Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines and immunotherapeutics for infectious diseases and cancer, announced clinical results demonstrating that its vaccine adjuvant, JVRS-100, when combined with a trivalent inactivated seasonal flu vaccine, generated robust T-cell mediated immune responses and antibody responses. Strong T-cell responses to influenza vaccine in humans have not been evidenced to date and remain an important goal for improved influenza vaccines particularly in elderly subjects. T-cell responses are critical to protection against influenza disease and recovery from infection.
Detailed results of the randomized, double-blind, multi-center Phase 1 clinical study will be presented at a podium presentation at the National Foundation for Infectious Diseases 12th Annual Conference on Vaccine Research meeting in Baltimore, MD, on April 27th, 2009 by Dr. Jeff Fairman, Vice-President of Research at Juvaris.
"The results from this trial confirm the results seen with JVRS-100 in pre-clinical studies, and the clinical data clearly support the broad potential benefits of an adjuvanted vaccine approach via the stimulation of both antibodies and T-cells, antigen dose reduction, single-dose administration, rapid immunity and improved cross-protection," said Grant Pickering, President and CEO of Juvaris. "We believe that JVRS-100 is ideally suited to address the unmet needs in the influenza market, including emerging threats such as the currently circulating swine flu, as well as to adjuvant other vaccines to treat infectious diseases where strong T-cell immunity is required."
In the Phase 1 study, 128 young adult subjects in groups of 20-24 were vaccinated with a licensed trivalent influenza vaccine with or without JVRS-100. The trial was designed to compare safety and immunogenicity 28 days after a single intramuscular immunization.
The efficacy endpoints were antibody measurements based on neutralizing and hemagglutination inhibiting (HAI) antibodies against the relevant flu virus strains, as well as T-cell responses measured by intracellular cytokine staining. Subjects receiving JVRS-100 adjuvanted vaccine were shown to have antibody responses to influenza A that were approximately two-fold higher than recipients of unadjuvanted vaccine. Importantly, significant T-cell responses, including polyfunctional T cells secreting multiple cytokines (interferon-Оі, interleukin-2, and tumor necrosis factor-О±) were observed in subjects receiving JVRS-100 adjuvant but not in subjects who received vaccine alone.
The primary safety objective of the study compared the safety and tolerability of JVRS-100 with vaccine vs. vaccine alone. The adjuvant was very well tolerated. The incidence of adverse events following vaccination with JVRS-100 at effective dose levels was similar to that in the vaccine-alone groups.
"The promising results from this clinical trial indicate that JVRS-100 can increase the immune response generated by existing vaccines without additional toxicity," said Thomas P. Monath, M.D., acting Chief Medical Officer at Juvaris. "We look forward to advancing JVRS-100 into Phase 2 clinical development in the elderly patient population and into trials with a pandemic (avian) influenza vaccine. The elderly appear to have functional defects in plasmacytoid dendritic cell (pDC) responses during immune stimulation. Recent research data from Juvaris indicate that JVRS-100 can increase immune responses in the absence of pDCs, suggesting that the adjuvant will be effective in the elderly."
Seasonal influenza affects approximately one billion people worldwide each year, and results in 5 million severe illnesses and 500,000 deaths. Approximately 90 percent of the deaths occur in the elderly, where flu infection can lead to severe complications from underlying diseases, pneumonia and death. Seasonal influenza vaccines, which are widely used in the U.S. and developed countries, are effective in approximately one-third of the elderly population. The emergence of new, highly pathogenic strains, like the swine influenza virus currently affecting Mexico and the U.S., illustrate the need for improved vaccines. Manufacturers of influenza vaccines are actively pursuing adjuvanted vaccines to improve efficacy and reduce vaccine dosage requirements.
About JVRS-100
JVRS-100 is a cationic lipid-DNA complex that is being developed as an adjuvant to improve the effectiveness of existing vaccines and to develop new vaccines against a variety of infectious diseases. Research indicates that the mechanism of action of JVRS-100 is distinct from other known adjuvants. The adjuvant complex self-assembles with disease-specific antigens and induces substantial antibody- and cell-mediated immune responses, particularly induction of CD4+ and CD8+ T lymphocytes. Immunological responses elicited by the lipid-DNA complexes have been successfully demonstrated in both prophylactic and therapeutic vaccine settings in multiple species. This platform provides the opportunity to develop many disease-specific immunotherapy products for which there are significant unmet medical needs.
About Juvaris
Juvaris BioTherapeutics is a clinical stage company developing adjuvanted vaccines and immunotherapeutics to treat infectious diseases and cancer. The Company's lead product candidate, JVRS-100, is currently in clinical development as an adjuvant to improve the efficacy of seasonal influenza vaccines in the elderly population. The Company is also developing vaccines for HSV-2, universal flu and pandemic flu and has initiated clinical development of an immunotherapeutic to treat acute leukemia with grant funding from a leading academic institution. Juvaris completed a Series A financing led by Kleiner Perkins Caufield & Byers and has been awarded multiple NIH grants. More information about the Company and its technology can be obtained at its website: juvaris.
Source
Juvaris BioTherapeutics
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четверг, 8 сентября 2011 г.
New International Field Of Research Established - Allergooncology
Research into the correlations between allergies and the development of
tumours - and possible benefits for future cancer treatments - has finally
become an established research discipline in its own right. That was the
conclusion at the 2nd International AllergoOncology Symposium, which took
place in Vienna at the weekend. The symposium's organiser, Prof.
Jensen-Jarolim, was extremely happy with the event, which was attended by
over 90 doctors and scientists from over 10 different countries. This
fascinating field of research, which she has succeeded in establishing with
support from the Austrian Science Fund FWF, has also been honoured with its
first review article in the international journal "Allergy".
Although scientists have been aware of the phenomenon for over 50 years, it
is only over the last three of these that there has been a dedicated field
of research looking into the influence of allergic reactions on the
development of tumours. Known as AllergoOncology, this discipline looks at
the ways that allergic reactions can inhibit the growth of cancer tumours.
This field of research was founded by Prof. Erika Jensen-Jarolim, head of
the Department of Pathophysiology at the Medical University of Vienna. Her
work on establishing AllergoOncology as a distinct field of medical research
began several years ago as part of a project run by the Austrian Science
Fund FWF.
Synergy & Symposium
Last weekend's International AllergoOncology Symposium in Vienna, the second
to be organised by Prof. Jensen-Jarolim, provided a host of international
immunologists and oncologists with the ideal opportunity to discuss
potential synergies in their work. The broad spread of topics covered at the
event included a presentation by Prof. Chris Parish from the John Curtin
School of Medical Research in Australia. He referred to a project during
which resistance to certain chemically induced tumours was achieved in a
mouse model through the administration of white blood cells, which are also
associated with allergies.
"Even if results from animal models cannot be transferred directly to
humans, projects like Prof. Parish's still demonstrate the enormous
therapeutic potential of AllergoOncology," comments Prof. Jensen-Jarolim.
Another project presented by Dr. Manuel Penichet, University of California,
which was carried out in cooperation with teams led by Prof. Hannah Gould,
King's College, London, and Prof. Jensen-Jarolim sought to combat breast
cancer. To do this, the team used a key characteristic of the special
antibodies that are jointly responsible for allergic reactions - IgE
antibodies. These antibodies have a highly reactive and long-lasting effect
against proteins that the body classes as unwanted. This IgE response can
also be accurately directed against protein structures in certain tumour
cells. This characteristic is being used by the team and can even be
enhanced by making specific adjustments to the antibody structure.
However, Prof. Jensen-Jarolim also felt that the potential of
AllergoOncology should be critically scrutinised during the symposium, and a
debate involving a panel of specialists led by the life science journalist
Johanna Award-Geissler provided the ideal solution. Prof. Jensen-Jarolim
explains: "To ensure a field of research survives in the long term, we need
to have people who are willing to be critical and we must put in place
consistent checks. That's why symposium participants were also presented
with data from a Viennese study of over 22,000 cancer patients, which had
been unable to identify any general link between mortality and the
concentration of IgE in serum, except in the case of lymphoma and leukaemia.
The reasons behind this will need to be analysed further."
A review article that was exclusively unveiled in advance at the weekend
showed just how much progress has already been made towards making
AllergoOncology an established field in international medicine and science.
The article is due to be published officially in the international journal
"Allergy" in a few weeks. From the FWF's perspective, both the symposium and
the state-of-the-art article demonstrate that providing early support for
newly emerging interdisciplinary fields of research such as AllergoOncology
really does make sense.
The full programme of the 2nd International AllergoOncology Symposium can be
found at: allergooncology.
Medizinische Universität WienInstitut für Pathophysiologie
Austrian Science Fund FWF
Buy Quinine Without Prescription
tumours - and possible benefits for future cancer treatments - has finally
become an established research discipline in its own right. That was the
conclusion at the 2nd International AllergoOncology Symposium, which took
place in Vienna at the weekend. The symposium's organiser, Prof.
Jensen-Jarolim, was extremely happy with the event, which was attended by
over 90 doctors and scientists from over 10 different countries. This
fascinating field of research, which she has succeeded in establishing with
support from the Austrian Science Fund FWF, has also been honoured with its
first review article in the international journal "Allergy".
Although scientists have been aware of the phenomenon for over 50 years, it
is only over the last three of these that there has been a dedicated field
of research looking into the influence of allergic reactions on the
development of tumours. Known as AllergoOncology, this discipline looks at
the ways that allergic reactions can inhibit the growth of cancer tumours.
This field of research was founded by Prof. Erika Jensen-Jarolim, head of
the Department of Pathophysiology at the Medical University of Vienna. Her
work on establishing AllergoOncology as a distinct field of medical research
began several years ago as part of a project run by the Austrian Science
Fund FWF.
Synergy & Symposium
Last weekend's International AllergoOncology Symposium in Vienna, the second
to be organised by Prof. Jensen-Jarolim, provided a host of international
immunologists and oncologists with the ideal opportunity to discuss
potential synergies in their work. The broad spread of topics covered at the
event included a presentation by Prof. Chris Parish from the John Curtin
School of Medical Research in Australia. He referred to a project during
which resistance to certain chemically induced tumours was achieved in a
mouse model through the administration of white blood cells, which are also
associated with allergies.
"Even if results from animal models cannot be transferred directly to
humans, projects like Prof. Parish's still demonstrate the enormous
therapeutic potential of AllergoOncology," comments Prof. Jensen-Jarolim.
Another project presented by Dr. Manuel Penichet, University of California,
which was carried out in cooperation with teams led by Prof. Hannah Gould,
King's College, London, and Prof. Jensen-Jarolim sought to combat breast
cancer. To do this, the team used a key characteristic of the special
antibodies that are jointly responsible for allergic reactions - IgE
antibodies. These antibodies have a highly reactive and long-lasting effect
against proteins that the body classes as unwanted. This IgE response can
also be accurately directed against protein structures in certain tumour
cells. This characteristic is being used by the team and can even be
enhanced by making specific adjustments to the antibody structure.
However, Prof. Jensen-Jarolim also felt that the potential of
AllergoOncology should be critically scrutinised during the symposium, and a
debate involving a panel of specialists led by the life science journalist
Johanna Award-Geissler provided the ideal solution. Prof. Jensen-Jarolim
explains: "To ensure a field of research survives in the long term, we need
to have people who are willing to be critical and we must put in place
consistent checks. That's why symposium participants were also presented
with data from a Viennese study of over 22,000 cancer patients, which had
been unable to identify any general link between mortality and the
concentration of IgE in serum, except in the case of lymphoma and leukaemia.
The reasons behind this will need to be analysed further."
A review article that was exclusively unveiled in advance at the weekend
showed just how much progress has already been made towards making
AllergoOncology an established field in international medicine and science.
The article is due to be published officially in the international journal
"Allergy" in a few weeks. From the FWF's perspective, both the symposium and
the state-of-the-art article demonstrate that providing early support for
newly emerging interdisciplinary fields of research such as AllergoOncology
really does make sense.
The full programme of the 2nd International AllergoOncology Symposium can be
found at: allergooncology.
Medizinische Universität WienInstitut für Pathophysiologie
Austrian Science Fund FWF
Buy Quinine Without Prescription
Vaccinated Children Vs. Unvaccinated Children -- What Are The Risks?
Alison M. Buttenheim, PhD, MBA, assistant professor at Penn Nursing answers parents' questions about childhood vaccines. Dr. Buttenheim is a public health researcher and social demographer who studies parent behavior and child health.
Q: What are vaccine refusal and delay?
A: Some parents decide not to have their children receive one or more of the vaccines recommended by the Centers for Disease Control, the American Academy of Pediatrics, and the Advisory Committee on Immunization Practices. Other parents choose to delay one or more vaccines. For example, if a child is scheduled to receive three shots at age two months, a parent might delay one of those shots for a few weeks or months. While some parents do this out of concern that too many needles at once may be traumatic for the child, research shows the unpleasant experience for the child is from the overall experience of getting shots, and not the specific number of shots given: Spreading out shots over several visits is actually more upsetting for most children.
Q: Are vaccine refusal and delay legal?
A: Each state has a required immunization schedule for entry into day care and school settings. Each state can also determine the process by which parents may claim an exemption from the schedule for their children. All states have provisions for medical exemptions, for example if the child has a specific immune disorder or an allergy that may make the vaccine unsafe for that child. Many states also have provisions for religious, philosophical, or personal belief exemptions, although the requirements to obtain these exemptions vary considerably from state to state. If a parent obtains an exemption according to state law, then the child may legally enroll in and attend day care or school.
Q: What prompts parents to refuse or delay vaccines for their children?
A: There has been a lot of research recently to try to understand parents' hesitancy around vaccines. One reason that has received a lot of media coverage is the unfounded idea that vaccines cause autism or other developmental or neurological conditions. This idea was first promoted in the late 1990s by a British doctor whose research has since been thoroughly discredited by the scientific community. Several rigorous scientific studies conducted since then have demonstrated that there is no link between vaccines and autism. However, this idea really persists in the minds of parents.
There are two other reasons for refusals or delays that we've heard in our research talking to parents. The first is the concern that the immunization schedule contains too many vaccines, which parents worry may overtax a child's immune system. Fortunately, this is not correct. The immunological challenge presented by the entire vaccination schedule is tiny compared to what a baby might encounter just crawling around on a floor or going on a trip to the supermarket. A baby's immune system is wonderfully designed to respond to these challenges, whether from bacteria on a toy or from the components of a vaccine.
The second reason we hear for opting out of the regular immunization schedule is the assumption that the diseases prevented by vaccines aren't common or dangerous. This tells us how successful the immunization program has been over the past decades: Most of us have never seen a case of measles or pertussis (whooping cough), and don't realize how dangerous these diseases can be, especially for young children. Unfortunately, due in part to parents not vaccinating their children, these disease are resurging in the U.S. We've seen recent outbreaks of measles in California and Minnesota, and California has had more pertussis cases in the past two years than they've seen in the last half-century. Parents should keep in mind that the reason they don't have to worry about these diseases is that the vaccines have been so successful in preventing them. But in order to maintain that level of protection, we need to make sure the vast majority of kids do get vaccinated. Children who can't get vaccinated are relying on the protection provided when everyone else is vaccinated an important concept called "herd immunity."
Q: If vaccinated children are in school with unvaccinated children, what are the possible adverse outcomes?
A: The adverse outcome we all want to avoid is an outbreak of a vaccine-preventable disease. Vaccines are very effective, but they are not 100 percent effective, so there is still a slight chance that a fully vaccinated child could contract a disease like measles if she were exposed to someone else with the disease. This could happen in any setting, but it's a particular concern if there is a large group of unvaccinated children in one classroom or one school. That gives a virus like measles a much better chance of finding a "susceptible" person - someone who can contract the disease and then pass it on to other people. So it's the clustering of unvaccinated kids in spatial or social groups like classrooms that we have to pay particular attention to.
Q: If parents of vaccinated children are concerned about their kids being in school with unvaccinated children, what can those parents do?
A: The easiest and most important thing to do is to make sure your child is up-to-date on all the recommended immunizations. Your pediatrician is very familiar with the vaccination schedule and will work with you to make sure your child is covered. You can learn more about the schedule from the CDC and from other reputable, credible sources like the Vaccine Education Center of the Children's Hospital of Philadelphia. When we talk to parents, they often say they are looking for information about vaccines presented in a straightforward, unbiased way. Both of these sites do a great job of that. They have lots of information about the science of vaccines, including how U.S. vaccine safety systems work, and can address concerns you might have about the vaccine schedule.
Another thing you can do is find out how many unvaccinated children are in your child's class or school. Sometimes this is as easy as asking the teacher or principal. Some states make that information available through their public health departments. What we know from our research in California is that the level of personal belief exemptions in an entering kindergarten class is usually higher in some types of schools than in other types of schools. For example, we know that Waldorf Schools in California have higher rates of exemptions compared to other schools. Parents who are worried about the presence of unvaccinated children in a school could start a conversation with the principal or PTA leadership to see how the issue might be addressed school-wide.
Source: University of Pennsylvania School of Nursing
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Q: What are vaccine refusal and delay?
A: Some parents decide not to have their children receive one or more of the vaccines recommended by the Centers for Disease Control, the American Academy of Pediatrics, and the Advisory Committee on Immunization Practices. Other parents choose to delay one or more vaccines. For example, if a child is scheduled to receive three shots at age two months, a parent might delay one of those shots for a few weeks or months. While some parents do this out of concern that too many needles at once may be traumatic for the child, research shows the unpleasant experience for the child is from the overall experience of getting shots, and not the specific number of shots given: Spreading out shots over several visits is actually more upsetting for most children.
Q: Are vaccine refusal and delay legal?
A: Each state has a required immunization schedule for entry into day care and school settings. Each state can also determine the process by which parents may claim an exemption from the schedule for their children. All states have provisions for medical exemptions, for example if the child has a specific immune disorder or an allergy that may make the vaccine unsafe for that child. Many states also have provisions for religious, philosophical, or personal belief exemptions, although the requirements to obtain these exemptions vary considerably from state to state. If a parent obtains an exemption according to state law, then the child may legally enroll in and attend day care or school.
Q: What prompts parents to refuse or delay vaccines for their children?
A: There has been a lot of research recently to try to understand parents' hesitancy around vaccines. One reason that has received a lot of media coverage is the unfounded idea that vaccines cause autism or other developmental or neurological conditions. This idea was first promoted in the late 1990s by a British doctor whose research has since been thoroughly discredited by the scientific community. Several rigorous scientific studies conducted since then have demonstrated that there is no link between vaccines and autism. However, this idea really persists in the minds of parents.
There are two other reasons for refusals or delays that we've heard in our research talking to parents. The first is the concern that the immunization schedule contains too many vaccines, which parents worry may overtax a child's immune system. Fortunately, this is not correct. The immunological challenge presented by the entire vaccination schedule is tiny compared to what a baby might encounter just crawling around on a floor or going on a trip to the supermarket. A baby's immune system is wonderfully designed to respond to these challenges, whether from bacteria on a toy or from the components of a vaccine.
The second reason we hear for opting out of the regular immunization schedule is the assumption that the diseases prevented by vaccines aren't common or dangerous. This tells us how successful the immunization program has been over the past decades: Most of us have never seen a case of measles or pertussis (whooping cough), and don't realize how dangerous these diseases can be, especially for young children. Unfortunately, due in part to parents not vaccinating their children, these disease are resurging in the U.S. We've seen recent outbreaks of measles in California and Minnesota, and California has had more pertussis cases in the past two years than they've seen in the last half-century. Parents should keep in mind that the reason they don't have to worry about these diseases is that the vaccines have been so successful in preventing them. But in order to maintain that level of protection, we need to make sure the vast majority of kids do get vaccinated. Children who can't get vaccinated are relying on the protection provided when everyone else is vaccinated an important concept called "herd immunity."
Q: If vaccinated children are in school with unvaccinated children, what are the possible adverse outcomes?
A: The adverse outcome we all want to avoid is an outbreak of a vaccine-preventable disease. Vaccines are very effective, but they are not 100 percent effective, so there is still a slight chance that a fully vaccinated child could contract a disease like measles if she were exposed to someone else with the disease. This could happen in any setting, but it's a particular concern if there is a large group of unvaccinated children in one classroom or one school. That gives a virus like measles a much better chance of finding a "susceptible" person - someone who can contract the disease and then pass it on to other people. So it's the clustering of unvaccinated kids in spatial or social groups like classrooms that we have to pay particular attention to.
Q: If parents of vaccinated children are concerned about their kids being in school with unvaccinated children, what can those parents do?
A: The easiest and most important thing to do is to make sure your child is up-to-date on all the recommended immunizations. Your pediatrician is very familiar with the vaccination schedule and will work with you to make sure your child is covered. You can learn more about the schedule from the CDC and from other reputable, credible sources like the Vaccine Education Center of the Children's Hospital of Philadelphia. When we talk to parents, they often say they are looking for information about vaccines presented in a straightforward, unbiased way. Both of these sites do a great job of that. They have lots of information about the science of vaccines, including how U.S. vaccine safety systems work, and can address concerns you might have about the vaccine schedule.
Another thing you can do is find out how many unvaccinated children are in your child's class or school. Sometimes this is as easy as asking the teacher or principal. Some states make that information available through their public health departments. What we know from our research in California is that the level of personal belief exemptions in an entering kindergarten class is usually higher in some types of schools than in other types of schools. For example, we know that Waldorf Schools in California have higher rates of exemptions compared to other schools. Parents who are worried about the presence of unvaccinated children in a school could start a conversation with the principal or PTA leadership to see how the issue might be addressed school-wide.
Source: University of Pennsylvania School of Nursing
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Family Physician Group Offered No-Cost Alternative To Funding From Coca-Cola
Leading Harvard School of Public Health (HSPH) nutrition and health researcher Walter Willett, M.D., Dr. P.H., has written a letter to the President-elect of the American Academy of Family Physicians (AAFP) offering an alternative to the organization's decision, announced in October, to accept a six-figure grant from the Coca-Cola Company to develop web content on beverages and maintaining a healthy lifestyle.
In his November 9, 2009 letter, Willett, chair of the Department of Nutrition at HSPH and a professor at Harvard Medical School, suggests that AAFP provide a link on its website to HSPH's popular Nutrition Source website (hsph.harvard.edu/nutritionsource), which contains multiple pages of easy-to-read content for lay people on how to achieve a healthy diet.
The healthy beverages section of the site, "Choosing Healthy Drinks" (hsph.harvard.edu/nutritionsource/healthy-drinks/), offers advice on how to limit sugary beverage consumption and handy guidelines on the amount of calories and sugar in soda, juice and other popular drinks. It also offers lower-calorie beverage options as a way to decrease the risk of obesity.
"I'd like to offer your organization the opportunity to link to our website's content and return the funding to Coca-Cola," says Willett in the letter. (For a copy of the complete letter click here). AAFP's announcement of its "alliance" with Coca-Cola is available here
Willett agrees that it is important to provide information about how people can incorporate foods and drinks they love into an overall healthy lifestyle. He points out, however, that research overwhelmingly suggests that the consumption of sugar-laden sodas is a leading cause of obesity in the U.S. today and that children are particularly at risk.
Linking to content that has already been created and vetted by Harvard School of Public Health without industry funding would offer AAFP the opportunity to provide this information to those who visit their website almost immediately, Willett says.
Walter Willett is a leading researcher and promoter of healthy eating for healthier lifestyles. He is the author of several best-selling books, including Eat, Drink and Be Healthy; Eat, Drink and Weigh Less; and The Fertility Diet. He was a co-author, along with Kelly D. Brownell, director of the Rudd Center for Food Policy and Obesity at Yale University, and other researchers of the article, "The Public Health and Economic Benefits of Taxing Sugar-Sweetened Beverages," which appeared in the October 15, 2009 edition of The New England Journal of Medicine.
Willett for many years has been a leading proponent of successful efforts to get trans fat out of restaurant foods and to have trans fat content labeled on food packaging.
Source: Todd Datz
Harvard School of Public Health
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In his November 9, 2009 letter, Willett, chair of the Department of Nutrition at HSPH and a professor at Harvard Medical School, suggests that AAFP provide a link on its website to HSPH's popular Nutrition Source website (hsph.harvard.edu/nutritionsource), which contains multiple pages of easy-to-read content for lay people on how to achieve a healthy diet.
The healthy beverages section of the site, "Choosing Healthy Drinks" (hsph.harvard.edu/nutritionsource/healthy-drinks/), offers advice on how to limit sugary beverage consumption and handy guidelines on the amount of calories and sugar in soda, juice and other popular drinks. It also offers lower-calorie beverage options as a way to decrease the risk of obesity.
"I'd like to offer your organization the opportunity to link to our website's content and return the funding to Coca-Cola," says Willett in the letter. (For a copy of the complete letter click here). AAFP's announcement of its "alliance" with Coca-Cola is available here
Willett agrees that it is important to provide information about how people can incorporate foods and drinks they love into an overall healthy lifestyle. He points out, however, that research overwhelmingly suggests that the consumption of sugar-laden sodas is a leading cause of obesity in the U.S. today and that children are particularly at risk.
Linking to content that has already been created and vetted by Harvard School of Public Health without industry funding would offer AAFP the opportunity to provide this information to those who visit their website almost immediately, Willett says.
Walter Willett is a leading researcher and promoter of healthy eating for healthier lifestyles. He is the author of several best-selling books, including Eat, Drink and Be Healthy; Eat, Drink and Weigh Less; and The Fertility Diet. He was a co-author, along with Kelly D. Brownell, director of the Rudd Center for Food Policy and Obesity at Yale University, and other researchers of the article, "The Public Health and Economic Benefits of Taxing Sugar-Sweetened Beverages," which appeared in the October 15, 2009 edition of The New England Journal of Medicine.
Willett for many years has been a leading proponent of successful efforts to get trans fat out of restaurant foods and to have trans fat content labeled on food packaging.
Source: Todd Datz
Harvard School of Public Health
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AMGA Lauds Senator Stabenow For Her Efforts To Ensure EMR Incentives For Medical Groups
The American Medical Group Association (AMGA) applauds Senator Debbie Stabenow (D-MI) for her efforts to assure fairness in payment of electronic medical record (EMR) incentive payments under the American Recovery and Reinvestment Act of 2009 (ARRA). Popularly known as the "stimulus bill," ARRA included incentive payments designed to stimulate widespread adoption of EMRs and to reward medical groups and other providers that were early adopters of this technology. Recently, however, the Center for Medicare and Medicaid Services (CMS) issued a proposed regulation that would have denied some of the nation's finest health care providers from receiving significant EMR incentive payments.
Senator Stabenow, along with 18 of her Senate colleagues, sent a letter to Health and Human Services (HHS) Secretary Kathleen Sebelius expressing their deep concern and disappointment over CMS's proposed regulation. Senator Stabenow wrote that the proposed rule was narrowly drawn and contrary to clear congressional intent.
The letter went on to say that excluding provider-based entities "would penalize some of the nation's pioneers of EMR use," including Henry Ford Health System, the University of Michigan Medical School and Faculty Practice, the Billings Clinic, the Cleveland Clinic, Innovis Health, and Geisinger Health System, among many others. Senator Stabenow asked Secretary Sebelius to instruct CMS to follow clear congressional intent in the final version of rule making to ensure that provider-based entity physicians were eligible for EMR incentive payments.
Donald W. Fisher, Ph.D., AMGA President and CEO, commented, "AMGA commends Senator Stabenow for her leadership on this issue and her efforts to ensure that some of the country's finest healthcare providers qualify to receive EMR incentive payments as the Congress originally intended. Many of the medical groups that will benefit from Senator Stabenow's efforts have been champions in the adoption of EMRs and should be recognized and rewarded for their efforts."
The American Medical Group Association represents medical groups, including some of the nation's largest, most prestigious medical practices, independent practice associations, and integrated healthcare delivery systems. AMGA's mission is to improve health care for patients by supporting multispecialty medical groups and other organized systems of care. The members of AMGA deliver health care to approximately 105 million patients in 49 states, nearly 1 in 3 Americans. Headquartered in Alexandria, Virginia, AMGA is the strategic partner for medical groups, providing a comprehensive package of benefits, including political advocacy, educational and networking programs and publications, benchmarking data services, and financial and operations assistance.
Source: American Medical Group Association (AMGA)
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Senator Stabenow, along with 18 of her Senate colleagues, sent a letter to Health and Human Services (HHS) Secretary Kathleen Sebelius expressing their deep concern and disappointment over CMS's proposed regulation. Senator Stabenow wrote that the proposed rule was narrowly drawn and contrary to clear congressional intent.
The letter went on to say that excluding provider-based entities "would penalize some of the nation's pioneers of EMR use," including Henry Ford Health System, the University of Michigan Medical School and Faculty Practice, the Billings Clinic, the Cleveland Clinic, Innovis Health, and Geisinger Health System, among many others. Senator Stabenow asked Secretary Sebelius to instruct CMS to follow clear congressional intent in the final version of rule making to ensure that provider-based entity physicians were eligible for EMR incentive payments.
Donald W. Fisher, Ph.D., AMGA President and CEO, commented, "AMGA commends Senator Stabenow for her leadership on this issue and her efforts to ensure that some of the country's finest healthcare providers qualify to receive EMR incentive payments as the Congress originally intended. Many of the medical groups that will benefit from Senator Stabenow's efforts have been champions in the adoption of EMRs and should be recognized and rewarded for their efforts."
The American Medical Group Association represents medical groups, including some of the nation's largest, most prestigious medical practices, independent practice associations, and integrated healthcare delivery systems. AMGA's mission is to improve health care for patients by supporting multispecialty medical groups and other organized systems of care. The members of AMGA deliver health care to approximately 105 million patients in 49 states, nearly 1 in 3 Americans. Headquartered in Alexandria, Virginia, AMGA is the strategic partner for medical groups, providing a comprehensive package of benefits, including political advocacy, educational and networking programs and publications, benchmarking data services, and financial and operations assistance.
Source: American Medical Group Association (AMGA)
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Pine Tree Bark Reduces Side Effects In Hypertensive Patients
A study published in the October journal of Clinical and Applied Thrombosis/Hemostasis shows Pycnogenol® (pic-noj-en-all), an antioxidant plant extract from the bark of the French maritime pine tree reduced edema, a typical side-effect of antihypertensive medications, by 36 percent in patients taking these medications.
According to Dr. Gianni Belcaro, lead researcher of the study, more than 35 percent of patients taking antihypertensive medications are believed to suffer from edema as a side-effect. This happens because the antihypertensive medications cause blood vessels to dilate, which allows easier blood flow and thus lowers blood pressure. However, as a side-effect this causes blood to pool in the vessels of the lower legs. In result they stretch and liquid seeps into tissue causing swelling (edema). Hypertension is a serious risk factor for developing severe cardiovascular incidents some time in the future and thus the necessity for treatment justifies the development of edema as a side-effect.
Antihypertensive medications reduce pressure by inhibiting constriction of blood vessels. "The larger the blood vessel diameter, the easier blood will flow with less pressure," said Dr. Belcaro. "In order to avoid blood pooling in the lower legs and feet (edema), blood vessel diameters must adjust when a person changes positions from laying down to standing up. Results of this study show Pycnogenol to improve blood circulation, avoiding blood pools and reducing edema."
The study sampled 53 hypertensive patients at the G D'annunzio University in Italy. All patients suffered from edema of their ankles and feet as a result of antihypertensive medications and were taking medications at the same dosage for at least four months. Twenty-three patients were being treated with ACE inhibitors (brand names Mavik®, Altace®) and 30 patients were being treated with nifedipine (calcium channel blockers) (brand names Adalat®, Procardia®).
The eight week study sampled 27 patients with 150 mg Pycnogenol treatment per day versus an equivalent dosage of placebo for the remaining 26 patients.
Blood vessels causing edema of the lower legs were measured using a strain gauge plethysmography (a general instrument for determining and registering variations in the size of an organ or limb). Patients were first measured in supine position then while standing up.
After an eight week Pycnogenol treatment, patients treated with ACE inhibitors experienced a 35 percent decrease of ankle swelling while patients being treated with nifedipine experienced a 36 percent decrease of ankle swelling. According to Dr. Belcaro, Pycnogenol helps defy a major side-effect of antihypertensive medication. Furthermore, Pycnogenol has a blood pressure-lowering effect itself and thus helps to achieve a healthy cardiovascular system.
Pycnogenol was chosen for the study because it has demonstrated its effectiveness with conditions such as edema, DVT and blood circulation improvement in many clinical trials. In 2005, a study published in Clinical and Applied Thrombosis/Hemostasis showed Pycnogenol to be effective in reducing edema during long airplane flights lasting 7-12 hours. In 2004, a study published in Life Sciences revealed patients who took prescribed high blood pressure medication were able to cut the dosage in half when they supplemented with Pycnogenol. More than 35 years of research exhibiting Pycnogenol's effectiveness for improved blood circulation and cardiovascular health can be found at www.pycnogenol.
About Pycnogenol®
Pycnogenol is a natural plant extract originating from the bark of the Maritime pine that grows along the coast of southwest France and is found to contain a unique combination of procyanidins, bioflavonoids and organic acids, which offer extensive natural health benefits. The extract has been widely studied for the past 35 years and has more than 220 published studies and review articles ensuring safety and efficacy as an ingredient. Today, Pycnogenol is available in more than 600 dietary supplements, multi-vitamins and health products worldwide. For more information or a copy of this study, visit www.pycnogenol.
Natural Health Science Inc., (NHS) based in Hoboken, New Jersey, is the North American distributor for Pycnogenol® (pic-noj-en-all) brand French maritime pine bark extract on behalf of Horphag Research. Pycnogenol® is a registered trademark of Horphag Research Ltd., Guernsey, and its applications are protected by U.S. patents #5,720,956 / #6,372,266 and other international patents. NHS has the exclusive rights to market and sell Pycnogenol® in North America and benefits from more than 35 years of scientific research assuring the safety and efficacy of Pycnogenol® as a dietary supplement. For more information about Pycnogenol® visit our web site at www.pycnogenol.
Contact: Melanie Nimrodi
MWW Group
View drug information on Mavik.
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According to Dr. Gianni Belcaro, lead researcher of the study, more than 35 percent of patients taking antihypertensive medications are believed to suffer from edema as a side-effect. This happens because the antihypertensive medications cause blood vessels to dilate, which allows easier blood flow and thus lowers blood pressure. However, as a side-effect this causes blood to pool in the vessels of the lower legs. In result they stretch and liquid seeps into tissue causing swelling (edema). Hypertension is a serious risk factor for developing severe cardiovascular incidents some time in the future and thus the necessity for treatment justifies the development of edema as a side-effect.
Antihypertensive medications reduce pressure by inhibiting constriction of blood vessels. "The larger the blood vessel diameter, the easier blood will flow with less pressure," said Dr. Belcaro. "In order to avoid blood pooling in the lower legs and feet (edema), blood vessel diameters must adjust when a person changes positions from laying down to standing up. Results of this study show Pycnogenol to improve blood circulation, avoiding blood pools and reducing edema."
The study sampled 53 hypertensive patients at the G D'annunzio University in Italy. All patients suffered from edema of their ankles and feet as a result of antihypertensive medications and were taking medications at the same dosage for at least four months. Twenty-three patients were being treated with ACE inhibitors (brand names Mavik®, Altace®) and 30 patients were being treated with nifedipine (calcium channel blockers) (brand names Adalat®, Procardia®).
The eight week study sampled 27 patients with 150 mg Pycnogenol treatment per day versus an equivalent dosage of placebo for the remaining 26 patients.
Blood vessels causing edema of the lower legs were measured using a strain gauge plethysmography (a general instrument for determining and registering variations in the size of an organ or limb). Patients were first measured in supine position then while standing up.
After an eight week Pycnogenol treatment, patients treated with ACE inhibitors experienced a 35 percent decrease of ankle swelling while patients being treated with nifedipine experienced a 36 percent decrease of ankle swelling. According to Dr. Belcaro, Pycnogenol helps defy a major side-effect of antihypertensive medication. Furthermore, Pycnogenol has a blood pressure-lowering effect itself and thus helps to achieve a healthy cardiovascular system.
Pycnogenol was chosen for the study because it has demonstrated its effectiveness with conditions such as edema, DVT and blood circulation improvement in many clinical trials. In 2005, a study published in Clinical and Applied Thrombosis/Hemostasis showed Pycnogenol to be effective in reducing edema during long airplane flights lasting 7-12 hours. In 2004, a study published in Life Sciences revealed patients who took prescribed high blood pressure medication were able to cut the dosage in half when they supplemented with Pycnogenol. More than 35 years of research exhibiting Pycnogenol's effectiveness for improved blood circulation and cardiovascular health can be found at www.pycnogenol.
About Pycnogenol®
Pycnogenol is a natural plant extract originating from the bark of the Maritime pine that grows along the coast of southwest France and is found to contain a unique combination of procyanidins, bioflavonoids and organic acids, which offer extensive natural health benefits. The extract has been widely studied for the past 35 years and has more than 220 published studies and review articles ensuring safety and efficacy as an ingredient. Today, Pycnogenol is available in more than 600 dietary supplements, multi-vitamins and health products worldwide. For more information or a copy of this study, visit www.pycnogenol.
Natural Health Science Inc., (NHS) based in Hoboken, New Jersey, is the North American distributor for Pycnogenol® (pic-noj-en-all) brand French maritime pine bark extract on behalf of Horphag Research. Pycnogenol® is a registered trademark of Horphag Research Ltd., Guernsey, and its applications are protected by U.S. patents #5,720,956 / #6,372,266 and other international patents. NHS has the exclusive rights to market and sell Pycnogenol® in North America and benefits from more than 35 years of scientific research assuring the safety and efficacy of Pycnogenol® as a dietary supplement. For more information about Pycnogenol® visit our web site at www.pycnogenol.
Contact: Melanie Nimrodi
MWW Group
View drug information on Mavik.
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New Implantable Device Could Track Tumor's Growth
Surgical removal of a tissue sample is now the standard for diagnosing cancer. Such procedures, known as biopsies, are accurate but only offer a snapshot of the tumor at a single moment in time.
Monitoring a tumor for weeks or months after the biopsy, tracking its growth and how it responds to treatment, would be much more valuable, says Michael Cima, MIT professor of materials science and engineering, who has developed the first implantable device that can do just that.
Cima and his colleagues recently reported that their device successfully tracked a tumor marker in mice for one month. The work is described in a paper published online in the journal Biosensors & Bioelectronics in April.
Such implants could one day provide up-to-the-minute information about what a tumor is doing -- whether it is growing or shrinking, how it's responding to treatment, and whether it has metastasized or is about to do so.
"What this does is basically take the lab and put it in the patient," said Cima, who is also an investigator at the David H. Koch Institute for Integrative Cancer Research at MIT.
The devices, which could be implanted at the time of biopsy, could also be tailored to monitor chemotherapy agents, allowing doctors to determine whether cancer drugs are reaching the tumors. They can also be designed to measure pH (acidity) or oxygen levels, which reveal tumor metabolism and how it is responding to therapy.
With current tools for detecting whether a tumor has spread, such as biopsy, by the time you have test results it's too late to prevent metastasis, said Cima.
"This is one of the tools we're going to need if we're going to turn cancer from a death sentence to a manageable disease," he said.
In the Biosensors & Bioelectronics study, human tumors were transplanted into the mice, and the researchers then used the implants to track levels of human chorionic gonadotropin, a hormone produced by human tumor cells.
The cylindrical, 5-millimeter implant contains magnetic nanoparticles coated with antibodies specific to the target molecules. Target molecules enter the implant through a semipermeable membrane, bind to the particles and cause them to clump together. That clumping can be detected by MRI (magnetic resonance imaging).
The device is made of a polymer called polyethylene, which is commonly used in orthopedic implants. The semipermeable membrane, which allows target molecules to enter but keeps the magnetic nanoparticles trapped inside, is made of polycarbonate, a compound used in many plastics.
Cima said he believes an implant to test for pH levels could be commercially available in a few years, followed by devices to test for complex chemicals such as hormones and drugs.
Lead author of the paper is Karen Daniel, a recent MIT PhD recipient. Other authors are recent PhD recipients Grace Kim and Christophoros Vassiliou; Marilyn Galindo, research affiliate in the Harvard-MIT Division of Health Sciences and Technology; Alexander Guimares, a radiologist at Massachusetts General Hospital; Ralph Weissleder, a professor of radiology at Harvard Medical School; Al Charest, visiting assistant professor of biology at MIT; and Institute Professor Robert Langer.
The research was funded by the National Cancer Institute Centers of Cancer Nanotechnology Excellence and the National Science Foundation.
Source:
Elizabeth Thomson
Massachusetts Institute of Technology
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Monitoring a tumor for weeks or months after the biopsy, tracking its growth and how it responds to treatment, would be much more valuable, says Michael Cima, MIT professor of materials science and engineering, who has developed the first implantable device that can do just that.
Cima and his colleagues recently reported that their device successfully tracked a tumor marker in mice for one month. The work is described in a paper published online in the journal Biosensors & Bioelectronics in April.
Such implants could one day provide up-to-the-minute information about what a tumor is doing -- whether it is growing or shrinking, how it's responding to treatment, and whether it has metastasized or is about to do so.
"What this does is basically take the lab and put it in the patient," said Cima, who is also an investigator at the David H. Koch Institute for Integrative Cancer Research at MIT.
The devices, which could be implanted at the time of biopsy, could also be tailored to monitor chemotherapy agents, allowing doctors to determine whether cancer drugs are reaching the tumors. They can also be designed to measure pH (acidity) or oxygen levels, which reveal tumor metabolism and how it is responding to therapy.
With current tools for detecting whether a tumor has spread, such as biopsy, by the time you have test results it's too late to prevent metastasis, said Cima.
"This is one of the tools we're going to need if we're going to turn cancer from a death sentence to a manageable disease," he said.
In the Biosensors & Bioelectronics study, human tumors were transplanted into the mice, and the researchers then used the implants to track levels of human chorionic gonadotropin, a hormone produced by human tumor cells.
The cylindrical, 5-millimeter implant contains magnetic nanoparticles coated with antibodies specific to the target molecules. Target molecules enter the implant through a semipermeable membrane, bind to the particles and cause them to clump together. That clumping can be detected by MRI (magnetic resonance imaging).
The device is made of a polymer called polyethylene, which is commonly used in orthopedic implants. The semipermeable membrane, which allows target molecules to enter but keeps the magnetic nanoparticles trapped inside, is made of polycarbonate, a compound used in many plastics.
Cima said he believes an implant to test for pH levels could be commercially available in a few years, followed by devices to test for complex chemicals such as hormones and drugs.
Lead author of the paper is Karen Daniel, a recent MIT PhD recipient. Other authors are recent PhD recipients Grace Kim and Christophoros Vassiliou; Marilyn Galindo, research affiliate in the Harvard-MIT Division of Health Sciences and Technology; Alexander Guimares, a radiologist at Massachusetts General Hospital; Ralph Weissleder, a professor of radiology at Harvard Medical School; Al Charest, visiting assistant professor of biology at MIT; and Institute Professor Robert Langer.
The research was funded by the National Cancer Institute Centers of Cancer Nanotechnology Excellence and the National Science Foundation.
Source:
Elizabeth Thomson
Massachusetts Institute of Technology
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Nautilus Neurosciences And Tribute Pharmaceuticals Announce Exclusive Canadian License For CAMBIA™ (diclofenac Potassium For Oral Solution)
Nautilus Neurosciences, Inc., a neurology-focused specialty pharmaceutical company, and Tribute Pharmaceuticals, a privately-held Canadian specialty pharmaceutical company, announced today their exclusive license agreement for the commercialization of CAMBIA™ (diclofenac potassium for oral solution) in Canada. CAMBIA™ is approved in the United States for the acute treatment of migraine with or without aura and was launched in the United States in June 2010.
"Canada is an important pharmaceutical market and opportunity for CAMBIA," said James Fares, Chairman and CEO, of Nautilus Neurosciences. "The management team at Tribute Pharmaceuticals has a wealth of experience in developing, launching and successfully commercializing new products in Canada. This partnership along with recent developments in the US has significantly enhanced our ability to market CAMBIA™ to the broader North American market and reach more people suffering from acute migraine headaches. We look forward to completing the expansion of our efforts through the addition of a partner for the family practice market in the United States in 2011."
Rob Harris, President & CEO of Tribute Pharmaceuticals points out that, "According to IMS, the prescription drug market in Canada for treating migraine headaches is valued at approximately one hundred and fifty million dollars." Many Canadians who suffer from migraines are dissatisfied with their current medication and hope for a better treatment. "Tribute Pharmaceuticals is very excited about the potential for CAMBIA™ in Canada and we look forward to building a strong partnership with Nautilus Neurosciences."
According to a survey published in the Journal of the American Board of Family Medicine, many people still hope to find a better treatment for their migraines, with more than a quarter dissatisfied with their treatment and fewer than a fifth of people who suffer migraines describing themselves as "very satisfied" with their treatment.
A novel, water-soluble, buffered diclofenac potassium powder, CAMBIA™ is the only prescription non - steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine. Engineered using Dynamic Buffering Technology™ (DBT), a patented absorption-enhancing technology developed by APR Applied Pharma Research S.A., CAMBIA™ is specifically designed for fast, effective relief from the symptoms of migraine. CAMBIA™ enters the bloodstream quickly and readily achieves peak plasma concentrations, providing pain relief in fifteen minutes for some patients.
Unites States Indication
CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older.
CAMBIA is not indicated for prophylactic therapy or for cluster headache.
Important Safety Information (United States)
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS NSAIDs, including CAMBIA, may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use or in patients with CV disease or risk factors for CV disease. CAMBIA is contraindicated for peri-operative pain in coronary artery bypass graft surgery. NSAIDs increase the risk of gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk.
Use the lowest effective dose for the shortest possible duration. Long-term administration of NSAIDs can result in serious and potentially fatal events, including CV thrombotic events or GI reactions.
CAMBIA is contraindicated in patients with hypersensitivity to diclofenac or other NSAIDs, and in patients with preexisting asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions have been reported in such patients. Anaphylactic reactions may also occur in patients with the aspirin triad or in patients without prior exposure to CAMBIA. CAMBIA is contraindicated in patients with the aspirin triad. Discontinue immediately if an anaphylactic reaction occurs.
Renal papillary necrosis and other renal injury may occur with long-term use of NSAIDs. Use CAMBIA with caution in patients at risk, including the elderly, those taking diuretics or ACE inhibitors, those with renal impairment, heart failure, or liver impairment. CAMBIA is not recommended in patients with advanced renal disease.
Use caution when prescribing CAMBIA with drugs known to be hepatotoxic (eg, acetaminophen, certain antibiotics, antiepileptics). Warn patients to avoid acetaminophen containing products while taking CAMBIA. The liver metabolizes almost 100% of diclofenac, and there is insufficient information to support dosing recommendations in patients with hepatic insufficiency. Hepatic effects range from transaminase elevations to liver failure. Discontinue CAMBIA immediately if abnormal liver tests persist or worsen.
NSAIDs can lead to new onset or worsening of preexisting hypertension. Monitor blood pressure closely during therapy. Patients taking ACE inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs. Note that fluid retention and edema have been observed in some patients taking NSAIDs. Use CAMBIA with caution in patients with fluid retention or heart failure.
Using CAMBIA with other NSAIDs (eg, aspirin) or with anticoagulants (eg, warfarin) is not advised due to increased risk of serious adverse events, such as GI bleeding. Use with caution in patients with a history of ulcers or GI bleeding. Anemia may occur in patients on NSAIDs. In patients on long-term therapy, check hemoglobin or hematocrit upon any sign or symptom of anemia or blood loss.
NSAIDs, including CAMBIA, can cause serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. Discontinue use immediately if rash or other signs of local skin reaction occur.
CAMBIA can harm fetuses. Starting at 30 weeks' gestation, pregnant women should avoid CAMBIA and other NSAIDs as premature closure of the ductus arteriosus in the fetus may occur. Use with caution in nursing mothers as it is not known if diclofenac is excreted in human milk.
The most common adverse events in clinical trials with CAMBIA were nausea and dizziness.
Source: Nautilus Neurosciences, Inc
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"Canada is an important pharmaceutical market and opportunity for CAMBIA," said James Fares, Chairman and CEO, of Nautilus Neurosciences. "The management team at Tribute Pharmaceuticals has a wealth of experience in developing, launching and successfully commercializing new products in Canada. This partnership along with recent developments in the US has significantly enhanced our ability to market CAMBIA™ to the broader North American market and reach more people suffering from acute migraine headaches. We look forward to completing the expansion of our efforts through the addition of a partner for the family practice market in the United States in 2011."
Rob Harris, President & CEO of Tribute Pharmaceuticals points out that, "According to IMS, the prescription drug market in Canada for treating migraine headaches is valued at approximately one hundred and fifty million dollars." Many Canadians who suffer from migraines are dissatisfied with their current medication and hope for a better treatment. "Tribute Pharmaceuticals is very excited about the potential for CAMBIA™ in Canada and we look forward to building a strong partnership with Nautilus Neurosciences."
According to a survey published in the Journal of the American Board of Family Medicine, many people still hope to find a better treatment for their migraines, with more than a quarter dissatisfied with their treatment and fewer than a fifth of people who suffer migraines describing themselves as "very satisfied" with their treatment.
A novel, water-soluble, buffered diclofenac potassium powder, CAMBIA™ is the only prescription non - steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine. Engineered using Dynamic Buffering Technology™ (DBT), a patented absorption-enhancing technology developed by APR Applied Pharma Research S.A., CAMBIA™ is specifically designed for fast, effective relief from the symptoms of migraine. CAMBIA™ enters the bloodstream quickly and readily achieves peak plasma concentrations, providing pain relief in fifteen minutes for some patients.
Unites States Indication
CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older.
CAMBIA is not indicated for prophylactic therapy or for cluster headache.
Important Safety Information (United States)
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS NSAIDs, including CAMBIA, may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use or in patients with CV disease or risk factors for CV disease. CAMBIA is contraindicated for peri-operative pain in coronary artery bypass graft surgery. NSAIDs increase the risk of gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk.
Use the lowest effective dose for the shortest possible duration. Long-term administration of NSAIDs can result in serious and potentially fatal events, including CV thrombotic events or GI reactions.
CAMBIA is contraindicated in patients with hypersensitivity to diclofenac or other NSAIDs, and in patients with preexisting asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions have been reported in such patients. Anaphylactic reactions may also occur in patients with the aspirin triad or in patients without prior exposure to CAMBIA. CAMBIA is contraindicated in patients with the aspirin triad. Discontinue immediately if an anaphylactic reaction occurs.
Renal papillary necrosis and other renal injury may occur with long-term use of NSAIDs. Use CAMBIA with caution in patients at risk, including the elderly, those taking diuretics or ACE inhibitors, those with renal impairment, heart failure, or liver impairment. CAMBIA is not recommended in patients with advanced renal disease.
Use caution when prescribing CAMBIA with drugs known to be hepatotoxic (eg, acetaminophen, certain antibiotics, antiepileptics). Warn patients to avoid acetaminophen containing products while taking CAMBIA. The liver metabolizes almost 100% of diclofenac, and there is insufficient information to support dosing recommendations in patients with hepatic insufficiency. Hepatic effects range from transaminase elevations to liver failure. Discontinue CAMBIA immediately if abnormal liver tests persist or worsen.
NSAIDs can lead to new onset or worsening of preexisting hypertension. Monitor blood pressure closely during therapy. Patients taking ACE inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs. Note that fluid retention and edema have been observed in some patients taking NSAIDs. Use CAMBIA with caution in patients with fluid retention or heart failure.
Using CAMBIA with other NSAIDs (eg, aspirin) or with anticoagulants (eg, warfarin) is not advised due to increased risk of serious adverse events, such as GI bleeding. Use with caution in patients with a history of ulcers or GI bleeding. Anemia may occur in patients on NSAIDs. In patients on long-term therapy, check hemoglobin or hematocrit upon any sign or symptom of anemia or blood loss.
NSAIDs, including CAMBIA, can cause serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. Discontinue use immediately if rash or other signs of local skin reaction occur.
CAMBIA can harm fetuses. Starting at 30 weeks' gestation, pregnant women should avoid CAMBIA and other NSAIDs as premature closure of the ductus arteriosus in the fetus may occur. Use with caution in nursing mothers as it is not known if diclofenac is excreted in human milk.
The most common adverse events in clinical trials with CAMBIA were nausea and dizziness.
Source: Nautilus Neurosciences, Inc
View drug information on Cambia; Warfarin Sodium tablets.
Buy Stromectol Without Prescription
Signal Genetics Announces Launch Of Revolutionary Molecular Test For Multiple Myeloma Patients
Signal Genetics, the parent company of Myeloma Health, a privately held predictive genetic testing company focused on oncology, today announced the launch of their revolutionary molecular test for individuals diagnosed with multiple myeloma, MyPRS™. The official launch of MyPRS™ will take place at the 52nd Annual American Society of Hematology (ASH) Meeting and Exposition in Orlando, Florida on December 4th. As part of the product launch the Company will begin executing a commercialization plan that includes offering the test to physicians through a direct salesforce and via select specialty commercial laboratories. The test will be performed at the Company's CLIA certified laboratory.
Myeloma Prognostic Risk Signature™ (MyPRS™) offers the most detailed expression profiling information for Multiple Myeloma patients available on the market. MyPRS™ analyzes and applies a proprietary algorithm to a defined number of relevant genes to determine the gene expression profile (GEP) associated with the patient's condition. The gene expression profiling behind MyPRS™ allows physicians to gain a predictive view of their patient's prognosis, enabling truly personalized treatment options.
"At Signal Genetics our goal is to make truly personalized treatments a reality, and with the launch of MyPRS™, that goal is brought one step closer to being achieved," said CEO, Joe Hernandez. "MyPRS™ is backed by robust science, the technology has been published in over 70 peer reviewed scientific journals, it uses the world's largest outcomes database to correlate patient disease profiles, and provides additional insights to a patient's specific Gene Expression Profile (GEP) beyond today's current FISH and Cytogenetic based assays."
According to Dr. Kenneth Anderson, Chief of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute, Harvard Medical School and member of Signal Genetics' Scientific Advisory Board, "Gene expression profiling has great potential to offer personalized medicine to patients with myeloma."
Source: Signal Genetics
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Myeloma Prognostic Risk Signature™ (MyPRS™) offers the most detailed expression profiling information for Multiple Myeloma patients available on the market. MyPRS™ analyzes and applies a proprietary algorithm to a defined number of relevant genes to determine the gene expression profile (GEP) associated with the patient's condition. The gene expression profiling behind MyPRS™ allows physicians to gain a predictive view of their patient's prognosis, enabling truly personalized treatment options.
"At Signal Genetics our goal is to make truly personalized treatments a reality, and with the launch of MyPRS™, that goal is brought one step closer to being achieved," said CEO, Joe Hernandez. "MyPRS™ is backed by robust science, the technology has been published in over 70 peer reviewed scientific journals, it uses the world's largest outcomes database to correlate patient disease profiles, and provides additional insights to a patient's specific Gene Expression Profile (GEP) beyond today's current FISH and Cytogenetic based assays."
According to Dr. Kenneth Anderson, Chief of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute, Harvard Medical School and member of Signal Genetics' Scientific Advisory Board, "Gene expression profiling has great potential to offer personalized medicine to patients with myeloma."
Source: Signal Genetics
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Free Service Improves GP Access For Deaf Patients, UK
Deaf patients are now able to enjoy better access to GP services thanks to a new partnership between SignHealth - the healthcare charity for Deaf people - and EMIS, the UK's leading provider of GP systems.
The charity's web-based SignTranslate communication program for Deaf people is being made available free of charge to all GP practices in England until 31st July 2009 - underpinned by one year of funding from SignHealth.
For the 5,000 plus surgeries that use the EMIS clinical system, access to SignTranslate will be instant via an embedded link from the EMIS desktop. Non-EMIS practices can access the service by logging on to the SignTranslate website.
.
The program translates over 300 medical questions into British Sign Language (BSL) using short video clips - offering a quick and easy way to improve communication during a GP consultation.
In addition to the translation of the pre-defined questions, the SignTranslate program also enables on-line access to "live" fully qualified BSL interpreters for a small fee. Via a web-cam, a Deaf patient can enjoy a fully interactive discussion with their doctor through the interpreter.*
Steve Powell, Chief Executive of SignHealth, said: "With only about 400 fully qualified interpreters in England to support approximately 70,000 Deaf people who use BSL as their first language, it can be a real challenge arranging a supported doctor's appointment. By funding SignTranslate to be free for every GP in England, we hope that every Deaf person will be able to see their doctor when necessary."
As well as BSL, SignTranslate gives spoken and written translations into 12 foreign languages. It is the only internet based translation tool of its kind in the UK.
*Note: the 'live' online interpreter service is not part of the one-year free offer and is charged at a rate of ВЈ2.50 a minute.
1. To see a demonstration of SignTranslate visit signhealth/login2.asp
If you would like a DVD copy of SignTranslate in action, please contact one of the above.
2. Please note; it is the convention adopted within the Deaf community of using an upper case D when referring to those who identify themselves culturally and linguistically as members of the Deaf community. Typically they are pre lingually deaf and use British Sign Language (BSL) as their first language
3. SignHealth is the only UK charity focussed on improving the mental and physical health of Deaf people. SignHealth already has a track record of delivering change in care and treatment and in providing supported living, advocacy, outreach, counselling and health promotion, all within a BSL supported environment. Projects are located in London, Manchester, Leeds and Birmingham. SignHealth also works with service providers to improve health services for Deaf people and with other health and Deaf charities to provide health information and education. Pending a funding application to the Big Lottery, SignHealth, in partnership with Deaf organisations across the UK, will launch the largest survey of the health of Deaf people in the UK later this year. signhealth
4. SignTranslate is wholly owned by SignHealth, the healthcare charity for Deaf people. SignTranslate provides unique web-based translation programmes for use with Deaf and hard of hearing people and those with limited English. SignTranslate also offers on-line interpreting for Deaf people via a simple web-cam. All interpreters are fully qualified and registered and follow a strict code of practice. Unlike other on-line interpreting service providers, SignTranslate does not require the purchase of specialist software. Just a PC with a broadband connection and a simple web-cam is all that's needed. The product is already being used in a small number of GP practices and PCTs in England. SignTranslate is working to ensure that all paying customers also receive the benefit of the one-year free trial.
5. EMIS is the UK's leading supplier of IT systems to GPs, providing the software that holds the medical records for 39 million NHS patients
nationwide. Around 56 per cent of GPs in the UK currently use EMIS software. emis-online. A link to the SignTranslate website has been embedded in the EMIS LV system and SignTranslate will soon be available for EMIS PCS systems.
SignTranslate
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The charity's web-based SignTranslate communication program for Deaf people is being made available free of charge to all GP practices in England until 31st July 2009 - underpinned by one year of funding from SignHealth.
For the 5,000 plus surgeries that use the EMIS clinical system, access to SignTranslate will be instant via an embedded link from the EMIS desktop. Non-EMIS practices can access the service by logging on to the SignTranslate website.
.
The program translates over 300 medical questions into British Sign Language (BSL) using short video clips - offering a quick and easy way to improve communication during a GP consultation.
In addition to the translation of the pre-defined questions, the SignTranslate program also enables on-line access to "live" fully qualified BSL interpreters for a small fee. Via a web-cam, a Deaf patient can enjoy a fully interactive discussion with their doctor through the interpreter.*
Steve Powell, Chief Executive of SignHealth, said: "With only about 400 fully qualified interpreters in England to support approximately 70,000 Deaf people who use BSL as their first language, it can be a real challenge arranging a supported doctor's appointment. By funding SignTranslate to be free for every GP in England, we hope that every Deaf person will be able to see their doctor when necessary."
As well as BSL, SignTranslate gives spoken and written translations into 12 foreign languages. It is the only internet based translation tool of its kind in the UK.
*Note: the 'live' online interpreter service is not part of the one-year free offer and is charged at a rate of ВЈ2.50 a minute.
1. To see a demonstration of SignTranslate visit signhealth/login2.asp
If you would like a DVD copy of SignTranslate in action, please contact one of the above.
2. Please note; it is the convention adopted within the Deaf community of using an upper case D when referring to those who identify themselves culturally and linguistically as members of the Deaf community. Typically they are pre lingually deaf and use British Sign Language (BSL) as their first language
3. SignHealth is the only UK charity focussed on improving the mental and physical health of Deaf people. SignHealth already has a track record of delivering change in care and treatment and in providing supported living, advocacy, outreach, counselling and health promotion, all within a BSL supported environment. Projects are located in London, Manchester, Leeds and Birmingham. SignHealth also works with service providers to improve health services for Deaf people and with other health and Deaf charities to provide health information and education. Pending a funding application to the Big Lottery, SignHealth, in partnership with Deaf organisations across the UK, will launch the largest survey of the health of Deaf people in the UK later this year. signhealth
4. SignTranslate is wholly owned by SignHealth, the healthcare charity for Deaf people. SignTranslate provides unique web-based translation programmes for use with Deaf and hard of hearing people and those with limited English. SignTranslate also offers on-line interpreting for Deaf people via a simple web-cam. All interpreters are fully qualified and registered and follow a strict code of practice. Unlike other on-line interpreting service providers, SignTranslate does not require the purchase of specialist software. Just a PC with a broadband connection and a simple web-cam is all that's needed. The product is already being used in a small number of GP practices and PCTs in England. SignTranslate is working to ensure that all paying customers also receive the benefit of the one-year free trial.
5. EMIS is the UK's leading supplier of IT systems to GPs, providing the software that holds the medical records for 39 million NHS patients
nationwide. Around 56 per cent of GPs in the UK currently use EMIS software. emis-online. A link to the SignTranslate website has been embedded in the EMIS LV system and SignTranslate will soon be available for EMIS PCS systems.
SignTranslate
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Which Type Of Whooping Cough Vaccine Should Be Used?
Vickers and colleagues analyzed the incidence of pertussis reported to the Saskatoon Regional Health Authority in Saskatchewan between Jan.1, 1995, and Sept. 30, 2005.
They found that children aged less than 1 year or aged between 1 and 4 years who had only received whole-cell pertussis (wP), or a combination of wP and acellular pertussis (aP), had a lower incidence of pertussis than children who had received only aP, whereas a reverse trend was seen in children aged 5-9 years.
They suggest that consideration be given to revisiting the optimal immunization strategy against pertussis.
In a related commentary, Halperin and De Serres note that these findings contradict those from other recent reports and surveillance data collected in Canada. They present reasons for this and support the continued use of the aP vaccine. Pertussis immunization is usually given as part of the "5-in-1" shot (DPTP-Hib) that is routinely administered to children at the ages of 2, 4, 6 and 18 months, and as part of a booster shot (DPTP) given at 4-6 years. Between July 1997 and April 1998, all provinces and territories in Canada switched from using the wP vaccine to using only the aP vaccine. Canada had a high incidence of pertussis, and studies showed that the Canadian wP vaccine introduced in the 1980s had low effectiveness.
p. 1213 Whole-cell and acellular pertussis vaccination programs and rates of pertussis among infants and young children -- David Vickers, Allen G. Ross, Raul C. Mainar-Jaime, Cordell Neudorf, Syed Shah
cmaj/pressrelease/pg1213.pdf
Contact: Dr. David Vickers
Canadian Medical Association Journal
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They found that children aged less than 1 year or aged between 1 and 4 years who had only received whole-cell pertussis (wP), or a combination of wP and acellular pertussis (aP), had a lower incidence of pertussis than children who had received only aP, whereas a reverse trend was seen in children aged 5-9 years.
They suggest that consideration be given to revisiting the optimal immunization strategy against pertussis.
In a related commentary, Halperin and De Serres note that these findings contradict those from other recent reports and surveillance data collected in Canada. They present reasons for this and support the continued use of the aP vaccine. Pertussis immunization is usually given as part of the "5-in-1" shot (DPTP-Hib) that is routinely administered to children at the ages of 2, 4, 6 and 18 months, and as part of a booster shot (DPTP) given at 4-6 years. Between July 1997 and April 1998, all provinces and territories in Canada switched from using the wP vaccine to using only the aP vaccine. Canada had a high incidence of pertussis, and studies showed that the Canadian wP vaccine introduced in the 1980s had low effectiveness.
p. 1213 Whole-cell and acellular pertussis vaccination programs and rates of pertussis among infants and young children -- David Vickers, Allen G. Ross, Raul C. Mainar-Jaime, Cordell Neudorf, Syed Shah
cmaj/pressrelease/pg1213.pdf
Contact: Dr. David Vickers
Canadian Medical Association Journal
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Repeatedly Working When Ill Boosts Risk Of Long Term Sick Leave
Repeatedly going to work when ill significantly boosts the chances of having to take long term sick leave later on, reveals research published ahead of print in the Journal of Epidemiology and Community Health.
Going to work when ill is an increasingly recognised phenomenon known as "sickness presence," but relatively little is known about the long term impact of this behaviour.
The researchers randomly selected almost 12,000 Danes of working age, who had been in continuous employment for at least a year, to answer questions on their attitudes to work, preparedness to take time off when ill, and general health.
They were asked how many times in the preceding year they had gone to work ill when it would have been reasonable to have stayed at home.
Their responses were married up with official records detailing periods of sick leave taken, and lasting at least a fortnight, over the next 18 months.
Poor general health, a heavy workload, work-family life conflicts, a good level of social support, holding a senior post, and obesity featured most often among those who repeatedly came to work, despite being ill.
Workers who had done this at least half a dozen times were 53% more likely to end up going off sick for two weeks, and 74% more likely to take more than two months of sick leave, compared with those who did not come to work when ill.
These findings held true even after taking account of known risk factors for long term sick leave, previous bouts of lengthy sickness absence, and prevailing health.
Short periods off sick may allow workers to cope better with the stresses of a demanding job, and, overall, the evidence is that employment is good for health, say the authors. But long term sick leave is associated with difficulties finding work, they warn.
Source
British Medical Journal
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Going to work when ill is an increasingly recognised phenomenon known as "sickness presence," but relatively little is known about the long term impact of this behaviour.
The researchers randomly selected almost 12,000 Danes of working age, who had been in continuous employment for at least a year, to answer questions on their attitudes to work, preparedness to take time off when ill, and general health.
They were asked how many times in the preceding year they had gone to work ill when it would have been reasonable to have stayed at home.
Their responses were married up with official records detailing periods of sick leave taken, and lasting at least a fortnight, over the next 18 months.
Poor general health, a heavy workload, work-family life conflicts, a good level of social support, holding a senior post, and obesity featured most often among those who repeatedly came to work, despite being ill.
Workers who had done this at least half a dozen times were 53% more likely to end up going off sick for two weeks, and 74% more likely to take more than two months of sick leave, compared with those who did not come to work when ill.
These findings held true even after taking account of known risk factors for long term sick leave, previous bouts of lengthy sickness absence, and prevailing health.
Short periods off sick may allow workers to cope better with the stresses of a demanding job, and, overall, the evidence is that employment is good for health, say the authors. But long term sick leave is associated with difficulties finding work, they warn.
Source
British Medical Journal
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'Outstanding' Primary-Care Researcher Receives Prestigious Award
The 'outstanding' work of Julia Hippisley-Cox, Professor of Clinical Epidemiology and General Practice at The University of Nottingham, has been recognised by the Royal College of General Practitioners.
Professor Hippisley-Cox has been awarded the highly prestigious John Fry Silver Medal - an award made each year to a younger member of the College who has promoted the discipline of general practice through research and publishing as a practicing GP.
Professor Hippisley-Cox said: "It's a great honour to receive this award and I would like to thank my colleagues, The University of Nottingham, EMIS and the general practices who have contributed data medical research without which much of the research would not have been possible."
Established in 1995, the award commemorates the work of John Fry, one of the founders of epidemiology in general practice and perhaps the most prominent GP of his generation involved in research.
Professor Mike Pringle, Medical Director of Revalidation at the Royal College of General Practitioners and Professor in Primary Care at The University of Nottingham, who presented the award, said: "Julia Hippisley-Cox's remarkable academic achievements make her a very worthy recipient of the John Fry Award."
There are two defining developments for which Professor Hippisley-Cox is renowned.
Having recognised the potential of routine GP electronic clinical records for research, Professor Hippisley-Cox established QResearch - the largest clinical research database in the world in partnership with leading clinical systems provider EMIS. This database is now used by researchers throughout the UK and, increasingly, in Europe. There have been over 100 research publications using its data so far.
She also established QSurveillance, the largest surveillance system of its kind worldwide - another partnership with EMIS. QSurveillance extracts routine clinical data from general practices so that it can be used to directly improve patient care. The systems looks at over 100 indicators for 23 million people in the UK every day. Not only is this used for monitoring flu - and it will be invaluable in an epidemic or pandemic - but it was also used in real time to examine the health effects of disasters such as the Buncefield fire and the Avon floods.
Professor Julia Hippisley-Cox is a General Practitioner and a focused and extremely prolific researcher whose innovative methods and academic rigor have been recognised by her peers in the UK and internationally. Her contribution was decisive in the recent excellent result for The University of Nottingham in the Research Assessment Exercise.
Professor Hippisley-Cox has used QResearch to develop a new model of cardiovascular risk assessment called QRisk. Soon every patient's records will contain an automatically calculated cardiovascular risk score, allowing GPs to identify and target those at greatest risk.
Last year Tony Avery, Professor of Primary Care in The University of Nottingham's Medical School, received the John Fry Award for promoting the discipline of general practice through research and publishing as a practising GP. Professor Avery is considered to be one of the leading patient-safety researchers in the world. He said: "It is quite clear from my knowledge of Julia's work that she is one of the most outstanding primary-care researchers in the world and the impact of her publications is phenomenal".
Qresearch® specialises in research and analyses using primary care electronic health data.
Qsurveillance® is a near real time surveillance scheme which will collect, analyse and report on rates of infectious diseases as well influenza related conditions, flu vaccine and pneumococcal vaccine uptake. QSurveillance already has the capability of providing timely data in the face of emerging public health problems. It can also respond to chemical incidents, concerns about safety of medication or report in extreme weather conditions (eg during a heat wave) to help estimate the scale of the problem and plan a response.
Qrisk® can be used to work out your risk of having a heart attack or stroke over the next 10 years. The QRISK®2 algorithm has been developed by doctors and academics working in the UK National Health Service and is based on routinely collected data from many thousands of GPs across the country who have freely contributed data for medical research. A software development kit is available to build the QRISK®2 engine into healthcare systems.
Source:
Professor Julia Hippisley-Cox
University of Nottingham
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Professor Hippisley-Cox has been awarded the highly prestigious John Fry Silver Medal - an award made each year to a younger member of the College who has promoted the discipline of general practice through research and publishing as a practicing GP.
Professor Hippisley-Cox said: "It's a great honour to receive this award and I would like to thank my colleagues, The University of Nottingham, EMIS and the general practices who have contributed data medical research without which much of the research would not have been possible."
Established in 1995, the award commemorates the work of John Fry, one of the founders of epidemiology in general practice and perhaps the most prominent GP of his generation involved in research.
Professor Mike Pringle, Medical Director of Revalidation at the Royal College of General Practitioners and Professor in Primary Care at The University of Nottingham, who presented the award, said: "Julia Hippisley-Cox's remarkable academic achievements make her a very worthy recipient of the John Fry Award."
There are two defining developments for which Professor Hippisley-Cox is renowned.
Having recognised the potential of routine GP electronic clinical records for research, Professor Hippisley-Cox established QResearch - the largest clinical research database in the world in partnership with leading clinical systems provider EMIS. This database is now used by researchers throughout the UK and, increasingly, in Europe. There have been over 100 research publications using its data so far.
She also established QSurveillance, the largest surveillance system of its kind worldwide - another partnership with EMIS. QSurveillance extracts routine clinical data from general practices so that it can be used to directly improve patient care. The systems looks at over 100 indicators for 23 million people in the UK every day. Not only is this used for monitoring flu - and it will be invaluable in an epidemic or pandemic - but it was also used in real time to examine the health effects of disasters such as the Buncefield fire and the Avon floods.
Professor Julia Hippisley-Cox is a General Practitioner and a focused and extremely prolific researcher whose innovative methods and academic rigor have been recognised by her peers in the UK and internationally. Her contribution was decisive in the recent excellent result for The University of Nottingham in the Research Assessment Exercise.
Professor Hippisley-Cox has used QResearch to develop a new model of cardiovascular risk assessment called QRisk. Soon every patient's records will contain an automatically calculated cardiovascular risk score, allowing GPs to identify and target those at greatest risk.
Last year Tony Avery, Professor of Primary Care in The University of Nottingham's Medical School, received the John Fry Award for promoting the discipline of general practice through research and publishing as a practising GP. Professor Avery is considered to be one of the leading patient-safety researchers in the world. He said: "It is quite clear from my knowledge of Julia's work that she is one of the most outstanding primary-care researchers in the world and the impact of her publications is phenomenal".
Qresearch® specialises in research and analyses using primary care electronic health data.
Qsurveillance® is a near real time surveillance scheme which will collect, analyse and report on rates of infectious diseases as well influenza related conditions, flu vaccine and pneumococcal vaccine uptake. QSurveillance already has the capability of providing timely data in the face of emerging public health problems. It can also respond to chemical incidents, concerns about safety of medication or report in extreme weather conditions (eg during a heat wave) to help estimate the scale of the problem and plan a response.
Qrisk® can be used to work out your risk of having a heart attack or stroke over the next 10 years. The QRISK®2 algorithm has been developed by doctors and academics working in the UK National Health Service and is based on routinely collected data from many thousands of GPs across the country who have freely contributed data for medical research. A software development kit is available to build the QRISK®2 engine into healthcare systems.
Source:
Professor Julia Hippisley-Cox
University of Nottingham
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Animal Studies Show Protection Against HIV In One-Third Of Subjects Vaccinated
New research at Oregon Health & Science University's Vaccine and Gene Therapy Institute suggests vaccines that specifically target HIV in the initial stages of infection before it becomes a rapidly replicating, system-wide infection - may be a successful approach in limiting the spread of the disease. The research is published in the early online edition of the journal Nature Medicine and will appear in a future printed edition.
The researchers used a vaccination method that involves creating and maintaining resistance by programming a portion of the body's immune system - effector memory T-cells - to look out for HIV at the site of infection.
"HIV appears to be vulnerable when it is first introduced into mucosal surfaces in the body," said Louis Picker, M.D., associate director of the OHSU VGTI and director of the VGTI's vaccine program. "However, once HIV spreads throughout the entire body, it replicates very rapidly and becomes difficult if not impossible to control. Our approach is to attack during this early period of vulnerability. The approach is similar to that of a homeowner who sprays their house with water before sparks land on the roof. This approach can prevent the roof from catching fire and, in the case of HIV, prevent the spread of the virus."
To determine whether they could proactively "educate" the immune system, scientists used a monkey model of AIDS - simian immunodeficiency virus (SIV) - the monkey counterpart to HIV. They introduced an altered monkey form of cytomegalovirus (CMV) programmed to express SIV proteins and trigger specialized effector memory T-cells to look for and attack SIV in its early stages.
In total, 12 rhesus macaque monkeys at the Oregon National Primate Research Center were vaccinated using this method. When the animals were later infected with SIV, one-third were protected.
The next step for the research team is to try to determine why only a portion of the monkeys who are vaccinated using this method are responding. The researchers also hope to expand the number of subjects to better determine the success rate of the therapy.
The research was funded by The National Institute of Allergy and Infectious Diseases and by the Bill and Melinda Gates Foundation.
Source: Jim Newman
Oregon Health & Science University
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The researchers used a vaccination method that involves creating and maintaining resistance by programming a portion of the body's immune system - effector memory T-cells - to look out for HIV at the site of infection.
"HIV appears to be vulnerable when it is first introduced into mucosal surfaces in the body," said Louis Picker, M.D., associate director of the OHSU VGTI and director of the VGTI's vaccine program. "However, once HIV spreads throughout the entire body, it replicates very rapidly and becomes difficult if not impossible to control. Our approach is to attack during this early period of vulnerability. The approach is similar to that of a homeowner who sprays their house with water before sparks land on the roof. This approach can prevent the roof from catching fire and, in the case of HIV, prevent the spread of the virus."
To determine whether they could proactively "educate" the immune system, scientists used a monkey model of AIDS - simian immunodeficiency virus (SIV) - the monkey counterpart to HIV. They introduced an altered monkey form of cytomegalovirus (CMV) programmed to express SIV proteins and trigger specialized effector memory T-cells to look for and attack SIV in its early stages.
In total, 12 rhesus macaque monkeys at the Oregon National Primate Research Center were vaccinated using this method. When the animals were later infected with SIV, one-third were protected.
The next step for the research team is to try to determine why only a portion of the monkeys who are vaccinated using this method are responding. The researchers also hope to expand the number of subjects to better determine the success rate of the therapy.
The research was funded by The National Institute of Allergy and Infectious Diseases and by the Bill and Melinda Gates Foundation.
Source: Jim Newman
Oregon Health & Science University
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A New Way Our Bodies Control Blood Pressure: The P450-EET System
If you are one of the millions of Americans with high blood pressure, more help is on the way. That's because a new research study published in the October 2010 print issue of The FASEB Journal shows that a protein, called P450, metabolizes arachidonic acid in our blood vessel walls to create a tiny molecule with a big name - epoxyeicosatrienoic acid (EET) - which in mice, turns off genes responsible for vascular inflammation and ultimately relaxes blood vessels to lower blood pressure. This protein and genes are also present in humans.
"We hope these results will help advance the development of new blood pressure lowering agents that increase EETs," said Craig R. Lee, M.D., from the National Institutes of Health's National Institute of Environmental Health Sciences in Research Triangle Park, N.C. "In particular, we hope that targeted-use of these new therapies in individuals with a poorly functioning P450-EET system will ultimately prove to be an effective treatment for patients with high blood pressure."
Lee and colleagues discovered this new protein using genetically modified mice with human P450 present in the cells lining the blood vessels, and using normal mice as a control group. The scientists found that the P450 caused the mice to produce EETs, which in turn caused the relaxation of blood vessels and lower blood pressure. When the mice were exposed to substances that increased blood pressure, the P450 mice had lower blood pressure and less damage to the kidneys than the normal mice. These results show that the P450-EET pathway is a target for the development of new blood pressure medications, and these findings may influence drug development for other diseases, such as coronary artery disease, stroke, and cancer.
"Whether you're a Type A personality, overweight and out of shape, or genetically wired to have high blood pressure, this research offers real hope," said Gerald Weissmann, M.D., Editor-in-Chief of The FASEB Journal "Having discovered a pivotal role for the P450-EET system, scientists can now develop a new class of drugs not only for lowering blood pressure, but also for preventing strokes and heart attacks."
Details:
Craig R. Lee, John D. Imig, Matthew L. Edin, Julie Foley, Laura M. DeGraff, J. Alyce Bradbury, Joan P. Graves, Fred B. Lih, James Clark, Page Myers, A. Ligon Perrow, Adrienne N. Lepp, M. Alison Kannon, Oline K. Ronnekleiv, Nabil J. Alkayed, John R. Falck, Kenneth B. Tomer, and Darryl C. Zeldin. Endothelial expression of human cytochrome P450 epoxygenases lowers blood pressure and attenuates hypertension-induced renal injury in mice. FASEB J. 2010 24: 3770-3781. DOI: 10.1096/fj.10-160119.
Source:
Cody Mooneyhan
Federation of American Societies for Experimental Biology
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"We hope these results will help advance the development of new blood pressure lowering agents that increase EETs," said Craig R. Lee, M.D., from the National Institutes of Health's National Institute of Environmental Health Sciences in Research Triangle Park, N.C. "In particular, we hope that targeted-use of these new therapies in individuals with a poorly functioning P450-EET system will ultimately prove to be an effective treatment for patients with high blood pressure."
Lee and colleagues discovered this new protein using genetically modified mice with human P450 present in the cells lining the blood vessels, and using normal mice as a control group. The scientists found that the P450 caused the mice to produce EETs, which in turn caused the relaxation of blood vessels and lower blood pressure. When the mice were exposed to substances that increased blood pressure, the P450 mice had lower blood pressure and less damage to the kidneys than the normal mice. These results show that the P450-EET pathway is a target for the development of new blood pressure medications, and these findings may influence drug development for other diseases, such as coronary artery disease, stroke, and cancer.
"Whether you're a Type A personality, overweight and out of shape, or genetically wired to have high blood pressure, this research offers real hope," said Gerald Weissmann, M.D., Editor-in-Chief of The FASEB Journal "Having discovered a pivotal role for the P450-EET system, scientists can now develop a new class of drugs not only for lowering blood pressure, but also for preventing strokes and heart attacks."
Details:
Craig R. Lee, John D. Imig, Matthew L. Edin, Julie Foley, Laura M. DeGraff, J. Alyce Bradbury, Joan P. Graves, Fred B. Lih, James Clark, Page Myers, A. Ligon Perrow, Adrienne N. Lepp, M. Alison Kannon, Oline K. Ronnekleiv, Nabil J. Alkayed, John R. Falck, Kenneth B. Tomer, and Darryl C. Zeldin. Endothelial expression of human cytochrome P450 epoxygenases lowers blood pressure and attenuates hypertension-induced renal injury in mice. FASEB J. 2010 24: 3770-3781. DOI: 10.1096/fj.10-160119.
Source:
Cody Mooneyhan
Federation of American Societies for Experimental Biology
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Scientists Identify Master Gene That Switches On Disease-Fighting Cells
The master gene that causes blood stem cells to turn into disease-fighting 'Natural Killer' (NK) immune cells has been identified by scientists, in a study published in Nature Immunology. The discovery could one day help scientists boost the body's production of these frontline tumour-killing cells, creating new ways to treat cancer.
The researchers have 'knocked out' the gene in question, known as E4bp4, in a mouse model, creating the world's first animal model entirely lacking NK cells, but with all other blood cells and immune cells intact. This breakthrough model should help solve the mystery of the role that Natural Killer cells play in autoimmune diseases, such as diabetes and multiple sclerosis. Some scientists think that these diseases are caused by malfunctioning NK cells that turn on the body and attack healthy cells, causing disease instead of fighting it. Clarifying NK cells' role could lead to new ways of treating these conditions.
The study was carried out by researchers at Imperial College London, UCL and the Medical Research Council's National Institute for Medical Research.
Natural Killer cells - a type of white blood cell - are a major component of the human body's innate, quick-response immune system. They provide a fast frontline defence against tumours, viruses and bacterial infections, by scanning the human body for cells that are cancerous or infected with a virus or a bacterial pathogen, and killing them.
NK cells - along with all other types of blood cell, both white and red - are continuously generated from blood stem cells in the bone marrow over the course of a person's lifetime. The gene E4bp4 identified in today's study is the 'master gene' for NK cell production, which means it is the primary driver that causes blood stem cells to differentiate into NK cells.
The researchers behind today's study, led by Dr Hugh Brady from the Department of Life Sciences at Imperial College London, are hoping to progress with a drug treatment for cancer patients which reacts with the protein expressed by their E4bp4 gene, causing their bodies to produce a higher number of NK cells than normal, to increase the chances of successfully destroying tumours.
Currently, NK cells isolated from donated blood are sometimes used to treat cancer patients, but the effectiveness of donated cells is limited because NK cells can be slightly different from person to person. Dr Brady explains: "If increased numbers of the patient's own blood stem cells could be coerced into differentiating into NK cells, via drug treatment, we would be able to bolster the body's cancer-fighting force, without having to deal with the problems of donor incompatibility."
Dr Brady and his colleagues at the MRC National Institute for Medical Research proved the pivotal role E4bp4 plays in NK production when they knocked the gene out in a mouse model. Without E4bp4 the mouse produced no NK cells whatsoever but other types of blood cell were unaffected. As well as proving their hypothesis about the function of the E4bp4 gene, this animal model will allow medical researchers, for the first time, to discover if NK cell malfunction is behind a wide range of medical conditions, including autoimmune disorders, inflammatory conditions, persistent viral infections, female infertility and graft rejection.
Dr Brady explains: "Since shortly after they were discovered in the 1970s some scientists have suspected that the vital disease-fighting NK cells could themselves be behind a number of serious medical conditions, when they malfunction. Now finally, with our discovery of the NK cell master gene and subsequent creation of our mouse model, we will be able to find out if the progression of these diseases is impeded or aided by the removal of NK cells from the equation. This will solve the often-debated question of whether NK cells are always the 'good guys', or if in certain circumstances they cause more harm than good."
The researchers were initially studying the effect of E4bp4 in a very rare but fatal form of childhood leukaemia when they discovered its importance for NK cells.
The study was funded by the charities CHILDREN with LEUKAEMIA and Leukaemia Research.
Source:
Danielle Reeves
Imperial College London
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The researchers have 'knocked out' the gene in question, known as E4bp4, in a mouse model, creating the world's first animal model entirely lacking NK cells, but with all other blood cells and immune cells intact. This breakthrough model should help solve the mystery of the role that Natural Killer cells play in autoimmune diseases, such as diabetes and multiple sclerosis. Some scientists think that these diseases are caused by malfunctioning NK cells that turn on the body and attack healthy cells, causing disease instead of fighting it. Clarifying NK cells' role could lead to new ways of treating these conditions.
The study was carried out by researchers at Imperial College London, UCL and the Medical Research Council's National Institute for Medical Research.
Natural Killer cells - a type of white blood cell - are a major component of the human body's innate, quick-response immune system. They provide a fast frontline defence against tumours, viruses and bacterial infections, by scanning the human body for cells that are cancerous or infected with a virus or a bacterial pathogen, and killing them.
NK cells - along with all other types of blood cell, both white and red - are continuously generated from blood stem cells in the bone marrow over the course of a person's lifetime. The gene E4bp4 identified in today's study is the 'master gene' for NK cell production, which means it is the primary driver that causes blood stem cells to differentiate into NK cells.
The researchers behind today's study, led by Dr Hugh Brady from the Department of Life Sciences at Imperial College London, are hoping to progress with a drug treatment for cancer patients which reacts with the protein expressed by their E4bp4 gene, causing their bodies to produce a higher number of NK cells than normal, to increase the chances of successfully destroying tumours.
Currently, NK cells isolated from donated blood are sometimes used to treat cancer patients, but the effectiveness of donated cells is limited because NK cells can be slightly different from person to person. Dr Brady explains: "If increased numbers of the patient's own blood stem cells could be coerced into differentiating into NK cells, via drug treatment, we would be able to bolster the body's cancer-fighting force, without having to deal with the problems of donor incompatibility."
Dr Brady and his colleagues at the MRC National Institute for Medical Research proved the pivotal role E4bp4 plays in NK production when they knocked the gene out in a mouse model. Without E4bp4 the mouse produced no NK cells whatsoever but other types of blood cell were unaffected. As well as proving their hypothesis about the function of the E4bp4 gene, this animal model will allow medical researchers, for the first time, to discover if NK cell malfunction is behind a wide range of medical conditions, including autoimmune disorders, inflammatory conditions, persistent viral infections, female infertility and graft rejection.
Dr Brady explains: "Since shortly after they were discovered in the 1970s some scientists have suspected that the vital disease-fighting NK cells could themselves be behind a number of serious medical conditions, when they malfunction. Now finally, with our discovery of the NK cell master gene and subsequent creation of our mouse model, we will be able to find out if the progression of these diseases is impeded or aided by the removal of NK cells from the equation. This will solve the often-debated question of whether NK cells are always the 'good guys', or if in certain circumstances they cause more harm than good."
The researchers were initially studying the effect of E4bp4 in a very rare but fatal form of childhood leukaemia when they discovered its importance for NK cells.
The study was funded by the charities CHILDREN with LEUKAEMIA and Leukaemia Research.
Source:
Danielle Reeves
Imperial College London
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Spellex Releases New Edition Of Comprehensive Medical And Pharmaceutical Spelling Software
Spellex announces a new spelling software release, which includes specialty words from the medical and pharmaceutical industries and compatibility for new word processing programs from Microsoft and Corel.
Benefits: Spellex's new medical and pharmaceutical spelling dictionaries offer an excellent alternative to paper medical dictionaries and pharmaceutical word books. By adding Spellex Medical 2008 and Spellex Pharmaceutical 2008 to a common English language spell checker, the spelling dictionaries will verify correctly spelled medical and pharmaceutical words and provide correct spelling choices for incorrectly spelled terms. The spell checkers also allow users to verify unsure spelling of medical and pharmaceutical words by using phonetic or typographical search. The user saves time and increases their accuracy. Both the standard English language dictionary and the Spellex industry dictionaries are checked simultaneously with one mouse click.
Medical: Spellex Medical 2008 adds more than 300,000 medical words from over 70 medical specialties to the basic speller. Spellex checks for accurate spelling of medical and surgical terms, procedures, diseases, drug names, acronyms, eponyms, medical devices, abbreviations, Greek terms and diacritical markings such as Behçet's syndrome and Legg-Calvé-Waldenström disease. Medical dictionary users can subscribe to the Spell-X-Plustm software subscription service for quarterly software updates of new medical terms, new medications, and more.
Pharmaceutical: Spellex Pharmaceutical 2008 correctly spells thousands of OTC drugs and prescription pharmaceuticals, generic and trade name drugs, Latin and Greek terms, orphan drugs, pharmaceutical manufacturers, drug distributors, and more. The pharmaceutical speller includes comprehensive pharmacologic - therapeutic classifications covering anesthetics, anti-infective agents, antineoplastic agents, cardiovascular drugs, central nervous system agents, dental agents, diagnostic agents, enzymes, gastrointestinal drugs, oxytocics, serums and vaccines, vitamins, and more!
Prices for the medical and pharmaceutical dictionaries start at $69.95 for single users and $374.95 for ten user licenses. Larger licenses and educational discounts are available. Spellex dictionaries are compatible with Microsoft, most Windows programs, developer tools, custom applications, Web browsers, and are available in US English or UK English.
To order the medical and pharmaceutical dictionary software or to request product information or a free evaluation copy, visit the Spellex Web site at spellexor contact Spellex at 800-442-9673 or 813-792-7000.
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Benefits: Spellex's new medical and pharmaceutical spelling dictionaries offer an excellent alternative to paper medical dictionaries and pharmaceutical word books. By adding Spellex Medical 2008 and Spellex Pharmaceutical 2008 to a common English language spell checker, the spelling dictionaries will verify correctly spelled medical and pharmaceutical words and provide correct spelling choices for incorrectly spelled terms. The spell checkers also allow users to verify unsure spelling of medical and pharmaceutical words by using phonetic or typographical search. The user saves time and increases their accuracy. Both the standard English language dictionary and the Spellex industry dictionaries are checked simultaneously with one mouse click.
Medical: Spellex Medical 2008 adds more than 300,000 medical words from over 70 medical specialties to the basic speller. Spellex checks for accurate spelling of medical and surgical terms, procedures, diseases, drug names, acronyms, eponyms, medical devices, abbreviations, Greek terms and diacritical markings such as Behçet's syndrome and Legg-Calvé-Waldenström disease. Medical dictionary users can subscribe to the Spell-X-Plustm software subscription service for quarterly software updates of new medical terms, new medications, and more.
Pharmaceutical: Spellex Pharmaceutical 2008 correctly spells thousands of OTC drugs and prescription pharmaceuticals, generic and trade name drugs, Latin and Greek terms, orphan drugs, pharmaceutical manufacturers, drug distributors, and more. The pharmaceutical speller includes comprehensive pharmacologic - therapeutic classifications covering anesthetics, anti-infective agents, antineoplastic agents, cardiovascular drugs, central nervous system agents, dental agents, diagnostic agents, enzymes, gastrointestinal drugs, oxytocics, serums and vaccines, vitamins, and more!
Prices for the medical and pharmaceutical dictionaries start at $69.95 for single users and $374.95 for ten user licenses. Larger licenses and educational discounts are available. Spellex dictionaries are compatible with Microsoft, most Windows programs, developer tools, custom applications, Web browsers, and are available in US English or UK English.
To order the medical and pharmaceutical dictionary software or to request product information or a free evaluation copy, visit the Spellex Web site at spellexor contact Spellex at 800-442-9673 or 813-792-7000.
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The Public Health Agency Of Canada Updates Recommendations On H1N1 Vaccine For Children
The Public Health Agency of Canada today updated its recommendations on H1N1 flu vaccine dosing for children between 3 years and 9 years of age.
The updated recommendations reflect findings from clinical trial results from Europe that suggest that a single half-dose of adjuvanted H1N1 flu vaccine for healthy children may provide an acceptable level of protection from infection from the H1N1 flu virus.
"For healthy children between 3 and 9 years old, this means that one shot may be enough to provide protection from the H1N1 flu virus," said Dr. David Butler-Jones, Chief Public Health Officer for Canada. "This is good news for parents of healthy children and for Canadians. It frees up resources that can be devoted to immunizing priority at-risk populations, which means that the H1N1 vaccine will be available for the general public sooner."
The updated recommendations include three components:
- Children between 6 months of age and under 3 years of age should receive two half-doses of adjuvanted H1N1 flu vaccine, administered at least 21 days apart. Guidance for children in this age group is unchanged.
- Children with chronic health conditions who are between 3 and 9 years of age should receive their first half-dose of the H1N1 flu vaccine as soon as possible. They should also receive a second half-dose of the H1N1 flu vaccine. The interval between the two half-doses should be a minimum of 21 days.
- Healthy children between 3 and 9 years of age should only receive a single half-dose of the H1N1 vaccine, and do not need to return for a second vaccine for now. This recommendation may be updated as more information becomes available.
Further adjustments to the vaccine dosage recommendations may be made once the results of additional research and clinical trials on vaccine effectiveness are available.
The updated recommendations and the studies they are based on have been reviewed with the Canadian Paediatric Society and the provinces and territories. The new guidance reflects the need to adopt a prudent approach to protecting younger children with weaker immune systems and children with underlying medical conditions. It also recognizes that other priority populations are at risk from the H1N1 flu virus and that the H1N1 vaccine should be made available to all Canadians as quickly as possible.
"When we first announced the populations that should have priority access to vaccines in Canada, we stressed three things," said Dr. Butler Jones. "Those who would benefit most should get it first; our guidance was not set in stone and would evolve based on new knowledge and evidence; and, we ordered enough vaccine so that all Canadians who want and need it will get it. This new guidance reflects these commitments."
Source
Public Health Agency of Canada
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The updated recommendations reflect findings from clinical trial results from Europe that suggest that a single half-dose of adjuvanted H1N1 flu vaccine for healthy children may provide an acceptable level of protection from infection from the H1N1 flu virus.
"For healthy children between 3 and 9 years old, this means that one shot may be enough to provide protection from the H1N1 flu virus," said Dr. David Butler-Jones, Chief Public Health Officer for Canada. "This is good news for parents of healthy children and for Canadians. It frees up resources that can be devoted to immunizing priority at-risk populations, which means that the H1N1 vaccine will be available for the general public sooner."
The updated recommendations include three components:
- Children between 6 months of age and under 3 years of age should receive two half-doses of adjuvanted H1N1 flu vaccine, administered at least 21 days apart. Guidance for children in this age group is unchanged.
- Children with chronic health conditions who are between 3 and 9 years of age should receive their first half-dose of the H1N1 flu vaccine as soon as possible. They should also receive a second half-dose of the H1N1 flu vaccine. The interval between the two half-doses should be a minimum of 21 days.
- Healthy children between 3 and 9 years of age should only receive a single half-dose of the H1N1 vaccine, and do not need to return for a second vaccine for now. This recommendation may be updated as more information becomes available.
Further adjustments to the vaccine dosage recommendations may be made once the results of additional research and clinical trials on vaccine effectiveness are available.
The updated recommendations and the studies they are based on have been reviewed with the Canadian Paediatric Society and the provinces and territories. The new guidance reflects the need to adopt a prudent approach to protecting younger children with weaker immune systems and children with underlying medical conditions. It also recognizes that other priority populations are at risk from the H1N1 flu virus and that the H1N1 vaccine should be made available to all Canadians as quickly as possible.
"When we first announced the populations that should have priority access to vaccines in Canada, we stressed three things," said Dr. Butler Jones. "Those who would benefit most should get it first; our guidance was not set in stone and would evolve based on new knowledge and evidence; and, we ordered enough vaccine so that all Canadians who want and need it will get it. This new guidance reflects these commitments."
Source
Public Health Agency of Canada
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Man's Best Friend? Not During Hay Fever Season
Ragweed allergy season can be even more miserable for those with dog, cat or dust mite allergies, according to new research. These year-round allergies appear to "pre-prime" the immune system so symptoms hit harder, according to a study recently published in the Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI).
Hay fever (known as seasonal allergic rhinitis) begins around the middle of August, when ragweed blooms. The typical symptoms sneezing, itching, stuffy nose and watery eyes can make sufferers miserable. Hay fever sufferers who also are allergic to cats, dogs or dust mites develop symptoms faster and (early on) more severely, the research suggests. Treating the cat, dog or dust mite allergy year round may help make the hay fever more manageable.
"People with hay fever react differently when ragweed allergy season arrives. Some start sneezing right away, and others don't, so we wanted to determine what makes certain people develop symptoms more quickly," said allergist Anne K. Ellis, MD, lead author of the study and an ACAAI member. "We tested a number of common perennial allergens and found that having an allergy to cats, dogs or dust mites sets hay fever sufferers up for faster onset of symptoms when exposed to ragweed."
The study included 123 people allergic to ragweed. Of those, 66 percent tested positive for cat allergies, 63 percent tested positive for dog allergies and 73 percent tested positive for dust mite allergies. All were exposed to ragweed for three hours in a special controlled room called the Environmental Exposure Unit (at Kingston General Hospital, Ontario), and completed symptom questionnaires every 30 minutes during exposure.
"On average, those who tested positive for cat, dog or dust mite allergies developed symptoms either faster than, or to a greater degree than those who tested negative for those allergies," said Dr. Ellis. "The differences seen at 90 minutes of exposure were less dramatic after 3 hours of exposure, however. That suggests that once the hay fever season is in full swing, the symptom differences between those with cat, dog or dust mite allergies and those without no longer exist."
To avoid the more intense early reaction, people with cat, dog and dust mite allergies should try to limit their exposure to those allergens before ragweed season starts, said Dr. Ellis. Because that often is not practical when it comes to family pets, an alternative is to treat their cat, dog or dust-mite allergies, she said.
"Allergy immunizations or year-round allergy medication can provide hay fever relief to those sufferers who have ongoing symptoms from cats, dogs or dust mites, even if they think the symptoms are mild and easily tolerated," said Neil Kao, MD, chair of the ACAAI Rhinitis/Sinusitis Committee. "They'll likely find ragweed allergy season easier to endure if they're treating their perennial allergies."
Those who suspect they have hay fever or other allergies should get tested by an allergist a doctor who is expert in diagnosing and treating allergies and asthma.
Source: American College of Allergy, Asthma and Immunology (ACAAI)
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Hay fever (known as seasonal allergic rhinitis) begins around the middle of August, when ragweed blooms. The typical symptoms sneezing, itching, stuffy nose and watery eyes can make sufferers miserable. Hay fever sufferers who also are allergic to cats, dogs or dust mites develop symptoms faster and (early on) more severely, the research suggests. Treating the cat, dog or dust mite allergy year round may help make the hay fever more manageable.
"People with hay fever react differently when ragweed allergy season arrives. Some start sneezing right away, and others don't, so we wanted to determine what makes certain people develop symptoms more quickly," said allergist Anne K. Ellis, MD, lead author of the study and an ACAAI member. "We tested a number of common perennial allergens and found that having an allergy to cats, dogs or dust mites sets hay fever sufferers up for faster onset of symptoms when exposed to ragweed."
The study included 123 people allergic to ragweed. Of those, 66 percent tested positive for cat allergies, 63 percent tested positive for dog allergies and 73 percent tested positive for dust mite allergies. All were exposed to ragweed for three hours in a special controlled room called the Environmental Exposure Unit (at Kingston General Hospital, Ontario), and completed symptom questionnaires every 30 minutes during exposure.
"On average, those who tested positive for cat, dog or dust mite allergies developed symptoms either faster than, or to a greater degree than those who tested negative for those allergies," said Dr. Ellis. "The differences seen at 90 minutes of exposure were less dramatic after 3 hours of exposure, however. That suggests that once the hay fever season is in full swing, the symptom differences between those with cat, dog or dust mite allergies and those without no longer exist."
To avoid the more intense early reaction, people with cat, dog and dust mite allergies should try to limit their exposure to those allergens before ragweed season starts, said Dr. Ellis. Because that often is not practical when it comes to family pets, an alternative is to treat their cat, dog or dust-mite allergies, she said.
"Allergy immunizations or year-round allergy medication can provide hay fever relief to those sufferers who have ongoing symptoms from cats, dogs or dust mites, even if they think the symptoms are mild and easily tolerated," said Neil Kao, MD, chair of the ACAAI Rhinitis/Sinusitis Committee. "They'll likely find ragweed allergy season easier to endure if they're treating their perennial allergies."
Those who suspect they have hay fever or other allergies should get tested by an allergist a doctor who is expert in diagnosing and treating allergies and asthma.
Source: American College of Allergy, Asthma and Immunology (ACAAI)
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Hair Cell-Derived Patient-Specific Heart Cells For Disease Modeling And Drug Screening
Hair follicle keratinocytes offer a simple and accessible route to generate patient-specific induced pluripotent stem cells, iPSCs, with minimum inconvenience for the patients, shows a study presented at the ESC Congress 2011. The study presented by Dr. Katrin Streckfuss-Boemeke from Germany, won the ESC Basic Science Young Investigators Award.
"Data gathered in this study demonstrates an easy and fast possibility to generate iPSCs from hair follicles of patients with genetic cardiac diseases and their further differentiation into functional cardiomyocytes. These cells will allow us to model the heart disease of these patients, to investigate the mechanisms of the disease, to perform drug screenings and to develop patient-specific therapeutic strategies," explained Dr Streckfuss-Boemeke.
Most iPSC described in previous studies were generated from skin fibroblasts or bone marrow cells which require surgical intervention. The aim of this study was to use an alternative cell source that could be readily and noninvasively isolated from patients and which shows a high proliferation rate for efficient reprogramming.
Heart disease is one of the leading causes of death in developed countries. Although the majority of cardiac death victims are elderly, many children and young adults under the age of 35 die each year due to various cardiac pathologies. Recent progress in the fields of molecular biology and human genetics have enabled identification of the genetic causes of many heart diseases, including multiple causes of sudden cardiac death (SCD).
Genetically determined cardiac diseases can be divided into two groups : diseases with a structural change of the heart, like hypertrophic cardiomyopathy (HCM) or arrhythmogenic right ventricular dysplasia (ARVD) and a second group, without structural changes, resulting in life-threatening cardiac arrhythmia. Examples are primary electric heart diseases (the channelopathies), as the long QT syndrome (LQTS), the short QT syndrome (SQTS), the Brugada syndrome (BrS) and the Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), which causes sudden unexpected cardiac death in apparently healthy young individuals.
Several genetic cardiac diseases are not rare, for example HCM (although it is most common cause of SCD in childhood), LQTS and BrS. However, several diseases are rare, for example, CPVT and ARVD, and are very often related to high mortality in children and young adults. The cumulative mortality of the CPVT cases is 30-50% by the age of 20-30 years.
Until now, most of studies of human cardiac developmental defects or adult diseases have been done in animal models, especially in mice. However, mice differ from humans in many ways; for example, a mouse heart beats at 500 beats per minute, while the human heart beats at 70 beats per min. Therefore, the use of pluripotent stem cells is a promising approach for studying cardiac diseases.
Pluripotent stem cells have two major properties: they can proliferate indefinitely and they can form about 220 different cell types present in the adult body, including functional cardiomyocytes. Lately, the reprogramming of somatic cells to induced pluripotent stem cells (so called iPSCs) has become very popular. For the pluripotency induction, proteins (e.g. the pluripotency factors Oct4, Sox2, Nanog, Lin28 Klf4, and cMyc) are introduced into the cells. Therefore, human iPSC cells offer the particularly attractive opportunity to convert somatic cells from patients with cardiac disease into iPSCs and differentiate these iPSCs into patient-specific cardiomyocytes. In this way we can establish a human heart disease model for analyzing molecular mechanisms and developing individual therapy strategies. This would not be possible by using heart biopsies from living patients, because of limitation regarding the procedure and the amount of the taken tissues.
However, most iPSC lines described in previous studies have been generated from skin fibroblasts or bone marrow cells that require surgical intervention on the patient for their isolation. Therefore, our aim was to use an alternative cell source that could be readily and noninvasively isolated from patients and shows a high proliferation rate for efficient reprogramming. We decided to use keratinocytes, which can be easily isolated from the hair of living human individuals.
Previous studies showed that hair-plucked keratinocytes are difficult to be cultivated with a low proliferation capacity. Therefore our first aim was the optimization of culture conditions for keratinocytes from human hair follicles. We plucked approximately 40 hairs from 41 individuals between 22-52 years, isolated and cultivated hair follicle keratinocytes with an efficiency of 90%. After 10 to 14 days we had a sufficient amount of keratinocytes in culture and started the induction of reprogramming of these hair cells into pluripotent stem cells. We introduced different combinations of pluripotency genes (Oct4, Sox2, Nanog, and Lin28 (OSNL) or Oct, Sox2, Klf4, and cMyc (OSKM) by using the lentiviral system. Oct4 and Sox2 are two transcription factors, which act as transcriptional activator of other pluripotency-associated genes. Nanog is more involved in the maintenance of pluripotency, and Lin28 for example has been used to enhance the efficiency of reprogramming. After 2-3 weeks we saw iPSC-colonies (Kera-iPSCs) in culture with a typical compact morphology of pluripotent human embryonic stem cells (hESCs).
We performed three sets of experiments for proving the pluripotency of the generated kera-iPSCs: First we analyzed the expression of typical pluripotency markers on gene and protein levels. We observed that the endogenous expression of OCT4 and SOX2 is very low in keratinocytes in contrast to a significantly increase in the keratinocyte-derived iPSCs. We detected no endogenous expression of NANOG and LIN28 in the keratinocytes but a highly induction in the iPSCs. These gene expression data were confirmed on the protein level. We were able to show that the kera-iPSCs were positive for markers common to pluripotent cells, including alkaline phosphatase, Nanog, Oct4, Sox2, Tra-1-60, and SSEA4.
The second proof of pluripotency of the generated iPSCs is their differentiation potential in vivo and therefore the ability to form teratomas. To test this, we injected the cells subcutaneously in immune-suppressed SCID-beige mice. After 8 weeks we observed the formation of teratomas, in which differentiating cells of all three germ layers were found, including cartilage, epithelium with intestinal differentiation and neural tissues.
In a last set of experiments we analysed the iPSC differentiation potential in vitro. Using the so-called embryoid body (EB) formation, we induced the cells to differentiate spontaneously into derivatives of all three embryonic germ layers in vitro. During this time in vitro, tissue-specific genes were expressed in a developmentally controlled manner, including AFP-positive hepatic cells, tyrosine-hydroxylase positive neuronal cells and troponinT-positive cardiac cells. But the most exciting observation during this differentiation is the rhythmically beating clusters in EB outgrowths.
All these experiments show that the hair keratinocyte-derived iPSCs are really pluripotent and can be differentiated into beating cardiomyocytes.
This data demonstrate an easy and fast possibility to generate iPSCs from hair follicles of patients with genetic cardiac diseases and their further differentiation into functional cardiomyocytes. In comparison to hair-follicle-derived cardiomyocytes from healthy individuals we will be able to model the heart disease, to investigate the mechanisms of the disease, to perform drug screenings and to develop patient-specific therapeutic strategies. In conclusion, hair follicle keratinocytes offer a simple and accessible route to generate patient-specific iPSCs, and with minimum inconvenience for the patients.
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"Data gathered in this study demonstrates an easy and fast possibility to generate iPSCs from hair follicles of patients with genetic cardiac diseases and their further differentiation into functional cardiomyocytes. These cells will allow us to model the heart disease of these patients, to investigate the mechanisms of the disease, to perform drug screenings and to develop patient-specific therapeutic strategies," explained Dr Streckfuss-Boemeke.
Most iPSC described in previous studies were generated from skin fibroblasts or bone marrow cells which require surgical intervention. The aim of this study was to use an alternative cell source that could be readily and noninvasively isolated from patients and which shows a high proliferation rate for efficient reprogramming.
Heart disease is one of the leading causes of death in developed countries. Although the majority of cardiac death victims are elderly, many children and young adults under the age of 35 die each year due to various cardiac pathologies. Recent progress in the fields of molecular biology and human genetics have enabled identification of the genetic causes of many heart diseases, including multiple causes of sudden cardiac death (SCD).
Genetically determined cardiac diseases can be divided into two groups : diseases with a structural change of the heart, like hypertrophic cardiomyopathy (HCM) or arrhythmogenic right ventricular dysplasia (ARVD) and a second group, without structural changes, resulting in life-threatening cardiac arrhythmia. Examples are primary electric heart diseases (the channelopathies), as the long QT syndrome (LQTS), the short QT syndrome (SQTS), the Brugada syndrome (BrS) and the Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), which causes sudden unexpected cardiac death in apparently healthy young individuals.
Several genetic cardiac diseases are not rare, for example HCM (although it is most common cause of SCD in childhood), LQTS and BrS. However, several diseases are rare, for example, CPVT and ARVD, and are very often related to high mortality in children and young adults. The cumulative mortality of the CPVT cases is 30-50% by the age of 20-30 years.
Until now, most of studies of human cardiac developmental defects or adult diseases have been done in animal models, especially in mice. However, mice differ from humans in many ways; for example, a mouse heart beats at 500 beats per minute, while the human heart beats at 70 beats per min. Therefore, the use of pluripotent stem cells is a promising approach for studying cardiac diseases.
Pluripotent stem cells have two major properties: they can proliferate indefinitely and they can form about 220 different cell types present in the adult body, including functional cardiomyocytes. Lately, the reprogramming of somatic cells to induced pluripotent stem cells (so called iPSCs) has become very popular. For the pluripotency induction, proteins (e.g. the pluripotency factors Oct4, Sox2, Nanog, Lin28 Klf4, and cMyc) are introduced into the cells. Therefore, human iPSC cells offer the particularly attractive opportunity to convert somatic cells from patients with cardiac disease into iPSCs and differentiate these iPSCs into patient-specific cardiomyocytes. In this way we can establish a human heart disease model for analyzing molecular mechanisms and developing individual therapy strategies. This would not be possible by using heart biopsies from living patients, because of limitation regarding the procedure and the amount of the taken tissues.
However, most iPSC lines described in previous studies have been generated from skin fibroblasts or bone marrow cells that require surgical intervention on the patient for their isolation. Therefore, our aim was to use an alternative cell source that could be readily and noninvasively isolated from patients and shows a high proliferation rate for efficient reprogramming. We decided to use keratinocytes, which can be easily isolated from the hair of living human individuals.
Previous studies showed that hair-plucked keratinocytes are difficult to be cultivated with a low proliferation capacity. Therefore our first aim was the optimization of culture conditions for keratinocytes from human hair follicles. We plucked approximately 40 hairs from 41 individuals between 22-52 years, isolated and cultivated hair follicle keratinocytes with an efficiency of 90%. After 10 to 14 days we had a sufficient amount of keratinocytes in culture and started the induction of reprogramming of these hair cells into pluripotent stem cells. We introduced different combinations of pluripotency genes (Oct4, Sox2, Nanog, and Lin28 (OSNL) or Oct, Sox2, Klf4, and cMyc (OSKM) by using the lentiviral system. Oct4 and Sox2 are two transcription factors, which act as transcriptional activator of other pluripotency-associated genes. Nanog is more involved in the maintenance of pluripotency, and Lin28 for example has been used to enhance the efficiency of reprogramming. After 2-3 weeks we saw iPSC-colonies (Kera-iPSCs) in culture with a typical compact morphology of pluripotent human embryonic stem cells (hESCs).
We performed three sets of experiments for proving the pluripotency of the generated kera-iPSCs: First we analyzed the expression of typical pluripotency markers on gene and protein levels. We observed that the endogenous expression of OCT4 and SOX2 is very low in keratinocytes in contrast to a significantly increase in the keratinocyte-derived iPSCs. We detected no endogenous expression of NANOG and LIN28 in the keratinocytes but a highly induction in the iPSCs. These gene expression data were confirmed on the protein level. We were able to show that the kera-iPSCs were positive for markers common to pluripotent cells, including alkaline phosphatase, Nanog, Oct4, Sox2, Tra-1-60, and SSEA4.
The second proof of pluripotency of the generated iPSCs is their differentiation potential in vivo and therefore the ability to form teratomas. To test this, we injected the cells subcutaneously in immune-suppressed SCID-beige mice. After 8 weeks we observed the formation of teratomas, in which differentiating cells of all three germ layers were found, including cartilage, epithelium with intestinal differentiation and neural tissues.
In a last set of experiments we analysed the iPSC differentiation potential in vitro. Using the so-called embryoid body (EB) formation, we induced the cells to differentiate spontaneously into derivatives of all three embryonic germ layers in vitro. During this time in vitro, tissue-specific genes were expressed in a developmentally controlled manner, including AFP-positive hepatic cells, tyrosine-hydroxylase positive neuronal cells and troponinT-positive cardiac cells. But the most exciting observation during this differentiation is the rhythmically beating clusters in EB outgrowths.
All these experiments show that the hair keratinocyte-derived iPSCs are really pluripotent and can be differentiated into beating cardiomyocytes.
This data demonstrate an easy and fast possibility to generate iPSCs from hair follicles of patients with genetic cardiac diseases and their further differentiation into functional cardiomyocytes. In comparison to hair-follicle-derived cardiomyocytes from healthy individuals we will be able to model the heart disease, to investigate the mechanisms of the disease, to perform drug screenings and to develop patient-specific therapeutic strategies. In conclusion, hair follicle keratinocytes offer a simple and accessible route to generate patient-specific iPSCs, and with minimum inconvenience for the patients.
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Traditional Chinese Medicinal Herbs May Help Women With Breast Cancer
Using Chinese herbs either alone or in conjunction with chemotherapy may help protect a breast cancer patient's bone marrow and immune system, as well as improving the woman's overall quality of life.
Sixty per cent of women undergoing chemotherapy for breast cancer experience a range of significant short term side effects. These include nausea, vomiting and fatigue, as well as inflammation of the gut lining, decreased numbers of red and white blood cells and decreased numbers of blood platelets.
Chinese medicinal herbs include mixtures of herbal compounds or extracts from herbs, and they are prescribed to counteract the side effects of chemotherapy. This Cochrane Systematic Review set out to see if there is conventional evidence indicating that these medicines are safe and whether there is evidence that the medicines are effective.
The researchers identified seven randomised studies involving 542 patients with breast cancer. By analysing these data, the researchers concluded that there was no evidence that the Chinese medicinal herbal treatment caused harm, and some evidence that it might reduce side effects.
"Further trials are needed before the effects of traditional Chinese medicines for people with breast cancer can be evaluated with any real confidence," says Assistant Professor Jing Li, who works at the Chinese Cochrane Centre in Chengdu, China.
Contact: Jennifer Beal
John Wiley & Sons, Inc.
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Sixty per cent of women undergoing chemotherapy for breast cancer experience a range of significant short term side effects. These include nausea, vomiting and fatigue, as well as inflammation of the gut lining, decreased numbers of red and white blood cells and decreased numbers of blood platelets.
Chinese medicinal herbs include mixtures of herbal compounds or extracts from herbs, and they are prescribed to counteract the side effects of chemotherapy. This Cochrane Systematic Review set out to see if there is conventional evidence indicating that these medicines are safe and whether there is evidence that the medicines are effective.
The researchers identified seven randomised studies involving 542 patients with breast cancer. By analysing these data, the researchers concluded that there was no evidence that the Chinese medicinal herbal treatment caused harm, and some evidence that it might reduce side effects.
"Further trials are needed before the effects of traditional Chinese medicines for people with breast cancer can be evaluated with any real confidence," says Assistant Professor Jing Li, who works at the Chinese Cochrane Centre in Chengdu, China.
Contact: Jennifer Beal
John Wiley & Sons, Inc.
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AmeriCares And Boehringer Ingelheim Open New, Expanded Free Clinic To Help Families Hit Hardest By Economic Hardship
Boehringer Ingelheim and AmeriCares Free Clinics announced the opening of a new, expanded clinic in Danbury to serve the medical needs of the working poor at a time when demand for such services is higher than ever due to economic pressures.
The clinic, located at 76 West Street, is a partnership between AmeriCares and Boehringer Ingelheim to address the urgent need for free, quality healthcare in the community's large uninsured population. With more Americans losing jobs and their health insurance every day, the new facility will help those hardest hit by the recession.
"We know from our recent Boehringer Ingelheim Family Health Survey that access to healthcare remains a significant issue in our community and nationwide, with half of Americans concerned about losing healthcare access and economic pressures exacerbating the problem," said J. Martin Carroll, President and CEO, Boehringer Ingelheim. "We share AmeriCares commitment to improving the health of patients and their families and are proud to provide this clinic for the people of Danbury at this time of critical need."
The Boehringer Ingelheim AmeriCares Free Clinic will serve thousands of patients in a modern health care facility. It replaces a smaller clinic AmeriCares has operated for 12 years in the basement of Ives Manor, a public housing complex.
One of three AmeriCares Free Clinics in Connecticut, the facility recruits volunteer physicians, registered nurses and interpreters, drawing on the resources of community hospitals, corporate partners, laboratories and pharmacies to ensure access to outpatient healthcare.
"Our extraordinary partnership with Boehringer Ingelheim allows us to provide free healthcare for even more self-employed patients trying to make ends meet, the newly unemployed and many others," said Karen Gottlieb, Executive Director, AmeriCares Free Clinics. "With increasing demand, this new facility couldn't open at a better time and should be upheld as an example of the tremendous benefit of communities working together to provide for those most in need."
Providing Essential Health Care to Thousands of People in Need
Since opening in 1997, the AmeriCares Free Clinic of Danbury has delivered $12 million worth of medical services to more than 6,500 patients. Today, the clinic has more than 3,500 patient visits annually, making it AmeriCares' busiest clinic. The larger facility will enable the clinic to serve more patients. Currently, there are three AmeriCares Free Clinics in Connecticut, operating in Norwalk, Bridgeport and Danbury.
"I probably wouldn't be alive today if it wasn't for the clinic. I am uninsured, and yet I have a primary care doctor, a urologist, an oncologist, a radiologist and even a pulmonologist at one of the top hospitals in the country," explains a patient at the Danbury clinic. "I never could have afforded this kind of treatment on my own. I have never seen such dedication or kindness at a medical facility."
An Ongoing Commitment to Patients and Families
In addition to providing the funds to make the new Boehringer Ingelheim AmeriCares Free Clinic possible, Boehringer Ingelheim also funds the Boehringer Ingelheim AmeriCares' mobile outreach program to increase access to healthcare in Danbury and surrounding communities. In addition, Boehringer Ingelheim has supported AmeriCares international programs.
The company provides free medication to the clinic and provides volunteer support, including a Boehringer Ingelheim physician that sees clinic patients on an ongoing basis.
"Our involvement with AmeriCares goes beyond our shared commitment to family health and the new clinic building," said Carroll. "Our family of employees also is helping serve our community as volunteers at the clinic."
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information, please visit us.boehringer-ingelheim.
Source
AmeriCares
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The clinic, located at 76 West Street, is a partnership between AmeriCares and Boehringer Ingelheim to address the urgent need for free, quality healthcare in the community's large uninsured population. With more Americans losing jobs and their health insurance every day, the new facility will help those hardest hit by the recession.
"We know from our recent Boehringer Ingelheim Family Health Survey that access to healthcare remains a significant issue in our community and nationwide, with half of Americans concerned about losing healthcare access and economic pressures exacerbating the problem," said J. Martin Carroll, President and CEO, Boehringer Ingelheim. "We share AmeriCares commitment to improving the health of patients and their families and are proud to provide this clinic for the people of Danbury at this time of critical need."
The Boehringer Ingelheim AmeriCares Free Clinic will serve thousands of patients in a modern health care facility. It replaces a smaller clinic AmeriCares has operated for 12 years in the basement of Ives Manor, a public housing complex.
One of three AmeriCares Free Clinics in Connecticut, the facility recruits volunteer physicians, registered nurses and interpreters, drawing on the resources of community hospitals, corporate partners, laboratories and pharmacies to ensure access to outpatient healthcare.
"Our extraordinary partnership with Boehringer Ingelheim allows us to provide free healthcare for even more self-employed patients trying to make ends meet, the newly unemployed and many others," said Karen Gottlieb, Executive Director, AmeriCares Free Clinics. "With increasing demand, this new facility couldn't open at a better time and should be upheld as an example of the tremendous benefit of communities working together to provide for those most in need."
Providing Essential Health Care to Thousands of People in Need
Since opening in 1997, the AmeriCares Free Clinic of Danbury has delivered $12 million worth of medical services to more than 6,500 patients. Today, the clinic has more than 3,500 patient visits annually, making it AmeriCares' busiest clinic. The larger facility will enable the clinic to serve more patients. Currently, there are three AmeriCares Free Clinics in Connecticut, operating in Norwalk, Bridgeport and Danbury.
"I probably wouldn't be alive today if it wasn't for the clinic. I am uninsured, and yet I have a primary care doctor, a urologist, an oncologist, a radiologist and even a pulmonologist at one of the top hospitals in the country," explains a patient at the Danbury clinic. "I never could have afforded this kind of treatment on my own. I have never seen such dedication or kindness at a medical facility."
An Ongoing Commitment to Patients and Families
In addition to providing the funds to make the new Boehringer Ingelheim AmeriCares Free Clinic possible, Boehringer Ingelheim also funds the Boehringer Ingelheim AmeriCares' mobile outreach program to increase access to healthcare in Danbury and surrounding communities. In addition, Boehringer Ingelheim has supported AmeriCares international programs.
The company provides free medication to the clinic and provides volunteer support, including a Boehringer Ingelheim physician that sees clinic patients on an ongoing basis.
"Our involvement with AmeriCares goes beyond our shared commitment to family health and the new clinic building," said Carroll. "Our family of employees also is helping serve our community as volunteers at the clinic."
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information, please visit us.boehringer-ingelheim.
Source
AmeriCares
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Vical Announces Breakthrough For Pandemic Influenza DNA Vaccines With Preliminary Human Data
Vical Incorporated
(Nasdaq: VICL) announced a breakthrough with preliminary clinical
trial data demonstrating that DNA vaccines can safely achieve significant
immune responses against H5N1 pandemic influenza in humans. DNA vaccines
are fundamentally different from conventional vaccines because they do not
contain any part of the virus itself, and may offer compelling advantages
in response to a pandemic outbreak because of significantly reduced
development and manufacturing times.
Specifically, preliminary human safety and immunogenicity data obtained
in a 100-subject Phase 1 trial of the company's Vaxfectin(R)-formulated
H5N1 pandemic influenza DNA vaccines demonstrated for the first time that
DNA vaccines have achieved potentially protective levels of antibody
responses (defined as hemagglutination inhibition, or HI, titers of at
least 40; responses ranged from 40 to 640) in up to 67% of evaluable
subjects in the higher dose cohorts. No significant safety issues were
observed at any of the Vical vaccine doses tested. These results support
further development of Vaxfectin(R)-formulated DNA vaccines, and could
position them as potential alternatives to conventional vaccines.
"The preliminary results from this Phase 1 trial indicate for the first
time that an adjuvanted DNA vaccination against H5N1 influenza is
well-tolerated and can induce impressive antibody responses even against
this relatively weak immunogen," said Robert B. Belshe, M.D., Dianna and J.
Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology,
Saint Louis University School of Medicine, who was the lead external safety
monitor for the study. "Successful development of a safe and effective DNA
vaccine will help address the potential public health threat of pandemic
influenza."
Vijay B. Samant, Vical's President and Chief Executive Officer, said,
"Our preliminary Phase 1 pandemic influenza vaccine results clearly
demonstrate the potential of Vaxfectin(R)-formulated DNA vaccines to
achieve antibody responses in the same range as conventional vaccines. The
ability to manufacture DNA vaccines in weeks rather than the months
required for conventional vaccines may provide a significant advantage when
dealing with an emerging infectious disease such as pandemic influenza.
This trial is also important because it marks the first successful safety
evaluation in humans for our Vaxfectin(R) adjuvant, which has potential
applications with both DNA vaccines and conventional protein-based
vaccines."
The double-blind, placebo-controlled, dose-escalation trial was
conducted in approximately 100 healthy volunteers age 18 to 45 at three
U.S. clinical sites. The trial was designed to assess safety and
immunogenicity following intramuscular vaccination with needle and syringe
or with the Biojector(R) 2000 needle-free injection system in different
cohorts, and to evaluate monovalent and trivalent Vaxfectin(R)-formulated
DNA vaccines at various doses. Preliminary results will be presented by
Vical's Vice President of Vaccine Research, Larry R. Smith, Ph.D., at 12:25
p.m. EDT today, Thursday, July 17, at the IBC Life Sciences Next Generation
Vaccines conference (National Harbor, MD - July 17-18).
In the Phase 1 trial, subjects were injected at Days 0 and 21. Primary
evaluation of antibody responses was by HI antibody titers, the accepted
standard correlate of protection for influenza vaccines. Responders were
those subjects achieving H5 HI titers of at least 40 and achieving at least
a four-fold increase from baseline HI titers. By Day 56, at least 50% and
up to 67% of evaluable subjects were responders in each of the three
cohorts receiving 0.5 mg or 1 mg H5 DNA doses, and there were no responders
in the placebo cohort. More than 90% of the responders had sustained HI
titers through the last measurement to date (Day 84). Neutralizing antibody
production against H5 was demonstrated separately by microneutralization
assays. For comparison, the protein-based pandemic influenza vaccine
currently stockpiled by the U.S. government was approved with HI titers of
40 or more in 44% of subjects by Day 56.
Even at the lowest dose tested (0.033 mg H5 DNA), one of the six
subjects was a responder by Day 56. Some subjects who received the highest
H5 DNA dose were responders at Day 21 after a single vaccine injection.
Preliminary analyses also showed cross-strain immune responses against a
strain of H5N1 from a clade not matching the vaccine. Cross-strain
protection could be important against emerging strains of pandemic
influenza that may not match vaccine stockpiles.
Additional assays are ongoing to further evaluate antibody responses,
breadth and magnitude of T-cell immune responses, cross-strain responses,
and the relative advantages of monovalent vs. trivalent vaccines and needle
vs. needle-free injection.
"These results are important to Vical for three reasons," added Mr.
Samant. "First, they encourage further development of pandemic influenza
DNA vaccines, for which we are currently exploring funding or partnering
options. Second, they support advancement of additional
Vaxfectin(R)-formulated DNA vaccines toward clinical testing. Third, they
provide new incentives for potential commercial partners and collaborators
to explore additional applications for our Vaxfectin(R) adjuvant for DNA
vaccines as well as protein and peptide-based vaccines. We are excited by
these strong preliminary antibody results, and we look forward to
evaluating more detailed immunogenicity data as they become available."
DNA vaccines may offer both technical and economic advantages compared
with conventional vaccine approaches. DNA vaccines encode certain proteins
associated with a target pathogen, rather than using any part of the
pathogen itself, and can prime the immune system as well as induce potent
antibody and T-cell immune responses. DNA vaccines contain no viral
particles, are non-infectious, and can be administered on a repeat basis
without unwanted immune responses. Additionally, DNA vaccines have the
potential to achieve proof of concept more quickly and cost-effectively
than conventional vaccines, and can be manufactured using uniform methods
of fermentation and purification, allowing significantly faster development
and production.
Vical's monovalent vaccine contains a plasmid (a closed loop of DNA)
encoding the hemagglutinin (HA) surface protein from the H5N1 influenza
virus strain, A/Vietnam/1203/04. It is designed primarily to elicit
antibody responses against the H5 protein but could elicit T-cell responses
against H5 as well. Vical's trivalent vaccine contains the H5 plasmid plus
separate plasmids encoding consensus sequences of two highly conserved
influenza virus proteins: nucleoprotein (NP) and ion channel protein (M2).
The trivalent vaccine is designed to elicit a combination of T-cell and
antibody responses against all three proteins. Both vaccines are formulated
with the company's Vaxfectin(R) adjuvant, which has demonstrated
effectiveness with a variety of DNA vaccines in multiple animal models as
well as dose-sparing and immune-enhancing ability in animals with a
conventional seasonal influenza vaccine.
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company's DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at vical.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected. Forward-looking statements include statements about the
preliminary results of the company's DNA vaccine Phase 1 clinical trial,
the effect of the preliminary Phase 1 clinical trial results on the
company's DNA vaccine and Vaxfectin(R) adjuvant programs and its
collaborative opportunities, and the design and potential benefits of the
company's pandemic influenza vaccine and DNA vaccines generally. Risks and
uncertainties include whether preliminary H5N1 DNA vaccine Phase 1 clinical
trial results will be confirmed upon further analysis or in larger studies;
whether DNA vaccines against H5N1 influenza or any other targets will be
successfully developed and commercialized; whether DNA vaccines will become
alternatives to conventional vaccines; whether DNA vaccines will achieve
immune responses in the same range as conventional vaccines in future
trials; whether infrastructure will be established to manufacture DNA
vaccines at commercial scale in weeks; whether additional data will provide
evidence of neutralizing antibody production, cross-strain immune
responses, or T-cell responses; whether further analysis will reveal any
advantages for the monovalent or trivalent vaccines or for the needle or
needle-free injection methods; whether Vical or others will secure funding
to advance the pandemic influenza DNA vaccine program; whether commercial
partners or collaborators will pursue additional Vaxfectin(R) applications;
whether any product candidates will be shown to be safe and efficacious in
clinical trials; the timing of clinical trials; whether Vical or its
collaborative partners will seek or gain approval to market any product
candidates; the dependence of the company on its collaborative partners;
and additional risks set forth in the company's filings with the Securities
and Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements.
Vical Incorporated
vical
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(Nasdaq: VICL) announced a breakthrough with preliminary clinical
trial data demonstrating that DNA vaccines can safely achieve significant
immune responses against H5N1 pandemic influenza in humans. DNA vaccines
are fundamentally different from conventional vaccines because they do not
contain any part of the virus itself, and may offer compelling advantages
in response to a pandemic outbreak because of significantly reduced
development and manufacturing times.
Specifically, preliminary human safety and immunogenicity data obtained
in a 100-subject Phase 1 trial of the company's Vaxfectin(R)-formulated
H5N1 pandemic influenza DNA vaccines demonstrated for the first time that
DNA vaccines have achieved potentially protective levels of antibody
responses (defined as hemagglutination inhibition, or HI, titers of at
least 40; responses ranged from 40 to 640) in up to 67% of evaluable
subjects in the higher dose cohorts. No significant safety issues were
observed at any of the Vical vaccine doses tested. These results support
further development of Vaxfectin(R)-formulated DNA vaccines, and could
position them as potential alternatives to conventional vaccines.
"The preliminary results from this Phase 1 trial indicate for the first
time that an adjuvanted DNA vaccination against H5N1 influenza is
well-tolerated and can induce impressive antibody responses even against
this relatively weak immunogen," said Robert B. Belshe, M.D., Dianna and J.
Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology,
Saint Louis University School of Medicine, who was the lead external safety
monitor for the study. "Successful development of a safe and effective DNA
vaccine will help address the potential public health threat of pandemic
influenza."
Vijay B. Samant, Vical's President and Chief Executive Officer, said,
"Our preliminary Phase 1 pandemic influenza vaccine results clearly
demonstrate the potential of Vaxfectin(R)-formulated DNA vaccines to
achieve antibody responses in the same range as conventional vaccines. The
ability to manufacture DNA vaccines in weeks rather than the months
required for conventional vaccines may provide a significant advantage when
dealing with an emerging infectious disease such as pandemic influenza.
This trial is also important because it marks the first successful safety
evaluation in humans for our Vaxfectin(R) adjuvant, which has potential
applications with both DNA vaccines and conventional protein-based
vaccines."
The double-blind, placebo-controlled, dose-escalation trial was
conducted in approximately 100 healthy volunteers age 18 to 45 at three
U.S. clinical sites. The trial was designed to assess safety and
immunogenicity following intramuscular vaccination with needle and syringe
or with the Biojector(R) 2000 needle-free injection system in different
cohorts, and to evaluate monovalent and trivalent Vaxfectin(R)-formulated
DNA vaccines at various doses. Preliminary results will be presented by
Vical's Vice President of Vaccine Research, Larry R. Smith, Ph.D., at 12:25
p.m. EDT today, Thursday, July 17, at the IBC Life Sciences Next Generation
Vaccines conference (National Harbor, MD - July 17-18).
In the Phase 1 trial, subjects were injected at Days 0 and 21. Primary
evaluation of antibody responses was by HI antibody titers, the accepted
standard correlate of protection for influenza vaccines. Responders were
those subjects achieving H5 HI titers of at least 40 and achieving at least
a four-fold increase from baseline HI titers. By Day 56, at least 50% and
up to 67% of evaluable subjects were responders in each of the three
cohorts receiving 0.5 mg or 1 mg H5 DNA doses, and there were no responders
in the placebo cohort. More than 90% of the responders had sustained HI
titers through the last measurement to date (Day 84). Neutralizing antibody
production against H5 was demonstrated separately by microneutralization
assays. For comparison, the protein-based pandemic influenza vaccine
currently stockpiled by the U.S. government was approved with HI titers of
40 or more in 44% of subjects by Day 56.
Even at the lowest dose tested (0.033 mg H5 DNA), one of the six
subjects was a responder by Day 56. Some subjects who received the highest
H5 DNA dose were responders at Day 21 after a single vaccine injection.
Preliminary analyses also showed cross-strain immune responses against a
strain of H5N1 from a clade not matching the vaccine. Cross-strain
protection could be important against emerging strains of pandemic
influenza that may not match vaccine stockpiles.
Additional assays are ongoing to further evaluate antibody responses,
breadth and magnitude of T-cell immune responses, cross-strain responses,
and the relative advantages of monovalent vs. trivalent vaccines and needle
vs. needle-free injection.
"These results are important to Vical for three reasons," added Mr.
Samant. "First, they encourage further development of pandemic influenza
DNA vaccines, for which we are currently exploring funding or partnering
options. Second, they support advancement of additional
Vaxfectin(R)-formulated DNA vaccines toward clinical testing. Third, they
provide new incentives for potential commercial partners and collaborators
to explore additional applications for our Vaxfectin(R) adjuvant for DNA
vaccines as well as protein and peptide-based vaccines. We are excited by
these strong preliminary antibody results, and we look forward to
evaluating more detailed immunogenicity data as they become available."
DNA vaccines may offer both technical and economic advantages compared
with conventional vaccine approaches. DNA vaccines encode certain proteins
associated with a target pathogen, rather than using any part of the
pathogen itself, and can prime the immune system as well as induce potent
antibody and T-cell immune responses. DNA vaccines contain no viral
particles, are non-infectious, and can be administered on a repeat basis
without unwanted immune responses. Additionally, DNA vaccines have the
potential to achieve proof of concept more quickly and cost-effectively
than conventional vaccines, and can be manufactured using uniform methods
of fermentation and purification, allowing significantly faster development
and production.
Vical's monovalent vaccine contains a plasmid (a closed loop of DNA)
encoding the hemagglutinin (HA) surface protein from the H5N1 influenza
virus strain, A/Vietnam/1203/04. It is designed primarily to elicit
antibody responses against the H5 protein but could elicit T-cell responses
against H5 as well. Vical's trivalent vaccine contains the H5 plasmid plus
separate plasmids encoding consensus sequences of two highly conserved
influenza virus proteins: nucleoprotein (NP) and ion channel protein (M2).
The trivalent vaccine is designed to elicit a combination of T-cell and
antibody responses against all three proteins. Both vaccines are formulated
with the company's Vaxfectin(R) adjuvant, which has demonstrated
effectiveness with a variety of DNA vaccines in multiple animal models as
well as dose-sparing and immune-enhancing ability in animals with a
conventional seasonal influenza vaccine.
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company's DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at vical.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected. Forward-looking statements include statements about the
preliminary results of the company's DNA vaccine Phase 1 clinical trial,
the effect of the preliminary Phase 1 clinical trial results on the
company's DNA vaccine and Vaxfectin(R) adjuvant programs and its
collaborative opportunities, and the design and potential benefits of the
company's pandemic influenza vaccine and DNA vaccines generally. Risks and
uncertainties include whether preliminary H5N1 DNA vaccine Phase 1 clinical
trial results will be confirmed upon further analysis or in larger studies;
whether DNA vaccines against H5N1 influenza or any other targets will be
successfully developed and commercialized; whether DNA vaccines will become
alternatives to conventional vaccines; whether DNA vaccines will achieve
immune responses in the same range as conventional vaccines in future
trials; whether infrastructure will be established to manufacture DNA
vaccines at commercial scale in weeks; whether additional data will provide
evidence of neutralizing antibody production, cross-strain immune
responses, or T-cell responses; whether further analysis will reveal any
advantages for the monovalent or trivalent vaccines or for the needle or
needle-free injection methods; whether Vical or others will secure funding
to advance the pandemic influenza DNA vaccine program; whether commercial
partners or collaborators will pursue additional Vaxfectin(R) applications;
whether any product candidates will be shown to be safe and efficacious in
clinical trials; the timing of clinical trials; whether Vical or its
collaborative partners will seek or gain approval to market any product
candidates; the dependence of the company on its collaborative partners;
and additional risks set forth in the company's filings with the Securities
and Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements.
Vical Incorporated
vical
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