FDA releases list of potential drug risks

WASHINGTON, 06 june 2009-- U.S. regulators on Thursday listed two dozen drugs, including weight-loss medicines and sleep disorder pills, that it is at an early stage of reviewing for potential safety problems.

Many of the issues have been previously disclosed, but remain under review by the Food and Drug Administration.

The FDA said it was checking Pfizer Inc's smoking cessation drug Chantix for possible risk of accidental injury, vision impairment and other issues, and Cephalon Inc's sleep disorder drugs Nuvigil and Provigil for a potential of serious skin reactions.

Other drugs listed included orlistat, a weight-loss drug sold by Roche Inc as the prescription product Xenical and by GlaxoSmithKline Plc as the over-the-counter drug Alli. The FDA said it was continuing to evaluate liver toxicity reports for orlistat.

The FDA also said Pfizer's overactive bladder drug Detrol was under investigation for reports of Stevens-Johnson syndrome, a serious skin reaction.

The FDA releases a quarterly list of safety probes as part of an effort to inform the public about early investigations of potential side effects that have been reported. The list released on Thursday covers October through December 2008.

The problems are potential safety issues and their appearance on the list "does not mean that FDA has identified a causal relationship" with the drug, the agency said.

Roche spokesman Terry Hurley, commenting on the listing of Xenical, said available data "does not suggest that orlistat is causally related" to liver problems, noting obesity itself is a risk factor for liver injury.

Glaxo spokeswoman Mary Anne Rhyne also said "no causal relationship ... has been established" between Alli and hepatitis, a liver disease.

Pfizer spokeswoman Sally Beatty said the maker of Chantix evaluates any reports of health problems and "as with all our medicines, we work with the FDA to ensure our labeling reflects the latest safety information."

The FDA had said last year it was taking a closer look at Chantix after reports of accidents, vision loss and other problems in hundreds of patients

A Cephalon spokeswoman did not immediately respond to a request for comment on Nuvigil and Provigil. Serious skin reactions were identified as an issue with the drugs in 2007 and the FDA continues to study the matter, the agency said.

A spokeswoman for Glaxo could not immediately be reached for comment on the listing of Alli.

Bristol-Myers Squibb Co's HIV drug, Sustiva, was listed due to one report of an eye-related birth defect. A description of the case was added to the drug's prescribing instructions in March 2009, the FDA said.

Bristol-Myers spokeswoman Cristi Barnett said the drug's label states it should only be used in pregnant women, "if the benefit to the patient justifies the potential risk to the fetus."

The FDA also is probing pancreatitis with Bayer AG's contraceptive Yasmin, the agency's list said. Bayer spokeswoman Rose Talarico said the listing "was not prompted by any change in the existing safety profile" of Yasmin and the company "continues to work with the FDA to ensure that the most up-to-date and accurate safety information" is included in the drug's label. The FDA posted the list on its Website here

MRSA hits those with inflammatory bowel disease

CHICAGO, 06 june 2009-- A Canadian study of people with inflammatory bowel disease shows that they are more likely to become infected with the "superbug" MRSA -- ie, methicillin-resistant Staphylococcus aureus -- than are patients with other gastrointestinal illnesses.

Inflammatory bowel disease covers conditions such as Crohn's disease and ulcerative colitis. The connection to MRSA was reported here during the Digestive Disease Week 2009 convention by Dr. Geoffrey C. Nguyen of the University of Toronto.

Nguyen looked at data on 116,842 hospital admissions for inflammatory bowel disease and found that the rate of MRSA infections increased from 1.6 to 3.8 cases per 1000 admissions between 1998 and 2004.

"This reflected an average 20 percent annual rise in odds of MRSA infection," Nguyen pointed out at a news conference. Rates of MRSA infection were 42 percent higher in the patients with inflammatory bowel disease than in hospitalized patients with other intestinal conditions.

Furthermore, after taking account of other factors, "the presence of MRSA was associated with a four-fold higher in-hospital mortality relative to those without MRSA," Nguyen said.

Again, this association was twice as strong for patients with MRSA who also had inflammatory bowel disease rather than some other GI disease.

"Inflammatory bowel disease patients with MRSA also had a significantly longer length of stay than those without inflammatory bowel disease, at 17.4 days versus 6.1 days, respectively," Nguyen said.

"We also want to caution that the study does not necessarily mean that MRSA is a cause of increased mortality among IBD patients," he told Reuters Health. His group plans to investigate deaths among people with inflammatory bowel disease who had MRSA, to determine the actual cause of death.

Antidepressant curbs cancer-related mental ills

NEW YORK, 06 june 2009 -- People with cancer often suffer mental impairment, but it seems this can be alleviated by treatment with Paxil, an SSRI-type antidepressant, according to results of a National Cancer Institute-supported study.

The findings were reported this week at the American Society of Clinical Oncology's annual meeting in Orlando.

"Cancer and its treatment impact important areas of cognitive function such as attention and memory, which are essential to patients' effective psychosocial functioning and quality of life," Dr. Pascal Jean-Pierre, from the University of Rochester, New York and colleagues point out in a meeting paper.

"Both depression and cancer-related cognitive dysfunction share the same networks in the brain," Jean-Pierre explained in an interview with Reuters Health, Therefore, he and his colleagues looked into Paxil treatment in close to 800 cancer patients aged 22 to 87 years.

The researchers found "significant differences" between the participants' reports of memory problems after their first round of chemotherapy (before Paxil) and after four cycles of chemo and treatment with Paxil.

Paxil had a significant beneficial effect on cancer-related mental impairment. Even after taking depression out of the equation, "we still saw a significant effect of Paxil on cognitive function," Jean-Pierre told Reuters Health.

"This was an exploratory analysis," he cautioned, "so future studies need to replicate these findings, but the results do show that using SSRIs and other psychostimulants might be an approach to cancer-related cognitive dysfunction."

He concluded, "It's worth moving forward and investigating this further."

More Canadians choosing to die at home

NEW YORK ,06 june 2009-- The number of Canadians who are opting to live out their last days at home instead of the hospital has increased over the past 15 years, according to a new study.

In 1994, about 78 percent of the nation's deaths occurred in a hospital, but by 2004 that figure had fallen to 61 percent, the study found.

The reasons for the decline are not known, but it happened in the absence of any direct shifts in government policy, researchers report in the journal Social Science & Medicine.

"My guess is that a lot of it has to do with the fact that death is no longer unexpected," lead researcher Donna M. Wilson, of the University of Alberta in Edmonton, Canada, said in a news release from the university.

"A lot of people are dying at an advanced age and you begin to accept the fact that it's going to happen and it (can be) a dignified event," Wilson said. "If you take the person to the hospital ... care is by strangers rather than family members."

The study found that while deaths in nursing homes increased -- from 3 percent of the total in 1994, to 10 percent in 2004 -- many more occurred in "non-institutional" settings, including people's own homes. In 2004, 30 percent of deaths happened in a non-institutional setting, up from less than 20 percent in 1994.

According to Wilson, the trend is a positive one not only because it may mean more people are choosing to die in the place where they are most comfortable, but also because it could free up more hospital beds for people who need life-saving treatments.

It also means that the Canadian health care system should do more to support people who opt to die at home, the researcher said.

Compared with countries such as the UK and U.S., Wilson's team notes, Canada has few hospice clinics and fewer home-care services aimed at making people comfortable in their last days.

"We need to start putting more money into home care and develop some hospices, have some courses for families and maybe build a few more nursing home beds," Wilson said.

She pointed out that as the Baby Boom generation ages, the number of Canadians dying each year could double over the next 10 to 20 years.

SOURCE: Social Science & Medicine, May 2009.

New approaches lower aneurysm risk: study

LONDON, 06 june 2009-- Better diagnosis and treatment over the last 30 years have considerably reduced the risk of dying from a highly fatal type of aneurysm, Dutch scientists reported on Thursday.

Techniques such as CT and MRI scans are now widely used in the developing world to detect aneurysms but it was not known how big an impact these tests and other improvements such as dedicated stroke units have had.

To find out, the team reviewed data on nearly 9,000 patients worldwide and found better treatment and diagnosis appear to have cut the risk of dying from a so-called subarachnoid hemorrhage from 51 percent in 1973 to just 35 percent in 2002.

"In future, (deaths) after (aneurysms) might decrease even more owing to new diagnostic and therapeutic methods," Dennis Nieuwkamp and colleagues from the University Medical Center in Utrecht in the Netherlands wrote in the journal Lancet Neurology.

Subarachnoid hemorrhages, which are a bursting of a blood vessel on the surface of the brain, affect only about eight in 100,000 people every year in wealthy countries.

But the aneurysms place a big burden on society because they kill many patients, while survivors are often disabled and dependent on somebody to care for them.

Nieuwkamp and his team reviewed 33 studies from 19 countries between 1973 and 2002 and adjusted for factors such as age and sex while also looking at regional differences.

They said the new technology had paid off. Aside from Japan where 12 percent fewer people died, there were no regional differences.

The researchers suggested that the difference in Japan might be due to how quickly people were admitted to the hospital for early treatment of an aneurysm.

Sedatives Increase Suicide Risk Among Elderly

Sedatives greatly increase the risk of suicide in the elderly, Swedish researchers say

05 june 2009--In their study, hypnotic medication also was linked with a greater likelihood of suicides in older people. "Sedative treatment was associated with an almost 14-fold increase of suicide risk in the crude analysis and remained an independent risk factor for suicide even after adjustment for the presence of mental disorders," wrote Anders Carlsten, of Gothenburg University. "Having a current prescription for a hypnotic was associated with a fourfold increase in suicide risk in the adjusted model."

The drugs may increase suicide risk in the elderly by triggering aggressive or impulsive behavior, or by providing the means to take an overdose, the researchers said. It's also possible that sedatives may merely be markers for other factors related to suicide, such as sleep disturbance, lack of a social network, interpersonal problems, alcohol abuse and physical disability.

"Persons with these problems might be more likely to seek health care and perhaps more likely to receive prescriptions for psychotropic drugs. However, given the extremely high prescription rates for these drugs, a careful evaluation of the suicide risk should always precede prescribing a sedative or hypnotic to an elderly individual," Carlsten said.

The study appears in the current issue of BMC Geriatrics.

More information

The U.S. National Institute of Mental Health has more about older adults and suicide.

Paclitaxel Stent Is Treatment Option for Patients Over 70

Stent found to have lower revascularization rate than bare metal stent in pooled data analysis

05 june 2009-- The paclitaxel-eluding stent (PES) can be used effectively in people over 70, according to an analysis of trial and registry data on almost 10,000 PES patients reported online June 2 in Circulation: Cardiovascular Interventions.

Daniel E. Forman, M.D., of Brigham and Women's Hospital in Boston, and colleagues pooled and analyzed the patient data from five randomized trials (2,271 PES patients, 1,397 bare metal stent [BMS] patients) and from two registries (7,492 PES patients) to assess the benefits of the device for older patients. The analysis stratified patients by age (under 60, 60 to 70, and over 70) and included PES comparisons to BMS.

At baseline, the researchers found that the patients over 70 had more adverse characteristics and comorbid conditions than the younger patients, such as chronic heart failure, prior bypass surgery, and high blood pressure. Analysis found that patients over 70 had a comparable rate of heart attack, stent thrombosis, and target lesion revascularization to younger patients. While the death rate for patients over 70 was higher than the younger patients, it was comparable to general population norms matched for age and gender. Compared to BMS patients, the PES patients over 70 had a significantly lower target lesion revascularization rate (22.2 versus 10.2 percent).

"This analysis of almost 10,000 cumulative patients who received PES demonstrated that age greater than 70 years had significantly more comorbid conditions and baseline risk factors, yet had comparable short- and long-term stent-related outcomes to younger patients," the authors conclude.

The study was supported by Boston Scientific. Several of the authors reported financial relationships with device making companies, including Boston Scientific.

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Diet may reduce risk of prostate cancer

Study suggests a diet low in fat and red meat and high in fruits and vegetables is beneficial in preventing and treating prostate cancer

Sydney,05 june 2009—A new review published in the Journal of Human Nutrition and Dietetics assessed whether certain modifications in diet have a beneficial effect on the prevention of prostate cancer. Results suggest that a diet low in fat and red meat and high in fruits and vegetables is beneficial in preventing and treating prostate cancer.

Robert W.-L. Ma and K. Chapman conducted an evidence-based review of dietary recommendations in the prevention of prostate cancer as well as in the management of patients with prostate cancer.

The researchers found that a diet low in fat, high in vegetables and fruit, and avoiding high energy intake, excessive meat, and excessive dairy products and calcium intake may be helpful in preventing prostate cancer, and for patients diagnosed with prostate cancer.

Specifically, consumption of tomatoes, cauliflower, broccoli, green tea, and vitamins including Vitamin E and selenium seemed to propose a decreased risk of prostate cancer. Consumption of highly processed or charcoaled meats, dairy products, and fats seemed to be correlated with prostate cancer.

"Although not conclusive, results suggest that general dietary modification has a beneficial effect on the prevention of prostate cancer," the authors conclude. "In patients with prostate cancer, dietary therapy allows patients to be an active participant in their treatment."

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This study is published in the June 2009 issue of the Journal of Human Nutrition and Dietetics. Media wishing to receive a PDF of this article may contact professionalnews@bos.blackwellpublishing.net.

Robert Ma is affiliated with The University of New South Wales and can be reached for questions at robertm_scholl@hotmail.com.

Journal of Human Nutrition and Dietetics is an international peer-reviewed journal publishing papers in applied nutrition and dietetics. Under the editorial guidance of a team of experts, the journal aims to meet the changing needs of those concerned with human nutrition and dietetics. Areas covered include clinical nutrition, the practice of therapeutic dietetics public health nutrition; health promotion; food choice; nutritional status; the psychology of eating behavior and the sociology of food.

Embracing your primitive nature can help in fight against depression

LAWRENCE, Kan., 05 june 2009 – He doesn't care for the term "caveman therapy." But Stephen Ilardi, associate professor of clinical psychology at the University of Kansas, has turned to our hunter-gatherer ancestors for clues about how to best combat major depressive disorder.

Further, Ilardi fingers our modern, industrialized lifestyle as the key culprit behind the burgeoning depression epidemic, which continues to worsen despite decades of sharp increases in pharmaceutical consumption.

"A century ago, according to the best epidemiological evidence we have, the lifetime rate of depressive illness in the U.S. was about 1 percent," said Ilardi. "The rate now stands at 23 percent. So we've had roughly a 20-fold increase over the course of a century. Since World War II there's been roughly a 10-fold increase. And a recent study found the rate of depression has more than doubled in just the past decade."

Published June 1, Ilardi's book, "The Depression Cure" (Da Capo Lifelong Books), is based on research suggesting that depression can be treated effectively by helping people reclaim healing habits from a more primitive way of life. In fact, Ilardi thinks this may be a superior approach than modern psychotherapy or antidepressant drugs, which typically work for only about half the patients who try them.

The KU researcher heads a large treatment study, dubbed the Therapeutic Lifestyle Change project, which calls for patients to adopt six healing elements from the ancient past: consuming more omega-3 fatty acids; using engaging activity to combat rumination; getting regular sunlight exposure; increasing physical exercise; connecting more with others socially; and getting increased (and healthier) sleep.

"As a species, humans were never designed for the pace of modern life," said Ilardi. "We're designed for a different time — a time when people were physically active, when they were outside in the sun for most of the day, when they had extensive social connections and enjoyed continual face time with their friends and loved ones, when they experienced very little social isolation, when they had a much different diet, when they got considerably more sleep and when they had much less in the way of a relentless, demanding, stress-filled existence."

Many elements of the hunter-gatherer lifestyle are robustly antidepressant, Ilardi said. In fact, the KU psychology professor mused that if the neurological benefits of exercise alone could be concentrated into a pill, it would become the best-selling, most-effective antidepressant ever marketed.

In addition to positive results from his own ongoing research study, Ilardi points to low rates of depression among contemporary peoples whose lifestyles mirror those of our ancestors. The American Amish, for example, have rates of depressive illness far lower than that of the broader American population. Likewise, anthropologist Edward Schieffelin observed that the Kaluli people of the New Guinea highlands — whose day-to-day existence of foraging and gardening is akin to that of our remote ancestors — are almost completely free of depressive illness.

For Ilardi, such findings are conclusive that depression primarily stems from modern living: social isolation, fast-food-laden diets, physical inactivity, sleep deprivation and less exposure to the outdoors.

Indeed, one in four Americans will experience depression during their lifetime. Ilardi asserted that depression is that largest single cause of work-related disability, one that increases a person's lifelong risk of heart disease, of some types of cancer and many forms of inflammatory illness. The psychology expert said depression can even become neurotoxic, leading to brain damage by suppressing levels of a key neural growth hormone needed to repair and maintain brain tissue.

The KU researcher said his passion for curing depression is personal.

"I've seen three of my own family members battle this illness, and I don't think anyone can encounter depression up close without gaining a greater sense of compassion for those who are suffering in its grip," he said. "It's something that hits very close to home for me and probably for many others. Virtually everyone knows someone with this affliction."

Association found between Parkinson's disease and pesticide exposure in French farm workers

News from Annals of Neurology

Paris, 05 june 2009– The cause of Parkinson's disease (PD), the second most frequent neurodegenerative disease after Alzheimer's disease, is unknown, but in most cases it is believed to involve a combination of environmental risk factors and genetic susceptibility. Laboratory studies in rats have shown that injecting the insecticide rotenone leads to an animal model of PD and several epidemiological studies have shown an association between pesticides and PD, but most have not identified specific pesticides or studied the amount of exposure relating to the association.

A new epidemiological study involving the exposure of French farm workers to pesticides found that professional exposure is associated with PD, especially for organochlorine insecticides. The study is published in Annals of Neurology, the official journal of the American Neurological Association.

Led by Alexis Elbaz M.D., Ph.D., of Inserm, the national French institute for health research in Paris, and University Pierre et Marie Curie (UPMC, Paris 6), the study involved individuals affiliated with the French health insurance organization for agricultural workers who were frequently exposed to pesticides in the course of their work. Occupational health physicians constructed a detailed lifetime exposure history to pesticides by interviewing participants, visiting farms, and collecting a large amount of data on pesticide exposure. These included farm size, type of crops, animal breeding, which pesticides were used, time period of use, frequency and duration of exposure per year, and spraying method.

The study found that PD patients had been exposed to pesticides through their work more frequently and for a greater number of years/hours than those without PD. Among the three main classes of pesticides (insecticides, herbicides, fungicides), researchers found the largest difference for insecticides: men who had used insecticides had a two-fold increase in the risk of PD.

"Our findings support the hypothesis that environmental risk factors such as professional pesticide exposure may lead to neurodegeneration," notes Dr. Elbaz.

The study highlights the need to educate workers applying pesticides as to how these products should be used and the importance of promoting and encouraging the use of protective devices. In addition to the significance of the study for those with a high level of exposure to pesticides, it also raises the question about the role of lower-level environmental exposure through air, water and food, and additional studies are needed to address this question.

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This study is published in Annals of Neurology. Media wishing to receive a PDF of this article may contact medicalnews@bos.blackwellpublishing.net.

Anti-clot drug combinations boost

CHICAGO, 04 june 2009-- Heart patients are often given two or three different drugs to prevent life-threatening blood clots but these combinations can double, triple or even quadruple the risk of stomach or intestinal bleeding, U.S. researchers said on Tuesday.

Clot-preventing drugs such as aspirin, warfarin or Coumadin and clopidogrel or Plavix sold by Bristol-Myers Squibb and Sanofi-Aventis are increasingly being given to heart patients in combinations.

"They are often prescribed to prevent that second event -- that heart attack or stroke," Dr. Neena Abraham of Baylor College of Medicine in Houston, Texas, told reporters at the Digestive Disease Week meeting in Chicago.

"However, each of these drugs independently is associated with a high risk of clinically significant upper gastrointestinal events, which are defined as ulcers of the stomach or intestines, bleeding or perforations," she said.

"These drugs are commonly prescribed in combination; however, the magnitude of the risk of using these drugs on the gastrointestinal tract remains relatively unknown."

To study this, Abraham and colleagues used national pharmacy data and medical records from the Veterans Affairs Department to identify people aged 60 to 99 who had been given four combinations of clot-preventing drugs.

Some got aspirin and an antiplatelet drug like Plavix that keeps blood platelets from forming clots. Others got an antiplatelet drug and an anticoagulant such as warfarin, which keeps the liver from making certain clotting factors. Some got aspirin and warfarin. And some got all three.

Of the more than 78,000 patients studied, 30.4 percent were prescribed some combination of anticlotting drugs, and 1,061 of these had bleeding events that needed immediate medical attention within the first year.

RISING RISK

"When we compared the risk of bleeding from these different combinations, what we see is a stepwise increase in risk," Abraham said.

The dual combination of an anticoagulant and antiplatelet drug, which proved to be least harmful, raised the risk of a serious bleeding problem within one year by 70 percent.

A combination of an aspirin and antiplatelet drug doubled the risk, while an aspirin-anticoagulant combination tripled the one-year bleeding risk.

And patients who got all three drugs had a four-fold increase in the risk of gastrointestinal bleeding within one year, Abraham said.

"These are significant gastrointestinal bleeding risks."

Abraham said triple therapy was most commonly given to younger patients in the study -- those aged 60 and 69 years of age -- and likely reflected recent changes in cardiac care.

She said the findings suggest the need for a careful balancing of the risks and benefits of these drugs.

Heart patients on triple therapy may want to ask their doctor about dropping down to a dual or single therapy.

"We know they are healthy for the heart at preventing strokes and heart attacks, but what physicians now need to consider is short-term potential risks of GI bleeding versus the potential long-term benefits of being on these protective drugs," she said.

Rosiglitazone Has Modest Effect on Vascular Measure

Drug linked to favorable effect on CIMT progression; clinical implications remain unclear

04 june 2009-- Rosiglitazone may inhibit the progression of vascular disease in individuals with pre-diabetes, according to research published in the June 2 issue of the Journal of the American College of Cardiology.

Eva M. Lonn, M.D., of McMaster University in Hamilton, Canada, and colleagues analyzed data from 1,425 subjects with impaired glucose tolerance or impaired fasting glucose who participated in the Study of Atherosclerosis with Ramipril and Rosiglitazone (STARR) trial. They were randomized to receive ramipril and rosiglitazone or their placebos, and were followed for a median of three years.

The researchers found that ramipril and placebo had similar effects on the primary and secondary outcomes, which were annualized change of aggregate maximum carotid intima-media thickness (CIMT) and annualized change of the mean far wall left and right common CIMT, respectively. Rosiglitazone did not have a significant effect on the primary outcome, but did significantly reduce the secondary outcome.

"The clinical implications of the study, however, are not extremely clear at present, particularly in view of the neutral effects of ramipril and the modest effects of rosiglitazone on CIMT in pre-diabetic patients found in the trial. Because rosiglitazone in particular is under close scrutiny after the results of the meta-analysis by Nissen and Wolski in 2007 and TZDs in general continue to be monitored in view of reports showing that these drugs can increase the risk for heart failure, the possible clinical application of the STARR findings remains uncertain," write the authors of an accompanying editorial.

The STARR trial was funded by Sanofi-Aventis, GlaxoSmithKline, and King Pharmaceuticals, which provided study medications and placebo. Several co-authors reported financial associations with two of these companies.

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Editorial

Oxygen + MRI might help determine cancer therapy success, researchers find

DALLAS , 04 june 2009-– A simple magnetic resonance imaging (MRI) test involving breathing oxygen might help oncologists determine the best treatment for some cancer patients, report researchers at UT Southwestern Medical Center.

Prior research has shown that the amount of oxygen present in a tumor can be a predictor of how well a patient will respond to treatment. Tumors with little oxygen tend to grow stronger and resist both radiotherapy and chemotherapy. Until now, however, the only way to gauge the oxygen level in a tumor, and thus determine which treatment might be more effective, was to insert a huge needle directly into the cancerous tumor.

The new technique, known as BOLD (blood oxygen level dependent) MRI, can detect oxygen levels in tumors without the need for an invasive procedure. The patient need only be able to breathe in oxygen when undergoing an MRI.

"The patient simply inhales pure oxygen, which then circulates through the bloodstream, including to the tumors," said Dr. Ralph Mason, professor of radiology, director of the UT Southwestern Cancer Imaging Center and senior author of a study appearing online and in a future edition of Magnetic Resonance in Medicine. "Using MRI, we can then go in and estimate how much oxygen a particular tumor is taking up, providing us some insight into how the tumor is behaving and what sort of treatment might be effective."

The most important finding, Dr. Mason said, is that BOLD MRI performed as well as the standard yet more invasive procedure for viewing tumors. That method, known as FREDOM (fluorocarbon relaxometry using echo planar imaging for dynamic oxygen mapping) MRI, requires the injection of a chemical called a reporter molecule directly into the tumor.

"The BOLD technique appears to indicate accurately the oxygen levels in tumors," Dr. Mason said. "Because BOLD is immediately applicable to patients, this holds promise as a new method for predicting response to therapy."

BOLD MRI has been used extensively in studying brain function, but the procedure has only recently begun to be used to assess blood oxygenation and vascular function in tumors.

Physicians at UT Southwestern are already testing BOLD MRI in patients with cervical, prostate, and head and neck cancer. They have proposed using it in lung cancer patients as well, Dr. Mason said. Previous research has shown that those specific tumor types are more likely to have little oxygen.

In the published study, researchers took multiple images of breast tumors implanted just below the skin of rats, which were given anesthesia to help them remain still during the imaging process. Humans do not require anesthesia, Dr. Mason said.

Dr. Mason said the team took the research back to the preclinical stage because they needed to better define what physicians were seeing in the clinic and whether the findings were reproducible.

Dr. Mason said that examining each form of cancer in this way presents its own technical challenges. For example, the motion of the lungs or the design of a face mask for breathing oxygen must be taken into account.

"If we can prove that the test is meaningful in animals, then it is that much more worthwhile to argue for doing it in a patient. This preclinical work provides the foundation for future clinical studies," Dr. Mason said. "It helps justify doing a larger clinical trial with the goal of ultimately becoming a diagnostic test for oncologists."

Researchers currently are trying to determine how much oxygen must be inhaled by a patient in order to be effective. The next step is to expand studies in patients and prove the relevance to more tumor types.

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Other UT Southwestern researchers involved in the research were Dr. Dawen Zhao, lead author and assistant professor of radiology; Dr. Lan Jiang, a postdoctoral researcher in radiation oncology; and Dr. Eric Hahn, consultant in radiology.

The work was supported by the Department of Defense and the National Cancer Institute. The MRI experiments were performed in UT Southwestern's Advanced Imaging Research Center, an NIH-funded basic and translational research facility.

New findings offer more complete view of breast cancer gene mutations in US population

NIH-supported study among the first to include African Americans, older women

BETHESDA, Md., 04 june 2009-– A large study funded by the National Institutes of Health today provided the clearest picture yet of the prevalence in the U.S. population of mutations in two genes associated with an increased risk of breast cancer. The genes are called Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2). In addition, the study identified key predictors for assessing which women are most likely to carry these genetic mutations.

Each year, approximately 200,000 women in the United States are diagnosed with breast cancer. The majority of breast cancer cases are caused by genetic changes that occur during a woman's lifetime and not by genetic mutations inherited from her parents. However, researchers estimate that inherited mutations play a role in anywhere from 5 to 27 percent of all breast cancer cases. In the mid 1990s, researchers found that mutations in the BRCA1 and BRCA2 genes are a major cause of the hereditary form of the disease. Women inheriting these mutations have a 40 to 85 percent lifetime risk of developing breast cancer, as well as an increased risk of ovarian cancer.

To date, most of the studies on BRCA1 and BRCA2 mutations have focused on families known to be at high risk for breast cancer and on women who develop breast cancer at a relatively young age. The new study, published today in the journal Cancer Research, looked at the prevalence and predictors of BRCA1 and BRCA2 mutations in under-studied groups of women, such as African Americans and older women.

"Studies of any notable size have focused almost exclusively on white women and young women. This research clearly was needed to improve our means of assessing the likelihood of carrying BRCA1 and BRCA2 mutations in a wider spectrum of women," said one of the study's lead investigators, Elaine Ostrander, Ph.D., chief of the Cancer Genetics Branch in the National Human Genome Research Institute's Division of Intramural Research. Dr. Ostrander was previously head of the genetics program at the Fred Hutchinson Cancer Research Center, which is the institution that led the study.

The researchers examined the prevalence and predictors of BRCA1 and BRCA2 mutations in 1,628 women with breast cancer and 674 similar women without breast cancer, all of whom were participants in the National Institute of Child Health and Human Development's (NICHD's) Women's Contraceptive And Reproductive Experiences (CARE) study. The women involved in the study were white and African American women, ages 35 to 64, who lived in the Atlanta, Detroit, Los Angeles, Philadelphia and Seattle metropolitan areas.

"The advantages of this study include its large sample size, inclusion of under-studied groups of women and the fact that the results are population based," said one of the study's co-authors, Robert Spirtas, Dr.P.H, former chief of NICHD's Contraception and Reproductive Health Branch and now retired.

Researchers found that 2.4 percent of the breast cancer patients had BRCA1 mutations and 2.3 percent had BRCA2 mutations. BRCA1 mutations were more common among white breast cancer patients (2.9 percent) than among African American patients (1.4 percent). Breast cancer patients of Jewish ancestry were also significantly more likely to have BRCA1 mutations than non-Jewish patients – 10.2 percent compared to 2.0 percent. For BRCA2, African American patients were slightly more likely to have mutations, 2.6 percent, than were white patients, 2.1 percent.

Based on their findings, the researchers went on to calculate the prevalence of BRCA1 and BRCA2 mutations in the general U.S. population. Among white and African American women ages 35 to 64, the prevalence of BRCA1 mutations is 0.06 percent and the prevalence of BRCA2 mutations is 0.4 percent, the researchers estimated.

"These findings from our large, population-based study are compatible with earlier estimates made by extrapolating from smaller studies. However, we found a slightly lower frequency of BRCA1 mutations and a higher frequency of BRCA2 mutations," said the study's other lead investigator, Kathleen Malone, Ph.D., Member of the Public Health Sciences Division at the Fred Hutchinson Cancer Center. "We think the difference lies in the fact that earlier studies were confined mainly to whites, and that African American women carry BRCA2 mutations more often than white women."

The researchers also identified key predictors of whether a woman with breast cancer is likely to carry a BRCA1 or BRCA2 mutation. Such information is important because it can help to improve means of assessing which women may benefit the most from genetic testing, increased breast cancer screening and other measures aimed at early detection, treatment or prevention. The most significant predictors for BRCA1 mutations were: Jewish ancestry, a family history of ovarian cancer and a family history of breast cancer occurring before age 45.

For BRCA2 mutations, researchers uncovered fewer predictors, and they had more modest effects. Among the breast cancer patients studied, the only significant predictors of a BRCA2 mutation were early age of onset (before age 45) in the patient herself or early onset of breast cancer in mother, sisters, grandmothers or aunts.

"These findings underscore why women need to learn as much as they can about their family health history and then share that information with their health-care professionals. However, it must be emphasized that the presence or absence of a predictive factor does not automatically equate with a high or low likelihood of carrying a breast cancer gene mutation," said NIH Director Elias A. Zerhouni, M.D. "The majority of women with breast cancer – even those with a family history of the disease – do not carry mutations in these genes. These predictors need to be considered in the context of each woman's complete family health history."

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In addition to the Fred Hutchinson Cancer Center, NHGRI and NICHD, the team included researchers from the National Cancer Institute; Bay State Medical Center, Springfield, Mass.; the University of Pennsylvania, Philadelphia; University of Southern California, Los Angeles; and Wayne State University, Detroit.

NEJM study finds radiofrequency ablation can reverse Barrett's esophagus, reduce cancer risk

A common result of prolonged gastroesophageal reflux disease, Barrett's esophagus is associated with increased risk for esophageal cancer

NEW YORK , 04 june 2009-- Patients who have gastroesophageal reflux disease (GERD) for a prolonged period have an increased risk of developing Barrett's esophagus, a pre-cancerous condition where the tissue lining the esophagus becomes damaged by stomach acid and transformed into something like the inside of the stomach. New research finds that radiofrequency ablation -- an endoscopic procedure involving targeted thermal energy -- was very successful at restoring the esophagus and reducing risk for cancer.

The study was conducted at 19 centers nationally, including NewYork-Presbyterian Hospital/Columbia University Medical Center. Results are published in the May 28 New England Journal of Medicine along with an accompanying editorial, which hails it as a "landmark study in the field."

"The current standard of care for Barrett's esophagus has been watchful waiting or surveillance -- delaying surgery until the first sign of cancer. This study offers powerful evidence that treatment using radiofrequency ablation can help prevent esophageal cancer by completely reversing overall Barrett's esophagus and its more severe tissue changes, or dysplasias," says study senior author Dr. Charles Lightdale, a gastroenterologist at NewYork-Presbyterian Hospital/Columbia University Medical Center and professor of clinical medicine at Columbia University College of Physicians and Surgeons.

While it is still rare for Barrett's esophagus to develop into esophageal cancer, incidence of the cancer has increased fivefold over the last 30 years. Treating esophageal cancer involves major surgery to remove a section of the organ. Five-year survival is less than 15 percent.

In the study, 127 patients with Barrett's esophagus and dysplasia were randomized to receive either radiofrequency ablation (RFA) or a control group which received a non-therapeutic endoscopic surveillance procedure and followed over 12 months. Overall, only 1 percent of those receiving RFA developed cancer, compared with 9 percent in the control group, and 77.4 percent of RFA patients had complete eradication of the disease, compared with 2.3 percent in the control group.

For patients with small amounts of tissue change (dysplasia), a complete eradication of dysplasia occurred in 90.5 percent of those in the ablation group, compared with 22.7 percent in the control group. For patients with more advanced, "high grade" dysplasia, complete eradication occurred in 81.0 percent in the ablation group, compared with 19 percent in the control group.

Currently many patients with high-grade dysplasia undergo an esophagectomy, a major surgery that removes a section of the esophagus. "This study shows that minimally invasive RFA should be the standard of care for these patients," says Dr. Lightdale, who has offered the procedure to patients at NewYork-Presbyterian/Columbia over the last five years.

The study found side effects of RFA were mild, and included increased risk for chest pain and a narrowing (stricture) of the esophagus. There was one reported case of upper gastrointestinal hemorrhage.

"While our study didn't look at other interventions, it's notable that the side effects associated with radiofrequency ablation were significantly less than those reported in studies of photodynamic therapy, a laser-based approach," says Dr. Lightdale.

RFA for Barrett's esophagus is a half-hour outpatient procedure performed under mild sedation. The energy is highly controlled, and can be limited to the thin layer of the esophagus, preventing injury to healthy tissue. RFA technology is widely used to treat tumors in the liver, kidney and bones; used to restore normal heart rhythms; and for varicose veins.

Barrett's esophagus affects about 1 percent of adults in the United States. Men develop Barrett's esophagus twice as often as women. Approximately 10 percent of patients with chronic reflux have the condition. Half of Barrett's patients don't have heartburn.

"Advanced Barrett's esophagus diminishes the painful symptoms of acid reflux making its diagnosis difficult in many patients. Therefore, it's important for anyone who has had prolonged GERD to be screened," says Dr. Lightdale.

Now that radiofrequency ablation has been shown to be effective in patients with dysplastic Barrett's esophagus, the next step is to see if it works for patients with less severe disease.

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The study's lead author is Dr. Nicholas J. Shaheen of the University of North Carolina at Chapel Hill. The research was sponsored by BÂRRX Medical Inc., maker of the radiofrequency ablation equipment used in the study.

Anti-clot drug combinations boost bleeding risks

CHICAGO, 03 june 2009- - Heart patients are often given two or three different drugs to prevent life-threatening blood clots but these combinations can double, triple or even quadruple the risk of stomach or intestinal bleeding, U.S. researchers said on Tuesday.

Clot-preventing drugs such as aspirin, warfarin or Coumadin and clopidogrel or Plavix sold by Bristol-Myers Squibb and Sanofi-Aventis are increasingly being given to heart patients in combinations.

"They are often prescribed to prevent that second event -- that heart attack or stroke," Dr. Neena Abraham of Baylor College of Medicine in Houston, Texas, told reporters at the Digestive Disease Week meeting in Chicago.

"However, each of these drugs independently is associated with a high risk of clinically significant upper gastrointestinal events, which are defined as ulcers of the stomach or intestines, bleeding or perforations," she said.

"These drugs are commonly prescribed in combination; however, the magnitude of the risk of using these drugs on the gastrointestinal tract remains relatively unknown."

To study this, Abraham and colleagues used national pharmacy data and medical records from the Veterans Affairs Department to identify people aged 60 to 99 who had been given four combinations of clot-preventing drugs.

Some got aspirin and an antiplatelet drug like Plavix that keeps blood platelets from forming clots. Others got an antiplatelet drug and an anticoagulant such as warfarin, which keeps the liver from making certain clotting factors. Some got aspirin and warfarin. And some got all three.

Of the more than 78,000 patients studied, 30.4 percent were prescribed some combination of anticlotting drugs, and 1,061 of these had bleeding events that needed immediate medical attention within the first year.

RISING RISK

"When we compared the risk of bleeding from these different combinations, what we see is a stepwise increase in risk," Abraham said.

The dual combination of an anticoagulant and antiplatelet drug, which proved to be least harmful, raised the risk of a serious bleeding problem within one year by 70 percent.

A combination of an aspirin and antiplatelet drug doubled the risk, while an aspirin-anticoagulant combination tripled the one-year bleeding risk.

And patients who got all three drugs had a four-fold increase in the risk of gastrointestinal bleeding within one year, Abraham said.

"These are significant gastrointestinal bleeding risks."

Abraham said triple therapy was most commonly given to younger patients in the study -- those aged 60 and 69 years of age -- and likely reflected recent changes in cardiac care.

She said the findings suggest the need for a careful balancing of the risks and benefits of these drugs.

Heart patients on triple therapy may want to ask their doctor about dropping down to a dual or single therapy.

"We know they are healthy for the heart at preventing strokes and heart attacks, but what physicians now need to consider is short-term potential risks of GI bleeding versus the potential long-term benefits of being on these protective drugs," she said.

Coffee seen OK for diabetic men

NEW YORK, 03 june 2009-- There's reassuring news for coffee lovers with type 2 diabetes. Drinking even fairly high amounts of coffee does not raise the risk of developing heart diseases in diabetic men or increase their risk of dying early, according to a brief report in the medical journal Diabetes Care.

Although research involving people in the general population has suggested no harmful effects on the heart from drinking coffee, there's been little information about any effect in people with diabetes, Dr. Rob M. van Dam and colleagues point out. Recently, however, there has been evidence suggesting that coffee consumption may impair diabetics' ability to process glucose.

To look into this, van Dam, from the Harvard School of Public Health, Boston, and colleagues studied data on 3497 diabetic men who were followed from 1986 to 2004. None of them had cardiovascular disease at the outset, and they all completed several dietary questionnaires during follow-up.

The researchers found that consumption of coffee, even four or more cups per day, did not significantly increase the risk of heart disease or the odds of dying during the study period, compared with subjects who did not drink any coffee.

The same held true whether or not the subjects smoked and regardless of how long they had had diabetes.

"Our findings do not support the hypothesis that habitual caffeinated coffee consumption increases risk of cardiovascular events or mortality among individuals with type 2 diabetes," the authors conclude.

SOURCE: Diabetes Care, June 2009.

Weight-Loss Surgery Options Compared in Super-Obese

03 june 2009-- A technique called duodenal switch surgery may be more effective than gastric bypass surgery for patients with obesity-related medical problems such as high cholesterol, diabetes and high blood pressure, according to a U.S. study that included 350 super-obese patients who were more than 200 pounds heavier than their ideal body weight.

The findings were presented Monday at Digestive Disease Week 2009 in Chicago.

In gastric bypass surgery, surgeons create a small gastric pouch that's separate from the rest of the stomach, but with duodenal switch surgery, the stomach is reshaped into a long narrow tube and the small intestine is reconfigured to reduce calorie absorption, according to a Digestive Disease Week news release.

In their new study, Dr. Vivek N. Prachand, an assistant professor of surgery at the University of Chicago, and colleagues looked at the rates of resolution of obesity-related diseases (whether patients were able to stop taking medications to treat their conditions) three years after either duodenal switch or gastric bypass surgery.

The rates of resolution for duodenal switch and gastric bypass were: diabetes, 100 percent vs. 60 percent; high blood pressure, 68 percent vs. 38.6 percent; high cholesterol, 72 percent vs. 26 percent; acid reflux; 48.5 percent vs. 76.9 percent, the study authors found.

In previous research, Prachand's team showed that super-obese patients who underwent duodenal switch surgery had better weight loss than those who had gastric bypass surgery. They believed that the greater weight loss among duodenal switch patients may explain why they had higher rates of resolution of obesity-related diseases. But this new study didn't find a link between amount of weight loss and resolution of obesity-related conditions, which suggests that other mechanisms besides weight loss may be at work.

The researchers also noted that reduced absorption of calories in duodenal switch surgery patients can lead to vitamin/nutrition deficiencies and, possibly, malnutrition.

"The effort to better manage the potential vitamin and nutritional deficiencies associated with duodenal switch surgery is worthwhile because it appears that the duodenal switch surgery is more successful in terms of weight loss and resolution of significant obesity-related disease for super-obese patients," Prachand said in the news release.

Heart drug may block breast cancer gene

WASHINGTON, 03 june 2009– A gene that is highly active in up to 20 percent of breast cancer cases might be blocked by a generically available blood pressure drug, U.S. researchers reported on Tuesday.

The gene, called AGTR1, caused normal breast cells to behave like cancer cells but the blood pressure drug losartan stopped them, the team at the University of Michigan found.

They transplanted human tumors that expressed AGTR1 -- meaning the gene was active -- into mice. Eight weeks after they gave the mice losartan the tumors shrank by 30 percent, they reported in the Proceedings of the National Academy of Sciences.

"What's also exciting is this gene is blocked by a drug that's already available on the market," Dr. Arul Chinnaiyan, who led the study, said in a statement.

Chinnaiyan and colleagues looked at nearly 3,200 microarrays -- gene chips -- taken from cancer patients and available in a database called Oncomine, which was set up to allow just such comparisons.

The gene they found the most often was ERBB2 -- already known to be behind 25 percent to 30 percent of breast tumors. This gene mutation is targeted by Genentech's drug Herceptin, known generically as trastuzumab.

Number two in the scan was AGTR1, also known as angiotensin II receptor type I. They found it was busy in 10 percent to 20 percent of the breast tumors -- none of them ERBB2-positive tumors.

"AGTR1 is very analogous to HER2 or ERBB2. HER2 is a bona fide treatment target for patients with that type of breast cancer," said Chinnaiyan, whose work is funded by the Howard Hughes Medical Institute.

"Losartan may be a viable therapy for women with AGTR1 over-expressing breast tumors. This study lays the groundwork for a clinical trial to test losartan to treat breast cancers positive for AGTR1," Chinnaiyan says.

Losartan, made generically by India's Aurobindo Pharma Ltd, is the generic equivalent of Merck & Co Inc's Cozaar.

Stool test shows promise in detecting many cancers

CHICAGO, 03 june 2009– Using just a stool sample, doctors may now be able to detect colon and many other cancers of the digestive tract including stomach, pancreatic, bile duct and esophageal cancer, U.S. researchers said on Tuesday.

They said a new test, which detects genetic material shed from the surface of cancer cells, found nearly 70 percent of assorted digestive tract cancers.

And the DNA test accurately showed negative results in all 70 healthy patients they tested, Dr. David Ahlquist of the Mayo Clinic in Minnesota told the Digestive Disease Week meeting in Chicago.

"It opens the door to detecting cancers that are, sadly, not screened. The mortality rates of these cancers is extremely high," Ahlquist said in a telephone interview.

"In pancreatic cancer, the five-year survival rate is only about 5 percent or less. Without detection at an early stage, it will be hard to make much progress."

Gastrointestinal cancers account for about one in four cancer deaths in the United States, but currently, patients are only routinely screened for colon cancer.

The stool sample test is an expanded version of a DNA test Ahlquist and colleagues are working on for colon cancer. It looks for evidence of cells from tumors and precancerous polyps as they pass through the gastrointestinal tract.

"What's common to all of the cancers in the GI tract is that they shed cells and they are going downstream and are excreted in the stool. We've exploited that common biology to explore this as a screening approach," Ahlquist said.

The team tested 70 patients with various cancers of the digestive tract, including colon, throat, esophagus, stomach, pancreatic, bile duct, gallbladder and small bowel to see if gene mutations could be found in stool samples. They also used the test on 70 healthy patients.

It found 65 percent of esophageal cancers, 62 percent of pancreatic cancers and 75 percent of bile duct and gallbladder cancers.

And it found 100 percent of both stomach and colorectal cancers. The test worked equally well on early and late-stage cancers. "We've looked at DNA changes that are cancer-specific. They have proved to be a very reliable marker in this study," he said.

Ahlquist said both he and Mayo Clinic have a financial interest in the DNA stool test, which they hope to license to a company that will commercialize it.

Heartburn drugs may raise risk of hip fractures: study

CHICAGO, 02 june 2009- Even short-term use of popular acid-reducing heartburn drugs may raise the risk of hip fractures, U.S. researchers said on Monday.

The increased risks appeared two years after patients started taking proton pump inhibitors such as Takeda Pharmaceutical Co's Prevacid and histamine-2 receptor antagonists, or H2RAs, such as GlaxoSmithKline's Zantac, researchers at Kaiser Permanente San Francisco told the Digestive Disease Week meeting in Chicago.

Other proton pump inhibitors include AstraZeneca's Nexium and Prilosec, Wyeth's Protonix and Eisai Co Ltd's Aciphex.

A study in August's Canadian Medical Association Journal suggested long-term use of proton pump inhibitors -- for at least five years -- may raise the risk of hip fractures.

Dr. Douglas Corley, who led the study, said in a statement "the increased risk with short-term use of acid-suppressing drugs suggests that even relatively brief periods of use may be associated with increased risk of hip fractures."

He said patients taking acid blockers should continue treatment at the lowest effective dose, but people at risk of osteoporosis should talk to their doctor about other treatment options.

For the study, Corley and colleagues analyzed data on nearly 40,000 patients taking acid-reducing drugs, and compared them to more than 130,000 patients not taking the drugs.

Patients who had hip fractures were 30 percent more likely to have taken proton pump inhibitors for at least two years, and 18 percent more likely to have taken H2RAs for at least two years.

Risks were lower in people who had taken lower doses.

Those who took less than one pill a day had a 12 percent increase in fracture risk. Patients who took one pill per day had a 30 percent increased risk, while those who took more than one pill a day had a 41 percent higher risk.

People aged 50 to 59 who had been on proton pump inhibitors for more than two years had the biggest increase in fracture risk with taking the drugs, they said.

Depression may indicate early Parkinson's disease

NEW YORK , 02 june 2009- Results of a new study provide more evidence that depressive symptoms are an early feature of Parkinson's disease, preceding the characteristic movement problems seen Parkinson's such as tremor and rigid muscles.

In the study, researchers found that starting antidepressant therapy was associated with a twofold increased risk of developing Parkinson's disease in the next 2 years.

Although several reports have shown a link between depressive symptoms and Parkinson's disease, it was unclear whether one caused the other or if both may arise from some common mechanism, Dr. A. Alonso and colleagues note in their report.

To look into these questions, they matched 999 patients with Parkinson's disease identified through records from 1995 to 2001 to 6261 "control" subjects. Initiation of antidepressant therapy was used as a marker for depressive symptoms.

Overall, subjects who began antidepressant therapy were 85 percent more likely to develop Parkinson's disease than were non-initiators, Alonso, from the University of Minnesota, Minneapolis, and colleagues note.

Further analysis showed that the association was strongest in the 2 years after starting antidepressant therapy, they report in the latest issue of the Journal of Neurology, Neurosurgery, and Psychiatry.

Based on their findings, Alonso and colleagues suggest that people with signs of depression who start to develop movement problems "be promptly evaluated to rule out a diagnosis of Parkinson's disease."

SOURCE: Journal of Neurology, Neurosurgery, and Psychiatry, June 2009.

Cervical cancer vaccine benefits older women: study

WASHINGTON, 02 june 2009 - Older women can benefit just as much as younger women from Merck's Gardasil vaccine against cervical cancer, researchers in Colombia reported on Monday.

They found that women ages 24 to 45 who had no history of cancer-causing genital warts or cervical disease were much less likely to become infected with the wart virus if they got the vaccine than women who got placebo jabs.

The study, published in the Lancet medical journal, points to a potentially lucrative new market for the vaccine against the human papilloma virus or HPV.

Merck, which paid for the Colombian study, has also shown that Gardasil is 90 percent effective in preventing sexually transmitted warts in men.

GlaxoSmithKline's rival vaccine Cervarix protects against two HPV strains and is used in Europe.

Dr. Nubia Munoz of the National Institute of Cancer in Bogota and colleagues tested 1,900 women who got the recommended series of three Gardasil shots and 1,900 who got sham injections.

After two years, four women who got the vaccine developed an HPV infection or cervical disease, compared to 41 in the placebo group, they wrote -- which translates to an efficacy of more than 90 percent.

HPV is the most common sexually transmitted disease in the world. About 20 million Americans are infected with it, according to the U.S. Centers for Disease Control and Prevention.

It is the main cause of cervical cancer, which kills 3,870 women a year in the United States and 300,000 globally.

It can also cause other types of cancer, including anal and penis cancer, as well as mouth and neck cancer. The CDC estimates that HPV caused 25,000 cases of cancer a year in the United States between 1998 and 2003.

PAP SMEARS

Many women in industrialized countries get regular exams of the cervix, called a Pap smear, to check for precancerous changes caused by the virus.

Gardasil is designed to protect against HPV types 16 and 18, which are known to cause about 70 percent of all cases of cervical cancer. It also is designed to protect against HPV strains 6 and 11, which cause genital warts.

Gardasil is approved in the United States for use in girls and women ages 9 to 26, but Merck is seeking to expand its use to older women. The vaccine does not protect anyone who has already been infected with one of the strains of HPV.

Vaccinating women over age 26 has not been approved by the U.S. Food and Drug Administration and is not included in U.S. CDC guidelines.

Munoz's team noted that older women may, however, be at risk.

"Changes in sexual behavior during the past 30 years, characterized by rising age at first marriage and an increase in divorce rates, have led to more widespread premarital sexual intercourse and acquisition of new sexual partners around middle age, respectively," they wrote.

"Published work suggests that in the USA, nearly 40 percent of men and women have married and divorced by 55 years of age, and that more than 25 percent of these people have remarried at least once," they added.

"As the potential for HPV infection and disease exists in women in their third, fourth, and fifth decades of life, these women could benefit from prophylactic HPV vaccination."

A mathematical model published in October showed that vaccinating older women against cervical cancer could cut rates in half for women through age 45.

Commonly used medications may produce cognitive impairment in older adults

INDIANAPOLIS, 02 june 2009 - Many drugs commonly prescribed to older adults for a variety of common medical conditions including allergies, hypertension, asthma, and cardiovascular disease appear to negatively affect the aging brain causing immediate but possibly reversible cognitive impairment, including delirium, in older adults according to a clinical review now available online in the Journal of Clinical Interventions in Aging, a peer reviewed, open access publication.

Drugs, such as diphenhydramine, which have an anticholinergic effect, are important medical therapies available by prescription and also are sold over the counter under various brand names such as Benadryl®, Dramamine®, Excederin PM®, Nytol®, Sominex®, Tylenol PM®, and Unisom®. Older adults most commonly use drugs with anticholinergic effects as sleep aids.

While it is known that these medications do have an effect on the brain and in the case of sleeping pills, are prescribed to act on the brain, the study authors suggest the amount of cognitive impairment caused by the drugs in older adults is not well recognized.

"The public, physicians, and even the Food and Drug Administration, need to be made aware of the role of these common medications, and others with anticholinergic effects, in causing cognitive impairment. Patients should write down and tell their doctor which over-the-counter drugs they are taking. Doctors, who often think of these medications simply as antihistamines, antidepressants, antihypertensives, sleep aids or even itching remedies, need to recognize their systemic anticholinergic properties and the fact that they appear to impact brain health negatively. Doing so, and prescribing alternative medications, should improve both the health and quality of life of older adults," said senior study author Malaz Boustani, M.D., Indiana University School of Medicine associate professor of medicine, Regenstrief Institute investigator, and research scientist with the IU Center for Aging Research.

Dr. Boustani and colleagues conducted a systematic evidence-based analysis of 27 peer reviewed studies of the relationship of anticholinergic effect and brain function as well as investigating anecdotal information. They found a strong link between anticholinergic effect and cognitive impairment in older adults.

"One of the goals of our work is to encourage the Food and Drug Administration to expand its safety evaluation process from looking only at the heart, kidney and liver effects of these drugs to include effects of a drug on the most precious organ in human beings, our brain," Dr. Boustani said.

"Many medications used for several common disease states have anticholinergic effects that are often unrecognized by prescribers" said Wishard Health Services pharmacist, Noll Campbell, Pharm.D., first author of the study, noting that these drugs are among the most frequently purchased over the counter products. "In fact, 50 percent of the older adult population use a medication with some degree of anticholinergic effect each day."

"Our main message is that older adults and their physicians should have conversations about the benefits and harms of these drugs in relation to brain health. As the number of older adults suffering from both cognitive impairment and multiple chronic conditions increases, it is very important to recognize the negative impact of certain medications on the aging brain," said Dr. Boustani.

The brain pharmacoepidemiology group of the IU Center for Aging Research currently is conducting a study of 4,000 older adults to determine if the long term use of medications with anticholinergic effects is linked to the irreversible development of cognitive impairment such as Alzheimer disease.

Back to normal: Surgery improves outcomes for spine patients

ROSEMONT, 02 june 2009— People with the spine disease called degenerative spondylolisthesis* -- who choose surgical treatment -- experience substantially greater relief from pain over time compared to those who do not have surgery, according to a study published in the June 2009 issue of The Journal of Bone and Joint Surgery (JBJS). In the past, physicians had been uncertain whether surgery provided significantly greater relief for patients, but these results help to confirm the advantages to surgery.

"There are thousands of surgeries completed each year to address degenerative spine conditions, yet, there has never been a large-scale trial to give us evidence that the surgeries really work, as compared to non-operative approaches," said study author James Weinstein, DO, MS, Third Century Professor and Chair of the departments of orthopaedics at Dartmouth Medical School and Dartmouth-Hitchcock Medical Center.

Dr. Weinstein and his colleagues collected data from 607 men and women diagnosed with spondylolisthesis who were enrolled in the Spine Patient Outcomes Research Trial (SPORT), a multi-center study that included participants from 13 medical centers in 11 states. The study was the largest ever conducted of spondylolisthesis patients.

"Until this study, our 'evidence' was anecdotal and based on patient reports. We wanted data-based, scientific evidence that we could share with patients to help them make their decisions about taking an operative vs. non-operative approach," Weinstein said.

Prior to completion of the study, SPORT looked at the three most common back conditions leading to surgery, which are:

• herniated disc;
• spinal stenosis; and
• spinal stenosis with degenerative spondylolisthesis.

To be included in the study, all patients had to meet certain criteria, including:

• nerve pain in the legs
• spinal stenosis revealed on cross-sectional imaging
• degenerative spondylolisthesis evident in radiograph imaging
• symptoms which lasted for at least 12 weeks
• physician confirmation that the patient was a surgical candidate.

"Our results indicate that in these patients, there was a clear advantage for surgery," said Dr. Weinstein. "Patients felt relief faster and at two and four years, reported better function, less pain, and higher satisfaction than those who chose to go the non-surgical route."

Approximately 80 percent of Americans suffer from back pain at some point in their lives. Back pain is the most common cause of work-related disability, as well as the most expensive in terms of workers compensation and medical costs. Degenerative spondylolisthesis is one example of this kind of painful back condition.

"Degenerative spine disease can be a debilitating condition. When well informed, surgery is a good treatment choice," said Weinstein.

SPORT investigators will be releasing additional studies focusing on cost-effectiveness and other factors in coming months.

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* Degenerative spondylolisthesis occurs when laxness in the spine causes one vertebra to slide forward and press against nerves, causing pain in the back and legs. The condition often occurs as a result of the aging process.

More Information: SPORT is the first comprehensive study to look at different ways of treating low back and leg pain and how effective they are for patients. The trial was funded by the National Institutes of Health (NIH) in recognition of how prevalent back problems are, and how disabling they can be. The research is meant to give patients and their physicians solid information to help guide them as they make decisions about how to treat their conditions. Approximately 2500 patients took part in the 5-year study.

Value of Taking Aspirin to Cut Heart Risk Varies

01 june 2009--Taking aspirin reduces heart attack risk in people with no previous history of vascular disease but increases the risk of internal bleeding, say British researchers who analyzed the results of 22 clinical trials.

This means the net effect in this group of patients is uncertain because the benefits and risks may cancel each other out. However, the researchers found that aspirin's benefits generally outweigh its risks among people who have vascular disease.

Colin Baigent, of the University of Oxford, and colleagues looked at serious vascular events (heart attack, stroke or vascular death) among 95,000 low-risk patients in six primary prevention trials and among 17,000 high-risk patients in 16 secondary prevention trials.

Among patients in the primary prevention trials, aspirin was found to reduce the risk of serious vascular events by 12 percent but increased the risk of internal bleeding by about one-third. Among patients in the secondary prevention studies -- who were already at high risk because they had previously experienced a stroke or heart attack -- aspirin reduced the risk of serious vascular events by about one-fifth, a benefit that outweighed the small additional risk of bleeding, the researchers said.

The results in both sets of trials were similar for men and women.

"The currently available trial results do not seem to justify general guidelines advocating the routine use of aspirin in all healthy individuals above a moderate level of risk for coronary heart disease," the study authors wrote in the May 30 issue of The Lancet.

"Drug safety really matters when making recommendations for tens of millions of healthy people," Baigent said in a news release. "We don't have good evidence that, for healthy people, the benefits of long-term aspirin exceed the risks by an appropriate margin. If effectiveness is uncertain, then cost-effectiveness calculations are irrelevant."

Drug Combo Proves Powerful Against Lung Cancer

01 june 2009-- A two-drug combination treatment proved successful in safely slowing advanced non-small cell lung cancer in a recent clinical trial.

In the study, a phase 3 trial involving 768 people with the disease, those who had erlotinib (Tarceva) added to their dose of the bevacizumab (Avastin) saw the progression of the disease slow more than if on bevacizumab alone. People on the combo therapy tolerated the drugs well and survived an average of 4.8 months before the disease grew worse, compared with 3.7 months for those on bevacizumab alone.

Non-small cell lung cancer, often linked to past tobacco use, is the most common of all lung cancers, according to the National Cancer Institute.

"This is the first study to show the addition of erlotinib to maintenance therapy prolongs progression-free survival in patients with advanced non-small cell lung cancer," the study's co-author, Dr. Vincent Miller, a thoracic oncologist at Memorial Sloan-Kettering Cancer Center in New York City, said in a news release from the center. "Knowing which patients will get the greatest benefit from this combination, based on the identification of biomarkers, will be an important next step in this research."

Maintenance therapy aims to slow a disease from getting worse and better the chance of surviving while recovering from stronger chemotherapy treatments, which can weaken and sicken the person.

Miller was to present the findings Saturday at the annual meeting American Society of Clinical Oncology, in Orlando, Fla.

Bevacizumab and erlotinib have previously shown promise in treating non-small cell lung cancer by blocking tumor growth.

Progress in fighting lung cancer

ORLANDO, Florida 01 june 2009 – Cancer specialists, gathered for an annual meeting, are reporting progress in the fight against lung cancer, the most common and deadliest form of cancer, but little progress in treating colorectal cancer.

Doctors and researchers at the 45th gathering of the American Society of Clinical Oncology (ASCO) -- the world's main cancer conference -- on Saturday learned of two studies showing progress in the battle against lung cancer.

The first study showed how the combination of two anti-cancer treatments following standard chemotherapy can slow the advance of lung cancer.

Patients treated with a combination of Tarceva, sold by the Swiss drugmaker Roche, and Avastin, a drug by Roche's Genentech unit, saw their cancer growth slow more than a control group treated with Avastin.

More than 750 patients were randomized to receive Avastin and a placebo, or Avastin and Tarceva. Those in the Tarceva group survived an average of 4.8 months before the cancer started growing again, compared to 3.7 months for the control group, said Vincent Miller, the study's main author.

The numbers translated to a 29 percent reduced risk of disease progression for patients who took a combination of Tarceva and Avastin.

"This is the first study to show that adding erlotinib (Tarceva) to maintenance therapy with bevacizumab (Avastin) delays disease progression in patients who have already received bevacizumab as part of their initial chemotherapy," said Miller.

A second study with 663 patients with advance lung cancer were given the drug Alimta, from US pharmaceutical Eli Lilly, which blocks cell growth.

Preliminary results showed that patients who took the drug lived 26 percent longer compared to a control group that took a placebo: 13.4 months against 10.6 months.

As in the first study, all the patients had already received four standard chemotherapy sessions.

"This study will change the overall standard of care," said Chandra Belani, the deputy director of the Penn State Cancer Institute, as she presented the research.

"Maintenance therapy with Alimta (permetrexed) offers a new paradigm for patients who have advanced lung cancer, because it has a low toxicity and can be given on an ongoing basis over a prolonged period of time to extend patients' lives," she said.

However there were few advances to report in the fight against colorectal cancer, the fourth most common in the United States and the second deadliest type of cancer.

Research on 2,710 patients with Phase Three colorectal cancer taking the drug Avastine along with standard chemotherapy treatment showed no difference in the survival rate or the recurrence of the tumor after three and a half years when compared to those not taking the drug.

Another study conducted in Italy among 747 patients with advanced colorectal cancer showed that the drug Eloxatine from the French firm Sanofi did not reduce the size of the tumor when combined with standard treatment used ahead of cancer surgery.

On Sunday, several sessions at the ASCO event, scheduled to end on Tuesday, will focus on the result of clinical tests on female breast and uterus cancer.

Immune therapies finally working against cancer

ORLANDO, Fla. 01 june 2009– First there was surgery, then chemotherapy and radiation. Now, doctors have overcome 30 years of false starts and found success with a fourth way to fight cancer: using the body's natural defender, the immune system.

The approach is called a cancer vaccine, although it treats the disease rather than prevents it.

At a cancer conference Sunday, researchers said one such vaccine kept a common form of lymphoma from worsening for more than a year. That's huge in this field, where progress is glacial and success with a new treatment is often measured in weeks or even days.

Experimental vaccines against three other cancers — prostate, the deadly skin disease melanoma and an often fatal childhood tumor called neuroblastoma — also gave positive results in late-stage testing in recent weeks, after decades of struggles in the lab.

"I don't know what we did differently to make the breakthrough," said Dr. Len Lichtenfeld of the American Cancer Society.

Instead of a single "A-Ha!" moment, there have been many "ah, so" discoveries about the immune system that now seem to be paying off, said Dr. John Niederhuber, director of the National Cancer Institute.

It's way too soon to declare victory. No one knows how long the benefits will last, whether people will need "boosters" to keep their disease in check, or whether vaccines will ever be a cure. Many vaccines must be custom-made for each patient. How practical will that be, and what will it cost?

Those are all good questions — but there are no answers yet, said Dr. Richard Schilsky, a University of Chicago cancer specialist who is president of the American Society of Clinical Oncology.

Several vaccine studies were reported over the weekend at the oncology group's annual meeting in Florida.

A big problem has been getting the immune system to "see" cancer as a threat, said Dr. Patrick Hwu, melanoma chief at the University of Texas M.D. Anderson Cancer Center. Viruses like the flu or polio are easily spotted by the immune system because they look different from human cells.

"But cancer comes from our own cells. And so it's more like guerrilla warfare — the immune system has trouble distinguishing the normal cells from the cancer cells," he said.

To help it do that, many cancer vaccines take a substance from a cancer cell's surface and attach it to something the immune system already recognizes as foreign — in the lymphoma vaccine's case, a shellfish protein.

"It's a mimic to what you're trying to kill, a training device to train the immune system to kill something," Hwu explained.

To make the attack as strong as possible, doctors add a substance to put the immune system on high alert.

Dr. Stephen Schuster of the University of Pennsylvania School of Medicine led a study testing BiovaxID, an experimental vaccine against follicular lymphoma developed by the National Cancer Institute. Rights to it are now held by Biovest International Inc. of Worcester, Mass., and some of his co-researchers have financial ties to the company.

To be in the study, patients had to have achieved a remission for at least six months with standard chemo. This often occurs with this type of lymphoma, but the disease usually comes back.

Researchers gave 41 patients the shellfish protein and an immune booster; 76 other patients were given those plus the vaccine. After nearly five years of followup, the average time until the cancer worsened was 44 months in the vaccine group and 30 months in the others.

Big gains also were seen with a neuroblastoma vaccine developed by the cancer institute. In a study of 226 patients, 86 percent of vaccine recipients were still alive after two years versus 75 percent of others not given the vaccine. Results were released by the oncology society two weeks ago.

The benefits from a melanoma vaccine developed by the cancer institute were more modest. It extended the time until patients relapsed — three months versus one and a half for those not given the vaccine.

Hilde Stapleton, 53, of suburban Houston, is one of the lucky ones it helped. Still, she found what many other vaccine recipients have learned: The vaccine had few side effects, but the immune system boosters were "like the worst case of flu you've ever had," she said.

The prostate cancer vaccine, Provenge, is farthest along. Its maker, Seattle-based Dendreon Corp., is seeking federal Food and Drug Administration approval for it. A study last month found that it extended survival by four months in men with very advanced disease.

Doctors unconnected with these experiments are cautiously optimistic.

"We've raised so many false hopes in the past," said Lichtenfeld of the Cancer Society. "What's different this time is we have the science reports to back up improvements."

Hormone therapy lifts lung cancer death risk: study

ORLANDO,01 june 2009- Use of menopausal hormone-replacement therapy increases the risk of death from lung cancer by 60 percent after five years, U.S. researchers reported on Saturday.

For smokers, the trial found that use of Prempro, Wyeth's combined estrogen/progestin hormone-replacement therapy, caused an extra death from non-small cell lung cancer for each 100 women during the study.

Doctors once thought that hormone therapy, or HRT, could protect women from chronic diseases, especially heart disease.

But use of the drugs plunged after 2002 when the large Women's Health Initiative study found that HRT could raise the risk not only of breast and ovarian cancer, but of strokes and other serious conditions.

"Women almost certainly shouldn't be using hormone replacement therapy and tobacco at the same time," said Dr. Rowan Chlebowski, a medical oncologist Harbor-UCLA Medical Center in Los Angeles and lead author of the study, which analyzed data from the WHI trial.

Since 2001, sales of Wyeth's hormone-replacement products have plunged by about 50 percent to around $1 billion a year, and the bulk of sales are now estrogen-replacement drug Premarin and cream formulations, said Joseph Camardo, head of medical affairs at Madison, New Jersey-based Wyeth.

"Practice has already changed significantly," he said. "Guidance and the label have changed ... use has shifted toward much shorter duration and lower doses."

The Wyeth official noted that the average age of women in the WHI study was 63, and the participants used high doses of Prempro over long periods of time.

Chlebowski said previous research suggested that hormones play a role in non-small cell lung cancer, the most common form of the disease, because women tend to have higher survival rates than men and respond better to certain therapies.

His study, presented here at a meeting of the American Society of Clinical Oncology, was the first to show a correlation in a randomized clinical trial setting.