Influenza is and remains a disease to reckon with. Seasonal epidemics around the world kill several hundred thousand people every year. In the light of looming pandemics if bird flu strains develop the ability to infect humans easily, new drugs and vaccines are desperately sought. Researchers at the European Molecular Biology Laboratory (EMBL) and the joint Unit of Virus Host-Cell Interaction (UVHCI) of EMBL, the University Joseph Fourier (UJF) and the National Centre for Scientific Research (CNRS), in Grenoble, France, have now precisely defined an important drug target in influenza. In this week's Nature they publish a high-resolution image of a crucial protein domain that allows the virus to hijack human cells and multiply in them.
When the influenza virus infects a host cell its goal is to produce many copies of itself that go on to attack even more cells. A viral enzyme, called polymerase, is key to this process. It both copies the genetic material of the virus and steers the host cell machinery towards the synthesis of viral proteins. It does this by stealing a small tag, called a cap, from host cell RNA molecules and adding it onto its own. The cap is a short extra piece of RNA, which must be present at the beginning of all messenger RNAs (mRNAs) to direct the cell's protein-synthesis machinery to the starting point. The viral polymerase binds to host cell mRNA via its cap, cuts the cap off and adds it to the beginning of its own mRNA - a process known as 'cap snatching'. But exactly how the polymerase achieves this and which of the three subunits of the enzyme does what, has remained controversial.
Researchers of the groups of Rob Ruigrok at the UVHCI and Stephen Cusack at EMBL have now discovered that part of a polymerase subunit called PA is responsible for cleaving the cap off the host mRNA.
"Our results came as a big surprise, because everybody thought that the cleaving activity resides in a different part of the polymerase," explains Rob Ruigrok, Vice-Director of the UVHCI.
"These new insights make PA a promising antiviral drug target. Inhibiting the cleaving of the cap is an efficient way to stop infection, because the virus can no longer multiply. Now we know where to focus drug design efforts," adds Stephen Cusack, Head of EMBL Grenoble and Director of the UVHCI.
The researchers produced crystals of the crucial PA domain and examined them with the powerful X-ray beams of the European Synchrotron Radiation Facility (ESRF) in Grenoble. The high-resolution image of the domain reveals the individual amino acids that constitute the active site responsible for cleaving the RNA; information that could guide the design of future antiviral drugs.
Only a few months ago the same group of scientists had already identified another key part of the influenza polymerase; a domain in the subunit called PB2 that recognises and binds to the host cap. Taken together the two findings provide a close-to-complete picture of the cap snatching mechanism that allows the influenza virus to take control over human cells.
Source: Anna-Lynn Wegener
European Molecular Biology Laboratory
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вторник, 13 сентября 2011 г.
New High-Speed Internet Health Information Network To Connect Colorado's Urban, Rural Health Care Providers
The Colorado Hospital Association (CHA) and the Colorado Behavioral Healthcare Council (CBHC) today announced that they have selected Qwest Communications (NYSE: Q) to provide high-speed broadband services that will link nearly 400 of the state's urban and rural health care and behavioral health providers, and facilitate telemedicine access. Once complete, the Colorado Telehealth Network will be the among the largest health care information networks in the United States.
The Colorado Telehealth Network, managed by CHA and CBHC and powered by Qwest, will also move Colorado one step closer to achieving one of Gov. Bill Ritter's promises: to significantly expand broadband communication to rural areas of the state.
"The ability of Colorado's health care providers to accurately exchange information with each other in a timely fashion is a critical component of the state's efforts to make health care more affordable, and to improve coverage and access," Ritter said. "I am pleased to see our vision of an interconnected system move one step closer to reality."
Once completed, the Colorado Telehealth Network will connect nearly 400 hospitals, clinics and other health care and behavioral health providers in Colorado to Qwest's national fiber-optic network and enable them to provide patients-especially those in rural areas-with state-of-the-art, long-distance medical care using speeds up to 100 megabits per second.
"Too many rural communities are isolated from many of the advanced diagnosis and treatment technologies available in urban areas," said CHA President and CEO Steven J. Summer. "The Colorado Telehealth Network, when implemented, will enable Coloradans to receive the right care, at the right place and at the right time."
Telehealth and telemedicine services provide patients in rural areas with access to critically needed medical specialists, in some instances without leaving their homes or communities. Intensive care providers can monitor critically ill patients around the clock and video conferencing allows specialists and mental health professionals to care for patients in different rural locations, often hundreds of miles away. The network will enhance the delivery of health services, help control costs and make care more affordable, reduce travel time for consumers, decrease medical errors and enable health care providers to share critical information. It also will minimize the amount of time workers are away from their jobs visiting health care professionals.
"The Colorado Telehealth Network will promote better health in many ways, while greatly reducing the need for rural residents to travel long distances to receive quality care," said George DelGrosso, executive director of the Colorado Behavioral Healthcare Council. "This innovative system will save lives and scarce health care resources."
Qwest will manage metro optical Ethernet and data networking technology to provide a secure, reliable, scalable voice and data platform to health care providers of all sizes, enabling them to share critical medical information over large distances, control costs and reduce patient travel time, thereby providing a better patient care experience. The high level of security and around-the-clock network management Qwest provides will help these medical institutions meet HIPAA compliance requirements.
"The Colorado Telehealth Network is an example of how Qwest's network solutions can eliminate the obstacle of geography and revolutionize the delivery of quality health care in rural areas of the state," said Sharon Montgomery, vice president, Qwest Government and Education Solutions. "Hospitals and clinics of all sizes will be able to use this technology to extend their reach to access remote information and expertise to deliver quality patient care to every community, regardless of location or size."
The Colorado Telehealth Network is funded by collaborating two awards from the Federal Communications Commission (FCC). An FCC award to CHA provides up to $4.6 million in federal funds over three years. When combined with a similar award to CBHC, $9.8 million will be available for the initiative. In addition, a 15 percent match from participating health care providers will supplement the program.
CHA and CBHC expect that the Colorado Telehealth Network will connect approximately 70 percent of the 388 eligible facilities by the end of the year and will complete connectivity in early 2010.
Source
Qwest Business
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The Colorado Telehealth Network, managed by CHA and CBHC and powered by Qwest, will also move Colorado one step closer to achieving one of Gov. Bill Ritter's promises: to significantly expand broadband communication to rural areas of the state.
"The ability of Colorado's health care providers to accurately exchange information with each other in a timely fashion is a critical component of the state's efforts to make health care more affordable, and to improve coverage and access," Ritter said. "I am pleased to see our vision of an interconnected system move one step closer to reality."
Once completed, the Colorado Telehealth Network will connect nearly 400 hospitals, clinics and other health care and behavioral health providers in Colorado to Qwest's national fiber-optic network and enable them to provide patients-especially those in rural areas-with state-of-the-art, long-distance medical care using speeds up to 100 megabits per second.
"Too many rural communities are isolated from many of the advanced diagnosis and treatment technologies available in urban areas," said CHA President and CEO Steven J. Summer. "The Colorado Telehealth Network, when implemented, will enable Coloradans to receive the right care, at the right place and at the right time."
Telehealth and telemedicine services provide patients in rural areas with access to critically needed medical specialists, in some instances without leaving their homes or communities. Intensive care providers can monitor critically ill patients around the clock and video conferencing allows specialists and mental health professionals to care for patients in different rural locations, often hundreds of miles away. The network will enhance the delivery of health services, help control costs and make care more affordable, reduce travel time for consumers, decrease medical errors and enable health care providers to share critical information. It also will minimize the amount of time workers are away from their jobs visiting health care professionals.
"The Colorado Telehealth Network will promote better health in many ways, while greatly reducing the need for rural residents to travel long distances to receive quality care," said George DelGrosso, executive director of the Colorado Behavioral Healthcare Council. "This innovative system will save lives and scarce health care resources."
Qwest will manage metro optical Ethernet and data networking technology to provide a secure, reliable, scalable voice and data platform to health care providers of all sizes, enabling them to share critical medical information over large distances, control costs and reduce patient travel time, thereby providing a better patient care experience. The high level of security and around-the-clock network management Qwest provides will help these medical institutions meet HIPAA compliance requirements.
"The Colorado Telehealth Network is an example of how Qwest's network solutions can eliminate the obstacle of geography and revolutionize the delivery of quality health care in rural areas of the state," said Sharon Montgomery, vice president, Qwest Government and Education Solutions. "Hospitals and clinics of all sizes will be able to use this technology to extend their reach to access remote information and expertise to deliver quality patient care to every community, regardless of location or size."
The Colorado Telehealth Network is funded by collaborating two awards from the Federal Communications Commission (FCC). An FCC award to CHA provides up to $4.6 million in federal funds over three years. When combined with a similar award to CBHC, $9.8 million will be available for the initiative. In addition, a 15 percent match from participating health care providers will supplement the program.
CHA and CBHC expect that the Colorado Telehealth Network will connect approximately 70 percent of the 388 eligible facilities by the end of the year and will complete connectivity in early 2010.
Source
Qwest Business
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LifeSaver - A Medical Emergency Record (EMR) And Medical History Repository On A Tiny Hardware Device
LifeSaver is a complete medical emergency record (EMR) and medical history repository on a tiny hardware device, portable in a wallet, on a necklace, or on a key ring.
If the bearer of this tiny USB drive is unable to speak, for example due to an accident, physical disability, injury or any other reason, LifeSaver will speak for her or him.
It contains all the pertinent emergency medical records / information that medical emergency response teams and doctors in a hospital need to correctly treat a patient; without wasting time on routine questions and tests hindering the rescue efforts. It contains the bearer's complete medical profile plus contact information and identifying pictures.
The patient's medical history, the medications, blood group, disabilities, insurance information and much more is instantly available. It can even be printed out, right in the ambulance and be delivered with the patient.
LifeSaver can be instrumental in saving lives for accident victims, disabled persons, soldiers, Alzheimer patients, diabetics, children, persons with life threatening allergies, boyscouts, outdoors / sports enthusiasts and many more.
It also includes MD, the bonus Medical Diary, which keeps track of blood glucose levels, cholesterol levels, weight and blood pressure values; all of which can be visualized as 3D charts and also as printouts.
A journal lets the owner keep track of their progress during dieting, disease tracking, visits, or their personal notes. Additionally, measurements and values can be visualized as 3D graphs or printed out.
Another important feature is the appointment book which lets the owner keep track of medical appointments and dates.
Lifesaver is a complete personal medical records software suite which can be the difference between life and death.
To a child injured away from home it could make the difference. To a parent with Alzheimer's it could mean a save return and treatment. To a sports or outdoors person it could mean rescue and/or identification and the list goes on...
Source:
wwwvivo/Main.htm
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If the bearer of this tiny USB drive is unable to speak, for example due to an accident, physical disability, injury or any other reason, LifeSaver will speak for her or him.
It contains all the pertinent emergency medical records / information that medical emergency response teams and doctors in a hospital need to correctly treat a patient; without wasting time on routine questions and tests hindering the rescue efforts. It contains the bearer's complete medical profile plus contact information and identifying pictures.
The patient's medical history, the medications, blood group, disabilities, insurance information and much more is instantly available. It can even be printed out, right in the ambulance and be delivered with the patient.
LifeSaver can be instrumental in saving lives for accident victims, disabled persons, soldiers, Alzheimer patients, diabetics, children, persons with life threatening allergies, boyscouts, outdoors / sports enthusiasts and many more.
It also includes MD, the bonus Medical Diary, which keeps track of blood glucose levels, cholesterol levels, weight and blood pressure values; all of which can be visualized as 3D charts and also as printouts.
A journal lets the owner keep track of their progress during dieting, disease tracking, visits, or their personal notes. Additionally, measurements and values can be visualized as 3D graphs or printed out.
Another important feature is the appointment book which lets the owner keep track of medical appointments and dates.
Lifesaver is a complete personal medical records software suite which can be the difference between life and death.
To a child injured away from home it could make the difference. To a parent with Alzheimer's it could mean a save return and treatment. To a sports or outdoors person it could mean rescue and/or identification and the list goes on...
Source:
wwwvivo/Main.htm
wwwvivo/Specials/MedicalNewsToday50.htm
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MedImmune Receives Complete Response Letter From FDA For New Formulation Of FluMist(R)
MedImmune, Inc.
(Nasdaq: MEDI) announced today that the U.S. Food and Drug Administration
(FDA) has issued a Complete Response Letter (CRL) for a supplemental
biologics license application (sBLA) related to the new formulation of
FluMist (Influenza Virus Vaccine Live, Intranasal) for the current approved
indication. With the sBLA, MedImmune is seeking approval to use
refrigerator-stable CAIV-T (cold adapted influenza vaccine, trivalent) in
preventing influenza in healthy individuals 5 to 49 years of age. The FDA
is requesting clarification and additional information relating to data
previously submitted.
"Based on our review of the letter received, we expect to fully respond
to the agency within two to four weeks," said Linda J. Peters, senior vice
president, regulatory affairs. "We are confident that our continued
interaction with the FDA will result in approval of the new formulation of
our intranasal vaccine in advance of the 2007-2008 influenza season. CAIV-T
will bring an added level of convenience to administering the vaccine and
establish the basis upon which the company plans to expand the product's
label."
MedImmune plans to submit a separate sBLA to the FDA within the next
few weeks requesting an expanded label for FluMist. This sBLA will include
data from a Phase 3 study involving approximately 8,500 children between 6
months and 59 months of age.
Ms. Peters added, "We remain on track with our plans to launch in time
for the 2007-2008 influenza season an improved formulation of our
intranasal influenza vaccine with an expanded indication down to one year
of age."
About FluMist
FluMist is indicated for active immunization for the prevention of
disease caused by influenza A and B viruses in healthy children and
adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of
age. There are risks associated with all vaccines, including FluMist. Like
any vaccine, FluMist does not protect 100 percent of individuals
vaccinated. In studies of people between the ages of 5 and 49 years, runny
nose was the most commonly reported side effect. Other common side effects
included various cold-like symptoms, such as headache, cough, sore throat,
tiredness/weakness, irritability, and muscle aches.
FluMist should not be used, under any circumstances, in anyone with an
allergy to any part of the vaccine, including eggs; in children and
adolescents receiving aspirin therapy; in people who have a history of
Guillain-Barre syndrome; and in people with known or suspected immune
system problems. Pregnant women and people with certain medical conditions,
asthma, or reactive airways disease should not get FluMist.
Please see the Prescribing Information at: flumist/pdf/prescribinginfo.pdf or visit
flumist
About CAIV-T
CAIV-T is an investigational intranasal, cold-adapted trivalent
influenza vaccine. It is the next-generation, refrigerator-stable
formulation of FluMist, which is a frozen, live attenuated cold-adapted
trivalent influenza vaccine. To date, the safety, tolerability and efficacy
of CAIV-T has been studied in both healthy and at-risk populations between
the ages of 6 weeks and 98 years.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value
to shareholders. Dedicated to advancing science and medicine to help people
live better lives, the company is focused on the areas of infectious
diseases, cancer and inflammatory diseases. With more than 2,300 employees
worldwide, MedImmune is headquartered in Maryland. For more information,
visit the company's website at medimmune.
This announcement contains, in addition to historical information,
certain "forward-looking statements" regarding the regulatory approval
process and development plans for CAIV-T. Such forward-looking statements
are based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change current
expectations and could cause actual outcomes and results to differ
materially from current expectations. In addition to risks and
uncertainties discussed in MedImmune's filings with the U.S. Securities and
Exchange Commission, no assurance exists that development efforts for
CAIV-T will succeed, that CAIV-T will receive required regulatory approval
or that, even if regulatory approval is received, CAIV-T will be
commercially successful. MedImmune undertakes no obligation to update any
forward-looking statement, whether as a result of new information, future
events or otherwise except as may be required by applicable law or
regulation.
MedImmune, Inc.
medimmune
View drug information on FluMist.
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(Nasdaq: MEDI) announced today that the U.S. Food and Drug Administration
(FDA) has issued a Complete Response Letter (CRL) for a supplemental
biologics license application (sBLA) related to the new formulation of
FluMist (Influenza Virus Vaccine Live, Intranasal) for the current approved
indication. With the sBLA, MedImmune is seeking approval to use
refrigerator-stable CAIV-T (cold adapted influenza vaccine, trivalent) in
preventing influenza in healthy individuals 5 to 49 years of age. The FDA
is requesting clarification and additional information relating to data
previously submitted.
"Based on our review of the letter received, we expect to fully respond
to the agency within two to four weeks," said Linda J. Peters, senior vice
president, regulatory affairs. "We are confident that our continued
interaction with the FDA will result in approval of the new formulation of
our intranasal vaccine in advance of the 2007-2008 influenza season. CAIV-T
will bring an added level of convenience to administering the vaccine and
establish the basis upon which the company plans to expand the product's
label."
MedImmune plans to submit a separate sBLA to the FDA within the next
few weeks requesting an expanded label for FluMist. This sBLA will include
data from a Phase 3 study involving approximately 8,500 children between 6
months and 59 months of age.
Ms. Peters added, "We remain on track with our plans to launch in time
for the 2007-2008 influenza season an improved formulation of our
intranasal influenza vaccine with an expanded indication down to one year
of age."
About FluMist
FluMist is indicated for active immunization for the prevention of
disease caused by influenza A and B viruses in healthy children and
adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of
age. There are risks associated with all vaccines, including FluMist. Like
any vaccine, FluMist does not protect 100 percent of individuals
vaccinated. In studies of people between the ages of 5 and 49 years, runny
nose was the most commonly reported side effect. Other common side effects
included various cold-like symptoms, such as headache, cough, sore throat,
tiredness/weakness, irritability, and muscle aches.
FluMist should not be used, under any circumstances, in anyone with an
allergy to any part of the vaccine, including eggs; in children and
adolescents receiving aspirin therapy; in people who have a history of
Guillain-Barre syndrome; and in people with known or suspected immune
system problems. Pregnant women and people with certain medical conditions,
asthma, or reactive airways disease should not get FluMist.
Please see the Prescribing Information at: flumist/pdf/prescribinginfo.pdf or visit
flumist
About CAIV-T
CAIV-T is an investigational intranasal, cold-adapted trivalent
influenza vaccine. It is the next-generation, refrigerator-stable
formulation of FluMist, which is a frozen, live attenuated cold-adapted
trivalent influenza vaccine. To date, the safety, tolerability and efficacy
of CAIV-T has been studied in both healthy and at-risk populations between
the ages of 6 weeks and 98 years.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value
to shareholders. Dedicated to advancing science and medicine to help people
live better lives, the company is focused on the areas of infectious
diseases, cancer and inflammatory diseases. With more than 2,300 employees
worldwide, MedImmune is headquartered in Maryland. For more information,
visit the company's website at medimmune.
This announcement contains, in addition to historical information,
certain "forward-looking statements" regarding the regulatory approval
process and development plans for CAIV-T. Such forward-looking statements
are based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change current
expectations and could cause actual outcomes and results to differ
materially from current expectations. In addition to risks and
uncertainties discussed in MedImmune's filings with the U.S. Securities and
Exchange Commission, no assurance exists that development efforts for
CAIV-T will succeed, that CAIV-T will receive required regulatory approval
or that, even if regulatory approval is received, CAIV-T will be
commercially successful. MedImmune undertakes no obligation to update any
forward-looking statement, whether as a result of new information, future
events or otherwise except as may be required by applicable law or
regulation.
MedImmune, Inc.
medimmune
View drug information on FluMist.
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Carfilzomib Demonstrates Encouraging Response Rates In Patients With Relapsed And/or Refractory Multiple Myeloma In An Ongoing Phase 2 Study
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced results from an ongoing Phase 2 study, known as the 004 study, of the company's lead proteasome inhibitor, carfilzomib. Results demonstrated promising overall response rates when carfilzomib was administered as a single agent in patients with relapsed and/or refractory multiple myeloma. These data were presented at the 51st annual meeting of the American Society of Hematology (ASH) in New Orleans.
Patients were divided into two populations: 73 evaluable patients with relapsed and/or refractory multiple myeloma who had not received prior bortezomib (Velcade®) treatment, classified as bortezomib-naive patients, and 33 evaluable patients with relapsed and/or refractory disease following bortezomib treatment, classified as bortezomib-treated patients.
Michael Wang, M.D., assistant professor, department of lymphoma and myeloma at the University of Texas M. D. Anderson Cancer Center and co-investigator of the study, reported that the bortezomib-naive patients when treated with carfilzomib achieved an overall response rate (ORR) of 46 percent in 54 evaluable patients at 20 mg/m2 and 53 percent in 19 evaluable patients with dose escalation to 27 mg/m2. Additionally, Dr. Wang reported interim results for secondary endpoints at the 20 mg/m2 dose, including time-to-progression (TTP) of 7.6 months and duration of response (DoR) of 8.4 months.
David Siegel, M.D., Ph.D., division chief of myeloma at the John Theurer Cancer Center and co-investigator of the study, reported that 33 evaluable patients who were previously treated with bortezomib achieved an ORR of 18 percent when administered carfilzomib. Dr. Siegel reported interim results for a secondary endpoint of TTP at 5.3 months and DoR of more than 9 months. More than 20 percent of patients were able to complete the full 12 cycles (48 weeks) of therapy in both studies without cumulative side effects.
"These interim results suggest that carfilzomib could benefit patients with multiple myeloma who are no longer responding to current therapies," said Dr. Siegel. "Additionally, given the low incidence of neuropathy and generally mild and manageable adverse events in this trial, these results suggest that increasing the dosage of carfilzomib up to 27 mg/m2 is well tolerated despite a high degree of coexisting medical conditions, such as renal insufficiency and diabetes."
Overall, treatment with carfilzomib was well tolerated and no unexpected side effects occurred. The most common grade 3 treatment-related adverse events occurred in less than 5 percent of the patients and included fatigue, pneumonia, neutropenia, lymphopenia and anemia. Peripheral neuropathy of any grade was rare and there were no grade 4 adverse events observed.
Other findings from the two populations include:
-- Carfilzomib has substantial single-agent activity despite several prior treatments with different combination regimens.
-- Carfilzomib was well-tolerated with chronic administration, even in patients with renal insufficiency.
-- Patients were able to remain on full-dose therapy for more than 12 cycles.
"These data support our ongoing carfilzomib program in multiple myeloma, a disease that has poor long-term survival, and for which there are no alternative courses of therapy for patients who relapse following treatment or become resistant to currently approved therapies," said Michael Kauffman, M.D., Ph.D., interim chief medical officer at Onyx. "There is a clear need to provide new treatment options to patients with multiple myeloma, and we are working to potentially file a New Drug Application for carfilzomib by the end of 2010."
Trial Design
This open-label, single agent ongoing Phase 2 study is being conducted in collaboration with the Multiple Myeloma Research Consortium, and is designed to enroll approximately 150 patients with relapsed and/or refractory multiple myeloma who have received 1-3 prior treatments. Patients included two populations: bortezomib-naive patients with relapsed and/or refractory multiple myeloma and bortezomib-treated patients with relapsed and/or refractory multiple myeloma. Prior therapies include alkylating agents, stem cell transplant, thalidomide, lenalidomide and anthracyclines, and bortezomib in the bortezomib-treated patients. To date, 73 evaluable bortezomib-naive patients (54 who received 20mg/m2 and 19 who received up to 27mg/m2), and 33 evaluable patients receiving previous treatment with bortezomib have been enrolled. The primary endpoint is overall response rate and secondary endpoints include TTP, DoR, overall survival and safety.
About Carfilzomib
Carfilzomib is a selective, next generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma. Carfilzomib is currently undergoing evaluation as a single agent in multiple Phase 2 and Phase 1 clinical trials in relapsed or refractory multiple myeloma. These trials include a Phase 2b monotherapy study, known as the 003 study, in patients with relapsed, refractory multiple myeloma, the pivotal trial that could support a new drug application (NDA) filing by the end of 2010. Carfilzomib is also being evaluated in advanced solid tumors.
About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with MM and approximately 20,000 new cases are diagnosed annually.(i) Worldwide, more than 180,000 people are living with MM and approximately 86,000 new cases are diagnosed annually.(ii)
About Onyx Pharmaceuticals, Inc
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a next-generation proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, a targeted alpha-folate inhibitor, is currently in Phase 1 testing.
Nexavar® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals.
Velcade® is a trademark of Millennium Pharmaceuticals, Inc.
Revlimid® and Thalomid® are registered trademarks of Celgene Corporation.
Forward Looking Statements
This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the anticipated benefits of the acquisition of Proteolix and the timing, progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of carfilzomib. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including the risk that Proteolix's operations will not be integrated successfully into Onyx's, the risk that Onyx may not realize the anticipated benefits of the acquisition and risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2008, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
(i) National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
(ii) International Agency for Research on Cancer , GLOBOCAN 2002 database
Source: Onyx Pharmaceuticals, Inc
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Patients were divided into two populations: 73 evaluable patients with relapsed and/or refractory multiple myeloma who had not received prior bortezomib (Velcade®) treatment, classified as bortezomib-naive patients, and 33 evaluable patients with relapsed and/or refractory disease following bortezomib treatment, classified as bortezomib-treated patients.
Michael Wang, M.D., assistant professor, department of lymphoma and myeloma at the University of Texas M. D. Anderson Cancer Center and co-investigator of the study, reported that the bortezomib-naive patients when treated with carfilzomib achieved an overall response rate (ORR) of 46 percent in 54 evaluable patients at 20 mg/m2 and 53 percent in 19 evaluable patients with dose escalation to 27 mg/m2. Additionally, Dr. Wang reported interim results for secondary endpoints at the 20 mg/m2 dose, including time-to-progression (TTP) of 7.6 months and duration of response (DoR) of 8.4 months.
David Siegel, M.D., Ph.D., division chief of myeloma at the John Theurer Cancer Center and co-investigator of the study, reported that 33 evaluable patients who were previously treated with bortezomib achieved an ORR of 18 percent when administered carfilzomib. Dr. Siegel reported interim results for a secondary endpoint of TTP at 5.3 months and DoR of more than 9 months. More than 20 percent of patients were able to complete the full 12 cycles (48 weeks) of therapy in both studies without cumulative side effects.
"These interim results suggest that carfilzomib could benefit patients with multiple myeloma who are no longer responding to current therapies," said Dr. Siegel. "Additionally, given the low incidence of neuropathy and generally mild and manageable adverse events in this trial, these results suggest that increasing the dosage of carfilzomib up to 27 mg/m2 is well tolerated despite a high degree of coexisting medical conditions, such as renal insufficiency and diabetes."
Overall, treatment with carfilzomib was well tolerated and no unexpected side effects occurred. The most common grade 3 treatment-related adverse events occurred in less than 5 percent of the patients and included fatigue, pneumonia, neutropenia, lymphopenia and anemia. Peripheral neuropathy of any grade was rare and there were no grade 4 adverse events observed.
Other findings from the two populations include:
-- Carfilzomib has substantial single-agent activity despite several prior treatments with different combination regimens.
-- Carfilzomib was well-tolerated with chronic administration, even in patients with renal insufficiency.
-- Patients were able to remain on full-dose therapy for more than 12 cycles.
"These data support our ongoing carfilzomib program in multiple myeloma, a disease that has poor long-term survival, and for which there are no alternative courses of therapy for patients who relapse following treatment or become resistant to currently approved therapies," said Michael Kauffman, M.D., Ph.D., interim chief medical officer at Onyx. "There is a clear need to provide new treatment options to patients with multiple myeloma, and we are working to potentially file a New Drug Application for carfilzomib by the end of 2010."
Trial Design
This open-label, single agent ongoing Phase 2 study is being conducted in collaboration with the Multiple Myeloma Research Consortium, and is designed to enroll approximately 150 patients with relapsed and/or refractory multiple myeloma who have received 1-3 prior treatments. Patients included two populations: bortezomib-naive patients with relapsed and/or refractory multiple myeloma and bortezomib-treated patients with relapsed and/or refractory multiple myeloma. Prior therapies include alkylating agents, stem cell transplant, thalidomide, lenalidomide and anthracyclines, and bortezomib in the bortezomib-treated patients. To date, 73 evaluable bortezomib-naive patients (54 who received 20mg/m2 and 19 who received up to 27mg/m2), and 33 evaluable patients receiving previous treatment with bortezomib have been enrolled. The primary endpoint is overall response rate and secondary endpoints include TTP, DoR, overall survival and safety.
About Carfilzomib
Carfilzomib is a selective, next generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma. Carfilzomib is currently undergoing evaluation as a single agent in multiple Phase 2 and Phase 1 clinical trials in relapsed or refractory multiple myeloma. These trials include a Phase 2b monotherapy study, known as the 003 study, in patients with relapsed, refractory multiple myeloma, the pivotal trial that could support a new drug application (NDA) filing by the end of 2010. Carfilzomib is also being evaluated in advanced solid tumors.
About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with MM and approximately 20,000 new cases are diagnosed annually.(i) Worldwide, more than 180,000 people are living with MM and approximately 86,000 new cases are diagnosed annually.(ii)
About Onyx Pharmaceuticals, Inc
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a next-generation proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, a targeted alpha-folate inhibitor, is currently in Phase 1 testing.
Nexavar® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals.
Velcade® is a trademark of Millennium Pharmaceuticals, Inc.
Revlimid® and Thalomid® are registered trademarks of Celgene Corporation.
Forward Looking Statements
This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the anticipated benefits of the acquisition of Proteolix and the timing, progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of carfilzomib. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including the risk that Proteolix's operations will not be integrated successfully into Onyx's, the risk that Onyx may not realize the anticipated benefits of the acquisition and risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2008, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
(i) National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
(ii) International Agency for Research on Cancer , GLOBOCAN 2002 database
Source: Onyx Pharmaceuticals, Inc
View drug information on Nexavar; Revlimid; Thalomid.
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Interaction Between Lymph And Liver Cells May Affect Immune Response
A new study on the ability of liver cells to interact with T cells (lymph cells that play a role in regulating the immune response) found that such interactions do occur and demonstrated the mechanism by which they may take place. The results may help explain the altered immune responses that occur with aging and other conditions and may be useful in developing therapies for viral hepatitis and autoimmune diseases.
The results of this study appear in the November 2006 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience.
The liver possesses an unusual ability to stimulate immune tolerance, possibly due to its distinctive architecture that allows T cells normally activated in the lymph system to become activated by liver cells. Normally, endothelial cells that line blood vessels form a physical barrier that prevents naГЇve (unactivated) T cells from accessing surrounding tissue; these cells must typically be activated by specialized cells known as professional antigen presenting cells (APCs) before they are able to migrate across the endothelium and interact with organ cells. Recent studies have shown that the liver is an exception in that liver cells may be able to act as APCs, activating T cells independently of the lymph system, a process which makes them less efficient. However, the question remains as to how T cells can cross the endothelial barrier to interact with liver cells.
A collaborative work between Alessandra Warren and David Le Couteur of the Centre for Education and Research on Ageing (CERA), Concord RG Hospital and Patrick Bertolino of the Centenary Institute, University of Sydney, Australia, has led to the first study investigating the interactions between lymphocytes (T cells), liver sinusoidal endothelial cells (LSECs) and hepatocytes (liver cells) using electron microscopy. LSECs are highly specialized endothelial cells that line the walls of hepatic sinusoid cells (gossamer-like structures that form the rich capillary network of the liver) and are perforated by fenestrations, or openings. The researchers hypothesized that the fenestrations could provide a portal through which liver cells and T cells could interact or that the interaction could take place across gaps between LSECs.
The study was conducted using mice whose livers had been injected with lymphocytes. The mouse livers were examined with two types of electron microscopy. Analysis of the images showed a large number of intrahepatic lymphocytes (IHLs) that had extensions similar to the dimensions of the fenestrations of the LSECs. These extensions were seen within the fenestrations and were observed to be in contact with minute projections on liver cells (hepatocyte microvilli). There were no observable gaps between LSECs and hepatocyte microvilli did not seem to interact with circulating lymphocytes. Further investigation showed that naive T cells displayed the same extensions as IHLs and were also able to interact with liver cells through LSEC fenestrations. The authors propose the term "trans-endothelial hepatocyte-lymphocyte interactions" (TEHLI) to describe these interactions.
The discovery of TEHLI is the first demonstration by electron microscopy of the interaction between naive T cells and liver cells in a living organism, which shows that the liver is an exception to the rule that T cells need to be activated by professional APCs in order to cross the endothelial barrier, and that hepatocytes can function as APCs. In fact, this T cell activation in the liver during early hepatitis C infection may contribute to the impaired immune response seen in chronic hepatitis C.
"As well as providing insight into the normal immune system, our observations might have implications for liver conditions associated with altered LSEC morphology and in particular those conditions associated with loss of fenestrations such as cirrhosis and old age," the authors conclude. "We have shown [in previous studies] that old age is associated with dramatic reductions in the fenestrations of LSECs therefore the altered immune responses of older people might in part be mechanistically linked to reduced opportunity for TEHLI in old age."
In an accompanying editorial in the same issue, Erin F. McAvoy and Paul Kubes of the University of Calgary in Alberta, Canada note that although the authors did not observe any interaction between hepatocyte microvilli and circulating lymphocytes, it is possible that this type of transient interaction is difficult to capture using electron microscopy. They suggest that the hepatocyte microvilli could function as a rapid screen for circulating lymphocytes, which might then decide to adhere and start the TEHLI process. "The notion that naive T lymphocytes are capable of directly interacting with hepatocytes contradicts the dogma that naive T cells cannot gain access to peripheral non-lymphoid tissues," the authors state, adding that the study furthers the notion that liver cells may be involved in hepatic immune tolerance. "Like any good study," they conclude, "the work of Warren et al., answers important questions but also raises some new and intriguing areas for further exploration."
Article: "T Lymphocytes Interact With Hepatocytes Through Fenestrations in Murine Liver Sinusoidal Endothelial Cells," Alessandra Warren, David G. Le Couteur, Robin Fraser, David G. Bowen, Geoffrey W. McCaughan, Patrick Bertolino, Hepatology; November 2006 (DOI: 10.1002/hep.21378).
Editorial: "Holey Endothelium: Gateways for Naive T Cell Activation," Erin F. McAvoy, Paul Kubes, Hepatology; November 2006 (DOI: 10.1002/hep.21421).
Contact: David Greenberg
John Wiley & Sons, Inc.
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The results of this study appear in the November 2006 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience.
The liver possesses an unusual ability to stimulate immune tolerance, possibly due to its distinctive architecture that allows T cells normally activated in the lymph system to become activated by liver cells. Normally, endothelial cells that line blood vessels form a physical barrier that prevents naГЇve (unactivated) T cells from accessing surrounding tissue; these cells must typically be activated by specialized cells known as professional antigen presenting cells (APCs) before they are able to migrate across the endothelium and interact with organ cells. Recent studies have shown that the liver is an exception in that liver cells may be able to act as APCs, activating T cells independently of the lymph system, a process which makes them less efficient. However, the question remains as to how T cells can cross the endothelial barrier to interact with liver cells.
A collaborative work between Alessandra Warren and David Le Couteur of the Centre for Education and Research on Ageing (CERA), Concord RG Hospital and Patrick Bertolino of the Centenary Institute, University of Sydney, Australia, has led to the first study investigating the interactions between lymphocytes (T cells), liver sinusoidal endothelial cells (LSECs) and hepatocytes (liver cells) using electron microscopy. LSECs are highly specialized endothelial cells that line the walls of hepatic sinusoid cells (gossamer-like structures that form the rich capillary network of the liver) and are perforated by fenestrations, or openings. The researchers hypothesized that the fenestrations could provide a portal through which liver cells and T cells could interact or that the interaction could take place across gaps between LSECs.
The study was conducted using mice whose livers had been injected with lymphocytes. The mouse livers were examined with two types of electron microscopy. Analysis of the images showed a large number of intrahepatic lymphocytes (IHLs) that had extensions similar to the dimensions of the fenestrations of the LSECs. These extensions were seen within the fenestrations and were observed to be in contact with minute projections on liver cells (hepatocyte microvilli). There were no observable gaps between LSECs and hepatocyte microvilli did not seem to interact with circulating lymphocytes. Further investigation showed that naive T cells displayed the same extensions as IHLs and were also able to interact with liver cells through LSEC fenestrations. The authors propose the term "trans-endothelial hepatocyte-lymphocyte interactions" (TEHLI) to describe these interactions.
The discovery of TEHLI is the first demonstration by electron microscopy of the interaction between naive T cells and liver cells in a living organism, which shows that the liver is an exception to the rule that T cells need to be activated by professional APCs in order to cross the endothelial barrier, and that hepatocytes can function as APCs. In fact, this T cell activation in the liver during early hepatitis C infection may contribute to the impaired immune response seen in chronic hepatitis C.
"As well as providing insight into the normal immune system, our observations might have implications for liver conditions associated with altered LSEC morphology and in particular those conditions associated with loss of fenestrations such as cirrhosis and old age," the authors conclude. "We have shown [in previous studies] that old age is associated with dramatic reductions in the fenestrations of LSECs therefore the altered immune responses of older people might in part be mechanistically linked to reduced opportunity for TEHLI in old age."
In an accompanying editorial in the same issue, Erin F. McAvoy and Paul Kubes of the University of Calgary in Alberta, Canada note that although the authors did not observe any interaction between hepatocyte microvilli and circulating lymphocytes, it is possible that this type of transient interaction is difficult to capture using electron microscopy. They suggest that the hepatocyte microvilli could function as a rapid screen for circulating lymphocytes, which might then decide to adhere and start the TEHLI process. "The notion that naive T lymphocytes are capable of directly interacting with hepatocytes contradicts the dogma that naive T cells cannot gain access to peripheral non-lymphoid tissues," the authors state, adding that the study furthers the notion that liver cells may be involved in hepatic immune tolerance. "Like any good study," they conclude, "the work of Warren et al., answers important questions but also raises some new and intriguing areas for further exploration."
Article: "T Lymphocytes Interact With Hepatocytes Through Fenestrations in Murine Liver Sinusoidal Endothelial Cells," Alessandra Warren, David G. Le Couteur, Robin Fraser, David G. Bowen, Geoffrey W. McCaughan, Patrick Bertolino, Hepatology; November 2006 (DOI: 10.1002/hep.21378).
Editorial: "Holey Endothelium: Gateways for Naive T Cell Activation," Erin F. McAvoy, Paul Kubes, Hepatology; November 2006 (DOI: 10.1002/hep.21421).
Contact: David Greenberg
John Wiley & Sons, Inc.
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Advanced Pancreatic Cancer Patients May Benefit From Bacteriolytic Therapy
The aim of cancer immunotherapy is the stimulation of immune mechanisms to recognize malignant cells and may be a useful complementary therapy to conventional anticancer therapy. Immunotherapy was initiated over 100 years ago when New York surgeon William B. Coley inoculated a bacterial vaccine consisting of Streptococcus pyogenes and Serratia marcescens. Several patients experienced a beneficial effect on malignancy and were finally cured of their tumours by the development of a potent immune response.
A research article published in the World Journal of Gastroenterology worked on this old idea. The research team led by Dr. Michael Linnebacher from the University of Rostock treated pancreatic carcinoma with Clostridium novyi-spores. In their experimental model they analyzed animals with tumours of different sizes. Treatment success depended on tumour size. Small tumours were completely unaffected whereas the treatment was toxic in cases of very large tumours. Most interestingly, tumours of a defined medium size completely disappeared and animals remained free of tumour recurrence. The authors showed that immune mechanisms were responsible for this success.
The bacterial spores germinate and grow in the oxygen-free tumour centres where they damage surrounding tumour cells. This together with an infection-driven infiltration of tumours by cells of the innate immune system leads to significant damage to tumours.
These data indicate that the application of bacteria may be a promising treatment strategy for patients with advanced pancreatic cancer and warrants further investigation.
Reference:
Maletzki C, Gock M, Klier U, Klar E, Linnebacher M. Bacteriolytic therapy of experimental pancreatic carcinoma. World J Gastroenterol 2010; 16(28): 3546-3552
Source:
Lin Tian
World Journal of Gastroenterology
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A research article published in the World Journal of Gastroenterology worked on this old idea. The research team led by Dr. Michael Linnebacher from the University of Rostock treated pancreatic carcinoma with Clostridium novyi-spores. In their experimental model they analyzed animals with tumours of different sizes. Treatment success depended on tumour size. Small tumours were completely unaffected whereas the treatment was toxic in cases of very large tumours. Most interestingly, tumours of a defined medium size completely disappeared and animals remained free of tumour recurrence. The authors showed that immune mechanisms were responsible for this success.
The bacterial spores germinate and grow in the oxygen-free tumour centres where they damage surrounding tumour cells. This together with an infection-driven infiltration of tumours by cells of the innate immune system leads to significant damage to tumours.
These data indicate that the application of bacteria may be a promising treatment strategy for patients with advanced pancreatic cancer and warrants further investigation.
Reference:
Maletzki C, Gock M, Klier U, Klar E, Linnebacher M. Bacteriolytic therapy of experimental pancreatic carcinoma. World J Gastroenterol 2010; 16(28): 3546-3552
Source:
Lin Tian
World Journal of Gastroenterology
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Health-Care Delivery Contributes To Racial Disparity In Colorectal Cancer
African-Americans with health insurance still face worse outcomes in colorectal cancer than Caucasians, Hispanics, and Asians, according to a new study. Published in the February 1, 2007 issue of CANCER, a peer-reviewed journal of the American Cancer Society, the study reveals that differences in utilization of screening tests and surgical treatment may contribute to poorer colorectal cancer survival rates in African-Americans.
Colorectal cancer is preventable and even curable. Improvements in the sensitivity and specificity of screening tests and in treatment protocols have resulted in overall declines in mortality rates for colorectal cancer. However, studies have demonstrated and continue to show clear ethnic/racial differences in survival. African-Americans have the worst outcome of any ethnic/racial group, while Caucasians tend to fare worse than Asians. Access to healthcare is often cited as the cause of these disparities. In fact, studies show that, in general, people with health insurance are more likely to access preventive care than those without. However, the impact of health insurance and potential access has on colorectal cancer mortality by race has not been explored to date.
Led by Chyke A. Doubeni, M.D., M.P.H. of the University of Massachusetts Medical School and the Meyers Primary Care Institute in Worcester, MA, researchers from the National Cancer Institute-funded Cancer Research Network investigated the association between tumor stage and risk of death by race in colorectal cancer and factors related to ethnic/racial differences in a population of insured persons.
The authors found that African-Americans were more likely to have advanced disease and were at greatest risk of death compared to other ethnicities/races. Caucasians and Hispanics had similar cancer mortality risks, and Asians and Pacific Islanders were least likely to die of the cancer. In addition, African-Americans were less likely to receive surgical treatment for their tumors compared to Caucasians. The analysis demonstrated that earlier detection and higher utilization of surgery would each, independently, improve mortality risk.
"Despite the availability of health care insurance," the authors identified significant "racial differences in survival from colorectal cancer among patients receiving care from integrated health care systems." That the authors found earlier detection and surgery would improve African-American outcomes suggests "disparities may be due to racial differences in the receipt of cancer prevention, detection and treatment services." The authors recommended the implementation of standardized protocols for the delivery of cancer care services to vulnerable populations to reduce disparities.
Article: "Racial Differences in Tumor Stage and Survival for Colorectal Cancer in an Insured Population," Chyke A. Doubeni, Terry S. Field, Diana S. M. Buist, Eli J. Korner, Carol Bigelow, Lois Lamerato, Lisa Herrinton, Virginia P. Quinn, Gene Hart, Mark C. Hornbrook, Jerry H. Gurwitz, Edward H. Wagner, CANCER; Published Online: December 21, 2006 (DOI: 10.1002/cncr.22437); Print Issue Date: February 1, 2006.
Contact: Amy Molnar
John Wiley & Sons, Inc.
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Colorectal cancer is preventable and even curable. Improvements in the sensitivity and specificity of screening tests and in treatment protocols have resulted in overall declines in mortality rates for colorectal cancer. However, studies have demonstrated and continue to show clear ethnic/racial differences in survival. African-Americans have the worst outcome of any ethnic/racial group, while Caucasians tend to fare worse than Asians. Access to healthcare is often cited as the cause of these disparities. In fact, studies show that, in general, people with health insurance are more likely to access preventive care than those without. However, the impact of health insurance and potential access has on colorectal cancer mortality by race has not been explored to date.
Led by Chyke A. Doubeni, M.D., M.P.H. of the University of Massachusetts Medical School and the Meyers Primary Care Institute in Worcester, MA, researchers from the National Cancer Institute-funded Cancer Research Network investigated the association between tumor stage and risk of death by race in colorectal cancer and factors related to ethnic/racial differences in a population of insured persons.
The authors found that African-Americans were more likely to have advanced disease and were at greatest risk of death compared to other ethnicities/races. Caucasians and Hispanics had similar cancer mortality risks, and Asians and Pacific Islanders were least likely to die of the cancer. In addition, African-Americans were less likely to receive surgical treatment for their tumors compared to Caucasians. The analysis demonstrated that earlier detection and higher utilization of surgery would each, independently, improve mortality risk.
"Despite the availability of health care insurance," the authors identified significant "racial differences in survival from colorectal cancer among patients receiving care from integrated health care systems." That the authors found earlier detection and surgery would improve African-American outcomes suggests "disparities may be due to racial differences in the receipt of cancer prevention, detection and treatment services." The authors recommended the implementation of standardized protocols for the delivery of cancer care services to vulnerable populations to reduce disparities.
Article: "Racial Differences in Tumor Stage and Survival for Colorectal Cancer in an Insured Population," Chyke A. Doubeni, Terry S. Field, Diana S. M. Buist, Eli J. Korner, Carol Bigelow, Lois Lamerato, Lisa Herrinton, Virginia P. Quinn, Gene Hart, Mark C. Hornbrook, Jerry H. Gurwitz, Edward H. Wagner, CANCER; Published Online: December 21, 2006 (DOI: 10.1002/cncr.22437); Print Issue Date: February 1, 2006.
Contact: Amy Molnar
John Wiley & Sons, Inc.
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Agreement For Donation Of Pandemic H1N1 Vaccine Signed
GlaxoSmithKline(GSK) is to donate 50 million doses of pandemic H1N1 vaccine to the World Health Organization (WHO) under an agreement signed at WHO headquarters in Geneva by the WHO Director-General, Dr Margaret Chan, and the Chief Executive Officer of GlaxoSmithKline, Mr Andrew Witty.
"We welcome this very generous donation by GlaxoSmithKline, which will go to protect the health of the world's poorest people. This is a real gesture of global solidarity towards those who would not be otherwise able to have access to the vaccine," said Dr. Margaret Chan. "WHO will now work to see that these vaccines are distributed to those who need them."
GSK expects to prepare the first shipments of vaccine to the WHO by the end of November. The WHO has a list of 95 developing countries that are eligible to receive donated vaccines, and aims to secure enough vaccines to cover 10 percent of the population of these countries.
Source
WHO
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"We welcome this very generous donation by GlaxoSmithKline, which will go to protect the health of the world's poorest people. This is a real gesture of global solidarity towards those who would not be otherwise able to have access to the vaccine," said Dr. Margaret Chan. "WHO will now work to see that these vaccines are distributed to those who need them."
GSK expects to prepare the first shipments of vaccine to the WHO by the end of November. The WHO has a list of 95 developing countries that are eligible to receive donated vaccines, and aims to secure enough vaccines to cover 10 percent of the population of these countries.
Source
WHO
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New Data Support Routine Childhood Vaccination With PREVENAR In Europe - Shown To Reduce Invasive Pneumococcal Disease In Young Children
Data presented at the 26th annual meeting of the European Society for
Paediatric Infectious Diseases (ESPID) in Graz, Austria, provide additional
evidence of the public health impact of the routine use of Prevenar*
(Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), which helps protect
against the seven pneumococcal serotypes causing the majority of disease
worldwide.(1)
Specifically, since the introduction of Prevenar, also referred to as
PCV7, into Germany's pediatric immunization schedule in 2006, there has been
a 50 percent reduction in vaccine-type invasive pneumococcal disease (IPD) in
children younger than 2 years old compared with a pre-vaccine baseline.(2) In
addition, a slight reduction in vaccine-type IPD among children aged 2-5
years old, an unvaccinated group, also was documented, suggesting a potential
"indirect" effect among older children who were not immunized.(2)
"These data are compelling and demonstrate the rapid reduction of IPD in
German children following the inclusion of Prevenar in Germany's national
childhood immunization schedule," says Dr. Mark van der Linden, Head of the
National Reference Center for Streptococci at the Institute of Medical
Microbiology, RWTH-Aachen, Germany. "Importantly, the results are consistent
with the disease reduction documented in France and the United Kingdom, where
young children are routinely immunized with Prevenar, highlighting the impact
of the vaccine in countries where it is used across Europe." (3),(4)
"Since pneumococcal disease is the number one vaccine-preventable cause
of death in children younger than five years of age, we are incredibly proud
of the growing body of evidence supporting universal childhood vaccination
with Prevenar and are committed in our mission to help save children's
lives," says Bernard Fritzell, Vice President, International Scientific &
Clinical Affairs, Wyeth.(5)
In view of the demonstrated vaccine efficacy and high disease burden in
young children, WHO recommends the priority inclusion of PCV7 in national
immunization programs worldwide.(6) Further, in January 2008, the Strategic
Advisory Group of Experts (SAGE) to WHO issued a preliminary recommendation
that pneumococcal disease prevention be ranked as a very high priority on a
global basis.(7) Prevenar, the only licensed pneumococcal conjugate vaccine,
is available in 88 countries worldwide and is part of the routine national
childhood immunization schedule in more than 20 of these countries, 12 of
which are in Europe.(8)
Pneumococcal Disease
Pneumococcal disease affects both children and adults and is a leading
cause of illness and death worldwide.(9) Pneumococcal disease is caused by
the bacterium Streptococcus pneumoniae and describes a group of illnesses,
including invasive infections, such as bacteremia/sepsis and meningitis, as
well as pneumonia and upper respiratory tract infections, including otitis
media and sinusitis.
Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious disease, gastrointestinal health,
central nervous system, inflammation, transplantation, hemophilia, oncology,
vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and
health care products companies. It is a leader in the discovery, development,
manufacturing and marketing of pharmaceuticals, vaccines, biotechnology
products, nutritionals and non-prescription medicines that improve the
quality of life for people worldwide. The Company's major divisions include
Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.
References
(1). Hausdorff WP, Bryant J, Paradiso PR. Which pneumococcal serogroups
cause the most invasive disease: implications for conjugate vaccine
formulation and use, part I. CID 2000; 30:100-21.
(2). van der Linden M, Reinert R. Effects of the national immunization
program for PCV7 on IPD in children in Germany. Poster presented at the 26th
annual meeting of the European Society for Paediatric Infectious Diseases
(ESPID).
(3). Lepoutre A, Varon E, Georges S, et al. Impact des recommandations de
vaccination antipneumococcique par le vaccin conjugГ© heptavalent sur
l'incidence des infections invasives Г pneumocoque chez les enfants de moins
de deux ans. Institut de Veille Sanitaire. 2006.
(4). Health Protection Agency (HPA): Centre for Infections. Cumulative
weekly number of reports of invasive pneumococcal disease due to any of the
seven serotypes present in PCV-7: children Buy Cipro Without Prescription
Paediatric Infectious Diseases (ESPID) in Graz, Austria, provide additional
evidence of the public health impact of the routine use of Prevenar*
(Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), which helps protect
against the seven pneumococcal serotypes causing the majority of disease
worldwide.(1)
Specifically, since the introduction of Prevenar, also referred to as
PCV7, into Germany's pediatric immunization schedule in 2006, there has been
a 50 percent reduction in vaccine-type invasive pneumococcal disease (IPD) in
children younger than 2 years old compared with a pre-vaccine baseline.(2) In
addition, a slight reduction in vaccine-type IPD among children aged 2-5
years old, an unvaccinated group, also was documented, suggesting a potential
"indirect" effect among older children who were not immunized.(2)
"These data are compelling and demonstrate the rapid reduction of IPD in
German children following the inclusion of Prevenar in Germany's national
childhood immunization schedule," says Dr. Mark van der Linden, Head of the
National Reference Center for Streptococci at the Institute of Medical
Microbiology, RWTH-Aachen, Germany. "Importantly, the results are consistent
with the disease reduction documented in France and the United Kingdom, where
young children are routinely immunized with Prevenar, highlighting the impact
of the vaccine in countries where it is used across Europe." (3),(4)
"Since pneumococcal disease is the number one vaccine-preventable cause
of death in children younger than five years of age, we are incredibly proud
of the growing body of evidence supporting universal childhood vaccination
with Prevenar and are committed in our mission to help save children's
lives," says Bernard Fritzell, Vice President, International Scientific &
Clinical Affairs, Wyeth.(5)
In view of the demonstrated vaccine efficacy and high disease burden in
young children, WHO recommends the priority inclusion of PCV7 in national
immunization programs worldwide.(6) Further, in January 2008, the Strategic
Advisory Group of Experts (SAGE) to WHO issued a preliminary recommendation
that pneumococcal disease prevention be ranked as a very high priority on a
global basis.(7) Prevenar, the only licensed pneumococcal conjugate vaccine,
is available in 88 countries worldwide and is part of the routine national
childhood immunization schedule in more than 20 of these countries, 12 of
which are in Europe.(8)
Pneumococcal Disease
Pneumococcal disease affects both children and adults and is a leading
cause of illness and death worldwide.(9) Pneumococcal disease is caused by
the bacterium Streptococcus pneumoniae and describes a group of illnesses,
including invasive infections, such as bacteremia/sepsis and meningitis, as
well as pneumonia and upper respiratory tract infections, including otitis
media and sinusitis.
Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious disease, gastrointestinal health,
central nervous system, inflammation, transplantation, hemophilia, oncology,
vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and
health care products companies. It is a leader in the discovery, development,
manufacturing and marketing of pharmaceuticals, vaccines, biotechnology
products, nutritionals and non-prescription medicines that improve the
quality of life for people worldwide. The Company's major divisions include
Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.
References
(1). Hausdorff WP, Bryant J, Paradiso PR. Which pneumococcal serogroups
cause the most invasive disease: implications for conjugate vaccine
formulation and use, part I. CID 2000; 30:100-21.
(2). van der Linden M, Reinert R. Effects of the national immunization
program for PCV7 on IPD in children in Germany. Poster presented at the 26th
annual meeting of the European Society for Paediatric Infectious Diseases
(ESPID).
(3). Lepoutre A, Varon E, Georges S, et al. Impact des recommandations de
vaccination antipneumococcique par le vaccin conjugГ© heptavalent sur
l'incidence des infections invasives Г pneumocoque chez les enfants de moins
de deux ans. Institut de Veille Sanitaire. 2006.
(4). Health Protection Agency (HPA): Centre for Infections. Cumulative
weekly number of reports of invasive pneumococcal disease due to any of the
seven serotypes present in PCV-7: children Buy Cipro Without Prescription
Seasonal Flu Campaign In England Continues To Achieve One Of The Highest Uptakes Rates In The 65+ Age Group In Europe
Figures from the flu vaccination programme 2006/07, showed seventy
four per cent of those aged 65 and over received a flu jab by the end
of January 2007, and 42 per cent of those under 65 in at risk groups
were vaccinated.
In 2006/07, 6.2 million people in the 65 and over group were
vaccinationed against flu. This figure is comparable to last year's
campaign. (2005/06.)
The achievements of the flu campaign are all the more impressive
considering that vaccine deliveries were delayed by several weeks due
to manufacturing problems.
A new flu vaccination programme was announced in January for people
who work in close contact with poultry; nearly all PCTs have plans
to implement the programme, targeted for completion by March 31.
The Department of Health is also publishing today the review of the
seasonal flu programme commissioned by the Health Secretary after the
2005/06 campaign. The review identifies a number of ways for the
Department of Health and the NHS to build on the programme's
successes. The main recommendations are:
Sustain progress achieved so far:
-- Improve uptake among occupational health groups (health workers)
-- Enhance the role of influenza co-ordinators and improve national,
regional and local co-ordination and contingency planning.
-- Explore the full range of delivery mechanisms available to the NHS
through different contract types
-- Review future options for the purchase, supply and delivery of
vaccine
Many recommendations have already been implemented, for example,
improving communication with vaccine manufacturers and GPs.
Secretary of State Patricia Hewitt welcomed the report and commended
the reviewers for such a thorough piece of work and said that the
Department will be considering the detailed recommendations.
The review found greater public awareness of avian and pandemic flu
in 2005 meant that some GP practices could not immediately meet
public demand for flu vaccine and this may have led to reports of
shortages.
Dr David Salisbury, Director of Immunisation at the Department of
Health said;
"It is important to acknowledge the excellent achievement made by the
GPs, nurses, health service providers and primary care organisations
in delivering the seasonal flu programme in 2006/07. More than six
million people aged 65 and over were immunised against flu, which can
be a serious illness for older people.
"The seasonal flu review recognises that England runs an effective
seasonal flu vaccination programme that achieves one of the highest
uptakes in Europe. We accept in principle the recommendations to
strengthen the programme, while recognising that some details may
need to be considered more fully . We look forward to consulting
widely about this."
-- Copies of the review are available from the Department of Health here.
-- Regarding flu vaccine uptake figures, we have extrapolated the
figures up to assume a 100 per cent return from GP practices. We have
worked out how many people would have been vaccinated if we had
received a 100 per cent return for each of the years. This makes the
assumption that there are no differences in the size of the GP
practices returning data.
-- Flu uptake figures are published by the HPA.
5. For risk groups announced in last year's CMO annual letter to the
NHS for the 2006/07 seasonal flu campaign see, click here (PDF).
-- Influenza is an acute viral infection and in most years occurs
predominantly during a six to eight week period during the winter.
-- For most people, this seasonal influenza is an unpleasant but self
limiting and not life endangering illness. In some people it may be
more severe, or complicated by secondary bacterial infections. The
very young, the elderly and people with underlying diseases such as
heart or chest disease are particularly at risk of serious illness
from influenza.
-- Poultry workers are being vaccinated as a precautionary measure
against a pandemic flu virus emerging in England.
dh
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four per cent of those aged 65 and over received a flu jab by the end
of January 2007, and 42 per cent of those under 65 in at risk groups
were vaccinated.
In 2006/07, 6.2 million people in the 65 and over group were
vaccinationed against flu. This figure is comparable to last year's
campaign. (2005/06.)
The achievements of the flu campaign are all the more impressive
considering that vaccine deliveries were delayed by several weeks due
to manufacturing problems.
A new flu vaccination programme was announced in January for people
who work in close contact with poultry; nearly all PCTs have plans
to implement the programme, targeted for completion by March 31.
The Department of Health is also publishing today the review of the
seasonal flu programme commissioned by the Health Secretary after the
2005/06 campaign. The review identifies a number of ways for the
Department of Health and the NHS to build on the programme's
successes. The main recommendations are:
Sustain progress achieved so far:
-- Improve uptake among occupational health groups (health workers)
-- Enhance the role of influenza co-ordinators and improve national,
regional and local co-ordination and contingency planning.
-- Explore the full range of delivery mechanisms available to the NHS
through different contract types
-- Review future options for the purchase, supply and delivery of
vaccine
Many recommendations have already been implemented, for example,
improving communication with vaccine manufacturers and GPs.
Secretary of State Patricia Hewitt welcomed the report and commended
the reviewers for such a thorough piece of work and said that the
Department will be considering the detailed recommendations.
The review found greater public awareness of avian and pandemic flu
in 2005 meant that some GP practices could not immediately meet
public demand for flu vaccine and this may have led to reports of
shortages.
Dr David Salisbury, Director of Immunisation at the Department of
Health said;
"It is important to acknowledge the excellent achievement made by the
GPs, nurses, health service providers and primary care organisations
in delivering the seasonal flu programme in 2006/07. More than six
million people aged 65 and over were immunised against flu, which can
be a serious illness for older people.
"The seasonal flu review recognises that England runs an effective
seasonal flu vaccination programme that achieves one of the highest
uptakes in Europe. We accept in principle the recommendations to
strengthen the programme, while recognising that some details may
need to be considered more fully . We look forward to consulting
widely about this."
-- Copies of the review are available from the Department of Health here.
-- Regarding flu vaccine uptake figures, we have extrapolated the
figures up to assume a 100 per cent return from GP practices. We have
worked out how many people would have been vaccinated if we had
received a 100 per cent return for each of the years. This makes the
assumption that there are no differences in the size of the GP
practices returning data.
-- Flu uptake figures are published by the HPA.
5. For risk groups announced in last year's CMO annual letter to the
NHS for the 2006/07 seasonal flu campaign see, click here (PDF).
-- Influenza is an acute viral infection and in most years occurs
predominantly during a six to eight week period during the winter.
-- For most people, this seasonal influenza is an unpleasant but self
limiting and not life endangering illness. In some people it may be
more severe, or complicated by secondary bacterial infections. The
very young, the elderly and people with underlying diseases such as
heart or chest disease are particularly at risk of serious illness
from influenza.
-- Poultry workers are being vaccinated as a precautionary measure
against a pandemic flu virus emerging in England.
dh
Buy Levaquin Without Prescription
Baucus To Release Detailed Universal Health Care Plan Today
Senate Finance Committee Chair Max Baucus (D-Mont.) on Wednesday will release a detailed universal health coverage plan that is "broadly compatible" with the proposal by President-elect Barack Obama, the New York Times reports.
Under the plan, employers of a certain size would be required to offer health insurance for workers or pay into a federal insurance fund. Tax credits would be available for small businesses that provide health coverage and to individuals and families who purchase insurance on the private market. A national health insurance exchange, similar to one proposed by Obama, would be established to allow consumers to compare and purchase policies from a menu of private plans, as well as a new public plan similar to Medicare. Insurers would be prohibited from denying coverage or charging different premiums based pre-existing health conditions. In addition, Baucus' plan would permit people ages 55 to 64 who do not have access to public or group coverage to buy into Medicare, and Medicaid would be available to everyone with incomes below the federal poverty level. SCHIP also would be expanded to cover all uninsured children in families with incomes up to 250% of the poverty level. The plan eventually would require all U.S. residents to obtain health coverage and would provide subsidies for those who could not otherwise afford it (Pear, New York Times, 11/12).
The 104-page plan, titled "Call to Action, Health Reform 2009," would aim to have every U.S. resident covered within 10 years (Connolly, Washington Post, 11/12). According to the report, "We all must realize that the costs of inaction, both in human and financial terms, will eventually be far greater than any initial outlays" (Freking, AP/Miami Herald, 11/12). Baucus suggested that the plan could be funded by reducing waste and fraud, emphasizing prevention and utilizing comparative-effectiveness research. In the short term, he said cutting payments to private insurers participating in the Medicare Advantage program also would provide some funding. According to the Post, "The most controversial idea is Baucus's suggestion to revisit the current tax treatment of employer-sponsored health insurance" (Washington Post, 11/12). The plan does not specify how large or small a company would have to be to fall under the rules, nor does it include a total cost estimate (Meckler, Wall Street Journal, 11/12). For those who do not obtain coverage, a penalty "would be enforced, possibly through the tax system," the plan states (New York Times, 11/12).
Baucus in the plan wrote, "I believe -- very strongly -- that every American has a right to high-quality health care ... and I believe Americans cannot wait any longer" (Wall Street Journal, 11/12). The Times reports that Obama aides "welcomed the Congressional efforts, had encouraged Congress to take the lead and still considered health care a top priority, despite the urgent need to address huge problems afflicting the economy" (New York Times, 11/12).
Kaiser Family Foundation President and CEO Drew Altman said, "We're at one of those rare moments that comes every 15 years when you have a chance" to make comprehensive health care changes, adding, "But a lot of things have to break right for it to happen" (Washington Post, 11/12). Ron Pollack, executive director of Families USA, said, "The prospects for meaningful health care reform have never looked better" (New York Times, 11/12).
Baucus plans to hold meetings next week with leaders of both parties in the Finance Committee and the Senate Health, Education, Labor and Pensions Committee (Wall Street Journal, 11/12).
Under the plan, employers of a certain size would be required to offer health insurance for workers or pay into a federal insurance fund. Tax credits would be available for small businesses that provide health coverage and to individuals and families who purchase insurance on the private market. A national health insurance exchange, similar to one proposed by Obama, would be established to allow consumers to compare and purchase policies from a menu of private plans, as well as a new public plan similar to Medicare. Insurers would be prohibited from denying coverage or charging different premiums based pre-existing health conditions. In addition, Baucus' plan would permit people ages 55 to 64 who do not have access to public or group coverage to buy into Medicare, and Medicaid would be available to everyone with incomes below the federal poverty level. SCHIP also would be expanded to cover all uninsured children in families with incomes up to 250% of the poverty level. The plan eventually would require all U.S. residents to obtain health coverage and would provide subsidies for those who could not otherwise afford it (Pear, New York Times, 11/12).
The 104-page plan, titled "Call to Action, Health Reform 2009," would aim to have every U.S. resident covered within 10 years (Connolly, Washington Post, 11/12). According to the report, "We all must realize that the costs of inaction, both in human and financial terms, will eventually be far greater than any initial outlays" (Freking, AP/Miami Herald, 11/12). Baucus suggested that the plan could be funded by reducing waste and fraud, emphasizing prevention and utilizing comparative-effectiveness research. In the short term, he said cutting payments to private insurers participating in the Medicare Advantage program also would provide some funding. According to the Post, "The most controversial idea is Baucus's suggestion to revisit the current tax treatment of employer-sponsored health insurance" (Washington Post, 11/12). The plan does not specify how large or small a company would have to be to fall under the rules, nor does it include a total cost estimate (Meckler, Wall Street Journal, 11/12). For those who do not obtain coverage, a penalty "would be enforced, possibly through the tax system," the plan states (New York Times, 11/12).
Baucus in the plan wrote, "I believe -- very strongly -- that every American has a right to high-quality health care ... and I believe Americans cannot wait any longer" (Wall Street Journal, 11/12). The Times reports that Obama aides "welcomed the Congressional efforts, had encouraged Congress to take the lead and still considered health care a top priority, despite the urgent need to address huge problems afflicting the economy" (New York Times, 11/12).
Kaiser Family Foundation President and CEO Drew Altman said, "We're at one of those rare moments that comes every 15 years when you have a chance" to make comprehensive health care changes, adding, "But a lot of things have to break right for it to happen" (Washington Post, 11/12). Ron Pollack, executive director of Families USA, said, "The prospects for meaningful health care reform have never looked better" (New York Times, 11/12).
Baucus plans to hold meetings next week with leaders of both parties in the Finance Committee and the Senate Health, Education, Labor and Pensions Committee (Wall Street Journal, 11/12).
Other Efforts
The Post notes that Sen. Edward Kennedy (D-Mass.) also is working on a health proposal and intends to have legislation drafted by Inauguration Day. A bill sponsored by Sens. Ron Wyden (D-Ore.) and Robert Bennett (R-Utah.) has support from eight Democratic and nine Republican members. "This shows it is possible to move in a bipartisan way," Wyden said (Washington Post, 11/12).
Dingell
In other congressional news, House Energy and Commerce Committee Chair John Dingell (D-Mich.), in his effort to retain his post against House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.), sent a letter to President-elect Obama this week requesting that health care reform be taken up quickly. In the letter, released on Tuesday, Dingell wrote, "I am eager to work with you to make this happen, and I appreciate that your transition team has been in contact with my staff to chart the path forward." The Energy and Commerce panel has jurisdiction over health policy (Soraghan, The Hill, 11/11).
The letter is available online (.pdf).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation.В All rights reserved.
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Research Breakthrough Targets Genetic Diseases
A cure for debilitating genetic diseases such as Huntington's disease, Friedreich's ataxia and Fragile X syndrome is a step closer to reality, thanks to a recent scientific breakthrough.
The finding, which was published in Science on January 15, is the result of a collaboration between a team led by Dr Sureshkumar Balasubramanian at The University of Queensland's School of Biological Sciences and Professor Dr Detlef Weigel at the Max Planck Institute for Developmental Biology in Germany.
It identifies an expansion of a repeat pattern in the DNA of the plant Arabidopsis thaliana that has striking parallels to the DNA repeat patterns observed in humans suffering from neuronal disorders such as Huntington's disease and Fredereich's ataxia.
Lead researcher from UQ, Dr Balasubramanian, said being able to use the plant as a model would pave the way toward better understanding of how these patterns change over multiple generations.
"It opens up a whole new array of possibilities for future research, some of which could have potential implications for humans," Dr Balasubramanian said.
The types of diseases the research relates to, which are caused by "triplet repeat expansions" in DNA, become more severe through the generations but were difficult to study in humans due to the long timeframes involved.
A plant model with a relatively short lifespan would allow scientists to study DNA mutations over several generations, Dr Balasubramanian said.
The study, called "A genetic defect caused by a triplet repeat expansion in Arabidopsis thaliana", also had implications beyond human diseases, Dr Balasubramanian said.
While the DNA patterns were previously only seen in humans, current findings have shown the patterns occur in in distant species such as plants, providing new scope for researchers in all disciplines of biology.
The University of Queensland, Brisbane Australia
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The finding, which was published in Science on January 15, is the result of a collaboration between a team led by Dr Sureshkumar Balasubramanian at The University of Queensland's School of Biological Sciences and Professor Dr Detlef Weigel at the Max Planck Institute for Developmental Biology in Germany.
It identifies an expansion of a repeat pattern in the DNA of the plant Arabidopsis thaliana that has striking parallels to the DNA repeat patterns observed in humans suffering from neuronal disorders such as Huntington's disease and Fredereich's ataxia.
Lead researcher from UQ, Dr Balasubramanian, said being able to use the plant as a model would pave the way toward better understanding of how these patterns change over multiple generations.
"It opens up a whole new array of possibilities for future research, some of which could have potential implications for humans," Dr Balasubramanian said.
The types of diseases the research relates to, which are caused by "triplet repeat expansions" in DNA, become more severe through the generations but were difficult to study in humans due to the long timeframes involved.
A plant model with a relatively short lifespan would allow scientists to study DNA mutations over several generations, Dr Balasubramanian said.
The study, called "A genetic defect caused by a triplet repeat expansion in Arabidopsis thaliana", also had implications beyond human diseases, Dr Balasubramanian said.
While the DNA patterns were previously only seen in humans, current findings have shown the patterns occur in in distant species such as plants, providing new scope for researchers in all disciplines of biology.
The University of Queensland, Brisbane Australia
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House Committee Approves Bill That Bans Discrimination Based On Genetics, Rejects Provision To Protect Fetuses
The House Education and Labor Committee on Wednesday approved by voice vote a bill (HR 493), sponsored by Rep. Louise Slaughter (D-N.Y.), that would prohibit health insurers or employers from accessing the genetic information of patients or employees and considering it for hiring, firing and other business decisions, the Wall Street Journal reports (Zhang, Wall Street Journal, 2/15). The committee also voted 27-20 to reject an amendment, sponsored by Rep. Tim Walberg (R-Mich.) that would have extended protections in the legislation to fetuses, according to CQ Today. The Senate Health, Education, Labor and Pensions Committee on Jan. 31 approved a similar bill (S 358), sponsored by Sen. Olympia Snowe (R-Maine) (Crowley, CQ Today, 2/14). Snowe has said she introduced the legislation, called the Genetic Information Nondiscrimination Act of 2007, because some women have said they were reluctant to be tested for genetic alterations that indicate increased risk of developing breast cancer because they feared difficulty in acquiring health insurance if they tested positive. Business groups, such as the U.S. Chamber of Commerce, have lobbied against such measures, saying that federal law on the issue is not needed because state laws already provide protection against such discrimination (Kaiser Daily Women's Health Policy Report, 1/22). The House bill is expected to pass the full chamber and be voted on in the Senate within two weeks, according to the Journal. President Bush has indicated that he would sign the measure (Wall Street Journal, 2/15).
APM's "Marketplace Morning Report" on Thursday reported on the legislation. The segment includes comments from Slaughter (Niiler, "Marketplace Morning Report," 2/15). A transcript and audio of the segment are available online.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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APM's "Marketplace Morning Report" on Thursday reported on the legislation. The segment includes comments from Slaughter (Niiler, "Marketplace Morning Report," 2/15). A transcript and audio of the segment are available online.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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Increased Research, Determination Needed In HIV/AIDS Vaccine Efforts, HIV Vaccine Enterprise Head Says
The disappointment that followed the cancellation of a Merck vaccine trial in September 2007 has been replaced by a renewed determination among the scientific community, Alan Bernstein, executive director of the Global HIV Vaccine Enterprise, said ahead of the 25th anniversary of the scientific paper announcing the discovery of HIV, the CP/Yahoo! News reports. "I could not guarantee that one day we'll have a vaccine," Bernstein said, adding, "But not to try is to say to all the 33 million people" who are living with HIV worldwide, as well as the 2.3 million people who contract the virus "every year," that researchers are "giving up."
May 20 is the 25th anniversary of the paper -- published in the journal Science by Luc Montagnier and colleagues at La Pitie-Salpetriere Hospital and the Institut Pasteur -- announcing the discovery of HIV. Science in its current issue has published an editorial by Bernstein, as well as additional articles about HIV/AIDS vaccine and prevention efforts, to mark the anniversary.
Bernstein in the editorial writes that people who use recent vaccine candidate setbacks to argue that such research is misplaced and that a vaccine cannot be developed are "misguided." He added, "The development of new drugs and new vaccines always take time and is never a straight line, and it's always marked by failures."
According to Bernstein, the result of a number of recent conferences to address HIV/AIDS vaccine research is a consensus to focus on more basic and early-stage clinical research. Such research will allow scientists to examine what happens when people contract HIV, as well as how the immune system functions, Bernstein said. "If we do the kinds of research that's needed to understand how we react to HIV, that ultimately will inform a lot of research on other pathogens," he said (Branswell, CP/Yahoo! News, 5/8).
A summary of Bernstein's editorial is available online.
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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May 20 is the 25th anniversary of the paper -- published in the journal Science by Luc Montagnier and colleagues at La Pitie-Salpetriere Hospital and the Institut Pasteur -- announcing the discovery of HIV. Science in its current issue has published an editorial by Bernstein, as well as additional articles about HIV/AIDS vaccine and prevention efforts, to mark the anniversary.
Bernstein in the editorial writes that people who use recent vaccine candidate setbacks to argue that such research is misplaced and that a vaccine cannot be developed are "misguided." He added, "The development of new drugs and new vaccines always take time and is never a straight line, and it's always marked by failures."
According to Bernstein, the result of a number of recent conferences to address HIV/AIDS vaccine research is a consensus to focus on more basic and early-stage clinical research. Such research will allow scientists to examine what happens when people contract HIV, as well as how the immune system functions, Bernstein said. "If we do the kinds of research that's needed to understand how we react to HIV, that ultimately will inform a lot of research on other pathogens," he said (Branswell, CP/Yahoo! News, 5/8).
A summary of Bernstein's editorial is available online.
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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UnitedHealthcare Reaffirms Coverage Of Propofol For Use In Colonoscopies
UnitedHealthcare, a UnitedHealth Group (NYSE:UNH) company, announced it will continue to provide coverage for the drug propofol, when used as an anesthesia for colonoscopies, and for anesthesiologists to administer the drug during this examination.
The company reaffirmed its coverage policy in response to recently announced changes to payment policies by other health insurance providers.
"Getting recommended routine screenings can save lives. According to the Centers for Disease Control and Prevention, more than 60 percent of deaths from colorectal cancer could be prevented if individuals age 50 and older were screened regularly," said Sam Ho, M.D., executive vice president and chief medical officer, UnitedHealthcare. "By covering propofol - an intravenous anesthetic that eases the discomfort associated with this procedure - and the anesthesiologist who administers the drug to ensure its safe usage, we are helping ensure that those members who require an anesthetic have access to this important colon-cancer screening procedure. Most people who undergo colonoscopies do not require an anesthetic; they have colonoscopies done with light sedation or, in some cases, no sedation at all."
To help determine its coverage policy, UnitedHealthcare reviewed current clinical literature and met with leading gastroenterologists and anesthesiologists to discuss safe and effective sedation for persons undergoing colonoscopy. Propofol is a useful anesthetic for persons with certain medical conditions that might otherwise make colonoscopy difficult. While it is administered intravenously, it is a true anesthetic, rather than a sedating agent, so the services of an anesthesiologist are required for its safe administration.
"UnitedHealthcare's policy leaves the decision surrounding colonoscopies and endoscopies to doctors and their patients," said Alfred D. Roston, M.D., president of the New York Society for Gastrointestinal Endoscopy. "By reaffirming its coverage policy, UnitedHealthcare clearly demonstrates its support for office-based, anesthesiologist-supported colonoscopy as a safe, convenient and cost-effective way to provide a critical health service."
Colorectal cancer is the second-leading cause of cancer deaths among Americans, according to the Federal Centers for Disease Control and Prevention (CDC). The most recent statistics show that about 145,000 men and women are diagnosed with colorectal cancer every year - and nearly 54,000 will die from the disease.
About UnitedHealthcare
UnitedHealthcare provides a full spectrum of consumer-oriented health benefit plans and services. The company organizes access to quality, affordable health care services on behalf of more than 26 million individual consumers, contracting directly with more than 550,000 physicians and care professionals and 4,800 hospitals nationwide to offer them broad, convenient access to services nationwide. UnitedHealthcare is one of the businesses of UnitedHealth Group (NYSE:UNH), a diversified Fortune 50 health and well-being company.
UnitedHealthcare
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The company reaffirmed its coverage policy in response to recently announced changes to payment policies by other health insurance providers.
"Getting recommended routine screenings can save lives. According to the Centers for Disease Control and Prevention, more than 60 percent of deaths from colorectal cancer could be prevented if individuals age 50 and older were screened regularly," said Sam Ho, M.D., executive vice president and chief medical officer, UnitedHealthcare. "By covering propofol - an intravenous anesthetic that eases the discomfort associated with this procedure - and the anesthesiologist who administers the drug to ensure its safe usage, we are helping ensure that those members who require an anesthetic have access to this important colon-cancer screening procedure. Most people who undergo colonoscopies do not require an anesthetic; they have colonoscopies done with light sedation or, in some cases, no sedation at all."
To help determine its coverage policy, UnitedHealthcare reviewed current clinical literature and met with leading gastroenterologists and anesthesiologists to discuss safe and effective sedation for persons undergoing colonoscopy. Propofol is a useful anesthetic for persons with certain medical conditions that might otherwise make colonoscopy difficult. While it is administered intravenously, it is a true anesthetic, rather than a sedating agent, so the services of an anesthesiologist are required for its safe administration.
"UnitedHealthcare's policy leaves the decision surrounding colonoscopies and endoscopies to doctors and their patients," said Alfred D. Roston, M.D., president of the New York Society for Gastrointestinal Endoscopy. "By reaffirming its coverage policy, UnitedHealthcare clearly demonstrates its support for office-based, anesthesiologist-supported colonoscopy as a safe, convenient and cost-effective way to provide a critical health service."
Colorectal cancer is the second-leading cause of cancer deaths among Americans, according to the Federal Centers for Disease Control and Prevention (CDC). The most recent statistics show that about 145,000 men and women are diagnosed with colorectal cancer every year - and nearly 54,000 will die from the disease.
About UnitedHealthcare
UnitedHealthcare provides a full spectrum of consumer-oriented health benefit plans and services. The company organizes access to quality, affordable health care services on behalf of more than 26 million individual consumers, contracting directly with more than 550,000 physicians and care professionals and 4,800 hospitals nationwide to offer them broad, convenient access to services nationwide. UnitedHealthcare is one of the businesses of UnitedHealth Group (NYSE:UNH), a diversified Fortune 50 health and well-being company.
UnitedHealthcare
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Reprogramming Immune System Cells To Produce Natural Killer Cells For Cancer
A team of researchers has developed a method to produce cells that kill tumour cells in the lab and prevent tumours forming in mouse models of cancer. Although the current work is in cells and mouse, if the research transfers to human biology, the new type of cell could be a new source for cell-based anticancer therapies.
The cells were produced by knocking out a single gene essential in the pathways of development of immune cells: the modified cells become a novel type, which the authors call Induced T to Natural Killer Cells (ITNK cells).
Many cell types cooperate in the immune system to battle invaders, such as bacteria and viruses, and to remove abnormal or dead cells. T lymphocytes/T cells play an important part in defending against pathogens and abnormal self cells. They are thought also to play a role in autoimmune disease.
In this research, T cells were transformed into cells similar to another type, Natural Killer (NK) cells, which commonly act against viruses and cancer cells.
"We have been examining ways to produce clinically useful immune system cells," explains Peng Li, PhD student and first author on the publication, from the Wellcome Trust Sanger Institute. "We had shown that a gene called Bcl11b was essential for normal development of immune system cells - and of particular interest in the development of T cells.
"Here we can see the fruits of that work: we show, for the first time, that we can modify the developmental fate of immune system cells to produce a novel type that - if we can see the same effect in humans - could be of enormous value in cancer treatment."
The Bcl11b protein is a master switch that works by regulating the activity of other genes and it was known to be important in the immune system. However, this role in T lymphocyte development is entirely novel.
In the careful research, the team first showed that the Bcl11b gene was active only in T cells in the immune system and that its activity was needed at the earliest stages of production of T cells. When the team knocked out the Bcl11b gene, the mice produced no T cells.
"Remarkably, the mice lacking the Bcl11b gene produced a new type of immune system cell - the Induced T to Natural Killer cells," explains Dr Pentao Liu, senior author on the project from the Wellcome Trust Sanger Institute. "This is the first time we have seen these cells and the first time a gene regulator like Bcl11b has been shown to carry out such an important role in T cells.
"Even more important, we can see that these reprogrammed killer cells can attack cancer cells, whether in test tubes or in mouse models."
The ITNK cells killed melanoma and lymphoma cells in experiment in test tubes and were much more efficient than unmodified Natural Killer cells in the mouse and in human.
But they worked also on cancers. When tumour cells were injected into mice they produced at least tenfold fewer tumour foci in the Bcl11b-deficient than in Bcl11b-competent mice.
"The reprogrammed killer cells were effective in preventing metastasis - spread of the tumour in mice," explains Dr Francesco Colucci, from the University of Cambridge School of Clinical Medicine Dept of Obstetrics & Gynaecology. "The killing seems to be specific to the tumour cells and the normal cells seem to be spared.
"This is a really exciting development that could, if it can be transferred to humans, lead to development of new effective anticancer treatments. The results are stunning. One problem with cellular therapies is that one needs to produce large number of cells, something this work suggests could be done fairly easily with reprogrammed killer cells"
The team also looked at the effects of the cells in the medium term and showed that the ITNK cells continued to survive for at least three months.
The team also looked at the effects of the cells in the medium term and showed that the ITNK cells continued to survive for at least three months. Equally important, they could find no evidence of abnormality in the mice carrying ITNK cells. This suggests that ITNK cells do not indiscriminately kill normal cells or cause other damage, leading to optimism that ITNK cells might perform well in future therapies.
Li P et al. (2010) Reprogramming of T cells to Natural Killer-like cells upon Bcl11b deletion. Science. Published online before print.
This work was supported by the Wellcome Trust, Biotechnology and Biological Sciences Research Council and the UK Medical Research Council.
Source:
Don Powell
Wellcome Trust Sanger Institute
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The cells were produced by knocking out a single gene essential in the pathways of development of immune cells: the modified cells become a novel type, which the authors call Induced T to Natural Killer Cells (ITNK cells).
Many cell types cooperate in the immune system to battle invaders, such as bacteria and viruses, and to remove abnormal or dead cells. T lymphocytes/T cells play an important part in defending against pathogens and abnormal self cells. They are thought also to play a role in autoimmune disease.
In this research, T cells were transformed into cells similar to another type, Natural Killer (NK) cells, which commonly act against viruses and cancer cells.
"We have been examining ways to produce clinically useful immune system cells," explains Peng Li, PhD student and first author on the publication, from the Wellcome Trust Sanger Institute. "We had shown that a gene called Bcl11b was essential for normal development of immune system cells - and of particular interest in the development of T cells.
"Here we can see the fruits of that work: we show, for the first time, that we can modify the developmental fate of immune system cells to produce a novel type that - if we can see the same effect in humans - could be of enormous value in cancer treatment."
The Bcl11b protein is a master switch that works by regulating the activity of other genes and it was known to be important in the immune system. However, this role in T lymphocyte development is entirely novel.
In the careful research, the team first showed that the Bcl11b gene was active only in T cells in the immune system and that its activity was needed at the earliest stages of production of T cells. When the team knocked out the Bcl11b gene, the mice produced no T cells.
"Remarkably, the mice lacking the Bcl11b gene produced a new type of immune system cell - the Induced T to Natural Killer cells," explains Dr Pentao Liu, senior author on the project from the Wellcome Trust Sanger Institute. "This is the first time we have seen these cells and the first time a gene regulator like Bcl11b has been shown to carry out such an important role in T cells.
"Even more important, we can see that these reprogrammed killer cells can attack cancer cells, whether in test tubes or in mouse models."
The ITNK cells killed melanoma and lymphoma cells in experiment in test tubes and were much more efficient than unmodified Natural Killer cells in the mouse and in human.
But they worked also on cancers. When tumour cells were injected into mice they produced at least tenfold fewer tumour foci in the Bcl11b-deficient than in Bcl11b-competent mice.
"The reprogrammed killer cells were effective in preventing metastasis - spread of the tumour in mice," explains Dr Francesco Colucci, from the University of Cambridge School of Clinical Medicine Dept of Obstetrics & Gynaecology. "The killing seems to be specific to the tumour cells and the normal cells seem to be spared.
"This is a really exciting development that could, if it can be transferred to humans, lead to development of new effective anticancer treatments. The results are stunning. One problem with cellular therapies is that one needs to produce large number of cells, something this work suggests could be done fairly easily with reprogrammed killer cells"
The team also looked at the effects of the cells in the medium term and showed that the ITNK cells continued to survive for at least three months.
The team also looked at the effects of the cells in the medium term and showed that the ITNK cells continued to survive for at least three months. Equally important, they could find no evidence of abnormality in the mice carrying ITNK cells. This suggests that ITNK cells do not indiscriminately kill normal cells or cause other damage, leading to optimism that ITNK cells might perform well in future therapies.
Li P et al. (2010) Reprogramming of T cells to Natural Killer-like cells upon Bcl11b deletion. Science. Published online before print.
This work was supported by the Wellcome Trust, Biotechnology and Biological Sciences Research Council and the UK Medical Research Council.
Source:
Don Powell
Wellcome Trust Sanger Institute
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Link Between Widely Used Osteoporosis Drugs And Heart Problems Probed
New research at Wake Forest University School of Medicine evaluated the link between a common class of drugs used to prevent bone fractures in osteoporosis patients and the development of irregular heartbeat.
The study's findings appear in the current issue of Drug Safety, a publication of the International Society of Pharmacovigilance covering the safe and proper use of medicines.
"Some trials show there could be a potential link between the use of bisphosphonates and the development of serious heart rhythm problems, but in our study the link wasn't conclusive," said Sonal Singh, M.D., M.P.H., an assistant professor of internal medicine and lead investigator for the study. "So we urge that additional investigations be conducted."
Bisphosphonates, found in prescription drugs including BonivaTM, FosomaxTM, ReclastTM and ActonelTM, inhibit the breakdown of bones, which reduces the risk of fractures, especially those of the spine and hips in older patients. The first such drugs were approved for use in the mid-1990s.
Early studies indicated that the use of bisphosphonates might cause problems with heart rhythm, or atrial fibrillation, which increases the risk for stroke or heart attack. For the study published this month, researchers analyzed the data from previous observational studies and clinical trials to determine the link between bisphosphonate therapy and irregular heart beat.
Researchers found that bisphosphonate use was associated with a significant increase in the incidence of "serious" heart rhythm disturbances, classified by hospitalization, disability or death resulting from the condition. However, when they included "non-serious" cases in their analysis, they found no overall increased risk of atrial fibrillation, the study shows.
"Our findings were discordant, with conflicting results," Singh said. "The challenge now is to figure out what it all means."
In the clinical trials reviewed, medical records of more than 13,000 patients who had osteoporosis or fractures and were given bisphosphonates were compared to the records of more than 13,000 patients who received a placebo during study participation. Researchers were looking for the incidence of irregular heartbeat first, and then stroke or death caused by stroke or heart attack as a secondary outcome. The patient files reviewed were primarily of women who were treated with bisphosphonates and were generally in their early 70s, according to the study.
"We found no risk of stroke and cardiovascular mortality in the trials," Singh said. "That was very reassuring."
The observational studies evaluated the risk of irregular heartbeat in patients treated with bisphosphonates compared with those who had not received the drug. A review of these studies found different results. One study showed an increased risk of irregular heartbeat in patients taking the drugs and others showed no associated risk.
"The amount of data on the outcome of bisphosphonate use is insufficient to make a definitive conclusion," said Vinodh Jeevanantham, M.D., an instructor of internal medicine and co-researcher on the School of Medicine study.
The federal Food and Drug Administration called the results of the previous bisphosphonate studies "discordant" in a November 2008 update to its safety review of the drug. The agency's review of four previous trials also found no link between bisphosphonates and irregular heartbeat but suggested the need for more research.
Given these results, physicians should not change they way they prescribe the drugs for the majority of patients with osteoporosis, Singh said, and patients should not stop taking them. He cautioned, however, that patients with pre-existing heart conditions and those with risk factors for rhythm disturbance should be especially vigilant for the development of atrial fibrillation, and doctors should continue to closely monitor patients at risk for atrial fibrillation who are taking bisphosphonates.
"People who develop atrial fibrillation after using bisphosphonates should be reporting it to regulatory agencies," Singh said.
Yoon K. Loke, M.D., MBBS, of the University of East Anglia, Norwich, United Kingdom, also participated in this study, which received no external funding.
Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children's Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university's School of Medicine and Piedmont Triad Research Park. The system comprises 1,056 acute care, rehabilitation and long-term care beds and has been ranked as one of "America's Best Hospitals" by U.S. News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America's Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.
Source: Wake Forest University Baptist Medical Center
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The study's findings appear in the current issue of Drug Safety, a publication of the International Society of Pharmacovigilance covering the safe and proper use of medicines.
"Some trials show there could be a potential link between the use of bisphosphonates and the development of serious heart rhythm problems, but in our study the link wasn't conclusive," said Sonal Singh, M.D., M.P.H., an assistant professor of internal medicine and lead investigator for the study. "So we urge that additional investigations be conducted."
Bisphosphonates, found in prescription drugs including BonivaTM, FosomaxTM, ReclastTM and ActonelTM, inhibit the breakdown of bones, which reduces the risk of fractures, especially those of the spine and hips in older patients. The first such drugs were approved for use in the mid-1990s.
Early studies indicated that the use of bisphosphonates might cause problems with heart rhythm, or atrial fibrillation, which increases the risk for stroke or heart attack. For the study published this month, researchers analyzed the data from previous observational studies and clinical trials to determine the link between bisphosphonate therapy and irregular heart beat.
Researchers found that bisphosphonate use was associated with a significant increase in the incidence of "serious" heart rhythm disturbances, classified by hospitalization, disability or death resulting from the condition. However, when they included "non-serious" cases in their analysis, they found no overall increased risk of atrial fibrillation, the study shows.
"Our findings were discordant, with conflicting results," Singh said. "The challenge now is to figure out what it all means."
In the clinical trials reviewed, medical records of more than 13,000 patients who had osteoporosis or fractures and were given bisphosphonates were compared to the records of more than 13,000 patients who received a placebo during study participation. Researchers were looking for the incidence of irregular heartbeat first, and then stroke or death caused by stroke or heart attack as a secondary outcome. The patient files reviewed were primarily of women who were treated with bisphosphonates and were generally in their early 70s, according to the study.
"We found no risk of stroke and cardiovascular mortality in the trials," Singh said. "That was very reassuring."
The observational studies evaluated the risk of irregular heartbeat in patients treated with bisphosphonates compared with those who had not received the drug. A review of these studies found different results. One study showed an increased risk of irregular heartbeat in patients taking the drugs and others showed no associated risk.
"The amount of data on the outcome of bisphosphonate use is insufficient to make a definitive conclusion," said Vinodh Jeevanantham, M.D., an instructor of internal medicine and co-researcher on the School of Medicine study.
The federal Food and Drug Administration called the results of the previous bisphosphonate studies "discordant" in a November 2008 update to its safety review of the drug. The agency's review of four previous trials also found no link between bisphosphonates and irregular heartbeat but suggested the need for more research.
Given these results, physicians should not change they way they prescribe the drugs for the majority of patients with osteoporosis, Singh said, and patients should not stop taking them. He cautioned, however, that patients with pre-existing heart conditions and those with risk factors for rhythm disturbance should be especially vigilant for the development of atrial fibrillation, and doctors should continue to closely monitor patients at risk for atrial fibrillation who are taking bisphosphonates.
"People who develop atrial fibrillation after using bisphosphonates should be reporting it to regulatory agencies," Singh said.
Yoon K. Loke, M.D., MBBS, of the University of East Anglia, Norwich, United Kingdom, also participated in this study, which received no external funding.
Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children's Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university's School of Medicine and Piedmont Triad Research Park. The system comprises 1,056 acute care, rehabilitation and long-term care beds and has been ranked as one of "America's Best Hospitals" by U.S. News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America's Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.
Source: Wake Forest University Baptist Medical Center
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Joslin's Latino Diabetes Initiative Unveils Enhanced Website
Latinos are twice as likely to develop diabetes as Caucasians, and half the Latinos born in the United States in this century are expected to get the disease. Helping to meet this challenge, Joslin Diabetes Center's Latino Diabetes Initiative-a comprehensive effort that combines clinical care, patient education, community outreach, research and healthcare team education-has upgraded its website with additional resources for Latinos with diabetes and their families in both English and Spanish.
"Raising awareness in the general community about diabetes in the Latino population is an important task for our Latino Diabetes Initiative," says Enrique Caballero, M.D., founder and director. "Our redesigned website allows us to share important information with many people about our work and the general challenges and opportunities with this group."
The upgraded site is 100% bilingual and bicultural-not simply translated from one language to the other. The landing page is in Spanish and from there you can toggle back and forth between the Spanish and English pages.
Sponsored by the Verizon Foundation, the website update features details about each of the key components about LDI services and activities. Additionally, it presents educational materials that the LDI has created or adapted in Spanish, as well as highlighting current and past research efforts to better understand the effects of diabetes in the Latino population.
LDI plans to expand the website's offerings further by incorporating interactive games and activities and bilingual video clips with tips on how to manage the disease for patients. It also will provide information on current research regarding diabetes in the Latino population and resources for healthcare providers who serve this community. As technology evolves, the possibility exists for further expansion of tools for more personalized interaction.
"The audience we reach is Latinos living with diabetes and those at risk as well as providers who serve this population," says Dr. Caballero. "We hope to raise awareness and inform people that not only is diabetes a manageable disease, but that there are resources available to help people to better understand and deal with it."
The greatest barriers to reaching Latinos via the Internet have been language and access. Not only has access been limited due to language barriers, the socio-economic status of much of this population tends to be low as a result of high immigration rates and low educational attainment. Compared to English-dominant men and women, Spanish-dominant and bilingual Latinos are less likely to have access to a personal computer or smartphone.
There is, however, evidence that this digital divide is decreasing. Internet use among Latino adults rose to 64% in 2008, according to the Pew Research Center. The relative youth of the Latino population also helps to smooth the adoption of Internet technologies. (Latinos had a median age of 27 years in 2009, compared with 37 years for the United States population as a whole.) Overall, current trends will dramatically broaden the potential reach of the LDI site and other online offerings that bring vital information and health care services to the Latino community.
Source:
Joslin Diabetes Center
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"Raising awareness in the general community about diabetes in the Latino population is an important task for our Latino Diabetes Initiative," says Enrique Caballero, M.D., founder and director. "Our redesigned website allows us to share important information with many people about our work and the general challenges and opportunities with this group."
The upgraded site is 100% bilingual and bicultural-not simply translated from one language to the other. The landing page is in Spanish and from there you can toggle back and forth between the Spanish and English pages.
Sponsored by the Verizon Foundation, the website update features details about each of the key components about LDI services and activities. Additionally, it presents educational materials that the LDI has created or adapted in Spanish, as well as highlighting current and past research efforts to better understand the effects of diabetes in the Latino population.
LDI plans to expand the website's offerings further by incorporating interactive games and activities and bilingual video clips with tips on how to manage the disease for patients. It also will provide information on current research regarding diabetes in the Latino population and resources for healthcare providers who serve this community. As technology evolves, the possibility exists for further expansion of tools for more personalized interaction.
"The audience we reach is Latinos living with diabetes and those at risk as well as providers who serve this population," says Dr. Caballero. "We hope to raise awareness and inform people that not only is diabetes a manageable disease, but that there are resources available to help people to better understand and deal with it."
The greatest barriers to reaching Latinos via the Internet have been language and access. Not only has access been limited due to language barriers, the socio-economic status of much of this population tends to be low as a result of high immigration rates and low educational attainment. Compared to English-dominant men and women, Spanish-dominant and bilingual Latinos are less likely to have access to a personal computer or smartphone.
There is, however, evidence that this digital divide is decreasing. Internet use among Latino adults rose to 64% in 2008, according to the Pew Research Center. The relative youth of the Latino population also helps to smooth the adoption of Internet technologies. (Latinos had a median age of 27 years in 2009, compared with 37 years for the United States population as a whole.) Overall, current trends will dramatically broaden the potential reach of the LDI site and other online offerings that bring vital information and health care services to the Latino community.
Source:
Joslin Diabetes Center
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E-Health 3.0: How Can The Semantic Web Change The World Of Internet Health Information?
Access to online health information is something most individuals take for granted these days. Whether sifting through a million Google hits or a laborious visit to WebMD, most people with access to a computer have utilized the current online health tools. Just ten years ago, few would give credence to reputable health information posted on the Web. Even fewer of us would rely on it as a primary or secondary source of medical information. Yet, recent Pew research suggests that 8 in 10 Internet users go online for health information totaling eight million health searches on a typical day. While the depth of information on the Web has increased dramatically, the ability to access the right information has floundered in comparison. Contextual data retrieval is particularly critical with health information and by most accounts the Internet is a mess in this regard. The ground breaking idea of a new search paradigm known as Semantic Web may hold the promise of a cure.
In health-related searches context takes on great importance; search results that are poor, inaccurate, or incomplete can misinform and confuse while information overload is equally problematic. Research has shown that the Internet is trusted second only to one's physician in health matters, and is often utilized as a first resource for medical information. This is especially troubling considering that the same Pew research established that 75% of individuals searching for health topics do not verify their sources. Verifying information source and quality is essential for health information considering most people start their online health search with a Google search before considering the MayoClinic or the National Institute of Health (NIH). Clearly there is a need for improved, accurate and in-depth health information retrieval online.
The traditional model of Web search engines, while satisfactory in the past, has fundamentally overstretched its capacity to aid the ordinary Internet user. The average online health search is redundant, piecemeal, and highly keyword sensitive. Health topics are myriad and are defined by complicated medical terminology. Are you searching for illness symptoms, treatment options, patient experiences, or drug interactions? Did you enter the correct medical term for your query? Which search hit should you choose? How do results even get ranked? In many ways, searching for medical information online is like sticking your hand into a grab bag. There are lots of choices, little influence on the outcome, and a high probability of being disappointed with the result. This model inevitably results in Internet users reaching back into the grab bag to find the desired result. Most people are used to this repetitive cycle of query, review, revise query, and review again. Inevitably with a complex and sensitive topic like medicine searches become complicated and difficult to refine. Internet users must ultimately rely on piecing together information from various sources of questionable veracity. The current sphere of online health information challenges both the healthcare and Web development communities to find a better way to disseminate important health information across the Internet. The answer may lie in a vision for the future of the Internet called the Semantic Web.
The Semantic Web concept was envisioned by World Wide Web pioneer Tim Berners-Lee as a system for connecting Web information based on the meaning and context of information. To summarize the difference between this idea and the current model, think of your current Google or Yahoo search as a popularity contest between sites that have mentioned your search keywords. Websites are ranked by search engines largely based on how frequently they are visited and updated. For the most part, the search engine does not understand how search terms may relate to the search result. In the Semantic Web model, data on the Internet contains contextual meaning so that a search can access information that you really want. Instead of merely presenting a list of websites with your keyword, the search can connect your search interest with information that is contextually related to the desired topic. The end product of a Semantic Web enabled search tool is the ability to produce a smarter Internet - one where users can actually communicate with the information on the Web instead of stumbling upon it.
Semantic Web health searches have the potential to bridge the gap in medical knowledge that exists between experts and average individuals through the use of intelligent features. Perhaps the most significant innovation ushered by the Semantic Web would be the ability to search in plain language sentences instead of medical jargon. Further, semantic search results would be contextual to the query. Thus, a search for "Heart risk for African-American men with diabetes" would produce results considering 'heart disease', 'African-American', 'men', and 'diabetes' together. Additionally, users will be able to filter results and aggregate information based on important topics such as treatment modalities, alternative therapies, clinical trials, localized clinician ratings, and a myriad of other options assembled in a central platform. A semantic health search will allow individuals to scour the Internet for health information that is truly pertinent to their unique circumstances - whether it be their age, race, sex, confluence of illnesses, or specific topical interests. Further, the health information produced by a Semantic Web search will empower the user with actionable information and resources to help users seek stay informed, understand their options, and seek proper care.
While the technology to begin utilizing Semantic Web architecture already exists, its complexity and a lack of leadership have hampered its proliferation. Part of the problem stems from a steep barrier to creation. Some areas of biomedical science have started to create the tools necessary to link pieces of data together by meaning through the creation of field specific "dictionaries" called ontologies. Ontologies, along with other semantic web development tools such as RDF, allow data to take on the added meaning necessary to make web searches intelligent. Yet, no field or specialty has fully stepped forward to push the web development community to a crucial tipping point of acceptance. Hot spots of intelligent search portals exist that utilize burgeoning forms of semantic technology - including Healia for consumer health and Gopubmed for biomedical research. By offering a superior means of filtering vast arrays of information compared to their traditional counterparts, these websites present a glimpse of what the Semantic Web might offer.
A shift to a Semantic Web search paradigm requires a particular field to expand beyond the confines of current search methodologies. Though some fields of science are taking the initiative within their niche to create Semantic Web technology, a larger movement is necessary to greater impact the Internet landscape. Yahoo's recent commitment to Semantic Web technology may spark a shift towards semantic data mining across the Web. The online health information sector has the potential to be a transformative agent in the shift from the traditional search model utilized today to one that addresses the Internet community's needs. By jumping to the forefront of Semantic Web technology, health information might become the most advanced form of accurate data sharing on the Internet. If so, we may look back at today's realm of Web health portals much the way we view the early days of the Internet in light of our current web advancements. Perhaps more importantly, this paradigm will empower the average individual to take charge of their medical care experience.
1 - Fox S. "Online Health Search 2006" Pew Internet and American Life Project. 2006
2 - Hawkes, Nigel. "More people consult Google over Health" Times Online 6 June 2005.
(timesonline/tol/news/uk/article530336.ece). Accessed 2/14/2008
3 - Fox S. "Online Health Search 2006" Pew Internet and American Life Project. 2006
Author: Alex Trzebucki
Biomedical Research Fellow
Healthcare Innovation and Technology Lab
www.hitlab
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In health-related searches context takes on great importance; search results that are poor, inaccurate, or incomplete can misinform and confuse while information overload is equally problematic. Research has shown that the Internet is trusted second only to one's physician in health matters, and is often utilized as a first resource for medical information. This is especially troubling considering that the same Pew research established that 75% of individuals searching for health topics do not verify their sources. Verifying information source and quality is essential for health information considering most people start their online health search with a Google search before considering the MayoClinic or the National Institute of Health (NIH). Clearly there is a need for improved, accurate and in-depth health information retrieval online.
The traditional model of Web search engines, while satisfactory in the past, has fundamentally overstretched its capacity to aid the ordinary Internet user. The average online health search is redundant, piecemeal, and highly keyword sensitive. Health topics are myriad and are defined by complicated medical terminology. Are you searching for illness symptoms, treatment options, patient experiences, or drug interactions? Did you enter the correct medical term for your query? Which search hit should you choose? How do results even get ranked? In many ways, searching for medical information online is like sticking your hand into a grab bag. There are lots of choices, little influence on the outcome, and a high probability of being disappointed with the result. This model inevitably results in Internet users reaching back into the grab bag to find the desired result. Most people are used to this repetitive cycle of query, review, revise query, and review again. Inevitably with a complex and sensitive topic like medicine searches become complicated and difficult to refine. Internet users must ultimately rely on piecing together information from various sources of questionable veracity. The current sphere of online health information challenges both the healthcare and Web development communities to find a better way to disseminate important health information across the Internet. The answer may lie in a vision for the future of the Internet called the Semantic Web.
The Semantic Web concept was envisioned by World Wide Web pioneer Tim Berners-Lee as a system for connecting Web information based on the meaning and context of information. To summarize the difference between this idea and the current model, think of your current Google or Yahoo search as a popularity contest between sites that have mentioned your search keywords. Websites are ranked by search engines largely based on how frequently they are visited and updated. For the most part, the search engine does not understand how search terms may relate to the search result. In the Semantic Web model, data on the Internet contains contextual meaning so that a search can access information that you really want. Instead of merely presenting a list of websites with your keyword, the search can connect your search interest with information that is contextually related to the desired topic. The end product of a Semantic Web enabled search tool is the ability to produce a smarter Internet - one where users can actually communicate with the information on the Web instead of stumbling upon it.
Semantic Web health searches have the potential to bridge the gap in medical knowledge that exists between experts and average individuals through the use of intelligent features. Perhaps the most significant innovation ushered by the Semantic Web would be the ability to search in plain language sentences instead of medical jargon. Further, semantic search results would be contextual to the query. Thus, a search for "Heart risk for African-American men with diabetes" would produce results considering 'heart disease', 'African-American', 'men', and 'diabetes' together. Additionally, users will be able to filter results and aggregate information based on important topics such as treatment modalities, alternative therapies, clinical trials, localized clinician ratings, and a myriad of other options assembled in a central platform. A semantic health search will allow individuals to scour the Internet for health information that is truly pertinent to their unique circumstances - whether it be their age, race, sex, confluence of illnesses, or specific topical interests. Further, the health information produced by a Semantic Web search will empower the user with actionable information and resources to help users seek stay informed, understand their options, and seek proper care.
While the technology to begin utilizing Semantic Web architecture already exists, its complexity and a lack of leadership have hampered its proliferation. Part of the problem stems from a steep barrier to creation. Some areas of biomedical science have started to create the tools necessary to link pieces of data together by meaning through the creation of field specific "dictionaries" called ontologies. Ontologies, along with other semantic web development tools such as RDF, allow data to take on the added meaning necessary to make web searches intelligent. Yet, no field or specialty has fully stepped forward to push the web development community to a crucial tipping point of acceptance. Hot spots of intelligent search portals exist that utilize burgeoning forms of semantic technology - including Healia for consumer health and Gopubmed for biomedical research. By offering a superior means of filtering vast arrays of information compared to their traditional counterparts, these websites present a glimpse of what the Semantic Web might offer.
A shift to a Semantic Web search paradigm requires a particular field to expand beyond the confines of current search methodologies. Though some fields of science are taking the initiative within their niche to create Semantic Web technology, a larger movement is necessary to greater impact the Internet landscape. Yahoo's recent commitment to Semantic Web technology may spark a shift towards semantic data mining across the Web. The online health information sector has the potential to be a transformative agent in the shift from the traditional search model utilized today to one that addresses the Internet community's needs. By jumping to the forefront of Semantic Web technology, health information might become the most advanced form of accurate data sharing on the Internet. If so, we may look back at today's realm of Web health portals much the way we view the early days of the Internet in light of our current web advancements. Perhaps more importantly, this paradigm will empower the average individual to take charge of their medical care experience.
1 - Fox S. "Online Health Search 2006" Pew Internet and American Life Project. 2006
2 - Hawkes, Nigel. "More people consult Google over Health" Times Online 6 June 2005.
(timesonline/tol/news/uk/article530336.ece). Accessed 2/14/2008
3 - Fox S. "Online Health Search 2006" Pew Internet and American Life Project. 2006
Author: Alex Trzebucki
Biomedical Research Fellow
Healthcare Innovation and Technology Lab
www.hitlab
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Landmark Study Demonstrates Potential Of Radioimmunotherapy For Treatment Of Indolent B-Cell Non-Hodgkin's Lymphoma
Cell Therapeutics, Inc.
(CTI) (Nasdaq and MTA: CTIC) announced that the Journal of Clinical
Oncology has published the results of the First-line Indolent Trial (FIT)
demonstrating that use of Zevalin(R)([90Y]-ibritumomab tiuxetan) in
consolidation therapy after remission induction in previously untreated
patients with follicular non-Hodgkin's lymphoma provided important patient
benefits including a significant improvement in progression free survival.
A companion editorial discussed the growing evidence for the efficacy of
radioimmunotherapy (RIT) in B-cell lymphomas. Cell Therapeutics has
submitted a supplemental Biologics License Application (sBLA) to the U.S.
Food and Drug Administration (FDA) for use of Zevalin in first-line
consolidation therapy based on the FIT data.
Oliver W. Press, M.D., Ph.D., Member of the Fred Hutchinson Cancer
Research Center and Professor at the University of Washington, commented in
his editorial that the studies "confirm and extend prior data demonstrating
the tremendous potential of RIT in the treatment of B-cell NHL at diagnosis
and after relapse at both conventional and myeloablative doses. Despite the
overwhelming body of evidence, however, RIT remains underused in the United
States and other countries. The reasons for this underuse have been widely
debated but seem to be related, at least partially, to logistic issues
involved in the transfer of care from the hematologist/oncologist to the
nuclear medicine physician, concerns about inadequate reimbursement by
Medicare for RIT, and exaggerated emphasis on delayed effects such as
marrow damage and secondary malignancies. It is hoped that studies such as
those in this issue would encourage wider appreciation and use of RIT."
"We couldn't agree more with Dr. Press' comments about the importance
of these results for patients with newly diagnosed follicular NHL as well
as his views as to why this important therapeutic option is underutilized
by physicians," noted James Bianco, M.D., CEO of Cell Therapeutics. "We
have been working with CMS in making reimbursement for RIT similar as any
biologic agent, and with the FDA on reviewing the FIT results for a
potential indication as consolidation therapy following first-line therapy
in newly diagnosed patients as well as removing the need for the
pre-treatment nuclear medicine scan on the basis of studies such as FIT and
accumulated safety data. We believe these steps will allow office based
hematologist/oncologists the ability to offer RIT with Zevalin to their
patients eliminating many of the current concerns that have limited patient
access to this important treatment option."
The multinational, randomized phase III First-line Indolent Trial (FIT)
evaluated the benefit and safety of a single infusion of Zevalin in 414
patients with CD20-positive follicular non-Hodgkin's lymphoma who had
achieved a partial response or a complete response after receiving a
variety of first-line chemotherapy regimens. The FIT trial demonstrated
that when used as a first-line consolidation therapy for patients with
follicular non-Hodgkin's lymphoma, Zevalin significantly improved the
median progression-free survival time from 13.3 months (control arm) to
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(CTI) (Nasdaq and MTA: CTIC) announced that the Journal of Clinical
Oncology has published the results of the First-line Indolent Trial (FIT)
demonstrating that use of Zevalin(R)([90Y]-ibritumomab tiuxetan) in
consolidation therapy after remission induction in previously untreated
patients with follicular non-Hodgkin's lymphoma provided important patient
benefits including a significant improvement in progression free survival.
A companion editorial discussed the growing evidence for the efficacy of
radioimmunotherapy (RIT) in B-cell lymphomas. Cell Therapeutics has
submitted a supplemental Biologics License Application (sBLA) to the U.S.
Food and Drug Administration (FDA) for use of Zevalin in first-line
consolidation therapy based on the FIT data.
Oliver W. Press, M.D., Ph.D., Member of the Fred Hutchinson Cancer
Research Center and Professor at the University of Washington, commented in
his editorial that the studies "confirm and extend prior data demonstrating
the tremendous potential of RIT in the treatment of B-cell NHL at diagnosis
and after relapse at both conventional and myeloablative doses. Despite the
overwhelming body of evidence, however, RIT remains underused in the United
States and other countries. The reasons for this underuse have been widely
debated but seem to be related, at least partially, to logistic issues
involved in the transfer of care from the hematologist/oncologist to the
nuclear medicine physician, concerns about inadequate reimbursement by
Medicare for RIT, and exaggerated emphasis on delayed effects such as
marrow damage and secondary malignancies. It is hoped that studies such as
those in this issue would encourage wider appreciation and use of RIT."
"We couldn't agree more with Dr. Press' comments about the importance
of these results for patients with newly diagnosed follicular NHL as well
as his views as to why this important therapeutic option is underutilized
by physicians," noted James Bianco, M.D., CEO of Cell Therapeutics. "We
have been working with CMS in making reimbursement for RIT similar as any
biologic agent, and with the FDA on reviewing the FIT results for a
potential indication as consolidation therapy following first-line therapy
in newly diagnosed patients as well as removing the need for the
pre-treatment nuclear medicine scan on the basis of studies such as FIT and
accumulated safety data. We believe these steps will allow office based
hematologist/oncologists the ability to offer RIT with Zevalin to their
patients eliminating many of the current concerns that have limited patient
access to this important treatment option."
The multinational, randomized phase III First-line Indolent Trial (FIT)
evaluated the benefit and safety of a single infusion of Zevalin in 414
patients with CD20-positive follicular non-Hodgkin's lymphoma who had
achieved a partial response or a complete response after receiving a
variety of first-line chemotherapy regimens. The FIT trial demonstrated
that when used as a first-line consolidation therapy for patients with
follicular non-Hodgkin's lymphoma, Zevalin significantly improved the
median progression-free survival time from 13.3 months (control arm) to
36.5 months (Zevalin arm) (pBuy Elimite Without Prescription
Electronic Device For Quick And Painless Glucose Test To Aid Diabetics Designed By Biomedical Engineers At University Of Calgary
A skin patch could one day provide a less-invasive alternative for diabetics who need to take regular samples of their own blood to keep glucose levels in check. The common method of drawing blood from fingertips and using glucose testing strips and metres can be painful, inconvenient and time-consuming.
Electrical engineers at the Schulich School of Engineering at the University of Calgary have patented a device called the Electronic Mosquito. The patch is approximately the size of a deck of cards and contains four micro-needles that "bite" sequentially at programmed intervals. The needles are electronically controlled to penetrate the skin deep enough to draw blood from a capillary, but not deep enough to hit a nerve. This means patients would experience little or no pain. The patch could be worn anywhere on the body where it could obtain accurate readings of capillary blood.
A sensor in each cell of the e-Mosquito measures sugar levels in the blood. This data can then be sent wirelessly to a remote device such a computer or a monitoring instrument worn on the wrist. The system could even be connected to an alarm to alert patients or doctors when blood sugar levels enter the danger zone.
"This is a dramatic improvement over manual poking, particularly for children and elderly patients," says Martin Mintchev, director of the Low Frequency Instrumentation Lab at the Schulich School of Engineering. "Our approach is radically different and offers a reliable, repeatable solution with the minor inconvenience of wearing something similar to an adhesive bandage."
Mintchev spent three years designing the e-Mosquito along with Karan Kaler, director of the Schulich School's Bio-Micro Electromechanical Systems (MEMS) Laboratory. Their next step is to make the components of the e-Mosquito smaller to fit more needles on the patch. Currently, there are four needles, so the patch would need to be changed at least once a day. Adding more needles would allow patients to wear the patch for longer periods of time or test their blood more frequently, even while they're asleep.
Eventually, Mintchev and Kaler hope to integrate a pump system so insulin injections can also become autonomous based on data from the e-Mosquito, thus converting the device into an external artificial pancreas.
"It's important to find an industry partner for this project," says David Reese, project manager with University Technologies International, the university's technology transfer, commercialization and incubation centre that works with U of C researchers to commercialize their technologies. "Industry has the resources and expertise to speed up the process of product development and bring this technology to market for the benefit of patients."
Diabetes has been described as a global epidemic. Approximately 246 million people around the world are affected by the disease. More than two million Canadians have diabetes, a number that is increasing because of the aging population and rising obesity rates, according to the Canadian Diabetes Association.
Source:
Jennifer Sowa
University of Calgary
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Electrical engineers at the Schulich School of Engineering at the University of Calgary have patented a device called the Electronic Mosquito. The patch is approximately the size of a deck of cards and contains four micro-needles that "bite" sequentially at programmed intervals. The needles are electronically controlled to penetrate the skin deep enough to draw blood from a capillary, but not deep enough to hit a nerve. This means patients would experience little or no pain. The patch could be worn anywhere on the body where it could obtain accurate readings of capillary blood.
A sensor in each cell of the e-Mosquito measures sugar levels in the blood. This data can then be sent wirelessly to a remote device such a computer or a monitoring instrument worn on the wrist. The system could even be connected to an alarm to alert patients or doctors when blood sugar levels enter the danger zone.
"This is a dramatic improvement over manual poking, particularly for children and elderly patients," says Martin Mintchev, director of the Low Frequency Instrumentation Lab at the Schulich School of Engineering. "Our approach is radically different and offers a reliable, repeatable solution with the minor inconvenience of wearing something similar to an adhesive bandage."
Mintchev spent three years designing the e-Mosquito along with Karan Kaler, director of the Schulich School's Bio-Micro Electromechanical Systems (MEMS) Laboratory. Their next step is to make the components of the e-Mosquito smaller to fit more needles on the patch. Currently, there are four needles, so the patch would need to be changed at least once a day. Adding more needles would allow patients to wear the patch for longer periods of time or test their blood more frequently, even while they're asleep.
Eventually, Mintchev and Kaler hope to integrate a pump system so insulin injections can also become autonomous based on data from the e-Mosquito, thus converting the device into an external artificial pancreas.
"It's important to find an industry partner for this project," says David Reese, project manager with University Technologies International, the university's technology transfer, commercialization and incubation centre that works with U of C researchers to commercialize their technologies. "Industry has the resources and expertise to speed up the process of product development and bring this technology to market for the benefit of patients."
Diabetes has been described as a global epidemic. Approximately 246 million people around the world are affected by the disease. More than two million Canadians have diabetes, a number that is increasing because of the aging population and rising obesity rates, according to the Canadian Diabetes Association.
Source:
Jennifer Sowa
University of Calgary
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Researchers Develop Blood Test To Detect Lung Cancer
Lung cancer is the leading cause of cancer death for both men and women in the United States and around the world, mainly because lung cancers are found in late stages and the best treatment opportunities already have been missed. In Kentucky, the incidence of lung cancer is 49 percent higher than the national rate. However, a new blood test being developed at the University of Kentucky could soon change all that.
For the past five years, Drs. Edward A. Hirschowitz and Li Zhong have led a team developing the blood test, which could potentially help detect lung cancer in early stages in people with high risk factors for developing the disease.
"Early detection of lung cancer is the key to improving survival," said Zhong, who was the lead author of a study appearing in the July issue of the Journal of Thoracic Oncology that described how the test is 90 percent accurate in correctly predicting non-small-cell lung cancer in patients years before any CT scan can detect it.
Although the researchers have received almost $1.5 million in funding for the development of the test from various sources, they recently received an additional $175,000 National Institutes of Health grant to transform the blood test into a format that real-world clinicians could easily use. And with further studies confirming the reliability of the new format, it could become the first blood test to predict cancer since the prostate specific antigen (PSA) test was introduced in the 1970s.
The multi-biomarker blood test, which works by identifying the body's own immune response to tumors, would help diagnose lung cancer at the earliest stage in those with high risk factors such as age, smoking and genetic history.
Globally, lung cancer is by far the biggest cancer killer, with 10 million people diagnosed each year. In the U.S. alone, the number of lung cancer deaths has risen for each of the past five years to nearly 164,000. The main reason for such a high fatality rate is that 85 percent of lung cancers are found in stages too advanced for best treatment opportunities, Zhong said. Half of all patients die within a year of diagnosis.
For the next two years, the UK research team will collaborate with the private biotechnology company 20/20 GeneSystems to develop the clinical application for the blood test.
"We are hoping in the next several years this test would become available to the public," Zhong said.
Both Hirschowitz and Zhong are faculty in the Division of Pulmonary, Critical Care and Sleep Medicine in the UK.
Contact: Hollye Staley
University of Kentucky
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For the past five years, Drs. Edward A. Hirschowitz and Li Zhong have led a team developing the blood test, which could potentially help detect lung cancer in early stages in people with high risk factors for developing the disease.
"Early detection of lung cancer is the key to improving survival," said Zhong, who was the lead author of a study appearing in the July issue of the Journal of Thoracic Oncology that described how the test is 90 percent accurate in correctly predicting non-small-cell lung cancer in patients years before any CT scan can detect it.
Although the researchers have received almost $1.5 million in funding for the development of the test from various sources, they recently received an additional $175,000 National Institutes of Health grant to transform the blood test into a format that real-world clinicians could easily use. And with further studies confirming the reliability of the new format, it could become the first blood test to predict cancer since the prostate specific antigen (PSA) test was introduced in the 1970s.
The multi-biomarker blood test, which works by identifying the body's own immune response to tumors, would help diagnose lung cancer at the earliest stage in those with high risk factors such as age, smoking and genetic history.
Globally, lung cancer is by far the biggest cancer killer, with 10 million people diagnosed each year. In the U.S. alone, the number of lung cancer deaths has risen for each of the past five years to nearly 164,000. The main reason for such a high fatality rate is that 85 percent of lung cancers are found in stages too advanced for best treatment opportunities, Zhong said. Half of all patients die within a year of diagnosis.
For the next two years, the UK research team will collaborate with the private biotechnology company 20/20 GeneSystems to develop the clinical application for the blood test.
"We are hoping in the next several years this test would become available to the public," Zhong said.
Both Hirschowitz and Zhong are faculty in the Division of Pulmonary, Critical Care and Sleep Medicine in the UK.
Contact: Hollye Staley
University of Kentucky
Buy Amikacin Without Prescription
NIST Can Help You 'MBARK' Onto Better Biometric Systems
Once a tool primarily used by law enforcement to help identify criminals, biometric technologies increasingly are being used by government and the private sector to authenticate a person's identity, provide security at the nation's borders and restrict access to secure sites--both buildings and computer networks. New software and other tools that can be used to help build improved biometric applications are now available from the National Institute of Standards and Technology (NIST).
Most biometric systems are "unimodal," meaning they rely on a single distinguishing physical characteristic--such as a fingerprint--for authenticating identity. But using a single feature can present problems. Poor illumination could make a face image unrecognizable; dirty or damaged sensor plates could affect fingerprint equipment. A multimodal system that has several sources of information, including fingerprint, face and iris data, can be more flexible and reliable. But most biometric equipment, including the sensors that capture data and the database that stores the information, are not interoperable. Organizations must either purchase a complete system or develop "middleware"--custom integration software--to link together applications.
NIST's new Multimodal Biometric Application Resource Kit (MBARK) provides a solution. Originally envisioned as a tool to develop a large database of face, fingerprint and iris images for performance testing of biometric systems, MBARK has evolved into a standardized, flexible middleware package that will enable organizations to plug in sensors from different manufacturers, saving dollars and time. The package, which includes example applications and public-domain source code, can help reduce the complexity and costs of building multimodal biometric applications. MBARK also can used by government and industry to develop standards and tests for biometric system interoperability and usability.
MBARK was developed as part of NIST's homeland security responsibilities and was funded by the Science and Technology Directorate of the U.S. Department of Homeland Security.
The USA Patriot Act and the Enhanced Border Security and Visa Entry Reform Act calls for NIST to develop and certify standards for verifying the identity of individuals and determining the accuracy of biometric technologies, including fingerprints, facial recognition and iris recognition.
For more information and to download MBARK, go to itl.nist/iad/894.03/nigos/nigos.html.
Contact: Jan Kosko
National Institute of Standards and Technology (NIST)
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Most biometric systems are "unimodal," meaning they rely on a single distinguishing physical characteristic--such as a fingerprint--for authenticating identity. But using a single feature can present problems. Poor illumination could make a face image unrecognizable; dirty or damaged sensor plates could affect fingerprint equipment. A multimodal system that has several sources of information, including fingerprint, face and iris data, can be more flexible and reliable. But most biometric equipment, including the sensors that capture data and the database that stores the information, are not interoperable. Organizations must either purchase a complete system or develop "middleware"--custom integration software--to link together applications.
NIST's new Multimodal Biometric Application Resource Kit (MBARK) provides a solution. Originally envisioned as a tool to develop a large database of face, fingerprint and iris images for performance testing of biometric systems, MBARK has evolved into a standardized, flexible middleware package that will enable organizations to plug in sensors from different manufacturers, saving dollars and time. The package, which includes example applications and public-domain source code, can help reduce the complexity and costs of building multimodal biometric applications. MBARK also can used by government and industry to develop standards and tests for biometric system interoperability and usability.
MBARK was developed as part of NIST's homeland security responsibilities and was funded by the Science and Technology Directorate of the U.S. Department of Homeland Security.
The USA Patriot Act and the Enhanced Border Security and Visa Entry Reform Act calls for NIST to develop and certify standards for verifying the identity of individuals and determining the accuracy of biometric technologies, including fingerprints, facial recognition and iris recognition.
For more information and to download MBARK, go to itl.nist/iad/894.03/nigos/nigos.html.
Contact: Jan Kosko
National Institute of Standards and Technology (NIST)
Buy Alesse Without Prescription
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