Stack Articles

Schistosomiasis Causes More Damage Than Previously Thought

2008-03-15T20:16:00.002-07:00

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.

Physical Activity Of Adolescent Girls Could Be Increased By After-School Programs

2008-03-15T20:16:00.001-07:00

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.

Heparin Investigation Update By Baxter

2008-03-15T20:15:00.000-07:00

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.

DEET Inhibits The Receptors That Allow Insects To Smell Their Human Prey

2008-03-15T20:14:00.002-07:00

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.

New Research On The Origins Of Asthma And Allergies Presented At Annual Meeting

2008-03-15T20:14:00.001-07:00

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.

$7.6 Million Grant To Develop Novel Treatment For Parkinson's Disease Awarded To Scripps Florida

2008-03-15T20:13:00.001-07:00

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.

Wasps Offer Clues To Which Came First, Social Dominance Or Big Brains

2008-03-15T20:12:00.000-07:00

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."

Merrimack Pharmaceuticals Completes Enrollment In A Phase 2 Study Of MM-093 In Patients With Rheumatoid Arthritis

2008-03-15T20:08:00.000-07:00

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.

Modeling Flu Pandemics May Help Prevent Them

2008-03-13T03:52:00.000-07:00

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:

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 models allowed researchers to analyze how combinations of targeted antiviral treatment, prophylaxis, and social-distancing strategies affect five intervention scenarios of varying stringency and disease transmissibility levels. Transmissibility of the virus is calculated as the average number of secondary cases that each primary case infects at the beginning of the epidemic, and how rapidly these cases arise. These data aid the researchers in estimating the likelihood that an epidemic will become a pandemic.

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

2008-03-13T03:51:00.001-07:00

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.

AVMA Applauds New State Laws That Make Dog Fighting A Felony Everywhere In The United States

2008-03-13T03:49:00.000-07:00

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.

Statement In Response To Allegations By Jim Devine MP, Nursing And Midwifery Council, UK

2008-03-13T03:47:00.000-07:00

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.

HHS Awards 550 Million Dollars For HIV/AIDS Care, Services

2008-03-13T03:45:00.000-07:00

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."

Inhaled Tuberculosis Vaccine More Effective Than Traditional Shot

2008-03-13T03:44:00.000-07:00

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."

http://captcha.chat.yahoo.com/go/captchat/?img=http://ab.login.yahoo.com/img/G8AiEuVZFem2nuSBGEe13eRyUhj8vfRn4gicXwsxRWhkmjQpWs6PY6F6gB0C65phAo3LHhFAX

2008-03-13T03:42:00.000-07:00

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.

Clinical Trial Shows Ubiquinol Has Significant Effect On Patients With Congestive Heart Failure

2008-03-13T03:36:00.000-07:00

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.

Baxter Heparin Contaminant Found

2008-03-06T06:13:00.000-08:00

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.

Listening To Cell Phones Impairs Driving, Study

2008-03-06T06:12:00.000-08:00

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."

Consuming Alcohol May Lead To High Blood Pressure

2008-03-06T06:11:00.000-08:00

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:

*1*1 genotype has highest alcohol intake
*1*2 genotype has intermediate alcohol intake
*2*2 genotype has lowest alcohol intake

Those with the *1*1 variant were 2.42 more likely to have hypertension than those with the *2*2 variant. People with the *1*2 variant were 1.72 times more likely to have hypertension than those with the *2*2 genotype. The researchers found no link between ALDH2 and hypertension among the women subgroup because they drank very little on average.

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

2008-03-06T06:09:00.000-08:00

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.

Rates Of Health Problems Among Urban American Indians Do Not Decline As Income Rises, According To Study

2008-03-06T06:08:00.002-08:00

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).

Baltimore Sun Examines Masai Practices That Could Lead To Spread Of HIV

2008-03-06T06:08:00.001-08:00

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).

WHI Follow Up Study Confirms Health Risks Of Long-Term Combination Hormone Therapy Outweigh Benefits For Postmenopausal Women

2008-03-06T06:06:00.000-08:00

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.

International Information Sharing Needed To Prevent Nuclear Threats

2008-03-06T06:05:00.000-08:00

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."

Study Shows That Parents Ignore The Risk Of Secondhand Smoke Exposure For Children

2008-03-06T06:02:00.000-08:00

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."

Earlier Diagnosis Of Dementia And Alzheimer's Disease From PET's Targeted Imaging

2008-03-06T05:56:00.000-08:00

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.

Las Vegas Clinic Shut After Hepatitis C Infections

2008-03-04T05:18:00.001-08:00

The City of Las Vegas shut down a clinic last week after health officials traced several cases of hepatitis C to the endoscopy centre.

According to an Associated Press report, city mayor Oscar Goodman said the clinic's licence has been suspended while health officials try to trace patients who were treated at the centre over the last four years and test them for hepatitis C.

Health officials have traced six reported cases of hepatitis C to the Endoscopy Center of Southern Nevada, and alleged the centre put patient safety at risk by reusing syringes and vials, said the AP report in the New York Times yesterday.

The head of the US Centers for Disease Control and Prevention (CDC), Dr Julie Gerberding, said in a media conference call that the the agency was concerned this could be "the tip of an iceberg" in improper practice across the whole country, reported the Washington Post.

Health officials in Nevada are trying to contact around 40,000 patients who were treated at the clinic between March 2004 and mid January 2008, and had received anesthesia by injection. The patients should be tested for hepatitis C, hepatitis B and HIV. The announcement on the Nevada state health department website says:

"Patients who had procedures requiring injected anesthesia at the Endoscopy Center of Southern Nevada, located at 700 Shadow Lane, Las Vegas will begin to receive letters this week."

Geberding said this kind of breach to patient safety:

"Should never happen in contemporary health care organizations."

Unfortunately, although this is the largest number of patients to be recalled for a "blood exposure", the CDC has seen similar practices in other large scale situations that have led to equivalent breaches of patient safety, she told the media.

This could be the tip of an iceberg and "we need to be much more aggressive about alerting clinicians about how improper this practice is," urged Geberding.

An emergency spending bill seeking to give the CDC more resources is coming before Congress in April, said the Washington Post.

Several lawsuits have been filed against the clinic and there is also an investigation under way by the Clark County district attorney, said the paper.

Five of the six cases traced to the clinic were treated on the same day and the connection was confirmed using genetic testing, head epidemiologist of the Southern Nevada Health District, Brian Labus, told the Post.

It is highly likely that as the 40,000 patients are traced and tested, more cases of hepatitis C will be found. But it is going to be very difficult to establish if they contracted the virus at the endoscopy centre because the prevalence in the general population is 4 per cent, said Labus.

Dr Dipak Desai, who heads the clinic took out space in the Las Vegas Review-Journal on Sunday to write a letter of regret where he expressed "deepest sympathy" for patients and their families, but there were no words of apology, just an offer to set up a fund to pay for the tests and a defence of practices at the clinic.

According to the Post, Desai wrote:

"The evidence does not support that syringes or needles were ever reused from patient to patient at the center."

Hepatitis C is a liver disease with an initial acute phase lasting about 6 months where most people show no symptoms, but some feel like they have the flu, feel tired and nauseous and become jaundiced. It is often misdiagnosed, unless a specific test is taken.

The acute phase is followed by a chronic infection phase that results in long term cirrhosis (scarring) of the liver. The disease progresses at different rates in different people.

About one in four people with hepatitis C get rid of the virus naturally, but the other 75 per cent will develop chronic infection, which in most cases will not shorten their lives. However, around one in five chronically infected people will develop severe cirrhosis which can lead to liver cancer or damage that is so bad they will need a transplant.

Hepatitis B is a similarly serious disease caused by a virus that also attacks the liver and can lead to lifelong infection, cirrhosis of the liver, liver cancer, liver failure, and death. However, most adults will recover and develop immunity.

According to the Washington Post, Nevada state health officials are investigating a second clinic that is believed to have re-used anesthetic vials but not syringes.

A hotline has been set up for anyone concerned or who needs further information on the investigation.

Britain's First Supermarket GP Surgery Opens In Manchester

2008-03-04T05:17:00.002-08:00

Shoppers at Sainsbury's Heaton Park supermarket in Blackley, North Manchester, UK, who can't get an appointment with their GP after 6 pm can now see a doctor at a medical centre based at the store.

The new GP surgery is staffed by local doctors who are working extra hours at the centre which opens two evenings a week and on Saturdays.

The Heywood, Middleton and Rochdale Primary Care Trust set up the supermarket medical centre in a consulting room in a pharmacy as part of a six-month pilot costing 126,000 pounds.

Patients can book to visit the Sainsbury's GP surgery via their own registered GP practice. The surgery will be open for appointments between 6.30 and 9.30 pm on Monday and Thursday, and from 11 am to 3 pm on Saturdays.

The scheme is the first example of the government's push to make healthcare more accessible. Last year it said shops could submit proposals to open GP surgeries.

People who are at work all day or have family commitments find it difficult to make an appointment to see their doctor during normal working hours and the NHS trust said this scheme would help to explore an alternative way to extend medical care outside of the normal GP surgery hours.

Chief Executive of Sainsbury's, Justin King, told the BBC that:

"This is a ground-breaking partnership that supports the government's wider aims to make healthcare more accessible."

He said Sainsbury's was in a good position to offer GPs and their patients a "convenient, safe and secure location for the provision of routine care", because of its role as a "major retailer, at the centre of many communities".

Dr Mohammed Jiva, whose firm Doctors in Store provides the GP service, told the Guardian newspaper that there is a real need for an instore scheme. He said:

"Can something like this help to give people some time back in their busy lives? We think it could be useful."

And it appears that shoppers feel the same. Jane Sutherland, interviewed by the paper while buying fish at the store said her husband might use the new GP centre because he wouldn't take time off work to see his normal doctor, but this new scheme gives him the option to see the doctor after work, and she added that he could "pick up a few bits while he's here".

Jiva said it was more than convenience that would attract people. It's a safe place, it's well lit, and the pharmacy is right on the premises.

But Guardian reporter Hugh Wilson was not so impressed with the waiting area, which comprises two plastic chairs and is in full view of shoppers.

However, it is early days, and people may be prepared to put up with a little discomfort to get the convenience and accessibility of an out of hours service. Kate Webb, health policy adviser for consumer watchdog Which? said:

"Recent Which? research has told us that getting evening and weekend appointments with a GP is a real priority for consumers, so this is an interesting development that could meet this demand and we look forward to seeing the results of the pilot."

Two New Lungs Might Be Better Than One

2008-03-04T05:17:00.001-08:00

Researchers in France and the US have concluded that for younger patients in the final stages of chronic obstructive pulmonary disease (COPD), survival is lengthened by transplanting both lungs compared to only one lung. The study, performed by Dr Gabriel Thabut, Service de Pneumologie B et transplantation pulmonaire, Hôpital Bichat, Paris, France, and colleagues, is published in the journal The Lancet.

COPD includes several diseases that limit airflow to the lungs, such as chronic bronchitis and emphysema, for example. Often, patients with end-stage lung diseases such as COPD can benefit most from lung transplantation. About 46% of lung transplants were performed in order to treat COPD from 1995 to 2006. This statistic includes both single and bilateral (both lung) transplantation, and the focus of this current research is to see which procedure leads to longer survival.

The researchers used data from the registry of the International Society for Heart and Lung Transplantation. Of 9,883 COPD patients between 1987 and 2006, 3,525 (35.7%) had bilateral lung transplantation (BLT) and 6,358 (64.3%) received single lung transplantation (SLT).

The median survival time after BLT was 6.41 years compared to 4.59 years for SLT patients. Thabut and colleagues used various statistical methods to control for pre-transplant characteristics, and with each method BLT continued to be associated with longer survival times than SLT.

"Bilateral lung transplantation leads to longer survival than single lung transplantation in patients with COPD, especially those who are younger than 60 years...Any potential survival benefit of bilateral lung transplantation for individuals with COPD must be weighed against the potential societal benefits of allocation of organs to patients with advanced lung diseases," note Thabut and colleagues.

For patients 60 years and older, the researchers found that BLT only had a small benefit in survival time compared to SLT. In addition, the researchers analyzed results with respect to time period. Patients who had an operation before 1998 had shorter survival times than those who had one after 1998 - median time of 4.5 years (pre-1998) compared to 5.3 years (post-1998).

An accompanying Comment by Dr E Clinton Lawrence, McKelvey Center for Lung Transplantation and Pulmonary Vascular Diseases, Emory University School of Medicine, Atlanta, GA, USA suggests that rather than lung transplantation, doctors and patients should consider options such as: surgical lung-volume reduction, use of endobronchial valves, lung rehabilitation, and programs to quit smoking.

He writes: "Lung transplantation is an imperfect solution for COPD and other diseases, with a 5-year survival rate of about 50%. There is a limited supply of organs suitable for transplantation and patients, usually not those with COPD, die on waiting lists. Diminution of demand through smoking-prevention programmes is a far better alternative to lung transplantation."

Stem Cells Prevented From Becoming Cartilage By Toxins In Cigarette Smoke

2008-03-04T05:16:00.000-08:00

A toxic pollutant spread by oil spills, forest fires and car exhaust is also present in cigarette smoke, and may represent a second way in which smoking delays bone healing, according to research presented at the annual meeting of the Orthopaedic Research Society in San Francisco.

In 2005, researchers from the University of Rochester Medical Center identified one ingredient in smoke, nicotine, that delays bone growth by influencing gene expression in the two-step bone healing process: stem cells become cartilage; cartilage matures into bone. In the current study, some of the same researchers found that a second smoke ingredient, the polyaromatic hydrocarbon benzo(a)pyrene (BaP), also slows bone healing, but in a different way.

Smoking has been shown to delay skeletal healing by as much as 60 percent following fractures. Slower healing means a greater chance of re-injury and can lead to chronic pain and disability. The obvious solution is for smokers to quit when they get hurt, but studies show that just 15 percent can.

"Our results provide the first evidence that BaP prevents stem cells from becoming cartilage cells as part of healing," said Regis J. O'Keefe, M.D., Ph.D., chair of the Department of Orthopaedics and Rehabilitation at the Medical Center and a study investigator. "These findings extend our understanding of the impact of cigarette smoke on a process that is critical to fracture repair. Perhaps down the road we will be able to speed bone healing among smokers in more than one way."

Study Details

Gene expression is the process by which instructions encoded in genes are followed for the building of proteins, the workhorses that make up the body's organs and carry its signals. In the current study, polymerase chain reaction (PCR), a technique that measures gene expression levels, revealed the genetic changes caused by exposure to BaP in mouse stem cells.

Among the many factors that influence gene expression are transcription factors, proteins designed to direct genes to create more or less of a protein. One such factor is Sex Determining Region Y-box 9 (SOX-9), required for the transition of stem cells into cartilage cells. The PCR results show that BaP in cigarette spoke interferes with SOX-9 expression in mesenchymal stem cells, blocking their conversion into cartilage cells. When this group of stem cells is free to differentiate, the newly formed cartilage cells immediately begin manufacturing collagen 2, the tough, fibrous protein framework for cartilage. Along with interfering with SOX-9, BaP was also found to reduce levels of type II collagen gene expression.

Past studies had shown that stem cells involved in cartilage formation contain proteins known to react with BaP called aryl hydrocarbon receptors. The current results suggest that BaP binding with these receptors may suppress SOX-9 activity, reducing the number of stem cells that turn into cartilage cells and the amount of collage produced. No one knows what such receptors are doing in these cells in the first place, but one theory has it that they signal cellular machinery to metabolize toxins.

The study compared the effect of BaP versus that of cigarette smoke extract, a substance representing all the ingredients in cigarette smoke. The hope was to confirm BaP as the specific cause of the observed effect on SOX-9. Results indeed suggest BaP alone may responsible for this specific mechanism of healing delay, since its effect was equal to the extract.

In addition measuring gene expression levels, researchers also conducted tests to show the effect of BaP visually. When newly differentiated cartilage cells begin to produce collagen in a culture dish, little mounds or nodules of collagen can be visualized using a stain. Staining experiments captured images showing BaP to "completely inhibit" collagen nodule deposition.

Along with O'Keefe, the Medical Center effort was led by Ming Kung, Donna Hoak, HsinChiu Ho, Edward Puzas and Michael Zuscik, all within the Department of Orthopaedics at the Medical Center.

"Smoking reduces the rate at which the two sides of a fracture come together," said Michael Zuscik, Ph.D., associate professor in the Department of Orthopaedics and Rehabilitation at the Medical Center. "We believe this new research will establish for the first time the mechanisms by which polyaromatic hydrocarbons interfere with the healing process."

In Patients With Advanced Chronic Hepatitis C - Serum Fibrosis Markers Correlate With Liver Fibrosis Stage

2008-03-04T05:15:00.001-08:00

A prospective study of patients with advanced chronic hepatitis C (CHC) revealed that a 3-variable model of serum fibrosis markers, including serum HA, TIMP-1 and platelet count, could identify cirrhosis with better accuracy than other published models. These findings are in the March issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD). The article is also available online at Wiley Interscience.

Liver biopsy is currently considered the best way to assess the stage and severity of chronic liver disease. However, it is limited by sampling error, understaging and variability in interpretation. Also, because of its risks, inconvenience and costs, it isn't practical to use to follow disease progression and treatment effects. As a result, researchers have been trying to develop less invasive tests that can accurately predict disease stage and fibrosis progression.

Researchers led by Robert Fontana of the University of Michigan Medical School examined a panel of serum fibrosis markers along with routine laboratory tests for their ability to estimate cirrhosis in a cohort of patients with advanced hepatitis C. They included 513 patients enrolled in the HALT-C trial, a prospective multi-center NIH study of extended peginterferon therapy for patients with hepatitis C and advanced fibrosis who were non-responders to prior antiviral therapy.

Fontana and his colleagues aimed to determine the utility of a panel of serum fibrosis markers including serum PIIINP, TIMP-1, HA, and YKL-40 in estimating initial disease stage in the subjects by comparing the markers with each patient's Ishak fibrosis score from liver biopsy. They also examined the relationship between the serum fibrosis markers and hepatic collagen content as measured by computerized morphometry.

"On univariate analysis, nearly all of the tested variables were independent predictors of cirrhosis," the authors report. They then conducted multivariate analyses and created a model that included TIMP-1, log HA and platelet count. "The 3-variable model was significantly better than any of the individual serum fibrosis markers alone in estimating the presence of cirrhosis," they write. The model had an area under the receiver operating curve of 0.81 and was better at predicting cirrhosis than other published models.

The model would have correctly categorized 153 HALT-C patients as having a low likelihood of cirrhosis with 86% accuracy. An additional 146 subjects would have been categorized as having a high likelihood of cirrhosis with 73 % accuracy.

The serum fibrosis markers also correlated with the collagen content of biopsy samples, however not as closely as they did with the Ishak fibrosis scores. This suggests that the serum fibrosis markers more closely reflect the pattern of fibrosis determined by standard light microscopy than the quantity of hepatic collagen determined by computerized morphometry.

The study was limited by the unique nature of the HALT-C patient population and by the fact that the models were not tested in an external validation cohort. Still, the researchers conclude, "on multivariate analysis, a 3-variable model consisting of TIMP-1, HA, and platelet count distinguished patients with non-cirrhotic CHC from those with cirrhosis. Also, this new model performed significantly better than other models based on routine laboratory tests, suggesting that serum fibrosis markers provide useful, incremental information in estimating disease stage in CHC."

The HALT-C study was supported by the National Institute of Diabetes and Digestive and Kidney Disease. Additional support was provided by the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute, National Center for Minority Health and Health Disparities, and by the General Clinical Research Center grants from the National Center for Research Resources. Additional funding to conduct this study was supplied by Hoffman-La Roche Inc., through a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health.

Rheumatoid Arthritis And Misdiagnoses

2008-03-04T05:14:00.000-08:00

In an article recommended by Annelies Boonen of Faculty of 1000 Medicine, researchers look at the way rheumatoid arthritis is diagnosed by analysing the administrative databases used by physicians in Quebec.

The authors of the paper, published in Arthritis & Rheumatism, report that general practitioners diagnosed 79% of the 10,001 rheumatoid arthritis cases but only 27% of patients then saw a rheumatologist. Half of these patients were seen in the first three months and of these it emerges that only 17% received confirmation they were actually suffering from rheumatoid arthritis.

Rheumatologist, Boonen says, "The low referral rates of cases with suspected rheumatoid arthritis to rheumatologists is worrisome, especially when considering the discrepancy in diagnoses between the initial diagnosis by the non-rheumatologists and the following diagnosis by the rheumatologists."

Boonen recommends further research to confirm the findings and explore the wider implications of the study. "If we really feel the window of opportunity for treatment of rheumatoid arthritis exists, rheumatologists should increase their efforts to raise diagnostic capabilities of first-line physicians towards early diagnosis and referral of suspected patients with rheumatoid arthritis".

President Bush Declares March As Red Cross Month

2008-03-04T05:13:00.002-08:00

In a tradition dating back to Franklin Delano Roosevelt, President George W. Bush declared March as Red Cross Month, calling it a time to "honor this charitable organization" and "reflect on its remarkable achievements and contributions to our country."

In a Proclamation signed today, the President cited examples of how the Red Cross had provided food, comfort and medical assistance to the victims of a number of disasters in 2007, from the tragic bridge collapse in Minnesota to the devastating wildfires in California. He also noted how the Red Cross provides vital assistance by organizing blood drives, teaching health and safety programs, and supporting our men and women in uniform.

Throughout the month, 750 Red Cross chapters across the country will celebrate in a variety of ways, including holding special events, trainings or fundraisers to give people an opportunity to support the organization through donations of time, money or blood. The Red Cross is also launching a new national advertising campaign with the message that when you support the American Red Cross, you change a life, starting with your own. You can view the new campaign here: http://www.redcross.org/advertising. The Red Cross also holds its National Convention in March.

The Red Cross also uses March to urge all Americans to get prepared. There are three simple actions to get "Red Cross Ready" for disasters and other emergencies: 1) Get a kit, 2) Make a plan and 3) Be informed.

"I thank President Bush for his support of the American Red Cross and for today's proclamation of March as Red Cross Month," said Mary S. Elcano, Acting President and CEO of the American Red Cross. "We hope all Americans will consider supporting the Red Cross so that we can be there whether it is a hurricane or a heart attack, a call for blood or a call for help."

The public can go to http://www.redcross.org to find out how they can support the Red Cross.

The full text of the President's proclamation:

A Proclamation by the President of the United States of America

In 1881, Clara Barton established the American Red Cross, and for years afterward, she led that organization in its noble cause to provide healing, comfort, and hope to those in need. Today, her legacy lives on through the millions of individuals who have answered the timeless call to serve others. During American Red Cross Month, we honor this charitable organization, and we reflect on its remarkable achievements and contributions to our country.

The American Red Cross exemplifies the good heart of this Nation by leading humanitarian efforts at home and around the world. This past year the American Red Cross provided food, comfort, and medical assistance to the victims of the tragic bridge collapse in Minnesota, the devastating wildfires in California, and the tornadoes that affected several Southern States. From the mountains of Peru to the lowlands of Bangladesh, the American Red Cross and its partners helped to provide relief abroad to those affected by natural disasters and humanitarian emergencies.

The American Red Cross also helps provide vital assistance by organizing blood drives, teaching health and safety programs, and providing lifesaving supplies. By compassionately supporting our men and women in uniform and their families, it helps to lift the spirits of our wounded warriors. During this month, we send our heartfelt gratitude to the volunteers and staff of the American Red Cross.

NOW, THEREFORE, I, GEORGE W. BUSH, President of the United States of America and Honorary Chairman of the American Red Cross, by virtue of the authority vested in me by the Constitution and laws of the United States, do hereby proclaim March 2008 as American Red Cross Month. I commend the dedicated efforts of the American Red Cross, and I encourage all Americans to help make our world a better place by volunteering their time, energy, and talents for others.

IN WITNESS WHEREOF, I have hereunto set my hand this twenty-eighth day of February, in the year of our Lord two thousand eight, and of the Independence of the United States of America the two hundred and thirty-second.

GEORGE W. BUSH

Some Patients May Be Spared An Unnecessary Procedure By New Test For Joint Infection

2008-03-04T05:13:00.001-08:00

A potential diagnostic test that could help surgeons confirm or rule out the presence of infection-causing bacteria in prosthetic joints that require surgical revision has been developed by researchers at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the National Institutes of Health (NIH). Such a test could spare a subgroup of people who need the surgery a time-consuming and costly treatment for infection, while helping to ensure that people who need the procedure get it. The test is described in the March issue of the Journal of Bone and Joint Surgery.

Each year, hundreds of thousands of joint replacement surgeries are performed in this country. And each year, thousands of them must be revised (the prosthetic joint must be removed and replaced) due to severe pain and swelling. These symptoms are often due to infection, says Rocky S. Tuan, Ph.D., chief of NIAMS' Cartilage Biology and Orthopaedics Branch.

The standard treatment for suspected infection is to remove the joint prosthesis and replace it with a spacer that has been impregnated with antibiotics. After about six weeks, patients must undergo another surgery to remove the spacer. Only then can the surgeon implant the new prosthesis.

The problem with this approach is that confirming the presence of infection-causing bacteria is an inexact science. Currently, doctors check for infection by culturing a sample of the joint fluid. A positive culture confirms live bacteria, making spacer surgery a certainty. A negative culture, however, does not necessarily mean there is no infection. In fact, Tuan says that estimates of the false negative rate for joint cultures in revision surgeries range from 27 percent to 50 percent. But because failure to treat an infected joint could lead to severe infection and limb amputation, spacer surgery is sometimes performed for safety's sake even when infection test results are inconclusive.

To get around the false-negative problem, Tuan and his colleagues developed a way to test for joint infections using polymerase chain reaction (PCR), which detects the presence of bacterial DNA. However, this approach proved to have pitfalls, too. It picked up all bacteria - even dead or dying bacteria that cannot perpetuate infection - thereby giving false positives.

Tuan says this new problem led them to expand their PCR approach by testing for bacterial messenger ribonucleic acid (mRNA). "When bacteria are dying, their mRNA is one of the first things to go," he says. As a result, the researchers hypothesized that a good mRNA test would not only detect bacteria, but would likely tell them if any bacteria they detected were still viable. Unlike DNA, mRNA is not directly quantifiable by known techniques, so the mRNA test that Tuan's group developed employs a process called reverse transcription PCR (RT-PCR) to convert the mRNA into DNA for measurement.

Tuan's group tested the validity of their new method by introducing bacteria into infection-free joint fluid to simulate infection. To ensure that the bacteria were indeed present, they used the PCR test, which accurately showed the amount of bacterial DNA. The researchers then treated the joint fluid cultures with potent antibiotics designed to kill off the bacteria. As expected, the PCR-DNA test still showed that the fluid contained plenty of bacteria, but when the group analyzed the cultures with the RT-PCR test for mRNA, they found that the viable bacteria population was declining.

Now Tuan's team is recruiting 50 people who need joint revision for a clinical trial that will involve testing patients' joint fluid for bacteria and then following them for 6 months to a year after surgery. They hope that the results from this study will validate the protocol to identify or rule out infections before a person begins a surgical revision.

Tuan would like to be able to tell patients who need infection treatment, "There is a really bad infection and we know what to do."

"But we also want to tell the person without infection that it's O.K. to put in a revision joint. That saves the spacer, the additional surgery and its associated risk, and 6 weeks of being laid up," Tuan says.

Risk Of Death For Heart Attack Patients Raised By Clinical Depression Even Years Later

2008-03-04T05:12:00.000-08:00

Depressed heart attack patients have a higher risk for sudden death in the months following a heart attack. Now a team led by researchers from Washington University School of Medicine in St. Louis has found that the risk continues for many years.

"There's a two- to four-fold increase in a person's risk of dying following a heart attack if they also happen to be depressed," says Robert. M. Carney, Ph.D., lead author of the new study and professor of psychiatry at Washington University. "Previously we thought the impact of depression was strongest for the first three to six months following a heart attack and then gradually dropped off within a couple of years. Instead, we found that the effect lasts for at least five years."

Carney, with colleagues from Duke University Medical Center, Harvard University, Yale University, the National Heart, Lung and Blood Institute (NIH) and the Mayo Clinic, followed more than 750 heart attack patients for five years. The findings will appear in an upcoming issue of the Journal of Affective Disorders and are currently available online.

Patients followed in the study had participated in the NIH-funded project Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD). A little less than half were diagnosed with depression.

In the five years following a heart attack, 106 patients died. Of those, 62 had been diagnosed with depression, while 44 had not. In gauging the effects of depression, the investigators also considered other risks including age, smoking, hypertension, gender and diabetes.

Some of those factors, like younger age and female gender, lower mortality risk. Smoking and diabetes tend to raise the risk of dying. Carney says his team used statistical methods to evaluate the ways in which the various factors influenced mortality risk. Then they removed the influence of all other factors from the risk equation in order to consider the statistical impact of depression itself.

"We found that after adjusting for those risk factors, depression continues to play a statistically significant role," he says.

One possible explanation for depression's lingering influence on mortality is its recurring nature. Because the disorder can come and go over many years, it also may continue to increase the risk of death for many years.

"People typically are depressed for a while, then they'll either get better with treatment or it may subside on its own," Carney says. "But depression can always recur, and we think that because it is a recurring problem, whatever depression is doing to mortality risk after a heart attack, it continues doing for quite a long time."

Past studies have differed over how much depression affects survival following a heart attack. But Carney believes these new findings are more reliable because all of the patients in this study were personally interviewed to determine their depression status, whereas other studies have relied on self-reporting.

"In our experience, self-reporting tends to overestimate the risk because it's often not possible to evaluate the causes of various symptoms on self-report questionnaires," he explains. "Say somebody reports having sleeping problems - that would go into the depression column as a symptom. But it's possible they are sleeping poorly because of a bad back or because they have to get up and go to the bathroom frequently during the night. During an interview, we can determine whether an individual symptom is related to depression or can be explained in some other way."

Carney's team also found that any clinically relevant depression increases the risk of death in heart attack patients. The risk was elevated both for patients with major depression, which requires the presence of five or more symptoms, and minor depression, which requires between two and four symptoms for diagnosis. Major depression was associated with higher risk, but minor depression also was associated with a significant increase in mortality risk.

Even with mounting evidence of a link between depression and death in heart attack patients, only about 25 to 30 percent of these patients receive antidepressant drugs or other depression treatments.

That doesn't surprise Carney. His team reported in 2003 in the Journal of the American Medical Association that providing treatment for depression seemed to have little effect on whether patients survived or had a second heart attack. This could be because the treatments don't work for all patients, Carney says, and he suggests if current depression treatments could be improved, survival rates might increase, too.

To this end, his team is studying whether omega-3 fatty acids - the fatty acids found in fish oil - might improve antidepressant therapies in heart patients. They're giving an antidepressant drug and a special formulation of omega-3 to some heart patients and comparing them to depressed heart patients who receive an antidepressant but no omega-3.

"We have not been satisfied with the effectiveness of standard antidepressants at alleviating depression in this population of patients," Carney says. "We're studying omega-3, because there's preliminary evidence that the fatty acids also might make depression therapies more effective, both in treating depression and in improving heart health."

Malignant Tumor Cells Controlled By Protein In Embryonic Stem Cells

2008-03-04T05:11:00.002-08:00

A protein that governs development of human embryonic stem cells (hESCs) also inhibits the growth and spread of malignant melanoma, the deadliest skin cancer, Northwestern University researchers have discovered. Metastatic melanoma, which develops from the transformation of skin pigment cells or melanocytes, has a death rate of more than 80 percent and a median survival of less than 7.5 months.

The Northwestern scientists, led by researcher Mary J. C. Hendrix, M.D., additionally found that the protein, called Lefty, prevents aggressive breast cancer cells from metastasizing. Death from metastatic breast cancer exceeded 40,000 in 2007, with over 180,000 new cases diagnosed in the United States.

Importantly, Lefty is secreted only in hESCs, and not in any other stem cell type tested - including stem cells isolated from amniotic fluid, cord blood or adult bone marrow - or placental cells.

Results of the study, described in an article in the March 3rd online version of The Proceedings of the National Academy of Sciences, build on an elegant body of research by the Hendrix lab to identify the genes and cellular pathways involved in cancer metastasis.

Dr. Hendrix is president and scientific director of the Children's Memorial Research Center and professor in The Robert H. Lurie Comprehensive Cancer Center of Northwestern University and at the Feinberg School of Medicine. Lynne-Marie Postovit, who was first author on the study and a post-doctoral trainee in the Hendrix lab, is currently an assistant professor at the University of Western Ontario, Canada.

Embryonic stem cells are pluripotent, meaning they can become any of 200-plus cell types in the adult body, depending on the signals they receive from their microenvironment (surrounding cells, tissues and vasculature). During cancer progression, malignant cells also receive and release signals from their microenvironment, cues that promote tumor growth and metastasis.

Groundbreaking work by Hendrix and colleagues is elucidating how, by becoming more like unspecialized stem cells, aggressive melanoma cells gain enhanced abilities to migrate, invade and metastasize while remaining virtually undetected by the immune system.

Hendrix and co-researchers previously demonstrated that a three-dimensional matrix conditioned by hESCs induced metastatic melanoma cells to revert to a normal, skin cell-like type with the ability to form colonies in th

"This observation allowed us to appreciate the powerful influence of the hESC microenvironment on the reprogramming of metastatic melanoma cells," Hendrix said.

In subsequent experiments, Hendrix, Postovit and co-researchers found that aggressive melanoma and breast cancer produce a "morphogenic" protein called Nodal, which is essential for human embryonic stem cell pluripotency (Topczewska et al, Nature Medicine 12:925-932, 2006). Other researchers have found that Nodal also is present in testicular cancer.

"Thus, Nodal may serve as a prognostic marker of aggressive behaviors in human cancers," Hendrix said.

As described in the PNAS study, the Lefty protein inhibits production of Nodal and therefore plays a major role in embryonic cell differentiation and development - under normal circumstances.

Hendrix and colleagues discovered that metastatic tumor cells do not express Lefty, allowing them to overproduce Nodal in an unregulated manner.

However, when the group exposed metastatic tumor cells to the microenvironment of hESCs containing Lefty, they witnessed dramatically reduced Nodal expression (production) in these cancer cells together with decreased tumor cell growth and invasiveness and an increase in apoptosis, or programmed cell suicide.

Although exposure to a hESC microenvironment inhibited Nodal expression and tumor growth in both metastatic melanoma and breast cancer cells, the breast cancer cells underwent more complex reprogramming. Melanoma cells responded to the hESC-derived factors within three days, but breast cancer cells required two additional days to achieve the most significant reduction in Nodal.

This discrepancy is likely due to differences in signaling mechanisms between the two cell types. Yet, despite the inherent differences between melanoma cells and breast cancer cells, these divergent tumor types both underwent cell suicide following exposure to the hESC microenvironment.

"The remarkable similarity of the responses of the two tumor types is likely attributable to the commonality of plasticity (for example, the aberrant and unregulated expression of Nodal) that indiscriminately unifies highly aggressive cancer cells, regardless of their tissue of origin," Hendrix said.

"Further, the tumor suppressive effects of the hECs microenvironment, by neutralizing the expression of Nodal in aggressive tumor cells, provide previously unexplored novel therapeutic modalities for cancer treatment," Hendrix said.

However, while findings from the study suggest that hESC-derived Lefty may have potential to prevent metastasis, it is not the only tumor suppressive factor within the embryonic microenvironment.

Observations from the study highlight the potential utility of isolating factors within the hESC microenvironment responsible for influencing tumor cell fate and reversing the cancerous properties of metastatic tumor cells, such as melanoma and breast cancer.

Teens Who Eat Breakfast Daily Found To Eat Healthier Diets Than Those Who Skip Breakfast

2008-03-04T05:11:00.001-08:00

University of Minnesota School of Public Health Project Eating Among Teens (EAT) researchers have found further evidence to support the importance of encouraging youth to eat breakfast regularly. Researchers examined the association between breakfast frequency and five-year body weight change in more than 2,200 adolescents, and the results indicate that daily breakfast eaters consumed a healthier diet and were more physically active than breakfast skippers during adolescence. Five years later, the daily breakfast eaters also tended to gain less weight and have lower body mass index levels - an indicator of obesity risk - compared with those who had skipped breakfast as adolescents.

Mark Pereira, Ph.D., corresponding author on the study, points out that this study extends the literature on the topic of breakfast habits and obesity risk because of the size and duration of the study. "The dose-response findings between breakfast frequency and obesity risk, even after taking into account physical activity and other dietary factors, suggests that eating breakfast may have important effects on overall diet and obesity risk, but experimental studies are needed to confirm these observations," he added.

Over the past two decades, rates of obesity have doubled in children and nearly tripled in adolescents. Fifty-seven percent of adolescent females and 33 percent of males frequently use unhealthy weight-control behaviors, and it is estimated that between 12 and 24 percent of children and adolescents regularly skip breakfast. This percentage of breakfast skippers, while alarming, has been found to increase with age.

Dianne Neumark-Sztainer, Ph.D., principal investigator of Project EAT, says that this research confirms the importance of teaching adolescents to start the day off 'right' by eating breakfast. "Although adolescents may think that skipping breakfast seems like a good way to save on calories, findings suggest the opposite. Eating a healthy breakfast may help adolescents avoid overeating later in the day and disrupt unhealthy eating patterns, such as not eating early in the day and eating a lot late in the evening."

Antibody Test For Malaria Developed By ETH Zurich Researchers

2008-03-04T05:07:00.000-08:00

New test for malaria protection

ETH Zurich professor Peter Seeberger has been working on a sugar-based malaria vaccine for years. The new test takes him one important step closer to his goal. The malaria pathogen plasmodium falciparum carries poisonous sugar molecules - called GPIs for short - on its surface that are able to be individually identified. Professor See-berger's research team is now developing a new method that demonstrates that the malaria pathogen's toxic sugar molecules trigger a specific immune reaction in adults.

Antibodies in blood from malaria regions

Tests show that blood samples taken from adults living in areas of Africa where malaria is endemic contain specific antibodies against particular GPIs. While infection is still possible despite the antibodies, the consequences are less serious. The immune system recognizes the poisonous sugar molecules as foreign bodies and blocks their toxic impact. Not living in high-risk areas, Europeans lack the relevant antibodies. As soon as Europeans are infected with malaria, the number of antibodies increases significantly. Subsequently, there is a direct link between the amount of antibodies and protection against the disease.

Inexpensive detection

This insight is thanks to a novel method for detecting antibodies. Faustin Kamena, a post-doc in Professor Seeberger's lab, has developed a special chip that can, inexpensively and with minute quantities of blood serum and sugar molecules, determine whether or not someone has formed particular antibodies against various GPIs. To this end, the researchers use the purest possible GPIs. These can be produced synthetically and in large amounts in a laboratory, as the Seeberger team has demonstrated in earlier research.

The new method involves affixing over 64 pads comprising pinpoint dots to glass slides. Every little pad consists of several tiny heaps of different GPIs in varying concentrations. When blood serum is then administered to such a pad, possible antibodies specifically bind to certain sugar molecules. Dyes then reveal to which GPIs the antibodies have attached themselves.

Help for infants

Thanks to the information obtained from the chip, scientists can produce the specific sugar molecules that the immune system has to recognize. The findings on natural re-sistance subsequently acquired are crucial to developing a sugar-based malaria vaccine. This could prove particularly beneficial to children in malaria-infested regions.

The millions of malaria sufferers are primarily infants under the age of five as only adults develop antibodies against the malaria pathogen's sugars. An infant's immune system is incapable of recognizing and combating the toxic sugar molecules. Consequently, a new, selective vaccine is now called for. Professor Seeberger states: "This evidence is another important step towards finding a malaria vaccine because we now know which antibodies protect adults."

Lack Of Political Will Blamed For Maternal Deaths

2008-03-03T08:46:00.002-08:00

UK parliament's Commons International Development Committee (CIDC) said in a new report released yesterday, to coincide with Mothering Sunday, that there is a lack of political will to reduce maternal deaths in the developing world, where there has been little change in the last 20 years to tackle the problem.

There are stark contrasts in the rates of maternal deaths in childbirth between the developed and the developing nations. For instance, while one in 8,200 women die in childbirth in the UK, for women in Niger this figure is one in seven, said the report.

Up to one million deaths in childbirth or during pregnancy could be avoided, and the report gives examples. For instance, fewer than half of women in sub-Saharan Africa have any trained medical help when they give birth.

Reducing maternal deaths is one of the Eight Millenium Goals set by the United Nations in 2000. The goal states:

"Reduce by three-quarters, between 1990 and 2015, the maternal mortality ratio".

According to Reuters, the CIDC report said that judging by the current rate, the target will not be reached, it is the one on which the least progress has been made, and that:

"A key factor in this collective failure has been insufficient political will to drive actions to improve the health of women, both at the international and national levels."

BBC News reports that the committee suggested the problem is hard to quantify because of lack of data from countries with the highest rates of maternal deaths, the tendency to under report them, and because national averages were used. The picture is very unclear in sub-Saharan Africa and Asia for instance.

Malcolm Bruce, chairman of the committee, told the press that:

"Whilst the number of maternal deaths for 2005 is cited as 536,000, the figure could be as high as 872,000."

He said they feared the truth probably lay nearer the higher figure. He said estimates show that for each maternal death, there are 30 further women who become ill, disabled or injured through pregancy, so:

"It is reasonable to assume that millions of women suffer in some way due to childbirth."

The UK government's aid overseas should focus on addressing the world shortage of midwives and making emergency obstetric care available to all women, said the CIDC report.

The UK's Department for International Development (DFID) should also help developing countries improve the way they collect medical data, and give more people acess to free drugs and make family planning services more widely available (this alone whould reduce maternal deaths and disability by 20 per cent at least, said the report).

According to the BBC, Douglas Alexander, International Development Secretary, said improving maternal health was one of the biggest challenges for developing countries:

"But without reliable statistics, basic healthcare and an improvement in the status of women, it will remain one of the most stubborn millennium development goals to tackle."

He said there was a "big push" in 2008 on the part of the UK and Prime Minister Gordon Brown, who would continue to play a leading role.

Director of the Partnership for Maternal, Newborn and Child Health at the World Health Organization, Dr Francisco Songane, also blamed insufficient political will for the appalling lack of progress in reducing maternal deaths worldwide. BBC News reported him telling the press that:

"In 2008 we have a crucial set of opportunities - including the upcoming G8 to be hosted by Japan - where political leaders can demonstrate their commitment to strengthen health services for women, newborns and children."

According to the WHO, more than 70 per cent of maternal deaths are caused by haemorrhage (25 per cent), infection (15 per cent), unsafe abortion (13 per cent), eclampsia (very high blood pressure leading to seizures, 12 per cent), and obstructed labour (8 per cent).

They estimate that one million children worldwide are left motherless every year, primarily because their mothers had no access to or could not afford quality health care. These children are also more likely to die within two years of their mothers' death, reports the WHO.

Why The Flu Virus Infects Mostly In Winter

2008-03-03T08:46:00.001-08:00

US scientists have discovered a possible reason why the flu virus is seasonal and tends to infect people mostly in the winter. It has a jacket that melts in the summer causing the virus to die off, and stays hard in the winter, until it enters a host where it melts and gets to work. The discovery could lead to new ways to prevent and treat the flu.

The findings are published in the 2nd March issue of the journal Nature Chemical Biology and are the result of a study carried out by senior investigator and neuroscientist Joshua Zimmerberg and colleagues. Zimmerberg is based at the Laboratory of Cellular and Molecular Biophysics (LCMB) in the National Institute of Child Health and Human Development (NICHD), in Bethesda, Maryland.

Zimmerberg and his team examined the structure of the flu virus, and its outer coat in particular, using nuclear magnetic resonance imaging.

The outer coat of the flu virus, and other respiratory viruses, are made of a fatty protein called hemagglutinin that hardens in cold conditions.

Zimmerberg told Reuters in a telephone interview that this was the "protein we make vaccines against". Hemagglutinin is where the "H" in flu virus names comes from.

When the virus enters a warm host, the hemagglutinin coat melts, and the virus gets to work infecting cells.

Hemagglutinin also helps the virus to bind to the target cell of its host, so the virus can fuse with it and allow its contents to invade the host cell.

During the summer, when the ambient temperature is much higher, the hemagglutinin coat is not able to stay hard and protect the virus, which is more likely to die before it can infect people.

"Like an M&M in your mouth, the protective covering melts when it enters the respiratory tract," Zimmerberg told Reuters.

"It's only in this liquid phase that the virus is capable of entering a cell to infect it," he added.

Duane Alexander, NICHD Director, said these results could suggest new ways to prevent and treat the flu by targeting the hemagglutinin coat.

Scientists have been puzzled for some time about why viruses like the flu are more prevalent in winter, speculating that perhaps it's because people spend more time indoors in confined environments, or because the sun's radiation kills more viruses in the summer. But none of these explanations is entirely satisfactory.

Viruses can't reproduce on their own. They have to enter a living cell and hijack its resources, reprogramming the cell DNA to do its bidding. The new copies of the virus don their hemagglutinin jackets and break out of the cell in large numbers.

The jacket hardens when the virus is shed by the warm host into the cold, so in winter, they stay insulated and alive, increasing the chance of infecting another host.

The jacket does not get hard all at once, Zimmerberg said they observed that it solidifies slowly, from 40 degrees Celsius (104 deg F) down to 4 degrees C (39 deg F). He said he and his colleagues believed this was how the virus managed to stay alive over a range of temperatures.

The researchers suggested that in winter it may even be harder to wash the virus off your hands because in the cold its hard shell protects it against soap and detergents.

Do We Need To Reassess Diabetes Diagnostics?

2008-03-03T08:45:00.000-08:00

A recent Article published in The Lancet suggests that the criteria for diagnosing diabetes mellitus could need reassessment. This conclusion comes from a study that looks at the connection between diabetes mellitus and a frequent diabetic complication called retinopathy.

Diabetes mellitus is a disorder due to an inability of pancreatic cells to produce enough insulin in order to prevent inappropriately high blood sugar (hyperglycemia). It is estimated to affect 380 million people by 2025. Diagnosis of the disorder, by both the World Health Organization (WHO) and the American Diabetes Association, is based on an individual's "fasting plasma glucose" (FPG) concentration. The guideline for diagnosis is a 7·0 mmol/L or higher FPG concentration.

Retinopathy is a common complication associated with diabetes that is characterized by small blood vessel damage to the eye; it can also lead to blindness. In the 1990s, three studies of retinopathy indicated that the condition was unusual for patients with an FPG below 7·0 mmol/L, but that the prevalence increased substantially above that threshold. These three studies used either direct clinical ophthalmoscopic examination or one retinal photograph, not multiple field retinal photographs that are now considered the gold standard of clinical trials. In addition, the Diabetes Prevention Program has reported that many people have signs of retinopathy even when their FPG is below 7·0 mmol/L.

This most recent study - conducted by Professor Tien Wong, Center for Eye Research Australia, University of Melbourne, VIC, Australia, and colleagues - analyzed three more papers that used multiple field retinal photographs in order to define retinopathy. The three studies include:

The Blue Mountains Eye Study (BMES), Australia, 3162 people
The Australian Diabetes, Obesity, and Lifestyle Study (AusDiab), Australia, 2182 people
The Multi-Ethnic Study of Atherosclerosis (MESA), USA, 6079 people.

Wong and colleagues report that 9.6% to 15.8% of the general population had retinopathy, and there was no evidence of a clear and consistent FPG threshold for the presence or incidence of retinopathy across the populations. Further, the usual FPG cutoff of 7·0 mmol/L was too high to capture all retinopathy cases. More than 60% of cases were missed because the FPG levels were below the limit.

"We found no uniform FPG glycemic threshold for retinopathy across different populations and poor performance of current FPG cutoffs in separating individuals with and without retinopathy, largely due to the much higher prevalence of retinopathy at low FPG concentrations than previous studies reported," write the authors.

Wong and colleagues conclude: "These findings could help unify the understanding of the risk of complications from diabetes, suggesting that both macrovascular (large vessel) and microvascular (small vessel) complications do not seem to respect a glycemic threshold. These findings further question the validity of the current WHO and American Diabetes Association approach of using retinopathy to derive FPG thresholds for diagnosing diabetes, and point to the need to revisit current diagnostic criteria for diabetes."

Drs. Quresh Mohamed and Alison Evans, Cheltenham General Hospital, Cheltenham, UK, wrote in an accompanying editorial that although the current diagnostic criteria may be limited, the FPG threshold is able to distinguish a set of patients with a much greater risk of harm. They suggest a need for larger prospective studies that analyze diabetes and the complications that are associated with it.

"We perhaps should focus less on a single universal cut-off and instead target resources on the basis of standardized evidence-based individual risk scores in which measures of glycemia are combined with other risk factors. But what would we tell our patients when they asked if they had diabetes? We are probably best sticking with what we know until a better alternative diagnostic tool becomes available," conclude Drs. Mohamed and Evans.

BIOTRONIK Launches Largest Worldwide Clinical Trial Using Wireless Home Monitoring Technologies

2008-03-03T08:44:00.000-08:00

BIOTRONIK, the pioneer in remote monitoring technologies for patients with cardiac devices, announced the launch of the landmark IMPACT Study (The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with Implanted ICD and CRT-D devices). The first patient was enrolled at the Thoracic & Cardiovascular Institute in Lansing, MI, USA, which marks the start of this large international, prospective, randomized trial. IMPACT will investigate whether the risk of stroke can be reduced in patients with cardiac devices and asymptomatic atrial fibrillation (AF) by early detection of these arrhythmias utilizing BIOTRONIK´s Home Monitoring technologies and a predefined anticoagulation plan.

Dr. Castellani, Principal Investigator at the Thoracic & Cardiovascular Institute in Lansing, MI commented: "We are very pleased to be enrolling the first patient in this important study which will further explore the potential benefits of remote Home Monitoring solutions. Studying the use of immediate detection of AF frequency and duration of AF episodes to guide anticoagulation in patients with a wide variety of stroke risks, will provide important information on the potential stroke reduction in this population."

The IMPACT study will enroll over 2,700 patients from 100 clinical centers worldwide and will utilize the BIOTRONIK´s Lumax family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-Ds) with BIOTRONIK's exclusive Home Monitoring solutions. Lumax ICD and CRT-D devices are part of BIOTRONIK´s most technologically advanced tachycardia product portfolio with the ability to detect episodes of AF, including the frequency and duration, even before the presence of clinical symptoms. The IMPACT study will further contribute to guidelines regarding anticoagulation for patients with AF and provide information on whether early anticoagulation in patients with AF documented by remote monitoring of cardiac device data can reduce the stroke and systemic embolism rate in this patient population. Remote monitoring of cardiac device data may be particularly relevant in patients with asymptomatic AF by allowing timely intervention as compared to conventional periodic in-office evaluation.

Dr. Halperin, Professor of Medicine and Director of Clinical Cardiology Services, Mount Sinai Medical Center, New York, NY, and IMPACT Steering Committee Co-Chair commented: "The IMPACT study is the first large randomized trial to evaluate the clinical utility of remote Home Monitoring technologies for the long-term management of patients, with implanted cardiac devices, at risk of developing AF and stroke. The study results will indicate how often these arrhythmias would otherwise go unnoticed and, perhaps more importantly, help us to better understand the relationship between AF and stroke events." Dr. Ip, Thoracic & Cardiovascular Institute, Lansing, MI, and IMPACT Steering Committee Co-Chair added: "Additionally, this is the largest prospective clinical trial to investigate the risk of stroke in patients who have frequent episodes of AF. The data from this important study will improve our anticoagulation strategy in patients with AF."

The IMPACT study was designed by an independent steering committee comprised of internationally renowned Electrophysiologists, Cardiologists and Neurologists to ensure the clinical validity of the study protocol. A Clinical Events Committee, Data Safety Monitoring Board and study statistician are all operationally independent of BIOTRONIK, the study sponsor. IMPACT is registered on clinicaltrials.gov.

"BIOTRONIK is proud to sponsor this important study which reaffirms our commitment to scientifically meaningful trials," said Jake Langer, President, BIOTRONIK, Inc. "BIOTRONIK is investing in clinical research that can make a significant difference in patient outcomes."

About BIOTRONIK

As one of the world's leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is present in all world markets. Known for having its finger on the pulse of the medical community, BIOTRONIK helps to assess the challenges physicians face, and provides the best solutions, be they cardiac implants, minimal invasive devices or other products and services ranging from diagnosis to electrotherapy and vascular intervention or therapy management. Quality, innovation, and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

VGX Pharmaceuticals Co-Founder Professor David B. Weiner To Chair The First DNA Vaccines Conference In Asia

2008-03-03T08:43:00.000-08:00

VGX Pharmaceuticals Inc. (VGX) announced that Professor David B. Weiner of the University of Pennsylvania will serve as the Chairman of the DNA Vaccines Asia 2008 Conference next week in Seoul, Korea. Professor Weiner is a pioneer in the field of DNA vaccines and a VGX co-founder.

The conference-the first of such meetings in Asia-will bring together the pioneering scientists and thought leaders of DNA vaccines and therapies in Asia and the US. The conference will be held on March 4th and has an agenda covering a broad range of topics including current DNA vaccine research, product development and manufacturing. In addition to Professor Weiner, the conference speakers include Professor Shan Lu of University of Massachusetts, Professor Bin Wang of China Agriculture University, Professor Chang-yuil Kang of Seoul National University, Professor Eiji Kobayashi of Jichi Medical School, and Dr. Ruxandra Draghia-Akli of VGX Pharmaceuticals and other distinguished experts in the field of DNA vaccines and therapies. The delegates at the conference represent professionals from biotechnology companies, major pharmaceutical companies, academic institutions, and government labs throughout Asia. The conference is sponsored by VGX and Biologics Resources, Inc.

FzioMed's Oxiplex Gel For Spine Surgery Approved In Canada

2008-03-03T08:42:00.000-08:00

FzioMed, Inc. announced that Health Canada has approved the company's Oxiplex(R) gel for use in lumbar spine surgery.

Oxiplex is an absorbable gel that is applied to spinal nerve roots during lumbar laminectomy, laminotomy and discectomy procedures. Oxiplex creates a temporary, protective barrier against the damaging effects of excessive fibrosis, inflammation and other irritants that can lead to recurrent postoperative pain. Oxiplex has been shown to improve spine surgery outcomes by significantly reducing postoperative leg pain, back pain and neurological symptoms.

"We are very pleased to add Canada to the growing list of countries where Oxiplex is approved," said John Krelle, FzioMed President and Chief Executive Officer.

Oxiplex is now approved in 49 countries and has been used in nearly 100,000 surgeries. Health Canada's approval of Oxiplex for spine surgery was based on final data from a U.S. multi-center, randomized, blinded, controlled study involving 352 patients. The company has filed a Pre-Market Approval Application with the FDA seeking approval to market Oxiplex in the U.S.

About Oxiplex Gel for Spine Surgery

Despite the success of spine surgical procedures, many patients later experience persistent or recurrent pain that is attributed to postoperative irritation of the nerve root. Oxiplex is an absorbable gel that is applied during lumbar spine surgery to provide a protective environment around the nerve root and physical separation of tissues during the healing process. Oxiplex does not interfere with normal healing and clears naturally from the body.

About FzioMed

FzioMed is a privately held medical device company developing and manufacturing absorbable, surgical biomaterials based on the company's patented polymer science. FzioMed's technology has uses in a variety of medical fields including spine surgery, orthopedics, gynecology, general surgery and aesthetic surgery. FzioMed products include Oxiplex/SP, the leading adhesion barrier for spine surgery, and Intercoat Adhesion Barrier Gel for peritoneal surgery, both marketed outside the U.S. FzioMed products are for investigational use only in the U.S.

'2-Faced' Particles Act Like Tiny Submarines

2008-03-02T07:28:00.000-08:00

For the first time, researchers at North Carolina State University have demonstrated that microscopic "two-faced" spheres whose halves are physically or chemically different - so-called Janus particles - will move like stealthy submarines when an alternating electrical field is applied to liquid surrounding the particles.

A paper describing the research, published in the Feb. 8, 2008, edition of Physical Review Letters, advances knowledge about how potential "smart" materials - think of tiny engines or sensors - can move around and respond to changes in their environment. Janus particles could be used as microscopic mixers, molecular "shuttles," self-propelling microsensors or means of targeted drug delivery.

The researchers - Dr. Orlin Velev, associate professor of chemical and biomolecular engineering at NC State and lead author of the paper; Sumit Gangwal, an NC State graduate student; Dr. Olivier Cayre, a post-doctoral researcher in Velev's lab; and Dr. Martin Bazant from Massachusetts Institute of Technology - created tiny two-faced gold and plastic particles and applied low frequency alternating current to the water containing the particles. The electric field was of voltage and frequency similar to the ones you'd get if you plugged a device into a socket in your home or office.

Velev says the micrometer-sized particles convert the electrical field into liquid motion around them and then unexpectedly propel themselves perpendicular to the direction of the powered electrodes - not in the direction of the electrical field, as would be expected. The particles always travel in the same orientation: with the plastic "face" as the front of the mini-submarine and the metallic "face" in the rear, Velev added.

The phenomenon - called "induced-charge electrophoresis," which had been predicted in a theoretical model by the MIT collaborator - had not been demonstrated previously.

The term "Janus particle" comes from the name of a Roman god with two faces. Velev says that these materials have the potential to perform a variety of applications.

"You can imagine other types of Janus particles comprising a 'smart gel' that responds to a change in its environment and then releases drugs, for example," Velev says. Fabricating these responsive materials on the microscale and nanoscale is an exciting and rapidly developing area of science, he adds.

"We are able to create tiny Janus particles of the same size and shape and are beginning to learn how to give them functionality," Velev said. "The next step is to create more complex particles that are able to perform more specialized functions in addition to propelling themselves around."

Genetic Cancer Link Discovered Between Humans And Dogs

2008-03-02T07:23:00.000-08:00

Cancer researchers at the University of Minnesota and North Carolina State University have found that humans and dogs share more than friendship and companionship - they also share the same genetic basis for certain types of cancer. Furthermore, the researchers say that because of the way the genomes have evolved, getting cancer may be inevitable for some humans and dogs.

Jaime Modiano, V.M.D., Ph.D., University of Minnesota College of Veterinary Medicine and Cancer Center, and Matthew Breen, Ph.D., North Carolina State University's Center for Comparative Medicine and Translational Research, collaborated on this research study. Their findings are published in the current issue of the journal Chromosome Research, a special edition on comparative cytogenetics and genomics research by scientists from around the world.

Genomes are divided into chromosomes, which act as nature's biological filing cabinets with genes located in specific places.

"Many forms of human cancer are associated with specific alterations to the number or structure of chromosomes and the genes they contain," Breen said. "We have developed reagents to show that the same applies to dog cancers, and that the specific genome reorganization which occurs in comparable human and canine cancers shares a common basis."

More specifically, Breen and Modiano found that the genetic changes that occur in dogs diagnosed with certain cancers of the blood and bone marrow, including chronic myelogenous leukemia (CML), Burkitt's lymphoma (BL), and chronic lymphocytic leukemia (CLL), are virtually identical to genetic abnormalities in humans diagnosed with the same cancers.

"We believe the implication of this finding is that cancer may be the consequence of generations of genetic evolution that has occurred similarly in dogs and humans," Modiano said. "This means that to some degree, cancer may be inevitable in some humans and dogs just because of the way our genomes have developed since the separation from a common ancestor."

"Since we know now that dogs and humans seem to share a common pathogenetic basis for some cancers, we believe that studying dog cancers may allow us to identify cancer-associated genes more easily in dog populations than in human populations. Once identified, we may be able to translate these findings to human cancers as we seek to provide a greater level of insight into cancer risk, diagnosis, and prognosis," said Modiano.

According to Breen and Modiano, dogs are good research subjects because they develop the disease spontaneously, and many of the modern breeds have developed over the past few hundred years using restricted gene pools. This selective breeding has preserved the genetics of a breed. It has also made some breeds more susceptible to certain cancers. These factors, coupled with the high degree of similarity between the genomes of dogs and humans, provided the researchers with an opportunity to compare the genomes and study the evolutionary genetic changes associated with cancer.

The human genome has 46 chromosomes and the dog genome contains 78 chromosomes. Sometimes, in the normal duplication process of cells, chromosomes can become rearranged or relocated. This rearrangement or relocation is called translocation. It can lead to a cell losing its normal function, becoming abnormal, and possibly developing into cancer.

"Interestingly, we found that the same translocation of chromosomes happens in dogs as in humans for the three blood and bone marrow cancers we studied," Modiano said.

Breen and Modiano conclude that despite millions of years of divergence, the evolving genomes of dogs and humans seem to have retained the mechanism associated with cancer, and that the conserved changes in the genomes have similar consequences in dogs and humans.

"Like ourselves, our pet dogs suffer from a wide range of spontaneous cancers. For thousands of years humans and dogs have shared a unique bond. In the 21st century this relationship is now strengthened to one with a solid biomedical basis; the genome of the dog may hold the keys to unlocking some of nature's most intriguing puzzles about cancer," Breen said.

The next step for Breen and Modiano is to use grants received from the National Cancer Institute to start pinpointing risk factors for cancer in various breeds of dogs.

Chemical 'Chords' Used By Neurons To Shape Signaling

2008-03-02T07:20:00.001-08:00

Researchers have discovered that neurons can use two different neurotransmitters that target the same receptor on a receiving neuron to shape the transmission of a nerve impulse. Although the researchers' experiments identified the "co-release" of the two neurotransmitters only in specific types of neurons in the brain's auditory center, their finding may apply more broadly in the brain, they said. Thus, the finding may represent a new way in which the brain precisely modulates the nerve impulses that travel from neuron to neuron in its circuitry.

Tao Lu and colleagues Maria Rubio and Laurence Trussell reported their findings in the February 28, 2008, issue of the journal Neuron, published by Cell Press.

To propagate a nerve impulse within neural circuitry, one neuron launches a burst of chemical signal called a neurotransmitter at a receiving neuron, where the neurotransmitter attaches to a specific receptor - like a key fitting a lock. That neurotransmitter-specific receptor is activated to trigger a nerve impulse in the receiving neuron.

Such nerve impulses, however, rather than being the electrical equivalent of a shotgun blast, are precisely modulated signals, like the finely shaped notes of an orchestra.

In studies over the past several decades, researchers had found evidence for co-release of different neurotransmitters by the same neuron. But they had assumed that in such cotransmission, each neurotransmitter targeted its own receptor on the receiving neuron.

However, Lu and colleagues performed biochemical and electrophysiological experiments on rat neurons and established that two neurotransmitters - called GABA and glycine - both target the glycine receptor in specific types of neurons. The neurons they studied reside in the part of the rat auditory system that processes sound location. Thus, shaping the timing of the nerve impulse is important for such processing.

Glycine acts as an inhibitory neurotransmitter in such neurons, and Lu and colleagues found that GABA acts on the glycine receptor to accelerate glycine-produced inhibition.

Lu and colleagues wrote that, although their studies only establish the role of GABA/glycine cotransmission in the specialized auditory neurons, other studies had found evidence for cotransmission in other areas of the brain. Such findings hint that the two neurotransmitters may work in concert elsewhere "at a single receptor to enhance the temporal resolution of inhibition."

"Of course, a hallmark of a great scientific study is the ability to approach an established problem from a fresh perspective," wrote Joshua Singer in a preview of the article in the same issue of Neuron. "And certainly the present work by Lu, Rubio, and Trussell characterizes this." Singer, who is at Northwestern University, asked, "Who would have thought that GABA [is a natural trigger for glycine receptors]? Not me, unfortunately."

Characteristics Of Prostate Cancer Detected By Digital Rectal Examination Only

2008-03-02T07:16:00.000-08:00

A report in the December, 2007 issue of Urology by Dr. Okotie and the group of Dr. William Catalona suggests the digital rectal examination (DRE) remains an important element of prostate cancer (CaP) screening. The group performed the study, as others have suggested that DRE is no longer necessary to CaP screening. For example, the European Randomized Study of Screening for Prostate Cancer states that a prostate biopsy should be offered for a PSA level of >3.0ng/ml but omits DRE.

From Dr. Catalona's database of 36,000 men participating in CaP screening between 1989 and 2001, 3,568 (10%) were diagnosed with CaP. Prior to 1995 a PSA level >4.0ng/ml and after 1995 a PSA level >2.5g/ml was the indication for prostate biopsy. The other indication has always been a DRE suspicious for CaP. Among men who had a prostate biopsy due to a suspicious DRE, 18% were diagnosed with CaP. Of the 3,568 men diagnosed with CaP, 2,233 underwent radical prostatectomy. Of the men treated with surgery, 303 (14%) were diagnosed with CaP by DRE alone, 1,426 (64%) on the basis of PSA, and 504 (22%) due to abnormalities in both the PSA and DRE.

Among men diagnosed with CaP due to an abnormal DRE alone who underwent surgery, 60 (20%) were non-organ confined, 56 (20%) had Gleason score 7 or higher, 49 (16%) had positive surgical margins, 8 (3%) had seminal vesicle invasion and 4 (1.3%) had lymph node metastasis. Comparing these pathologic features to CaP detected due to abnormalities in both PSA and DRE findings revealed that adverse pathology was significantly more likely if both the PSA and DRE were abnormal, compared to either test alone. The 10 year progression-free survival rate was 83%, 82%, and 63% for CaP detected by DRE only, PSA only, and both PSA and DRE, respectively. Overall survival and cancer-specific survival were also significantly higher for CaP detected by an abnormality on only DRE or PSA compared to both tests. This data supports a role for both DRE and PSA in CaP screening.

Why Men In The United Kingdom Still Want The Prostate Specific Antigen Test

2008-03-02T07:08:00.000-08:00

In a report in the January 2008 issue of Qualitative Health Research, an Oxford University team of sociologists led by Alison Chapple analyzed British men's views and experiences regarding PSA screening. The UK has no formal national screening program for prostate cancer (CaP) but in 2001 the UK Department of Health introduced the Prostate Cancer Risk Management Program (PCRMP), which gives men access to the PSA test if they are first informed about its benefits and limitations. All general practitioners in UK received information about the PCRMP. The authors who have previously reported on British men's views on heath screening sought to explore men's views since the PCRMP was introduced.

The objectives of the research was to explore men's understanding of the PSA test, their perceptions of the information they received, the factors that they said influenced them when deciding whether to have a test, and their understanding of the results. The analysis included 30 men who underwent 1-2 hour interviews in their homes. Participant range was ages 40-78, almost all were white and most were recruited via their general practitioner

. Overall, the views were similar to those noted prior to the introduction of the PCRMP. Most men described having been given little information and encouraged by wives, friends, and the media to have the test. Three aspects dominated the views of the men interviewed; that PSA is perceived and approached by men and doctors as "just another blood test", that any testing for cancer is responsible health behavior, and that there is a lack of communication about the uncertainty that is inherent in the test and treatment options. Some men viewed PSA screening as civic duty to advance medical science, others as prevention is better than cure. Overall however, men interviewed were still unsure about the meaning of the PSA test and received little information from their general practitioners. Men often seemed unprepared for the possible adverse consequences of having the test, including the uncertainties about the value of treatment.

Endogenous Sex Hormones And The Risk Of Prostate Cancer: A Prospective Study

2008-03-02T06:58:00.000-08:00

Relationship between Endogenous Sex Hormones and Prostate Cancer Not Demonstrated in Prospective Study: Previous epidemiologic studies relating serum hormone levels to prostate cancer (CaP) risk have been inconclusive. In the International Journal of Cancer, Dr. Weiss and associates report a large nested case-control study including 727 cases and 889 controls using pre-diagnostic serum samples in the prospective Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. They examined associations between androstenedione (4-A), testosterone (T), sex hormone-binding globulin (SHBG), and 3 androstanedio glucuronide (3-diolG) with the risk of CaP. This study had the benefit of a large size that would permit evaluation of androgen-associated risks in relation to CaP aggressiveness and to consider risks in population subgroups.

The PLCO screening trial is a two-armed, randomized controlled trial designed to evaluate the effectiveness of prostate, lung, colorectal, and ovarian cancer screening and to investigate etiologic factors and early markers of cancer. Case diagnosis followed an elevated PSA (57%), an abnormal rectal exam (14%), and both (17%). Most serum hormone levels were not correlated with PSA in cases or controls, however T:SHBG was correlated with PSA in controls. Although risks tended to increase with greater total, free, and bioavailable T, and to decrease with greater SHBG, these findings were not statistically significant. T:SHBG ratio, however, was associated with increased risk for CaP especially in men age 65 years and older.

In summary, there is not significant convincing evidence of a relationship between serum sex hormones and prostate cancer.

Endophytic Lesions: A Predictor Of Failure In Laparoscopic Renal Cryoablation

2008-03-02T06:52:00.000-08:00

The tissue ablative techniques for renal tumor management continue to be in their investigational phase. This group highlights the technical limitations associated with cryotherapy of anteriorly located, endophytic tumors. These tumors are often not amenable to percutaneous CT guided cryotherapy and therefore are approached laparoscopically. If endophytic, as opposed to exophytic, these tumors can be very difficult to accurately locate visually even with intra-operative, laparoscopic ultrasound imaging. In this study of laparoscopic cryotherapy for 35 renal tumors, multivariate analysis showed that only the endophytic nature of the tumor was a clear predictor of failure of the treatment, because these treatments are heavily reliant on intra-operative ultrasound targeting. Until intra-operative laparoscopic imaging can be significantly improved these cryotherapy failures will continue to occur due to technical error. These patients must be closely surveilled to identify any treatment failure and retreated expeditiously.

Animal Magnetism Provides A Sense Of Direction

2008-03-01T06:49:00.000-08:00

They may not be on most people's list of most attractive species, but bats definitely have animal magnetism. Researchers from the Universities of Leeds and Princeton have discovered that bats use a magnetic substance in their body called magnetite as an 'internal compass' to help them navigate.

Dr Richard Holland from Leeds' Faculty of Biological Sciences and Professor Martin Wikelski from Princeton University studied the directions in which different groups of Big Brown bats flew after they had been given different magnetic pulses and released 20km north of their home roost. The findings are published in PLoS ONE.

Dr Holland was part of the team which, in 2006, discovered that bats used the Earth's magnetic field to get around, but until now, how bats were able to sense the field was still unknown. Big Brown bats were put through a magnetic pulse 5000 times stronger than the Earth's magnetic field, but orientated the opposite way(1).

Dr Holland said: "We had three groups of bats. One had undergone the magnetic pulse with a different orientation, and one control group had received no pulse at all. The third group had undergone the pulse, but in the same orientation as the Earth's magnetic field. By including this group, we could easily see if changes in behaviour were the result of confusion caused by the pulse itself rather the impact of its orientation on the magnetite."

The control group made their way home as normal, as did those which had undergone the pulse with the same orientation to the Earth's magnetic field. But of those which had been through the pulse with a different orientation, half went home but half went in the opposite direction.

"This clearly showed that it is the magnetite in their cells which give bats their direction as we were able to change how the bats used it as an internal compass, turning their north into south," says Dr Holland. "But as only half were affected, it's likely there is another mechanism as well, which in some bats enabled them to override the impact of the pulse."

Magnetite is found in the cells of many birds and mammals, including humans, but if we were once able to find our way by an internal compass, it's a skill we appear to have lost long ago.

The researchers were able to conduct their unique experiment by use of radio transmitters on the bats which were monitored from the ground and from a plane to verify the signals were correct. However, this kind of monitoring is limited to short distances, so the team is now in discussions with NASA and ESA about using satellites to help track smaller migratory birds and mammals.

The satellites currently used by scientists can only track larger sea birds over 300g, although 60 per cent of mammals and 80 per cent of birds are below this size. The technology exists to track this size of target, but no satellite has yet been launched.

Dr Holland believes tracking this size of bird or mammal is of key importance. "Birds and mammals carry and spread diseases, such as rabies or bird flu, and plotting their migration and movement can help us predict this spread. Large movements of birds can act as pests in themselves, but other species are scarce and need conservation support. We were only able to make our discovery through studying bats in the wild. But for many creatures, satellite tracking is the only way to study them in their natural habitat to help tackle these issues."

Researcher Finds Not Everyone Can Successfully Learn Through Online Courses, Despite Their Popularity

2008-03-01T06:48:00.000-08:00

Since the 1990s, online courses have provided an opportunity for busy adults to continue their education by completing courses in the comfort of their own homes. However, this may not be the best solution for everyone. A researcher at the University of Missouri has found some students may find success in these types of courses more easily than others.

Shawna L. Strickland, clinical assistant professor in the MU School of Health Professions, studied the demographics and personality types of distance learners.

"Correlations between learning styles and success in distance education have shown to be inconclusive," Strickland said. "However, one common theme reappears: the successful traits of a distance learner are similar to the successful traits of an adult learner in traditional educational settings."

With a mere 30 percent of distance learners actually completing their courses, learning more about the characteristics of these students would help educators structure online courses to be as beneficial as possible. Considering the lack of institutional support and isolation involved in the nature of online courses, success in these courses requires a person that is determined and responsible, Strickland said.

"The success of distance learning is dependent on communication among the learner, his or her peers and the instructor," Strickland said. "To encourage success in distance learning, it is necessary to evaluate each individual's needs on a case-by-case basis."

One trait that aids in distance learning is related to personality type. Strickland found those with quiet, introverted personalities are more likely to feel comfortable with online learning courses. Shy individuals have a tendency to be uninvolved in the typical classroom setting. Online courses allow them to complete work on their own with a degree of anonymity.

"Distance learning allows the learner to overcome traditional barriers to learning such as location, disabilities, time constraints and familial obligations," Strickland said. "However, not every learner will be successful in a distance learning environment."

Launch Of BioMed Central's 'BMC Research Notes' Shines Light On Science's 'Dark Data:' New Venture Ensures A Fuller Scientific Record

2008-03-01T06:47:00.001-08:00

Not all scientific research leads to groundbreaking conclusions. Valuable research data all over the world is hidden away in lab drawers, unexposed to the light of day, and unused by the scientific community. This body of idle knowledge, or "dark data", is now being set free with the launch of BioMed Central's BMC Research Notes.

BMC Research Notes, a new open access journal, is publishing scientifically sound research across all fields of biology and medicine. This enables researchers to publish updates to previous research, software tools and databases, data sets, small-scale clinical studies, and reports of confirmatory or 'negative' results. The liberating of this "dark data" ensures that this important information is published in standard, reusable formats and is fully searchable and easily harvested for reuse by the scientific community.

Exposing this "dark data" to the light will prove hugely significant for encouraging future advances, and will lead to an increased level of data sharing within the scientific community.

Commenting on the launch of BMC Research Notes, Prof Christophe Ampe of the University of Ghent stated "I strongly support the idea of having this type of informative journal for data otherwise lost for the scientific community. In my view the recent trend not to publish negative results may affect the progression of science in the long term. I often wonder how many times negative experiments are duplicated by different research groups?"

BMC Research Notes will provide a home for short publications, case studies, incremental updates to previous work, results of individual experiments and similar materials that currently lack a credible outlet.

In a similar manner to BioMed Central's other innovative journals (such as Biology Direct and the Journal of Medical Case Reports), BMC Research Notes will make vast deposits of data publicly and freely accessible for researchers and general public alike.

Prof Tina Jaskoll from the University of Southern California heralded the establishment of BMC Research Notes stating "This new journal is long overdue and I applaud BioMed Central for launching it".

Genetic Factors In Smoking Also Increase Risk Of Chronic Bronchitis

2008-03-01T06:45:00.001-08:00

Smoking is a known risk factor for respiratory diseases like chronic bronchitis, but genes also play a significant role in its development, according to researchers in Sweden, who studied more than 40,000 Swedish twins to determine the extent to which behavior, environment and genes each play a role ion the development of chronic bronchitis.

"[S]moking behavior has a known genetic component and smoking is a primary risk factor for chronic bronchitis," wrote Jenny Hallberg, of the Department of Public Health Sciences at Karolinska Institutet in Stockholm. Hereditability accounted for 40 percent of the risk for chronic bronchitis, but, interestingly, 14 percent of the genetic risk was also linked to a genetic predisposition to smoke, whether or not the individual actually smoked. Chronic bronchitis along with emphysema account for most cases of chronic obstructive pulmonary disease, or COPD.

The research was published in the first issue for March of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

The researchers analyzed data from the Screening Across Lifespan Twin (SALT) study in Sweden, which surveyed all known living twins in Sweden born in 1958 or earlier. The survey included questions on zygosity whether the twins shared 100 or 50 percent of their genetic material smoking history and a checklist of common diseases. The interview asked specific screening questions designed to determine whether the interviewee had chronic bronchitis.

The investigators used the survey data and statistical modeling to tease apart the genetic and environmental influences that comprise an individual's risk of developing chronic bronchitis: genetic factors, shared environmental factors (i.e., experienced by both twins) and non-shared environmental factors.

"[This] study on the population-based Swedish Twin Registry, showing a genetic effect for the development of chronic bronchitis that does not differ by sex is the first to our knowledge to quantify heritability of the disease," she said.

Because chronic bronchitis had previously been reported to be more prevalent in women than men, the results pointed to a number of intriguing possibilities. "It is possible that women are more prone to report symptoms," remarked Dr. Hallberg. "Or, more likely, this could be an effect of smoking being more harmful for women due to their smaller lungs from start (exposure to cigarette smoke relative to body size)."

Dr. Hallberg cautioned that the finding that the genetic factors that contribute to chronic bronchitis were largely independent of those that contribute to smoking should not be interpreted to mean that smoking has no effect on chronic bronchitis. "Although there was some genetic interplay, it is safe to say that smoking itself, and not the genes that predispose one to smoking, is a larger risk factor in developing chronic bronchitis of environmental exposures primarily smoking than genetic predisposition. This is true of both men and women," said Dr. Hallberg.

The investigators are currently working on a clinical follow-up study that is relating clinical measures of lung function to obstruction. "We believe that it is important to also include testing of lung function to disentangle whether there are genetic differences by sex," said Dr. Hallberg. "There is also data in the literature that social factors have different importance for smoking behavior in men and women. We know much less regarding the genetic influences."

Biomagnetics Developed For Use In New Breast Cancer Test

2008-03-01T06:44:00.002-08:00

A team from UCL has developed a new medical device which will make the early detection of breast cancer more cost effective and easier to administer. The team which won a prestigious Brian Mercer Feasibility Award from the Royal Society yesterday plans to use magnetic nanoparticles and an extremely sensitive magnetometer called the 'HistoMag' to detect cancerous cells in samples of breast tissue.

"Each year 35,000 women are diagnosed with breast cancer in the UK and the testing programme is a massive undertaking," says Professor Quentin Pankhurst of the London Centre for Nanotechnology and the UCL Department of Physics & Astronomy. "Until now, pathologists had to stain tissue samples with brown dyes to help them determine whether they were normal or cancerous. In terms of streamlining the process, the main problem is that all of the results are open to interpretation and each test has to be individually checked by a specialist.

"At UCL we've been working in the relatively new area of biomagnetics to develop a technique which provides more quantitative and reliable results, whilst also enabling pathologists to identify abnormal tissue sections much more quickly.

"Cancerous cells have a protein on their surface called HER2. We use a solution of HER2 antibodies, tagged with magnetic nanoparticles, to stain the tissue sample. Using the HistoMag we can detect the quantity of tagged antibodies which attach themselves to the HER2 protein, which in turn provides us with an accurate picture of the spread of cancerous cells."

By automating the process through which cancerous cells are detected and quantified, HistoMag will not only ease the pressure on pathologists but also help to identify the 15-30% of patients who are likely to benefit from being treated with the drug Herceptin. At a cost of £30,000 per patient per annum it is essential to target Herceptin at those women who will respond positively to it.

The team, led by Professor Pankhurst, is one of only seven groups to receive a Brian Mercer Feasibility Award from the Royal Society this year. The £25,000 award will enable the team to re-engineer the HistoMag, increasing its sensitivity before it goes on to clinical trials. Their goal is to make the device generally available to pathologists in 2010.

The Royal Society Brian Mercer Awards were announced in a ceremony on the 28th February 2008. More information on this and other award schemes may be found on the Royal Society website.

Sex Differences Extend Into The Brain

2008-03-01T06:44:00.001-08:00

What was once speculation is now being confirmed by scientists: the brains of women and men are different in more ways than one.

Discoveries by scientists over the past 10 years have elucidated biological sex differences in brain structure, chemistry and function. "These variations occur throughout the brain, in regions involved in language, memory, emotion, vision, hearing and navigation," explains Larry Cahill, Ph.D., an associate professor in the Department of Neurobiology and Behavior at the University of California, Irvine.

While women and men struggle to communicate with each other and ponder why they don't think and react to things in similar ways, science is proving that the differences in our brains may have more serious implications beyond our everyday social interactions.

Scientists are looking into ways that sex-based brain variations affect the thought processes and behavior of men and women differently. According to Cahill, "their discoveries could point the way to sex-specific therapies for men and women with neurological conditions such as Alzheimer's disease, schizophrenia, depression, addiction and post-traumatic stress disorder."

To better understand the implications of sex differences in the brain, it is important to examine disease entities in depth. Take Alzheimer's disease, for example. Significant differences exist between men and women who suffer from the disease.

"There are growing indications that the disease pathology, and the relationship between pathology and behavioral disturbance, differs significantly between the sexes," Cahill wrote in a paper published in Nature Reviews Neuroscience. Pathology refers to the way a disease develops within the body.

"Let us first consider Alzheimer's disease-related pathology. Alzheimer's disease-related neurofibrillary pathology associated with abnormally phosphorylated tau protein differs in the hypothalamus of men and women: up to 90 percent of older men show this pathology, whereas it is found in only 8-10 percent of age-matched women."

In other words, abnormalities caused by Alzheimer's disease may differ between the sexes and result in different symptoms or behavioral problems for women and men with the disease.

There are several other notable differences in pathology between the sexes in Alzheimer's disease. Gaining a better understanding of the relationship between pathology and how disease presentation affects men and women differently could pave the path for future sex-specific therapies.

Schizophrenia is another disease that affects men and women differently. Differences include age of onset, symptoms and the time course of the disease. In addition, structural brain differences are apparent. According to Cahill, "men with schizophrenia show significantly larger ventricles than do healthy men, whereas no such enlargement is seen in women with schizophrenia."

Researchers do not understand the implications of these differences yet, but the study of sex differences in the brain is advancing quickly. Aiding researchers in their work is a new guidebook for investigating sex differences in the brain. Published by Oxford University Press, "Sex Differences in the Brain: From Genes to Behavior" provides scientists with the basic tools for investigating sex differences in brain and behavior and insight into areas where important progress in understanding physiologically relevant sex differences has already been made.

The book is edited by members of the Society for Women's Health Research's Isis Fund Network on Sex, Gender, Drugs and the Brain.

"Scientific evidence of sex differences in the brain is regularly emerging now," said Sherry Marts, Ph.D., author of the book's preface and vice president of scientific affairs for the Society for Women's Health Research. "This book outlines current knowledge, conceptual approaches, methodological capabilities, and challenges to continued progress. It is an important tool in the quest to turn the science of sex differences into appropriate care for all patients both male and female."

As researchers continue to explain how sex influences brain function, we will see more diagnostic tools and therapies that successfully account for the biological differences between women and men. That will mean better health outcomes for all patients.

Certain Vitamin Supplements May Increase Lung Cancer Risk, Especially In Smokers

2008-03-01T06:42:00.002-08:00

Vitamin supplements do not protect against lung cancer, according to a study of more than 77,000 vitamin users. In fact, some supplements may even increase the risk of developing it.

"Our study of supplemental multivitamins, vitamin C, vitamin E and folate did not show any evidence for a decreased risk of lung cancer," wrote the study's author, Christopher G. Slatore, M.D., of the University of Washington, in Seattle. "Indeed, increasing intake of supplemental vitamin E was associated with a slightly increased risk of lung cancer."

The findings were published in the first issue for March of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine.

Dr. Slatore and colleagues selected a prospective cohort of 77,126 men and women between 50 and 76 years of age in the Washington state VITAL (VITamins And Lifestyle) study, and determined their rate of developing lung cancer over four years with respect to their current and past vitamin usage, smoking, and other demographic and medical characteristics.

Of the original cohort, 521 developed lung cancer, the expected rate for a low-risk cohort such as VITAL. But among those who developed lung cancer, in addition to the unsurprising associations with smoking history, family history, and age, there was a slight but significant association between use of supplemental vitamin E and lung cancer.

"In contrast to the often assumed benefits or at least lack of harm, supplemental vitamin E was associated with a small increased risk of lung cancer," said Dr. Slatore.

When modeled continuously, the increased risk was equivalent to a seven percent rise for every 100 mg/day. "This risk translates into a 28 percent increased risk of lung cancer at a dose of 400 mg/day for ten years," wrote Dr. Slatore. The increased risk was most prominent in current smokers.

The idea that vitamin supplements are healthy, or at the very least, do no harm, comes from the desire of many people to mimic the benefits of a healthy diet with a convenient pill says Tim Byers, M.D., M.P.H., of the University of Colorado School of Medicine in an editorial in the same issue of the journal. However, he points out, "fruits contain not only vitamins but also many hundreds of other phytochemical compounds whose functions are not well understood."

The World Cancer Research Fund and the American Cancer Society recommend two servings of fruit each day, based on a study that previously found a 20 percent increase in cancer risk among people who ate the least amount of fruit. This recommendation "would likely lead to a reduced risk for lung cancer, as well as reduced risk of several other cancers and cardiovascular disease," writes Dr. Byers. "However, any benefit to the population of smokers from increasing fruit intake to reduce cancer risk by 20 percent would be more than offset if even a small proportion of smokers decided to continue tobacco use in favor of such a diet change."

These findings have broad public health implications, given the large population of current and former smokers and the widespread use of vitamin supplements. "Future studies may focus on other components of fruits and vegetables that may explain the decreased risk [of cancer] that has been associated with fruits and vegetables," writes Dr. Slatore. "Meanwhile," he says, "our results should prompt clinicians to counsel patients that these supplements are unlikely to reduce the risk of lung cancer and may be detrimental."

Genetic Variation Associated With Treatment Response In A Clinical Study Of A New Atypical Antipsychotic Fiaptatm (iloperidone)

2008-03-01T06:42:00.001-08:00

A study reported in the journal Pharmacogenomics suggests that a genetic variation in the Ciliary Neurotrophic Factor gene (CNTF) may affect response to antipsychotic treatment. The study, conducted by Vanda Pharmaceuticals Inc., included patients with acute symptoms of schizophrenia who were treated either with Fiapta(TM) (iloperidone), a novel atypical antipsychotic agent currently under review with the FDA, or placebo. Patients were also studied for a genetic variation in the CNTF gene. CNTF is a neurotrophic factor important for neuronal survival and recovery after injury. About 75% of the population carry two intact copies of the CNTF protein while 25% carry one or two truncated copies of the protein.

As previously reported in the clinical study overall, it was shown that Fiapta(TM) was significantly more effective than placebo in treating both the positive and negative symptoms of schizophrenia. In addition, Fiapta(TM) showed significant improvement from baseline in all symptoms across all patient genotypes of CNTF.

In the patient population carrying both intact copies of CNTF (representing 75% of the population), Fiapta(TM) treatment was significantly better than placebo in symptom improvement. In patients carrying at least one truncated copy of the CNTF protein, placebo and Fiapta(TM) treated patients had a significant improvement from baseline indicating an enhanced placebo response among this group of patients.

"This is a pioneering effort in understanding why some people respond to antipsychotic medication and others do not. The results of this prospective study on the genetics of drug response offer tantalizing clues on the involvement of neurotrophic factors in schizophrenia," said Steven G. Potkin, MD, Professor of Psychiatry, Robert R. Sprague Chair in Brain Imaging, and Director, Clinical Psychiatric Research at the University of California, Irvine.

These findings suggest that neurotrophic factors like CNTF and genetic variations within them may play important roles in antipsychotic response and the course of illness of patients with schizophrenia. "This study is an important first step towards understanding the role of genetic variation in antipsychotic treatment response and eventually the introduction of personalized medicine in the treatment of schizophrenia," noted Dr. Anil Malholtra, MD, Director, Division of Psychiatry Research, The Zucker Hillside Hospital.

Endocrine Disrupting Chemicals Cause Wild Birds To Change Their Tune

2008-03-01T06:37:00.000-08:00

Considerable attention has been paid to the effects of endocrine disrupting chemicals in aquatic environments, but rather less attention has been given to routes of contamination on land. A new study, published in PLoS ONE on February 27 by researchers at Cardiff University, reveals that wild birds foraging on invertebrates contaminated with environmental pollutants, show marked changes in both brain and behaviour: male birds exposed to this pollution develop more complex songs, which are actually preferred by the females, even though these same males usually show reduced immune function compared to controls.

Katherine Buchanan and her colleagues studied male European starlings (Sturnus vulgaris) foraging at a sewage treatment works in the south-west UK and analysed the earthworms that constitute their prey. The researchers found that those birds exposed to environmentally-relevant levels of synthetic and natural estrogen mimics developed longer and more complex songs compared to males in a control group.

Specifically, birds dosed with the complete spectrum of endocrine disrupting chemicals found in the invertebrates spent longer singing, sang more often and produced more complex songs, a sexually selected trait important in attracting females for reproduction even though birds dosed at these ecologically relevant levels also showed reduced immune function.

The study also addresses the mechanism for this effect, as the researchers found that the high vocal centre (HVC), the area of the brain that controls male song complexity, is significantly enlarged in the contaminated birds. Estrogen causes masculinisation of the songbird brain and the HVC is enriched with estrogen receptors. Neural development is thus susceptible to exposure to chemicals which mimic estrogen, or to enhanced estrogen levels. The results also confirm the plasticity of the adult songbird brain.

Finally, the scientists found that female starlings prefer the song of males exposed to the mixture of endocrine disrupting chemicals, suggesting the potential for population level effects on reproductive success.

"This is the first evidence that environmental pollutants not only affect, but paradoxically enhance a signal of male quality such as song," said Katherine Buchanan, the corresponding author of the paper. "These results may have consequences of population dynamics of an already declining species."

Baxter Recalls All Heparin Vial Products

2008-02-29T05:43:00.000-08:00

Baxter International Inc announced yesterday, Thursday 28th February, that it was recalling all remaining multi-dose and single-dose heparin sodium and HEP -LOCK heparin flush products now that alternative suppliers are able to meet national demand for them.

Heparin sodium is a vital ingredient in surgical and medical procedures that has been used throughout the US since the 1930s. It is injected into millions of Americans every year to stop potentially fatal blood clots in their veins, arteries and lung. The drug is made from the lining of pig intestines and most of it comes from China.

The announcement was in a statement released by the US Food and Drug Administration on behalf of the drug company.

This follows the recall in January of nine lots of Baxter's heparin sodium injection multi-dose vials as a precautionary measure after hundreds of patients had severe allergic reactions, and also four patients died, after receiving the product. The drug company also stopped making the product pending a fuller investigation.

The FDA has since admitted that a Chinese plant that supplied Baxter with the heparin active ingredient, which is made from pigs' intestines, was not inspected by the agency. The agency said it had confused the supplier with another similarly named Chinese supplier on its database that had already been approved.

The HEP-LOCK heparin flush (used to flush intravenous lines and equipment to prevent blood clots) and single dose heparin sodium vials were not recalled because they had not been linked to the adverse reactions and it was essential to keep supplies of this vital ingredient flowing until the demand could be met by an alternative source.

Baxter produces nearly half the US demand for heparin used in operating rooms, dialysis centers and other critical care areas. Pulling their products before an alternative source was found would have "created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction", said the FDA.

The agency has concluded there is now sufficient capacity from other suppliers and has given Baxter the go ahead to recall its remaining heparin sodium injection and heparin flush products.

According to Sandra Kweder, deputy director of FDA's Center for Drug Evaluation and Research, the only Baxter products that are still on the market use heparin sourced from a different supplier. These products contain heparin in premixed IV solution bags and have not been associated with adverse events.

Exactly how the patients came to have allergic reactions to the affected products is still a mystery. The FDA has sent two officers to China where an initial investigation found problems linked to incomplete removal of impurities, plant conditions and management of waste.

According to the Washington Post, Michael Rogers, director of the FDA's field investigation division, said that while the agency was concerned about what the investigators observed at the plant, it was not linking these concerns to the adverse events associated with Baxter's products.

The full Baxter product recall now comprises:

Heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials.

Heparin sodium injection 5000 units/mL 10mL multi-dose vials.

Heparin sodium injection 10,000 units/mL 4mL multi-dose vials.

Heparin sodium injection 1000 USP units/mL single-dose vials.

Heparin sodium injection 5000 USP units/mL single-dose vials.

Heparin sodium injection 10,000 USP units/mL single-dose vials.

All preserved and preservative-free 10 USP units/mL and 100 USP units/mL vials of HEP-LOCK and HEP-LOCK U/P.

The recall excludes Baxter's bagged heparin pre-mix IV solutions of heparin sodium in 5 per cent dextrose injection and heparin sodium in 0.9 per cent sodium chloride injection, said the company.

President of Baxter's Medication Delivery business, Peter J Arduini said:

"We have assurance from the US Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs."

"The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue," he added.

Increased Lung Cancer Risk Associated With Certain Vitamin Supplements

2008-02-29T05:42:00.000-08:00

A recent study published in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine reports that vitamin supplements do not protect against lung cancer, and may in fact increase the risk of developing it.

Dr. Christopher G. Slatore of the University of Washington and colleagues performed the analysis by selecting a prospective cohort of 77,126 people between 50 and 76 years of age who were all in the Washington State VITAL (VITamins And Lifestyle) program. The researchers analyzed the rate of lung cancer development over four years and how it correlates with current and past vitamin usage, smoking, and other characteristics pertaining to demography and medical history.

Slatore writes, "Our study of supplemental multivitamins, vitamin C, vitamin E and folate did not show any evidence for a decreased risk of lung cancer." In addition, he notes that participants who increased intake of supplemental vitamin E had slightly higher risks of lung cancer.

From the 77,126 people, 521 developed lung cancer; this is in line with the expected rate for this low-risk group. However, those who did develop lung cancer had a slight significant association between lung cancer and supplemental vitamin E in addition to the typical associations with smoking history, family history, and age.

According to the model, a person taking 100 mg/day of vitamin E for ten years increases the risk of lung cancer by seven percent. This is like a 28 percent increase in risk for a 400 mg/day dose for ten years. Slatore notes that this increase in risk was largely confined to current smokers.

Since so many people currently or used to smoke and so many people take vitamin supplements, the study findings can benefit public health. "Future studies may focus on other components of fruits and vegetables that may explain the decreased risk [of cancer] that has been associated with fruits and vegetables," notes Dr. Slatore. "Meanwhile, our results should prompt clinicians to counsel patients that these supplements are unlikely to reduce the risk of lung cancer and may be detrimental."

An editorial in the same journal issue by Dr. Tim Byers of the University of Colorado School of Medicine suggests people want to easily take a pill instead of eating a healthy diet, and this is why they believe that vitamin supplements are healthy or relatively harmless.

However, "fruits contain not only vitamins but also many hundreds of other phytochemical compounds whose functions are not well understood," writes Byers. One study found a 20 percent increase in cancer risk among people who ate the least amount of fruit, and this has led to the World Cancer Research Fund and the American Cancer Society to recommend two fruit servings each day.

Two servings of fruit per day "would likely lead to a reduced risk for lung cancer, as well as reduced risk of several other cancers and cardiovascular disease," writes Dr. Byers. "However, any benefit to the population of smokers from increasing fruit intake to reduce cancer risk by 20 percent would be more than offset if even a small proportion of smokers decided to continue tobacco use in favor of such a diet change."

Eat Your Broccoli, Save Your Bladder

2008-02-29T05:39:00.000-08:00

According to a recent report in the American Association for Cancer Research's journal Cancer Research, receiving a concentrated extract of freeze dried broccoli sprouts reduced the development of animal bladder tumors by more than half.

Researcher Yuesheng Zhang, the study's chief investigator, notes that the finding is in line with previous human epidemiological studies that have shown a relationship between eating cruciferous vegetables and reducing the risk of bladder cancer. Zhang remarks: "Although this is an animal study, it provides potent evidence that eating vegetables is beneficial in bladder cancer prevention."

It is strongly held that cruciferous vegetables are effective tissue protectors partly due to isothyiocyanates (ITCs) - phytochemicals with well-known cancer preventive traits. Cruciferous vegetables such as mature broccoli, cabbage, kale, and collard greens have ITCs. Zhang notes that the bladder is especially sensitive to these natural chemicals: "In our experiments, the broccoli sprout ITCs after oral administration were selectively delivered to the bladder tissues through urinary excretion."

Compared to mature broccoli, broccoli sprouts have about 30 times more ITCs. The extract of broccoli sprouts given to animals in the study contains about 600 times more ITCs than mature broccoli.

High doses of the extract were associated with the greatest protection against bladder cancer development. However, humans who are at an increased risk for the cancer and who seek to receive protective benefits from broccoli most likely would not have to consume copious amounts of broccoli sprouts.

"Epidemiologic studies have shown that dietary ITCs and cruciferous vegetable intake are inversely associated with bladder cancer risk in humans. It is possible that ITC doses much lower than those given to the rats in this study may be adequate for bladder cancer prevention," Zhang said.

The researchers studied five groups of rats in order to test if and how well the sprout concentrate prevents bladder tumors. One group was a control and received nothing, and a second was given only the broccoli extract. These two groups did not present any tumors nor toxicity from the broccoli extract.

Zhang and colleagues gave the remaining three groups a chemical, N-butyl-N-(4-hydroxybutyl) nitrosamine (BBN) in drinking water that stimulates bladder cancer development. Two of the three cancer groups received broccoli extracts two weeks prior to receiving the drinking water with the carcinogenic chemical.

Almost all (96%) of the rats who received only BBN developed an average of two tumors each. Of the rats who received a low dose of broccoli extract, 74% developed cancer - about 1.39 tumors on average.

A high dosage of extract was associated with the least amount of tumors - 38% of this group developed cancer and the average number of tumors per rat was 0.46. The tumors that did develop in these animals were small in size compared to the ones that developed in the other groups.

Peer-Reviewed Science Must Be The Source For Policy Decisions Regarding Drug Harm-Reduction

2008-02-29T05:32:00.000-08:00

The authors of a Reflection and Reaction comment in the March issue of The Lancet Infectious Diseases take a hard line on some health policy research posted on the Internet, especially regarding evidence based drug harm reduction. In particular, they focus on a website posted as the Institute on Global Drug Policy (IGDP) which prevents itself as"an online open access journal," but also happens to be a part of the Drug Free America Foundation, a non-profit organization that supports "efforts to oppose policies based on the concept of harm reduction."According to the authors, politicians must beware the misleading intentions of sites such as this one to prevent making improperly informed decisions about health policy.

Harm-reduction programs attempt to address the issues related to illegal drugs by means other than total abstinence, such as needle exchanges. According to the authors, Drs Evan Wood, Julio Montaner, and Thomas Kerr, British Columbia Centre for Excellence in HIV/AIDS, St Paul's Hospital, and Department of Medicine, University of British Columbia, Vancouver, Canada, there is indeed a formidable (and expanding) mass of evidence that these harm reduction measures are beneficial. However, groups such as IGDP have focused their efforts in agains this effort, including the above mentioned website, which claims to exist for the dissemination of "opinion essays."

The authors say that this has influenced Canada's health policy already: "The DFAF seems to have had some recent success with this approach. In an apparent effort to persuade Canada's Prime Minister Stephen Harper that his government should withdraw support from North America's first medically supervised injecting facility (SIF) in Vancouver, the website recently published a critique of the SIF...The website has also posted a range of articles against needle exchange and other evidence based harm reduction programmes. The conclusions of the needle exchange articles clearly contradict scientific consensus documents, such as a recent report by the US Institute of Medicine."

Since these IGDP articles were published online, Canada's new federal government announced a new anti-drug strategy that increases law enforement efforts while perhaps endangering the future of the Vancouver SIF. According to the authors, it is troubling that Canada's federal health minister recently publicly referred to the IGDP report while claiming there is "growing debate" about SIF, despite all studies in conventional scientific publications indicating multiple benefits with negligible negative effects.

The authors conclude, attempting to analyze the public popularity of such actions. "It remains to be seen whether what has been described as the Canadian federal government's new 'ideological' opposition to harm reduction will win them votes. Unlike in the USA, where surveys suggest the public supports the country's 'war on drugs', recent surveys in Canada suggest that the Canadian public is catching up to science when is comes to support for harm reduction programmes. Although the Canadian public may be gaining wisdom, advancing evidence-based public health will now require that politicians are able to tell the difference between valid peer-reviewed science and essays posted on the websites of lobby groups."

Dietitians Top 10 List For A Healthier You… What You Need To Know…

2008-02-29T05:31:00.000-08:00

March is National Nutrition Month(R). As the organization bringing you National Nutrition Month(R), this year, Dietitians of Canada shines the spotlight on food and nutrition and offers their Top 10 List for a Healthier You. It's what Canadians need to know to take action to eating healthier, being more active and feeling great.

Confused about… what is a healthy weight for you? what is a portion size? how to read the Nutrition Facts panel on packaged food to make the best choice? or, which vegetables and fruits have the most antioxidants? The Dietitians Top 10 List can guide you down the road to good health.

"There's lots of advice in the market place and in the media about nutrition and health," says Mary Sue Waisman, registered dietitian and official spokesperson for DC's National Nutrition Month®. "When it comes to making wise food choices, get your advice from the most trusted source - a registered dietitian," adds Waisman. "Dietitians across Canada have weighed the evidence and identified 10 key steps to tune up Canadians' eating habits and reduce their risk of developing chronic diseases, added Ms. Waisman. "Take the Dietitians of Canada challenge for making 10 positive changes to eating and activity habits - at home, at school, at work and at play."

The goal this year is to help Canadians discover practical solutions to eat well and live well. Throughout March, dietitians in your community will be engaging people in healthy eating activities. Watch for grocery store tours to help consumers decipher nutrition labels and dietitians hosting discussions and providing presentations on how to help family members eat healthier.

Make National Nutrition Month® the time to get on the right track with healthy eating and active living. Start by making the Dietitians of Canada website http://www.dietitians.ca/eatwell your 'go to' place for trusted nutrition information and for fun and healthy eating ideas. Talk to a registered dietitian and together develop a personal plan that meets your needs, preferences and lifestyle. To find a registered dietitian in your area, visit http://www.dietitians.ca/find.

Dietitians of Canada's website offers a number of resources with practical food solutions to help consumers make healthier food choices. At http://www.dietitians.ca/eatwell, consumers can assess their food choices, based on Canada's Food Guide, through the interactive tool EATracker. It provides personalized feedback on the total intake of energy and essential nutrients and compares this to what is recommended for age, gender and activity level. Consumers can create a one-day menu with Let's Make a Meal! and analyze their favourite recipes with the Recipe Analyzer.

Dietitians of Canada represents and supports almost 6000 dietitians across Canada and has led the National Nutrition Month® Campaign for over 27 years.

Dietitians of Canada acknowledges its food industry partners who help to bring National Nutrition Month® messages to Canadians. This year's sponsors are: Eurest - Chartwells -Morrison members of Compass Group Canada, Dairy Farmers of Canada and General Mills Canada Corporation.

School Nutrition Experts Call For Child Nutrition Funding And Uniform Nutrition Standards

2008-02-29T05:11:00.000-08:00

Early next month, more than 700 school nutrition professionals will discuss the crisis in funding for school meal programs and urge the Congress to require science-based, yet practical, uniform national school nutrition standards to govern the sale of all foods and beverages available during the school day. The School Nutrition Association's (SNA) 36th annual Legislative Action Conference in Washington, DC, March 2-5, 2008, will bring together school nutrition directors and supervisors, nutritionists, state child nutrition directors and foodservice industry representatives.

The emphasis on nutrition standards will build from efforts related to the drafting of the Farm Bill last year. This year however, as the national economic picture becomes more uncertain, school nutrition professionals will also provide lawmakers with the facts on school meal costs. The child nutrition programs are both under pressure to serve nutritious meals to more low-income children while being pinched by increased food, labor and milk costs.

"The federal government currently reimburses schools $2.47 for each balanced, healthy meal provided to children from families making 130% of poverty or less. A latte costs more. This is not adequate to cover the cost of producing a school meal," said Mary Hill SNS, president of SNA. The costs of food, transportation, labor and benefits, training, equipment and indirect expenses, are all increasing rapidly and meal charges as well as federal, state and local financial support for the child nutrition programs have not kept pace.

The key legislative issues the School Nutrition Association (SNA) is advocating for this year are:

- Giving the Secretary of Agriculture the authority to regulate and enforce the sale of food and beverages outside of the cafeteria.

- Requiring all a la carte and competitive food sales to be consistent with the Dietary Guidelines, as is required for school meals.

- Requiring national uniformity for the school meal pattern throughout the country. Children in all states and local districts need the same nutrients to grow and be healthy. The current lack of uniformity is increasing the cost of the programs.

- In the face of record food, labor and milk process, calling for adequate funding to support healthful meals being offered through school nutrition programs.

Activities of the 36th Annual Legislative Action Conference at the J.W. Marriot Hotel in Washington, DC will also include:

- Senate Agriculture, Nutrition and Forestry Committee Chair Tom Harkin (D-Iowa) and Ranking Member Saxby Chambliss (R-Ga.) as well as House Agriculture Committee Chair Colin Peterson (D-Minn.) Noted political commentator Amy Walter will give the opening keynote address.

- Panel discussions will include SNA's 2008 legislative priorities, perspectives on the need for national nutrition standards, the school nutrition funding crisis and an update on child nutrition activities from the USDA.

- SNA members will take their message to Capitol Hill, sharing the nutritional value of school meals and the need for key policy changes with members of Congress on March 4, 2007.

- On Tuesday, March 4, 2007, SNA president Mary Hill, SNS is scheduled to testify at a hearing held by the House Committee on Education and Labor.

- The Global Child Nutrition Foundation and SNA will honor the Executive Director of the Congressional Hunger Center Ed Cooney with the 2008 Gene White Lifetime Achievement Award at the "A Possible Dream Gala" on Tuesday evening, March 4, at the Ronald Reagan Building and International Trade Center. Other award recipients will be Geri Dee, SNS, 2007 Outstanding School Nutrition Director of the Year and Mimi Ford 2007 Individual Industry Member of the Year. Proceeds from the evening will benefit the Global Child Nutrition Foundation's initiatives to promote sustainable school feeding programs worldwide.

The School Nutrition Association is a national, non-profit professional organization representing more than 55,000 members who provide high-quality, low-cost meals to students across the country. The Association and its members are dedicated to feeding children safe and nutritious meals. SNA is the only association devoted exclusively to protecting and enhancing children's health and well being through school meals and sound nutrition education.

Wonderful Variety Of Pomegranate Juice Is The Leader In Healthy Beverages

2008-02-29T05:07:00.000-08:00

A recent study published in the Journal of Agriculture and Food Chemistry found that pomegranate juice from the California-grown Wonderful variety of pomegranate is the leader in the healthy beverage category by demonstrating the most complete free radical scavenging activity, greater protection of LDL-cholesterol from oxidation, and the highest polyphenol content compared to red wine and several juices.

The study, led by Dr. David Heber at the Center for Human Nutrition, David Geffen School of Medicine, University of California Los Angeles, found that POM Wonderful 100% Pomegranate Juice tested higher in overall phenolic content and antioxidant activity than red wine and Concord grape, blueberry and orange juices. POM Wonderful 100% Pomegranate Juice even ranked higher than other beverages that have recently been touted as containing superior levels of antioxidants such as acai juice and white and green teas. Unlike all previous studies that only included one test against these other types of beverages, this Heber study conducted a series of seven tests on all the beverages, resulting in a novel and more accurate methodology.

"Often times, a beverage will make a claim about its superior antioxidant content based on the results of one test alone that provides the highest antioxidant capacity," said Dr. Heber. "What is important about this study is that all the beverages included were run against several tests resulting in a more complete assessment of a beverage's antioxidant activity and capability."

Results of the study showed that POM Wonderful 100% Pomegranate Juice had the greatest range of free radical fighting ability. The antioxidant potency composite index was at least 20% greater than any other beverage included in the study. To determine overall antioxidant content and functionality, each of the polyphenol-rich beverages included in the study were run against four tests for antioxidant potency.* In addition, all beverages were tested for their ability to inhibit LDL oxidation and evaluated for total polyphenol content.

POM Wonderful 100% Pomegranate Juice is the only pomegranate juice backed by $23 million in medical research. Over the last decade, 10 medical research studies have been published in peer-reviewed journals documenting the beneficial effects of POM Wonderful 100% Pomegranate Juice on human health, particularly in regards to heart disease, prostate cancer and erectile dysfunction. Through its proprietary juicing technology, POM Wonderful is the only company able to extract the full benefits of polyphenol antioxidants and guarantee its juice is 100% authentic pomegranate juice derived from its California-grown Wonderful variety of pomegranate.

For more information regarding the health benefits of POM Wonderful 100% Pomegranate Juice, visit http://www.pomegranatetruth.com/.

About POM Wonderful

POM Wonderful is the largest producer of California Wonderful pomegranates and the company exclusively grows and sells this variety. The company also juices its fresh pomegranates to make its delicious, all-natural, POM Wonderful Pomegranate Juice and POMx, a highly-concentrated, incredibly powerful blend of all-natural polyphenol antioxidants harnessed from the pomegranate by a patent-pending process. POMx is available exclusively in POM Tea, Light POM Tea, POMx Pills® and POMx Liquid. ® POM Wonderful Pomegranate Juice, POM Tea and Light POM Tea are available year-round at retail and are found in the refrigerated section of supermarkets and grocery stores nationwide. POMx Pills and POMx liquid are available at http://www.pompills.com/. To learn more, visit http://www.pomwonderful.com/.

* Antioxidant potency tests include Tolox equivalent antioxidant capacity (TEAC), total oxygen radical absorbance capacity (ORAC), free radical scavenging capacity by 2, 2-diphenyl-1-picrylhydrazyl (DPPH) and ferric reducing antioxidant power (FRAP).

UNAIDS Welcomes United States Congressional Action To Renew Its Global AIDS Programme

2008-02-29T05:01:00.000-08:00

The Joint United Nations Programme on HIV/AIDS welcomes the news that the United States House of Representatives Committee on Foreign Affairs has approved the "Tom Lantos and Henry J. Hyde Global Leadership on HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008." This action sends a strong signal that the United States is committed to maintaining its leadership role in the global response to AIDS.

UNAIDS also welcomes news that the reauthorization includes the key principles of promoting a truly global effort supported by bold new investments; moving from an "emergency" to a "sustainability" strategy; and maximizing effectiveness of investments through partnership and coordination.

Past and current investments are working. For example, more than 2.5 million people have access to HIV treatment with new encouraging data expected soon. HIV prevalence among young pregnant women (15-24) attending antenatal clinics has declined since 2000/2001 in 11 of the 15 most affected countries. New HIV infections can be prevented if the world remains committed to scaling up essential HIV prevention, treatment, care, and support efforts globally.

With more than 32 million people infected with HIV worldwide, the global commitment to AIDS has never been more important. UNAIDS is pleased with the bipartisan vote in the committee and hopes the US Congress maintains the momentum to move this legislation forward.

UNAIDS is an innovative joint venture of the United Nations, bringing together the efforts and resources of the UNAIDS Secretariat and ten UN system organizations in the AIDS response. The Secretariat headquarters is in Geneva, Switzerland-with staff on the ground in more than 80 countries. Coherent action on AIDS by the UN system is coordinated in countries through UN theme groups, and joint programmes on AIDS. UNAIDS' Cosponsors include UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, ILO, UNESCO, WHO and the World Bank.

Mysteries Of Vitamin A Metabolism During Embryonic Development Unlocked By Rutgers Researchers

2008-02-29T05:00:00.000-08:00

Researchers at Rutgers have unlocked some of the mysteries of how the developing embryo reacts to fluctuations in the amount of vitamin A present in the maternal blood stream. Their results are presented in the February 28 issue of the Journal of Biological Chemistry.

The researchers studied the role of LRAT, a protein that facilitates the formation of vitamin A stores in the body, during embryonic development. In particular, they showed how LRAT protects developing tissues from potentially toxic levels of vitamin A that have been ingested by the mother. Although this function of LRAT had previously been hypothesized in adults, this is the first time that its role has been demonstrated during embryonic development.

The developing mammalian embryo is entirely dependent on the maternal circulation for its supply of retinoids, the vitamin A metabolites produced in the body. These are essential nutrients and they control the formation of the embryo's heart, central nervous system, eyes and other important organs and tissues. Malformations of the developing embryo can occur when too little, or too much, vitamin A is consumed by the mother.

"We were looking for the mechanisms that allow the fetus to maintain adequate amount of retinoids, whether the mother has over- or under-consumed vitamin A," said Dr. Loredana Quadro, an assistant professor in the Department of Food Science and member of the Center for Lipid Research at the Rutgers School of Environmental and Biological Sciences. "We also looked at the effects of different levels of vitamin A being transferred from the mother to the fetus."

When vitamin A is ingested, it is converted into retinyl ester (RE) in the intestine from where it is secreted in the bloodstream packaged with other dietary lipids into lipoprotein particles called chylomicrons. The majority of dietary RE reaches the liver, the main body storage site of vitamin A. Under insufficient dietary vitamin A intake, the liver transforms RE into retinol (ROH), which is then secreted into the bloodstream bound to retinol-binding protein (RBP), its sole specific serum carrier, to be delivered to the target tissues. Upon intake through a specific membrane receptor named Stra6, ROH is ultimately converted to retinoic acid (RA), which is the active form of vitamin A. If tissue RA is in excess, it is transformed into inactive forms, such as 4-hydroxy retinoic acid or 4-oxo retinoic acid (OXO-RA) by the action of a specific enzyme named Cyp26A1.

"When we think about vitamin A, we think about one compound," said Quadro. "But in reality, the term vitamin A comprises a family of different compounds. Each one has a slightly different action, and plays a different role."

The Rutgers researchers took a closer look at how ROH is metabolized into RE and RA to maintain an optimal balance of retinoids during the formation of the embryo. Mutant mice lacking both RBP and LRAT were generated to perform this study, so as to interfere with the two main pathways of maternal vitamin A delivery to the fetus (ROH-RBP from the liver stores and RE of dietary origin).

"We hypothesized that the lack of ROH-RBP and LRAT would make the embryo more vulnerable to changes in maternal dietary vitamin A intake," said Quadro "and our data proved this to be correct. Indeed, a severe embryonic vitamin A deficiency is readily attainable when the mothers are deprived of dietary vitamin A during pregnancy. Therefore, this strain turned out to be a very good model to study how embryonic development is affected by fluctuations in the amount of retinoids present in the maternal diet and hence in the maternal circulation".

The researchers identified LRAT, Cyp26A1 and Stra6 as the three key molecular players that act in coordination to protect the developing tissues from potentially detrimental levels of vitamin A ingested by the mother. "Understanding vitamin A metabolism in the developing fetus could have broad implications," said Quadro. "Consumption of large doses of dietary supplements and vitamins, including vitamin A, has become a very common practice in recent years, generating the necessity to investigate the effects of high doses of vitamin A intake at different stages of the lifecycle, including pregnancy and development. These studies expand our knowledge of maternal-fetal nutrition and dietary contribution to embryonic development and may ultimately provide new insight into appropriate dietary practices during pregnancy."

This research was lead by Quadro and carried out primarily by her lab members, Youn-Kyung Kim, a graduate assistant, and Dr. Lesley Wassef, a post-doctoral associate. Others contributing to the study were Leora Hamberger, a former research assistant in Quadro's laboratory, Dr. William Blaner and Roseann Piantedosi from Columbia University and Dr. Krzysztof Palczewski from Case Western Reserve.

Efforts To Fix Or Kill Lung Cancer Cells Thwarted By Protein

2008-02-29T04:53:00.000-08:00

A protein that helps lung cancer cells thrive appears to do so by blocking healthy cells' ability to fix themselves when radiation or chemicals, such as nicotine, damage their DNA, according to a University of Florida study to be published Friday (Feb. 29) in the journal Molecular Cell.

High levels of the protein, known as Bc12, are found in the cells of lung cancer patients who smoke.

Previous UF research has shown that nicotine activates the protein, which helps tumor cells live long past their natural lifespan and resist chemotherapy. The new findings explain how the protein enables cancer cells to circumvent the body's own efforts to change them back into healthy cells -- or evade treatments designed to kill them.

Cancer is frequently associated with the accumulation of genetic aberrations in cells' chromosomes. If these damaged cells can't access their built-in repair system and subsequently survive long enough to divide and multiply, they pass along their mutations.

"If a cell experiences DNA damage, often that DNA can be repaired. But we found that Bc12 can block the DNA repair mechanism, which promotes tumor formation and genetic instability," said Dr. Xingming Deng, an assistant professor in UF's College of Medicine who is affiliated with the UF Shands Cancer Center. "This is a very important fundamental mechanism that explains why this protein has (a cancer-forming) function."

Researchers say just one cell that develops a genetic mutation and is unable to repair itself could be enough for a full-blown tumor to develop.

"Lung cancer is the No. 1 killer of all cancer types; it is the most dangerous," Deng said. "We wanted to find a way to treat lung cancer, how to prevent lung cancer, because lung cancer prognosis is very poor."

Nearly 162,000 people will die from lung cancer in 2008, accounting for about 29 percent of all cancer deaths, according to the American Cancer Society. More people die of lung cancer than of colon, breast and prostate cancers combined.

In the study, UF scientists performed a series of laboratory experiments on lung cancer cells in culture that illuminated the molecular chain of events that allows Bc12 to disrupt DNA repair.

Deng also plans to explore the possibility that nicotine-induced activation of Bc12 can be blocked to increase chemotherapy's effectiveness.

"This will probably help us in the future find ways to prevent tumors," said Deng, adding that the protein could be a target for drug development. "We can target this mechanism and somehow find a way to prevent tumor formation."

he research was funded by about $1.2 million in grants from the National Institutes of Health and the Flight Attendant Medical Research Institute. FAMRI was established in 1997 as a result of a $300 million settlement between airline flight attendants and the tobacco industry. The nonprofit organization awards grants for research focusing on smoking-related illnesses.

Give Flu Shots To All Kids Says CDC Panel

2008-02-28T06:25:00.001-08:00

A panel of experts that advises the US Centers for Disease Control and Prevention (CDC) recommends all American children over 6 months be vaccinated against seasonal flu, starting as soon as possible but perhaps more feasibly in the 2008-09 flu season because most doctors will have ordered all their flu shots for the current season.

The CDC does not have to follow the recommendation of its Advisory Committee on Immunization Practices but it usually does. The panel met yesterday, Wednesday 27th February, in Atlanta, Georgia, and voted unanimously in favour of the recommendation.

The current CDC recommendation is for vaccination of children between 6 months and 5 years old. This new recommendation, if adopted, will extend to all children between the age of 6 months and 18 years old.

This move adds about 30 million children to the flu vaccination list across the country, said CDC Curtis Allen to the press. Although there are nearly 60 million children aged 5 to 18 in the US, a lot of them are already covered under current recommendations, he said in a telephone interview with Reuters.

The CDC predicts the actual number that will get the vaccination will be around 7 million, based on current take up rates.

Between 5 and 20 per cent of the US population get the flu every year, and the disease kills about 36,000 people across the country every year, most of them elderly, but some healthy children too.

The 26 US states monitored by the CDC lost 68 children to the flu last year, half of whom were school age. 22 children have died so far this year, said the Los Angeles Times.

More than two thirds of Americans should have the flu shot every year, but most of them don't know this, said the CDC. This new recommendation makes it clear that all children should be vaccinated, said the panel.

According to a Bloomberg news report, pediatrics professor at Oklahoma State University, Stanley Grogg, told the panel just before it voted that the previous situation was too complicated, resulting in too many vulnerable unvaccinated children. It is much easier to remember a blanket recommendation for all children up to the age of 18, "than jumps along the way", he said.

It will not be mandatory for every child to have the flu shot, which is also available as a nasal spray, but the CDC's declaration will make it more likely that doctors will store and offer the vaccine.

Director of the CDC's National Center for Immunization and Respiratory Diseases, Dr Anne Schuchat, told the media:

"This new recommendation will help parents understand that all children can benefit from vaccination."

CDC approval means flu vaccinations will most likely be covered by insurance. The government insurance scheme for children, for example, covers about 45 per cent of American children, said the Los Angeles Times.

The CDC referred to a study on flu vaccination among children aged from 6 to 23 months that showed full vaccination (two shots) reduced hospital stays due to flu by around 75 per cent between 2005 to 2007, and partial vaccination (one shot) had a similar result.

Gary Stein of Families Fighting Flu, who lost his 4 year old daughter, Jessica, to the flu in 2002, spoke at the advisory meeting. He said afterwards they were "very pleased" with the panel's decision. He told Reuters that:

"Doctors follow these recommendations in advising their patients."

"Parents read it, and vaccination rates are so low that this awareness strongly follows the guidance," he added.

Health officials are hoping the new recommendation, if adopted, will also help to restore public confidence in flu vaccination. The flu shots this year have not been as good a match as usual to the types of flu viruses that are circulating. Out of the last 19 years, this has happened 3 times.

Corn Genome Unravelled

2008-02-28T06:19:00.002-08:00

A group of scientists have completed a working draft of the genome sequence of corn, also known as maize, a widely grown crop that is vital to US agriculture. They hope the unravelling of this genome will speed up the development of better crop varieties to meet growing demand for food, animal feed and fuel.

The team, led by Dr Richard K Wilson, director of Washington University's Genome Sequencing Center in St Louis, Missouri, will reveal its work today, Thursday 28th February, at the 50th Annual Maize Genetics Conference in Washington, DC.

The draft includes about 95 per cent of the corn genome. Wilson and colleagues hope to complete the rest by the end of the year.

"Although it's still missing a few bits, the draft genome sequence is empowering," said Wilson.

"Virtually all the information is there, and while we may make some small modifications to the genetic sequence, we don't expect major changes," he added.

Maize, or corn, is an underlying foodstuff used in the manufacture of a wide variety of foods and other products, from the more familiar breakfast cereal to ethanol, shoe polish and toothpaste. It is also a vital food for cattle and other animals.

Wilson said that this first draft is "exciting" because:

"It's the first comprehensive glimpse at the blueprint for the corn plant."

"Scientists now will be able to accurately and efficiently probe the corn genome to find ways to improve breeding and subsequently increase crop yields and resistance to drought and disease," he added.

There are 2 billion DNA nucleotide bases in the corn genome, making it about the same size as the human genome. This is significantly larger than the rice genome which has about 430 million bases.

A DNA nucleotide base is a chemical building block of which there are four kinds, each represented by a letter: A for adenine, G for guanine, C for cytosine, and T for thymine.

The hardest part of the work Wilson and colleagues faced was to get the order of the bases right. About 80 per cent of the DNA sequence is repeated, and corn has 50,000 to 60,000 genes, about twice as many as humans. Many of these genes are mobile (transposons), making them much more difficult to "count" compared to the stationary ones.

Genes are large groups of nucleotide pairs that either code for a type of protein or cell component, or regulate the expression of other genes. An organism's complexity does not depend on the number of genes in its genome. And some genes have sequences in common with other genes. The concept of a gene is not fixed and still changing as scientists discover more about them.

Wilson explained that the task of sequencing the corn genome was:

"Like putting together a 1,000 piece jigsaw puzzle with lots of blue sky and blue water, with only a few small sailboats on the horizon."

"There were not a lot of landmarks to help us fit the pieces of the genome together," he added.

Other cereal crops could also benefit from this research, not just other varieties of corn, but also rice, wheat and barely, and other applications.

The research project, backed by the National Science Foundation (NSF), the US Department of Agriculture and the US Department of Energy, with a budget of nearly 30 million dollars, started in 2005.

NSF director Arden L Bement Jr stressed the importance of corn as "one of the most economically important crops for our nation".

"Completing this draft sequence of the corn genome constitutes a significant scientific advance and will foster growth of the agricultural community and the economy as a whole," he said.

The rest of the team includes scientists from the University of Arizona in Tucson, Cold Spring Harbor Laboratory in New York and Iowa State University.

Wilson and colleagues have been sharing the sequencing information they have unravelled through the online public DNA database, GenBank and maizesequence.org.

The precise variety of corn that Wilson and colleagues have been studying is called B73, which was developed at Iowa State University several decades ago. B73 is known for its high yield and is widely used for commercial breeding of corn and also for research.

Plant biologist Dr Ralph S. Quatrano, who is Spencer T Olin Professor and chair of Washington University's Department of Biology spoke of the range of applications of this discovery:

"The genome will help unravel the basic biology of corn. That information can be used to look for genes that make corn more nutritious or more efficient for ethanol production, for example."

The genome sequence of rice has already been unravelled, so sequencing a second grain crop will help scientists to find the genetic similarities and differences between them, said Quatrano.

Project collaborator Dr Rob Martienssen of Cold Spring Harbor Laboratory, was also enthusiastic about this:

"The maize genome sequence will be of great interest to maize geneticists and biologists around the world, but also will be an important resource for plant breeding and biotechnology companies."

"The maize sequence will be an invaluable reference for research, especially in renewable energy and biofuels, similar in significance to the human genome sequence for biomedical research," added Martienssen.

Over 40 per cent of the world's corn is produced in the US, where a record 13.1 billion bushels were grown in 2007, representing a 25 per cent increase on 2006, according to the US Department of Agriculture.

Antibiotic Resistant E. Coli Could Soon Become Prevalent, Similar To MRSA

2008-02-28T06:19:00.001-08:00

It is possible that hospital types of antibiotic resistant Escherichia coli (E. coli) bacteria may soon infect patients in community settings. This would be a situation similar to that of community-acquired meticillin-resistant Staphylococcus aureus (MRSA), according to a Review published in March in The Lancet Infectious Diseases.

Often, these E. coli infections manifest themselves as urinary tract infections. Recent reports have also described antibiotic resistant E. coli strains in bloodstream infections. The authors of the report, Dr Johann Pitout, Calgary Laboratory Services, Calgary, and University of Calgary, Alberta, Canada and Dr Kevin Laupland, University of Calgary, Alberta, Canada, state that the antibiotic resistant E. coli bacteria that cause these infections should be identified soon to prevent their transmission and help select more effective antibiotics.

This Review focused on types of E. coli that produce β-lactamases -- these enzymes help give E. coli their antibiotic resistance. Notably, many surveys since 2000 from various European countries (including UK, Spain, Italy, Greece, and Canada) have shown a trend of resistance to various antibiotics in E. coli. According to the authors, "Infection control practitioners and clinicians need the clinical laboratory to rapidly identify and characterize different types of resistant bacteria efficiently to minimize the spread of these bacteria and help select more appropriate antibiotics...these bacteria have become widely prevalent in the community setting in certain areas of the world and they are most likely being imported into the hospital setting."

They recommend that funding be directed internationally to follow and monitor the propagation of these resistant E. coli in hospital and community settings. Their conclusion is that the risk of bloodstream infections in the community caused by this bacteria, while currently low, may in the future become a regular clinical problem, especially in the β-lactamase producing E. coli. These infections are currently rare, but it is possible that, in the near future, clinicians will be regularly confronted with hospital types of bacteria causing infections in patients from the community, a scenario very similar to that of community-acquired MRSA."

House Foreign Affairs Committee, White House Meet To Discuss Global AIDS Program Bill

2008-02-28T06:15:00.002-08:00

House Foreign Affairs Committee members and White House officials met on Tuesday and agreed on a compromise draft bill to reauthorize the U.S. global HIV/AIDS plan, CQ Politics reports. Under the compromise bill, $50 billion would be allocated for the President's Emergency Plan for AIDS Relief over the next five years -- an increase from the $30 billion the President had previously called for. The new draft, like an earlier version, would remove a controversial provision that requires one-third of HIV prevention funding be spent on abstinence-only education, according to CQ Politics.

Although the compromise measure moves away from the explicit abstinence-only earmark, it calls for "balanced funding" for prevention programs in target countries, including all elements of the ABC approach to HIV prevention -- which stands for abstinence, be faithful and use condoms.

According to CQ Politics, the compromise draft bill also would retain the so-called "anti-prostitution" pledge that an earlier version of the bill had dropped. The compromise bill also would allow funding for HIV testing and education in family planning clinics, but language was dropped from an earlier draft of the bill that would have authorized the use of PEPFAR funds to support contraceptive activities in the context of HIV/AIDS programming. The move to integrate services between HIV/AIDS services and reproductive health groups on the ground has long been sought by Democrats and their allies in the family planning and public health community (Graham-Silverman, CQ Politics, 2/27).

The House Foreign Affairs Committee is scheduled to consider the compromise bill today (CQ Politics, 2/27).

Comments

The Tuesday meeting was the first time that House Foreign Affairs Committee members and White House officials met to discuss the draft bill. Acting committee Chair Howard Berman (D-Calif.) "appeared ready" to move forward with negotiations, CQ Today reports. "I very much want it to be bipartisan, but I also want the program to be effective," Berman said on Tuesday, adding, "Effectiveness is the key."

Democratic committee spokesperson Lynne Weil said it is "very encouraging that the White House and the minority staff finally came to the table on this bill." Bill O'Keefe, senior director for advocacy at Catholic Relief Services, said, "They're all good people who want desperately to preserve the program, and they don't want to do anything to jeopardize what is possibly the most successful U.S. policy venture in the last eight years."

However, some groups have said that a compromise on the reauthorization bill "would be a disappointment" and that a "harsh debate was inevitable," according to CQ Today. "There's nothing about offering contraception to women that isn't going to be turned into something about abortion," Jodi Jacobson, director of advocacy at the American Jewish World Service, said (Graham-Silverman, CQ Today, 2/26).

NPR's "Morning Edition" on Wednesday reported on the PEPFAR bill (Wilson, "Morning Edition," NPR, 2/27). Audio of the segment is available online.

Congressional Democrats Might Use Budget Reconciliation Process To Pass Medicare Bill

2008-02-28T06:15:00.001-08:00

Leaders of the House and Senate Budget committees on Tuesday said that they might use the fiscal year 2009 budget reconciliation process to pass a Medicare bill with a provision to prevent a scheduled 10% reduction in physician reimbursements, CQ Today reports. According to CQ Today, use of the budget reconciliation process, which allows legislation to move through the Senate without the threat of a filibuster, is an "attractive option for Democrats who have watched Senate Republicans halt many of their priorities over the past year."

Senate Budget Committee Chair Kent Conrad (D-N.D.) and House Budget Committee Chair John Spratt (D-S.C.) said that they likely will make a decision about whether to use the budget reconciliation process early in the week of March 3 (Clarke, CQ Today, 2/26). Debate on the budget resolution will begin on the Senate floor during the week of March 10 (Johnson, CongressDaily, 2/26).

Senate Finance Committee Chair Max Baucus (D-Mont.) seeks to delay the scheduled reduction in physician reimbursements for 18 months -- a proposal that would cost between $12 billion and $15 billion over five years -- as part of the Medicare bill (Johnson/Cohn, CongressDaily, 2/26). In December 2007, Congress passed legislation that delayed the reduction, previously scheduled to take effect on Jan. 1, for six months (CQ Today, 2/26). Baucus also seeks to expand low-income subsidies for the prescription drug benefit and rural subsidies as part of the Medicare bill.

According to analysts, the Medicare legislation could cost more than $20 billion over five years. "Offsetting that proposal will require Democrats to trim areas that are unacceptable to Republicans, such as private Medicare Advantage plans," CongressDaily reports. Baucus said that "Medicare Advantage is certainly on the table" as a possible source for offsets, as well as individual health care providers and medical education programs (Johnson/Cohn, CongressDaily, 2/26). Republican Response
Senate Budget Committee ranking member Judd Gregg (R-N.H.) on Tuesday criticized the possible use of the budget reconciliation process to pass a Medicare bill. He said Democrats "learned last year that they can use reconciliation as a protection to expand spending in the federal government. I suspect they are going to do that again." He added, "I don't think there is any question they intend to use Medicare Advantage to continue to fund new initiatives" (Johnson, CongressDaily, 2/26).

Senate Minority Whip Jon Kyl (R-Ariz.) said, "In the past we've always used reconciliation to pull back on mandatory spending, reduce taxes, and it certainly is not designed to enable the Congress to spend more money," adding, "And if that's the way it's used, then I think you'll see Republicans resisting very strongly" (Johnson/Cohn, CongressDaily, 2/26).

Opinion Pieces Address Issues Related To Health Care Reform

2008-02-28T06:14:00.000-08:00

Summaries of two recent opinion pieces about issues related to health care reform appear below.

Joseph Dorsey/Donald Berwick, Boston Globe: "The closest you can come to heresy in today's health care policy debate is to suggest that managed care can help and that capitation is the best way to pay for it," Dorsey, former medical director at Harvard Pilgrim Health Care, and Berwick, president and CEO of the Institute for Healthcare Improvement, write in a Globe opinion piece. According to the authors -- who both practiced medicine within a managed care system under the Harvard Community Health Plan -- managed health care "was a great idea when it first emerged, before the term got hijacked by insurance companies that claimed to manage care but in many cases only managed money." They add that, in managed care, details "matter -- a strong focus on patient satisfaction, compensation and incentives, sound leadership, transparent and sophisticated measurement and information" -- and that, when "done right, managed care works." The authors conclude, "Maybe, properly defined and designed, these may not be dirty words after all" (Dorsey/Berwick, Boston Globe, 2/27).
Ruth Marcus, Washington Post: "Away from the distorting glare of the campaign trail," a "remarkable thing is happening in the national health care debate": A group of 12 senators has agreed to "sign on to health care legislation" sponsored by Sens. Ron Wyden (D-Ore.) and Bob Bennett (R-Utah) that is "far more radical than anything the presidential candidates have proposed," Post columnist Marcus writes. According to Marcus, the bill (S 334), called the Healthy Americans Act, "would ... blow up the existing health insurance system." The legislation is "based on the premise ... that covering everyone is required for getting costs under control" and has "something for everyone to dislike," she writes, adding, "No one -- not even Wyden and Bennett -- agrees with every aspect of their proposal" (Marcus, Washington Post, 2/27).

Potential Drug Targets Found In Scripps Study Of Sepsis In Mice

2008-02-28T06:13:00.000-08:00

"We have identified a key connection of signaling pathways in the cascade of events leading to sepsis. This defines a crucial point where the immune system spirals out of control to cause severe sepsis and where there is an opportunity for therapeutic intervention," says Scripps Research Professor Wolfram Ruf, who led the research with his postdoctoral fellow Frank Niessen. Their results are published in the February 27 advance, online issue of Nature.

Ruf and his colleagues identified a new cross talk involving the vascular coagulation system and certain cells in the immune system. By disrupting this cross talk, they were able to rescue mice from death due to sepsis. Though there is no guarantee this preclinical success will translate into human therapies, these proof-of-principle experiments may improve the diagnosis of heterogeneous sepsis syndromes and yield potent drugs for treating people who suffer from sepsis.

A Severe, Fast-Moving Disease

Sepsis is a severe, fast-moving, dramatic, and often fatal disease caused by an overwhelming bacterial infection that enters the bloodstream. These invading bacteria produce endotoxins and other toxic chemicals that trigger a widespread inflammatory response of the innate immune system - a response that is necessary, as it turns out, because without the inflammation, the body cannot fight off the bacterial infection.

Unfortunately, this inflammation can also spiral out of control leading to septic shock. During sepsis, the inflammation triggers widespread coagulation in the bloodstream. This coagulation can block blood vessels in vital organs, starving the organs of oxygen and damaging them. The organs can be further damaged when the blood starts to flow again because the lining of the blood vessels remain leaky due to inflammatory cytokines and damage by intravascular coagulation. This leads to edema, the buildup of liquid in tissues and allows immune cells to exit the bloodstream and enter the tissue. Inside the tissues, the immune cells can cause severe damage and organ failure. Frequently, the vital function of kidneys and lungs are affected.

Sepsis syndrome can be either fulminant or protracted when patients are not able to cope with and to recover from severe infections. Overall, the prognosis for sepsis is dire. It is one of the leading causes of death for both infants and adults in the United States, and, according to the Centers for Disease Control and Prevention (CDC), it accounted for more than 33,000 deaths in 2004 alone - the last year for which complete statistics are available.

Numerous therapeutic approaches to treating sepsis have been tried through the years. For many years, the only option was to administer powerful, broad-spectrum antibiotics to control the bacterial infection. By the time these were administered, however, it was often too late. The antibiotics did not affect the existing bacterial toxins in the bloodstream, and they could not counter what appeared to be a self perpetuating inflammatory response that results from these toxins. Therapeutic approaches that attempt to reduce inflammation have proven to make people worse off than they were without treatment because those therapies compromise the immune response, unshackling the bacteria in the process.

Another possible approach to intervention involves exploiting the connection between coagulation and immunity, and anticoagulants have proven to be an effective treatment in severe sepsis. In recent years, the U.S. Food and Drug Administration (FDA) approved a recombinant form of activated protein C (Xigris) for treating sepsis, which is believed to work, in part, by controlling coagulation. However, other anticoagulants have failed in clinical trials and recent experiments in mice indicate that Xigris protects the vascular endothelium directly through cell signaling, rather than regulating coagulation.

A New View of Sepsis

The coagulation cascade is a tightly controlled mechanism designed primarily to prevent blood loss due to injury, but is also aberrantly activated in diseases like Ebola and sepsis. Though the link between coagulation and inflammation is one that scientists have known about for years, the exact molecules that connect coagulation to the inflammatory response in sepsis have remained a mystery. Ruf and his colleagues, wanting to understand the process, turned to knockout mice missing signaling receptors for coagulation enzymes, called the protease activated receptors (PARs).

Specifically, they found that mice lacking PAR1, also known as the thrombin receptor, were less likely to die from sepsis. Surprisingly, PAR1-deficient animals initially became very sick when exposed to endotoxin, but recovered more quickly from systemic inflammation and thereby escaped the deadly complication of sepsis syndrome. It turned out that normal mice could also be rescued from death when they received pharmacological drugs that block the PAR1 receptor or very high doses of coagulation inhibitors. This therapeutic intervention was successful, even when inflammation had already peaked. These experiments provided the first clue to indicate that it is the cell signaling component of the coagulation cascade that triggers severe systemic inflammatory response syndromes.

It was originally believed that coagulation in the blood stream damages endothelial cells that line the vasculature. This damage, in turn, helps activate platelets and leucocytes to cause thrombosis and organ damage. Ruf and his colleagues discovered that - unexpectedly - coagulation activates the immune system directly to promote sepsis syndrome. In particular, the dendritic cells of the mouse's immune system play an important role and these cells are perturbed in the lymphatic system, rather than in the blood stream.

Typically dendritic cells produce potent pro-inflammatory cytokines in the lymph nodes during immune reactions. When the dendritic cells sense the increased coagulation in sepsis, they migrate faster through the lymphatic system and as a result do not stay put in the lymph nodes. This causes a release of inflammatory cytokines and chemical signals directly into the lymph. Lymphatic fluid is constantly recycled into the blood stream through the thoracic duct. This major lymph vessel connects to the blood stream immediately before blood enters the lungs. In sepsis, inflammatory mediators in the lymph fluid are thereby directly delivered to one of the most vital organs in the body.

In further research of this novel sepsis mechanism, Ruf and his colleagues uncovered downstream components of the PAR1 signaling pathway. Making use of chemical probes provided by the Scripps Molecular Screening Center, they identified that protease signaling on the dendritic cells induces the production of sphingosine 1 phosphate (S1P), a bioactive lipid that activates another G protein-couples receptor, the S1P receptor 3 (S1P3). In mice that lacked this receptor, they showed that dendritic cells are also responsible for triggering disseminated intravascular coagulation in sepsis. Through the connection between S1P3 and PAR1, dendritic cells are caught in an amplification circuit whereby they activate coagulation, and are in turn excited by one of the enzymes in the coagulation cascade to produce severe systemic inflammation.

Ruf and his colleagues showed that interrupting the S1P3 and PAR1 communication not only prevents the spread of inflammation though the body, but confines the inflammatory reaction to a desired location: the lymph node where the immune system fights microorganisms. This research provides a new view of sepsis and identifies potential targets that might restore a beneficial inflammatory response while blocking the deadly consequences of sepsis. The researchers are now evaluating which targets would be most amenable to clinical development and are testing the broader relevance of this pathway for other infectious diseases.

In addition to Ruf and Niessen, the article, "Dendritic cell PAR1-S1P3 signalling couples coagulation and inflammation," was authored by Florence Schaffner, Christian Furlan-Freguia, Rafal Pawlinski, Gourab Bhattacharjee, Jerold Chun, and Hugh Rosen at The Scripps Research Institute and Claudia K. Derian and Patricia Andrade-Gordon at Johnson & Johnson PRD. It appears in the February 27, 2007 issue of the journal Nature.

Support for this work was provided by grants from the National Institutes of Health and from the Deutsche Forschungsgemeinschaft.

About The Scripps Research Institute

The Scripps Research Institute is one of the world's largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus in 2009.

Medicaid Changes; Should Be Suspended Until Change In Administration, Senate Budget Chair Says

2008-02-28T06:12:00.001-08:00

Changes in Medicaid rules proposed last week by the federal Centers for Medicare and Medicaid Services should be suspended until the next presidential administration, Senate Budget Committee Chair Kent Conrad (D-N.D.) said Tuesday, CongressDaily reports. Conrad said that a moratorium on four Medicaid regulations could be extended into the next Congress for $1 billion. He added that a longer suspension of the rule changes would be difficult to enact because it would cost $15 billion (Johnson, CongressDaily, 2/27).

The new rules would reduce federal payments for public hospitals, teaching hospitals and services for the disabled, among others. The rule changes would allow states to offer alternative benefit packages called "benchmark" plans, which would provide Medicaid beneficiaries with health coverage that has the same value as plans offered to other individuals in the same state. The proposed rule changes also would allow states to revise existing premium and cost-sharing plans to make them more similar to those allowed under SCHIP.

According to CMS, the rule changes are in line with the Bush administration's "goals of aligning Medicaid more closely with private market insurance and giving states more control over their Medicaid benefits packages." State governors and congressional Democrats have criticized the proposed changes, claiming they would shift billions of dollars in costs to the states, which could lead to cutbacks in services (Daily Women's Health Policy Report, 2/25).

On Tuesday, five governors testified before the House Energy and Commerce Health Subcommittee against the proposed rule changes. Mississippi Gov. Haley Barbour (R) said that he appreciates the Bush administration's moratorium on some Medicaid rules, adding, "It would suit us if you would do that for some of the (other) rules." Georgia Gov. Sonny Purdue (R), Massachusetts Gov. Deval Patrick (D), Ohio Gov. Ted Strickland (D) and Washington state Gov. Christine Gregoire (D) also testified at the hearing (CongressDaily, 2/27).

CMS' proposed changes, which would implement provisions of a 2006 budget reconciliation bill (PL 109-171) and a 2006 package to extend tax provisions (PL 109-432), have a 30-day public comment period (Daily Women's Health Policy Report, 2/25).

Senate Approves Legislation That Would Reauthorize, Overhaul Indian Health Care Improvement Act

2008-02-28T06:11:00.001-08:00

The Senate on Tuesday voted 83-10 to approve the Indian Health Care Improvement Act reauthorization bill (S 1200), CQ Today reports (Armstrong, CQ Today, 2/26). The bill would authorize $35 billion over the next decade for the Indian Health Service to expand health coverage and services for about 1.8 million American Indians and Alaska Natives (Holland, Seattle Post-Intelligencer, 2/26).

The bill would:

Increase the number of American Indians in health care professions;
Increase funding for cancer and diabetes screenings, mental health and prevention programs;
Prompt construction and modernization of health clinics on reservations; and
Expand tribal access to Medicare and Medicaid (Jalonick, AP/Denver Post, 2/26).

Joe Garcia, president of the National Congress of American Indians, said, "It's about time, and I applaud the Senate for this historic vote," adding, "Federal prisoners continue to receive better health care than native people, and this is a major step in reversing that alarming statistic" (Casteel, The Oklahoman, 2/27).

The Senate on Tuesday also voted 56-38 to approve an amendment by Sen. Gordon Smith (R-Ore.) that would create a pool of money for health facility construction to be distributed among all tribes, rather than targeting specific tribes. According to Smith, some tribes have never received funding to build health care facilities.

House companion legislation remains in committee, but Rep. Frank Pallone (D-N.J.) said he likely would not make major changes to the Senate measure (CQ Today, 2/26). Pallone said he expects the bill "will move fairly quickly" through the House (Seattle Post-Intelligencer, 2/26).

San Francisco Chronicle Opinion Pieces Discuss Issues Related To Medicare

2008-02-28T06:08:00.000-08:00

The San Francisco Chronicle on Wednesday published two opinion pieces that discuss issues related to Medicare. Summaries appear below.

Spyros Andreopoulos: The Medicare prescription drug benefit "has fulfilled its goal of providing drug coverage to Medicare beneficiaries" but "has failed to protect low-income Americans from high out-of-pockets costs for their medications," Andreopoulos, director emeritus of the Office of Communication and Public Affairs at Stanford University Medical Center, writes in a Chronicle opinion piece. In addition, he writes, "program costs that critics had feared would exceed government projections by as much as $750 billion by the end of the decade have materialized sooner than expected." According to Andreopoulos, the "soaring" costs of the program could "harm Medicare's core mission and the elderly." He writes, "Because a tax increase is out of the question, one obvious solution is to amend" the 2003 Medicare law and "limit the drug benefit." Andreopoulos concludes, "Limiting an entitlement may prove politically impossible, but it would be better to admit that the new law was a mistake and fix it than to cut benefits piecemeal," a move that would "leave the program's future and its recipients in perpetual limbo" (Andreopoulos, San Francisco Chronicle, 2/27).
Donna Arduin: "Clearly, the Medicare recovery audit program is working," but a bill supported by the "hospital lobby" would suspend the expansion of the program to protect those who "have built their business models around their annual Medicare windfall," Arduin, president of Arduin, Laffer & Moore: Econometrics, writes in a Chronicle opinion piece. She adds, "Medicare ... drowns in waste and abuse," and, although audits recovered more than $350 million in overpayments in three states in 2007, some lawmakers support the legislation, which would "throw a life preserver to the health care organizations that improperly bill the program for billions of dollars each year." According to Arduin, the bill would suspend the nationwide expansion of the pilot program scheduled for next month until a "laundry list of 'concerns' and 'issues' can be evaluated in depth," although "virtually every concern raised by hospitals has already been addressed by Medicare." The "government calls recovery audits a credible deterrent to improper billing," she writes, adding, "It's no wonder that hospitals and other health care providers ... want the program stopped." Arduin concludes, "Recovery auditing is the life preserver that Medicare needs now" (Arduin, San Francisco Chronicle, 2/27).

Magic' Johnson Calls For More HIV Testing Among Blacks, End To Stigma

2008-02-28T06:05:00.000-08:00

As part of his "I Stand With Magic" campaign, former National Basketball Association player Earvin "Magic" Johnson on Tuesday encouraged a crowd of about 300 at the Miami-based Greater Bethel AME Church to be tested for HIV, the Miami Herald reports.

The "I Stand With Magic" campaign, a partnership between the Magic Johnson Foundation and Abbott Laboratories, aims to reduce the number of new HIV cases among blacks by half. Johnson also visited Miami Jackson High School.

Two mobile HIV testing centers were set up outside the church event.

Johnson called on attendees to help eliminate HIV stigma, saying, "We need to urge people to get tested." He added, "We have a major problem, a crisis in our community and only we can take care of it. Blacks and browns, we need to come together."

Florence Greer, a minority AIDS coordinator with the Florida Department of Health, said, "Particularly in the African-American community, we're stressing testing. If you look at four people who are HIV positive, only three people know."

Blacks represent about 20% of the Miami-Dade County population, but 58% of AIDS cases and 46% of HIV cases reported in 2007, according to data from the county Health Department (Lebovich, Miami Herald, 2/27).

Drug Resistant TB Rising Globally, WHO Survey

2008-02-27T06:43:00.000-08:00

A new survey by the World Health Organization (WHO) has found the highest rates ever recorded for multidrug-resistant tuberculosis (MDR-TB) globally are occurring today. This is the largest survey on drug resistant TB ever to be conducted, the data for which was collected between 2002 and 2006.

The survey, published Monday 26th February and titled Anti-tuberculosis drug resistance in the world, covers 90,000 TB patients in 81 countries and also found that 45 countries have recorded cases of extensively drug-resistant tuberculosis ((XDR-TB). This is the first time the WHO survey has covered this virtually untreatable form of TB, and because many countries are not equipped to diagnose it, the real picture could be worse.

TB is an infectious airborne respiratory disease caused by a bacteria that is spread by the coughing of infected people. Despite the disease being preventable and curable, 8.8 million people caught it and 1.6 million died in 2005.

If detected early and treated completely, a person with TB can quickly become non-infectious and will eventually be completely cured. However, the bacteria has evolved into numerous drug resistant forms, a scenario that presents public health authorities with major challenges in the campaign to eradicate the disease.

Director of the WHO Stop TB Department, Dr Mario Raviglione, said:

"TB drug resistance needs a frontal assault. If countries and the international community fail to address it aggressively now we will lose this battle."

He added that, as well as confronting resistant forms of TB and saving lives:

"Programmes worldwide must immediately improve their performance in diagnosing all TB cases rapidly and treating them until cured, which is the best way to prevent the development of drug resistance."

There are nearly half a million new cases of MDR-TB globally a year, the WHO estimates from the new survey data. This represents about 5 per cent of all new 9 million TB infections.

The highest incidence of MDR-TB was found in Baku, the capital of Azerbaijan, which lies between Eastern Europe and Western Asia. Here the survey found nearly a quarter of new cases of TB were of the multidrug resistant type.

Other Eastern European and Asian countries were next in line: Moldova (19.4 per cent), Donetsk in the Ukraine (16 per cent), Tomsk Oblast in the Russian Federation (15 per cent), and Tashkent in Uzbekistan (14.8 per cent). These rates exceed the highest levels of drug resistant TB published in the 2004 WHO report.

According to the WHO, there are comparable rates of widespread MDR-TB in China.

The new survey also found a significant association between HIV infection and MDR-TB, typified by the situation in Latvia and the Ukraine where MDR-TB is nearly twice as common in patients with HIV as in TB patients without HIV.

However, all is not doom and gloom and the new report also highlights successes. Estonia and Latvia, two Baltic countries that 13 years ago were classed as drug-resistant TB hotspots, are said to be showing signs of stabilizing, with notification of new TB cases falling. This follows a substantial injection of funds to support a campaign against MDR-TB.

The survey included data on drug resistant forms of TB from only six African countries, not enough to reveal the extent of the problem in a part of the world with the highest overall incidence of TB.

According to the WHO, it is virtually impossible to get data on drug resistant TB in Africa because of lack of the right equipment and staff trained to spot the drug resistant forms of the disease.

Principal author of the report, and TB expert with the WHO, Abigail Wright, said:

"Without these data, it is difficult to estimate the true burden and trends of MDR-TB and XDR-TB in the region."

"It is likely there are outbreaks of drug resistance going unnoticed and undetected," she added.

Nearly 5 billion dollars is needed to establish overall control of TB in low and middle income countries in 2008, estimates the WHO. 1 billion of this is needed for MDR-TB and XDR-TB. But all the money is not yet forthcoming: there is a shortfall of 2.5 billion, which includes a half billion gap for MDR-TB and XDR-TB.

Executive Secretary of the Stop TB Partnership, Dr Marcos Espinal pointed to the seriousness of this shortfall:

"The threat created by TB drug resistance demands that we fill these gaps, as laid out in the Global Plan to Stop TB, a roadmap for halving TB prevalence and deaths compared with 1990 levels by 2015."

America Will Be Spending One Fifth Of GDP On Healthcare By 2017

2008-02-27T06:42:00.000-08:00

A new US government analysis estimates that the country's spending on national health will continue to grow steadily and reach nearly 20 per cent of gross domestic product (GDP) by 2017, outpacing economic growth and inflation. GDP is the total value of all goods and services a country produces.

The new analysis was prepared by the Office of the Actuary in the Centers for Medicare and Medicaid Services (CMS) and is published online in the journal Health Affairs. It is also available on the CMS website.

CMS Acting Administrator Kerry Weems, said:

"The cost of health care continues to be a real and pressing concern."

It's not just about the quantity, but the quality as well, said Kerry:

"Making sure we are paying for high quality health care services, not just the number of services provided, is just one of the most critical issues facing the American public and the federal government now and in the future."

The report estimates that growth in US health care spending was 6.7 per cent in 2007 and will remain steady at that rate for the next decade. At this rate, it will grow more rapidly than estimated growth in the general economy (4.9 per cent) and general inflation (2.4 per cent) over the same period.

In 2006, the last year for which full actual figures were included in the analysis, US spending on healthcare was 16.0 per cent of GDP. The CMS estimates this to be 16.3 per cent for 2007 and will grow over the next 10 years to reach a total of over 4.3 trillion dollars, or 19.5 per cent of GDP in 2017.

This overall figure breaks down into many areas of detail, each moving at a different rate. For example:

Growth in public health spending, due to the implementation of Medicare Part D, is expected to slow down from 8.2 per cent a year in 2006 to 6.8 per cent in 2008.

Public health spending growth is then expected to rise again, gradually, toward 2017 as the baby boom generation starts to claim Medicare.

Between now and 2017, growth in health spending is estimated to outpace GDP growth by an average of 1.9 per cent a year.

This is smaller than the average 2.7 per cent difference over the last 30 years.

Growth in private health spending, including out of pocket and private insurance, is expected to climb back up to 6.3 per cent a year in 2007, following a dip to 5.4 per cent in 2006, also thought to be due to Medicare Part D.

This is then expected to peak at 6.6 per cent in 2009, then decelerate to 2017, as the economy slows down in the latter part of the projection period.

Spending on prescription drugs is expected to slow down from 8.5 per cent in 2006 to 6.7 per cent a year in 2007, mostly reflecting the slower growth in drug prices.

After that, to 2017, it is expected to accelerate, partly because the growth in dispensing rate for generics will level off, and treatments will increasingly call for earlier drug interventions.

Medicare Part D is unlikely to affect total national health expenditure growth over the period to 2017 since the per head figure for those on Medicare will be the same as that of those who are not on the program.

Medicare Part D, a program to subsidize prescription drugs for people on the US government's Medicare insurance program for the over 65s and others, came into effect in January 2006.

Kerry urged:

"This projection of health care spending reminds us that we need to accelerate our efforts to improve our health care delivery system to make sure that Medicare and Medicaid are sustainable for future generations of beneficiaries and taxpayers."

The full report tracks health spending by source of funds, including private and public (Medicare, Medicaid), and type of service (hospital, doctors, prescriptions, and so on). The latest estimates start after 2006 and project through to 2017.

Pre-Eclampsia Risk To Mothers And Babies Is Greater For Smokers

2008-02-27T06:39:00.000-08:00

The results of a new study published in the journal Hypertension reveal that if women give up smoking before or during pregnancy, they can reduce their risk of pre-eclampsia.

Pre-eclampsia is a high-risk medical condition when hypertension (high blood pressure) arises in pregnancy along with increased protein in urine; it leads to hundreds of baby deaths every year. Women who continue to smoke during pregnancy and who suffer from pre-eclampsia are risking the lives of their unborn children.

It is known that a major public health problem centers on women who smoke while pregnant. Researchers have found that about 30% of pregnant women smoke, resulting in significant health problems to the unborn child. An estimated 4000 fetal deaths (including miscarriages) every year are due to smoking while pregnant, and it can lead to premature births, low birth weight, cot death, and asthma as well as attention deficit and learning problems in childhood.

The study linking smoking and pre-eclampsia was carried out by researcher Fiona Broughton Pipkin of the University of Nottingham and colleagues from the Genetics of Pre-Eclampsia Consortium (GOPEC). Funding was provided by the British Heart Foundation.

"Pre-eclampsia and eclampsia are the second most frequent cause of death in pregnancy in this country and cause an estimated 70,000 deaths worldwide among pregnant women each year. In 2005, 742 babies died as a direct result of pregnancy hypertension in England and Wales. Ten times this number are delivered prematurely for the same reason. They risk short-term breathing problems, potential brain damage and long-term cardiovascular disease. The deaths are the tip of an iceberg for hospital admissions and worry for mothers, babies and families," explains Pipkin.

The multi-center cohort study consisted of 1001 white Western European women with moderate to severe pre-eclampsia and their babies. The researchers found that those in the group who were smokers were more likely to have premature deliveries (before 34 weeks), babies with lower birth weights, or babies with other adverse outcomes. In addition, smokers were five times more likely to develop eclampsia, characterized by convulsions or seizures.

Summarizing the study results, of the 1001 women with pre-eclampsia:

34.8% of smokers delivered before 34 weeks (26.8% of former smokers and 21.3% of non-smokers did).
46.1% of smokers had underweight babies (37.5% of former smokers and 27.9% of non-smokers did).
65.6% had babies with adverse outcomes (60% of former smokers and 50.4% of non-smokers did).

"Research like this study from The University of Nottingham is vital to help us understand the full effects of lifestyle choices on our heart and circulatory health and that of our children. Smoking is clearly potentially very harmful to mother and baby, and we need to support women in quitting at every stage of pregnancy," reports Ellen Mason, a cardiac nurse at the British Heart Foundation (BHF).

Professor Pipkin adds: "Although a recent article suggested that smoking in pregnancy is less damaging to the unborn baby than commonly supposed, GOPEC argues that smoking CAN make a bad situation worse for both mother and baby in pre-eclampsia."

They find that stopping smoking limits the damage.

"I feel very strongly that pregnant women should be encouraged as actively as possible to stop smoking, and this paper provides yet more reasons why," concludes Pipkin.

Researchers from the University of Nottingham, in a separate study, will analyze 1050 pregnant women to see the effects of using nicotine patches during pregnancy. The Smoking, Nicotine and Pregnancy (SNAP) trial (a £1.3m clinical trial) will study the safety and effectiveness of nicotine replacement therapy (NRT) for expectant mothers who wish to give up smoking, as well as effects on the child's behavior and development.

What Women Think During Their First Pregnancy

2008-02-27T06:36:00.000-08:00

Pregnant women who perceive having a well-balanced relationship with their parents during their childhood will experience fewer difficulties in the transition to motherhood, as opposed to women whose relationship with their parents was characterized by unresolved anger or rejection reveals a new study conducted at the University of Haifa. The study also found that women who tend to deny negative experiences in early childhood relationships expected to experience a relationship with their future children characterized by less warmth compared to other women who participated in the study.

The research, which was conducted by Ora Gazit under the direction of Dr. Miri Scharf, examined 160 Jewish women in the last trimester of their first pregnancy who live with their husband or partner. The researchers examined the expectations, thoughts and emotions of the pregnant women regarding themselves as future mothers and their future relationships with their babies based on two approaches related to identity building. The first focuses on the way people perceive their early childhood relationship with their parents and how this is reflected in their thoughts, perceptions and behavior during their lives. The second focuses on existing differences between people whose motivation is derived from an aspiration for success and those who are motivated by an aspiration to avoid failure.

The results of the study revealed that women whose early childhood relationships with their parents were characterized by rejection and unresolved conflicts, expected to experience a high measure of separation anxiety, thought their child would be more demanding of them and thought they would set a lot boundaries, compared to other women in the study.

Among women who described their early childhood relationships with their parents as being characterized by rejection but who had difficulty recalling many of the events representative of this relationship, the study found a majority had positive thoughts about their impending motherhood and towards their unborn child. However, in comparison to the remainder of the women in the study, they expected to develop a less warm and close relationship with their baby. The women who had a balanced view of their early relationship with their parents had the most optimal expectations towards their impending motherhood. They expected to feel a low level of separation anxiety from their child, thought childrearing would be easy and that their relationship would be characterized by warmth.

In addition, the study found that women who were characterized by wanting to advance and reach set goals were positive and more optimistic, in comparison to women who were characterized by abstention and concern with self-defense, security and responsibility. According to the researchers, women in the first group thought they would be more fulfilled in parenthood, saw themselves and their child in a more positive light, thought they would be more productive and warm as mothers and expected to have good communication with their child. "The results of the research show that there is great importance in evaluating thoughts, perceptions and feelings about parental identity during pregnancy. Such an evaluation will enable early identification of women who are concerned they will have difficulty contending with parental roles and offer them tools that will help them adapt better to the transition to motherhood," summarized the researchers.

Anorexics Who Commit Suicide Use Extreme Methods, Leaving Little Doubt Of Intent

2008-02-27T06:34:00.002-08:00

A disturbing new study, notable during this Eating Disorder Awareness Week, challenges assumptions that the high suicide rate among anorexics can be explained by compromised physical health that leads to death from the slightest attempt. Research to be published in the Journal of Affective Disorders shows that anorexics who are suicidal use highly lethal methods suggesting an overwhelming wish to die.

According to lead author, University of Vermont assistant professor of psychology Jill Holm-Denoma, while psychiatrists and other doctors have long observed that people with anorexia nervosa die by suicide at surprisingly high rates, there had been no data about what methods they were using to kill themselves. The assumption was often that these are people on the verge of death anyway; they are so malnourished and underweight that the smallest suicide attempt could easily lead to death.

Holm-Denoma's research, however, suggests a different explanation. Among anorexics who commit suicide, the methods used tend to be overwhelmingly lethal in conjunction with a low potential for being rescued, means that would be likely to kill anyone. She found that women (the vast majority of people who suffer from anorexia) were burning themselves, jumping in front of trains and hanging themselves, among other extreme acts.

"I wouldn't say that a defining feature of anorexia is a wish to die," says Holm-Denoma, "but among the subgroup of people with anorexia who attempt suicide, they have a strong wish to die and they engage in an act of self injury that has a very high likelihood of killing them right away."

Holm-Denoma, an expert on treating eating disorders, is available to discuss this research as well as other aspects of eating disorders. Approximately one percent of adolescent and young adult females suffer from anorexia and about twice as many have bulimia. And the population of people with eating disorders is growing outside of the traditional group, notably young, white, middle- to- upper- middle-class women. According to Holm-Denoma, as racial and ethnic minorities, as well as older women, are increasingly becoming media targets for the thin ideal, clinicians are seeing a rise in eating disorders from groups once thought to be protected.

Both anorexia and bulimia are also associated with high rates of mood, anxiety, substance use and personality disorders. A third category of eating disorder, binge eating, afflicts up to four percent of the population, and affects men and women equally. The combined effects take a huge toll. Anorexia, in fact, has the highest mortality rate of any psychiatric disorder.

Mounting Evidence Of Increased Mortality From Drug Used By Anemic Cancer Patients

2008-02-27T06:34:00.001-08:00

Millions of cancer patients take drugs to boost their red blood cells and health when they become anemic after chemotherapy. But a new study by Northwestern University's Feinberg School of Medicine shows these drugs, called erythropoiesis-stimulating agents (ESAs), actually raise patients' risk of death, possibly by stimulating the growth of cancer cells.

A meta-analysis of 51 trials with 13,613 patients revealed a 10 percent increased risk of death among cancer patients taking ESAs compared to patients who did not take them. The study, lead by Charles Bennett, M.D., the A.C. Buehler Professor in Economics and Aging at the Feinberg School, will be published in the Journal of the American Medical Association today, February 27.

The Northwestern study is the first to demonstrate a quantifiable increased risk of death from EPAs and is based on the largest number of trials ever examined for this purpose.

"The FDA says if you use the drug in moderation, it should be safe," Bennett said. "But our findings, in conjunction with basic science studies, raise the concern that the drug may be stimulating cancer and shortening cancer patients' survival."

"It's troubling that 15 years after the drug came out, we finally came to this realization," said Bennett, who also is a hematologist and oncologist at Northwestern Memorial Hospital and the Jesse Brown VA Medical Center.

The JAMA paper is an update of a poster presentation Bennett made to the American Society of Clinical Oncology in June 2007.

One of the study's co-authors, Stephen Lai, M.D., assistant professor at the University of Pittsburgh Medical Center, tested the response of cancer cells to an ESA in the laboratory. Lai, a head and neck surgeon, saw a significant effect when he added an ESA called erythropoietin to head and neck cancer cells in tissue culture.

"We saw a dramatic change," Lai said. "Adding 'epo' (erythropoietin) to the cells increased their ability to migrate or invade. Our basic science findings and the clinical trial results suggest that giving cancer patients 'epo' for their anemia may actually cause their tumors to progress."

Lai's basic science study is part of a growing body of studies that demonstrate erythropoietin expression and function in a variety of human cancers as presented at a National Cancer Institute workshop on erythropoietin and tumor progression December 2007 in Bethesda, Md.

The FDA approved the ESAs erythropoietin and darbepoetin in 2003 as a treatment for anemic cancer patients to avoid blood transfusions. However, evidence linking these drugs to a higher risk of death has been mounting. In March 2007, the FDA issued a public health advisory on EPAs, warning of an increased risk of serious and life-threatening side effects.

Ironically, Bennett noted, "The later clinical trials were conducted to see if these drugs help people live longer. But, it turns out, this is not the case."

ESAs produced up to $6 billion in cancer-anemia related sales last year for pharmaceutical firms, Bennett said, and represented Medicare's largest pharmaceutical expenditure.

Bennett began investigating these drugs when the study's senior author, Michael Henke, M.D., professor of medicine in radiation oncology at the University of Freiburg in Germany, first raised an alarm in 2003. For the new study, Bennett and his co-authors updated a 2006 analysis by the Cochrane Collaboration with more recent statistics from 13 additional Phase III trials. The 2006 Cochrane study did not show an increased risk of death, Bennett said.

"This is why it's important to continuously look at the data," Bennett said. "You can't let it fall by the wayside. Just a year out of date is not acceptable. Importantly, the more recent clinical studies were larger and addressed the issue of survival."

The Northwestern study also confirmed a previously known 57 percent increased risk of blood clots in the legs or lungs for cancer patients receiving ESAs. But the higher blood clot risk did not explain the 10 percent increased risk of death shown in his study, Bennett said.

"We know that ESA's may prevent a blood transfusion, but if I had cancer and I needed a blood transfusion, I would be much more conservative about taking ESAs," Bennett said. "The current FDA recommendation is these drugs are safe for cancer patients as long their hemoglobin levels aren't raised too high. Our data do not support that."

Lai cautioned that various solid tumors such as breast cancer, colon cancer and melanoma may react differently to ESAs. "The exact effect and size of that effect may be different depending upon the type of tumor. Additional research is clearly necessary, and we have to be careful about generalizing these results before further research is conducted," he said.

On March 13, the FDA's Oncologic Drugs Advisory Committee will meet in Gaithersburg, Md. to discuss the cumulative data, including the recent study results, regarding the use of ESAs for cancer patients, Bennett said.

New Technique Produces Intermediate-iPS Cells Faster And More Plentifully Than Previous Methodologies

2008-02-27T06:31:00.000-08:00

PrimeGen Biotech has announced that company researchers have successfully used purified proteins and DNAs in non-viral methods to reprogram adult human cells into stem cells.

Participating in this week's Stem Cell Summit in New York, the company reported that this new class of stem cells -- derived from adult human tissues such as skin -- has properties of embryonic stem cells (ESC), as well as stem cells referred to as "induced pluripotent stem cells" or iPS cells.

Relying on a high efficiency particle delivery system to transport proteins and DNA molecules directly into cells from human skin, retina and kidney, researchers found that after one week, stem cell colonies arose that exhibited the markers of ESC and iPS cells. They also found that PrimeGen's reprogramming technology is orders of magnitude more efficient and three to four times faster than previous viral methods - requiring just a week or two, rather than a month or more, to display the pluripotent markers.

Unlike iPS cells produced by other investigators in the US and Japan, PrimeGen researchers are the first to use methods that do not involve potentially tumor-causing viruses or genetic manipulations. And unlike embryonic stem cells, these methods use adult skin and other tissues from the patient, not embryos. As such, the company continues in its mandate to produce high quality cells that will be suitable for future patient therapies.

"We believe these new methods for making iPS cells could solve many inherent problems and offer great promises for translation into clinical trials," said John S. Sundsmo, President, PrimeGen Biotech. "Because these methods are so rapid and efficient, we believe they may provide a springboard into therapies that use a patient's own cells to prepare stem cells, thus, eliminating graft rejection and risks of graft versus host disease. We see these results as a critical step towards bringing safe, ethical, individualized stem cell treatments into the clinic."

PrimeGen has submitted its results, as scientific abstracts, to the 6th International Society of Stem Cell Research Annual Meeting, to be held in Philadelphia this June. Cells from PrimeGen Biotech are also currently being studied in several independent academic labs.

About PrimeGen Biotech LLC

PrimeGen Biotech is dedicated to the research and therapeutic applications of adult stem cells, leading to individualized patient therapies. Entering its fifth year of operations at the pre-clinical stage of product development, the company specializes in two core technologies: germ line stem cells and therapeutic reprogramming. Pioneering work on induced pluripotent stem cells (iPS cells), positions PrimeGen as a leader in moving this breakthrough from research to therapy. Future applications of both PrimeGen core technologies will enlist a patient's own adult tissue cells to generate stem cells for regenerative and restorative medical treatments. Based in Irvine, California, PrimeGen Biotech is a privately held, Delaware limited liability company.

New Bladder Cancer Therapy For Patients Unresponsive To Standard Treatment

2008-02-27T06:29:00.000-08:00

As many as half of patients with superficial bladder cancer do not respond to the standard first-line chemotherapy placed into the bladder, according to current multi-center outcomes data. When this happens, typically, their only option is surgical removal of the bladder. Now, researchers at the Herbert Irving Comprehensive Cancer Center of NewYork-Presbyterian Hospital and Columbia University Medical Center are investigating an FDA-approved metastatic breast-cancer drug called Abraxane® that may prove a safe and effective alternative to surgery for these patients.

Bladder cancer is the fourth leading cause of cancer in men and the ninth leading cause of cancer in women in the United States. In a given year, more than 60,000 new cases are diagnosed, and 13,000 will die from the disease.

"When the standard treatment does not work, currently the only option is surgical removal of the bladder -- something that, for all patients, is unappealing, and for some sicker patients is not even possible. With this study, we hope to find an effective second line medical option for these patients," says Dr. James McKiernan, director of urologic oncology at the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital and Columbia University Medical Center, and vice chairman of the Department of Urology and assistant professor of urology at Columbia University College of Physicians and Surgeons.

The Phase I/II study will follow 18 patients for six weeks to assess dosage safety, followed by a second group of 19 patients who will be followed for six weeks to measure the effectiveness of the therapy.

The study is open to patients with recurrent bladder cancer that has not responded to standard therapy -- BCG (bacillus Calmette-Guerin) treatment.

In 2006, Dr. McKiernan, together with departmental chair Dr. Mitchell C Benson, led a phase I study of the drug Taxotere, also used to treat breast cancer, on a similar patient population, finding the drug to be safe with 12 of 18 patients responding (results were published in the July 1, 2006, Journal of Clinical Oncology). Since then, a favorable percentage of patients have survived with intact bladders.

Abraxane, he believes, will show similar or better results. "Abraxane has an analogous structure to Taxotere, but has the advantage of being more soluble due to its solvent-free formulation allowing for administration at higher concentrations," says Dr. McKiernan. "In one study of Abraxane for metastatic breast cancer, the drug successfully shrank tumors and had few side effects."

Antidepressants Only Benefit The Severely Depressed, Study

2008-02-26T16:56:00.001-08:00

A new study by researchers in the UK suggests that antidepressants only benefit the very severely depressed and are no more effective than a placebo for everyone else.

The meta-analytical study (ie one that systematically pools the results of other studies) is the work of Dr Irving Kirsch, from the University of Hull, and his colleagues, and is published today, 26th February, in the open access journal PLoS Medicine.

Antidepressants are prescribed for the treatment of clinical depression, and the most widely used are the "new generation" drugs, the SSRIs such as fluoxetine (Prozac) and venlafaxine (Effexor).

Previous meta-analytical studies of antidepressants have already suggested they have only modest benefits over placebos, and the authors pointed out that when data from unpublished trials are included, the benefits are so small they fall below the criteria for clinical significance. What has not been clear in the past however, is whether within this overall result, the effectiveness of antidepressants depends on how severely depressed patients are when they start treatment.

Kirsch and colleagues pooled all the available full data sets from all clinical trials submitted to the US Food and Drug Administration (FDA) for licensing four of the new generation of antidepressants, the SSRIs fluoxetine (Prozac), venlafaxine (Effexor), nefazodone (Serzone), and paroxetine (Seroxat, Paxil). The data came from both published and unpublished trials.

The point of including data from unpublished as well as published trials, is to avoid potential bias arising from the omission of "disappointing" unpublished findings.

SSRI stands for "selective serotonin reuptake inhibitors". This new type of antidepressant, like the older ones, works by attempting to stabilize chemicals in the brain that influence mood, except that SSRIs specifically target and increase the circulating levels of a brain chemical called serotonin, a neurotransmitter that regulates mood. They do this by inhibiting the reuptake of serotonin so that more of it is available for binding to cell receptors.

Using meta-analytical techniques (a way of pooling data from a range of studies as if they were one big study with broadly the same objectives) the authors assessed the relation between the initial severity of depression and the improvements shown by drug and placebo groups, as well as the relation between initial severity and differences in drug-placebo improvement scores.

The results showed that:

Drug-placebo differences got bigger as initial severity went up.

This difference was hardly noticeable at moderate levels of initial depression, went up to a relatively small difference for patients with severe depression, and reached a level that would be classed as clinically significant only in those patients at the extreme end of the very depressed scale.

The improvement seemed to result from the most severely depressed patients not responding as well to placebo compared to their less depressed counterparts, than because they responded better to the active drug.

Kirsch and colleagues concluded that:

"Drug-placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients."

"The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication," they added.

In other words, the difference in effect between drug and placebo was only clinically significant in those patients who were very severely depressed at the start of their treatment and this effect was more likely due to a weaker response to the placebo than a stronger response to the drug itself in that group.

This study is important because although licensing authorities like the FDA in the US and NICE (National Institute for Health and Clinical Excellence) in the UK have approved SSRIs for treating depression, there are nagging doubts about how effective they are.

Depression, which affects about 1 in 6 people at some point in their life, is a serious medical condition characterized by imbalances in brain chemicals that regulate mood. The illness, which can last for months and sometimes years, makes a person feel unmotivated, worthless, hopeless, and sometimes even that life is so futile it would be better to be dead. Depression is often a cause of suicide.

Severity of depression is measured using a questionnaire called the Hamilton Rating Scale of Depression (HRSD) which comprises up to 21 items. If the total score comes to 18 or more, the person is classed as severely depressed.

For an antidepressant to receive a license, clinical trials have to show that it can significantly improve the HRSD score compared to a placebo.

Different countries have slightly different clinical criteria for how much the HRSD score has to improve by before the drug can be licensed to treat depression. In the UK, NICE require that the drug show an improvement in the HRSD score of 3.

A previous meta-analysis of published and unpublished trials sent to the FDA for licensing these drugs showed they only have an average benefit of 1.8 HRSD points.

The reason this study was done was to find out if underneath this 1.8 average there might be subgroups of patients for whom the improvement score was significantly higher, perhaps within the range required by NICE.

And indeed, this is what Kirsch and colleagues found: the clinical criteria were only met when the drugs were used to treat the most severely depressed patients, that is ones with an initial HRSD score of 28 or more, at the extreme end of the scale. And perhaps just as important, is the finding that this effect did not arise as a result of responding to the drug, but because of decreased responsiveness to the placebo.

This last, rather surprising finding, provides a new direction for future research.

Antibiotics Frequently Given To Patients With Advanced Dementia

2008-02-26T16:55:00.001-08:00

A new study by researchers in the US found that people with advanced dementia are frequently given antibiotics toward the end of life, and has thrown into question whether this practice should be curtailed in view of the increased risk of developing drug resistant superbugs.

The study is the work of Drs Erika D'Agata and Susan L Mitchell of the Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, and is published in the 25th February issue of the Archives of Internal Medicine.

Advanced dementia patients in nursing homes are at high risk of infections and antimicrobial exposure near the end of life, wrote the researchers.

D'Agata and Mitchell studied a group of 214 residents, of average age 85.2, with advanced dementia being cared for in 21 nursing homes in and around Boston.

The residents were assessed between 2003 and 2006 and then every three months for up to 18 months. At each assessment, the number and type of antibiotics prescribed, with reasons (indication), were noted from records kept at the nursing home.

They found that:

Over an average 322 days of follow up, 142 (66.4 per cent) of the group received at least one course of antibiotics (mean number of courses per resident was 4.0 with standard deviation of 3.7).

The mean number of days of antibiotic treatment for every 1,000 resident days for the whole group was 53.0 (standard deviation 4.3).

The most frequently prescribed antibiotics were quinolones and third-generation cephalosporins.

These accounted for 38.3 and 15.2 per cent of 540 prescribed antimicrobial therapy courses, respectively.

The most common reason for an antibiotic prescription was respiratory tract infection, which accounted for 46.7 per cent of all courses.

Of the 99 residents who died, 42 (42.4 per cent) of them had received antibiotics in the 2 weeks before death.

Among these 99, the number who received antibiotics went up significantly as they approached death.

The proportion of residents taking antibiotics in the last two weeks of life was seven times greater compared with six to eight weeks before death.

The number of antibiotics prescribed and the days of therapy per 1,000 resident-days also went up significantly as death approached.

30 of the 72 courses (41.7 per cent) taken in the last two weeks of life were given intravenously as opposed to by mouth (this could be distressing and uncomfortable for patients with advanced dementia).

D'Agata and Mitchell concluded that:

"Persons with advanced dementia are frequently exposed to antimicrobials, especially during the 2 weeks before death."

With regard to the implications of this practice they suggested it should be evaluated with respect to two things: "the individual treatment burden near the end of life and its contribution to the emergence of antimicrobial resistance in the nursing home setting."

Writing in an editorial in the same issue of the journal, Drs Mitchell J. Schwaber and Yehuda Carmeli of the Tel Aviv Medical Center in Israel commented that:

"The findings in this study require the medical community to ask whether the extensive use of antibiotics in this particular patient population is appropriate, taking two factors into consideration: the benefit to the patient treated and the risk imposed on other patients."

They are not suggesting a flat refusal to give antibiotics to severely demented elderly people, or even that policies restricting their use should be introduced. They suggest antibiotics should be considered alongside every other carefully weighed decision such as resuscitation and major surgery.

As well as weighing up the the interests of the patient and the risk to others, they concluded that:

"All such decisions must ultimately be made individually, based on the medical situation and the expressed wishes of the patient and family, as well as on the physician's judgment of the benefits and risks entailed in treating vs. not treating."

The controversy about the public health implications arises because previous research has shown that nursing homes can harbour drug resistant bacteria, and these can spread into hospitals when nursing home residents are admitted.

An Associated Press report notes the comments of various experts, discussing the implications of this study. A geriatrician and ethicist at the University of Chicago Medical Center, Dr Daniel Brauner, said being more careful with antibiotics means doctors would have to keep a much closer watch on nursing home residents. But, he said "I'm sure a lot of these antibiotics were prescribed over the telephone".

Another problem of course, even with close monitoring, is that the doctor sometimes can't tell if the patient is approaching death. Dr Eric Tangalos, a geriatrician at the Mayo Clinic told the Associated Press that:

"Until that decision is made that death is imminent, there's always hope. People do recover from those infections."

On the other hand, is the problem of what constitutes quality of life in those last few weeks, as Bruce Jennings, a bioethicist with a research institute on medical ethics, the Hastings Center, put it:

"You might rescue the patient from life-threatening pneumonia and they live a few days, weeks or even months longer. But the extra time you have bought them by that rescue is not beneficial."

Mitchell said doctors should discuss these things with the patient's family, in the same way as they disucss whether a feeding tube should be used. She also commented that none of the residents in the study had made living wills stating their wishes on antibiotic treatment.

Over 5 million Americans are living with dementia, about 70 per cent of whom will be cared for in nursing homes as they approach the end of their lives.

Hormone Therapy Compromised Breast Cancer Diagnosis Via Mammogram And Biopsy

2008-02-26T16:54:00.002-08:00

A new US study found that women taking combined hormone therapy had an increased risk of otherwise avoidable abnormal mammograms and breast biopsies that compromised the ability of these two methods to help diagnose breast cancer.

The study was carried out by lead author Dr Rowan T Chlebowski, an investigator at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed), and colleagues, and is published in the 25th February issue of the Archives of Internal Medicine.

In a press statement Chlebowski said that the findings "represent a concern for post-menopausal women who are considering hormone therapy".

The effect of combined hormone therapy on the detection of breast cancer has not been determined before, wrote the researchers in their background information to the article.

Chlebowski and colleagues studied 16,608 women enrolled in the 15-year Women's Health Initiative (WHI) clinical trial that started in 1993. The women were randomly assigned to two treatment groups: a hormone group and a placebo group.

The hormone group received a combination of estrogen and progestin (equine estrogens at 0.625 mg a day and medroxyprogesterone acetate at 2.5 mg a day).

The women underwent mammogram and breast exams at the start of the trial and annually thereafter. Breast biopsies were also performed if indicated from the clinical findings.

The team then looked at the effect of the combined hormones on breast cancer detection over 5.6 years.

They found that:

The hormone group had a higher frequency of mammograms with abnormalities compared with the placebo group (35 versus 25 per cent).

Women in the hormone group had a 4 per cent greater risk of having a mammogram with abnormalities after one year and this risk was 11 per cent after five years, compared to the women in the placebo group.

There was a lower sensitivity for breast cancer detection and increased cumulative frequency of breast biopsy in the hormone group (10.0 versus 6.1 per cent.

Breast cancers were significantly increased and diagnosed at higher stages in the hormone group.

But despite this, biopsies in the hormone group diagnosed cancer less frequently compared with the placebo group (14.8 versus 19.6 per cent).

When hormone therapy was stopped, the adverse effect on mammograms remained significantly different to that of placebo for at least 12 months after.

Chlebowski and colleagues concluded that:

"Use of conjugated equine estrogens plus medroxyprogesterone acetate for approximately 5 years resulted in more than 1 in 10 and 1 in 25 women having otherwise avoidable mammogram abnormalities and breast biopsies, respectively, and compromised the diagnostic performance of both."

They added that:

"This adverse effect on breast cancer detection should be incorporated into risk-benefit discussions with women considering even short-term combined hormone therapy."

Chlebowski advised women considering hormone therapy to "take the results of this study into consideration and consult with their physicians before undergoing even short-term hormone therapy".

He said that the results were relevant for women just entering the menopause as well:

"After discontinuation of combined hormone therapy, the adverse effects on mammogram and breast biopsy performance were seen even in younger women in the fifth decade of life."

Plenaxis(R) Is The First GnRH Antagonist, A New Class Of Hormone Treatment Which Gives Physicians Added Control Of Prostate Cancer

2008-02-26T16:54:00.001-08:00

Speciality European Pharma (SEP) announced the launch of Plenaxis(R) in Germany. Plenaxis(R) is used to treat advanced and metastatic hormone responsive prostate cancer and it causes a rapid and sustained decline in testosterone levels, thereby giving quick control of prostate cancer symptoms. Once the disease is under control, the physician can choose to either keep the patient on Plenaxis® or to stop treatment and recommence once there is evidence of disease activity returning. This is attractive because, on stopping treatment with Plenaxis® the patient's testosterone levels will return to the normal range whilst the disease remains under control. In addition to the quick control of testosterone, Plenaxis avoids any testosterone flare and removes the need for concomitant use of anti-androgen therapy.

Commenting on the launch of Plenaxis®, Geoff McMillan, the CEO of SEP, said, "Plenaxis® is an important product, both for SEP and for sufferers of prostate cancer. Plenaxis is the first new type of hormone treatment for prostate cancer to be introduced for many years and it gives patients and physicians added control of this disease."

Ken Watters, Chief Medical Officer of SEP added that "prostate cancer is an important cause of morbidity and mortality in males over 50 years old. The emerging treatment modalities are especially suited to Plenaxis® with it's rapid and sustained disease control and quick testosterone recovery".

About SEP

Founded in April 2006, SEP acquired Proreo Pharma International in December 2006 and with it rights to Haemopressin®, a product sold in several European and international markets for the treatment of bleeding oesophageal varices. In January 2007 SEP acquired world-wide rights to Plenaxis®, the world's first approved GnRH antagonist for the treatment of prostate cancer. In July 2007 SEP announced that it had secured rights for Amphocil®, a treatment for life threatening fungal infections, in Germany, Italy and France. SEP is backed by Advent Venture Partners.

Speciality European Pharma

About Advent Venture Partners

Advent Venture Partners ("Advent Ventures") is one of the most experienced venture capital firms in the UK. Established in 1981 it invests in both the Life Science and Technology sectors. Advent Ventures has raised over £1 billion from institutional investors across Europe and the USA since 1998. It has backed around 60 life science companies of which, to date, 19 have obtained public listings and a further 9 companies have been sold, including PowderMed (to Pfizer) and KuDOS Pharmaceuticals (to AstraZeneca).

Investments by the Advent Ventures Life Sciences team include Norwegian radiopharmaceuticals company Algeta; Dutch gene-medicine company Amsterdam Molecular Therapeutics; UK-based Thiakis, which develops hormone-based treatments for obesity; and the Swiss therapeutic antibody company 4-Antibody.

Advent Venture Partners

Flu Season At Its Peak: Experts Have Tips For Staying Healthy

2008-02-26T16:53:00.001-08:00

According to the CDC's latest report the USA's flu epidemic continues to spread with an increase in every state and a dozen new deaths among children, according to Nancy Cox, director of the Centers for Disease Control and Prevention's influenza division.

Nationally, 49 states reported widespread influenza this week. Florida is the only state not reporting widespread influenza; it is at the regional level, a step down.

Though a flu season's duration can't be predicted, the latest numbers "suggest we may be nearing the peak," Cox said. And this season a mismatch in the current flu vaccine covers only one of the three active flu strains, leaving people with less protection against two of the circulating strains.

"To prevent getting the flu, you want to raise your immune system," says Steven Lamm, MD, of New York University's School of Medicine. "Your whole nutrient state is at stake -- take vitamin D, vitamin C/Ester-C. Do not go to work if you are sick as you will be highly contagious."

Immune health expert, Mark Moyad, MD, University of Michigan, adds, "Now is the time to be ever more vigilant about protecting yourself from the flu, and there are things you can do that will help." Dr. Moyad's stay-well tips, which apply year-round as well, are below:

-- Wash your hands. Carry hand sanitizers with you at all times

-- Take vitamin C/Ester-C -- shown to boost immunity: 500 - 1000 mgs daily

-- Stay hydrated. Drinking fluids helps flush out impurities in the system

-- Avoid direct contact with anyone who is sick

-- Sleep -- being rested is one of the body's best defense mechanisms

Dr. Moyad also stresses the importance of proper nutrition and regular exercise as ways to stave off illness and keep the immune system operating at optimal levels.

Breast Cancer Action Disagrees With FDA's Avastin Ruling

2008-02-26T16:52:00.002-08:00

Breast Cancer Action (BCA) strongly disagrees with the Food and Drug Administration's decision giving accelerated approval to biotech company Genentech's application to market its drug Avastin as a treatment for metastatic breast cancer at this time.

"The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, today's decision is a victory for drug companies, but not for patients," BCA Executive Director Barbara A. Brenner said.

BCA has long opposed Genentech's application, arguing that no evidence has been presented that shows Avastin improves overall survival or quality of life.

In its application to the FDA, Genentech said that a clinical trial indicated that Avastin prolongs progression-free survival. However, BCA argued - and continues to argue -- that that endpoint is meaningless because (1) it does not address the patient's quality of life during those additional months, a very real question because of some of the serious side effects a number of the women experienced, and (2) it has not been shown in this case to correlate with overall survival. The data from another trial done by Genentech's parent, Roche, has not been released, but it appears that it has the same limitations.

Breast Cancer Action is a national watchdog and advocacy organization that carries the voices of people affected by breast cancer to inspire and compel the changes necessary to end the breast cancer epidemic.

Since 1998, BCA has refused to accept funds from corporations that may create a real or apparent conflict of interest for BCA. Corporations covered by this policy include pharmaceutical companies.