Researchers from Johns Hopkins University determined that immune responses to the tetanus vaccine were not changed when rituximab in combination with methotrexate (MTX) was compared with MTX alone in patients with rheumatoid arthritis (RA). Responses to a pneumococcal vaccination (Pneumovax® pneumonia vaccine), however, were reduced in RA patients with rituximab. Complete findings of this study are published in the January 2010 issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.
According to the Centers for Disease Control and Prevention (CDC), RA affects 1.3 million adults in the U.S. (2005). RA patients may be at an increased risk of infection because of impaired immune function due to the disease as well as from the use of immunsuppressive medications. As a result, vaccinations against infections are an essential part of rheumatic disease management. How immunosuppressive agents alter the effectiveness of vaccines in RA patients was the focus of the clinical trial led by Clifton O. Bingham III, M.D.
The controlled study enrolled 103 RA patients from 26 centers in the U.S. between January 2006 and December 2007. Patients treated with a stable dose (10-25 mg/week) of MTX were randomly allocated to two groups: placebo and treatment with rituximab (2 x 1000 mg given two weeks apart). Both groups were immunized with the tetanus and pneumococcal vaccines along with keyhole limpet hemocyanin (KLH) to evaluate humoral immunity and skin tested with Candida albicans to evaluate the cellular immune response.
Results indicate that 39.1% of patients in the rituximab+MTX group and 42.3% of MTX-only patients demonstrated a 4-fold rise in the anti-tetanus IgG titer. A 2-fold rise was confirmed in 54.7% of rituximab-treated patients and 61.5% of subjects on MTX alone. The research demonstrates that RA patients given a tetanus vaccine responded the same to tetanus vaccination regardless of whether they received MTX alone or rituximab in combination with MTX.
Patients treated only with MTX had a greater response to the pneumonia vaccine compared with those also receiving rituximab. Researchers found that only 57% of patients treated with rituximab had a response to one type of pneumococcal vaccine (Pneumovax®) compared with 82% of MTX-only patients.
The ability to maintain a positive delayed-type hypersensitivity (DTH) response to the Candida albicans skin test was comparable in both groups with 77.4% of rituximab-treated patients and 70% of MTX-only patients responding. "Our study, the first to examine DTH responses, confirmed that rituximab had no incremental effect on the patient's ability to mount a DTH response," said Dr. Bingham.
Treatment with rituximab produces a rapid depletion of B cells from the circulation, impacting the body's immune function. This depleted B cell pool begins to recover approximately 6-9 months after the initial treatment with rituximab. In his editorial also published in Arthritis & Rheumatism, E. William St. Clair, M.D. from Duke University Medical Center highlighted the need for further research into the effects of rituximab treatment.
"Further studies similar to Bingham et al are necessary to understand the complex effects of rituximab therapy on immune responses," noted Dr. St. Clair. "This study only evaluated immunization responses approximately 6 months after rituximab was administered; the responses at earlier time points, based on animal studies and its mechanism of action, may have been further attenuated," St. Clair added.
Source: Wiley - Blackwell
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суббота, 10 сентября 2011 г.
Uncovering The Secrets Of Getting California Health Insurance To Pay For Autism Treatments
Autism is a neurobiological condition which is often responsive to Applied Behavior Analysis (ABA) therapy, yet most health insurance companies fail to provide this medically necessary service to their members. For the past 7 years, AB 88, known as the Mental Health Parity Act, has been on the books in California. This piece of legislation obliges private health insurance companies to offer treatment services for enrolled members who are diagnosed with autism; but actually getting health insurance to pay for these interventions is a challenge. Up to this point, the advocacy movement to enforce this law has been relatively quiet. Most parents find that insurance companies are not willing to cooperate or give coverage for autism without a fight. To date, there are at least 15 cases in the state that have gone through the full process of request, denial, appeal, and independent medical review (IMR) resulting in families with autistic children receiving insurance funding for intensive ABA services.
Wellspring is eager to assist families through this process, which if successful will provide families with options for treatment as well as alleviating the Regional Center of some of the burden of responsibility for funding of such services.
Wellspring is excited to announce a free seminar for parents that want to use their health insurance to pay for autism treatments. The featured speakers are Dr. Karen Fessel and Feda Almaliti, who have successfully secured private insurance for the funding of autism treatment for their children.
Karen Fessel, Dr PH
Autism Parent and Advocate
Karen Fessel is the proud parent of a 14 year old son with Asperger's, and a 10 year old typical daughter. Karen has a Doctorate in Public Health from UC Berkeley. She has served as a parent advocate on the Autism Advisory Workgroup. She fields questions on an insurance help website, and serves on the Special Ed Advisory Committee of the Lafayette School District. Karen has filed and won several complaints and IMRs against three different insurance companies. Many families have benefited from Karen's personal guidance and have secured insurance coverage for their child's treatment.
Feda Almaliti
Autism Parent and Advocate
Feda Almaliti is the proud parent of 3 boys ages 4 through 10. Her youngest son was diagnosed with autism at 18 months, and since then she has fought tirelessly to get him the help he needs. Recently she fought and won an IMR that resulted in Kaiser paying for 26 hours of ABA, 2 hours of speech therapy, and 2 hours of occupational therapy, weekly. Feda's battle with Kaiser has been featured on local ABC and CBS news stations. Feda is dedicated to helping other parents because "It is the parents who have helped and supported me in my journey through autism."
Their presentation will be invaluable to families who have private insurance and who would like to pursue their insurance carrier for the vital health care supports that their autistic children need. This team has lead parents in some of the biggest wins in the state of California related to autism: securing 40 hours a week of ABA paid by insurance!
Source: Wellspring
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Wellspring is eager to assist families through this process, which if successful will provide families with options for treatment as well as alleviating the Regional Center of some of the burden of responsibility for funding of such services.
Wellspring is excited to announce a free seminar for parents that want to use their health insurance to pay for autism treatments. The featured speakers are Dr. Karen Fessel and Feda Almaliti, who have successfully secured private insurance for the funding of autism treatment for their children.
Karen Fessel, Dr PH
Autism Parent and Advocate
Karen Fessel is the proud parent of a 14 year old son with Asperger's, and a 10 year old typical daughter. Karen has a Doctorate in Public Health from UC Berkeley. She has served as a parent advocate on the Autism Advisory Workgroup. She fields questions on an insurance help website, and serves on the Special Ed Advisory Committee of the Lafayette School District. Karen has filed and won several complaints and IMRs against three different insurance companies. Many families have benefited from Karen's personal guidance and have secured insurance coverage for their child's treatment.
Feda Almaliti
Autism Parent and Advocate
Feda Almaliti is the proud parent of 3 boys ages 4 through 10. Her youngest son was diagnosed with autism at 18 months, and since then she has fought tirelessly to get him the help he needs. Recently she fought and won an IMR that resulted in Kaiser paying for 26 hours of ABA, 2 hours of speech therapy, and 2 hours of occupational therapy, weekly. Feda's battle with Kaiser has been featured on local ABC and CBS news stations. Feda is dedicated to helping other parents because "It is the parents who have helped and supported me in my journey through autism."
Their presentation will be invaluable to families who have private insurance and who would like to pursue their insurance carrier for the vital health care supports that their autistic children need. This team has lead parents in some of the biggest wins in the state of California related to autism: securing 40 hours a week of ABA paid by insurance!
Source: Wellspring
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Small Eye Syndrome Associated With Congenital Heart Disease
Patients with microphthalmia (MAC) have an increased risk of congenital heart disease (CHD) and other malformations, according to a new study. The disease, also known as Small Eye Syndrome, causes eye defects and is only seen in about two of every 10,000 births. Researchers from Albert Einstein Medical Center examined 225 cases and collected data about malformations associated with MAC. A subanalysis was performed to determine if a correlation between CHD and malformations was predictable. Researchers found that the incidence of CHD was significantly higher in patients with MAC, than it was in the general population. Furthermore, if CHD was present in patients with MAC, the incidence of malformations was significantly increased.
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Contact: Jennifer Stawarz
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Caltech Scientists Help Launch The First Standard Graphical Notation For Biology
Researchers at the California Institute of Technology (Caltech) and their colleagues in 30 laboratories worldwide have released a new set of standards for graphically representing biological information - the biology equivalent of the circuit diagram in electronics. This visual language should make it easier to exchange complex information, so that biological models are depicted more accurately, consistently, and in a more readily understandable way.
The new standard, called the Systems Biology Graphical Notation (SBGN), was published in the August 8 issue of the journal Nature Biotechnology.
Researchers use standardized visual languages to communicate complex information in many scientific and engineering fields. A well-known example is the circuit diagram in electrical engineering. However, until now, biology lacked a standardized notation for describing biological interactions, pathways, and networks, even though the discipline is dominated by graphical information.
The SBGN project was launched in 2005 as a united effort to specifically develop a new graphical standard for molecular and systems-biology applications. The project, which was initiated by Hiroaki Kitano of the Systems Biology Institute in Tokyo, Japan, is coordinated by Nicolas Le NovГЁre of the European Molecular Biology Laboratory's European Bioinformatics Institute in Cambridge, England, and senior research fellow Michael Hucka, codirector of the Biological Network Modeling Center at Caltech's Beckman Institute. The international team of researchers that created SBGN is composed of biochemists, modelers, and computer scientists, who developed the notation in collaboration with a broader community of researchers constituting the target user community.
"Engineers, architects, physicists, and software developers all have standard graphical notations for depicting the things they work on, which makes it possible for everyone in those fields to be on the same page, as it were," says Hucka. "I think SBGN represents the first truly broad-based attempt at establishing the same kind of standardization in biology."
SBGN will make it easier for biologists to understand each other's models and share network diagrams more easily, which, Hucka says, has never been more important than in today's era of high-throughput technologies and large-scale network reconstruction efforts. A standard graphical notation will help researchers share this mass of data more efficiently and accurately, which will benefit systems biologists working on a variety of biochemical processes, including gene regulation, metabolism, and cellular signaling.
"Finally, and perhaps most excitingly," adds Hucka, "I believe that, just as happened with the engineering fields, SBGN will act as an enabler for the emergence of new industries devoted to the creation of software tools for working with SBGN, as well as its teaching and publication."
Previous graphical notations in biology have tended to be ambiguous, used in different ways by different researchers, and only suited to specific needs - for example, to represent metabolic networks or signaling pathways. Past efforts to create a more rigid notation failed to become accepted as a standard by the community. Hucka and his collaborators believe that SBGN should be more successful because it represents a more concerted effort to establish a standard by engaging many biologists, modelers, and software-tool developers. In fact, many of those involved in the SBGN effort are the same pioneers who proposed previous notations, demonstrating the degree to which they endorse SBGN as a new standard.
To ensure that this new visual language does not become too vast and complicated, the researchers decided to define three separate types of diagram, which describe molecular process, relationships between entities, and links among biochemical activities. These different types of diagrams complement each other by representing different "views" of the same information, presented in different ways for different purposes, but reusing most of the same graphical symbols. This approach reduces the complexity of any one type of diagram while broadening the range of what can be expressed about a given biological system.
"As biology focuses more on managing complexity with quantitative and systematic methods, standards such as SBGN play an essential role. SBGN combines an intuitive notation with the rigorous style of engineering and math," says John Doyle, the John G. Braun Professor of Control and Dynamical Systems, Bioengineering, and Electrical Engineering at Caltech.
"As with SBML (the Systems Biology Markup Language), Mike and his collaborators have provided the kind of solid foundation that the whole community can build on. SBML has been a highly successful standardization effort for software interoperability, and SBGN is sure to have the same kind of impact on human communication in biology," Doyle adds.
The work at Caltech in the paper, "The Systems Biology Graphical Notation," was supported by the New Energy and Industrial Technology Development Organization and a Beckman Institute grant funding the Biological Network Modeling Center.
Source:
Kathy Svitil
California Institute of Technology
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The new standard, called the Systems Biology Graphical Notation (SBGN), was published in the August 8 issue of the journal Nature Biotechnology.
Researchers use standardized visual languages to communicate complex information in many scientific and engineering fields. A well-known example is the circuit diagram in electrical engineering. However, until now, biology lacked a standardized notation for describing biological interactions, pathways, and networks, even though the discipline is dominated by graphical information.
The SBGN project was launched in 2005 as a united effort to specifically develop a new graphical standard for molecular and systems-biology applications. The project, which was initiated by Hiroaki Kitano of the Systems Biology Institute in Tokyo, Japan, is coordinated by Nicolas Le NovГЁre of the European Molecular Biology Laboratory's European Bioinformatics Institute in Cambridge, England, and senior research fellow Michael Hucka, codirector of the Biological Network Modeling Center at Caltech's Beckman Institute. The international team of researchers that created SBGN is composed of biochemists, modelers, and computer scientists, who developed the notation in collaboration with a broader community of researchers constituting the target user community.
"Engineers, architects, physicists, and software developers all have standard graphical notations for depicting the things they work on, which makes it possible for everyone in those fields to be on the same page, as it were," says Hucka. "I think SBGN represents the first truly broad-based attempt at establishing the same kind of standardization in biology."
SBGN will make it easier for biologists to understand each other's models and share network diagrams more easily, which, Hucka says, has never been more important than in today's era of high-throughput technologies and large-scale network reconstruction efforts. A standard graphical notation will help researchers share this mass of data more efficiently and accurately, which will benefit systems biologists working on a variety of biochemical processes, including gene regulation, metabolism, and cellular signaling.
"Finally, and perhaps most excitingly," adds Hucka, "I believe that, just as happened with the engineering fields, SBGN will act as an enabler for the emergence of new industries devoted to the creation of software tools for working with SBGN, as well as its teaching and publication."
Previous graphical notations in biology have tended to be ambiguous, used in different ways by different researchers, and only suited to specific needs - for example, to represent metabolic networks or signaling pathways. Past efforts to create a more rigid notation failed to become accepted as a standard by the community. Hucka and his collaborators believe that SBGN should be more successful because it represents a more concerted effort to establish a standard by engaging many biologists, modelers, and software-tool developers. In fact, many of those involved in the SBGN effort are the same pioneers who proposed previous notations, demonstrating the degree to which they endorse SBGN as a new standard.
To ensure that this new visual language does not become too vast and complicated, the researchers decided to define three separate types of diagram, which describe molecular process, relationships between entities, and links among biochemical activities. These different types of diagrams complement each other by representing different "views" of the same information, presented in different ways for different purposes, but reusing most of the same graphical symbols. This approach reduces the complexity of any one type of diagram while broadening the range of what can be expressed about a given biological system.
"As biology focuses more on managing complexity with quantitative and systematic methods, standards such as SBGN play an essential role. SBGN combines an intuitive notation with the rigorous style of engineering and math," says John Doyle, the John G. Braun Professor of Control and Dynamical Systems, Bioengineering, and Electrical Engineering at Caltech.
"As with SBML (the Systems Biology Markup Language), Mike and his collaborators have provided the kind of solid foundation that the whole community can build on. SBML has been a highly successful standardization effort for software interoperability, and SBGN is sure to have the same kind of impact on human communication in biology," Doyle adds.
The work at Caltech in the paper, "The Systems Biology Graphical Notation," was supported by the New Energy and Industrial Technology Development Organization and a Beckman Institute grant funding the Biological Network Modeling Center.
Source:
Kathy Svitil
California Institute of Technology
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New AARP Research Analyzes Three Issues Key To Comprehensive Health Reform, USA
As the health care reform debate intensifies
across the country, AARP today released three new
reports on major issues to health care reform. The
AARP reports analyze health plan designs, cost shifting
for expensive "specialty" drugs, and the access to
coverage for Americans age 50-64.
"The President and Congressional leaders have made it clear
that health reform must happen this year, and we're working
with them to make sure it improves options for older
Americans who currently face enormous obstacles in the
private market, as well as strengthens lifeline programs
like Medicare," said AARP Policy Director John Rother.
"This important research can inform the debate to help our
elected officials make smart decisions that ensure every
American has access to quality, affordable health care."
The three reports released today are:
"Health Care Reform: What's at Stake for 50- to 64-year-
olds?" - This report by AARP's Public Policy Institute
analyzes recent data on the fastest growing segment of the
uninsured population. Key findings include that more than
a quarter (28%) of Americans age 50-64 spend more than 10%
of their income on health care-more than one-and-a-half times
as many as younger Americans. The complete report is available
here.
"How Consumer Choice Affects Health Coverage Plan Design" -
A key challenge of health care reform will be designing new
coverage programs for people who are currently without access.
This AARP Public Policy Institute report uses employer
experience with health coverage to illustrate the trade-offs
and issues in designing benefit packages. The complete report
is available here.
"The Tier 4 Phenomenon: Shifting the High Cost of Drugs to
Consumers" - Study of the practice of shifting massive costs
to patients in the form of percentage co-insurance-as opposed
to fixed-dollar co-pays-for super expensive "miracle" drugs.
This report is especially timely given anticipated
developments of legislation to create a pathway to create
generic biologics. The complete report is available
here.
For more information, please visit aarp.
AARP is a nonprofit, nonpartisan membership organization that
helps people 50+ have independence, choice and control in ways
that are beneficial and affordable to them and society as a
whole. AARP does not endorse candidates for public office or
make contributions to either political campaigns or candidates.
We produce AARP The Magazine, the definitive voice for 50+
Americans and the world's largest-circulation magazine with
over 34.5 million readers; AARP Bulletin, the go-to news source
for AARP's 40 million members and Americans 50+; AARP Segunda
Juventud, the only bilingual U.S. publication dedicated
exclusively to the 50+ Hispanic community; and our website,
AARP. AARP Foundation is an affiliated charity that
provides security, protection, and empowerment to older persons
in need with support from thousands of volunteers, donors, and
sponsors. We have staffed offices in all 50 states, the
District of Columbia, Puerto Rico, and the U.S. Virgin Islands.
AARP
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across the country, AARP today released three new
reports on major issues to health care reform. The
AARP reports analyze health plan designs, cost shifting
for expensive "specialty" drugs, and the access to
coverage for Americans age 50-64.
"The President and Congressional leaders have made it clear
that health reform must happen this year, and we're working
with them to make sure it improves options for older
Americans who currently face enormous obstacles in the
private market, as well as strengthens lifeline programs
like Medicare," said AARP Policy Director John Rother.
"This important research can inform the debate to help our
elected officials make smart decisions that ensure every
American has access to quality, affordable health care."
The three reports released today are:
"Health Care Reform: What's at Stake for 50- to 64-year-
olds?" - This report by AARP's Public Policy Institute
analyzes recent data on the fastest growing segment of the
uninsured population. Key findings include that more than
a quarter (28%) of Americans age 50-64 spend more than 10%
of their income on health care-more than one-and-a-half times
as many as younger Americans. The complete report is available
here.
"How Consumer Choice Affects Health Coverage Plan Design" -
A key challenge of health care reform will be designing new
coverage programs for people who are currently without access.
This AARP Public Policy Institute report uses employer
experience with health coverage to illustrate the trade-offs
and issues in designing benefit packages. The complete report
is available here.
"The Tier 4 Phenomenon: Shifting the High Cost of Drugs to
Consumers" - Study of the practice of shifting massive costs
to patients in the form of percentage co-insurance-as opposed
to fixed-dollar co-pays-for super expensive "miracle" drugs.
This report is especially timely given anticipated
developments of legislation to create a pathway to create
generic biologics. The complete report is available
here.
For more information, please visit aarp.
AARP is a nonprofit, nonpartisan membership organization that
helps people 50+ have independence, choice and control in ways
that are beneficial and affordable to them and society as a
whole. AARP does not endorse candidates for public office or
make contributions to either political campaigns or candidates.
We produce AARP The Magazine, the definitive voice for 50+
Americans and the world's largest-circulation magazine with
over 34.5 million readers; AARP Bulletin, the go-to news source
for AARP's 40 million members and Americans 50+; AARP Segunda
Juventud, the only bilingual U.S. publication dedicated
exclusively to the 50+ Hispanic community; and our website,
AARP. AARP Foundation is an affiliated charity that
provides security, protection, and empowerment to older persons
in need with support from thousands of volunteers, donors, and
sponsors. We have staffed offices in all 50 states, the
District of Columbia, Puerto Rico, and the U.S. Virgin Islands.
AARP
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Drug Side Effect Labeling Has Reached Information Overload
The lists of potential side effects that accompany prescription drugs have ballooned in size, averaging 70 reactions per drug, a number that can overwhelm physicians trying to select suitable treatments for their patients, according to a new study of drug labels.
Long lists of drug side effects - whether found in magazine advertisements or in package inserts - are a familiar sight to patients and doctors. Now researchers from the Regenstrief Institute and the Indiana University School of Medicine have quantified just how complex drug labels have become.
In the study, appearing in the May 23, 2011 issue of the Archives of Internal Medicine, the researchers found that the average label contains 70 different side effects, with more commonly prescribed drugs averaging around 100 side effects. The upper range was remarkably high, with a single label containing as many as 525 reactions. The study involved analysis of more than 5,600 drug labels and more than half a million labeled effects.
"Having a high number of side effects on a drug's label should not suggest that the drug is unsafe. In fact, much of this labeling has less to do with true toxicity than with protecting manufacturers from potential lawsuits," said lead author Jon Duke, M.D., Regenstrief Institute investigator and assistant professor of medicine at the IU School of Medicine.
"But having all these labeled side effects can overwhelm doctors who must weigh the risks and benefits when prescribing a medication. The Food and Drug Administration has taken steps to discourage such 'overwarning,' but at present information overload is the rule rather than the exception," Dr. Duke said.
The authors looked at different classes of medications to determine if certain types of drugs were more likely to have a high number of labeled effects. The greatest number of side effects was found in antidepressants, antiviral medications, and newer treatments for Restless Legs Syndrome and Parkinson's disease. In general, medications typically used by psychiatrists and neurologists had the most complex labels, while drugs used by dermatologists and ophthalmologists had the least.
To conduct this research, the investigators developed computer software capable of identifying side effects in drug labels with 95 percent accuracy. This software, known as SPLICER, can be used to monitor labeling patterns on an ongoing basis and detect changing trends.
"It would take many months of work to read through the 5,600 drug labels and identify all of the side effects. SPLICER can read and process this many labels in about a day on a supercomputer and with nearly the same accuracy as a human. This is especially important since new labels are constantly being created and old ones revised," said co-author Regenstrief Investigator Jeff Friedlin, D.O., assistant professor of family medicine at the IU School of Medicine.
Despite the overwhelming amount of information found in current drug labeling, Dr. Duke remains optimistic.
"With current technology, drug labels could be transformed from lengthy static documents to dynamic resources, capable of delivering personalized patient information. Such labels could take into account the individual patient's medical conditions and highlight those side effects that could be especially dangerous.
"We can't stop the growing wave of drug information," said Dr. Duke, "but we can do a better job of presenting it efficiently to health care providers."
The study, "A Quantitative Analysis of Adverse Events and 'Overwarning' in Drug Labeling" was co-authored by Dr. Duke, Dr. Friedlin and Patrick Ryan, M.Eng. of the University of North Carolina. The work was conducted with support from the Regenstrief Institute and the National Library of Medicine.
Source:
Cindy Fox Aisen
Indiana University School of Medicine
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Long lists of drug side effects - whether found in magazine advertisements or in package inserts - are a familiar sight to patients and doctors. Now researchers from the Regenstrief Institute and the Indiana University School of Medicine have quantified just how complex drug labels have become.
In the study, appearing in the May 23, 2011 issue of the Archives of Internal Medicine, the researchers found that the average label contains 70 different side effects, with more commonly prescribed drugs averaging around 100 side effects. The upper range was remarkably high, with a single label containing as many as 525 reactions. The study involved analysis of more than 5,600 drug labels and more than half a million labeled effects.
"Having a high number of side effects on a drug's label should not suggest that the drug is unsafe. In fact, much of this labeling has less to do with true toxicity than with protecting manufacturers from potential lawsuits," said lead author Jon Duke, M.D., Regenstrief Institute investigator and assistant professor of medicine at the IU School of Medicine.
"But having all these labeled side effects can overwhelm doctors who must weigh the risks and benefits when prescribing a medication. The Food and Drug Administration has taken steps to discourage such 'overwarning,' but at present information overload is the rule rather than the exception," Dr. Duke said.
The authors looked at different classes of medications to determine if certain types of drugs were more likely to have a high number of labeled effects. The greatest number of side effects was found in antidepressants, antiviral medications, and newer treatments for Restless Legs Syndrome and Parkinson's disease. In general, medications typically used by psychiatrists and neurologists had the most complex labels, while drugs used by dermatologists and ophthalmologists had the least.
To conduct this research, the investigators developed computer software capable of identifying side effects in drug labels with 95 percent accuracy. This software, known as SPLICER, can be used to monitor labeling patterns on an ongoing basis and detect changing trends.
"It would take many months of work to read through the 5,600 drug labels and identify all of the side effects. SPLICER can read and process this many labels in about a day on a supercomputer and with nearly the same accuracy as a human. This is especially important since new labels are constantly being created and old ones revised," said co-author Regenstrief Investigator Jeff Friedlin, D.O., assistant professor of family medicine at the IU School of Medicine.
Despite the overwhelming amount of information found in current drug labeling, Dr. Duke remains optimistic.
"With current technology, drug labels could be transformed from lengthy static documents to dynamic resources, capable of delivering personalized patient information. Such labels could take into account the individual patient's medical conditions and highlight those side effects that could be especially dangerous.
"We can't stop the growing wave of drug information," said Dr. Duke, "but we can do a better job of presenting it efficiently to health care providers."
The study, "A Quantitative Analysis of Adverse Events and 'Overwarning' in Drug Labeling" was co-authored by Dr. Duke, Dr. Friedlin and Patrick Ryan, M.Eng. of the University of North Carolina. The work was conducted with support from the Regenstrief Institute and the National Library of Medicine.
Source:
Cindy Fox Aisen
Indiana University School of Medicine
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Preclinical Data Show Alfacell's ONCONASE(R) Inhibits Tumor Growth Of Non-Small Cell Lung Cancer, Breast Cancer Cells
Alfacell
Corporation (Nasdaq: ACEL) today announced that in vivo and in vitro
preclinical data presented in a poster at the American Association for
Cancer Research (AACR) Annual Meeting show that ONCONASE (ranpirnase)
significantly inhibits tumor growth of non-small cell lung cancer (NSCLC)
and breast cancer cells.
In the poster titled "Increased apoptosis and reduced lactate levels by
ranpirnase in human lung and breast cancer", Intae Lee, Ph.D. and
collaborators at the University of Pennsylvania demonstrated that ONCONASE
significantly inhibited tumor growth by inducing apoptosis (cell death) in
A549 and NCI-H1975 human NSCLC cells and MDA-MB-231 and MCF-7 human breast
cancer cells without damaging non-cancerous cells such as HLF-1 human lung
fibroblast and NCI/3T3 fibroblast. Additionally, the data indicated that
twice weekly injections of ONCONASE were more effective than an equivalent
single dose injection in these tumor types.
"The findings of our investigation suggest important potential clinical
uses of ONCONASE for the treatment of NSCLC and breast cancer," said Dr.
Lee.
Kuslima Shogen, Alfacell's chairman and chief executive officer, added:
"This research adds to the extensive published data that supports our
continued development of ONCONASE for multiple cancer indications. The
ONCONASE franchise includes the gateway indication of malignant
mesothelioma and several other tumor types for which we are continuing
preclinical and clinical studies."
About ONCONASE(R)
ONCONASE is a first-in-class therapeutic product candidate based on
Alfacell's proprietary ribonuclease (RNase) technology. A natural protein
isolated from the leopard frog, ONCONASE has been shown in the laboratory
and clinic to target cancer cells while sparing normal cells. ONCONASE
triggers apoptosis, the natural death of cells, via multiple molecular
mechanisms of action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a
biopharmaceutical product candidate that works in a manner similar to RNA
interference (RNAi) through late-stage clinical trials. The product
candidate, ONCONASE, is an RNase that overcomes the challenges of targeting
RNA for therapeutic purposes while enabling the development of a new class
of targeted therapies for cancer and other life-threatening diseases. In
addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell
is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer
(NSCLC) and other solid tumors. For more information, visit
alfacell.
Safe Harbor
This press release includes statements that may constitute "forward-
looking" statements, usually containing the words "believe," "estimate,"
"project," "expect" or similar expressions. Forward-looking statements
involve risks and uncertainties that could cause actual results to differ
materially from the forward-looking statements. Factors that would cause or
contribute to such differences include, but are not limited to,
uncertainties involved in transitioning from concept to product,
uncertainties involving the ability of the company to finance research and
development activities, potential challenges to or violations of patents,
uncertainties regarding the outcome of clinical trials, the company's
ability to secure necessary approvals from regulatory agencies, dependence
upon third-party vendors, and other risks discussed in the company's
periodic filings with the Securities and Exchange Commission. By making
these forward-looking statements, the company undertakes no obligation to
update these statements for revisions or changes after the date of this
release.
Alfacell Corporation
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Corporation (Nasdaq: ACEL) today announced that in vivo and in vitro
preclinical data presented in a poster at the American Association for
Cancer Research (AACR) Annual Meeting show that ONCONASE (ranpirnase)
significantly inhibits tumor growth of non-small cell lung cancer (NSCLC)
and breast cancer cells.
In the poster titled "Increased apoptosis and reduced lactate levels by
ranpirnase in human lung and breast cancer", Intae Lee, Ph.D. and
collaborators at the University of Pennsylvania demonstrated that ONCONASE
significantly inhibited tumor growth by inducing apoptosis (cell death) in
A549 and NCI-H1975 human NSCLC cells and MDA-MB-231 and MCF-7 human breast
cancer cells without damaging non-cancerous cells such as HLF-1 human lung
fibroblast and NCI/3T3 fibroblast. Additionally, the data indicated that
twice weekly injections of ONCONASE were more effective than an equivalent
single dose injection in these tumor types.
"The findings of our investigation suggest important potential clinical
uses of ONCONASE for the treatment of NSCLC and breast cancer," said Dr.
Lee.
Kuslima Shogen, Alfacell's chairman and chief executive officer, added:
"This research adds to the extensive published data that supports our
continued development of ONCONASE for multiple cancer indications. The
ONCONASE franchise includes the gateway indication of malignant
mesothelioma and several other tumor types for which we are continuing
preclinical and clinical studies."
About ONCONASE(R)
ONCONASE is a first-in-class therapeutic product candidate based on
Alfacell's proprietary ribonuclease (RNase) technology. A natural protein
isolated from the leopard frog, ONCONASE has been shown in the laboratory
and clinic to target cancer cells while sparing normal cells. ONCONASE
triggers apoptosis, the natural death of cells, via multiple molecular
mechanisms of action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a
biopharmaceutical product candidate that works in a manner similar to RNA
interference (RNAi) through late-stage clinical trials. The product
candidate, ONCONASE, is an RNase that overcomes the challenges of targeting
RNA for therapeutic purposes while enabling the development of a new class
of targeted therapies for cancer and other life-threatening diseases. In
addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell
is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer
(NSCLC) and other solid tumors. For more information, visit
alfacell.
Safe Harbor
This press release includes statements that may constitute "forward-
looking" statements, usually containing the words "believe," "estimate,"
"project," "expect" or similar expressions. Forward-looking statements
involve risks and uncertainties that could cause actual results to differ
materially from the forward-looking statements. Factors that would cause or
contribute to such differences include, but are not limited to,
uncertainties involved in transitioning from concept to product,
uncertainties involving the ability of the company to finance research and
development activities, potential challenges to or violations of patents,
uncertainties regarding the outcome of clinical trials, the company's
ability to secure necessary approvals from regulatory agencies, dependence
upon third-party vendors, and other risks discussed in the company's
periodic filings with the Securities and Exchange Commission. By making
these forward-looking statements, the company undertakes no obligation to
update these statements for revisions or changes after the date of this
release.
Alfacell Corporation
alfacell
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