An abstract of the commentary is available online.
Small Practices: Physician practices spent an average of about $44,000 per full-time equivalent provider to implement an EHR system and about $8,500 per provider to maintain the system, according to a study of 14 solo and small group practices with EHR systems. On average, the practices recouped the costs of the systems through business savings within two and a half years, although "some practices didn't recoup the investments for years," the AP/Sun reports. The study was led by researchers at the University of California-San Francisco (AP/Las Vegas Sun, 9/14).
An abstract of the study is available online.
Group Practices: About 14.1% of group practices use an EHR system, according to a nationwide survey conducted by researchers at the Medical Group Management Association Center for Research and the University of Minnesota School of Public Health and funded by the Agency for Healthcare Research and Quality. The percentage of practices with EHR systems increased as the size of the group practices increased, the survey found. About 12.5% of practices with five or fewer full-time equivalent physicians reported use of an EHR system, compared with 15.2% for practices with six to 10 FTE physicians, 18.9% for practices with 11 to 20 FTE physicians and 19.5% for groups with 20 or more FTE physicians, according to the survey. The average cost of purchasing and implementing an EHR system was $32,606 per FTE physician, with monthly maintenance costs of $1,500 per FTE physician, the survey found. In addition, the average cost of EHR system implementation was about 25% higher than initial vendor estimates, the survey found (CQ HealthBeat [2], 9/14).
An abstract of the study is available online.
NCQA Opens Public Comment Period
In related news, the National Committee for Quality Assurance will be accepting public comment on its Physician Practice Connection program until Oct. 11, CQ HealthBeat reports. The program recognizes physicians who use health care IT in their practices. It includes 80 practices representing 700 physicians (CQ HealthBeat [3], 9/14).
Broadcast Coverage
APM's "Marketplace" on Wednesday reported on the studies. The segment includes comments from Hillestad; Robert Miller, a health economist at the University of California-San Francisco; and Woolhandler (Palmer, "Marketplace," APM, 9/14).
The complete segment is available online in RealPlayer.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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EHRs Would Benefit Consumer-Directed Care, Sen. Porter Writes
"[I]n order to realize the full benefit of consumer-directed health care, policy makers need broad dissemination of health information technology -- particularly providing help from the consumers' perspective -- on the legislative front burner," Rep. Jon Porter (R-Nev.) writes in a Washington Times opinion piece. According to Porter, a member of the House Ways and Means Committee, "[I]ntroducing more consumer choice in American health care will never reach its full potential until patients have the information to make informed decisions," and "[e]lectronic health records are an essential component for patients to make informed and safe decisions." Porter writes, "One of the reasons why progress has been slow in adopting new applications like electronic personal-health records is that ... many consumers believe they are already being utilized." According to Porter, "Closing this gap between perception and reality is one of the keys to stimulating more consumer demand." Porter concludes, "There are many health care issues that demand Congress' attention. Legislation promoting speedier deployment of electronic health records has bipartisan support, saves money and will promote better health outcomes. And for those of us interested in advancing consumer-directed health care, it will provide the necessary information to make that goal a reality" (Porter, Washington Times, 4/4).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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Interfering With A Double-Edged Sword: Novel Anti-Inflammatory Functions For Interferons
Animals react to infections in a number of ways. Among the first is the production of cell factors such as interferons and IL-1beta. Interferons have several functions, including activating a series of intracellular signals such as Tyk2 (Tyrosine kinase 2), while IL-1beta is important for the induction of inflammation, which helps directly to protect the body against attack. However, inflammation must be kept tightly in check as it may also harm the body. Cells control IL-1beta activity in a number of ways, regulating not only the amount of messenger RNA (mRNA) that encodes the IL-1beta protein but also the processing and release of "mature" IL-1beta protein. Surprisingly, interferons may also inhibit the production of IL-1b protein and thus suppress inflammation. This conclusion comes from Marta Radwan and Rita Stiefvater in Birgit Strobl's group at the University of Veterinary Medicine, Vienna and is published in the current issue of the Journal of Immunology.
Radwan and Stiefvater have shown that cells control the way in which the IL-1beta mRNA is used to make IL-1beta protein. They measured the levels of IL-1beta protein in cells that lack Tyk2, one of the key components of the interferon signalling pathway. Although the amount of IL-1beta protein in these cells was increased, the amount of IL-1beta mRNA was not affected by the absence of Tyk2 and there was no apparent change to the stability of the mRNA. Instead the mRNA was more actively translated (copied) to protein and Radwan and Stiefvater were able to prove that the effect stemmed from a heightened association with polysomes, the complexes that actively synthesize proteins.
Interferons have long been known to inhibit translation of mRNAs in general but there have been recent indications that they may also stimulate the translation of particular mRNAs. IL-1beta is known to be involved in a wide range of autoimmune and inflammatory diseases, conditions in which the immune system either overreacts or reacts against itself. IL-1beta thus represents an attractive target for treatment of such diseases. As Birgit Strobl says, "The novel mode of IL-1beta regulation and the finding that interferon can inhibit IL-1beta production could turn out to be very important." Indeed, the finding that Tyk2 may inhibit the production of IL-1beta protein might have consequences for the development of strategies for the treatment of these widespread and serious conditions.
Notes:
The paper Tyrosine kinase 2 controls interleukin-1beta production at the translational level by Marta Radwan, Rita Stiefvater, Tom Grunert, Omar Sharif, Ingrid Miller, Martina Marchetti-Deschmann, GГјnter Allmaier, Manfred Gemeiner, Sylvia Knapp, Pavel Kovarik|, Mathias MГјller and Birgit Strobl is published in the 185(6)/2010 issue of the Journal of Immunology.
The work was funded in part by the Austrian Science Fund (FWF) via grants to Mathias MГјller and Birgit Strobl and undertaken in the framework of the Special Research Programme (SFB) "Jak-Stat-Signalling from Basics to Disease", hosted by the University of Veterinary Medicine, Vienna, the University of Vienna and the Medical University of Vienna. Collaborators from the Vienna University of Technology, the Center for Molecular Medicine, Vienna, the Medical University of Vienna and the Max F. Perutz Laboratories, Vienna also contributed to the research.
Source:
Birgit Strobl
University of Veterinary Medicine -- Vienna
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Radwan and Stiefvater have shown that cells control the way in which the IL-1beta mRNA is used to make IL-1beta protein. They measured the levels of IL-1beta protein in cells that lack Tyk2, one of the key components of the interferon signalling pathway. Although the amount of IL-1beta protein in these cells was increased, the amount of IL-1beta mRNA was not affected by the absence of Tyk2 and there was no apparent change to the stability of the mRNA. Instead the mRNA was more actively translated (copied) to protein and Radwan and Stiefvater were able to prove that the effect stemmed from a heightened association with polysomes, the complexes that actively synthesize proteins.
Interferons have long been known to inhibit translation of mRNAs in general but there have been recent indications that they may also stimulate the translation of particular mRNAs. IL-1beta is known to be involved in a wide range of autoimmune and inflammatory diseases, conditions in which the immune system either overreacts or reacts against itself. IL-1beta thus represents an attractive target for treatment of such diseases. As Birgit Strobl says, "The novel mode of IL-1beta regulation and the finding that interferon can inhibit IL-1beta production could turn out to be very important." Indeed, the finding that Tyk2 may inhibit the production of IL-1beta protein might have consequences for the development of strategies for the treatment of these widespread and serious conditions.
Notes:
The paper Tyrosine kinase 2 controls interleukin-1beta production at the translational level by Marta Radwan, Rita Stiefvater, Tom Grunert, Omar Sharif, Ingrid Miller, Martina Marchetti-Deschmann, GГјnter Allmaier, Manfred Gemeiner, Sylvia Knapp, Pavel Kovarik|, Mathias MГјller and Birgit Strobl is published in the 185(6)/2010 issue of the Journal of Immunology.
The work was funded in part by the Austrian Science Fund (FWF) via grants to Mathias MГјller and Birgit Strobl and undertaken in the framework of the Special Research Programme (SFB) "Jak-Stat-Signalling from Basics to Disease", hosted by the University of Veterinary Medicine, Vienna, the University of Vienna and the Medical University of Vienna. Collaborators from the Vienna University of Technology, the Center for Molecular Medicine, Vienna, the Medical University of Vienna and the Max F. Perutz Laboratories, Vienna also contributed to the research.
Source:
Birgit Strobl
University of Veterinary Medicine -- Vienna
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College Students And Hand Hygiene: Proper Tools, Attention-Getting Tactics Required
The path to poor hand sanitation is paved with good intentions, according to researchers from Kansas State and North Carolina State universities.
As college campuses prepare for an expected increase in H1N1 flu this fall, the researchers said students' actions will speak louder than words.
"Many students say they routinely wash their hands," said Douglas Powell, an associate professor of food safety at Kansas State University. "But even in an outbreak situation, many students simply don't."
In February 2006, Powell and two colleagues -- Ben Chapman, an assistant professor at North Carolina State University, and research assistant Brae Surgeoner -- observed hand sanitation behavior during an outbreak. What was thought to have been norovirus sickened nearly 340 students at the University of Guelph in Canada.
Hand sanitation stations and informational posters were stationed at the entrance to a residence hall cafeteria, where the potential for cross-contamination was high. The researchers observed that even during a high-profile outbreak, students followed recommended hand hygiene procedures just 17 percent of the time. In a self-reported survey after the outbreak had subsided, 83 of 100 students surveyed said they always followed proper hand hygiene but estimated that less than half of their peers did the same.
The results appear in the September issue of the Journal of Environmental Health.
Powell said that in addition to providing the basic tools for hand washing - vigorous running water, soap and paper towels - college students, especially those living in residence halls, need a variety of messages and media continually encouraging them to practice good hand hygiene.
"Telling people to wash their hands or posting signs that say, 'Wash your hands' isn't enough," said Chapman. "Public health officials need to be creative with their communication methods and messages."
Most students surveyed perceived at least one barrier to following recommended hand hygiene procedures. More than 90 percent cited the lack of soap, paper towels or hand sanitizer. Additional perceived barriers were the notion that hand washing causes irritation and dryness, along with just being lazy and forgetful about hand washing. Fewer than 7 percent said a lack of knowledge of the recommended hand hygiene procedures was a barrier.
"Providing more facts is not going to get students to wash their hands," Powell said. "Compelling messages using a variety of media - text messages, Facebook and traditional posters with surprising images - may increase hand washing rates and ultimately lead to fewer sick people."
Source:
Douglas Powell
Kansas State University
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As college campuses prepare for an expected increase in H1N1 flu this fall, the researchers said students' actions will speak louder than words.
"Many students say they routinely wash their hands," said Douglas Powell, an associate professor of food safety at Kansas State University. "But even in an outbreak situation, many students simply don't."
In February 2006, Powell and two colleagues -- Ben Chapman, an assistant professor at North Carolina State University, and research assistant Brae Surgeoner -- observed hand sanitation behavior during an outbreak. What was thought to have been norovirus sickened nearly 340 students at the University of Guelph in Canada.
Hand sanitation stations and informational posters were stationed at the entrance to a residence hall cafeteria, where the potential for cross-contamination was high. The researchers observed that even during a high-profile outbreak, students followed recommended hand hygiene procedures just 17 percent of the time. In a self-reported survey after the outbreak had subsided, 83 of 100 students surveyed said they always followed proper hand hygiene but estimated that less than half of their peers did the same.
The results appear in the September issue of the Journal of Environmental Health.
Powell said that in addition to providing the basic tools for hand washing - vigorous running water, soap and paper towels - college students, especially those living in residence halls, need a variety of messages and media continually encouraging them to practice good hand hygiene.
"Telling people to wash their hands or posting signs that say, 'Wash your hands' isn't enough," said Chapman. "Public health officials need to be creative with their communication methods and messages."
Most students surveyed perceived at least one barrier to following recommended hand hygiene procedures. More than 90 percent cited the lack of soap, paper towels or hand sanitizer. Additional perceived barriers were the notion that hand washing causes irritation and dryness, along with just being lazy and forgetful about hand washing. Fewer than 7 percent said a lack of knowledge of the recommended hand hygiene procedures was a barrier.
"Providing more facts is not going to get students to wash their hands," Powell said. "Compelling messages using a variety of media - text messages, Facebook and traditional posters with surprising images - may increase hand washing rates and ultimately lead to fewer sick people."
Source:
Douglas Powell
Kansas State University
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Pharmion And MethylGene Start Phase 2 Combination Clinical Trial With MGCD0103 And Vidaza(R) In Patients With Relapsed Or Refractory Hodgkin Lymphoma
Pharmion
Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) announced
the enrollment of the first patient in a Phase 2 clinical trial (Trial
CL002) evaluating MGCD0103, the Companies' isotype-selective histone
deacetylase inhibitor (HDACi) product candidate, in combination with
Vidaza(R) (azacitidine for injection), Pharmion's DNA demethylating agent,
in patients with relapsed or refractory Hodgkin lymphoma (HL) or
non-Hodgkin lymphoma (NHL).
Patients will receive 75 mg/m2 of Vidaza either intravenously or
subcutaneously in combination with an oral dose of MGCD0103 in 28 day
cycles. Key objectives for this study are to determine the overall response
rate, progression free survival and duration of response. The trial will
enroll up to 75 patients at cancer centers in North America and will
include a pharmacokinetic equivalency study.
"We are aggressively exploring the utility of epigenetic drug
combinations in the treatment of cancer," said Andrew Allen, Pharmion's
executive vice president and chief medical officer. "The biology of cancer
suggests multiple epigenetic mechanisms cooperate to silence tumor
suppressor genes, which raises the simple hypothesis that attacking these
mechanisms with drug combinations may be superior to single-agent therapy.
In this trial, we are combining Vidaza, our DNA methyltransferase
inhibitor, with MGCD0103, our isotype-selective HDAC inhibitor, in a
clinical study of this therapeutic approach. We are unique in our ability
to conduct a trial like this, using drugs from our own portfolio."
"We are delighted to be participating in this trial of Vidaza and
MGCD0103," commented Dr. Anas Younes, Professor of Medicine and Director,
Clinical Investigation and Translational Research in the Department of
Lymphoma/Myeloma, M.D. Anderson Cancer Center and a principal investigator
for this trial. "There have been no new approved therapies in
relapsed/refractory Hodgkin lymphoma for decades. As epigenetics is thought
to play a role in lymphoma, this clinical study will help build an
understanding of the role of HDAC inhibitors and demethylating agents in
the treatment of non-Hodgkin and Hodgkin lymphoma."
Encouraging anti-tumor activity has been demonstrated in a Phase 2
clinical study of MGCD0103 as a single agent in the relapsed or refractory
Hodgkin lymphoma patient population. Data from the ongoing study, presented
at the American Society of Hematology (ASH) annual meeting last month,
reported an objective complete and partial response (CR and PR) rate of 38
percent and a disease control rate of 43 percent in 21 evaluable patients
in the 110mg cohort. Eighty-six percent of patients who had CT scans
experienced a reduction in tumor size, with 57 percent experiencing a tumor
reduction of greater than 30 percent. The two CR patients have a
preliminary progression-free survival (PFS) of 14 and nine months at the
time of analysis, and the range of PFS from the responder group is 56 to
greater than 396 days. Adverse events associated with MGCD0103
administration of grade 3 or higher included pneumonia (15 percent),
thrombocytopenia (12 percent) and fatigue (nine percent). Dose modification
was effective in many of these patients.
About MGCD0103
MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor
The compound is currently in one Phase 1 combination clinical trial with
Taxotere(R) for solid tumors, two Phase 1/2 combination trials with
Vidaza(R) for hematological malignancies and with Gemzar(R) for pancreatic
cancer; and five Phase 2 clinical trials in hematological malignancies.
MGCD0103 has received orphan drug designation from the U.S. Food and
Drug Administration (FDA) and has been designated an orphan medicinal
product by the European Medicines Agency (EMEA) for the treatment of
Hodgkin lymphoma.
About Vidaza
In May 2004, Vidaza became the first drug approved by the FDA for the
treatment of patients with Myelodysplastic Syndromes (MDS). The FDA
approved Vidaza, the first in a new class of drugs called demethylation
agents, for treatment of all five MDS subtypes. These subtypes include:
refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS)
if accompanied by neutropenia or thrombocytopenia or requiring
transfusions; refractory anemia with excess blasts (RAEB), refractory
anemia with excess blasts in transformation (RAEB-T), and chronic
myelomonocytic leukemia (CMMoL).
Vidaza is believed to exert its antineoplastic effects by causing
hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic
cells in the bone marrow. The concentration of Vidaza required for maximum
inhibition of DNA methylation in vitro does not cause major suppression of
DNA synthesis. Hypomethylation may restore normal function to genes that
are critical for differentiation and proliferation. The cytotoxic effects
of Vidaza cause the death of rapidly dividing cells, including cancer cells
that are no longer responsive to normal growth control mechanisms. Non-
proliferating cells are relatively insensitive to Vidaza. Vidaza was
approved for IV administration in January 2007.
About Epigenetic Therapy
DNA methylation and histone deacetylation are the two most studied
epigenetic regulators of gene expression. Vidaza reverses the effects of
DNA hypermethylation with subsequent tumor suppressor gene re-expression.
MGCD0103 exerts its epigenetic effects by acting as an oral
isotype-selective HDAC inhibitor. Together, the two act synergistically to
induce suppressor gene re-expression and favorably influence the clinical
course of cancer. Pharmion strongly believes that by targeting two separate
epigenetic pathways simultaneously, the combination of drugs targeting DNA
methylation and histone deacetylation can either increase the
susceptibility of cancer cells to standard chemotherapy or act as a potent
therapeutic regimen in its own right.
About Hodgkin Lymphoma
Hodgkin lymphoma (HL) is a cancer of the lymphatic system that begins
in the lymph nodes and progresses to other organs, including the lungs,
liver, bone and bone marrow. It is characterized by the presence of
Reed-Sternberg cells. Currently, there is no known cause of the disease,
but epigenetic alterations including changes in histone acetylation, have
been identified. In addition, the Epstein-Barr virus, HIV and familial
history are known risk factors. The disease is slightly more prevalent in
men than women, and the median age of diagnosis is 38.
About Non-Hodgkin Lymphoma
Non-Hodgkin lymphoma (NHL) are any of a large group of cancers of the
immune system. NHLs can occur at any age and are often marked by enlarged
lymph nodes, fever, and weight loss. There are many different types of NHL,
which can be divided into aggressive (fast-growing) and indolent
(slow-growing) types and can be classified as either B-cell or T-cell NHL.
B-cell NHLs include Burkitt lymphoma, diffuse large B-cell lymphoma,
follicular lymphoma, immunoblastic large cell lymphoma, precursor
B-lymphoblastic lymphoma, and mantle cell lymphoma. T-cell NHLs include
mycosis fungoides, anaplastic large cell lymphoma, and precursor
T-lymphoblastic lymphoma. Lymphomas related to lymphoproliferative
disorders following bone marrow or stem cell transplantation are usually
B-cell NHLs. Currently, there is no known cause of the disease, but
epigenetic alterations including histone acetylation, have been identified.
In addition, the Epstein-Barr virus, HIV, Hepatitis-C and familial history
are known risk factors.
Г§The disease is slightly more prevalent in men then women, and is most
common in those over the age of 60. According to the American Cancer
Society, there are approximately 59,000 new cases of non-Hodgkin lymphomas
diagnosed each year in the U.S. DLBCL is the most common form of NHL
lymphomas accounting for up to 30 percent of newly-diagnosed cases.
Important Vidaza Safety Information
Vidaza is contraindicated in patients with a known hypersensitivity to
Vidaza or mannitol and in patients with advanced malignant hepatic tumors.
In clinical studies, the most commonly occurring adverse reactions by
SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%),
vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%),
fatigue (35.9%), injection site erythema (35.0%), constipation (33.6%),
neutropenia (32.3%) and ecchymosis (30.5%). Other adverse reactions
included dizziness (18.6%), chest pain (16.4%), febrile neutropenia
(16.4%), myalgia (15.9%), injection site reaction (13.6%), aggravated
fatigue (12.7%) and malaise (10.9%). The most common adverse reactions by
IV route also included petechiae (45.8%), rigors (35.4%), weakness (35.4%)
and hypokalemia (31.3%).
Because treatment with Vidaza is associated with neutropenia and
thrombocytopenia, complete blood counts should be performed as needed to
monitor response and toxicity, but at a minimum, prior to each dosing
cycle. Because Vidaza is potentially hepatotoxic in patients with severe
pre- existing hepatic impairment, caution is needed in patients with liver
disease. In addition, Vidaza and its metabolites are substantially excreted
by the kidneys and the risk of toxic reactions to this drug may be greater
in patients with impaired renal function. Because elderly patients are more
likely to have decreased renal function, it may be useful to monitor renal
function.
Vidaza may cause fetal harm. While receiving treatment with Vidaza,
women of childbearing potential should avoid becoming pregnant, and men
should avoid fathering a child. In addition, women treated with Vidaza
should not nurse.
About Pharmion
Pharmion is a leading global oncology company uniquely focused on
acquiring, developing and commercializing innovative products for the
treatment of hematology and oncology patients in the U.S., Europe and
additional international markets. Pharmion has a number of products on the
market including the world's first approved epigenetic drug, Vidaza(R), a
DNA demethylating agent. For additional information about Pharmion, please
visit the company's website at pharmion.
About MethylGene
MethylGene Inc. (TSX: MYG) is a publicly-traded biopharmaceutical
company focused on the discovery, development and commercialization of
novel therapeutics for cancer. The Company's lead product, MGCD0103, is an
oral isotype-selective HDAC inhibitor presently in multiple clinical trials
for solid tumors and hematological malignancies, including Phase 2
monotherapy and Phase 1 and Phase 2 combination trials with Vidaza(R),
Gemzar(R) and Taxotere(R). MGCD265 is an oral kinase inhibitor targeting
the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition,
MethylGene has several preclinical programs: MGCD290 an HDAC inhibitor in
combination with azoles for fungal infections; an HDAC program for
Huntington's disease; and a sirtuins program for cancer. MethylGene's
development and commercialization partners include Pharmion Corporation,
Taiho Pharmaceutical and EnVivo Pharmaceuticals. Please visit our website
at methylgene.
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995: This release contains forward-looking statements relating to
the planned development program for MGCD0103, which express the current
beliefs and expectations of management. Such statements are based on
current expectations and involve a number of known and unknown risks and
uncertainties that could cause Pharmion's future results, performance or
achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such differences
include, but are not limited to, the potential failure of MGCD0103, to
demonstrate safety and efficacy in clinical and non-clinical testing; the
ability to complete regulatory submissions and gain regulatory approvals in
a timely manner; the ability to initiate and complete trials at the
referenced times; the impact of competition from other products under
development by Pharmion's competitors; the uncertainty of the regulatory
environment and changes in the health policies of various countries;
acceptance and demand for new pharmaceutical products and new therapies;
uncertainties regarding market acceptance of products newly launched,
currently being sold or in development; failure of third-party
manufacturers to produce the product volumes required on a timely basis and
fluctuations in currency exchange rates. Additional risks and uncertainties
relating to Pharmion and its business can be found in the "Risk Factors"
section of Pharmion's Quarterly Report on Form 10-Q for the quarterly
period ended September 30, 2007, its Annual Report on Form 10-K for the
year ended December 31, 2006 and in our other filings with the U.S.
Securities and Exchange Commission. Forward-looking statements speak only
as of the date on which they are made, and Pharmion undertakes no
obligation to update publicly or revise any forward-looking statement,
whether as a result of new information, future developments or otherwise.
Pharmion Corporation
pharmion
View drug information on Vidaza.
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Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) announced
the enrollment of the first patient in a Phase 2 clinical trial (Trial
CL002) evaluating MGCD0103, the Companies' isotype-selective histone
deacetylase inhibitor (HDACi) product candidate, in combination with
Vidaza(R) (azacitidine for injection), Pharmion's DNA demethylating agent,
in patients with relapsed or refractory Hodgkin lymphoma (HL) or
non-Hodgkin lymphoma (NHL).
Patients will receive 75 mg/m2 of Vidaza either intravenously or
subcutaneously in combination with an oral dose of MGCD0103 in 28 day
cycles. Key objectives for this study are to determine the overall response
rate, progression free survival and duration of response. The trial will
enroll up to 75 patients at cancer centers in North America and will
include a pharmacokinetic equivalency study.
"We are aggressively exploring the utility of epigenetic drug
combinations in the treatment of cancer," said Andrew Allen, Pharmion's
executive vice president and chief medical officer. "The biology of cancer
suggests multiple epigenetic mechanisms cooperate to silence tumor
suppressor genes, which raises the simple hypothesis that attacking these
mechanisms with drug combinations may be superior to single-agent therapy.
In this trial, we are combining Vidaza, our DNA methyltransferase
inhibitor, with MGCD0103, our isotype-selective HDAC inhibitor, in a
clinical study of this therapeutic approach. We are unique in our ability
to conduct a trial like this, using drugs from our own portfolio."
"We are delighted to be participating in this trial of Vidaza and
MGCD0103," commented Dr. Anas Younes, Professor of Medicine and Director,
Clinical Investigation and Translational Research in the Department of
Lymphoma/Myeloma, M.D. Anderson Cancer Center and a principal investigator
for this trial. "There have been no new approved therapies in
relapsed/refractory Hodgkin lymphoma for decades. As epigenetics is thought
to play a role in lymphoma, this clinical study will help build an
understanding of the role of HDAC inhibitors and demethylating agents in
the treatment of non-Hodgkin and Hodgkin lymphoma."
Encouraging anti-tumor activity has been demonstrated in a Phase 2
clinical study of MGCD0103 as a single agent in the relapsed or refractory
Hodgkin lymphoma patient population. Data from the ongoing study, presented
at the American Society of Hematology (ASH) annual meeting last month,
reported an objective complete and partial response (CR and PR) rate of 38
percent and a disease control rate of 43 percent in 21 evaluable patients
in the 110mg cohort. Eighty-six percent of patients who had CT scans
experienced a reduction in tumor size, with 57 percent experiencing a tumor
reduction of greater than 30 percent. The two CR patients have a
preliminary progression-free survival (PFS) of 14 and nine months at the
time of analysis, and the range of PFS from the responder group is 56 to
greater than 396 days. Adverse events associated with MGCD0103
administration of grade 3 or higher included pneumonia (15 percent),
thrombocytopenia (12 percent) and fatigue (nine percent). Dose modification
was effective in many of these patients.
About MGCD0103
MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor
The compound is currently in one Phase 1 combination clinical trial with
Taxotere(R) for solid tumors, two Phase 1/2 combination trials with
Vidaza(R) for hematological malignancies and with Gemzar(R) for pancreatic
cancer; and five Phase 2 clinical trials in hematological malignancies.
MGCD0103 has received orphan drug designation from the U.S. Food and
Drug Administration (FDA) and has been designated an orphan medicinal
product by the European Medicines Agency (EMEA) for the treatment of
Hodgkin lymphoma.
About Vidaza
In May 2004, Vidaza became the first drug approved by the FDA for the
treatment of patients with Myelodysplastic Syndromes (MDS). The FDA
approved Vidaza, the first in a new class of drugs called demethylation
agents, for treatment of all five MDS subtypes. These subtypes include:
refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS)
if accompanied by neutropenia or thrombocytopenia or requiring
transfusions; refractory anemia with excess blasts (RAEB), refractory
anemia with excess blasts in transformation (RAEB-T), and chronic
myelomonocytic leukemia (CMMoL).
Vidaza is believed to exert its antineoplastic effects by causing
hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic
cells in the bone marrow. The concentration of Vidaza required for maximum
inhibition of DNA methylation in vitro does not cause major suppression of
DNA synthesis. Hypomethylation may restore normal function to genes that
are critical for differentiation and proliferation. The cytotoxic effects
of Vidaza cause the death of rapidly dividing cells, including cancer cells
that are no longer responsive to normal growth control mechanisms. Non-
proliferating cells are relatively insensitive to Vidaza. Vidaza was
approved for IV administration in January 2007.
About Epigenetic Therapy
DNA methylation and histone deacetylation are the two most studied
epigenetic regulators of gene expression. Vidaza reverses the effects of
DNA hypermethylation with subsequent tumor suppressor gene re-expression.
MGCD0103 exerts its epigenetic effects by acting as an oral
isotype-selective HDAC inhibitor. Together, the two act synergistically to
induce suppressor gene re-expression and favorably influence the clinical
course of cancer. Pharmion strongly believes that by targeting two separate
epigenetic pathways simultaneously, the combination of drugs targeting DNA
methylation and histone deacetylation can either increase the
susceptibility of cancer cells to standard chemotherapy or act as a potent
therapeutic regimen in its own right.
About Hodgkin Lymphoma
Hodgkin lymphoma (HL) is a cancer of the lymphatic system that begins
in the lymph nodes and progresses to other organs, including the lungs,
liver, bone and bone marrow. It is characterized by the presence of
Reed-Sternberg cells. Currently, there is no known cause of the disease,
but epigenetic alterations including changes in histone acetylation, have
been identified. In addition, the Epstein-Barr virus, HIV and familial
history are known risk factors. The disease is slightly more prevalent in
men than women, and the median age of diagnosis is 38.
About Non-Hodgkin Lymphoma
Non-Hodgkin lymphoma (NHL) are any of a large group of cancers of the
immune system. NHLs can occur at any age and are often marked by enlarged
lymph nodes, fever, and weight loss. There are many different types of NHL,
which can be divided into aggressive (fast-growing) and indolent
(slow-growing) types and can be classified as either B-cell or T-cell NHL.
B-cell NHLs include Burkitt lymphoma, diffuse large B-cell lymphoma,
follicular lymphoma, immunoblastic large cell lymphoma, precursor
B-lymphoblastic lymphoma, and mantle cell lymphoma. T-cell NHLs include
mycosis fungoides, anaplastic large cell lymphoma, and precursor
T-lymphoblastic lymphoma. Lymphomas related to lymphoproliferative
disorders following bone marrow or stem cell transplantation are usually
B-cell NHLs. Currently, there is no known cause of the disease, but
epigenetic alterations including histone acetylation, have been identified.
In addition, the Epstein-Barr virus, HIV, Hepatitis-C and familial history
are known risk factors.
Г§The disease is slightly more prevalent in men then women, and is most
common in those over the age of 60. According to the American Cancer
Society, there are approximately 59,000 new cases of non-Hodgkin lymphomas
diagnosed each year in the U.S. DLBCL is the most common form of NHL
lymphomas accounting for up to 30 percent of newly-diagnosed cases.
Important Vidaza Safety Information
Vidaza is contraindicated in patients with a known hypersensitivity to
Vidaza or mannitol and in patients with advanced malignant hepatic tumors.
In clinical studies, the most commonly occurring adverse reactions by
SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%),
vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%),
fatigue (35.9%), injection site erythema (35.0%), constipation (33.6%),
neutropenia (32.3%) and ecchymosis (30.5%). Other adverse reactions
included dizziness (18.6%), chest pain (16.4%), febrile neutropenia
(16.4%), myalgia (15.9%), injection site reaction (13.6%), aggravated
fatigue (12.7%) and malaise (10.9%). The most common adverse reactions by
IV route also included petechiae (45.8%), rigors (35.4%), weakness (35.4%)
and hypokalemia (31.3%).
Because treatment with Vidaza is associated with neutropenia and
thrombocytopenia, complete blood counts should be performed as needed to
monitor response and toxicity, but at a minimum, prior to each dosing
cycle. Because Vidaza is potentially hepatotoxic in patients with severe
pre- existing hepatic impairment, caution is needed in patients with liver
disease. In addition, Vidaza and its metabolites are substantially excreted
by the kidneys and the risk of toxic reactions to this drug may be greater
in patients with impaired renal function. Because elderly patients are more
likely to have decreased renal function, it may be useful to monitor renal
function.
Vidaza may cause fetal harm. While receiving treatment with Vidaza,
women of childbearing potential should avoid becoming pregnant, and men
should avoid fathering a child. In addition, women treated with Vidaza
should not nurse.
About Pharmion
Pharmion is a leading global oncology company uniquely focused on
acquiring, developing and commercializing innovative products for the
treatment of hematology and oncology patients in the U.S., Europe and
additional international markets. Pharmion has a number of products on the
market including the world's first approved epigenetic drug, Vidaza(R), a
DNA demethylating agent. For additional information about Pharmion, please
visit the company's website at pharmion.
About MethylGene
MethylGene Inc. (TSX: MYG) is a publicly-traded biopharmaceutical
company focused on the discovery, development and commercialization of
novel therapeutics for cancer. The Company's lead product, MGCD0103, is an
oral isotype-selective HDAC inhibitor presently in multiple clinical trials
for solid tumors and hematological malignancies, including Phase 2
monotherapy and Phase 1 and Phase 2 combination trials with Vidaza(R),
Gemzar(R) and Taxotere(R). MGCD265 is an oral kinase inhibitor targeting
the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition,
MethylGene has several preclinical programs: MGCD290 an HDAC inhibitor in
combination with azoles for fungal infections; an HDAC program for
Huntington's disease; and a sirtuins program for cancer. MethylGene's
development and commercialization partners include Pharmion Corporation,
Taiho Pharmaceutical and EnVivo Pharmaceuticals. Please visit our website
at methylgene.
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995: This release contains forward-looking statements relating to
the planned development program for MGCD0103, which express the current
beliefs and expectations of management. Such statements are based on
current expectations and involve a number of known and unknown risks and
uncertainties that could cause Pharmion's future results, performance or
achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such differences
include, but are not limited to, the potential failure of MGCD0103, to
demonstrate safety and efficacy in clinical and non-clinical testing; the
ability to complete regulatory submissions and gain regulatory approvals in
a timely manner; the ability to initiate and complete trials at the
referenced times; the impact of competition from other products under
development by Pharmion's competitors; the uncertainty of the regulatory
environment and changes in the health policies of various countries;
acceptance and demand for new pharmaceutical products and new therapies;
uncertainties regarding market acceptance of products newly launched,
currently being sold or in development; failure of third-party
manufacturers to produce the product volumes required on a timely basis and
fluctuations in currency exchange rates. Additional risks and uncertainties
relating to Pharmion and its business can be found in the "Risk Factors"
section of Pharmion's Quarterly Report on Form 10-Q for the quarterly
period ended September 30, 2007, its Annual Report on Form 10-K for the
year ended December 31, 2006 and in our other filings with the U.S.
Securities and Exchange Commission. Forward-looking statements speak only
as of the date on which they are made, and Pharmion undertakes no
obligation to update publicly or revise any forward-looking statement,
whether as a result of new information, future developments or otherwise.
Pharmion Corporation
pharmion
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