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The results of a Phase IIa clinical trial of BrachySil for the treatment of advanced, inoperable pancreatic cancer were presented at American Society of Clinical Oncolgy-GI (ASCO-GI) this weekend in a poster presented by Dr. Paul Ross, Chief Investigator in the study and Consultant Medical Oncologist at Guy's and St. Thomas' NHS Foundation Trust.

The trial, designed as a safety study, successfully showed that BrachySilTM, in combination with standard chemotherapy (gemcitabine), was well tolerated with no clinically significant adverse events related to BrachySil. Data showed disease control in 82% of patients and an overall median survival of 309 days. BrachySil was found to be easily deliverable by endoscopic ultrasound. BrachySilTM is a novel oncology product which comprises a combination of BioSiliconTM, a proprietary porous silicon, and the isotope 32Phosphorus, a proven anti-cancer therapeutic.

"These findings are very interesting, and although this was a small study and was not designed to prove efficacy, these results are encouraging," said Dr. Ross.

In the trial, seventeen patients were treated with BrachySil injected directly into the primary tumors via endoscopic ultrasound (used to assist in locating the delivery point). All patients had advanced inoperable pancreatic cancer and received gemcitabine in addition to BrachySil. CT assessments of response were performed at weeks 8, 16 and 24. The study was conducted at three major centers for cancer therapy: Guy's and St Thomas' NHS Foundation Trust, UK, University Hospital Birmingham NHS Foundation Trust, UK and Singapore General Hospital.

Pancreatic cancer is the fourth most frequent cause of cancer death, and at least 80% of patients present with inoperable locally advanced or metastatic disease. The median survival for these patients following diagnosis is typically less than six months with standard chemotherapy. Accordingly, there is significant clinical and market demand for more effective therapies.

Dr Paul Ashton, Managing Director of pSivida Limited, the company that developed BrachySil and sponsored the trial, said, "We are very pleased with the favorable results of this study of BrachySil for the treatment of advanced, inoperable pancreatic. Our next step for BrachySil is a dose-ranging study planned to commence this quarter."

http://psivida.com/

A new study sheds light on the relationship between women who smoke while pregnant or are exposed to second-hand smoke and an increased risk of SIDS to their babies.

Researchers at McMaster University have found a mechanism that explains why an infant's ability to respond to oxygen deprivation after birth-or a hypoxic episode-is dramatically compromised by exposure to nicotine in the womb, even light to moderate amounts.

The findings are published online in the journal Federation of American Societies for Experimental Biology (FASEB) and will appear in the May 2008 print issue.

"While cigarette smoke contains many different compounds, we found there is a direct impact of one component, nicotine, on the ability of certain cells to detect and respond to oxygen deprivation," says Josef Buttigieg, lead author and a PhD graduate student in the department of Biology. "When a baby is lying face down in bed, for example, it should sense a reduction in oxygen and move its head. But this arousal mechanism doesn't work as it should in babies exposed to nicotine during pregnancy."

The research, which was conducted on laboratory rats in collaboration with Dr. Alison Holloway, explains the critical role that catecholamines-a group of hormones released by the adrenal glands-play in a baby's transition to the outside world.

During birth, the baby is exposed to low oxygen, which signals the adrenal glands to release the catecholamines, which contain adrenaline, or the 'fight or flight' hormone, explains Buttigieg.

It is these catecholamines that signal the baby's lungs to reabsorb fluid, to take its first breath, and help the heart to beat more efficiently. And for some months after birth, the adrenal gland still acts as an oxygen sensor, aiding in the baby's arousal and breathing responses during periods of apnea or asphyxia. But the ability to release catecholamines during these moments-a critical event in the adaptation of life outside the womb-is impaired due to nicotine exposure.

"At birth, the nervous control of the adrenal gland is not active and so a baby relies on these direct oxygen sensing mechanisms to release catecholamines," says Colin Nurse, academic advisor on the study and a professor in the department of Biology. "But nicotine causes premature loss of these mechanisms, which would normally occur later in development after nervous control is established. Thus, the infant becomes much more vulnerable to SIDS."

http://www.mcmaster.ca/

For some women, digital mammography may be a better screening option than film mammography, according to newly published results from a national study led by a University of North Carolina at Chapel Hill researcher.

The results, from the Digital Mammographic Imaging Screening Trial (DMIST), appear in the February issue of Radiology. UNC's Dr. Etta D. Pisano is principal investigator and lead author of the study, which found that digital mammography performed better than film mammography for pre- and perimenopausal women under age 50 with dense breasts.

"We looked at a cross-section of characteristics," Pisano said. "This paper confirms that if you are under 50, pre- or perimenopausal, and have dense breasts, you should definitely be screened with digital rather than film."

Pisano is Kenan professor of radiology and biomedical engineering and vice dean for academic affairs and in the UNC School of Medicine. She is also director of the Biomedical Research Imaging Center and a member of UNC Lineberger Comprehensive Cancer Center.

DMIST enrolled 49,528 women at 33 centers in the U.S. and Canada. The women underwent both digital and film mammography. Breast cancer status was determined for 42,760 women.

"The original DMIST results showed that digital was statistically similar to film in the overall screening population but performed better than film in pre- and perimenopausal women under 50," Pisano said.

For this paper, the researchers sought to retrospectively compare the accuracy of digital mammography versus film mammography in subgroups defined by combinations of age, menopausal status and breast density, using either biopsy results or follow-up information.

They compared results in 10 different subgroups of women: pre- and perimenopausal women under age 50 with fatty breasts, pre- and perimenopausal women under age 50 with dense breasts, postmenopausal women under 50 with fatty breasts, postmenopausal women under 50 with dense breasts, pre- and perimenopausal women between the ages of 50 and 64 with fatty breasts, pre- and perimenopausal women age 50 to 64 with dense breasts, postmenopausal women age 50 to 64 with fatty breasts, postmenopausal women age 50 to 64 with dense breasts, women over age 65 with fatty breasts and women over 65 with dense breasts.

The results confirmed the trial's original findings in favor of improved diagnostic accuracy of digital mammography over film for pre- and perimenopausal women under 50 years old with dense breasts. The findings also showed a trend toward improved diagnostic accuracy of film over digital mammography for women over 65 with fatty breasts. However, this finding was not statistically significant, and further investigation is needed to determine the reason that film performed slightly better in this subgroup. For other groups evaluated, there was no significant difference.

http://www.unc.edu/

Even low-intensity group support helps motivate young American Indian women to hit the produce aisle, a new study suggests.

After participating, these women reported upping their intake of fruits and vegetables - a dietary change that can lower this population's increased risk of developing type 2 diabetes.

The study targeted urban American Indian women, ages 18 to 40, because more than half of American Indians live in cities and they often have limited access to diabetes-prevention services, said lead author Janice Thompson, Ph.D., of the University of Bristol in England.

In the study, published in the March issue of the American Journal of Preventive Medicine, women learned about diet and exercise strategies in monthly, two-plus hour sessions with trained American Indian facilitators. Of 200 original participants, 135 stayed with the study for the entire 18 months.

Sixty-four of the remaining participants experienced the group intervention. These women took 15-minute walks together, traded healthy recipes and practical exercise tips, and learned how to make smarter food shopping and restaurant choices.

They also set weight-loss and exercise goals, and discussed motivational examples like other American Indian women growing their own vegetables and bringing veggie dishes to tribal feasts.

The other 71 women, along with program participants, received medical check-ups every six months during the study period.

Besides eating more greens, group participants seemed to lose more weight immediately after the program than their control peers. However, after 18 months, weight loss in the group and control participants was similar.

At study's end, both group and control participants decreased their waist size and LDL, or "bad" cholesterol, reduced their television viewing, and cut back on calories, sugar and fat. Exercise levels remained stable.

Why the similar health benefit for both sets of women? It is likely because all they all became more health-conscious, given the study focus and regular clinic visits, Thompson said. "These were all highly motivated women - even those without the curriculum."

Nevertheless, women in the group program had the health edge with their higher consumption of fruits and vegetables, Thompson said, suggesting that even a light, monthly group session can better prevent diabetes.

The group support makes the difference, said Kelly Acton, M.D., diabetes expert at the Indian Health Service, because "these women give each other positive feedback. One might say, 'I don't like broccoli either, but here's this great green bean recipe.' It's the power of community."

http://www.hbns.org/

The following is a statement by William V. Corr, Executive Directior of the Campaign for Tobacco-Free Kids:

As state legislatures across the country convene their 2008 sessions, an important new study provides powerful evidence of the direct relationship between increased funding for state tobacco prevention and cessation programs and declines in adult smoking.

The study, being published in the February 2008 issue of the American Journal of Public Health, examined state tobacco prevention and cessation funding levels from 1995 to 2003 and found that the more states spent on these programs, the larger the declines they achieved in adult smoking, even when controlling for other factors such as increased tobacco prices. The researchers also calculated that if every state had funded their programs at the levels recommended by the U.S. Centers for Disease Control (CDC) during that period, there would have been between 2.2 million and 7.1 million fewer smokers in the United States by 2003. The Campaign for Tobacco-Free Kids estimates that such smoking declines would have saved between 700,000 and 2.2 million lives as well as between $20 billion and $67 billion in health care costs.

The new study was conducted by researchers at the CDC and RTI International, an independent nonprofit research institute based in Research Triangle Park, N.C. The study adds to earlier research, using similar methods, which demonstrated the same type of relationship between program spending and youth smoking declines. These studies, along with reviews by the Institute of Medicine of the National Academies of Sciences, the President's Cancer Panel and numerous other experts demonstrate conclusively that state tobacco prevention and cessation programs work to prevent kids from smoking and help adults quit, thereby saving lives and health care dollars.

This overwhelming evidence that state tobacco prevention and cessation programs work and deliver so many health and financial benefits leaves elected leaders with no excuse for failing to fund such programs in every state at CDC-recommended levels. The decision should be an easy one:

• The problem is huge and warrants urgent action. Tobacco use is the leading preventable cause of death in the U.S, resulting in 400,000 premature deaths and costing the nation nearly $100 billion in health care bills each year.
• We know the solution works. Comprehensive, well-funded state tobacco prevention and cessation programs are highly effective, especially when combined with higher tobacco taxes and smoke-free workplace laws.
• States have the revenue. The states will collect about $25 billion this year in revenue from the tobacco settlement and tobacco taxes. It would take just 15 percent of this revenue for each state to fund a tobacco prevention and cessation program at the CDC's new recommended levels. Right now, the states are spending less than 3 percent.
• The public supports it. Poll after poll shows that Americans strongly believe tobacco settlement and tax dollars should be spent on tobacco prevention.

States with well-funded programs have reported strong success. Washington state, with a well-funded tobacco prevention and cessation program, has reduced adult smoking by 24 percent since it launched the program in 1999. Washington's dramatic decline in adult smoking translates to more than 230,000 fewer smokers in the state, saving about $2.1 billion in future health care costs.

Despite the overwhelming evidence that state tobacco prevention and cessation programs are highly effective when they are funded appropriately, only three states currently fund these programs at even the minimum level recommended by the CDC (http://www.tobaccofreekids.org/reports/settlements/). This is part of the reason that declines in both youth and adult smoking in the United States have stalled in recent years. With the tobacco companies spending more $13.4 billion per year marketing their deadly products, it is imperative that state leaders act now to fund programs that we know work to prevent kids from smoking and help smokers quit.

The CDC recently updated its recommendations to the states for funding and implementing tobacco prevention and cessation programs, taking into account new scientific evidence, state experiences and cost factors such as inflation and population increases since last issuing its recommendations in 1999 (see CDC's Best Practices for Comprehensive Tobacco Control Programs - 2007 at www.cdc.gov/tobacco/tobacco_control_programs/stateandcommunity/best_practices/ index.htm). The new study should spur state legislatures and governors to heed the CDC's call for greater investment in programs proven to reduce smoking, save lives, and save money.