Pancreatic Cancers: Chemotherapy Plus Synthetic Compound Provides Potent Anti-Tumor Effect

Human pancreatic cancer cells dramatically regress when treated with chemotherapy in combination with a synthetic compound that mimics the action of a naturally occurring "death-promoting" protein found in cells, researchers at UT Southwestern Medical Center have found.



The research, conducted in mice, appears in today's issue of Cancer Research and could lead to more effective therapies for pancreatic and possibly other cancers, the researchers said.



"This compound enhanced the efficacy of chemotherapy and improved survival in multiple animal models of pancreatic cancer," said Dr. Rolf Brekken, associate professor of surgery and pharmacology and the study's senior author. "We now have multiple lines of evidence in animals showing that this combination is having a potent effect on pancreatic cancer, which is a devastating disease."



In this study, Dr. Brekken and his team transplanted human pancreatic tumors into mice, then allowed the tumors to grow to a significant size. They then administered a synthetic compound called JP1201 in combination with gemcitabine, a chemotherapeutic drug that is considered the standard of care for patients with pancreatic cancer. They found that the drug combination caused regression of the tumors.



"There was a 50 percent regression in tumor size during a two-week treatment of the mice," Dr. Brekken said. "We also looked at survival groups of the animals, which is often depressing in human therapeutic studies for pancreatic cancer because virtually nothing works. We found not only significant decrease in tumor size, but meaningful prolongation of life with the drug combination."



The drug combination was also effective in an aggressive model of spontaneous pancreatic cancer in mice.



The compound JP1201 was created in 2004 by UT Southwestern researchers to mimic the action of a protein called Smac. The researchers discovered Smac in 2000 and found that this protein plays a key role in the normal self-destruction process present in every cell.



Cell death, or apoptosis, is activated when a cell needs to be terminated, such as when a cell is defective or is no longer needed for normal growth and development. In cancer cells, this self-destruct mechanism is faulty and lead to breaks in the cell-death cascade of events. The synthetic Smac, or Smac mimetic, developed at UT Southwestern inhibits these breaks, allowing the cell to die.



"In essence, we're inhibiting an inhibitor," Dr. Brekken said. "And we're allowing the apoptotic cascade to kick off, resulting in the death of cancer cells."



UT Southwestern researchers are using Smac mimetics in breast and lung cancer research, as well. Dr. Brekken said the next step is to develop a compound based on JP1201 that can be tested in humans in clinical trials.



Other UT Southwestern researchers involved in the study included lead author Dr. Sean Dineen, surgery resident; Dr. Christina Roland, surgery resident; Rachel Greer, student research assistant in the Nancy B. and Jake L. Hamon Center for Therapeutic Oncology Research; Juliet Carbon, senior research associate in surgery and in the Hamon Center; Jason Toombs, research assistant in surgery and in the Hamon Center; Dr. Puja Gupta, a pediatric hematology/oncology fellow; Dr. Noelle Williams, associate professor of biochemistry; and Dr. John Minna, director of the W.A. "Tex" and Deborah Moncrief Jr. Center for Cancer Genetics and of the Hamon Center.



The research was supported by Susan G. Komen for the Cure and Joyant Pharmaceuticals, a Dallas-based company and UT Southwestern spinoff that is developing medical applications of Smac-mimetic compounds.



Source:

Connie Piloto


UT Southwestern Medical Center

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Returning Troops Benefit From Innovative Virtual Reality Exposure Therapy

An article published in a forthcoming issue of the Journal of Traumatic Stress is one of the first to provide evidence of the effectiveness of exposure therapy with active duty military service members suffering from posttraumatic stress disorder (PTSD). The study shows that virtual reality exposure therapy resulted in significant reductions in PTSD symptoms after an average of seven treatment sessions. Additionally, 62 % of patients reported clinically meaningful, reliable change in PTSD symptoms.



During the treatment the soldier repeatedly revisits the memory, and through the use of their imagination they safely access emotions related to the original traumatic experience. Revisiting the memory while safely emotionally engaged, reduces anxiety, and allows the engagement process to be comfortably repeated. Lead author Dr. Greg Reger, "We know that lengthy military deployments in stressful environments with exposure to multiple, potentially traumatic events can lead to the desire to emotionally 'unplug.' By using multi-sensory virtual reality that can be customized in real time, the provider can help activate the memory with relevant sights, sounds, vibrations, even scents that resemble aspects of the event that is haunting them."



A clinical trial with Vietnam veterans and World Trade Center survivors has shown that virtual exposure therapy is an innovative and effective form of treatment. The current research extends those findings to the population of military service members returning from deployments to Iraq or Afghanistan with PTSD.



Reger, "It is possible that virtual reality exposure therapy would provide a more appealing treatment option to a young, technologically savvy generation of service members and veterans. In addition, it is possible that a treatment option like virtual reality exposure would be viewed by some service members as less stigmatizing than traditional treatment approaches. If accurate, virtual reality exposure therapy might provide us with the opportunity to treat service members and veterans who may not otherwise seek help."



Source:

Bethany Carland-Adams

Wiley-Blackwell

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NPA Issues Oral Methotrexate SOP, UK

The NPA has produced a resource to help members, in England and Wales, review their dispensing procedures in order to minimise the risks associated with oral methotrexate therapy. The resource comprises a template Standard Operating procedure (SOP) for the supply of oral methotrexate and guidance notes.


The model NPA SOP incorporates the National Patient Safety Agency (NPSA) guidance from Patient Safety Alert 13 - Improving Compliance with Oral Methotrexate Guidelines. The NPA's SOP and guidance notes draws on the areas specific to community pharmacy.


Ruth Wakeman, NPA Information Department Manager said: "The guidance notes and SOP on supply of oral methotrexate help provide all the necessary information in a straightforward format. It is important for members to ensure that they are complying with the NPSA advice."


'Supplying Oral Methotrexate' can be downloaded from the NPA website npa/members. Although applicable directly to England and Wales, the SOP resource may also be of interest to pharmacy contractors from Scotland and Northern Ireland. All NPA SOPs and information materials can be found within the NPA Document Store area.

National Pharmacy Association

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Risk Of Death Not Reduced By Flu Shot

The widely-held perception that the influenza vaccination reduces overall mortality risk in the elderly does not withstand careful scrutiny, according to researchers in Alberta. The vaccine does confer protection against specific strains of influenza, but its overall benefit appears to have been exaggerated by a number of observational studies that found a very large reduction in all-cause mortality among elderly patients who had been vaccinated.



The results will appear in the first issue for September of the American Journal of Respiratory and Critical Care Medicine, a publication of the American Thoracic Society.



The study included more than 700 matched elderly subjects, half of whom had taken the vaccine and half of whom had not. After controlling for a wealth of variables that were largely not considered or simply not available in previous studies that reported the mortality benefit, the researchers concluded that any such benefit "if present at all, was very small and statistically non-significant and may simply be a healthy-user artifact that they were unable to identify."



"While such a reduction in all-cause mortality would have been impressive, these mortality benefits are likely implausible. Previous studies were likely measuring a benefit not directly attributable to the vaccine itself, but something specific to the individuals who were vaccinated - a healthy-user benefit or frailty bias," said Dean T. Eurich,Ph.D. clinical epidemiologist and assistant professor at the School of Public Health at the University of Alberta. "Over the last two decades in the United Sates, even while vaccination rates among the elderly have increased from 15 to 65 percent, there has been no commensurate decrease in hospital admissions or all-cause mortality. Further, only about 10 percent of winter-time deaths in the United States are attributable to influenza, thus to suggest that the vaccine can reduce 50 percent of deaths from all causes is implausible in our opinion."



Dr. Eurich and colleagues hypothesized that if the healthy-user effect was responsible for the mortality benefit associated with influenza vaccination seen in observational studies, there should also be a significant mortality benefit present during the "off-season".



To determine whether the observed mortality benefits were actually an effect of the flu vaccine, therefore, they analyzed clinical data from records of all six hospitals in the Capital Health region in Alberta. In total, they analyzed data from 704 patients 65 years of age and older who were admitted to the hospital for community-acquired pneumonia during non-flu season, half of whom had been vaccinated, and half of whom had not. Each vaccinated patient was matched to a non-vaccinated patient with similar demographics, medical conditions, functional status, smoking status and current prescription medications.



In examining in-hospital mortality, they found that 12 percent of the patients died overall, with a median length of stay of approximately eight days. While analysis with a model similar to that employed by past observational studies indeed showed that patients who were vaccinated were about half as likely to die as unvaccinated patients, a finding consistent with other studies, they found a striking difference after adjusting for detailed clinical information, such as the need for an advanced directive, pneumococcal immunizations, socioeconomic status, as well as sex, smoking, functional status and severity of disease. Controlling for those variables reduced the relative risk of death to a statistically non-significant 19 percent.



Further analyses that included more than 3,400 patients from the same cohort did not significantly alter the relative risk. The researchers concluded that there was a difficult to capture healthy-user effect among vaccinated patients.



"The healthy-user effect is seen in what doctors often refer to as their 'good' patients - patients who are well-informed about their health, who exercise regularly, do not smoke or have quit, drink only in moderation, watch what they eat, come in regularly for health maintenance visits and disease screenings, take their medications exactly as prescribed - and quite religiously get vaccinated each year so as to stay healthy. Such attributes are almost impossible to capture in large scale studies using administrative databases," said principal investigator Sumit Majumdar, M.D., M.P.H., associate professor in the Faculty of Medicine & Dentistry at the University of Alberta.



The finding has broad implications:
For patients: People with chronic diseases such as chronic respiratory diseases e.g. chronic obstructive pulmonary disease, immuno-compromised patients, healthcare workers, family members or friends who take care of elderly patients and others with greater exposure or susceptibility to the influenza virus should still be vaccinated. "But you also need to take care of yourself. Everyone can reduce their risk by taking simple precautions," says Dr. Majumdar. "Wash your hands, avoid sick kids and hospitals during flu season, consider antiviral agents for prophylaxis and tell your doctor as soon as you feel unwell because there is still a chance to decrease symptoms and prevent hospitalization if you get sick - because flu vaccine is not as effective as people have been thinking it is."


For vaccine developers: Previously reported mortality reductions are clearly inflated and erroneous - this may have stifled efforts at developing newer and better vaccines especially for use in the elderly.


For policy makers: Efforts directed at "improving quality of care" are better directed at where the evidence is, such as hand-washing, vaccinating children and vaccinating healthcare workers.

Finally, Dr. Majumder said, the findings are a reminder to researchers that "the healthy-user effect is everywhere you don't want it to be."



###



Source: Keely Savoie


American Thoracic Society

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Nutraceuticals And Prostate Cancer Prevention: A Current Review

UroToday - Nutraceutical is a new term in prostate cancer research that relates to nutritional or wholistic treatments. Nutraceuticals generally refer to isolated compounds, usually from plant matter, that are unmodified with demonstrated benefit against chronic disease or cancer. A high percentage of patients at risk for prostate cancer or already diagnosed with the disease are interested in alternative therapies such as nutraceuticals. With the highly prevalent nature of PCa and its latent clinical effects, there is intense interest in prevention strategies.


Furthermore, now that many urology practices carry a significant number of patients on active surveillance, mechanisms to retard the disease are a priority. 5 alpha reductase inhibitor therapy is one approach in such patients, but use of these drugs comes at the price of significant side effects and cost. Nutraceutical compounds are generally inexpensive and rarely have any adverse effects unless used at exceedingly high doses.


The most notable nutraceutical compounds examined in prostate cancer prevention are vitamin D, vitamin E, selenium, lycopene, soy, and green tea. Aside from vitamin E, the data on these compounds is largely retrospective and in many cases contradictory. As a consequence, most of these compounds have been ruled out as effective agents against PCa despite a lack of good evidence for their ineffectiveness. Some are still under investigation and new nutraceuticals such as pomegranate are in the cue with over 30 randomized control trials registered in the area of nutraceuticals.


Of these compounds, soy has the most compelling evidence for benefit, albeit moderate in strength, in both primary prevention and patients on active surveillance. Some promising results are also available for green tea and pomegranate. However, we feel that many of the other compounds should not be ruled out based on contradictory low quality case-control studies. The future of these compounds is uncertain, but interest remains high.


We hope future studies will be higher quality in the form of randomized control trials to avoid the confusion of countless contradictory case-control studies. Our review of nutraceuticals in prostate cancer prevention comprehensively surveys the literature on these compounds with discussions on and newer promising compounds.


Greg Trottier, Peter J. Bostrom, Nathan Lawrenstchuk and Neil E. Fleshner as part of Beyond the Abstract on UroToday. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations, etc., of their research by referencing the published abstract.


UroToday - the only urology website with original content global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:
www.urotoday


Copyright © 2010 - UroToday

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Preliminary Evaluation Of Reliability And Criterion Validity Of Actiwatch-Score

Restoration of normal physical activity is a primary objective of most chronic pain rehabilitative interventions,
yet few clinically practical objective measures of activation exist. We evaluated the measurement properties of the Actiwatch-Score (AW-S). We conducted separate trials to examine concordance between units when worn concurrently at the same and different body sites and to compare the AW-S with a validated optical three-dimensional motion-tracking system. The data indicate that the AW-S has excellent interunit reliability and good criterion validity, but its intersite reliability varies with activity type. These results suggest that this device, and those like it, warrants further investigation and is likely to yield valuable data regarding the optimal application of this technology.




The Journal of Rehabilitation Research and Development (JRRD) has been a leading research journal in the field of rehabilitation medicine and technology for over 40 years. Formerly the Bulletin of Prosthetics Research, JRRD debuted in 1983 to include cross-disciplinary findings in rehabilitation. JRRD, a scientifically indexed journal, publishes original research papers, review articles, as well as clinical and technical commentary from U.S. and international researchers on all rehabilitation research disciplines.


JRRD publishes in both print and electronic formats, increasing the journal's dissemination from a hard copy circulation of 8,000 to 2.3 million Web downloads in 2005. Currently, there are over 1,000 peer-reviewed articles available in electronic format and free for downloading. JRRD will initiate an archiving program in 2005 to make all issues of JRRD and the Bulletin of Prosthetics Research available online.


Journal of Rehabilitation Research and Development

Now Available Online and in Print: www.rehab.research.va

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Pollen.com Introduces New Features To Help Allergy Sufferers

Responding to numerous user requests, Pollen, one of the most visited allergy web sites, announced the addition of two new features, Pollen History and Two-City Comparison, to its popular site for people who suffer from seasonal allergies. Pollen, a division of SDI , has also added a shopping feature for those who wish to comparison-shop for anti-allergenic products.


Pollen History provides a 30-day allergy index history by zip code. The proprietary index assigns a weighted value to key factors such as the pollen count, weather, and wind speed and direction. Visitors can use the chart to track whether allergy conditions are increasing or decreasing over time. In the near future, the site will introduce a 90-day look-back, which will be the most extensive pollen history available on the web.


The launch of Pollen History has generated rave reviews from users. One mother wrote in, "This helps me so much! My daughter is not yet 2 and she is suffering from asthma symptoms. When she has a flare-up, I look on here to see if there is a connection with the pollen levels."


The Two-City Comparison Chart, not found on any other web site, allows Pollen visitors to compare the pollen intensity in their own area with that of another location for the next four days by plugging in the two zip codes. The chart that pops up displays bar graphs showing the pollen severity levels in the two locations for each day.


"When people with allergies travel on business, vacation, or relocate, they want to know how the expected pollen levels in other areas compare with what they're currently experiencing," explains Glenn Connery, manager of the application development/web group for SDI. "Our Two-City Comparison helps people plan their medication use and their outdoor activities a little better. The comparison feature has also been used by parents whose children have allergies and are going away to college in a different city."


Pollen will soon expand both Pollen History and Two-City Comparison to include breakdowns of specific pollen sources such as trees, plants, and grasses.


Site visitors can already get more information on pollen-emitting flora by clicking on the icon for Pollen Library. This feature provides data and photos for more than 1100 plant species, searchable by county for all 48 contiguous states in the U.S.


The new "Allergy Buyers Club" feature allows Pollen users to shop online for a wide range of allergy relief and healthy home products, including air purifiers, dehumidifiers, water filters, furnace filters, vacuum cleaners and hypoallergenic bedding.


Pollen, one of the top allergy sites in both Google and Yahoo rankings, reaches more than 200 million people annually. These include over 30 million people who visit the site directly, and 170 million who access Pollen features through radio and TV station websites across the U.S., as well as weather, health and wellness sites.


Over the past decade, Pollen has continuously improved its methodology and created new features to further benefit people with allergies. Many of these ideas have come from users who provide feedback on the site.


"This is a user-driven service," Connery says. "We're fortunate to have such an interested and involved audience, and we try to respond to their suggestions by providing the features that they want. Their feedback really makes a difference in the usefulness of the site."


About Pollen


Pollen, a division of SDI, has been supplying important information to many millions of people with allergic conditions for nearly 10 years. Among its free services are charts of current and predicted pollen levels, pollen histories, e-mail alerts, and educational materials on how to manage seasonal allergies.


About SDI


Since 1982, SDI has been delivering the most innovative healthcare data products and analytic services on the market to the pharmaceutical, biotech, healthcare, medical device, and consumer packaged goods industries. SDI is a leading provider of de-identified patient-level data, as well as real-time localized disease and treatment surveillance and modeling data. SDI takes a consultative approach to designing the best analyses for its clients, combined with expert study execution and analytical expertise to produce superior insights. Its current roster of client companies in the pharmaceutical/biotech sector includes all of the top 20 firms. For more information, call 610.834.0800 or visit survdata.


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Proposed Budget In California Would Cut Cash Assistance To Elderly, Disabled Documented Immigrants

The California Assembly Budget Committee last week released a 69-page counterproposal rejecting a plan by Gov. Arnold Schwarzenegger (R) to eliminate the state's Cash Assistance Program for Immigrants, which provides financial assistance to documented disabled, blind and elderly immigrants, the Contra Costa Times reports (O'Brien, Contra Costa Times, 6/5). The program -- established in 1998 -- covers about 10,000 documented immigrants who are ineligible for Supplemental Security Income because they are not citizens. It provides roughly $860 monthly in assistance for individuals and $1,504 for couples (Ustinova, San Francisco Chronicle, 6/5).

Cutting the program could save the state $111 million, according to Schwarzenegger's proposal. In Alameda and Contra Costa counties, where about 1,100 residents receive benefits from the program, officials say that if the governor's proposal takes effect, many of the program's beneficiaries would seek help from general assistance programs. The general assistance grants provide smaller payouts, but they cost counties more because the money comes from local budgets, according to the Times. Stefanie Pfingstl, a manager of the Contra Costa County Workforce Services Bureau, said the average general assistance payout is $375 per month(Contra Costa Times, 6/5).

Comments
Jane Gelfand, managing legal director at the not-for-profit Positive Resource Center, said the cash assistance program is an "absolute lifesaving benefit for the few people we can get on it," adding, "Without it, there is no income, no health insurance, no housing, no food and no other basic necessities" (San Francisco Chronicle, 6/5).

Pfingstl said, "It's really the most vulnerable group of people," adding that the "impact to the clients is they are going to have less money at a time when the economy is not good." She noted that the Schwarzenegger administration has proposed cutting the program in the past, but the state Legislature blocked the proposal (Contra Costa Times, 6/5).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Results Of The China Seat Belt Intervention

China accounts for around 15% of the world's total number of deaths from traffic accidents each year. Motor vehicle production has tripled since the 1990s and despite the availability of seat belts in almost all passenger cars in China and laws requiring restraint use, the habitual use of seat belts is low. With the human toll alone from road traffic injuries in China around 100,000 deaths per year, there is an urgency to implement such interventions in the major cities.



Lead investigator at The George Institute for International Health, Professor Mark Stevenson says, "Research indicates that the risk of death is reduced by up to 60% in drivers using seat belts compared with those not using a seat belt. Prior to the intervention, around half of all drivers/passengers in Guangzhou used seat belts. Our study shows that, since implementation of the intervention, 62% of drivers and passengers in Guangzhou are wearing a seat belt (with an even greater improvement among taxi drivers - more than 20% increase in seat belt use). This translates into the equivalent of 530 Disability Adjusted Life Years (DALYs) saved as a result of the intervention."



The seat belt intervention utilised a novel blend of scientific expertise with practical approaches including enhanced law-enforcement practices, extensive social marketing and health education. According to Mr. Wu Guanghui of Guangzhou Municipal Bureau of Public Security, "Activities to increase seat belt use, awareness and compliance have been implemented with great success. We accomplished significant improvements in Guangzhou city with seat belt law enforcement training for traffic officers in conjunction with the intensive enforcement program. The results have shown that enhanced police enforcement and road safety communication strategies contributed to raising the prevalence of seat belt use in the city and reducing road traffic injuries.



World Health Organization (WHO) Representative in China, Dr Henk Bekedam noted that the results of the intervention set a good example for other cities in China. "Interventions such as this can save lives. Preventing road injury requires a sustained cross-sectoral effort and the China Seatbelt Intervention has been successful in bringing together a range of important Government, community and private sector partners committed to reducing death and injury on China's roads. WHO is proud to have been part of this effort. The next challenge is replicating these great results around China."



Dr. Zhang Li from the China Ministry of Health said, "Raising the use of seat belts will significantly reduce road traffic deaths and injuries. We are extremely pleased with the outcome of this project which involved strong collaborations of government, scientists, and industry."



Dr. Gary Dirks, Group Vice President and President for BP China added, "We are proud to have contributed to the project that provided the opportunity for government, researchers and industry to work together to build capacity in road safety and at the same time make joint effort to raise public awareness on seat belts."


###



Contact: Emma Orpilla


Research Australia

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Racial Segregation A Strong Factor In Learning Disparities, Study Finds

Racial segregation in the schools is fueling the learning disparity between young black and white children, while out-of-school factors are more important to the growth of social class gaps, according to a study by Emory University sociologist Dennis Condron.



His findings were published in the October issue of the American Sociological Review.



Condron was perplexed by prior research showing that schools narrow the achievement gap among students of varying social classes while widening the gap between black and white students. To tease out possible reasons for this difference, he analyzed data from the Kindergarten Cohort of the Early Childhood Longitudinal Study.



He found that between the fall and spring of first grade, black students' reading and math skills fall almost two months behind those of white students. After controlling for other factors, the data suggested that segregation of schools was a primary driver of this early black-white learning disparity. In contrast, out-of-school factors explained the growth of social class gaps.



"This research adds an important piece to the puzzle of when and why social class and black-white inequalities in academic achievement emerge," says Condron, assistant professor of sociology. "And I hope it raises awareness that social class and black-white achievement gaps come from different sources to some extent. We tend to speak of 'the' achievement gap, but in reality different gaps probably have different sources and require different solutions."



His research also indicated that regardless of social class, black students are less often taught by certified teachers than are white students, and black students are far more likely than white students to attend predominantly minority schools, high-poverty schools and schools located in disadvantaged neighborhoods.



The findings are "a reminder of a persistent problem," Condron says, decades after the 1954 U.S. Supreme Court decision in Brown v. the Board of Education of Topeka struck down state laws establishing separate schools for black and white students.



"De facto segregation remains high these days, with important implications for education," he says. "When it comes to both housing and schools, race trumps class as the central axis upon which blacks and whites are segregated. Real solutions to the black-white achievement gap lie far beyond schools and require changes to society more broadly."



Condron's study is the lead article in the October issue of the American Sociological Review, which also features two other studies of educational inequality.



A specialist in educational disparities, Condron is currently analyzing data on more than 80 countries to research the impact of economic inequality on countries' average achievement levels.



Source:
Beverly Clark


Emory University

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Pennsylvania House Passes Bill Limiting Insurers Ability To Base Rates On Health History For Individual, Small-Business Plans

The Pennsylvania House on Tuesday voted 131-72 to approve legislation (HB 2005) that would limit the ability of insurers to consider certain factors, such as health history, when setting rates for health plans offered to individuals and small businesses, the Pittsburg Post-Gazette reports. The measure would allow insurers to set rates based on age and geographic region.

The bill also would require insurers to spend 85% of premiums on health care. Insurers violating the rule could be required to issue rebates to policyholders. In addition, the legislation would allow the Pennsylvania Department of Insurance to disapprove requests for rate increases if an insurer has not operated efficiently or has not controlled costs for avoidable hospital-acquired infections or chronic disease management.

The provisions of the bill are similar to those included in Gov. Ed Rendell's (D) Prescription for Pennsylvania plan to reduce health care costs and improve quality, the Post-Gazette reports. Rendell spokesperson Chuck Ardo said, "The governor is certainly pleased that progress is being made and is hopeful legislators will see the urgency of working on the rest of the plan."

The House on Tuesday also approved legislation (HB 2098) that would allow insurers to not pay hospitals for preventable medical errors that result in death or serious disability (Fahy, Pittsburgh Post-Gazette, 4/2).

Opinion Piece
Pennsylvania lawmakers are considering proposals that would "provide health insurance for all by 'aggregation,' or patching together" existing state and federal programs and employment-based insurance with "new state pools and/or subsidies," Theodore Marmor, a professor emeritus at the Yale School of Management, and Jerry Mashaw, a professor at Yale Law School, write in a Philadelphia Inquirer opinion piece.

They continue that while the "patchwork approach has obvious limitations ... it avoids the massive political obstacles to a complete overhaul of existing health insurance arrangements," and Rendell's "particular approach has much to like," as it is "more serious about cost control and unified coverage than the Massachusetts program, or the proposals of the presidential hopefuls," they write. The Pennsylvania House has approved "a similar, though less ambitious, version" of Rendell's plan, according to Marmor and Mashaw.

Rendell's plan "mixes his administration's thoughtful reform with fashionable platitudes," such as the idea that expanded coverage of preventive medicine and wellness programs will generate savings, but while these "may be admirable, ... no industrial democracy has constrained the costs of universal health insurance through such devices," the piece states. It concludes, "Such appeals represent the persistent pursuit of panaceas," and "[s]etting panaceas aside would make Pennsylvania's reform approach more convincing" (Marmor/Mashaw, Philadelphia Inquirer, 3/31).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Role Of Aerosols In Climate Change Examined In Science Paper

A group of scientists affiliated with the International Geosphere-Biosphere Programme (IGBP) have proposed a new framework to account more accurately for the effects of aerosols on precipitation in climate models. Their work appears in Science magazine.



The increase in atmospheric concentrations of man-made aerosols - tiny particles suspended in the air - from such sources as transportation, industry, agriculture, and urban land use not only poses serious problems to human health, but also has an effect on weather and climate.



Recent studies suggest that increased aerosol loading may have changed the energy balance in the atmosphere and at the Earth's surface, and altered the global water cycle in ways that make the climate system more prone to precipitation extremes.



It appears that aerosol effects on clouds can induce large changes in precipitation patterns, which in turn may change not only regional water resources, but also may change the regional and global circulation systems that constitute the Earth's climate.



The proposed framework improves scientists' ability to simulate present and future climates by integrating, for the first time, the radiative and microphysical effects of aerosols on clouds. The radiative effects of aerosols on clouds mostly act to suppress precipitation, because they decrease the amount of solar radiation that reaches the land surface, and therefore cause less heat to be available for evaporating water and energizing convective rain clouds. Microphysical effects of aerosols can slow down the conversion of cloud drops into raindrops, which shuts off precipitation from very shallow and short-lived clouds.



Model simulations suggest that this delay of early rain causes greater amounts of cloud water and rain intensities later in the life cycle of the cloud. This suggests that rain patterns are shifting, leading to possible drought in one area and flooding downwind in another area. In addition, greater cooling below and heating above leads to enhanced upward heat transport. Model simulations have shown that greater heating in the troposphere enhances the atmospheric circulation system, shifting weather patterns due to changes convective activity.



Investigations of aerosol/precipitation effects are especially relevant to policy issues, as effects on the hydrological cycle may affect water availability, a great concern in many regions of the world. The IPCC, in its latest climate change assessment report, declared aerosols to be "the dominant uncertainty in radiative forcing (a concept used for quantitative comparisons of the strength of different human and natural agents in causing climate change)". Therefore, aerosols, clouds and their interaction with climate are still the most uncertain areas of climate change and require multidisciplinary coordinated research efforts.



To that end, authors of the Science article are participating in a new, international research project designed to study the connections between aerosols, clouds, precipitation and climate (ACPC project). The project will bring together an international multidisciplinary group of scientists from the areas of aerosol physics and chemistry, cloud dynamics, and cloud microphysics under theauspices of two international research programmes, the International Geosphere-BiosphereProgramme (IGBP) and the World Climate Research Programme (WCRP).



###



The International Geosphere-Biosphere Programme (IGBP) is an international, interdisciplinary scientific research program built on networking and integration that studies global environmental change. It addresses scientific questions where an international approach is the best or the only way to provide an answer. It adds value to a large number of individual, national and regional research projects through integrating activities to achieve enhanced scientific understanding. The Vision of IGBP is to provide scientific knowledge to improve the sustainability of the living Earth.



Source: Mary Ann Williams


International Geosphere-Biosphere Programme

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Secret relationships go sour quickly, according to new study by psychologists

Secret romantic relationships are hot, right? Movies and television dramas are full of them, and they almost always seem
intense, the gateway to a new life filled with promise if not outright ecstasy.


If you believe that, two psychologists who are about to publish research on the subject have a word of advice for you on
Valentine's Day: Get a life.


"We found virtually nothing good in the long-term about secret romantic relationships," said W. Keith Campbell of the
University of Georgia. "In the beginning, the secrecy may increase the allure, but in every study we conducted it was
ultimately detrimental to a quality relationship."


The research, which will be published in March in the journal Personal Relationships, was co-authored by Craig Foster of the
U.S. Air Force Academy.


"Secret relationships seem fun and exciting to many people, but the results of our research do not support that view," said
Foster. "Individuals in secret romantic relationships consistently report lower levels of relationship quality. These results
are inconsistent with a common belief that secret romances are fun and exciting. When individuals think of secret romances,
they probably imagine late-night clandestine meetings where the potential for being caught enhances the romantic experience;
however, a realistic portrait of romantic relationships reveals that maintaining secrecy is more frustrating than fun."



Research on secrecy in romantic relationships is surprisingly thin, the authors say, and that "may be related to a belief
that romantic secrecy is a blithe topic that does not genuinely affect many individuals." Considering how many relationships
are secret and the stress they put on friends and family, not to mention lovers, the lack of information may seem, to many,
downright odd.


There are many reasons for romantic secrecy, of course. The authors cite as examples of relationships that may require
secrecy ones that are homosexual, interracial or interreligious. Just as often, however, secret workplace romances occur, and
though they sometimes fade before causing lasting damage, friends and family are often trapped in a web of divided loyalties
and deceit.


The authors based their conclusions on three studies, based on question-and-answer surveys, with undergraduate students from
the University of North Carolina. In the first study, romantic secrecy predicted lower levels of initial relationship quality
and decreased relationship quality over a two-week period. The second and third studies confirmed that romantic secrecy's
allure rapidly degrades during the beginning weeks of such a relationship.


"Most of those in the survey didn't say they got involved in a secret relationship because it looked like fun," said
Campbell. "The main reason is that they didn't want friends and family finding out."


If secret relationships can be shown to be unsatisfactory for most people, then why are such relationships the backbone of
soap operas, many mainstreams movies and hundreds of books published each year? It may be because it's more about escape than
about love, and of course, since Romeo and Juliet (and really long before) the idea of secret lovers has exerted a strong
pull on the popular imagination.


"Members of secret relationships likely observe others sharing their romantic relationship information with their friends,
while they must continually inhibit the desire to share their own experiences," said Foster. "In the case of severe romantic
secrecy, relationship members are required to lie about their activities and their relationship status for weeks, months or
years. Members of stigmatized relationships, such as homosexual or interracial relationships, may experience additional
frustration as the need for romantic secrecy is enforced by a greater social problem."


Campbell, author of the just-released When You Love a Man Who Loves Himself (Sourcebooks Casablanca) is considered a national
expert on narcissism, and the new study, he says, points out there may be some benefits to secrecy at the very earliest
stages of a secret romantic relationship. Such benefits, however, are currently unclear at best and may well be the topic of
another study on the subject.


Most people in secret relationships end up better off than Romeo and Juliet, of course. Then again, living to regret it might
actually be worse - at least for a dramatist - than apparently blissful sacrifice.


Phil Williams - philfranklin.uga.edu

University of Georgia

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Opening Statement For Meeting Of Joint Committee On Health And Children 's Regarding Recent Legislation Of "Legal Highs", Ireland

The Misuse of Drugs Act 1977 and regulations made thereunder regulate and control the import, export, production, supply and possession of a range of named narcotic drugs and psychotropic substances listed in the Schedules to the Act. An Order of the Government is necessary to declare additional substances to be "controlled drugs" for the purposes of the Act. The Minister for Health & Children then makes regulations to place controls on the import, export, production, supply and possession which are appropriate to the substances which have been declared to be controlled drugs.


At its meeting on 2 March 2010, the Government agreed to a proposal from the Minister for Health and Children to make a Declaration Order under the Misuse of Drugs Act 1977 declaring a range of so-called "legal highs" to be controlled drugs. Following the Government Decision, the draft Declaration Order and associated draft Statutory Instruments were drawn up and on 1 April 2010 these were notified to the EU Commission in accordance with the Technical Standards Directives 98/34/EC and 98/48/EC which require Member States to notify draft technical regulations which may impact on trade. This process involves a 3 month stand still period. However, in light of growing concerns about the health risks associated with the use of legal highs, application was subsequently made to the Commission to use an urgency procedure and forego the 3 month stand still. The EU Commission advised on 10 May 2010 that the legislation could be implemented without the need to await the expiry of the 3 month period.


At its meeting on 11 May 2010, the Government made the Misuse of Drugs Act 1977 (Controlled Drugs) (Declaration) Order 2010 (S.I. 199 of 2010) declaring a range of legal highs to be controlled drugs. On the same day the Minister for Health and Children also signed three Statutory Instruments: the Misuse of Drugs (Amendment) Regulations 2010 (S.I. 200 of 2010), the Misuse of Drugs (Designation) (Amendment) Order 2010 (S.I. 201 of 2010) and the Misuse of Drugs (Exemption) (Amendment) Order 2010 (S.I. 202 of 2010), to give effect to the Government decision.


In this legislation a large range of "legal high" substances, which had been on sale in headshops, were declared to be controlled drugs, including:


- synthetic cannabinoids (contained in SPICE products),


- benzylpiperazine (BZP) and piperazine derivatives (commonly known as 'party pills'),


- mephedrone, methylone, methedrone, butylone, flephedrone, MDPV (often sold as baths salts or plant food), and


- Gamma butyrolactone and 1,4 Butanediol


This legislation has brought under control approximately 200 individual substances and covers the vast majority of products of public health concern, which were on sale in headshops.


The process of introducing controls under the Misuse of Drugs Act is complex, particularly for substances which have legitimate uses but also have the potential to be misused. Some of the substances which have been controlled have legitimate uses in the pharmaceutical and chemicals industries e.g. two of the BZP derivatives are used to manufacture authorised medicines, and GBL and 1,4 BD are widely used in the manufacture of plastics, as industrial solvents, as well as in many consumer products such as paints, toiletries, cleaning products, food products and others. Consequently it was necessary to engage with other Government Departments and organisations to ensure that appropriate and proportionate controls were introduced.


Controlling substances under the Misuse of Drugs Act is an ongoing process which involves national and international cooperation and engagement. Substances are scheduled under the Act in accordance with Ireland's obligations under international conventions and EU Council decisions and/or where there is evidence that the substances are causing significant harm to public health in Ireland. The list of scheduled substances is kept under ongoing review. For example, in 2006 and 2009 respectively, psychotropic ('magic') mushrooms and the party pill BZP were declared controlled drugs and their possession and sale became illegal. At a national level, the Department of Health & Children works closely with the Department of Justice and Law Reform, the Office of the Minister for Drugs, the National Advisory Committee on Drugs, the Gardai, the Customs Service, the Forensic Science Laboratory, the Irish Medicines Board, the Health Research Board and others to monitor emerging trends in the development of new psychoactive substances. At an international level the Department engages with the European Monitoring Centre for Drugs and Drug Addiction and the United Nations Office of Drug Control regarding international trends in the emergence of new substances and drug control.


In addition to the recent controls on legal highs introduced by the Minister for Health and Children, the Minister for Justice and Law Reform is bringing forward the Criminal Justice (Psychoactive Substances) Bill 2010 which aims to ensure that the sale or supply of substances which may not be specifically proscribed under the Misuse of Drugs Act, but which have psychoactive effects, will be a criminal offence.


The Minister for Health and Children will be keeping the list of controlled legal highs under review and has indicated that if individuals seek to circumvent the recent controls on certain legal high substances by importing other substances that are currently not subject to control under the Misuse of Drugs Act, Government approval will be sought to ban additional substances if such substances pose a risk to public health.

Source
Department of Health and Children, Ireland

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Oncogenic Activation Of Androgen Receptor

UroToday - Dr. Hsing-Jien Kung, University of California, Davis presented "Oncogenic Activation of Androgen Receptor" in the session "New Ideas in Prostate Cancer Recurrence after Castration".


Dr. Kung discussed AR activation via mutation and AR activation by neuropeptides. The cell line CWR22 is androgen independent and after castration 35% will demonstrate AI relapse. A subtype CWR22Rv1 is AI, but androgen responsive. The mechanism responsible for this was investigated. A duplication mutation in AR axon 3 results in protein cleavage and is constitutively activated, which was reversible when the wild type AR was transfected back into the cell. Calpain is the enzyme that is responsible for the cleavage to yield the truncated molecule. A Calpain inhibitor blocked this.


Regarding nonsteroidal activation of AR by neuropeptides, androgen-deprivation in cell lines results in neuroendocrine differentiation and AI growth. These cells are post-mitotic, apoptosis resistant, express neuronal markers and release neurokines. Neuropeptides exogenously administered to LNCaP cells resulted in AI growth. Neuropeptide expressing LNCaP cells grown in castrated mice demonstrate nuclear translocation. AR responsive genes (about half) are induced in this model as demonstrated by AR chromatin immunoprecipitation assay (ChIP) on chip assay. The neuropeptide bombesin recruits AR to the proximal ARE promoter site, but not the enhancer site. This suggests that the activation of AR has different conformation with neuropeptide activation compared with DHT activation. A tyrosine kinase complex of Src, FAK and Etk are the mediators of the neuropeptide mediated activation of AR. The Src kinase inhibitor PP2 blocks the AI growth and migration of neuropeptide tumors. AR phosphorylation may be direct or indirect by Src. This paradigm applies to IL-6, IL-8 and other growth factors. This research provides significant insight into growth factor and neurokine mediated activation of AR.


From the SUO/SBUR Joint Meeting - Saturday, May 19, 2007 - AUA Annual Meeting, Anaheim, CA


Reported by UroToday Contributing Editor Christopher P. Evans, MD, FACS


UroToday - the only urology website with original content global urology key opinion leaders actively engaged in clinical practice.


To access the latest urology news releases from UroToday, go to:
www.urotoday


Copyright © 2006 - UroToday

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Sen. Baucus Says He Would Attach SCHIP Funding To Iraq War Spending If Needed

Senate Democratic leaders on Wednesday said that if a consensus cannot be reached with Republicans on a stop-gap spending measure for SCHIP, a spending provision for the program will be attached to an Iraq supplemental bill set to be discussed in late March or early April, CongressDaily reports. An aide for the Senate leadership said this maneuver would be a "last resort" to secure funding. Senate Finance Committee Chair Max Baucus (D-Mont.) said that reauthorization of SCHIP is a top priority for his committee, and he promised that Congress would authorize interim grants for the remainder of this year for 14 states that are expected to face SCHIP funding shortfalls totaling $745 million. Some states, including New Jersey, are expected to run out of funding in the next several weeks. The Senate Finance Committee in May is scheduled to mark up a bill to reauthorize the program, and Baucus expects to have some bipartisan support for the measure. According to CongressDaily, analysts say it would cost $60 billion to cover all those eligible for the program over five years, and the Congressional Research Service estimates that it would cost at least $12 billion in new funding to continue coverage for current beneficiaries. The Bush administration has asked for a $5 billion increase in funding in its fiscal year 2008 budget proposal, which many lawmakers say would be insufficient. New Jersey Gov. Jon Corzine (D) said Bush's recommended funding levels show his "misplaced priorities." Corzine added, "This administration has not done its part, and states have been struggling with the consequences" (Johnson/Cohn, CongressDaily, 2/15).

Adult Coverage Under SCHIP
The AP/Richmond Times-Dispatch on Thursday examined how in recent years some states have expanded SCHIP coverage to include some adults, which now is exacerbating budget shortfalls. The financial crunch has led Bush and other Republican lawmakers to say that it is "time to refocus the program as it was originally intended -- on children," while Democrats say that "the solution to the uninsured problem is not removing health care from those who now have it," the AP/Times-Dispatch reports. Of the six million people enrolled in the program, 640,000 are adults (AP/Richmond Times-Dispatch, 2/15).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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New Think Tank Will Research, Develop Technology To Reduce Medication Errors

A coalition of physician, pharmacy, health insurer and other groups on Wednesday announced the formation of the Center for Improving Medication Management, a think tank based in Washington, D.C., that will conduct research and develop programs on the use of technology to help reduce medication errors, CQ HealthBeat reports. According to sponsors -- which include SureScripts, the American Academy of Family Physicians, the BlueCross and BlueShield Association, Humana, Intel and the Medical Group Management Association -- the center will promote best practices for the use of electronic prescribing technology that links physicians, pharmacists and patients. The center also will conduct research on the use of such technology to improve the dispensation, use and evaluation of medications.

Sponsors maintain that the broad adoption of such technology could help reduce medication errors and provide patients with more information about their treatments. Recent studies have found that only about half of U.S. patients take their medications as prescribed, according to sponsors. Bern Shen, director of strategic planning at the Intel Digital Health Group, said, "Because medication nonadherence is estimated to account for between 10% to 20% of hospital admissions and adds up to $100 billion a year to health care costs in the U.S. alone, innovations related to e-prescription and improving patients' success in taking medications as prescribed have the potential to greatly improve both clinical and economic outcomes."

Carolyn Clancy, director of the Agency for Healthcare Research and Quality, added, "Medication adherence is America's new drug problem." Mark Merritt, president of the Pharmaceutical Care Management Association, said the formation of the center indicates that "e-prescribing is at a tipping point," adding, "The time is right for action" (CQ HealthBeat, 8/15).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Sanofi Pasteur Presents Safety Data On Menactra(R) Vaccine Given To Infants At Infectious Disease Society Meeting

Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), presented Safety of a Quadrivalent (A,C,Y,W-135) Meningococcal Vaccine When Given to Infants with Other Pediatric Vaccines at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) this past weekend. The annual meeting of physicians, scientists, and other health-care professionals who specialize in infectious diseases was held from October 29 through November 1 in Philadelphia, PA.


In the phase III, open-label, controlled, multicenter safety study, infants from the United States were enrolled to receive the quadrivalent, meningococcal conjugate vaccine (MCV4) at 9 months of age and then MCV4 concomitantly with the measles-mumps-rubella vaccine (MMRV), pneumococcal conjugate vaccine (PCV7), and a Hepatitis A (HepA) vaccine at 12 months of age. In the control group, 12-month-olds received only MMRV, PCV7, and HepA.


"The investigators concluded that the two-dose Menactra vaccine was generally well-tolerated by the infants in the study," said Miriam Pina, M.D., Sanofi Pasteur's clinical director who presented the data at IDSA. According to Pina, the most common side effects experienced in this study were minor and short-term, including injection site pain, redness, swelling and irritability.


About Menactra Vaccine


Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is the only licensed conjugate vaccine in the U.S. for persons 2 through 55 years of age for active immunization against invasive meningococcal disease caused by N meningitidis serogroups A, C, Y, and W-135. Since it was first licensed in the U.S. by the Food & Drug Administration in 2005, more than 28 million doses of Menactra vaccine have been distributed.


Side effects to Menactra vaccine include headache, fatigue, and injection site pain, redness, and swelling. Other side effects may occur. Vaccination should be avoided by persons with known hypersensitivity (severe allergic reaction) to any ingredient of the vaccine, including latex (which is used in the vial stopper), or by any persons previously diagnosed with Guillain-Barre syndrome. There is a potential for an increased chance of getting Guillain-Barre syndrome following vaccination. Vaccination with Menactra vaccine may not protect all individuals.


About sanofi-aventis


Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).


Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2008, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development.


Forward Looking Statements


This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.


Source: Sanofi Pasteur

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Outlining The Barriers To Adoption Of Electronic Personal Health Records

Interest in personal health records as an electronic tool to manage health information is increasing dramatically. A group led by a UCSF researcher has identified cost, privacy concerns, design shortcomings and difficulties sharing information across different organizations as critical barriers hindering broad implementation of electronic personal health records.



The barriers are discussed in a paper appearing in the March-April 2009 issue of the journal Health Affairs.



"It is imperative that these barriers hampering adoption of personal health records be addressed. We do not have the 'best of breed' yet, but I do believe that if we encourage nimble innovative solutions, we can achieve the ideal personal health record," said James S. Kahn, MD, professor of clinical medicine at UCSF's Positive Health Program at San Francisco General Hospital.



The paper notes that costs may be offset by improvement in health activities and reduced administrative costs. The difficulty of making personal health record data portable for patients as they change health organizations is a key factor limiting wider and more rapid adoption.



"Personal health records controlled by patients that are interoperable with other systems so that they can take their records with them are also essential for empowering patients and ensuring their control over their own health care. Exploring other technologies such as mobile phones as an easier entry point for consumers to access their records could play an important role as well," said Kahn.



The authors posit a dynamic relationship as patients' behavior influences personal health record acceptance and personal health record adoption influences consumers' behavior.



"For instance, a personal health record could interact with patients through automated mechanisms such as alerts or reminders and improve medication adherence. Consumer-to-consumer interactions through social networking sites could provide group support for healthy behavior changes such as tobacco abatement," said Kahn.



Kahn has directed the development of the Health Care Evaluation Record Organizer (HERO) at Ward 86, UCSF's outpatient HIV/AIDS clinic at San Francisco General Hospital, a public hospital where many patients are in a safety net situation.



"In addition, we need to recognize that some established personal health record vendors may not respond to all patient needs. We are actively trying to understand how personal health records can be used in a safety net setting in a public hospital," added Kahn.



Notes:



Co-authors include Veenu Aulakh, program director at the California Healthcare Foundation and Adam Bosworth, president and CEO of Keas Inc., in San Francisco.



Funding from the Commonwealth Fund and the National Institutes of Health supports Kahn's work.



UCSF's Positive Health Program at San Francisco General Hospital is affiliated with the AIDS Research Institute (ARI) at UCSF. UCSF ARI houses hundreds of scientists and dozens of programs throughout UCSF and affiliated labs and institutions, making ARI one of the largest AIDS research entities in the world.



UCSF is a leading university dedicated to defining health worldwide through advanced biomedical research, graduate level education in the life sciences and health professions, and excellence in patient care.



Source: Jeff Sheehy


University of California - San Francisco

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Removal Of Pelvic Lymph Nodes Or Radiotherapy Cannot Be Recommended As Routine Treatments In Women With Early Endometrial Cancer (Astec Study)

Two Articles published Online first and in an upcoming edition of The Lancet show that two common adjuvant treatments for women with early endometrial cancer - removing the pelvic lymph nodes or external beam radiotherapy - should not be part of routine care. The Articles were Dr Ann Marie Swart, Medical Research Council (MRC) Clinical Trials Unit, London, UK, and Professor Henry Kitchener, University of Manchester, UK, and colleagues on behalf of the ASTEC study group and the ASTEC/EN.5 writing committee.


The first Article examined the benefits of removal of the pelvic lymph nodes (pelvic lymphadenectomy), in addition to the standard treatments of hysterectomy and removal of both ovaries and both fallopian tubes (bilateral salpingo-oophorectomy/BSO). Removal of the pelvic lymph nodes has been used to establish whether or not there is disease outside the uterus and is also a therapeutic procedure. In this randomised trial, the researchers analysed 1408 women from 85 centres in four countries* with endometrial cancer believed to be localised. Of these, 704 were randomly assigned to standard surgery (hysterectomy and BSO, peritoneal washing, and palpation of para-aortic nodes**; while the other 704 were assigned to standard surgery plus pelvic lymphadenectomy. The primary outcome was overall survival.


The researchers found that, after a median follow-up of just over three years, 88 women in the standard surgery died compared with 103 in the lymphadenectomy group - meaning women in the lymphadenectomy group were actually 16% more likely to die in the lymphadenectomy group. When looking at the combined chances of death or recurrent disease, 144 women in the lymphadenectomy group experienced one or the other, compared with 107 in the standard group - an increased risk of 35% for women having their pelvic lymph nodes removed.


The authors conclude: "This randomised trial has shown no evidence of a benefit for systematic lymphadenectomy for endometrial cancer in terms of overall, disease-specific, and recurrence-free survival. This study is one of the largest reported surgical gynaecological cancer trials...Pelvic lymphadenectomy cannot be recommended as routine procedure for therapeutic purposes outside of clinical trials."


In the second Article, the effects of external beam radiotherapy (EBR) are examined. EBR has been offered to women who have had successful surgery (hysterectomy/BSO) for early endometrial cancer, but are considered to have an increased risk of recurrence due to their particular cancer pathology. This Article analyses 789 women from the ASTEC study plus a further 116 from the EN.5 study, from 112 centres in seven countries***. The patients were randomly assigned after surgery to observation (453 women) or to EBR (452). EBR was delivered in 20-25 daily fractions up to the target dose. Again the primary outcome was overall survival.


The researchers found that, after a median follow-up of 58 months, 68 women in the observation group had died, compared with 67 in the EBR group. There was no evidence that overall survival was higher in the EBR group, and 5-year overall survival was 84% in both groups. When combined in a meta-analysis with other trials, these results again showed no benefit for overall survival for EBR. With brachytherapy (placement of a small radioactive pellet near to the cancer site) used in 53% of women in the trial, the local recurrence rate in the observation group at 5 years was 6%.


The authors conclude: "The ASTEC/EN.5 trial has shown no evidence of a benefit
for external beam radiotherapy for early endometrial cancer at intermediate or high risk of recurrence, in terms of overall, disease-specific, and disease-specific
recurrence-free survival. Combining these findings with data from other trials, we can exclude even a very small benefit of radiotherapy on overall survival... Adjuvant
external beam radiotherapy cannot be recommended as part of routine treatment to improve survival for women with early endometrial cancer at intermediate or high risk
of recurrence, and brachytherapy might be preferred for local control."


In an accompanying Comment, Dr Michael Höckel and Dr Nadja Dornhöfer, Department of Obstetrics and Gynaecology, Women's and Children's Centre, University of Leipzig, Germany, say: "For the currently available supplementary treatments 'less may be more' for most patients with early-stage endometrial cancer and 'different may be better' for the patients with high-risk tumours."


*Four countries: UK, Poland, South Africa, New Zealand


**palpation= feeling of the para aortic nodes, which if abnormal would be removed, and, if found to contain cancer would mean that the patient was not eligible for the radiotherapy trial.


***Seven countries: UK, Canada, Poland, Norway, New Zealand, Australia, USA


"Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study."

The writing committee on behalf of the ASTEC study group

The Lancet, December 13, 2008DOI:10.1016/S0140-6736(08)61766-3


Source

Tony Kirby

Press Officer

The Lancet

32 Jamestown Road

Camden

London

NW1 7BY

thelancet

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Pramipexole Clinical Trial Programme In Restless Legs Syndrome (RLS) Reveals New Significant Results

Results from a large pramipexole trial programme in Restless Legs Syndrome (RLS) conducted by Boehringer Ingelheim were presented at the 12th European Federation of Neurological Societies (EFNS) Annual Congress held in Madrid, Spain, from 23 to 26 August. The results of two large Phase IV trials showed that while pramipexole significantly improves the characteristic symptoms of RLS among patients with moderate to severe RLS, it also demonstrated significant beneficial effects on associated symptoms such as limb pain and health-related quality of life, including associated mood disturbance.1,2 Limb pain and mood disturbance are important secondary ailments commonly experienced by RLS patients,3-5 and these studies are the first in which an approved RLS treatment has demonstrated benefits addressing these symptoms in a clinical study in RLS patients.


Study details:


Two combined phase IV double-blind, randomised, 12-week trials assessing the impact of pramipexole on associated pain showed significant improvement in RLS overall and in RLS-associated limb pain in the pramipexole treatment arms (n=381; 0.125-0.75 mg/day) compared with placebo (n=378). (Patients rated pain with a visual analogue scale (VAS) before and after treatment).1


- At endpoint, scores on the International RLS Study Group Rating Scale (IRLS) decreased more (i.e. symptoms were reduced) in patients treated with pramipexole than with placebo (adjusted mean of -14.2 vs -8.1, p

The impact of RLS is far-reaching and goes beyond the uncontrollable urge to move one's legs or the inability to sleep, and, therefore, effective treatments need to address the range of symptoms that limit daily activity experienced by patients. These new data add to the evidence for pramipexole as a simple, effective therapy for patients with moderate to severe RLS.


Please be advised


This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.


About Restless Legs Syndrome (RLS)


Restless Legs Syndrome is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. Restless Legs Syndrome affects up to ten percent of the population worldwide aged between 30 and 79 years6 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.5 The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. Restless Legs Syndrome also has considerable impact on social activities that require immobility.


About pramipexole


Pramipexole (known under the trade names Mirapexin®, Sifrol®, Mirapex® and Pexola®) is a compound from Boehringer Ingelheim research first approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s disease, as monotherapy or in combination with levodopa. Pramipexole was approved in 2006 for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS). Pramipexole is currently marketed in over 70 countries across the globe.


The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, fatigue and dizziness. The most commonly reported adverse reactions in early and late Parkinson's disease in clinical trials were dizziness, nausea, dyskinesia, hypotension, somnolence, insomnia, hallucination, constipation, headache and fatigue.


Pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.


About Boehringer Ingelheim


The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.


In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. boehringer-ingelheim


Related links: Information Pack on Restless Legs Syndrome


References


1 Hornyak M et al. Amelioration of Nocturnal Limb Pain by Double-Blind Pramipexole for Restless Legs Syndrome. Presented 24 August 2008, 12th Annual Meeting of the Associated Professional Sleep Societies (EFNS), Madrid, Spain.; Poster # P1300.


2 Montagna P et al. Effect of Pramipexole on Quality of Life (QOL) in Patients With Restless Legs Syndrome (RLS) and Mood Disturbance. Presented 24 August 2008, 12th Annual Meeting of the Associated Professional Sleep Societies (EFNS), Madrid, Spain.; Poster # P1689.


3 Kushida C et al. Burden of Restless Legs Syndrome on health-related quality of life. Qual Life Res 2006; 16(4):617-624.


4 Hening WC et al. Impact, diagnosis and treatment of Restless Legs Syndrome in a primary care population: REST (RLS epidemiology, symptoms and treatment) primary care study. Sleep Med 2004; 5(3):237-246.


5 Allen RP et al. Restless Legs Syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165(11):1286-1292.


6 Phillips B et al. Epidemiology of Restless Legs symptoms in adults. Arch Intern Med 2000; 160(14): 137-2141.

Boehringer Ingelheim


View drug information on Mirapex; Pramipexole.

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New York Times Profiles Doctor Arrested For Off-Label Prescribing

The New York Times on Saturday profiled Maryland psychiatrist Peter Gleason, who federal authorities arrested in March and later charged for "doing something that has become common among doctors: promoting a drug for purposes other than those approved by the federal government." Federal prosecutors allege that Gleason received large fees from Jazz Pharmaceuticals to promote the narcolepsy medication Xyrem as a treatment for depression and pain relief, uses not approved by FDA. Federal prosecutors allege that Gleason conspired with Jazz to recommend Xyrem for potentially dangerous uses. According to the Times, the case has "put the spotlight on the murky financial relationships between drug companies and the physicians they use to promote their medicines." Pharmaceutical companies, which cannot directly market medications for uses that FDA has not approved, often sponsor seminars or continuing medical education classes and pay physicians to make presentations to promote their products for both approved and off-label uses. The Gleason case "could establish limits on what doctors can do to help companies sell their drugs," the Times reports. Steven Nissen, interim chair of cardiovascular medicine at the Cleveland Clinic, said that the case could "have a chilling effect on physicians because, when we give lectures, we assume that giving an opinion about the use of a drug is not going to get us into legal difficulty" (Berenson, New York Times, 7/22).


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.



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Research Reveals Parents' Stress Leaves Lasting Marks On Children's Genes

Researchers at the University of British Columbia and the Child & Family Research Institute have shown that parental stress during their children's early years can leave an imprint on their sons' or daughters' genes - an imprint that lasts into adolescence and may affect how these genes are expressed later in life.



The study, published online in the journal Child Development, focused on epigenetics - the expression of genes as opposed to the underlying sequence of DNA. A central component of epigenetics is methylation, in which a chemical group attaches to parts of the DNA - a process that acts like a dimmer on gene function in response to social and physical environments.



Michael S. Kobor, a UBC associate professor of medical genetics, measured methylation patterns in cheek cell DNA collected recently by University of Wisconsin researchers from more than 100 adolescents. These patterns were compared to data obtained by the University of Wisconsin in 1990 and 1991, when these same children were infants and toddlers, and their parents were asked to report on their stress levels = including depression, family-expressed anger, parenting stress and financial stress.



Comparing DNA methylation to stress, Kobor's team found that higher stress levels reported by mothers during their child's first year correlated with methylation levels on 139 DNA sites in adolescents. They also discovered 31 sites that correlated with fathers' higher reported stress during their child's pre-school years (three-and-a-half to four-and-a-half years old).



"To our knowledge, this is the first demonstration, using carefully collected longitudinal data, that parental adversity during a child's first years leads to discernible changes in his or her 'epigenome,' measurable more than a decade later," says Kobor, a scientist at the Centre for Molecular Medicine and Therapeutics at the Child and Family Research Institute (CFRI), and a Mowafaghian Scholar at the Human Early Learning Partnership (HELP). "This literally illustrates a mechanism by which experiences 'get under the skin' to stay with us for a long time."



The team also found that fathers' stress level is more strongly associated with DNA methylation in daughters, while mothers' stress level has an effect with both boys and girls. This reinforces other research showing that the absence of fathers or their lack of participation in parenting is associated with an earlier onset of puberty and difficult temperamental traits in girls, but not in boys.



In general, none of the genes whose methylation level correlated with stress were among those best known to play a role in controlling a person's behaviour or reaction to environmental stress. But they did find some genes that had a consistent change in methylation levels at more than one site on the DNA, including one involved in the production of insulin, the hormone that regulates blood sugar levels, and three other genes possibly involved in brain development.



"What is particularly intriguing is that a mother's higher stress levels during infancy, but not during the preschool years, leads to epigenetic changes," says co-author Clyde Hertzman, a professor in UBC's School of Population and Public Health and director of HELP. "And the opposite is true for fathers - it's their higher stress during a child's preschool years, but not during their infancy, that counts."



"These results confirm what early childhood experts have long known - those first few years are a crucial period that sets the stage for much of what happens to the individual later in life," said co-author Thomas Boyce, a professor at UBC's Human Early Learning Partnership and a scientist at CFRI. "It helps explain why a child's socioeconomic status is the single most powerful predictor of childhood health and that individual's lifelong health."



The UBC team's collaborators at the University of Wisconsin were Marilyn J. Essex, a professor of psychiatry, and Jeffrey Armstrong, a psychiatry researcher. UBC research assistants Lucia Lam and Sarah Neumann performed the work in Michael Kobor's lab. The research was supported by the U.S. National Institute of Mental Health, the Canadian Institute for Advanced Research and the Djavad Mowafaghian Foundation.

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