The health burden of an Asian strain of the parasitic flatworm schistosomiasis is more damaging to the global health burden than previously thought, according to a study published on March 5, 2008 in the open-access journal PLoS Neglected Tropical Diseases.
Schistosomiasis, a parasitic flatworm of the genus Schistosoma, can localize in several parts of the body but commonly affects the intestines. Symptoms include abdominal pain, fever, cough, diarrhea, abnormally high eosinophil count, and enlargement of the liver and spleen, and it is transmitted through certain species of snails. It primarily infects people in developing countries, infecting an estimated 207 million people in 76 (mostly developing) countries. There are several species of the Schistosoma genus that affect humans -- this study focused on Schistosomiasis japonica, found in China and the Philippines.
Through the Global Burden of Disease project, the World Health Organization (WHO) estimates the incidence, prevalence, severity, and length of over 130 major causes of illness, injury, and death throughout the world. A statistical measure known as the disability-adjusted life year (DALY) is used, which means to estimate the number of years of life lost due to premature death and any years lost in disability. This data is often used by policy makers to determine the level of funding for prevention programs, treatment efforts, and research.
According to the WHO, schistosomiasis has a low disease burden, with a 0.005 DALY score on a scale of 0 (for perfect health) to 1 (for death.) However, the burder of schistosomiasis has not been examined in more than a decade. To this end, the researchers performed a literature search to find data, and a decision model approach to re-examine the burden of this disease. The researchers calculated that the symptoms of Schistosomiasis japonica is 7 to 46 times greater than the current estimate. The team arrived at an estimate of 0.098 to 0.186. This study is the first to focus on one strain of the disease, and it is part of an ever growing group of evidence that this common parasitic disease is more damaging than previously estimated for global health.
"Schistosomiasis has a detrimental impact on nutrition and growth and development and can lead to major organ damage and death," study author Julia Finkelstein , of the Harvard School of Public Health, Boston, USA, says. "Current measures may severely underestimate the disability-related impact of the infection and need to be revised."
Dr. Charles King, of Case Western Reserve University, Cleveland, USA, who was not involved in the study but wrote an accompanying Expert Commentary article, predicted that, "Ultimately, these new measures of schistosomiasis-associated disability will translate into a greater priority to control schistosomiasis." Integrating new approaches and discoveries with these old estimates will, he says,"be essential to providing a balanced and fair assessment of neglected tropical diseases, and for properly setting disease control priorities for these disabling diseases of poverty."
About PLoS Neglected Tropical Diseases
PLoS Neglected Tropical Diseases (http://www.plosntds.org/) is a peer-reviewed, open-access journal devoted to the pathology, epidemiology, prevention, treatment, and control of the neglected tropical diseases, as well as public policy relevant to this group of diseases. All works published in PLoS Neglected Tropical Diseases are open access, which means that everything is immediately and freely available subject only to the condition that the original authorship and source are properly attributed. The Public Library of Science uses the Creative Commons Attribution License, and copyright is retained by the authors.
About the Public Library of Science
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org.
Saturday, March 15, 2008
Physical Activity Of Adolescent Girls Could Be Increased By After-School Programs
Afterschool programs can modestly increase the amount of physical activity among girls in middle school, according to new results from the Trial of Activity for Adolescent Girls (TAAG), a multiple site, community based study supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.
Results are published in the article, "Promoting Physical Activity in Middle School Girls," in the March issue of the American Journal of Preventive Medicine.
The study found that programs which linked schools in 6 geographic regions of the U.S. with community partners (such as the YMCA or YWCA, local health clubs, and community recreation centers) increased time spent in moderate-to-vigorous physical activity among the middle-school female students by about 2 minutes per day, or 80 calories a week. This finding occurred after three years of the intervention but not after two years. Physical activity was measured using accelerometers (a device for measuring the acceleration of motion), rather than self-reported. The authors write that results suggest this improved level of activity could prevent excess weight gain of about 2 pounds per year (or 0.82 kg per year), which, if sustained, could prevent a girl from becoming overweight as a teenager or adult.
In addition, TAAG showed a reduction of 8.2 minutes of sedentary behavior in girls in the intervention schools. Furthermore, the best results were seen in programs offered between 2 p.m. and 5 p.m. on weekdays, which suggest that afterschool programs are more effective than programs offered at other times, such as morning weekdays and weekends. The study results support the need for schools and community programs to work together to provide opportunities for physical activity programs in afterschool settings.
Researchers have found that as youth, especially girls, become adolescents, their level of physical activity decreases, putting them at risk for becoming overweight.
Results are published in the article, "Promoting Physical Activity in Middle School Girls," in the March issue of the American Journal of Preventive Medicine.
The study found that programs which linked schools in 6 geographic regions of the U.S. with community partners (such as the YMCA or YWCA, local health clubs, and community recreation centers) increased time spent in moderate-to-vigorous physical activity among the middle-school female students by about 2 minutes per day, or 80 calories a week. This finding occurred after three years of the intervention but not after two years. Physical activity was measured using accelerometers (a device for measuring the acceleration of motion), rather than self-reported. The authors write that results suggest this improved level of activity could prevent excess weight gain of about 2 pounds per year (or 0.82 kg per year), which, if sustained, could prevent a girl from becoming overweight as a teenager or adult.
In addition, TAAG showed a reduction of 8.2 minutes of sedentary behavior in girls in the intervention schools. Furthermore, the best results were seen in programs offered between 2 p.m. and 5 p.m. on weekdays, which suggest that afterschool programs are more effective than programs offered at other times, such as morning weekdays and weekends. The study results support the need for schools and community programs to work together to provide opportunities for physical activity programs in afterschool settings.
Researchers have found that as youth, especially girls, become adolescents, their level of physical activity decreases, putting them at risk for becoming overweight.
Heparin Investigation Update By Baxter
As reported in previous updates, Baxter's sophisticated analytical procedures, including capillary electrophoresis and nuclear magnetic resonance spectroscopy, identified an unknown material in some lots of the active pharmaceutical ingredient (API) for heparin, which is supplied to Baxter by Scientific Protein Laboratories (SPL).
I. Further analysis of contaminant rules out proteins, dioxins and other chemicals
The heparin impurity that has been found in the API lots associated with adverse clinical events is chemically very similar to the heparin molecule itself. Heparin is called a polysaccharide because it is composed of many sugar-like units, and likewise, the impurity contains polysaccharides. One reason it has been difficult to determine the precise chemical structure of the impurity is because it is so similar to heparin, making it hard to separate the two in sophisticated chemical analyses.
Through its research to date, Baxter has ruled out protein impurities in the suspect heparin API. Therefore, bacterial-derived protein molecules such as pertussis, botulinum, shiga, diphtheria, cholera, and tetanus toxin, to name a few, can be ruled out as the heparin impurity. Other chemicals such as tetrodotoxin (from puffer fish), lead and dioxins (formed when hydrocarbons with chlorine are burned) also do not match the identified heparin impurity.
While Baxter's analysis is not complete, the company has evidence that the unknown material is a highly sulfated glucosaminoglycan-like (GAG-like) material. While heparinlike, the material is structurally different from naturally-occurring heparin. The unknown material has approximately the same molecular weight as heparin and is similar in other ways, which is why standard testing would not detect its presence.
II. Investigation focus turns to supply chain and determining causality of allergic reactions
"In this investigation, there are three key questions that we are trying to answer - what exactly is the contaminant, where in the supply chain was it introduced, and can we prove that this contaminant is in fact causing the reactions we've seen," explained Norbert G. Riedel, corporate vice president and chief scientific officer of Baxter International Inc.
Dozens of Baxter scientists, manufacturing and quality experts have been working seven days a week since late December 2007, when the company began to see the increase in heparin-related adverse event reports. More than 40 different laboratory methodologies and hundreds of different tests have been employed in these investigations, including state-of-the-art analytical instrumentation such as nuclear magnetic resonance spectroscopy, which Baxter is now using on a continuous basis.
III. No fatalities have been confirmed by medical evidence to be caused by allergic reactions to Baxter heparin
At this point in time, neither Baxter nor the U.S. Food and Drug Administration (FDA) investigations have confirmed that Baxter heparin has caused any fatalities as a result of an allergic reaction. Baxter has received reports of a number of deaths. The company determined that there are four cases in which patients received Baxter heparin and suffered an allergic-type reaction to heparin that may have contributed to the adverse outcome, though there is not yet enough medical data available to draw a firm conclusion that the reaction caused death. In each of these cases, the patient had multiple underlying complex medical conditions and patients in three of these four cases had either undergone, or were in the process of undergoing, invasive cardiac surgery.
The company has received approximately 600 heparin-related adverse reaction reports to date.
"Patient safety is Baxter's highest priority, and we take our responsibility to investigate any report we receive seriously," Riedel said. "The company investigates as thoroughly as possible, contacting the person or institution that reported the event, checking sales records, medical records, and visiting the institution for further inquiry when appropriate. Baxter will continue its diligent investigation into the reports it receives."
"The continued collaboration between Baxter, FDA and SPL, as well as the consolidators, workshops and other links in the supply chain, is critical to putting all of the pieces together and determining root cause," Riedel said. "Baxter remains committed to facilitating this collaboration and providing the technical expertise necessary to resolve this issue. We stand ready to assist SPL and regulatory authorities in implementing additional measures to ensure that this does not happen again."
"We are confident that through our quick actions, significant resources and technological capabilities, we have been able to materially assist the FDA and other countries' regulatory agencies in identifying and resolving this issue before it manifested itself more widely in the industry," concluded Riedel.
I. Further analysis of contaminant rules out proteins, dioxins and other chemicals
The heparin impurity that has been found in the API lots associated with adverse clinical events is chemically very similar to the heparin molecule itself. Heparin is called a polysaccharide because it is composed of many sugar-like units, and likewise, the impurity contains polysaccharides. One reason it has been difficult to determine the precise chemical structure of the impurity is because it is so similar to heparin, making it hard to separate the two in sophisticated chemical analyses.
Through its research to date, Baxter has ruled out protein impurities in the suspect heparin API. Therefore, bacterial-derived protein molecules such as pertussis, botulinum, shiga, diphtheria, cholera, and tetanus toxin, to name a few, can be ruled out as the heparin impurity. Other chemicals such as tetrodotoxin (from puffer fish), lead and dioxins (formed when hydrocarbons with chlorine are burned) also do not match the identified heparin impurity.
While Baxter's analysis is not complete, the company has evidence that the unknown material is a highly sulfated glucosaminoglycan-like (GAG-like) material. While heparinlike, the material is structurally different from naturally-occurring heparin. The unknown material has approximately the same molecular weight as heparin and is similar in other ways, which is why standard testing would not detect its presence.
II. Investigation focus turns to supply chain and determining causality of allergic reactions
"In this investigation, there are three key questions that we are trying to answer - what exactly is the contaminant, where in the supply chain was it introduced, and can we prove that this contaminant is in fact causing the reactions we've seen," explained Norbert G. Riedel, corporate vice president and chief scientific officer of Baxter International Inc.
Dozens of Baxter scientists, manufacturing and quality experts have been working seven days a week since late December 2007, when the company began to see the increase in heparin-related adverse event reports. More than 40 different laboratory methodologies and hundreds of different tests have been employed in these investigations, including state-of-the-art analytical instrumentation such as nuclear magnetic resonance spectroscopy, which Baxter is now using on a continuous basis.
III. No fatalities have been confirmed by medical evidence to be caused by allergic reactions to Baxter heparin
At this point in time, neither Baxter nor the U.S. Food and Drug Administration (FDA) investigations have confirmed that Baxter heparin has caused any fatalities as a result of an allergic reaction. Baxter has received reports of a number of deaths. The company determined that there are four cases in which patients received Baxter heparin and suffered an allergic-type reaction to heparin that may have contributed to the adverse outcome, though there is not yet enough medical data available to draw a firm conclusion that the reaction caused death. In each of these cases, the patient had multiple underlying complex medical conditions and patients in three of these four cases had either undergone, or were in the process of undergoing, invasive cardiac surgery.
The company has received approximately 600 heparin-related adverse reaction reports to date.
"Patient safety is Baxter's highest priority, and we take our responsibility to investigate any report we receive seriously," Riedel said. "The company investigates as thoroughly as possible, contacting the person or institution that reported the event, checking sales records, medical records, and visiting the institution for further inquiry when appropriate. Baxter will continue its diligent investigation into the reports it receives."
"The continued collaboration between Baxter, FDA and SPL, as well as the consolidators, workshops and other links in the supply chain, is critical to putting all of the pieces together and determining root cause," Riedel said. "Baxter remains committed to facilitating this collaboration and providing the technical expertise necessary to resolve this issue. We stand ready to assist SPL and regulatory authorities in implementing additional measures to ensure that this does not happen again."
"We are confident that through our quick actions, significant resources and technological capabilities, we have been able to materially assist the FDA and other countries' regulatory agencies in identifying and resolving this issue before it manifested itself more widely in the industry," concluded Riedel.
DEET Inhibits The Receptors That Allow Insects To Smell Their Human Prey
Fifty years have passed since the United States Department of Agriculture and the U.S. Army invented DEET to protect soldiers from disease-transmitting insects (and, in the process, made camping trips and barbecues more pleasant for the rest of us civilians). But despite decades of research, scientists still didn't know precisely how it worked. Now, by pinpointing DEET's molecular target in insects, researchers at Rockefeller University have definitively shown that the widely used bug repellent acts like a chemical cloak, masking human odors that blood-feeding insects find attractive. The research, which will be published in the March 13 issue of Science Express, now makes it possible not only to systematically improve upon the repellent properties of DEET but also to make it a safer chemical.
"For all these years, there were a lot of theories but no consensus on how DEET worked," says Leslie Vosshall, head of the Laboratory of Neurogenetics and Behavior. "Does it smell bad to mosquitoes or does it blind them to odors" It was a great unsolved problem."
Mosquitoes are strongly attracted to odors in human breath and sweat, including carbon dioxide, lactic acid and an alcohol-based compound called 1-octen-3-ol. Different receptors within their olfactory system detect these odors, among others, and lead them to their prey. DEET simply interferes with the proper functioning of odorant receptors, making the hunt for a tasty meal all the more difficult.
But this interference is selective.
To see DEET's effect on different odorant receptors, the researchers recorded the electrical activity of cells in the mosquito olfactory system while exposing the insects to the chemical. They found that DEET only shuts down those receptors that work in tandem with a smell coreceptor called Or83b, which is present in all insects. Whereas DEET shuts down the receptor pairs that detect 1-octen-3-ol and two other sweaty odors, it doesn't affect the lone receptor that detects carbon dioxide. That's because this carbon dioxide receptor doesn't require Or83b to function, whereas the sweaty-odor receptors do. "Each receptor complex has different properties," says Vosshall. "And the idea is that DEET is acting on the uniqueness of this complex."
Since mosquitoes that lack this coreceptor have yet to be genetically engineered, Vosshall and her group used fruit fly mutants that do not have the coreceptor. While normal flies avoid a vial treated with DEET, the researchers found that flies without the coreceptor ventured into the vials, suggesting that Or83b is required to detect this potent chemical. Vosshall then proved that DEET specifically affected the receptor/coreceptor as a unit by isolating the RNA of each and injecting both into a frog egg. As expected, DEET inhibited the odorant receptor/coreceptor complex even in this environment, which was isolated from the olfactory system.
By targeting the coreceptor complex rather than the coreceptor alone, DEET doesn't shut down the entire olfactory system, says Vosshall. "Instead, it seems to shut down strategically different parts of it. It just shuts down enough of these receptors to confuse the mosquito or blind it to the odors it finds attractive."
Although DEET is widely used, concerns about its potential health risks have prompted scientists to pursue alternatives, though so far none have proven to be significantly more effective than DEET. "We now know how DEET works, and this is the first step in making significantly better insect repellents," says Vosshall.
"For all these years, there were a lot of theories but no consensus on how DEET worked," says Leslie Vosshall, head of the Laboratory of Neurogenetics and Behavior. "Does it smell bad to mosquitoes or does it blind them to odors" It was a great unsolved problem."
Mosquitoes are strongly attracted to odors in human breath and sweat, including carbon dioxide, lactic acid and an alcohol-based compound called 1-octen-3-ol. Different receptors within their olfactory system detect these odors, among others, and lead them to their prey. DEET simply interferes with the proper functioning of odorant receptors, making the hunt for a tasty meal all the more difficult.
But this interference is selective.
To see DEET's effect on different odorant receptors, the researchers recorded the electrical activity of cells in the mosquito olfactory system while exposing the insects to the chemical. They found that DEET only shuts down those receptors that work in tandem with a smell coreceptor called Or83b, which is present in all insects. Whereas DEET shuts down the receptor pairs that detect 1-octen-3-ol and two other sweaty odors, it doesn't affect the lone receptor that detects carbon dioxide. That's because this carbon dioxide receptor doesn't require Or83b to function, whereas the sweaty-odor receptors do. "Each receptor complex has different properties," says Vosshall. "And the idea is that DEET is acting on the uniqueness of this complex."
Since mosquitoes that lack this coreceptor have yet to be genetically engineered, Vosshall and her group used fruit fly mutants that do not have the coreceptor. While normal flies avoid a vial treated with DEET, the researchers found that flies without the coreceptor ventured into the vials, suggesting that Or83b is required to detect this potent chemical. Vosshall then proved that DEET specifically affected the receptor/coreceptor as a unit by isolating the RNA of each and injecting both into a frog egg. As expected, DEET inhibited the odorant receptor/coreceptor complex even in this environment, which was isolated from the olfactory system.
By targeting the coreceptor complex rather than the coreceptor alone, DEET doesn't shut down the entire olfactory system, says Vosshall. "Instead, it seems to shut down strategically different parts of it. It just shuts down enough of these receptors to confuse the mosquito or blind it to the odors it finds attractive."
Although DEET is widely used, concerns about its potential health risks have prompted scientists to pursue alternatives, though so far none have proven to be significantly more effective than DEET. "We now know how DEET works, and this is the first step in making significantly better insect repellents," says Vosshall.
New Research On The Origins Of Asthma And Allergies Presented At Annual Meeting
Viral illnesses that produce wheezing are very common in early childhood, but not all children who wheeze in the first several years of life go on to develop asthma. D.J. Jackson, MD and colleagues at the University of Wisconsin, Madison presented their study at the 2008 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia.
Wheezing with respiratory syncytial virus (RSV) infections has previously been associated with increased risk of developing asthma later in childhood. Jackson and colleagues confirmed this finding, but discovered a novel finding as well: wheezing illnesses during the first three years of life caused by rhinovirus, the most common cause of "colds" in children and adults, were the strongest predictor of asthma at age 6 years.
Exposure to diesel exhaust particles and indoor endotoxin during early childhood increases the risk for persistent wheeze at age three
Diesel exhaust particles (DEP) and endotoxin, found in bacteria, may act together to promote wheezing in young children, according to a new study presented at the 2008 AAAAI Annual Meeting in Philadelphia.
Children enrolled in the Cincinnati Childhood Allergy and Air Pollution Study (CCAAPS), a NIEHS sponsored study, were evaluated at age 3. Exposure to high levels of DEP prior to age 1 was associated with a two-fold increased risk for wheezing. Children exposed to both DEP and high levels of endotoxin were at risk for wheezing at age three.
Patrick Ryan, PhD and colleagues at the University of Cincinnati in Cincinnati, Ohio concluded that children exposed to DEP during infancy may be at increased risk for the development of wheezing at age 3, and this relationship is modified by indoor exposure to endotoxin.
Allergens in urban elementary schools and homes of children with asthma
William Sheehan, MD and colleagues at Children's Hospital Boston, Boson, MA studied the association between allergens in schools and childhood asthma. They investigated allergen exposure in schools compared to homes with a specific focus on children with asthma. This new study was presented at the 2008 AAAAI Annual Meeting in Philadelphia.
The study was based on collecting 66 samples from various rooms in four Northeastern US urban elementary schools and 38 student bedrooms. Samples were analyzed for cat, dog, cockroach, dust mites, and mouse urinary protein.
The study, presented at the 2008 AAAAI Annual Meeting in Philadelphia, shows higher levels of mouse urine, but lower levels of dust mites in schools versus homes. It is important to recognize that children with asthma may encounter varying levels of allergens in environments outside the home, such as schools.
Exposure to mouse allergens in US homes is associated with asthma symptoms
Asthma, which remains a significant public health concern in the U.S., affects millions of Americans. To evaluate the importance of mouse allergen in asthma, Päivi Salo, PhD and colleagues at the National Institute of Environmental Health Sciences examined whether elevated levels of mouse allergen were associated with asthma among the study participants.
Results from a national survey demonstrate that elevated mouse allergen levels in the home are associated with asthma symptoms in allergic individuals. The National Survey of Lead and Allergens (NSLAH) was the first study to estimate mouse allergen levels and examine residential exposure to mouse allergen in a nationally representative sample of U.S. households. The study confirms that mouse allergen is an important household allergen and aggravates asthma symptoms among asthma sufferers.
Although mouse allergen is a well-recognized allergen in occupational settings, it has only recently been recognized as an important allergen in homes. To date, the majority of the research has focused on inner-city homes in which mouse allergen has been found to be ubiquitous. The findings from the NSLAH suggest that the presence of mouse allergen in U.S. homes is surprisingly common even outside urban areas. Of the surveyed homes, 82% had detectable levels of mouse allergen and, in 35% of the homes; allergen concentrations exceeded a level that has been associated with increased mouse allergen sensitization rates. Elevated levels were most commonly found in high-rise apartments and mobile homes, older homes, and low-income homes.
The results showed that in allergic individuals, higher levels of mouse allergen significantly increased the likelihood of having asthma symptoms. Because elevated levels of the allergen were not restricted to inner-city areas, this study suggests that mouse allergen is an important household allergen outside of urban environments. For allergic individuals, reducing allergen levels in the home is an essential part of asthma control and treatment. Therefore, mice may not be welcome visitors in homes where allergic and asthmatic individuals reside.
Health care utilization is higher among patients whose asthma is not well-controlled
The study by Theresa Guilbert, MD and colleagues aimed to determine whether asthma control is associated with increased healthcare resource utilization. This new study was present at the 2008 AAAAI Annual Meeting.
The study interviewed patients receiving any prescription asthma treatment in the past year. Patients whose asthma was not well-controlled at baseline had a higher risk of an asthma-related event compared to patients with controlled asthma. Adults with asthma that was not well-controlled were at 4-times greater risk for office visits and 4.5 times greater risk for ER visits. Children with asthma that was not well-controlled were at 4-times greater risk for office visits and tended to have an increased risk of ER visits.
Asthma that is not well-controlled is associated with increased healthcare resource utilization. Asthma control determination using ACT/C-ACT may help clinicians and patients decrease the risk of these events. Additional studies to determine if monitoring asthma control could lead to reduced healthcare resource utilization could be valuable.
These studies were presented at the 2008 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI). The AAAAI is the largest professional medical specialty organization in the United States representing allergists, asthma specialists, clinical immunologists, allied health professionals and others with special interest in the research and treatment of allergic disease.
Allergy/immunology specialists are pediatric or internal medicine physicians who have elected an additional two years of training to become specialized in the treatment of asthma, allergy and immunologic disease.
The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Allergy/immunology specialists are pediatric or internal medicine physicians who have elected an additional two years of training to become specialized in the treatment of asthma, allergy and immunologic disease. Established in 1943, the AAAAI has more than 6,500 members in the United States, Canada and 60 other countries.
Wheezing with respiratory syncytial virus (RSV) infections has previously been associated with increased risk of developing asthma later in childhood. Jackson and colleagues confirmed this finding, but discovered a novel finding as well: wheezing illnesses during the first three years of life caused by rhinovirus, the most common cause of "colds" in children and adults, were the strongest predictor of asthma at age 6 years.
Exposure to diesel exhaust particles and indoor endotoxin during early childhood increases the risk for persistent wheeze at age three
Diesel exhaust particles (DEP) and endotoxin, found in bacteria, may act together to promote wheezing in young children, according to a new study presented at the 2008 AAAAI Annual Meeting in Philadelphia.
Children enrolled in the Cincinnati Childhood Allergy and Air Pollution Study (CCAAPS), a NIEHS sponsored study, were evaluated at age 3. Exposure to high levels of DEP prior to age 1 was associated with a two-fold increased risk for wheezing. Children exposed to both DEP and high levels of endotoxin were at risk for wheezing at age three.
Patrick Ryan, PhD and colleagues at the University of Cincinnati in Cincinnati, Ohio concluded that children exposed to DEP during infancy may be at increased risk for the development of wheezing at age 3, and this relationship is modified by indoor exposure to endotoxin.
Allergens in urban elementary schools and homes of children with asthma
William Sheehan, MD and colleagues at Children's Hospital Boston, Boson, MA studied the association between allergens in schools and childhood asthma. They investigated allergen exposure in schools compared to homes with a specific focus on children with asthma. This new study was presented at the 2008 AAAAI Annual Meeting in Philadelphia.
The study was based on collecting 66 samples from various rooms in four Northeastern US urban elementary schools and 38 student bedrooms. Samples were analyzed for cat, dog, cockroach, dust mites, and mouse urinary protein.
The study, presented at the 2008 AAAAI Annual Meeting in Philadelphia, shows higher levels of mouse urine, but lower levels of dust mites in schools versus homes. It is important to recognize that children with asthma may encounter varying levels of allergens in environments outside the home, such as schools.
Exposure to mouse allergens in US homes is associated with asthma symptoms
Asthma, which remains a significant public health concern in the U.S., affects millions of Americans. To evaluate the importance of mouse allergen in asthma, Päivi Salo, PhD and colleagues at the National Institute of Environmental Health Sciences examined whether elevated levels of mouse allergen were associated with asthma among the study participants.
Results from a national survey demonstrate that elevated mouse allergen levels in the home are associated with asthma symptoms in allergic individuals. The National Survey of Lead and Allergens (NSLAH) was the first study to estimate mouse allergen levels and examine residential exposure to mouse allergen in a nationally representative sample of U.S. households. The study confirms that mouse allergen is an important household allergen and aggravates asthma symptoms among asthma sufferers.
Although mouse allergen is a well-recognized allergen in occupational settings, it has only recently been recognized as an important allergen in homes. To date, the majority of the research has focused on inner-city homes in which mouse allergen has been found to be ubiquitous. The findings from the NSLAH suggest that the presence of mouse allergen in U.S. homes is surprisingly common even outside urban areas. Of the surveyed homes, 82% had detectable levels of mouse allergen and, in 35% of the homes; allergen concentrations exceeded a level that has been associated with increased mouse allergen sensitization rates. Elevated levels were most commonly found in high-rise apartments and mobile homes, older homes, and low-income homes.
The results showed that in allergic individuals, higher levels of mouse allergen significantly increased the likelihood of having asthma symptoms. Because elevated levels of the allergen were not restricted to inner-city areas, this study suggests that mouse allergen is an important household allergen outside of urban environments. For allergic individuals, reducing allergen levels in the home is an essential part of asthma control and treatment. Therefore, mice may not be welcome visitors in homes where allergic and asthmatic individuals reside.
Health care utilization is higher among patients whose asthma is not well-controlled
The study by Theresa Guilbert, MD and colleagues aimed to determine whether asthma control is associated with increased healthcare resource utilization. This new study was present at the 2008 AAAAI Annual Meeting.
The study interviewed patients receiving any prescription asthma treatment in the past year. Patients whose asthma was not well-controlled at baseline had a higher risk of an asthma-related event compared to patients with controlled asthma. Adults with asthma that was not well-controlled were at 4-times greater risk for office visits and 4.5 times greater risk for ER visits. Children with asthma that was not well-controlled were at 4-times greater risk for office visits and tended to have an increased risk of ER visits.
Asthma that is not well-controlled is associated with increased healthcare resource utilization. Asthma control determination using ACT/C-ACT may help clinicians and patients decrease the risk of these events. Additional studies to determine if monitoring asthma control could lead to reduced healthcare resource utilization could be valuable.
These studies were presented at the 2008 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI). The AAAAI is the largest professional medical specialty organization in the United States representing allergists, asthma specialists, clinical immunologists, allied health professionals and others with special interest in the research and treatment of allergic disease.
Allergy/immunology specialists are pediatric or internal medicine physicians who have elected an additional two years of training to become specialized in the treatment of asthma, allergy and immunologic disease.
The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Allergy/immunology specialists are pediatric or internal medicine physicians who have elected an additional two years of training to become specialized in the treatment of asthma, allergy and immunologic disease. Established in 1943, the AAAAI has more than 6,500 members in the United States, Canada and 60 other countries.
$7.6 Million Grant To Develop Novel Treatment For Parkinson's Disease Awarded To Scripps Florida
Philip LoGrasso, associate professor and senior director for drug discovery at Scripps Florida, will lead the project as principal investigator. LoGrasso, who joined Scripps Florida in 2005, previously held positions at Merck and the NIH.
The new five-year grant will fund research to develop a compound to treat neurodegeneration in Parkinson's disease. The goal of the project is to bring the potential treatment to the point where Scripps Research and potential partners can file an application for an investigational new drug - the first step in the lengthy clinical trials process required by the U.S. Food and Drug Administration.
An estimated one million Americans are believed to suffer from Parkinson's disease, according to the Parkinson's Disease Foundation; approximately 40,000 new cases are reported annually. Patients with Parkinson's suffer from a loss of dopaminergic neurons, the source of dopamine, a neurotransmitter that plays a key role in motor reflexes and cognitition. While some loss of dopaminergic neurons is common, Parkinson's patients routinely lose more than half.
"Development of a drug that prevents dopaminergic neurodegeneration would be a quantum leap in the clinical treatment of Parkinson's disease," LoGrasso said. "All current therapies treat only the symptoms of the disease, not the underlying pathologies. Current treatments also tend to lose therapeutic efficacy over time, or have adverse side effect profiles that make their long-term use difficult."
A Classic Approach
To develop the new small-molecule compound, LoGrasso will work with a team of Scripps Research scientists. Together, the team represents a range of experience in pharmaceutical preclinical drug development, encompassing the fields of medicinal chemistry, biochemistry, cell biology, structural biology, behavioral pharmacology, drug metabolism and pharmacokinetics, and toxicology.
The team will use what LoGrasso calls a classical pharmaceutical approach to drug development, which involves annual milestones and multiple compound tracking.
"Our research plan is designed to mitigate the risk of developing a single compound that may fail due to specific problems, and to maximize the chance for clinical success by having back-up compounds," LoGrasso said. "We believe that using this approach to optimize small-molecule inhibitors will create a series of compounds with favorable pharmacokinetic properties and safety profiles."
The scientists will examine small-molecule compounds that inhibit c-jun-N-terminal kinase 2/3 (JNK 2/3). Pronounced Junk, JNK 2/3 is an important contributor to stress-induced apoptosis (cell death) and has been shown to play a significant role in neuronal survival. As such, the kinase is a highly viable target for drugs to treat neurodegenerative disorders like Parkinson's disease.
Previous research has shown that small-molecule and peptide inhibitors of the JNK target protect dopaminergic neurons in both acute and chronic models of Parkinson's disease. Previous research has also shown that the JNK2/3 knockout mouse models - mice that lack the gene for JNK2/3 - suffer fewer Parkinson's-like symptoms.
The scientists hope to identify approximately three compounds that demonstrate in vivo efficacy by the third year, and a top compound by year four of the research program.
"When we're finished, our aim it is to have a safe, efficacious compound with sufficient preclinical safety data to support human clinical studies," LoGrasso said.
The new five-year grant will fund research to develop a compound to treat neurodegeneration in Parkinson's disease. The goal of the project is to bring the potential treatment to the point where Scripps Research and potential partners can file an application for an investigational new drug - the first step in the lengthy clinical trials process required by the U.S. Food and Drug Administration.
An estimated one million Americans are believed to suffer from Parkinson's disease, according to the Parkinson's Disease Foundation; approximately 40,000 new cases are reported annually. Patients with Parkinson's suffer from a loss of dopaminergic neurons, the source of dopamine, a neurotransmitter that plays a key role in motor reflexes and cognitition. While some loss of dopaminergic neurons is common, Parkinson's patients routinely lose more than half.
"Development of a drug that prevents dopaminergic neurodegeneration would be a quantum leap in the clinical treatment of Parkinson's disease," LoGrasso said. "All current therapies treat only the symptoms of the disease, not the underlying pathologies. Current treatments also tend to lose therapeutic efficacy over time, or have adverse side effect profiles that make their long-term use difficult."
A Classic Approach
To develop the new small-molecule compound, LoGrasso will work with a team of Scripps Research scientists. Together, the team represents a range of experience in pharmaceutical preclinical drug development, encompassing the fields of medicinal chemistry, biochemistry, cell biology, structural biology, behavioral pharmacology, drug metabolism and pharmacokinetics, and toxicology.
The team will use what LoGrasso calls a classical pharmaceutical approach to drug development, which involves annual milestones and multiple compound tracking.
"Our research plan is designed to mitigate the risk of developing a single compound that may fail due to specific problems, and to maximize the chance for clinical success by having back-up compounds," LoGrasso said. "We believe that using this approach to optimize small-molecule inhibitors will create a series of compounds with favorable pharmacokinetic properties and safety profiles."
The scientists will examine small-molecule compounds that inhibit c-jun-N-terminal kinase 2/3 (JNK 2/3). Pronounced Junk, JNK 2/3 is an important contributor to stress-induced apoptosis (cell death) and has been shown to play a significant role in neuronal survival. As such, the kinase is a highly viable target for drugs to treat neurodegenerative disorders like Parkinson's disease.
Previous research has shown that small-molecule and peptide inhibitors of the JNK target protect dopaminergic neurons in both acute and chronic models of Parkinson's disease. Previous research has also shown that the JNK2/3 knockout mouse models - mice that lack the gene for JNK2/3 - suffer fewer Parkinson's-like symptoms.
The scientists hope to identify approximately three compounds that demonstrate in vivo efficacy by the third year, and a top compound by year four of the research program.
"When we're finished, our aim it is to have a safe, efficacious compound with sufficient preclinical safety data to support human clinical studies," LoGrasso said.
Wasps Offer Clues To Which Came First, Social Dominance Or Big Brains
There's new evidence supporting the idea that bigger brains are better. A study of a tropical wasp suggests that the brainpower required to be dominant drives brain capacity.
University of Washington researchers have found that key processing regions in the brains of both males and females of one wasp species not only increased in size with age but were also associated with being dominant. The study also showed different patterns of brain development in males and females. Certain subregions were larger in males and others were larger in females. This matched expectations based on males' greater use of vision and females' greater reliance on their antennae.
UW researchers Sean O'Donnell and Yamile Molina found increased brain growth in areas of the insects' brains called the mushroom bodies, which vaguely resemble the cerebrum in humans and other vertebrates. A mushroom body sits atop each hemisphere of the wasp brain. The mushroom bodies process input from the eyes and antennae, and are involved in learning and memory.
The social paper wasp that was studied, Mischocyttarus mastigorphorus, is unusual because males are dominant over females, a rarity among social insects, said O'Donnell, a UW associate professor of psychology. Most social insect societies - bees, ants and wasps - are predominantly female, with males short-lived and subordinate.
O'Donnell and Molina, a UW doctoral student, focused on a part of the insects' mushroom body, called the calyx, where neural connections are made. While the overall size of the calyces did not differ between the males and females, specific subregions were larger in each sex. Males rely on vision when they leave the nest for mating opportunities, and the part of the calyx that receives visual input was larger. In contrast, most female interaction takes place on the nest, where tactile and odor senses are important and the part of the calyx that received input from the antennae was bigger among the females.
"When you are dominant among insects you get more food," O'Donnell said, "and in this case it gives males more energy to leave the nest and mate. The fact that the males are dominant and long-lived makes this species interesting from a neurobiological standpoint. We think they have pretty sophisticated cognition compared to males of other wasp species."
The researchers studied five wasp colonies in a tropical cloud forest near Monteverde, Costa Rica. They first marked all resident adult wasps on the nests and these individuals were excluded from further analyses. Newly emerged wasps then were captured and marked over the next several days and returned to their nest. Each colony then was observed in the morning and afternoon every three days over the course of more than a month. Behavioral data such as giving and receiving aggression were collected, as well as time spent on and off the nest. After this observation period, sections of the wasps' brains were examined under a microscope.
Among the unanswered questions stemming from this study include how long these wasps live and how long these patterns of brain growth continued.
"We only followed them for 42 days, so we don't know how long they live," said O'Donnell. "We also don't know if their brain development is similar to humans in terms of if and when they start to decline cognitively.
He said an exciting new idea - the social challenge hypothesis - suggests that large human brains evolved in response to the demands of complex social interactions. The wasp work extends this idea to individual brain variation.
"Do you get to be dominant because of a big brain or does being dominant drive brain size? That's still an open question and we don't know which comes first," said O'Donnell. "This study suggests the high cognitive demands of being dominant drive brain capacity and supports the social brain hypothesis. The next step is to broaden the scope of the research by looking at more species of paper wasps. We are interested in how brains evolve in concert with social evolution. There is the intriguing possibility that there are similar patterns across wide spans of evolutionary time. My goal is to get a bigger sample of social wasp species and examine this."
"You are looking at super-distant animals when you compare wasps and people. Yet there may be an interesting commonality between them. Increased brainpower may be part of being social, no matter who you are. What makes this exciting is we see some common patterns in how brains change as societies evolve. As we see changes in social complexity, there are changes in brain structure. If it is good for people it should be good for wolves, dolphins and paper wasps."
University of Washington researchers have found that key processing regions in the brains of both males and females of one wasp species not only increased in size with age but were also associated with being dominant. The study also showed different patterns of brain development in males and females. Certain subregions were larger in males and others were larger in females. This matched expectations based on males' greater use of vision and females' greater reliance on their antennae.
UW researchers Sean O'Donnell and Yamile Molina found increased brain growth in areas of the insects' brains called the mushroom bodies, which vaguely resemble the cerebrum in humans and other vertebrates. A mushroom body sits atop each hemisphere of the wasp brain. The mushroom bodies process input from the eyes and antennae, and are involved in learning and memory.
The social paper wasp that was studied, Mischocyttarus mastigorphorus, is unusual because males are dominant over females, a rarity among social insects, said O'Donnell, a UW associate professor of psychology. Most social insect societies - bees, ants and wasps - are predominantly female, with males short-lived and subordinate.
O'Donnell and Molina, a UW doctoral student, focused on a part of the insects' mushroom body, called the calyx, where neural connections are made. While the overall size of the calyces did not differ between the males and females, specific subregions were larger in each sex. Males rely on vision when they leave the nest for mating opportunities, and the part of the calyx that receives visual input was larger. In contrast, most female interaction takes place on the nest, where tactile and odor senses are important and the part of the calyx that received input from the antennae was bigger among the females.
"When you are dominant among insects you get more food," O'Donnell said, "and in this case it gives males more energy to leave the nest and mate. The fact that the males are dominant and long-lived makes this species interesting from a neurobiological standpoint. We think they have pretty sophisticated cognition compared to males of other wasp species."
The researchers studied five wasp colonies in a tropical cloud forest near Monteverde, Costa Rica. They first marked all resident adult wasps on the nests and these individuals were excluded from further analyses. Newly emerged wasps then were captured and marked over the next several days and returned to their nest. Each colony then was observed in the morning and afternoon every three days over the course of more than a month. Behavioral data such as giving and receiving aggression were collected, as well as time spent on and off the nest. After this observation period, sections of the wasps' brains were examined under a microscope.
Among the unanswered questions stemming from this study include how long these wasps live and how long these patterns of brain growth continued.
"We only followed them for 42 days, so we don't know how long they live," said O'Donnell. "We also don't know if their brain development is similar to humans in terms of if and when they start to decline cognitively.
He said an exciting new idea - the social challenge hypothesis - suggests that large human brains evolved in response to the demands of complex social interactions. The wasp work extends this idea to individual brain variation.
"Do you get to be dominant because of a big brain or does being dominant drive brain size? That's still an open question and we don't know which comes first," said O'Donnell. "This study suggests the high cognitive demands of being dominant drive brain capacity and supports the social brain hypothesis. The next step is to broaden the scope of the research by looking at more species of paper wasps. We are interested in how brains evolve in concert with social evolution. There is the intriguing possibility that there are similar patterns across wide spans of evolutionary time. My goal is to get a bigger sample of social wasp species and examine this."
"You are looking at super-distant animals when you compare wasps and people. Yet there may be an interesting commonality between them. Increased brainpower may be part of being social, no matter who you are. What makes this exciting is we see some common patterns in how brains change as societies evolve. As we see changes in social complexity, there are changes in brain structure. If it is good for people it should be good for wolves, dolphins and paper wasps."
Merrimack Pharmaceuticals Completes Enrollment In A Phase 2 Study Of MM-093 In Patients With Rheumatoid Arthritis
Merrimack Pharmaceuticals, Inc. announced that enrollment has been completed in a Phase 2 trial of 100 patients that evaluates the safety and efficacy of its lead product, MM-093, in patients suffering from rheumatoid arthritis (RA). MM-093 is a recombinant version of human alpha-fetoprotein (AFP).
The randomized, double-blind, placebo-controlled, Phase 2 study is being conducted at 20 centers throughout the United States. The objective of this study is to examine the safety and efficacy of MM-093 in patients with moderate to severe, active RA despite treatment with stable doses of methotrexate. Each patient receives 60mg of MM-093 per week or placebo for 12 weeks and will then be followed for a period of 4 weeks. In addition to evaluating the safety of MM-093, patients will be assessed for changes in the signs and symptoms of their disease using standard clinical outcome measurements for RA, such as ACR20 and DAS28 scores. Patients who complete the study are eligible to participate in an ongoing Open-Label Extension study, which has enrolled over 35 patients to date.
"We are pleased to have completed enrollment and are thankful for the enthusiasm of the investigators who have worked diligently to enroll patients," said Dr. William Slichenmyer, Senior Vice President and Chief Medical Officer at Merrimack. "We believe MM-093 represents a promising and novel approach to the treatment of a broad range of autoimmune diseases. We look forward to completing the study and communicating the results later this year."
In addition to the ongoing studies in RA, MM-093 is currently being tested in a pilot study for patients with certain types of autoimmune uveitis, an inflammatory disorder of the eye.
Merrimack controls a strong intellectual property estate around MM-093 including 15 issued patents and a number of pending applications, both in the U.S. and internationally, which cover composition of matter, production methods and therapeutic uses of the drug.
Merrimack Pharmaceuticals, Inc., is a biotechnology company focused on the discovery and development of novel treatments for diseases in the areas of autoimmunity and cancer. Its lead compound, MM-093, is currently in clinical development to treat patients with rheumatoid arthritis or with autoimmune uveitis. MM-093 is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency. The company's proprietary Network Biology discovery platform, developed with the help of leading scientists from MIT and Harvard, enables the high throughput profiling of protein networks as a basis for improved validation, lead identification and speed in the development of innovative, effective and safe therapeutics. Merrimack is a privately-held company based in Cambridge, Massachusetts.
The randomized, double-blind, placebo-controlled, Phase 2 study is being conducted at 20 centers throughout the United States. The objective of this study is to examine the safety and efficacy of MM-093 in patients with moderate to severe, active RA despite treatment with stable doses of methotrexate. Each patient receives 60mg of MM-093 per week or placebo for 12 weeks and will then be followed for a period of 4 weeks. In addition to evaluating the safety of MM-093, patients will be assessed for changes in the signs and symptoms of their disease using standard clinical outcome measurements for RA, such as ACR20 and DAS28 scores. Patients who complete the study are eligible to participate in an ongoing Open-Label Extension study, which has enrolled over 35 patients to date.
"We are pleased to have completed enrollment and are thankful for the enthusiasm of the investigators who have worked diligently to enroll patients," said Dr. William Slichenmyer, Senior Vice President and Chief Medical Officer at Merrimack. "We believe MM-093 represents a promising and novel approach to the treatment of a broad range of autoimmune diseases. We look forward to completing the study and communicating the results later this year."
In addition to the ongoing studies in RA, MM-093 is currently being tested in a pilot study for patients with certain types of autoimmune uveitis, an inflammatory disorder of the eye.
Merrimack controls a strong intellectual property estate around MM-093 including 15 issued patents and a number of pending applications, both in the U.S. and internationally, which cover composition of matter, production methods and therapeutic uses of the drug.
Merrimack Pharmaceuticals, Inc., is a biotechnology company focused on the discovery and development of novel treatments for diseases in the areas of autoimmunity and cancer. Its lead compound, MM-093, is currently in clinical development to treat patients with rheumatoid arthritis or with autoimmune uveitis. MM-093 is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency. The company's proprietary Network Biology discovery platform, developed with the help of leading scientists from MIT and Harvard, enables the high throughput profiling of protein networks as a basis for improved validation, lead identification and speed in the development of innovative, effective and safe therapeutics. Merrimack is a privately-held company based in Cambridge, Massachusetts.
Thursday, March 13, 2008
Modeling Flu Pandemics May Help Prevent Them
An article published in the Early Edition of the Proceedings of the National Academy of Sciences in the United States of America suggests that we can reduce the likelihood of a pandemic influenza outbreak in the United States by quickly implementing social-distancing measures alongside antiviral treatment and prophylaxis (preventive measures) until a vaccine becomes accessible.
The study was conducted by three teams of researchers in the US and England who worked closely with federal officials. The teams and an informatics group - part of the Models of Infectious Disease Agent Study (MIDAS) Network, funded by the National Institute of General Medical Sciences (NIGMS) - set out to study several intervention combinations to aid the planning process for a national pandemic.
The authors, led by M. Elizabeth Halloran, M.D., D.Sc. and Ira M. Longini Jr., Ph.D., (Fred Hutchinson Cancer Research Center and professors of biostatistics at the University of Washington), investigated the natural course of infectious diseases by using sophisticated mathematical and statistical models. Longini notes that to make sure the results were robust, the federal government wanted three groups to be working on the same problem. The data, says Longini, "would be used to inform national pandemic planning," and thus they got the highest level of input.
Since a flu vaccine was not available when the researchers began the study, they focused on the effectiveness of using antiviral and social-distancing interventions (e.g. closing schools) together in order to prevent an influenza pandemic. According to earlier studies, models have shown that an available vaccine, even if low-efficacy, would be helpful in reducing the speed of a pandemic.
Halloran notes: "The good news was that all three of the disease-modeling groups involved in the study found that an outbreak of pandemic flu similar to the pandemic of 1918 could be mitigated if these measures were implemented quickly."
One research team consisted of Halloran, Longini, a computer scientist Shufu Xu, and others at the Los Alamos National Laboratories. Researchers at Imperial College in London and the University of Pittsburgh comprised a second group, and a third group included researchers at Virginia Bioinformatics Institute at Virginia Tech in Blacksburg, Va.
Each research team used separate but similar computer models. They calculated how influenza would disperse in a city of about 8.6 million people, such as Chicago, IL. The models assumed that residents of the virtual community interacted in households, schools, workplaces, and the community, just as they usually do. The models all assumed attack-rate patterns that were analogous to US flu pandemics that have occurred in the past.
To take into account real-world unpredictability and several other characteristics of the disease and the population, Halloran and colleagues use stochastic modeling when predicting the spread of influenza. The first step in building pandemic models requires researchers to come up with various assumptions about the ways in which people interact and how the virus spreads. They can then introduce intervention strategies to the model in order to test how effective they are.
Two categories of intervention were assessed:
The three computer simulations predict about 47 to 60 percent of the population will have symptomatic influenza if there is no intervention.
In the least-stringent scenario, interventions were implemented after 1 percent of the population had developed symptomatic influenza, schools were closed, 60 percent of clinical influenza patients received antivirals and their contacts received prophylaxis, 30 percent complied with quarantine, and 60 percent complied with social-distancing measures.
The three computer-modeling groups predict an 83 to 94 percent reduction in cases of influenza using combined intervention strategies at a lower transmissibility of the virus, even in the least-stringent scenario.
Longini maintains that the researchers "ran this simulation with the assumption that the pandemic was as virulent and lethal as the 1918 pandemic." He adds: "Even when modeling the situation of pandemic flu, with a modest compliance range in social-distancing measures, and modest ability to identify and treat and prophylax with antivirals, the interventions were similarly - though not identically - effective in all three models."
The researchers believe that the policy implications of these findings are noteworthy. "If one could achieve these levels of compliance, ascertainment and social distancing, then there is a possibility of considerably mitigating a pandemic until a vaccine was available." They caution, though, that the levels of disease ascertainment and compliance that were entered into the models may not be realistic.
"These models, which are built from the best available data and with the best tools, contribute greatly to our understanding of how a pandemic could spread and what measures might protect the public's health," said Jeremy M. Berg, Ph.D., director of the NIGMS, which supports the MIDAS program. "But they are not our only resource; field work and experimental studies remain critical and will enhance the quality and reliability of these and other models," conclude the authors.
The study was conducted by three teams of researchers in the US and England who worked closely with federal officials. The teams and an informatics group - part of the Models of Infectious Disease Agent Study (MIDAS) Network, funded by the National Institute of General Medical Sciences (NIGMS) - set out to study several intervention combinations to aid the planning process for a national pandemic.
The authors, led by M. Elizabeth Halloran, M.D., D.Sc. and Ira M. Longini Jr., Ph.D., (Fred Hutchinson Cancer Research Center and professors of biostatistics at the University of Washington), investigated the natural course of infectious diseases by using sophisticated mathematical and statistical models. Longini notes that to make sure the results were robust, the federal government wanted three groups to be working on the same problem. The data, says Longini, "would be used to inform national pandemic planning," and thus they got the highest level of input.
Since a flu vaccine was not available when the researchers began the study, they focused on the effectiveness of using antiviral and social-distancing interventions (e.g. closing schools) together in order to prevent an influenza pandemic. According to earlier studies, models have shown that an available vaccine, even if low-efficacy, would be helpful in reducing the speed of a pandemic.
Halloran notes: "The good news was that all three of the disease-modeling groups involved in the study found that an outbreak of pandemic flu similar to the pandemic of 1918 could be mitigated if these measures were implemented quickly."
One research team consisted of Halloran, Longini, a computer scientist Shufu Xu, and others at the Los Alamos National Laboratories. Researchers at Imperial College in London and the University of Pittsburgh comprised a second group, and a third group included researchers at Virginia Bioinformatics Institute at Virginia Tech in Blacksburg, Va.
Each research team used separate but similar computer models. They calculated how influenza would disperse in a city of about 8.6 million people, such as Chicago, IL. The models assumed that residents of the virtual community interacted in households, schools, workplaces, and the community, just as they usually do. The models all assumed attack-rate patterns that were analogous to US flu pandemics that have occurred in the past.
To take into account real-world unpredictability and several other characteristics of the disease and the population, Halloran and colleagues use stochastic modeling when predicting the spread of influenza. The first step in building pandemic models requires researchers to come up with various assumptions about the ways in which people interact and how the virus spreads. They can then introduce intervention strategies to the model in order to test how effective they are.
Two categories of intervention were assessed:
- Medical intervention: surveillance used to identify cases, and antiviral agents are used to treat patients and prevent the disease among close contacts
- Non-pharmaceutical: social distancing - closing schools, voluntary quarantine, restricting travel restrictions
The three computer simulations predict about 47 to 60 percent of the population will have symptomatic influenza if there is no intervention.
In the least-stringent scenario, interventions were implemented after 1 percent of the population had developed symptomatic influenza, schools were closed, 60 percent of clinical influenza patients received antivirals and their contacts received prophylaxis, 30 percent complied with quarantine, and 60 percent complied with social-distancing measures.
The three computer-modeling groups predict an 83 to 94 percent reduction in cases of influenza using combined intervention strategies at a lower transmissibility of the virus, even in the least-stringent scenario.
Longini maintains that the researchers "ran this simulation with the assumption that the pandemic was as virulent and lethal as the 1918 pandemic." He adds: "Even when modeling the situation of pandemic flu, with a modest compliance range in social-distancing measures, and modest ability to identify and treat and prophylax with antivirals, the interventions were similarly - though not identically - effective in all three models."
The researchers believe that the policy implications of these findings are noteworthy. "If one could achieve these levels of compliance, ascertainment and social distancing, then there is a possibility of considerably mitigating a pandemic until a vaccine was available." They caution, though, that the levels of disease ascertainment and compliance that were entered into the models may not be realistic.
"These models, which are built from the best available data and with the best tools, contribute greatly to our understanding of how a pandemic could spread and what measures might protect the public's health," said Jeremy M. Berg, Ph.D., director of the NIGMS, which supports the MIDAS program. "But they are not our only resource; field work and experimental studies remain critical and will enhance the quality and reliability of these and other models," conclude the authors.
Many Children Unimmunized And Susceptible To Measles, Mumps, And Rubella
A large study of children born between 2000 and 2002 in the United Kingdom has determined that there are not enough children being immunized against measles, mumps and rubella (MMR) in order to ensure appropriate control of these diseases. These results were published on February 29, 2008 in BMJ.
The combined measles, mumps, and rubella immunization has been used in the UK since 1988. It is generally administered to children at the age of one year, and is continued in a booster several years later. Uptake of the second shot is much lower than the first, but it is necessary for adequate protection from disease. Single antigen vaccines are also available, but are not licensed for use in the UK, and are only available on a private basis.
Research published in 1998 suggested a link between the vaccine and autism and bowel disease, and rates of vaccination fell from 92% in 1995 to 79% in 2003. Although MMR uptake rates have increased recently, more cases of the measles were reported in 2007 than for any year in the past decade.
Investigators at the UCL Institute of Child Health and the Great Ormond Street Hospital for Children found that, by the age of three, 88.6% of children had been immuzied with MMR. Additionally, 5.2% had received at least one of the three individual vaccines, and 6.1% were not immunized. Of the children with at least one single vaccination, just over half had received all three.
The researchers also explored the social, economic, and cultural factors that went into uptake, and the parents' reasons for omitting the MMR vaccine. For this, focused on uptake of the first dose of MMR. Children without MMR immunization were more likely to: come from a large family, have a mother who smoked, and have a mother who was younger than average (under 20 years) or older than average (more than 34 years) at the time of birth. In comparison with the full immunization, parents who chose single vaccines were more likely to be white, well educated, wealthy, older, and have single children. Parents who chose not to have their child immunized overwhelmingly (74.4%) stated that it was a "conscious decision," often citing general fear, an impression that the vaccine was dangerous, the purported link to autism, and negative media attention.
Although the MMR vaccination rates in this study were high, the authors stress that this is far below the level necessary to prevent disease outbreak. A substantial proportion of children still remain at risk for avoidable infection -- for the most part, this is because parents consciously decide against immunization. Additionally, the single antigen vaccines are not considered a good substitute for the combined MMR vaccine. The authors conclude that improvement in this area is essential, and to achieve most effective control of these vaccine preventable diseases, many different measures should be used to target the low uptake groups.
The combined measles, mumps, and rubella immunization has been used in the UK since 1988. It is generally administered to children at the age of one year, and is continued in a booster several years later. Uptake of the second shot is much lower than the first, but it is necessary for adequate protection from disease. Single antigen vaccines are also available, but are not licensed for use in the UK, and are only available on a private basis.
Research published in 1998 suggested a link between the vaccine and autism and bowel disease, and rates of vaccination fell from 92% in 1995 to 79% in 2003. Although MMR uptake rates have increased recently, more cases of the measles were reported in 2007 than for any year in the past decade.
Investigators at the UCL Institute of Child Health and the Great Ormond Street Hospital for Children found that, by the age of three, 88.6% of children had been immuzied with MMR. Additionally, 5.2% had received at least one of the three individual vaccines, and 6.1% were not immunized. Of the children with at least one single vaccination, just over half had received all three.
The researchers also explored the social, economic, and cultural factors that went into uptake, and the parents' reasons for omitting the MMR vaccine. For this, focused on uptake of the first dose of MMR. Children without MMR immunization were more likely to: come from a large family, have a mother who smoked, and have a mother who was younger than average (under 20 years) or older than average (more than 34 years) at the time of birth. In comparison with the full immunization, parents who chose single vaccines were more likely to be white, well educated, wealthy, older, and have single children. Parents who chose not to have their child immunized overwhelmingly (74.4%) stated that it was a "conscious decision," often citing general fear, an impression that the vaccine was dangerous, the purported link to autism, and negative media attention.
Although the MMR vaccination rates in this study were high, the authors stress that this is far below the level necessary to prevent disease outbreak. A substantial proportion of children still remain at risk for avoidable infection -- for the most part, this is because parents consciously decide against immunization. Additionally, the single antigen vaccines are not considered a good substitute for the combined MMR vaccine. The authors conclude that improvement in this area is essential, and to achieve most effective control of these vaccine preventable diseases, many different measures should be used to target the low uptake groups.
AVMA Applauds New State Laws That Make Dog Fighting A Felony Everywhere In The United States
The American Veterinary Medical Association (AVMA) is pleased to announce that dog fighting is now a felony everywhere in the United States. Last week, Wyoming made dog fighting a felony, the 50th state in the country to do so.
"For many years, the AVMA has recommended that animal fighting be considered a felony offense in this country, giving it the legal classification and punishment that a blood sport of this sort deserves," explains Adrian Hochstadt, assistant director of State Legislative and Regulatory Affairs at the AVMA. "The AVMA condemns any and all events involving animals in which injury or death is intended, and we encourage veterinarians to collaborate with law enforcement with respect to recognition, enforcement, and education about dog fighting. Together, we can help break down the criminal networks that perpetrate these violent crimes against animals."
On March 4, 2008, Wyoming Gov. Dave Freudenthal signed legislation that increased the penalty in that state for participating in dog fighting from a misdemeanor to a felony. Idaho passed similar legislation just a week earlier, making it the 49th state to make dog fighting a felony. The issue of dog fighting gained national attention last year after Atlanta Falcons quarterback Michael Vick was arrested and prosecuted for involvement in the blood sport.
"For many years, the AVMA has recommended that animal fighting be considered a felony offense in this country, giving it the legal classification and punishment that a blood sport of this sort deserves," explains Adrian Hochstadt, assistant director of State Legislative and Regulatory Affairs at the AVMA. "The AVMA condemns any and all events involving animals in which injury or death is intended, and we encourage veterinarians to collaborate with law enforcement with respect to recognition, enforcement, and education about dog fighting. Together, we can help break down the criminal networks that perpetrate these violent crimes against animals."
On March 4, 2008, Wyoming Gov. Dave Freudenthal signed legislation that increased the penalty in that state for participating in dog fighting from a misdemeanor to a felony. Idaho passed similar legislation just a week earlier, making it the 49th state to make dog fighting a felony. The issue of dog fighting gained national attention last year after Atlanta Falcons quarterback Michael Vick was arrested and prosecuted for involvement in the blood sport.
Statement In Response To Allegations By Jim Devine MP, Nursing And Midwifery Council, UK
The Nursing and Midwifery Council rejects allegations made by Jim Devine MP. There is an open invitation to Mr Devine and his colleagues to meet us to discuss their concerns and to give us an opportunity to respond. We are saddened that they felt unable to do so.
Read the rest of the statement
Background
On 18th February, Jim Devine MP (Labour, Livingston), made the following remarks to Ben Bradshaw MP, Minister of State for Health Services, during the course of the debate on amendments to the Health and Social Care Bill: "Will my Hon. friend meet me and members of the Nursing and Midwifery Council who are concerned about the structure of that body? It appears to be very racist and to employ a bullying strategy".
Similar allegations were subsequently made by John Smith MP (Labour, Vale of Glamorgan).
The NMC issued the following statement on 19 February in response to media enquiries regarding Mr Devine's remarks:
"The Nursing & Midwifery Council (NMC) in both its Council and workforce is a diverse organisation that has a good track record in promoting equality and diversity. The NMC has in place a specific equality and diversity unit to promote equality and diversity within the NMC. In addition, we have created an independent Appointments Board to monitor the membership of those who hear professional misconduct and health cases and to create greater opportunities for involvement and participation from diverse communities.
As a regulator, public body and employer, the NMC takes its statutory responsibilities very seriously. Any allegations of discrimination on whatever grounds are investigated fully and in accordance with the principles of good practice. The NMC also has legal responsibilities in relation to the confidentiality of current and former members of staff. It would be utterly inappropriate for the NMC to breach confidentiality by commenting on dealings relating to current or former employees. For these reasons the NMC will also not comment on any ongoing investigations.
The NMC is rigorous in ensuring that all decisions on payments made to individuals on redundancy or termination of employment strictly adhere to best practice in corporate governance. All such payments for senior staff are fully audited in accordance with the NMC's financial procedures. They are also referred to Council Members on the Remuneration and Appointments Committee. Their role is to advise on all issues relating to the termination of employment and termination payments to members of the senior management team".
The NMC does not recognise the organisation that Mr Devine and Mr Smith describe. The NMC has not been formally approached by either Mr Devine or Mr Smith with any evidence to support the allegations which have been made in Parliament and to the media. The NMC has written to both MPs requesting that they meet with the NMC and take the opportunity to gain first-hand experience of the NMC, its staff and the important work that we do to safeguard the health and well being of patients and the public by meeting with us.
The NMC's response to the debate in Westminster Hall, 11 March 2008
On 11 March, Mr Devine held at debate on the NMC in Westminster Hall. View a full transcript of the debate [PDF]. The NMC then issued the following statement on 12 March:
The Nursing and Midwifery Council rejects allegations made by Jim Devine MP. There is an open invitation to Mr Devine and his colleagues to meet us to discuss their concerns and to give us an opportunity to respond. We are saddened that they felt unable to do so.
We very much welcome the Minister's assistance and the opportunity for independent scrutiny of our governance and operating processes by the Charity Commission and the Council for Healthcare Regulatory Excellence.
We are confident that this will provide us with the opportunity - thus far denied - to put forward our case. Independent scrutiny will give us a chance to demonstrate that we are a fully accountable, open and transparent organisation which does not tolerate discrimination of any kind.
The NMC's workforce is extremely diverse, highly competent and committed to delivering excellence in regulation and public protection and will continue to do so.
Read the rest of the statement
Background
On 18th February, Jim Devine MP (Labour, Livingston), made the following remarks to Ben Bradshaw MP, Minister of State for Health Services, during the course of the debate on amendments to the Health and Social Care Bill: "Will my Hon. friend meet me and members of the Nursing and Midwifery Council who are concerned about the structure of that body? It appears to be very racist and to employ a bullying strategy".
Similar allegations were subsequently made by John Smith MP (Labour, Vale of Glamorgan).
The NMC issued the following statement on 19 February in response to media enquiries regarding Mr Devine's remarks:
"The Nursing & Midwifery Council (NMC) in both its Council and workforce is a diverse organisation that has a good track record in promoting equality and diversity. The NMC has in place a specific equality and diversity unit to promote equality and diversity within the NMC. In addition, we have created an independent Appointments Board to monitor the membership of those who hear professional misconduct and health cases and to create greater opportunities for involvement and participation from diverse communities.
As a regulator, public body and employer, the NMC takes its statutory responsibilities very seriously. Any allegations of discrimination on whatever grounds are investigated fully and in accordance with the principles of good practice. The NMC also has legal responsibilities in relation to the confidentiality of current and former members of staff. It would be utterly inappropriate for the NMC to breach confidentiality by commenting on dealings relating to current or former employees. For these reasons the NMC will also not comment on any ongoing investigations.
The NMC is rigorous in ensuring that all decisions on payments made to individuals on redundancy or termination of employment strictly adhere to best practice in corporate governance. All such payments for senior staff are fully audited in accordance with the NMC's financial procedures. They are also referred to Council Members on the Remuneration and Appointments Committee. Their role is to advise on all issues relating to the termination of employment and termination payments to members of the senior management team".
The NMC does not recognise the organisation that Mr Devine and Mr Smith describe. The NMC has not been formally approached by either Mr Devine or Mr Smith with any evidence to support the allegations which have been made in Parliament and to the media. The NMC has written to both MPs requesting that they meet with the NMC and take the opportunity to gain first-hand experience of the NMC, its staff and the important work that we do to safeguard the health and well being of patients and the public by meeting with us.
The NMC's response to the debate in Westminster Hall, 11 March 2008
On 11 March, Mr Devine held at debate on the NMC in Westminster Hall. View a full transcript of the debate [PDF]. The NMC then issued the following statement on 12 March:
The Nursing and Midwifery Council rejects allegations made by Jim Devine MP. There is an open invitation to Mr Devine and his colleagues to meet us to discuss their concerns and to give us an opportunity to respond. We are saddened that they felt unable to do so.
We very much welcome the Minister's assistance and the opportunity for independent scrutiny of our governance and operating processes by the Charity Commission and the Council for Healthcare Regulatory Excellence.
We are confident that this will provide us with the opportunity - thus far denied - to put forward our case. Independent scrutiny will give us a chance to demonstrate that we are a fully accountable, open and transparent organisation which does not tolerate discrimination of any kind.
The NMC's workforce is extremely diverse, highly competent and committed to delivering excellence in regulation and public protection and will continue to do so.
HHS Awards 550 Million Dollars For HIV/AIDS Care, Services
HHS Secretary Mike Leavitt has announced $550 million in grants to fund primary care and support services for individuals living with HIV/AIDS in 56 cities and major urban areas.
The grants are awarded to 22 eligible metropolitan areas (EMAs) with the highest number of people living with HIV/AIDS, and to 34 transitional grant areas (TGAs) experiencing increases in HIV/AIDS cases and emerging care needs.
The awards are provided under Part A of the Ryan White HIV/AIDS Program, which is administered by HHS' Health Resources and Services Administration.
To be eligible as EMAs, metropolitan areas must have a cumulative total of more than 2,000 AIDS cases over the most recent five-year period and a population of 50,000 or more persons.
Cities are considered TGAs if they have at least 1,000, but not more than 1,999, cumulative AIDS cases during the most recent five years, and a population of 50,000 or more persons.
"Historically, Part A grants target care and services to major urban areas with the highest concentration of HIV/AIDS cases," said HRSA Administrator Elizabeth Duke. "But these funds also enable us to direct essential services such as counseling and testing to emerging areas to help reduce the spread of HIV/AIDS."
The grants are awarded to 22 eligible metropolitan areas (EMAs) with the highest number of people living with HIV/AIDS, and to 34 transitional grant areas (TGAs) experiencing increases in HIV/AIDS cases and emerging care needs.
The awards are provided under Part A of the Ryan White HIV/AIDS Program, which is administered by HHS' Health Resources and Services Administration.
To be eligible as EMAs, metropolitan areas must have a cumulative total of more than 2,000 AIDS cases over the most recent five-year period and a population of 50,000 or more persons.
Cities are considered TGAs if they have at least 1,000, but not more than 1,999, cumulative AIDS cases during the most recent five years, and a population of 50,000 or more persons.
"Historically, Part A grants target care and services to major urban areas with the highest concentration of HIV/AIDS cases," said HRSA Administrator Elizabeth Duke. "But these funds also enable us to direct essential services such as counseling and testing to emerging areas to help reduce the spread of HIV/AIDS."
Inhaled Tuberculosis Vaccine More Effective Than Traditional Shot
A novel aerosol version of the most common tuberculosis (TB) vaccine, administered directly to the lungs as an oral mist, offers significantly better protection against the disease in experimental animals than a comparable dose of the traditional injected vaccine, researchers report this week in the Proceedings of the National Academy of Sciences.
The aerosol vaccine -- under development through a collaboration between Harvard University and the international not-for-profit Medicine in Need (MEND) -- could provide a low-cost, needle-free TB treatment that is highly stable at room temperature.
"Rising rates of tuberculosis and drug-resistant disease in developing countries have amply illustrated the need for more effective vaccines," says David Edwards, the Gordon McKay Professor of the Practice of Biomedical Engineering in Harvard's School of Engineering and Applied Sciences. "While most new TB vaccines continue to call for needle injection, our vaccine could provide safer, more consistent protection by eliminating these injections and the need for refrigerated storage. We see great promise for this new treatment."
Says Barry R. Bloom, dean of the Harvard School of Public Health: "Tuberculosis is one of the most resistant and challenging diseases to protect against, and the successful results of aerosol delivery using nanoparticle technology offers a potentially new platform for immunization. Were the animal results here confirmed in human studies, this technology could be used not only for TB vaccines, but those protecting against other infectious diseases as well."
The current PNAS paper by Edwards, Bloom, and colleagues at the University of North Carolina-Chapel Hill, the Aeras Global TB Vaccine Foundation, MEND South Africa, the Harvard School of Public Health and School of Engineering and Applied Sciences, and Manta is based on studies involving guinea pigs, a species of rodent highly sensitive to TB.
Among guinea pigs vaccinated with the aerosol treatment and subsequently exposed to TB, less than 1 percent of lung and spleen tissue showed effects of the disease. By contrast, in animals treated with the same dose of the traditional injected vaccine, some 5 percent of lung tissue and 10 percent of spleen tissue showed symptoms following TB exposure.
Administered to 100 million infants annually, the current Bacillus Calmette-Guérin (BCG) vaccine for TB is the world's most widely administered childhood vaccine. Dried into a powder by freezing and delivered by needle injection, the vaccine requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. These limitations have prompted calls from public health experts and physicians for alternative treatments.
The rapid-drying process by which the aerosol vaccine is made resembles the technique used in the manufacture of powdered milk. In the aerosol vaccine, particles form at micrometer and nanometer scales and in spherical and elongated shapes, a combination that appears to improve dispersal in the mouth.
While commonly used with food, cosmetics, and pharmaceuticals, this spray drying of small and large molecules is seldom used for drying cellular material. The new technique enables TB vaccines, and potentially other bacterial and viral-based vaccines, to sidestep the traditional problems associated with keeping vaccines chilled.
"Spray drying is lower-cost than BCG, easily scalable for manufacturing, and ideal for needle-free use, such as via inhalation," says Edwards, an international leader in aerosol drug and vaccine delivery. "Its greater stability at room temperature could ultimately provide a better means of creating and delivering vaccine throughout the world."
The aerosol vaccine -- under development through a collaboration between Harvard University and the international not-for-profit Medicine in Need (MEND) -- could provide a low-cost, needle-free TB treatment that is highly stable at room temperature.
"Rising rates of tuberculosis and drug-resistant disease in developing countries have amply illustrated the need for more effective vaccines," says David Edwards, the Gordon McKay Professor of the Practice of Biomedical Engineering in Harvard's School of Engineering and Applied Sciences. "While most new TB vaccines continue to call for needle injection, our vaccine could provide safer, more consistent protection by eliminating these injections and the need for refrigerated storage. We see great promise for this new treatment."
Says Barry R. Bloom, dean of the Harvard School of Public Health: "Tuberculosis is one of the most resistant and challenging diseases to protect against, and the successful results of aerosol delivery using nanoparticle technology offers a potentially new platform for immunization. Were the animal results here confirmed in human studies, this technology could be used not only for TB vaccines, but those protecting against other infectious diseases as well."
The current PNAS paper by Edwards, Bloom, and colleagues at the University of North Carolina-Chapel Hill, the Aeras Global TB Vaccine Foundation, MEND South Africa, the Harvard School of Public Health and School of Engineering and Applied Sciences, and Manta is based on studies involving guinea pigs, a species of rodent highly sensitive to TB.
Among guinea pigs vaccinated with the aerosol treatment and subsequently exposed to TB, less than 1 percent of lung and spleen tissue showed effects of the disease. By contrast, in animals treated with the same dose of the traditional injected vaccine, some 5 percent of lung tissue and 10 percent of spleen tissue showed symptoms following TB exposure.
Administered to 100 million infants annually, the current Bacillus Calmette-Guérin (BCG) vaccine for TB is the world's most widely administered childhood vaccine. Dried into a powder by freezing and delivered by needle injection, the vaccine requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. These limitations have prompted calls from public health experts and physicians for alternative treatments.
The rapid-drying process by which the aerosol vaccine is made resembles the technique used in the manufacture of powdered milk. In the aerosol vaccine, particles form at micrometer and nanometer scales and in spherical and elongated shapes, a combination that appears to improve dispersal in the mouth.
While commonly used with food, cosmetics, and pharmaceuticals, this spray drying of small and large molecules is seldom used for drying cellular material. The new technique enables TB vaccines, and potentially other bacterial and viral-based vaccines, to sidestep the traditional problems associated with keeping vaccines chilled.
"Spray drying is lower-cost than BCG, easily scalable for manufacturing, and ideal for needle-free use, such as via inhalation," says Edwards, an international leader in aerosol drug and vaccine delivery. "Its greater stability at room temperature could ultimately provide a better means of creating and delivering vaccine throughout the world."
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Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) announced that the company has completed enrollment in the first of two pivotal phase 3 clinical trials examining the safety and efficacy of prulifloxacin for the treatment of travelers' diarrhea. Travelers' diarrhea is characterized by diarrhea along with other related symptoms including nausea, vomiting, abdominal pain or cramping, and fecal urgency.
"Completing patient enrollment for this first trial is an important milestone in Optimer's Prulifloxacin development program," said Michael N. Chang, Ph.D., CEO and President of Optimer. "We look forward to completing the analysis of the data from this trial."
This multi-center, double-blind, randomized and placebo-controlled clinical trial compares the safety and efficacy of prulifloxacin versus placebo in adult travelers suffering acute bacterial gastroenteritis. Clinical trial sites included locations in the U.S., Mexico and Peru. The primary endpoint is time-to-last-unformed-stool. Secondary endpoints include clinical cure based on relief of symptoms and microbiological eradication rates.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer has two late-stage anti-infective product candidates. OPT-80, currently in two pivotal Phase 3 clinical trials, is being developed for the treatment of Clostridium difficile infections, the most common hospital-acquired diarrhea. Prulifloxacin, also in two pivotal Phase 3 clinical trials, is an antibiotic being developed for the treatment of travelers' diarrhea, a form of infectious diarrhea. Additional information regarding Optimer can be found at http://www.optimerpharma.com.
Forward-looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to prulifloxacin and the timing of clinical trials and anticipated results thereof. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
"Completing patient enrollment for this first trial is an important milestone in Optimer's Prulifloxacin development program," said Michael N. Chang, Ph.D., CEO and President of Optimer. "We look forward to completing the analysis of the data from this trial."
This multi-center, double-blind, randomized and placebo-controlled clinical trial compares the safety and efficacy of prulifloxacin versus placebo in adult travelers suffering acute bacterial gastroenteritis. Clinical trial sites included locations in the U.S., Mexico and Peru. The primary endpoint is time-to-last-unformed-stool. Secondary endpoints include clinical cure based on relief of symptoms and microbiological eradication rates.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer has two late-stage anti-infective product candidates. OPT-80, currently in two pivotal Phase 3 clinical trials, is being developed for the treatment of Clostridium difficile infections, the most common hospital-acquired diarrhea. Prulifloxacin, also in two pivotal Phase 3 clinical trials, is an antibiotic being developed for the treatment of travelers' diarrhea, a form of infectious diarrhea. Additional information regarding Optimer can be found at http://www.optimerpharma.com.
Forward-looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to prulifloxacin and the timing of clinical trials and anticipated results thereof. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
Clinical Trial Shows Ubiquinol Has Significant Effect On Patients With Congestive Heart Failure
Patients suffering from advanced congestive heart failure exhibited significantly improved heart function after supplementing with ubiquinol, according to a recent clinical trial. Ubiquinol, only available in supplement form since late 2006, is the active antioxidant form of Coenzyme Q10 (CoQ10). CoQ10, a vitamin-like substance found in every cell in the body, plays a vital role in cellular energy production and protects cells from free radical damage.
In the first clinical trial evaluating ubiquinol effects on late-stage congestive heart failure, cardiologist Peter Langsjoen found that critically ill patients who supplemented with ubiquinol for just three months experienced a 24 to 50 percent increase in their hearts' ability to pump blood. In some cases, patients' plasma levels of CoQ10, which are key to overall heart health, more than tripled. At the start of the study, each of the patients evaluated had a life expectancy of less than six months. However, all demonstrated significantly improved heart function by the trial's end, and survived past initial expectations.
"The effects of ubiquinol on late-stage heart failure patients resulted in striking improvements beyond anything I've seen in 25 years of cardiology practice," said Dr. Langsjoen, who conducted the research in Tyler, Texas. "It is my strong feeling that this ubiquinol product is a major breakthrough."
Scientists at Kaneka Corporation, the world's largest manufacturer of CoQ10, developed the method to produce ubiquinol, commercially available as KanekaQH™, for supplemental use. Because the reduced ubiquinol reverts back to CoQ10 when exposed to air and light, the process of stabilizing the nutrient outside of the body took more than a decade to test and perfect before it was launched a little more than a year ago.
"Over the last several years, our team of scientists have documented that KanekaQH can be several times more absorbable than CoQ10, but to see that higher bioavailability translate into such staggering improvements in these patients' lives is particularly gratifying," said Dr. Robert Barry of Kaneka Nutrients, L.P., who recently released a book entitled The Power of KanekaQH™ (Ubiquinol): The Key to Energy, Vitality and a Healthy Heart in which he documents some of the most intriguing research to date on CoQ10 and ubiquinol in regards to aging and heart health.
The oxidized form of CoQ10, ubiquinone, was first used as a dietary supplement for cardiac patients in Japan 40 years ago. It has since gained popularity worldwide for the many health and condition-specific benefits identified in the thousands of studies conducted since its discovery in 1957.
Two forms of CoQ10: Ubiquinone and Ubiquinol
Both ubiquinone and ubiquinol are essential to generating cellular energy and sustaining life; however, the reduced form, ubiquinol, is responsible for the powerful antioxidant benefits associated with CoQ10. More than 90 percent of the CoQ10 found in a healthy person's plasma is in its reduced ubiquinol form.
For the past 40 years, only ubiquinone was available as a supplement. KanekaQH™, the world's only supplemental ubiquinol, has only been available for the past year. The ingredient, manufactured exclusively by Kaneka, is currently available in more than 30 consumer supplements and is the subject of a number of new trials expected to begin in 2008.
"Cardiovascular patients, those fighting age-related diseases and even healthy people over the age of 40 have a critical need to optimize plasma CoQ10 levels within their bodies," explained Dr. Barry. "Because it's so much better absorbed by the body, KanekaQH™ can raise CoQ10 levels more effectively and, as we're seeing from Dr. Langsjoen's study, can have tremendous health impact on those suffering from debilitating diseases."
An abstract of Dr. Langsjoen's supplemental ubiquinol study is available at http://www.kanekaqh.com/clinicaltrials. Full results of the study are expected to be published in a major scientific journal in 2008.
In the first clinical trial evaluating ubiquinol effects on late-stage congestive heart failure, cardiologist Peter Langsjoen found that critically ill patients who supplemented with ubiquinol for just three months experienced a 24 to 50 percent increase in their hearts' ability to pump blood. In some cases, patients' plasma levels of CoQ10, which are key to overall heart health, more than tripled. At the start of the study, each of the patients evaluated had a life expectancy of less than six months. However, all demonstrated significantly improved heart function by the trial's end, and survived past initial expectations.
"The effects of ubiquinol on late-stage heart failure patients resulted in striking improvements beyond anything I've seen in 25 years of cardiology practice," said Dr. Langsjoen, who conducted the research in Tyler, Texas. "It is my strong feeling that this ubiquinol product is a major breakthrough."
Scientists at Kaneka Corporation, the world's largest manufacturer of CoQ10, developed the method to produce ubiquinol, commercially available as KanekaQH™, for supplemental use. Because the reduced ubiquinol reverts back to CoQ10 when exposed to air and light, the process of stabilizing the nutrient outside of the body took more than a decade to test and perfect before it was launched a little more than a year ago.
"Over the last several years, our team of scientists have documented that KanekaQH can be several times more absorbable than CoQ10, but to see that higher bioavailability translate into such staggering improvements in these patients' lives is particularly gratifying," said Dr. Robert Barry of Kaneka Nutrients, L.P., who recently released a book entitled The Power of KanekaQH™ (Ubiquinol): The Key to Energy, Vitality and a Healthy Heart in which he documents some of the most intriguing research to date on CoQ10 and ubiquinol in regards to aging and heart health.
The oxidized form of CoQ10, ubiquinone, was first used as a dietary supplement for cardiac patients in Japan 40 years ago. It has since gained popularity worldwide for the many health and condition-specific benefits identified in the thousands of studies conducted since its discovery in 1957.
Two forms of CoQ10: Ubiquinone and Ubiquinol
Both ubiquinone and ubiquinol are essential to generating cellular energy and sustaining life; however, the reduced form, ubiquinol, is responsible for the powerful antioxidant benefits associated with CoQ10. More than 90 percent of the CoQ10 found in a healthy person's plasma is in its reduced ubiquinol form.
For the past 40 years, only ubiquinone was available as a supplement. KanekaQH™, the world's only supplemental ubiquinol, has only been available for the past year. The ingredient, manufactured exclusively by Kaneka, is currently available in more than 30 consumer supplements and is the subject of a number of new trials expected to begin in 2008.
"Cardiovascular patients, those fighting age-related diseases and even healthy people over the age of 40 have a critical need to optimize plasma CoQ10 levels within their bodies," explained Dr. Barry. "Because it's so much better absorbed by the body, KanekaQH™ can raise CoQ10 levels more effectively and, as we're seeing from Dr. Langsjoen's study, can have tremendous health impact on those suffering from debilitating diseases."
An abstract of Dr. Langsjoen's supplemental ubiquinol study is available at http://www.kanekaqh.com/clinicaltrials. Full results of the study are expected to be published in a major scientific journal in 2008.
Thursday, March 6, 2008
Baxter Heparin Contaminant Found
The US Food and Drug Administration (FDA) announced yesterday, 5th March, they had found evidence that the heparin blood thinning product made by Baxter that has been linked to several deaths and serious reactions in hundreds of patients contains a contaminant that is hard to detect using standard tests.
Speaking at a news conference, FDA Deputy Commissioner Dr Janet Woodcock is reported by the New York Times as saying:
"At this point, we do not know whether the introduction was accidental or whether it was deliberate."
Woodcock said the FDA had not yet established how the compound got into the active ingredient.
According to the FDA, 19 people have died in the last 14 months and 785 are reported to be gravely ill of severe allergic reactions after receiving injections of Baxter's heparin, but investigators have not yet established a direct link between these events and the contaminated heparin. Most of the patients were already in a serious condition and had undergone surgery.
The mysterious ingredient was only found in Baxter International Inc products whose active ingredient was sourced in China, but because of the complexity of the supply chain it is not possible to say for certain if the contaminant was introduced in China, said an ABC News report.
Heparin sodium is injected into millions of Americans every year in operating rooms, dialysis and critical care centers, to stop potentially fatal blood clots developing in their veins, arteries and lungs. The drug has been used throughout the US since the 1930s and is made from the lining of pig intestines. Most of the primary ingredient is made in China.
Baxter, which supplies half of the US demand for heparin, recalled all its multi-dose and single-dose heparin sodium and HEP-LOCK heparin flush products last month.
The FDA said that the contaminant is similar to heparin and cannot be detected using standard quality control tests. The samples they tested had between 5 and 20 per cent of the contaminant, which like heparin is a complex molecule and is also made from pig intestines, reported WebMD. The FDA is planning to offer laboratories a simpler way to test for the contaminant.
The WebMD report said Woodcock stressed in the news conference that no direct link has yet been established between the contaminant and the adverse reactions:
"We don't yet have direct causal link between the contaminant and adverse events. Some of the batches of heparin causing the effect have this contaminant in them. So there is an association between the heparin-like compound and adverse events, but no causal relation yet."
Baxter executives held a separate news conference where they reported they had traced the contaminant to raw materials sourced from China by its supplier, Scientific Protein Laboratories (SPL).
SPL issued a statement saying that it was too early to make a direct link between these raw materials from China and the adverse events.
A spokesman for SPL, Wayne Pines, told the New York Times that there is no information to say whether the contamination was deliberate, nothing had been proved and no one knew what happened:
"There is no evidence of counterfeiting or tampering or anything of that nature," said Pines.
President of medication delivery at Baxter, Peter J Arduini, said that the US had been sourcing heparin from China for over 10 years, and that before opening their own plant in China, SPL had already been obtaining heparin's active ingredient from there "for years".
Arduini said that over the last 12 years, over half a billion doses of heparin supplied to the US market contained active ingredient sourced in China, reported WebMD.
Arduini said Baxter had ruled out problems at the end of the process where inactive ingredients are added and the product is packaged. The problem is happening before the product reaches Baxter he told the news conference, it's either before it gets to the SPL plant, or it's in the processing before it reaches Baxter:
"The active pharmaceutical ingredient is now the primary focus of our investigation," said Arduini according to ABC News.
According to the New York Times, the heparin market in China has been in "turmoil" over the last 12 months because of widespread pig disease. Some farmers have been selling sick pigs and heparin producers have had to "scramble" for new sources of raw material.
The symptoms of the allergic reactions following the heparin injections reported to the FDA include nausea, vomiting, difficulty breathing, excessive sweating, and abrupt fall in blood pressure that can lead to life-threatening shock.
Baxter maintain that the total death toll is 4 and not 19.
Speaking at a news conference, FDA Deputy Commissioner Dr Janet Woodcock is reported by the New York Times as saying:
"At this point, we do not know whether the introduction was accidental or whether it was deliberate."
Woodcock said the FDA had not yet established how the compound got into the active ingredient.
According to the FDA, 19 people have died in the last 14 months and 785 are reported to be gravely ill of severe allergic reactions after receiving injections of Baxter's heparin, but investigators have not yet established a direct link between these events and the contaminated heparin. Most of the patients were already in a serious condition and had undergone surgery.
The mysterious ingredient was only found in Baxter International Inc products whose active ingredient was sourced in China, but because of the complexity of the supply chain it is not possible to say for certain if the contaminant was introduced in China, said an ABC News report.
Heparin sodium is injected into millions of Americans every year in operating rooms, dialysis and critical care centers, to stop potentially fatal blood clots developing in their veins, arteries and lungs. The drug has been used throughout the US since the 1930s and is made from the lining of pig intestines. Most of the primary ingredient is made in China.
Baxter, which supplies half of the US demand for heparin, recalled all its multi-dose and single-dose heparin sodium and HEP-LOCK heparin flush products last month.
The FDA said that the contaminant is similar to heparin and cannot be detected using standard quality control tests. The samples they tested had between 5 and 20 per cent of the contaminant, which like heparin is a complex molecule and is also made from pig intestines, reported WebMD. The FDA is planning to offer laboratories a simpler way to test for the contaminant.
The WebMD report said Woodcock stressed in the news conference that no direct link has yet been established between the contaminant and the adverse reactions:
"We don't yet have direct causal link between the contaminant and adverse events. Some of the batches of heparin causing the effect have this contaminant in them. So there is an association between the heparin-like compound and adverse events, but no causal relation yet."
Baxter executives held a separate news conference where they reported they had traced the contaminant to raw materials sourced from China by its supplier, Scientific Protein Laboratories (SPL).
SPL issued a statement saying that it was too early to make a direct link between these raw materials from China and the adverse events.
A spokesman for SPL, Wayne Pines, told the New York Times that there is no information to say whether the contamination was deliberate, nothing had been proved and no one knew what happened:
"There is no evidence of counterfeiting or tampering or anything of that nature," said Pines.
President of medication delivery at Baxter, Peter J Arduini, said that the US had been sourcing heparin from China for over 10 years, and that before opening their own plant in China, SPL had already been obtaining heparin's active ingredient from there "for years".
Arduini said that over the last 12 years, over half a billion doses of heparin supplied to the US market contained active ingredient sourced in China, reported WebMD.
Arduini said Baxter had ruled out problems at the end of the process where inactive ingredients are added and the product is packaged. The problem is happening before the product reaches Baxter he told the news conference, it's either before it gets to the SPL plant, or it's in the processing before it reaches Baxter:
"The active pharmaceutical ingredient is now the primary focus of our investigation," said Arduini according to ABC News.
According to the New York Times, the heparin market in China has been in "turmoil" over the last 12 months because of widespread pig disease. Some farmers have been selling sick pigs and heparin producers have had to "scramble" for new sources of raw material.
The symptoms of the allergic reactions following the heparin injections reported to the FDA include nausea, vomiting, difficulty breathing, excessive sweating, and abrupt fall in blood pressure that can lead to life-threatening shock.
Baxter maintain that the total death toll is 4 and not 19.
Listening To Cell Phones Impairs Driving, Study
Scientists in the US have shown that listening to a cell phone while driving was enough distraction to cause drivers to make the same type of driving errors as they would under the influence of alcohol.
The study is the work of neuroscientist Dr Marcel Just and colleagues at the Center for Cognitive Brain Imaging at Carnegie Mellon University in Pittsburgh, Pennsylvania, and is to be published shortly in the journal Brain Research.
Even if you are not talking, just listening to a cell phone conversation can significantly reduce the amount of brain activity associated with driving, said the researchers, who asked volunteers to drive on a simulator while they observed their brains using an MRI (magnetic resonance image) scanner.
Using cell phones while driving has been a matter of controversy for some time, but this is the first study to look at listening alone as a distraction.
Just and colleagues found that listening alone reduced brain activity associated with driving by 37 per cent. Based on driving simulator results, this would be enough to cause a driver to weave out of their lane, said the researchers.
"Drivers need to keep not only their hands on the wheel; they also have to keep their brains on the road," said Just in a prepared statement.
Just and colleagues invited 29 volunteers to to use a driving simulator while inside an MRI brain scanner. The simulator gave them a winding road to drive on at a fixed but challenging speed. There were two conditions: undisturbed or while listening. While listening, the volunteers listened to statements and had to decide whether they were true or false, a similar level of cognitive processing as would be involved in a normal listening activity.
The researchers used the latest functional magnetic resonance imaging (fMRI) technology to measure second by second changes in brain activity in 20,000 places, each being about the size of a peppercorn, they said.
Compared to the undisturbed scenario, the listening while driving scenario showed a 37 per cent decrease in activity in the brain's parietal lobe, the part of the brain that is associated with driving and processes sensory inputs that are important for navigation and spatial awareness. The occipital lobe, which processes visual signals, also showed reduced activity, said the researchers.
Using measures of performance on the simulator, the researchers observed that the driving while listening scenarios resulted in much poorer quality of driving. When in listening while driving mode the volunteers made more errors in lane discipline, such as deviating from the middle and hitting a guardrail.
The study suggests that hands free and voice activated cell phones do not go far enough to ease safety concerns because the distraction of listening would still remain.
The researchers said that other distractions such as listening to the radio, eating or talking to a passenger can also divert a driver, and although there is no evidence of how these distractions compare to listening to a cell phone, they suggest cell phones are different because, as Just explained:
"Talking on a cell phone has a special social demand, such that not attending to the cell conversation can be interpreted as rude, insulting behavior."
A passenger, on the other hand, because he or she is physically in the car with the driver, can see if anything urgently needs the driver's attention and will stop talking, it is a situation that is less likely to put social pressure on the driver.
Just said the clear message of this study is that:
"Engaging in a demanding conversation could jeopardize judgment and reaction time if an atypical or unusual driving situation arose."
He warned that:
"Heavy traffic is no place for an involved personal or business discussion, let alone texting."
Previous studies had suggested that driving and listening used two differnt parts of the brain and could work independently of each other, thus allowing the driver to "multi-task" safely.
But this study suggests otherwise, said Just, it doesn't matter how different the tasks are, the brain can only do so much at one time.
The study is an example of the new science of neuroergonomics that studies the match between technology and human ability by bringing together brain science and research on human-computer interaction.
Neuroergonomicists are starting to observe humans operating ships, cars, and other vehicles where the driver's position is beginning to look more and more like the cockpit of an aircraft with all the technology interfaces that now exist.
Every additional device demands brain activity, increasing the likelihood that resources crucial for making fine judgements on the road are compromised.
If brain resource for safe driving is limited, then perhaps it should be devoted to paying attention to those devices that help the driver make these judgements, rather than the cell phone, iPod, CD, radio, or even DVD player.
"Drivers' seats in many vehicles are becoming highly instrumented cockpits," Just explained, "and during difficult driving situations, they require the undivided attention of the driver's brain."
The study is the work of neuroscientist Dr Marcel Just and colleagues at the Center for Cognitive Brain Imaging at Carnegie Mellon University in Pittsburgh, Pennsylvania, and is to be published shortly in the journal Brain Research.
Even if you are not talking, just listening to a cell phone conversation can significantly reduce the amount of brain activity associated with driving, said the researchers, who asked volunteers to drive on a simulator while they observed their brains using an MRI (magnetic resonance image) scanner.
Using cell phones while driving has been a matter of controversy for some time, but this is the first study to look at listening alone as a distraction.
Just and colleagues found that listening alone reduced brain activity associated with driving by 37 per cent. Based on driving simulator results, this would be enough to cause a driver to weave out of their lane, said the researchers.
"Drivers need to keep not only their hands on the wheel; they also have to keep their brains on the road," said Just in a prepared statement.
Just and colleagues invited 29 volunteers to to use a driving simulator while inside an MRI brain scanner. The simulator gave them a winding road to drive on at a fixed but challenging speed. There were two conditions: undisturbed or while listening. While listening, the volunteers listened to statements and had to decide whether they were true or false, a similar level of cognitive processing as would be involved in a normal listening activity.
The researchers used the latest functional magnetic resonance imaging (fMRI) technology to measure second by second changes in brain activity in 20,000 places, each being about the size of a peppercorn, they said.
Compared to the undisturbed scenario, the listening while driving scenario showed a 37 per cent decrease in activity in the brain's parietal lobe, the part of the brain that is associated with driving and processes sensory inputs that are important for navigation and spatial awareness. The occipital lobe, which processes visual signals, also showed reduced activity, said the researchers.
Using measures of performance on the simulator, the researchers observed that the driving while listening scenarios resulted in much poorer quality of driving. When in listening while driving mode the volunteers made more errors in lane discipline, such as deviating from the middle and hitting a guardrail.
The study suggests that hands free and voice activated cell phones do not go far enough to ease safety concerns because the distraction of listening would still remain.
The researchers said that other distractions such as listening to the radio, eating or talking to a passenger can also divert a driver, and although there is no evidence of how these distractions compare to listening to a cell phone, they suggest cell phones are different because, as Just explained:
"Talking on a cell phone has a special social demand, such that not attending to the cell conversation can be interpreted as rude, insulting behavior."
A passenger, on the other hand, because he or she is physically in the car with the driver, can see if anything urgently needs the driver's attention and will stop talking, it is a situation that is less likely to put social pressure on the driver.
Just said the clear message of this study is that:
"Engaging in a demanding conversation could jeopardize judgment and reaction time if an atypical or unusual driving situation arose."
He warned that:
"Heavy traffic is no place for an involved personal or business discussion, let alone texting."
Previous studies had suggested that driving and listening used two differnt parts of the brain and could work independently of each other, thus allowing the driver to "multi-task" safely.
But this study suggests otherwise, said Just, it doesn't matter how different the tasks are, the brain can only do so much at one time.
The study is an example of the new science of neuroergonomics that studies the match between technology and human ability by bringing together brain science and research on human-computer interaction.
Neuroergonomicists are starting to observe humans operating ships, cars, and other vehicles where the driver's position is beginning to look more and more like the cockpit of an aircraft with all the technology interfaces that now exist.
Every additional device demands brain activity, increasing the likelihood that resources crucial for making fine judgements on the road are compromised.
If brain resource for safe driving is limited, then perhaps it should be devoted to paying attention to those devices that help the driver make these judgements, rather than the cell phone, iPod, CD, radio, or even DVD player.
"Drivers' seats in many vehicles are becoming highly instrumented cockpits," Just explained, "and during difficult driving situations, they require the undivided attention of the driver's brain."
Consuming Alcohol May Lead To High Blood Pressure
People who drink regularly have higher systolic blood pressure than people who do not, according to a recent article published in PLoS Medicine. Researcher Sarah Lewis (University of Bristol, UK) and colleagues report that systolic blood pressure levels are about 7 mmHg higher in frequent drinkers than in people who do not drink.
Systolic blood pressure refers to the peak pressure in the arteries around the time that the heart muscle contracts. It is measured in millimeters of mercury (mmHg), and a normal value for a resting, healthy adult human is 120 mmHg.
The study authors conducted a meta-analysis by assessing results from five published studies. Each study focused on the link between blood pressure and a variation in the gene for aldehyde dehydrogenase 2 (ALDH2) - the enzyme that removes alcohol from the body.
Some individuals receive two copies of the variant form of this gene from their parents. They have the ALDH2 *2*2 genotype and experience adverse symptoms when drinking alcohol such as nausea and flushness. Other people receive a *1*2 genotype or a *1*1 genotype and consequently drink more alcohol than those with the *2*2 genotype. Since alcohol consumption seems to be the only lifestyle factor that the genetic variants affect, the authors argue that a relationship between ALDH2 genotypes and blood pressure is sufficient to establish a relationship between blood pressure and alcohol intake.
The ALDH2 gene variant is common in Japan, and most of the studies in the analysis were performed there. To aid interpretation of the results, the three genotypes can be grouped according to degree of alcohol intake:
Narrowly, the findings suggest that for Japanese men, the degree of alcohol consumption has an effect on blood pressure. In order to expand results and improve the estimate of alcohol's effect on blood pressure, additional large-scale studies are necessary.
Systolic blood pressure refers to the peak pressure in the arteries around the time that the heart muscle contracts. It is measured in millimeters of mercury (mmHg), and a normal value for a resting, healthy adult human is 120 mmHg.
The study authors conducted a meta-analysis by assessing results from five published studies. Each study focused on the link between blood pressure and a variation in the gene for aldehyde dehydrogenase 2 (ALDH2) - the enzyme that removes alcohol from the body.
Some individuals receive two copies of the variant form of this gene from their parents. They have the ALDH2 *2*2 genotype and experience adverse symptoms when drinking alcohol such as nausea and flushness. Other people receive a *1*2 genotype or a *1*1 genotype and consequently drink more alcohol than those with the *2*2 genotype. Since alcohol consumption seems to be the only lifestyle factor that the genetic variants affect, the authors argue that a relationship between ALDH2 genotypes and blood pressure is sufficient to establish a relationship between blood pressure and alcohol intake.
The ALDH2 gene variant is common in Japan, and most of the studies in the analysis were performed there. To aid interpretation of the results, the three genotypes can be grouped according to degree of alcohol intake:
- *1*1 genotype has highest alcohol intake
- *1*2 genotype has intermediate alcohol intake
- *2*2 genotype has lowest alcohol intake
Narrowly, the findings suggest that for Japanese men, the degree of alcohol consumption has an effect on blood pressure. In order to expand results and improve the estimate of alcohol's effect on blood pressure, additional large-scale studies are necessary.
Women Have Small Increased Cancer Risk Three Years After Ending HRT, Study Finds
Women taking combination hormone replacement therapy have a slightly increased risk of cancer three years after ending treatment, but initial increases in cardiovascular risks appear to fade, according to a follow-up study published in the Journal of the American Medical Association Wednesday, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 3/5). The study also found that improved bone health and increased risks of blood clots, stroke and heart attack seen among some HRT users fell to normal rates after women stopped taking the drugs.
For the study, researchers led by Gerardo Heiss at the University of North Carolina-Chapel Hill analyzed an earlier NIH-sponsored Women's Health Initiative study (Parker-Pope, New York Times, 3/5). NIH researchers ended the WHI study of combination HRT in July 2002, three years earlier than scheduled, because they determined that the treatment might increase the risk for heart disease, invasive breast cancer and other health problems (Daily Women's Health Policy Report, 2/27).
The new analysis followed 15,730 postmenopausal women who participated in a WHI study. The researchers found 281 cancers among the women who received Wyeth's HRT Prempro, compared with 218 in the placebo group. The researchers also found 343 heart attacks, strokes and blood clots in the HRT group, compared with 323 in the placebo group, a statistically insignificant difference. The mortality rate from all causes was 15% higher among women taking Prempro than those taking a placebo, but the higher rate was not considered statistically significant, according to the study (Maugh, Los Angeles Times, 3/5).
The study found a 0.3% increased risk of cancer for each woman who took HRT, or about three additional cases annually per 1,000 women (New York Times, 3/5). The study also found a 27% higher risk of developing breast cancer among HRT users three years after halting treatment (Los Angeles Times, 3/5). Although breast cancer comprised the majority of cancer cases, the researchers also found a higher rate of other cancers, such as lung cancer, among HRT users.
It is unclear how long women have an increased cancer risk after ending HRT, Marcia Stefanick, a professor of medicine at the Stanford Prevention Research Center and senior author of the study, said. The new findings likely will encourage researchers to look into how HRT might increase the risk of cancers that have not previously been associated with the therapy, such as lung cancer, the Washington Post reports (Stein, Washington Post, 3/5). The study was funded by the National Heart, Lung and Blood Institute (Los Angeles Times, 3/5).
Reaction
According to the San Francisco Chronicle, the study reinforces some physicians' views that women should take the smallest possible dose of HRT for as little time as possible. Stefanick said she does not think the study's findings "should be frightening to women" but added that she thinks "women should only go on [HRT] if they have severe symptoms. They should really think about whether they're so bad off that they want to start something that comes with all these risks" (Allday, San Francisco Chronicle, 3/5). Heiss added that the study's findings are of "modest magnitude" and are "not something to be alarmed about, but it's something to be aware of."
Gary Stiles, chief medical officer at Wyeth, said the company does not believe the new study "provides any new guidance" (Wall Street Journal, 3/5). Peter Ravdin of the M.D. Anderson Cancer Center, who recently reported a nationwide decrease in new cancer cases, said the new analysis's findings could have happened by chance. "They just didn't have the statistical power to identify a decrease that we've seen in the population data," Ravdin said, adding, "All the epidemiological data argues against their results" (Washington Post, 3/5).
An abstract of the study is available online.
ABCNews.com on Tuesday reported on the study (McKenzie, ABCNews.com, 3/4). Video of the segment is available online. Expanded ABC News coverage also is available online.
NPR's "All Things Considered" on Tuesday also reported on the study. The segment includes comments from Heiss and JoAnn Manson, director of preventive medicine at Brigham and Women's Hospital (Neighmond, "All Things Considered," NPR, 3/4). Audio of the segment is available online.
For the study, researchers led by Gerardo Heiss at the University of North Carolina-Chapel Hill analyzed an earlier NIH-sponsored Women's Health Initiative study (Parker-Pope, New York Times, 3/5). NIH researchers ended the WHI study of combination HRT in July 2002, three years earlier than scheduled, because they determined that the treatment might increase the risk for heart disease, invasive breast cancer and other health problems (Daily Women's Health Policy Report, 2/27).
The new analysis followed 15,730 postmenopausal women who participated in a WHI study. The researchers found 281 cancers among the women who received Wyeth's HRT Prempro, compared with 218 in the placebo group. The researchers also found 343 heart attacks, strokes and blood clots in the HRT group, compared with 323 in the placebo group, a statistically insignificant difference. The mortality rate from all causes was 15% higher among women taking Prempro than those taking a placebo, but the higher rate was not considered statistically significant, according to the study (Maugh, Los Angeles Times, 3/5).
The study found a 0.3% increased risk of cancer for each woman who took HRT, or about three additional cases annually per 1,000 women (New York Times, 3/5). The study also found a 27% higher risk of developing breast cancer among HRT users three years after halting treatment (Los Angeles Times, 3/5). Although breast cancer comprised the majority of cancer cases, the researchers also found a higher rate of other cancers, such as lung cancer, among HRT users.
It is unclear how long women have an increased cancer risk after ending HRT, Marcia Stefanick, a professor of medicine at the Stanford Prevention Research Center and senior author of the study, said. The new findings likely will encourage researchers to look into how HRT might increase the risk of cancers that have not previously been associated with the therapy, such as lung cancer, the Washington Post reports (Stein, Washington Post, 3/5). The study was funded by the National Heart, Lung and Blood Institute (Los Angeles Times, 3/5).
Reaction
According to the San Francisco Chronicle, the study reinforces some physicians' views that women should take the smallest possible dose of HRT for as little time as possible. Stefanick said she does not think the study's findings "should be frightening to women" but added that she thinks "women should only go on [HRT] if they have severe symptoms. They should really think about whether they're so bad off that they want to start something that comes with all these risks" (Allday, San Francisco Chronicle, 3/5). Heiss added that the study's findings are of "modest magnitude" and are "not something to be alarmed about, but it's something to be aware of."
Gary Stiles, chief medical officer at Wyeth, said the company does not believe the new study "provides any new guidance" (Wall Street Journal, 3/5). Peter Ravdin of the M.D. Anderson Cancer Center, who recently reported a nationwide decrease in new cancer cases, said the new analysis's findings could have happened by chance. "They just didn't have the statistical power to identify a decrease that we've seen in the population data," Ravdin said, adding, "All the epidemiological data argues against their results" (Washington Post, 3/5).
An abstract of the study is available online.
ABCNews.com on Tuesday reported on the study (McKenzie, ABCNews.com, 3/4). Video of the segment is available online. Expanded ABC News coverage also is available online.
NPR's "All Things Considered" on Tuesday also reported on the study. The segment includes comments from Heiss and JoAnn Manson, director of preventive medicine at Brigham and Women's Hospital (Neighmond, "All Things Considered," NPR, 3/4). Audio of the segment is available online.
Rates Of Health Problems Among Urban American Indians Do Not Decline As Income Rises, According To Study
Rates of diabetes, obesity and smoking remain consistent across income levels among American Indians living in urban areas, according to a study released Wednesday by the Urban Indian Health Institute, the AP/Contra Costa Times reports. For the study, Maile Taualii, scientific director at the Institute, and colleagues analyzed five years of data from a random digit dial telephone survey conducted by CDC in 34 cities. Researchers found that as incomes of urban American Indians increased, rates of binge drinking and tobacco use remained the same, or in some cases increased. This is at odds with rates among other racial groups, which usually decline as income increases, Taualii said.
According to Taualii, in the general population, those with lower incomes tend to experience higher rates of health problems, such as diabetes and obesity. Taualii said, "When Indian folks drink, it appears to have nothing to do with how much money they have, and that's not true for any other racial group," adding, "There seems to be a sense of hopelessness, a sense that diabetes, alcoholism and other health problems are inevitable in the community."
More than half of American Indians and Alaska Natives in the U.S. live in cities. Most receive health care at government-funded tribal clinics in or near the urban areas where they live, but staff at some clinics have reported difficulty in treating patients because of budgetary constraints. The Senate last week approved legislation (S 1200) that would increase funding for Indian Health Service programs, as well as provide funding to construct new facilities, modernize clinics and recruit more American Indians into medical professions (Burke, AP/Contra Costa Times, 3/4).
According to Taualii, in the general population, those with lower incomes tend to experience higher rates of health problems, such as diabetes and obesity. Taualii said, "When Indian folks drink, it appears to have nothing to do with how much money they have, and that's not true for any other racial group," adding, "There seems to be a sense of hopelessness, a sense that diabetes, alcoholism and other health problems are inevitable in the community."
More than half of American Indians and Alaska Natives in the U.S. live in cities. Most receive health care at government-funded tribal clinics in or near the urban areas where they live, but staff at some clinics have reported difficulty in treating patients because of budgetary constraints. The Senate last week approved legislation (S 1200) that would increase funding for Indian Health Service programs, as well as provide funding to construct new facilities, modernize clinics and recruit more American Indians into medical professions (Burke, AP/Contra Costa Times, 3/4).
Baltimore Sun Examines Masai Practices That Could Lead To Spread Of HIV
The Baltimore Sun on Sunday profiled the Masai communities in Kenya and Tanzania, including some of their practices that could lead to the spread of HIV. HIV prevalence is low among Masai because they generally do not have sexual relationships with other groups. Among Kenyan Masai, HIV prevalence is estimated at 2.5%, about half of the national average, the Sun reports.
According to the Sun, the risk of HIV is increasing among Masai communities because concurrent sexual partnerships are traditionally considered proper. In addition, many Masai have low awareness of HIV/AIDS and how to prevent transmission of the virus. Masai men are beginning to travel to urban areas for work, having sex with non-Masai women and then transmitting the virus when they return to their communities. In addition, polygamous marriages contribute to an increased risk of HIV among Masai.
Edward Porokwa, who directs a not-for-profit group that lobbies for Masai and other traditional groups, said, "It is a very dangerous environment for the Masai," adding that "everybody will be bombed" as members of the group begin to transmit HIV (Calvert, Baltimore Sun, 3/2).
According to the Sun, the risk of HIV is increasing among Masai communities because concurrent sexual partnerships are traditionally considered proper. In addition, many Masai have low awareness of HIV/AIDS and how to prevent transmission of the virus. Masai men are beginning to travel to urban areas for work, having sex with non-Masai women and then transmitting the virus when they return to their communities. In addition, polygamous marriages contribute to an increased risk of HIV among Masai.
Edward Porokwa, who directs a not-for-profit group that lobbies for Masai and other traditional groups, said, "It is a very dangerous environment for the Masai," adding that "everybody will be bombed" as members of the group begin to transmit HIV (Calvert, Baltimore Sun, 3/2).
WHI Follow Up Study Confirms Health Risks Of Long-Term Combination Hormone Therapy Outweigh Benefits For Postmenopausal Women
New results from the Women's Health Initiative (WHI) confirm that the health risks of long-term use of combination (estrogen plus progestin) hormone therapy in healthy, postmenopausal women persist even a few years after stopping the drugs and clearly outweigh the benefits. Researchers report that about three years after women stopped taking combination hormone therapy, many of the health effects of hormones such as increased risk of heart disease are diminished, but overall risks, including risks of stroke, blood clots, and cancer, remain high. The WHI is sponsored by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
Results of the WHI three-year follow-up study of the estrogen plus progestin clinical trial are published in the March 5, 2008, issue of the Journal of the American Medical Association.
"The good news is that after women stop taking combination hormone therapy, their risk of heart disease appears to decrease," noted Elizabeth G. Nabel, M.D., NHLBI director. "However, these findings also indicate that women who take estrogen plus progestin continue to be at increased risk of breast cancer, even years after stopping therapy. Today's report confirms the study's primary conclusion that combination hormone therapy should not be used to prevent disease in healthy, postmenopausal women."
The FDA recommends that hormone therapy never be used to prevent heart disease, and, when hormone therapy is used for menopausal symptoms, it should only be taken at the smallest dose and for the shortest time possible.
The new findings are from a follow-up study of 15,730 postmenopausal women with an intact uterus, ages 50 to 79 years (average age of 63) at enrollment, who participated in the WHI estrogen-plus-progestin clinical trial. Participants were randomly assigned to receive a combination of estrogen (0.625 milligrams of conjugated equine estrogens per day) plus progestin (2.5 mg of medroxyprogesterone acetate) or placebo (inactive pill). The main estrogen-plus-progestin study was stopped in 2002 after an average of 5.6 years of treatment due to an increase in breast cancer. Women on combination hormone therapy were also at increased risk of stroke, blood clots, and heart disease, while their risk of colorectal cancer and hip fractures was lower, compared to women who did not take hormone therapy.
The follow-up study began in July 2002 after women in the study were instructed to stop taking combination hormone therapy, and continued through March 2005, with participants followed for an average of 2.4 years. All study participants were examined at least once a year by a WHI clinician and received an annual breast examination and mammogram, with biopsies performed as needed. During the follow-up study, the numbers of heart attacks, strokes, and blood clots were not significantly different between the two groups (overall, 343 cardiovascular events among those who initially received hormone therapy versus 323 among those who did not). In addition, the number of deaths was not significantly different (233 women who had been in the hormone therapy group died, versus 196 women who had been in the placebo group).
"After being on combination hormone therapy for several years, the women's risk of cardiovascular disease was significantly higher - from a 29 percent increase in heart attacks to a 41 percent increase in strokes and nearly twice the risk of serious blood clots - compared to the women who did not take hormones," said Michael S. Lauer, M.D., director of the NHLBI Division of Prevention and Population Sciences. "While it is reassuring that heart attack risk decreased and that the risks for stroke and blood clots did not grow after the women stopped taking hormones, this study provides further evidence that five years of combination hormone therapy is harmful. All the accumulated risks do not simply disappear."
The study also found that other effects of combination hormones, such as decreased risk of colorectal cancer and hip fractures, also stopped when therapy ended.
"We continue to encourage women to use hormones only if needed for menopausal symptoms, and for the shortest time possible, and to adopt and maintain a healthy lifestyle, that is, engage in regular physical activity, maintain a healthy body weight, consume a diet low in saturated fat, and to not smoke, to reduce their risks of cardiovascular and other chronic diseases," said Marcia Stefanick, Ph.D., professor of medicine at Stanford University, Stanford, Calif., and a coauthor of the paper, as well as chair of the WHI Steering Committee. She added that women should know their cholesterol and blood pressure levels and other health risks and take preventative measures, as needed.
In contrast to the other effects, the risk of breast cancer continued at a rate similar to that seen during treatment. Women who had stopped taking estrogen plus progestin were about 27 percent more likely to develop breast cancer than the women who didn't take hormones during the study, with 79 women in the post-treatment group developing breast cancer during the three-year follow-up study, compared to 60 women in the non-treatment group.
"The hormones' effects on breast cancer appear to linger," noted Leslie Ford, M.D., associate director for clinical research in the Division of Cancer Prevention of the NIH's National Cancer Institute. "These findings reinforce the importance of women getting regular breast exams and mammograms, even after they stop hormone therapy."
Researchers also report a 24 percent increased risk of developing any form of cancer among women who had been in the treatment group. Overall, there were 63 more diagnoses of cancer during the follow-up study, or three per 1,000 participants per year, among women who had taken combination hormone therapy compared to women who did not take hormones during the study (281 diagnoses compared to 218). A more detailed analysis on the cancer findings is underway.
"The continued increased risk of breast cancer clearly plays a role in the increased overall risk of cancer years after stopping long-term estrogen plus progestin therapy, and it is important that we continue to follow these women," added Stefanick, noting that the new results provide further evidence that the health risks of long-term combination hormone therapy outweigh the benefits.
The WHI is a major, 15-year research program designed to address the most frequent causes of death, disability, and poor quality of life in postmenopausal women: cardiovascular disease, cancer, and osteoporosis. The principal findings from the two WHI hormone therapy trials, which studied 27,347 postmenopausal women on estrogen plus progestin, estrogen-alone, or placebo, found that the overall risks of long-term use of hormone therapy outweigh the benefits. Both of these trials were stopped early because of increased health risks and failure to prevent heart disease, a key question of the studies.
In addition to NCI, NHLBI collaborates on the WHI with the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, and the Office of Research on Women's Health, all parts of the NIH. Wyeth-Ayerst Research provided the medication and placebo for the hormone study.
Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at: http://www.nhlbi.nih.gov.
The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases.
Results of the WHI three-year follow-up study of the estrogen plus progestin clinical trial are published in the March 5, 2008, issue of the Journal of the American Medical Association.
"The good news is that after women stop taking combination hormone therapy, their risk of heart disease appears to decrease," noted Elizabeth G. Nabel, M.D., NHLBI director. "However, these findings also indicate that women who take estrogen plus progestin continue to be at increased risk of breast cancer, even years after stopping therapy. Today's report confirms the study's primary conclusion that combination hormone therapy should not be used to prevent disease in healthy, postmenopausal women."
The FDA recommends that hormone therapy never be used to prevent heart disease, and, when hormone therapy is used for menopausal symptoms, it should only be taken at the smallest dose and for the shortest time possible.
The new findings are from a follow-up study of 15,730 postmenopausal women with an intact uterus, ages 50 to 79 years (average age of 63) at enrollment, who participated in the WHI estrogen-plus-progestin clinical trial. Participants were randomly assigned to receive a combination of estrogen (0.625 milligrams of conjugated equine estrogens per day) plus progestin (2.5 mg of medroxyprogesterone acetate) or placebo (inactive pill). The main estrogen-plus-progestin study was stopped in 2002 after an average of 5.6 years of treatment due to an increase in breast cancer. Women on combination hormone therapy were also at increased risk of stroke, blood clots, and heart disease, while their risk of colorectal cancer and hip fractures was lower, compared to women who did not take hormone therapy.
The follow-up study began in July 2002 after women in the study were instructed to stop taking combination hormone therapy, and continued through March 2005, with participants followed for an average of 2.4 years. All study participants were examined at least once a year by a WHI clinician and received an annual breast examination and mammogram, with biopsies performed as needed. During the follow-up study, the numbers of heart attacks, strokes, and blood clots were not significantly different between the two groups (overall, 343 cardiovascular events among those who initially received hormone therapy versus 323 among those who did not). In addition, the number of deaths was not significantly different (233 women who had been in the hormone therapy group died, versus 196 women who had been in the placebo group).
"After being on combination hormone therapy for several years, the women's risk of cardiovascular disease was significantly higher - from a 29 percent increase in heart attacks to a 41 percent increase in strokes and nearly twice the risk of serious blood clots - compared to the women who did not take hormones," said Michael S. Lauer, M.D., director of the NHLBI Division of Prevention and Population Sciences. "While it is reassuring that heart attack risk decreased and that the risks for stroke and blood clots did not grow after the women stopped taking hormones, this study provides further evidence that five years of combination hormone therapy is harmful. All the accumulated risks do not simply disappear."
The study also found that other effects of combination hormones, such as decreased risk of colorectal cancer and hip fractures, also stopped when therapy ended.
"We continue to encourage women to use hormones only if needed for menopausal symptoms, and for the shortest time possible, and to adopt and maintain a healthy lifestyle, that is, engage in regular physical activity, maintain a healthy body weight, consume a diet low in saturated fat, and to not smoke, to reduce their risks of cardiovascular and other chronic diseases," said Marcia Stefanick, Ph.D., professor of medicine at Stanford University, Stanford, Calif., and a coauthor of the paper, as well as chair of the WHI Steering Committee. She added that women should know their cholesterol and blood pressure levels and other health risks and take preventative measures, as needed.
In contrast to the other effects, the risk of breast cancer continued at a rate similar to that seen during treatment. Women who had stopped taking estrogen plus progestin were about 27 percent more likely to develop breast cancer than the women who didn't take hormones during the study, with 79 women in the post-treatment group developing breast cancer during the three-year follow-up study, compared to 60 women in the non-treatment group.
"The hormones' effects on breast cancer appear to linger," noted Leslie Ford, M.D., associate director for clinical research in the Division of Cancer Prevention of the NIH's National Cancer Institute. "These findings reinforce the importance of women getting regular breast exams and mammograms, even after they stop hormone therapy."
Researchers also report a 24 percent increased risk of developing any form of cancer among women who had been in the treatment group. Overall, there were 63 more diagnoses of cancer during the follow-up study, or three per 1,000 participants per year, among women who had taken combination hormone therapy compared to women who did not take hormones during the study (281 diagnoses compared to 218). A more detailed analysis on the cancer findings is underway.
"The continued increased risk of breast cancer clearly plays a role in the increased overall risk of cancer years after stopping long-term estrogen plus progestin therapy, and it is important that we continue to follow these women," added Stefanick, noting that the new results provide further evidence that the health risks of long-term combination hormone therapy outweigh the benefits.
The WHI is a major, 15-year research program designed to address the most frequent causes of death, disability, and poor quality of life in postmenopausal women: cardiovascular disease, cancer, and osteoporosis. The principal findings from the two WHI hormone therapy trials, which studied 27,347 postmenopausal women on estrogen plus progestin, estrogen-alone, or placebo, found that the overall risks of long-term use of hormone therapy outweigh the benefits. Both of these trials were stopped early because of increased health risks and failure to prevent heart disease, a key question of the studies.
In addition to NCI, NHLBI collaborates on the WHI with the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, and the Office of Research on Women's Health, all parts of the NIH. Wyeth-Ayerst Research provided the medication and placebo for the hormone study.
Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at: http://www.nhlbi.nih.gov.
The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases.
International Information Sharing Needed To Prevent Nuclear Threats
Information about the characteristics of nuclear and other radioactive materials stored and used by countries needs to be shared globally to combat the illicit trafficking of nuclear materials and nuclear terrorism, says a report published by the Royal Society.
The report which looks at the issues surrounding the detection of nuclear threats such as the smuggling of nuclear warheads and radioactive materials to make dirty bombs concludes that shared international databases would aid the growing field of nuclear forensics by speeding up and improving the identification of the origins of nuclear materials. It is hoped that this may deter future terrorism attempts.
Professor Roger Cashmore, Chair of the advisory group that produced the report, said: "To reduce the risk of nuclear terrorism we need to increase our ability to detect and respond to the misuse of nuclear materials. This can help the international collection and sharing of information about nuclear materials."
The report which represents the views of over 70 of the world's leading scientific and policy experts from the UK, USA, Russia, Israel and Europe highlights the need for countries that have a nuclear power industry or nuclear weaponry to share technical data for instance on the types of nuclear fuel used by their commercial power stations, or nuclear material used for defence.
"For example, nuclear reactors may use a specific type of fuel, such as uranium pellets. This fuel is then processed to produce nuclear waste products with particular characteristics. Indicators such as these make nuclear materials inherently traceable."
Databases of this type of information are crucial to trace the source of the material after smuggling or, in a worst case scenario, a nuclear incident.
Professor Cashmore continued: "If a bomb made from a certain type of uranium or plutonium was detonated, knowing where that material was processed would enable authorities to trace it back to a specific country's industrial or defence facility. Currently this process could take months but if international information was shared, it could take weeks or even days. Such efficiency would act as a strong deterrent to potential smugglers.
"Information on the type of nuclear materials held by countries is valuable only if it is globally available. At present there is no requirement for countries to collect or share information on their nuclear industry or weaponry."
The report notes that in the UK, as in many countries, there is considerable sensitivity in the commercial and military communities over sharing information on the types and quantities of nuclear material.
"It is of course critical to ensure homeland security is protected. But nuclear and other radioactive materials of concern are spread throughout the world - along with people willing to smuggle them. It is crucial to take account of the potential global threat of trafficking when considering whether it is appropriate to share such sensitive information.
"Consistent international materials databases, used alongside existing surveillance and intelligence, will undoubtedly improve the prevention of nuclear threats and will build international confidence in nuclear security."
The report which looks at the issues surrounding the detection of nuclear threats such as the smuggling of nuclear warheads and radioactive materials to make dirty bombs concludes that shared international databases would aid the growing field of nuclear forensics by speeding up and improving the identification of the origins of nuclear materials. It is hoped that this may deter future terrorism attempts.
Professor Roger Cashmore, Chair of the advisory group that produced the report, said: "To reduce the risk of nuclear terrorism we need to increase our ability to detect and respond to the misuse of nuclear materials. This can help the international collection and sharing of information about nuclear materials."
The report which represents the views of over 70 of the world's leading scientific and policy experts from the UK, USA, Russia, Israel and Europe highlights the need for countries that have a nuclear power industry or nuclear weaponry to share technical data for instance on the types of nuclear fuel used by their commercial power stations, or nuclear material used for defence.
"For example, nuclear reactors may use a specific type of fuel, such as uranium pellets. This fuel is then processed to produce nuclear waste products with particular characteristics. Indicators such as these make nuclear materials inherently traceable."
Databases of this type of information are crucial to trace the source of the material after smuggling or, in a worst case scenario, a nuclear incident.
Professor Cashmore continued: "If a bomb made from a certain type of uranium or plutonium was detonated, knowing where that material was processed would enable authorities to trace it back to a specific country's industrial or defence facility. Currently this process could take months but if international information was shared, it could take weeks or even days. Such efficiency would act as a strong deterrent to potential smugglers.
"Information on the type of nuclear materials held by countries is valuable only if it is globally available. At present there is no requirement for countries to collect or share information on their nuclear industry or weaponry."
The report notes that in the UK, as in many countries, there is considerable sensitivity in the commercial and military communities over sharing information on the types and quantities of nuclear material.
"It is of course critical to ensure homeland security is protected. But nuclear and other radioactive materials of concern are spread throughout the world - along with people willing to smuggle them. It is crucial to take account of the potential global threat of trafficking when considering whether it is appropriate to share such sensitive information.
"Consistent international materials databases, used alongside existing surveillance and intelligence, will undoubtedly improve the prevention of nuclear threats and will build international confidence in nuclear security."
Study Shows That Parents Ignore The Risk Of Secondhand Smoke Exposure For Children
A new study by researchers at John Hopkins Bloomberg School of Public Health found that parents are doing little to protect their children from exposure to secondhand smoke.
A household study, conducted in 31 countries, found that 82 percent of parents who smoked reported smoking around their children.
The study, published in the April edition of the American Journal of Public Health found that the measurements of nicotine levels from household air and children's hair samples indicated high levels of exposure to secondhand smoke amongst those living with a smoker. The study is among the first to demonstrate that childhood exposure to secondhand smoke is a global concern.
Heather Wipfli, PhD, project director at the Bloomberg School's Institute for Global Tobacco Control said, "Our research clearly shows that parents are failing to protect their children from secondhand smoke exposure, perhaps because they are unaware of the risks. The results highlight the need to improve public awareness of the importance of going outside to smoke to limit the exposure to children living in the home."
A related study, also published in the American Journal of Public Health, concluded that paternal smoking diverts money from basic necessities to cigarettes, putting children at greater risk for chronic malnutrition. Richard Semba, MD, MPH, a professor with the Johns Hopkins School of Medicine, and his colleagues found that paternal smoking was associated with increased mortality among infants and children under age 5 in Indonesia.
Semba said, "Tobacco control should be considered as part of the strategy for reducing child mortality."
A household study, conducted in 31 countries, found that 82 percent of parents who smoked reported smoking around their children.
The study, published in the April edition of the American Journal of Public Health found that the measurements of nicotine levels from household air and children's hair samples indicated high levels of exposure to secondhand smoke amongst those living with a smoker. The study is among the first to demonstrate that childhood exposure to secondhand smoke is a global concern.
Heather Wipfli, PhD, project director at the Bloomberg School's Institute for Global Tobacco Control said, "Our research clearly shows that parents are failing to protect their children from secondhand smoke exposure, perhaps because they are unaware of the risks. The results highlight the need to improve public awareness of the importance of going outside to smoke to limit the exposure to children living in the home."
A related study, also published in the American Journal of Public Health, concluded that paternal smoking diverts money from basic necessities to cigarettes, putting children at greater risk for chronic malnutrition. Richard Semba, MD, MPH, a professor with the Johns Hopkins School of Medicine, and his colleagues found that paternal smoking was associated with increased mortality among infants and children under age 5 in Indonesia.
Semba said, "Tobacco control should be considered as part of the strategy for reducing child mortality."
Earlier Diagnosis Of Dementia And Alzheimer's Disease From PET's Targeted Imaging
Researchers involved in a large, multi-institutional study using positron emission tomography (PET) imaging with the radiotracer fluorodeoxyglucose (FDG) were able to classify different types of dementia with very high rates of success, raising hopes that dementia diagnoses may one day be made at earlier stages.
"Previously, scientists have been able to look only at the surface of the brain to differentiate various types of dementia," said Lisa Mosconi, Ph.D., assistant professor of psychiatry at the New York University School of Medicine. "With FDG PET, we were able to develop standardized disease-specific patterns from which we could correctly classify dementia more than 94 percent of the time."
The study, which was reported in the March issue of the Journal of Nuclear Medicine, measured the cerebral metabolic rate of glucose (CMRglc) - the amount of sugar the brain uses to fuel its activities - in various areas of the organ. A decrease in this rate is indicative of a loss of nerve cells and of dysfunction associated with dementia. Because FDG behaves like glucose when injected into the body, its location in the PET scans pinpointed the specific area where glucose utilization had fallen below normal levels as compared to an age-appropriate control group.
"Each type of dementia examined - Alzheimer's disease (AD), frontotemporal dementia (FTD), and dementia with Lewy bodies (DLB) - affects a different area of the brain. Based on where in the brain this decrease occurred, we were able to determine which type of dementia a patient had," Mosconi explained.
For instance, only AD patients have severe CMRglc reductions in the hippocampus (a part of the brain located deep in the organ and, prior to this study, unreachable for examination), whereas FTD patients have only mild abnormalities in the area and DLB patients have no hippocampal hypometabolism. "We believe that the ability to measure this embedded area in the brain will be important in identifying AD at an early stage," added Mosconi.
This is also the first study to use FDG PET to compare an early stage of dementia known as mild cognitive impairment (MCI) with dementing diseases other than AD. According to the researchers, the results suggest that the ability to detect differentiated uptake of glucose may result in earlier and more accurate diagnoses of MCI and better disease management.
"Because the incidence of these disorders is expected to increase dramatically as the baby-boomer generation ages, accurate diagnosis is extremely important - particularly at the early and mild stages of dementia when life-style changes and therapeutic interventions would be most effective," said Mosconi.
AD and other forms or dementia can take several years to progress to a debilitating stage, and a diagnosis based on FDG-PET assessments at the first sign of onset may improve the prognosis of MCI patients. "Early diagnosis may enable earlier treatment and empower people to plan for their future sooner, including financial and legal matters. It is also important for individuals at risk to take care of treatable risk factors, such as hypertension and high cholesterol levels," said Mosconi. "By changing their diet and increasing exercise, many MCI patients may deter dementia for years - perhaps even until more effective treatments are developed."
The study comprised 548 subjects and is the largest FDG PET study measuring brain metabolism in different dementing disorders to date. Researchers from PET centers in the United States and Europe were able to apply and share objective image analysis procedures easily, opening up the possibility that this diagnostic procedure could be adapted to a clinical setting.
Dementia is a general term for a progressive brain dysfunction that results in the loss of memory and other intellectual abilities serious enough to interfere with daily life. MCI patients demonstrate a decline of cognitive performance that is more pronounced than expected from age but not severe enough to meet criteria for dementia. The clinical course of these patients is challenging to forecast on the basis of clinical measures alone. Many diseases can result in a form of dementia, the most common one being AD, a progressive and fatal brain disease. According to the Alzheimer's Association, more than five million people in the United States have AD, and by 2050, that number could triple. Currently it is the seventh leading cause of death in the United States.
"Previously, scientists have been able to look only at the surface of the brain to differentiate various types of dementia," said Lisa Mosconi, Ph.D., assistant professor of psychiatry at the New York University School of Medicine. "With FDG PET, we were able to develop standardized disease-specific patterns from which we could correctly classify dementia more than 94 percent of the time."
The study, which was reported in the March issue of the Journal of Nuclear Medicine, measured the cerebral metabolic rate of glucose (CMRglc) - the amount of sugar the brain uses to fuel its activities - in various areas of the organ. A decrease in this rate is indicative of a loss of nerve cells and of dysfunction associated with dementia. Because FDG behaves like glucose when injected into the body, its location in the PET scans pinpointed the specific area where glucose utilization had fallen below normal levels as compared to an age-appropriate control group.
"Each type of dementia examined - Alzheimer's disease (AD), frontotemporal dementia (FTD), and dementia with Lewy bodies (DLB) - affects a different area of the brain. Based on where in the brain this decrease occurred, we were able to determine which type of dementia a patient had," Mosconi explained.
For instance, only AD patients have severe CMRglc reductions in the hippocampus (a part of the brain located deep in the organ and, prior to this study, unreachable for examination), whereas FTD patients have only mild abnormalities in the area and DLB patients have no hippocampal hypometabolism. "We believe that the ability to measure this embedded area in the brain will be important in identifying AD at an early stage," added Mosconi.
This is also the first study to use FDG PET to compare an early stage of dementia known as mild cognitive impairment (MCI) with dementing diseases other than AD. According to the researchers, the results suggest that the ability to detect differentiated uptake of glucose may result in earlier and more accurate diagnoses of MCI and better disease management.
"Because the incidence of these disorders is expected to increase dramatically as the baby-boomer generation ages, accurate diagnosis is extremely important - particularly at the early and mild stages of dementia when life-style changes and therapeutic interventions would be most effective," said Mosconi.
AD and other forms or dementia can take several years to progress to a debilitating stage, and a diagnosis based on FDG-PET assessments at the first sign of onset may improve the prognosis of MCI patients. "Early diagnosis may enable earlier treatment and empower people to plan for their future sooner, including financial and legal matters. It is also important for individuals at risk to take care of treatable risk factors, such as hypertension and high cholesterol levels," said Mosconi. "By changing their diet and increasing exercise, many MCI patients may deter dementia for years - perhaps even until more effective treatments are developed."
The study comprised 548 subjects and is the largest FDG PET study measuring brain metabolism in different dementing disorders to date. Researchers from PET centers in the United States and Europe were able to apply and share objective image analysis procedures easily, opening up the possibility that this diagnostic procedure could be adapted to a clinical setting.
Dementia is a general term for a progressive brain dysfunction that results in the loss of memory and other intellectual abilities serious enough to interfere with daily life. MCI patients demonstrate a decline of cognitive performance that is more pronounced than expected from age but not severe enough to meet criteria for dementia. The clinical course of these patients is challenging to forecast on the basis of clinical measures alone. Many diseases can result in a form of dementia, the most common one being AD, a progressive and fatal brain disease. According to the Alzheimer's Association, more than five million people in the United States have AD, and by 2050, that number could triple. Currently it is the seventh leading cause of death in the United States.
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