Pope Urges Boycott of Italian Referendum to Loosen Restrictions on Embryonic Stem Cell Research, Fertility Treatment

Pope Benedict XVI on Monday endorsed a call by Italian bishops for voters to boycott next month’s referendum that could repeal some aspects of a 2004 law that banned embryonic stem cell research and restricted access to assisted reproductive technology, the… New York Times reports (Fisher/Povoledo, New York Times, 5/31). The law allows fertility treatments only for heterosexual couples who live together and are of childbearing age and bans the use of donated sperm or eggs, prohibits prenatal screening for abnormalities, and prohibits doctors from freezing embryos or using them for scientific research (Kaiser Daily Reproductive Health Report, 1/18). The referendum, which is scheduled for June 12-13, would repeal several sections of the law, including the provision that defines life as beginning at conception, the bans on donated sperm and eggs and surrogate parenthood, the prohibition of research involving embryos, the requirement that couples undergoing IVF create no more than three embryos at a time and the requirement that embryos cannot be implanted together, according to the New York Times (New York Times, 5/31). In order for the law to be changed, more than 50% of all registered voters must participate in the referendum and the majority of voters must vote in favor of the changes, according to the Los Angeles Times (Wilkinson, Los Angeles Times, 5/31). According to several recent polls, most Italians support the proposed changes but fewer than half of registered voters are expected to vote in the referendum (New York Times, 5/31).

Pope Comments, Abortion Issue
Although the pope on Monday did not use the word “boycott,” he said he was close to the bishops “in word and prayer” and that their stand on the referendum made them “truly good pastors,” according to Reuters (Pullella, Reuters, 5/30). “You are obliged to illuminate the choice of Catholics and of all citizens in the imminent referendum on assisted procreation,” the pope said, while speaking to an Italian bishops’ conference, adding that the Catholic Church in Italy is “defending the sacredness of human life and the promotion of the role of the family in society” (AFP/Yahoo! News, 5/30). However, the pope did not mention any details of the law or referendum, according to the AP/Boston Globe (Simpson, AP/Boston Globe, 5/31). Some opponents of the 2004 law say that the Catholic Church and other supporters of the statute are trying to use it to help repeal Italy’s law allowing legal abortion, the New York Times reports. Because the 2004 law defines life as beginning at conception, opponents say it could “open the door” to repealing the country’s abortion law, which was adopted by referendum in 1981, according to the New York Times (New York Times, 5/31).

“Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily Reproductive Health Report, search the archives, or sign up for email delivery at www.kaisernetwork/dailyreports/repro The Kaiser Daily Reproductive Health 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.

The Growing Epidemic Of Stroke In Women

Studies on unique stroke risk factors among women and gender disparities in stroke care are featured in a special issue of Stroke: Journal of the American Heart Association.

According to an editorial accompanying the special issue, stroke among women is the third leading cause of death, a leading cause of disability and an ongoing epidemic, with women accounting for more than 60 percent of all stroke deaths in the United States.

Publishing such research is timely, said Tobias Kurth, M.D., Sc.D., senior scientist at INSERM Unit 708 – Neuroepidemiology, Paris, France, and associate epidemiologist at Brigham and Women’s Hospital in Boston, Mass., and Marie-Germaine Bousser, M.D., head of the Neurology Department of the Hospital LariboisiГЁre in Paris, editorial co-authors, who wrote, “Projections indicate that the prevalence and incidence of stroke will increase by 2020 in both sexes, but that these figures are magnified in women. By 2050, mortality from stroke will be 30 percent higher in women than men.”

They said while the understanding of stroke in women has been substantially improved over the last decades, “Many open questions in the epidemiology, etiology, and outcome of stroke among women remain, however. Substantive efforts by the American Heart Association/American Stroke Association with their Go Red For Women campaign have been started and will continue to improve the awareness of cardiovascular disease and stroke in women and will induce new research efforts.”

“Science and research have been critical components of our Go Red For Women initiative since its inception,” said Lori Mosca, M.D., Go Red For Women spokesperson and director of preventive cardiology at New York-Presbyterian Hospital. “These new research findings showing women have unique risk factors for stroke and are more greatly impacted by the consequences of stroke should be a wake-up call for women to raise their awareness of stroke risk and for healthcare providers to close treatment gaps that can save lives.”

Among studies presented in this special issue:
Researchers found the overall quality of care for women with ischemic stroke was lower than that for men. They compared the use of seven different treatments that are indicative of excellent evidence-based stroke care in more than 380,000 men and women hospitalized with acute stroke. The treatments included timely use of tPA (clot-busting drug), aspirin (in the hospital and at discharge, which accounts for two treatments), blood thinners (Warfarin), cholesterol treatment, smoking cessation and prevention of blood clots in the legs. These data are from more than 1,100 U.S. hospitals that participated in the American Heart Association/American Stroke Association Get With The Guidelines – Stroke quality improvement program between 2003 and 2008.

“After accounting for baseline differences in age and other health conditions, we found that women were 14 percent less likely to receive perfect care – referred to as defect-free care – compared to men,” said Mathew Reeves, Ph.D., the study’s lead author and associate professor of epidemiology at Michigan State University in East Lansing. “Although the absolute differences were modest, lower quality of care in women was seen in all measures. However, larger, clinically important differences were seen in the proportion of women treated with intravenous tPA and in cholesterol treatment.”

Additionally, the researchers found that after accounting for baseline differences in age and other variables, women had a similar in-hospital death rate following stroke as men, but women were 16 percent less likely to be discharged home following stroke compared to men.

“We found that these sex differences in care cannot be ‘explained away’ based on the obvious gender differences in factors, such as age,” Reeves said. “Future studies should look at aspects of medical care that were not collected in this study; for example, patient or family preference for limitations in care, or physician decisions impacting care delivery.”

In an analysis of the Get With The Guidelines – Stroke database in Colorado, researchers found 47 gender differences among 126 elements studied. Compared to men, women in Colorado were older and more significantly impacted by acute stroke. Men had higher incidences of coronary artery disease, high cholesterol, diabetes, carotid stenosis and tobacco smoking, while women had higher incidences of atrial fibrillation and hypertension. Common prevention strategies, such as use of cholesterol-lowering drugs, were less likely to be used in women at risk for stroke than in men. Authors noted overall acute stroke treatment of women appeared “less aggressive” than for men.

Researchers analyzing data from the Framingham Heart Study observed 1136 strokes (638 in women) during 56 years of follow-up and found that women were significantly older than men at the time of their first stroke. They also found that women had a higher stroke incidence above 85 years of age, lower incidence than men at all other ages and a higher lifetime risk of stroke at all ages.

While researchers found no significant differences between the genders in stroke subtype, severity and case fatality (or death) rates between genders, women were significantly more disabled prior to stroke and in the acute phase of stroke. At three-to-six months post-stroke, women were more likely than men to be disabled, single and institutionalized.

Researchers from Michigan State University found that presenting symptoms did not explain gender differences in emergency department (ED) waiting times for stroke patients. They collected data on 1,922 acute stroke cases at 15 hospitals across Michigan, evaluating the time it took for patients in the ED to be examined by a physician (door-to-doctor time) and the time it took to undergo brain imaging (door-to-image time). They found:

Women were significantly less likely than men to present with at least one typical stroke warning sign or to be identified as a suspected stroke case.

Women had 12 percent longer door-to-doctor and 16 percent longer door-to-image intervals than men.

The results did not change after taking into consideration presenting symptoms, age, delayed arrival to the ED and other variables. Researchers concluded that women who had an acute stroke experienced greater ED delays than men, and that these delays were not attributable to gender differences in presenting symptoms, age or other confounders.

Researchers at the University of Connecticut asked a group of predominately white, well-educated and high-income women, 50 to 70 years old, who had at least one stroke risk factor, to answer a five-part questionnaire about stroke knowledge, risk perception, risk factors, access to health care and demographics.

Only two of the 37 (5.7 percent) women with atrial fibrillation and 11 out of the 71 women with heart disease (15.5 percent) identified their health condition as a risk factor for stroke.

Only 63.9 percent of the women with atrial fibrillation reported taking warfarin or a blood thinner to reduce their stroke risk.

The researchers conclude that educational strategies must advocate for and target high-risk women.

Current recommendations for stroke prevention during early pregnancy in women with a prior stroke history are based on limited evidence, with uncertainty involved in balancing the fetal risk of medication against the maternal risk of recurrent stroke. Researchers in this study surveyed 384 actively practicing U.S. members of the American Academy of Neurology Stroke and Vascular
Neurology section, asking what antithrombotic (or anti-clotting medication), if any, they would use during first trimester pregnancy in women with a prior history of stroke, either unrelated or related to a previous pregnancy.

Of the 230 responses, 75 percent used some form of antithrombotic therapy for women with a history of prior stroke not related to pregnancy and 88 percent used an antithrombotic for women with a history of prior stroke related to pregnancy.

About half chose aspirin and 7 percent chose low molecular weight heparin for stroke unrelated to pregnancy; while 41 percent chose aspirin and 25 percent chose low molecular weight heparin for stroke related to pregnancy.

The authors conclude that while most practitioners agree that women with a history of stroke should receive a medication to prevent stroke during the first trimester, they tend to disagree which drug or drugs to use. They recommend a national registry of maternal and fetal outcome data is needed to guide practitioners in this setting.

Funding sources and individual author disclosures can be found on the respective manuscripts.
To view the special issue of Stroke, go to stroke.ahajournals. To learn more about Go Red For Women, visit GoRedForWomen.

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Statements and conclusions of study authors that are published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association’s policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at americanheart/corporatefunding.

NR09 – 1023 (Stroke/GRFW)

Additional Resources:
Knowing the signs of stroke can be as simple as five easy steps, learn more at strokeassociation/giveme5.

A comprehensive selection of media resources for Go Red For Women can be found at goredforwomen/media_resources.aspx.

The HEART for Women Act is legislation that would help ensure heart disease and stroke are more widely recognized and more effectively treated in women, for more information visit americanheart/heartforwomenact.

The American Stroke Association, a division of the American Heart Association, offers a number of tools and educational materials to strokeassociation.

Power To End Stroke is an education and awareness campaign that embraces and celebrates the culture, energy, creativity and lifestyles of African Americans, visit powertoendstroke.

Stroke Connection magazine offers information to help reduce stroke risks and help stroke survivors live life to its fullest, to learn more go to strokeassociation/strokeconnection.

A comprehensive selection of media resources for heart and stroke disease among African-Americans can be found at: americanheart/presenter.jhtml?identifier=3025278.

More information on the Get With the Guidelines hospital quality improvement program can be found at americanheart/GetWithTheGuidelines

Source: Cathy Lewis

American Heart Association

View drug information on Warfarin Sodium tablets.

Progression Of Parkinson’s Disease May Be Prevented By Widely Used Cholesterol-Lowering Drug

Simvastatin, a commonly used, cholesterol-lowering drug, may prevent Parkinson’s disease from progressing further. Neurological researchers at Rush University Medical Center conducted a study examining the use of the FDA-approved medication in mice with Parkinson’s disease and found that the drug successfully reverses the biochemical, cellular and anatomical changes caused by the disease.

“Statins are one of the most widely used cholesterol-lowering drugs throughout the world,” said study author Kalipada Pahan, PhD, professor of neurological sciences at Rush University Medical Center. “This may be a safer approach to halt the disease progression in Parkinson’s patients.”

Pahan and colleagues from Rush, along with researchers at the University of Nebraska Medical Center in Omaha published these findings in the October 28 issue of the Journal of Neurosciences.

The authors have shown that the activity of one protein called p21Ras is increased very early in the midbrain of mice with Parkinson’s pathology. Simvastatin enters into the brain and blocks the activity of the p21Ras protein and other associated toxic molecules, and goes on to protect the neurons, normalize neurotransmitter levels, and improves the motor functions in the mice with Parkinson’s.

“Understanding how the disease works is important to developing effective drugs that protect the brain and stop the progression of Parkinson’s,” said Pahan. “If we are able to replicate these results in Parkinson’s patients in the clinical setting, it would be a remarkable advance in the treatment of this devastating neurodegenerative disease.”

The study was supported by grants from National Institutes of Health and Michael J. Fox Foundation for Parkinson’s Research.

Parkinson’s is a slowly progressive disease that affects a small area of cells within the mid-brain known as the substantia nigra. Gradual degeneration of these cells causes a reduction in dopamine, which is a vital chemical neurotransmitter. The decrease in dopamine results in one or more of the classic signs of Parkinson’s disease that includes, resting tremor on one side of the body, generalized slowness of movement, stiffness of limbs, and gait or balance problems. The cause of Parkinson’s disease is unknown. Both environmental and genetic causes of the disease have been postulated.

Parkinson’s disease affects about 1.2 million patients in the United States and Canada. Although 15 percent of patients are diagnosed before age 50, it is generally considered a disease that targets older adults, affecting one of every 100 persons over the age of 60. This disease appears to be slightly more common in men than women.

Source: Deborah Song

Rush University Medical Center

Study reveals tobacco’s 6.3 million death toll, UK

Tobacco has killed 6.3 million people – close to the current population of London* – across the UK during the last half
century.

The new figures – released by Cancer Research UK days before No Smoking Day (Wednesday 9 March) – come from Sir Richard Peto,
Professor of Medical Statistics at the University of Oxford.

The statistics include new data on the very high death toll paid by Scotland.

The research was funded by the Medical Research Council, Cancer Research UK and the British Heart Foundation.

Between 1950 and 2000, 42 per cent of deaths in middle age (35-69) in UK men were caused by smoking, peaking in the 1960s
when tobacco caused half of all deaths in middle-aged men.

Over the same time period, tobacco caused 16 per cent of deaths in middle age in UK women, peaking in the late 1980s when
smoking caused about one quarter of all deaths in middle-aged women.

With respect to cancer, smoking continues to cause proportionally more cancer deaths in Scotland than in England and Wales.

Although the number of people who smoke is now decreasing north and south of the border, in the year 2000 smoking still
caused 42 per cent of deaths among Scottish men from cancer, compared with 35 per cent in England and Wales. In women,
smoking caused 28 per cent of deaths from cancer in Scotland, compared with 20 per cent in England and Wales.

The story is much the same for vascular diseases – in England nearly one in five premature deaths* from heart and circulatory
disease in women in 2000 were caused by smoking, but in Scotland, this figure soared to around one in three.

The new statistics also contain some good news. The proportion of deaths in middle age in UK men attributed to smoking fell
from a high of 48 per cent in 1965 to 25 per cent in 2000. In women that proportion fell from a high of 24 per cent in 1990
to 21 per cent in 2000.

These numbers are still falling, chiefly because many people have stopped smoking.

Sir Richard Peto, Professor of Medical Statistics and Epidemiology at Oxford, says: “A lot of people have stopped smoking,
which has led to rates of tobacco deaths falling faster in the UK than anywhere else in the world.

“The proportion of deaths in middle-aged men caused by tobacco in the UK has fallen from about half 40 years ago to
approximately a quarter now. The proportion of UK middle-aged women killed by smoking has fallen from about a quarter 20
years ago to about a fifth now.”

These statistics re-emphasise the benefits of quitting. Stopping at age 50 halves risk of dying of a tobacco related disease,
and stopping at 30 avoids almost all of it.

Sir Richard adds: “On average, those who continue to smoke lose 10 years of life but stopping smoking at ages 60, 50, 40 or
30 gains 3, 6, 9 or the full 10 years of life expectancy. Of those who continue to smoke, half will be killed by their
habit.”

Maura Gillespie, Head of Public Affairs at the British Heart Foundation, says: “These shocking statistics illustrate the
devastating impact of smoking on the lives of people across the country. Stopping smoking is the single most important thing
any smoker can do to stave off heart disease and seize back years of life.

Professor Colin Blakemore, Chief Executive of the Medical Research Council, says: “This unique study has played a crucial
role in our understanding of the links between smoking, disease and prevention. It shows the value of long-term investment in
clinical research to provide accurate information about health and disease prevention. With this information, people can then
make positive choices to improve their health.”

Cancer Research UK’s Director of Tobacco Control, Jean King, says: “These new statistics are startling. The fact that
tobacco’s death toll over the past 50 years equates to nearly the population of London is a graphic illustration of the
devastation smoking causes. Smoking bereaves thousands of families every year. And it damages our economy by killing one of
our greatest resources – people.

“But there is also good news. The UK has seen the world’s most dramatic decrease in tobacco deaths. In part this is due to
more people wanting to quit and successfully doing so.

“Sir Richard Peto’s earlier work with Sir Richard Doll has demonstrated that quitting can greatly reduce the risk of dying
from a smoking-related illness.

“Next week’s No Smoking Day gives current smokers the chance to seek support and to quit.”

ENDS

*(1) Population of London: 7,172,091 (2001 Census) or, out-of-hours, the duty press officer on 07050 264 059.

*(2) Premature death defined as death before the age of 70

Notes for editors

– In Scotland, tobacco killed 682,000 people between 1950 and 2000 – more than the current populations of Edinburgh and
Aberdeen combined*.

– Smoking prevalence in UK men aged 35-59 decreased from over 80 per cent in 1950 to 30 per in 2000.

– In women aged 35-59, smoking prevalence decreased from a peak of 50 per cent in 1970 to 27 per cent in 2000.

– The full data from this study are available at ctsu.ox.ac/~tobacco/contents.htm.

– For tips and advice for anyone giving up smoking visit the No Smoking Day website at nosmokingday or call the NHS smokers’ helpline on
0800 169 0 169 or the Quitline on 0800 00 22 00.

– More than half all cases of cancer can be prevented by simple lifestyle changes according to Cancer Research UK’s Reduce
the Risk campaign which was launched in January.

– Stopping smoking is top of the campaign’s priority list which also includes staying in shape, eating and drinking
healthily, being sunsmart and attending for screening.

*(3) Population of Edinburgh: 448,624 (2001 Census); Population of Aberdeen: 212,125 (2001 Census)

Media contact

If you would like to get in touch with the Cancer Research UK press office, please go to their contacts page.

This is a press
release from Cancer Research UK

Can Adjuvant Vaccination Or Tyrosine Kinase Inhibitors Therapy Play A Role In The Treatment Of Patients With Surgically Resected Renal Cell Carcinoma?

Recurrence rates of patients with localized and surgically treated renal cell carcinoma (RCC) range between 35-65%. Data resulting from several trials indicate cancer-specific survival (CSS) rates after 5 and 10 years of 74.2% and 67.2% – clearly demonstrating the need for adjuvant treatment options for tumor control in these patients, adjusted to the individual oncological risk profile. However, until now there has been no standard adjuvant treatment available for patients at high risk of relapse after nephrectomy. Standard postsurgical follow-up includes aftercare and, in case of tumor progress, surgical resection of metastases and treatment with targeted therapies that generally result in only poor survival rates.

Importantly, with regard on upcoming adjuvant treatment strategies with tyrosine kinase inhibitors (TKI), the question has been raised of whether there is still a role for vaccination therapy in the era of these targeted therapies. In this article, results from current randomized phase-III trials and other relevant studies regarding adjuvant treatment approaches in surgically resected RCC were reviewed with special interest on vaccination immuotherapy – particularly regarding future options of this therapeutic approach.

The main points of this perspective article can be summarized as follow:

– Immunotherapeutic treatment with cytokines (IL-2, IFN-О±) has not been proven to be effective in the adjuvant setting. Also adjuvant radiotherapy, hormonal treatment with medroxyprogesterone acetate, and adjuvant treatment with thalidomide did not show survival benefit in the adjuvant setting. In addition it has to be mentioned that in all published studies examining the above referenced treatment modalities, patients in the trial arms had worse prognoses compared with patients in the control arms.

– The first (and to date, only) phase-III trial demonstrating significantly improved PFS for patients after surgical resection of RCC with special benefit in pT3-tumours from an adjuvant vaccination therapy (Reniale®) was published by Jocham et al. in 2004. However, due to methodologic concerns, Reniale® has not been approved by the EMEA until now. In 2009, a retrospective matched-pair analysis published by May et al. has proven the significant enhancement of PFS and also overall survival in patients treated with (Reniale®)

– Peptide-based vaccination with HSPCC (Oncophage®) did not show significant survival benefit in the largest phase-III trial finished to date regarding adjuvant treatment strategies in RCC, but revealed (not significantly) improved PFS in earlier stage tumours (AJCC stages I/II). OS are not mature to date, but will follow. Further research regarding the efficacy of HSPCC in combination with immunregulatory agents is required.

– Currently, CA-IX is the most promising molecule marker in RCC. A good safety profile and observed benefits in phase-II-trials in metastastic RCC have led to the rationale of using the monocloncal antibody against CA-IX (cG250; Rencarex®) in an adjuvant setting in a placebo-controlled phase-III trial, which started in 2004 and is still ongoing.

– Three phase-III trials examining the influence of the TKIs sunitinib and sorafenib on PFS have started within the recent years. These approaches might be promising not only due to the well-known antiangiogenic but also of immunomodulatory effects of these agents.

– Detection of new TAAs and immunostimulatory peptides and increasing inside in the molecular biology will probably lead to the development of more powerful antigen-specific vaccines in future.

– Patient selection by prognostic scores including tumor specific, clinical, and molecular information is reasonable for scheduling patients to different treatment approaches. Furthermore, preoperative prognostic scores are available making it feasible to schedule patients for treatment strategies requiring presurgical management (e.g. autologous tumor cell vaccination).

– Further research is required regarding adjuvant vaccination therapies combined with immune-enhancing and immunomodulatory therapeutic approaches (e.g. Treg depletion) or currently used antiangiogenic drugs also showing immunomodulatory effects in order to increase the immunological efficacy and, hence, represent possible promising treatment strategies especially in lower stage RCC.

Brookman-May Sabine, May Matthias 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:
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Medicare Advantage Is Reducing Preventable Hospital Readmissions For Seniors

A new analysis of federal and state government data provides further evidence that seniors in Medicare Advantage have lower risk-adjusted hospital readmission rates than patients in Medicare’s traditional fee-for-service (FFS) program, according to a report released by America’s Health Insurance Plans (AHIP). The study analyzed data from nine states and found reductions in risk-adjusted hospital readmission rates averaging 14-29 percent among seniors in Medicare Advantage compared with Medicare FFS enrollees.

Preventing avoidable hospital admissions and readmissions protects patients from the risks associated with inpatient settings, such as infection, and is an indication that patients are getting the care and services they need on an outpatient basis to stay healthy and avoid complications that can lead to hospital readmissions.

According to a study published in the New England Journal of Medicine, nearly one-fifth (19.6 percent) of Medicare fee-for-service beneficiaries who had been discharged from a hospital were rehospitalized within 30 days, and 34 percent were rehospitalized within 90 days. Moreover, half of patients who were rehospitalized within 30 days did not have a physician visit between the time of discharge and rehospitalization – suggesting that one of the reasons patients ended up back in the hospital was lack of needed follow-up care.

“There is a crisis facing our nation’s health care system with the increase and frequency of preventable hospital readmissions that has significant patient safety and quality implications,” said Karen Ignagni, President and CEO of AHIP. “Health plans have implemented programs that are helping patients get appropriate follow-up care and avoid preventable hospital readmissions and emergency room visits. These programs can serve as a model for policymakers on how to address this important issue.”

Addressing preventable hospital readmissions has been a top priority for policy experts, lawmakers, and health care stakeholders. In fact, the recently enacted Patient Protection and Affordable Care Act of 2010 requires Medicare to establish a hospital readmissions reduction program beginning in 2013. The program would reduce payments to specified hospitals for certain readmissions.

The new AHIP report was based on an analysis of hospital discharge datasets provided by the Agency for Healthcare Research and Quality (AHRQ) as well as state discharge data acquired directly from the states of Pennsylvania and Texas. In the states studied, estimated risk-adjusted readmission rates were about 27-29 percent lower in Medicare Advantage than Medicare FFS per enrollee, 16-18 percent lower per person with an admission, and14-17 percent lower as measured per hospitalization.

This report is the fourth in a series of studies comparing patterns of care among patients with Medicare Advantage coverage and in Medicare’s traditional fee-for-service program. The new nine-state report is an expanded version of a preliminary AHIP report released in September 2009, which showed reductions in certain risk-adjusted readmission rates of 15 percent in California and 33 percent in Nevada.

AHIP has also entered into a partnership with MedAssurant, Inc., a leading health care research and solutions provider, to further study readmission rates among seniors in Medicare Advantage and fee-for-service Medicare. MedAssurant has a large dataset uniquely suited for this purpose. Preliminary findings have yielded similar results to previous AHIP reports, and have been submitted to a medical journal for publication.

“There have been significant changes to the Medicare Advantage program over the past several months,” said Cary Sennett, MD, PhD, MedAssurant’s Chief Medical Officer who is leading the MedAssurant analysis. “We think it vital that policy be informed by research, and are pleased to bring our analytic capabilities to AHIP to assure that this research is available to the policy-making community.”

AHIP also released a new publication that provides company specific examples of the types of programs and services that health plans have implemented to reduce preventable hospital admissions, readmissions, and emergency room visits. Examples of the types programs include the following:

- Expanding patient access to urgent care centers, after-hours care, and nurse help lines give patients safe alternatives to emergency rooms for non-emergency care.

- Arranging for phone calls and, in some cases, in-home visits by nurses and other professionals to make sure that follow-up appointments are kept, medications are being taken safely, care plans are being followed, medical equipment is delivered, and home health care is being received.

- Offering intensive case management to help patients at high risk of hospitalization access the medical, behavioral health, and social services they need.

- Arranging for home visits by multidisciplinary teams of clinicians, who provide comprehensive care, teach patients and their caregivers how to take medications correctly, and link families with needed community resources.

- Revamping physician payment incentives to promote care coordination and improved health outcomes.

Source
America’s Health Insurance Plans

Largest-ever Study On Kidney Disease In Children To Be Led By Johns Hopkins Children’s Center

The early progression of chronic kidney disease in children and teens is poorly understood, but a national research team led by Johns Hopkins scientists is launching the largest-ever study to learn more about this often-stealthy killer.

“There has never, to our knowledge, been a study designed to systematically assess the changes in kidney function over time in children with early kidney disease and to determine how these changes affect behavior, learning, heart disease risk and growth,” says Susan Furth, M.D., Ph.D., a nephrologist at the Johns Hopkins Children’s Center, one of the project’s three principal investigators and lead author of a report on the study, appearing in the Clinical Journal of the American Society of Nephrology.

This NIH-funded, 57-center study hopes to follow over a period of four years 540 children ages 1 through 16 with mild to moderate kidney disease. The Johns Hopkins Children’s Center is one of two clinical coordinating sites, along with the Children’s Hospital at the University of Missouri-Kansas City. The Johns Hopkins Bloomberg School of Public Health is the study’s data coordinating center.

Researchers will collect blood, urine, fingernail and hair samples and will monitor kidney function, height, weight, blood pressure and heart disease by the use of echocardiograms. Periodic surveys are planned to track everything from quality of life and social and cognitive development to sexual maturation during puberty, which is often delayed in teens with kidney disease. Patients will fill out questionnaires detailing everything from symptoms, to use of medications and dietary supplements, to lifestyle and exercise. Researchers will harvest cell lines to study the genetic elements of kidney disease.

Results will be reported incrementally, but some preliminary findings are already in. For example, using data from the pilot study, researchers have refined an existing method – used mostly in Europe – that measures glomerular filtration rate (GFR). GFR, which measures the kidneys’ filtering capacity, is the most precise indicator of kidney function and status.

The new, improved method, which measures how fast the kidneys clear an injected contrast agent from the blood, promises to become the new gold standard for kidney function estimates in clinical trials and will also help researchers refine existing GFR-estimate formulas that doctors use for children. The current methods for estimating GFR yield faulty results in children 25 percent of the time.

Kidney disease in children tends to start and evolve silently. More than one-third (37 percent) of kidney transplant patients in 2001 were between the ages of 20 and 44, and the majority of them likely developed the disease in childhood, researchers say. Researchers estimate that 650,000 Americans will develop end-stage renal disease by 2010, costing the health care system $28 billion a year.

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Co-investigators in the study are Alvaro Muсoz and Stephen Cole of the Johns Hopkins Bloomberg School of Public Health; Marva Moxey-Mims of the National Institute of Diabetes and Digestive and Kidney Diseases; Frederick Kaskel of Montefiore Medical Center, New York; Robert Mak of Oregon Health & Science University; George Schwartz of the University of Rochester, New York; Craig Wong of the University of New Mexico; and Bradley Warady of the University of Missouri-Kansas City.

Founded in 1912 as the children’s hospital of the Johns Hopkins Medical Institutions, the Johns Hopkins Children’s Center offers one of the most comprehensive pediatric medical programs in the country, from performing emergency trauma surgery, to finding causes and treatments for childhood cancers, to delivering a child’s good bill of health. The Johns Hopkins Children Center’s Pediatric Trauma Service is Maryland’s only state-designated trauma center for children. With recognized Centers of Excellence in 20 pediatric subspecialties including cardiology, transplant, psychiatric illnesses and genetic disorders, Children’s Center physicians, nurses and staff provide compassionate care to more than 90,000 children each year. For more information, please visit: hopkinschildrens/

Contact: Katerina Pesheva
Johns Hopkins Medical Institutions

When ICU Docs Help Take Care Of Brain Dead Donors, More Organs Saved For Transplant

More than twice as many lungs and nearly 50 percent more kidneys could be recovered for transplant operations if intensive care physicians were to work with organ procurement organization (OPO) coordinators to monitor and manage donor bodies after brain death has occurred, according to an analysis by UPMC and University of Pittsburgh School of Medicine physicians that is now in the online version of the American Journal of Transplantation.

After a patient who has consented to be an organ donor is declared brain dead, an OPO coordinator takes over medical management and intensive care unit (ICU) physicians typically are no longer involved, explained lead author Kai Singbartl, M.D., assistant professor of critical care medicine at the University of Pittsburgh School of Medicine and a UPMC intensivist. The OPO coordinators follow established protocols to maintain tissues and organs for eventual transplant.

“Our analysis shows an intensivist at the donor’s bedside who aids and advises the OPO coordinator can result in a greater likelihood of recovering organs that are deemed acceptable for transplant, which would mean that each donor could help us save more lives, ” he said. “The gap between the number of people on waiting lists and the number of available organs is growing, so measures that increase the pool of organs are very much needed.”

In 2008, UPMC Presbyterian implemented an intensivist-led organ donor support team (ODST) approach in which after a potential organ donor was declared brain dead, one of six dedicated intensivists, who did not provide care for the donor prior to death, joined the OPO coordinator at the bedside. Standard protocols were supported by physician interventions, such as adjustments to optimize oxygenation and meticulously balance blood pressure and flow, fluids and other bodily functions to optimize the likelihood of sustaining as many organs as possible for transplant.

“We would care for donors for a few hours or up to a day, depending on medical needs and other factors,” Dr. Singbartl said. “The number of donors in our study is not large enough to determine whether a particular medical intervention played a key role, but it’s very clear from our experience that this team approach did make a difference.”

Data from adult brain dead donors between July 1, 2008 and June 30, 2009 was compared to data from July 1, 2007 to June 30, 2008, before the ODST approach had been used. In the earlier time period, 31 percent, or 66 out of 210 potentially available organs were transplanted. In the ODST period, 44 percent, or 113 out of 258 potentially available organs were transplanted.

Most of the increase after implementation of the ODST approach was due to a more than 200% increase in transplanted lungs and a nearly 50% percent increase in transplanted kidneys. Heart and liver transplant rates did not change significantly.

“Conversion of medically unsuitable donors into actual donors, better resuscitation of unstable donors, optimization of organ function, and improved communication between OPO staff, ICU team and transplant surgeons” or the combination of these factors likely contributed to success and should be further evaluated, the researchers said.

Notes:

Co-authors include Raghavan Murugan, M.D., A. Murat Kaynar, M.D., David W. Crippen, M.D., Richard L. Simmons, M.D., and Joseph M. Darby, M.D., Departments of Critical Care Medicine and Surgery, University of Pittsburgh School of Medicine; and Kurt Shutterly, R.N., and Susan A. Stuart, R.N., Center for Organ Recovery and Education, Pittsburgh, Pa.

Source:
Anita Srikameswaran
University of Pittsburgh Schools of the Health Sciences

Tengion Adds The Johns Hopkins Hospital As An Additional Clinical Trial Site For Its Phase I Neo-Urinary Conduit™ Clinical Trial

Tengion, Inc., a leader in regenerative medicine, announced it has added The Johns Hopkins Hospital in Baltimore, Maryland as a second clinical trial site for its Phase I clinical trial of the Company’s lead product candidate, the Tengion Neo-Urinary Conduit™, in bladder cancer patients requiring bladder removal.

“The addition of Johns Hopkins as the second clinical trial site is expected to expand enrollment efforts already underway at the University of Chicago site by expanding the pool of potential patients considered for entry in the trial,” said Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion. “With its well-deserved international reputation for clinical excellence, we believe that Johns Hopkins and the Brady Urological Institute is an ideal site for our first clinical trial of this novel technology.”

In addition to the participation of the primary investigator, Trinity Bivalacqua, M.D., Ph.D., the addition of Johns Hopkins as a study site allows for the participation of Mark Schoenberg, M.D., Bernard L. Schwartz Distinguished Professor of Urologic Oncology as a sub-investigator in the study. Dr. Schoenberg, a leader in urologic oncology, has consulted with Tengion on the development of the Neo-Urinary Conduit and the study’s surgical protocol for the past 3 years. His consulting relationship with Tengion and participation as a sub-investigator are being managed by the Johns Hopkins University School of Medicine in accordance with its conflict of interest policies.

The initiation of the Phase I Neo-Urinary Conduit clinical trial at the University of Chicago was announced earlier this year. The study, which initially will enroll up to five patients with bladder cancer following bladder removal (cystectomy), is designed to establish the safety profile for the product as well as to optimize the surgical technique and the ideal post-surgical patient care that is intended to provide superior clinical outcomes. Utilizing the Company’s proprietary organ regeneration technology, the Neo-Urinary Conduit is an implant designed to catalyze regeneration of native-like urinary tissue in patients who require a urinary diversion following cystectomy. The Neo-Urinary Conduit is produced using the patient’s own smooth muscle cells from a routine fat biopsy and not cells from the diseased bladder, eliminating the risk of reintroducing cancerous cells from the bladder into the patient.

About Bladder Cancer

According to the National Cancer Institute, bladder cancer is the sixth most common form of cancer in the United States with approximately 10,000 cases per year of bladder cancer requiring bladder removal. Following bladder removal, patients require some form of urinary diversion. Most patients are currently treated by using a segment of bowel tissue to construct a conduit for urine to exit from the body into an ostomy bag. In its simplest form, the reconstruction involves creating a tubular structure out of bowel tissue and then connecting it to the ureters at one end and the skin at the other.

Forward-Looking Statements

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to the Company’s: (i) plans to develop and commercialize its product candidates, including the Neo-Urinary Conduit; and (ii) ongoing and planned preclinical studies and clinical trials. Although the Company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the Company’s business is subject to significant risk and uncertainties, and there can be no assurance that its actual results will not differ materially from its expectations. These risks and uncertainties include, among others: (i) the Company may have difficulty enrolling patients in its clinical trials, including the Phase I clinical trial for its Neo-Urinary Conduit; (ii) patients enrolled in the Company’s clinical trials may experience adverse events related to its product candidates, which could delay the Company’s clinical trials or cause the Company to terminate the development of a product candidate; and (iii) the Company may be unable to progress its product candidates that are undergoing preclinical testing into clinical trials. For further information with respect to factors that could cause the Company’s actual results to differ materially from expectations, reference is made to the reports the company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or expectations contained in this release.

Source: Tengion, Inc

First treatment for deadliest form of stroke unveiled at 5th World Stroke Congress in Vancouver

People who suffer from intracerebral haemorrhage, the deadliest form of stroke, have the first effective treatment, according to a presentation by Novo Nordisk today at the 5th World Stroke Congress in Vancouver. Through the most comprehensive clinical trial on hemorrhagic stroke, NovoSeven® (recombinant Factor VIIa, rFVIIa) has shown to reduce bleeding and have a positive impact on disabilities associated with intracerebral haemorrhage (ICH) when administered early after onset.

ICH is the most deadly and least treatable form of stroke. ICH patients face the highest rates of mortality or severe disability of all stroke victims, and until now no proven ICH treatment has been identified. Those patients who survive an ICH are left with more severe resulting disabilities and complications than survivors of other forms of stroke [1], including – often total – loss of movement, speech and mental capability.

“We are extremely encouraged by this trial data for NovoSeven®, which confirms there is at last a proven, safe treatment for this most deadly type of stroke,” said Lars Rebien Sшrensen, president and CEO of Novo Nordisk. “NovoSeven® may finally offer a much-needed lifeline to ICH patients. This study of the use of NovoSeven® in ICH is a major breakthrough for ICH patients and specialists.”

“It is also an extraordinary extension of the positive results obtained in the treatment of trauma victims late last year and an important development for Novo Nordisk’s R&D pipeline and our NovoSeven® expansion programme. At present we are also exploring the potential for this versatile product in other critical bleeding scenarios such as surgery and gastrointestinal bleeding.”

A non-invasive, direct treatment

By travelling to the ICH site through the circulatory system, rFVIIa reaches ruptured vessels in the brain without invasive surgery, and can accelerate the coagulation process from within. In this way, rFVIIa can limit the haematoma (blood leakage) size, which is a vital predictor of outcome for ICH patients. Smaller haematomas are less damaging to the brain, and are related to better clinical outcomes for patients2.

Promising results

The results show that NovoSeven® can reduce haemorrhage growth when administered early and has impact on the major functional neurological and disability measures.

Importantly, results demonstrated that patients treated with NovoSeven® had significantly improved neurological and functional outcome after treatment, implying a lasting patient benefit in terms of reduced disability and dependency on help. This is the first time such encouraging results have been observed in any ICH trial.

The study showed that treatment with NovoSeven® for ICH was associated with a minor, non-significant increase in thromboembolic events that was vastly outweighed by highly significant clinical benefits across the trial.

This is the largest ICH study performed to date and represents a significant advance in Novo Nordisk’s knowledge of ICH evolution and ability to improve its management strategies around this clinical setting.

“There is no question that NovoSeven® is a major advance in the field of ICH research,” said Dr Stephan Mayer, associate professor of Neurology and Neurosurgery, Columbia University, New York. “This trial data, which suggests the wait for a recognised ICH treatment may soon be at an end, will be welcomed worldwide. This could benefit many thousands of lives a year.”

Next steps

Novo Nordisk will immediately liaise with regulatory agencies in the effort to achieve approval for the use of NovoSeven® as the first treatment of ICH.

About NovoSeven®:

– NovoSeven® has been successfully treating people with haemophilia with inhibitors since 1996, when it was first approved. NovoSeven® is approved in this indication in the US, Japan and the EU. In the EU NovoSeven® is also indicated for the treatment of bleeding episodes in people undergoing surgery or invasive procedures with congenital FVII deficiency or with Glanzmann’s thrombasthenia with antibodies to GPIIb-IIa and/or HLA, and with past or present refractoriness to platelet transfusions.

About ICH:

– Intracerebral Haemorrhage (ICH) is bleeding within the brain which starts spontaneously rather than from external factors such as head trauma. During ICH, blood accumulates in the brain, creating a reservoir of blood called a haematoma. Larger haematomas are more likely to create permanent brain damage which can cause severe permanent physical and mental disability, and in many cases death.

– Stroke is estimated to occur in over 700,000 [2] patients a year of which approximately 10-15% will be ICH (the US only). This represents over 80,000 patients. Mortality occurs in approximately 35-52% of these patients within one month, and only 20% of the remaining patients are likely to be living independently.

About the trial:

– This large international phase II ICH trial began in August 2002. 400 patients were involved in a multi-center (20 countries worldwide), randomized, double-blind, placebo-controlled trial. Patients were divided into four groups of 100 patients, comparing 3 doses of rFVIIa (40, 80, and 160 µg/kg) with placebo. Patients all had spontaneous ICH confirmed by Computed Tomography (CT) scan within 3 hours of onset, and were treated within 1 hour of the admission CT scan.

– The outcome measures were change in ICH volume between admission and 24 hour CT scans, the proportion of patients who were dead or severely disabled at 90 days, and overall adverse effects over the study period.

About the 5th World Stroke Congress:

Attracting 2,000 delegates from around the world, the fifth quadrennial World Stroke Congress in Vancouver, British Columbia, Canada, features the brightest medical minds, research and advancements in the study of stroke, the second leading cause of death and the first leading cause of disability worldwide. kenes/stroke2004/wel.htm.

For more information:
Linda Bilben, Reputations Corporation, 604-689-8801, 604-781-9297
Ian Edwards, Reputations Corporation, 604-689-8801, 604-816-7291
Susan T Jackson, Novo Nordisk, 609-919-7776
Gitte Dethlefsen, Novo Nordisk, (+45) 4442 1960

CONTACT:
Carole Bullock
at the World Stroke Congress
Vancouver, B.C.
(214) – 706-1279