Edmund's Newsletter
December 18, 2007
Issue: #51 Volume 7

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In This Issue
Blood Pressure Drug Telmisartan Shows Powerful Activity Against Stroke
Drug Combination Shrinks Breast Cancer Metastases in Brain
Green Tea May Protect Brain Cells Against Parkinson's Disease
New Study Suggests Why Vaccines Directed Against Cancer, HIV Don't Work
Message to the Elderly: It's Never Too Late to Prevent Illness!
Strong Link Between Obesity and Colorectal Cancer
The Truth About Plastic Surgery and the Doctors Who Perform It
Believe It Or Not
News From MedWatch
Recently Approved Drugs/Indications
FDA Recalls and Safety Alerts in the Past 60 Days
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Blood Pressure Drug Telmisartan Shows Powerful Activity Against Stroke
Telmisartan, a drug widely used to help control blood pressure, may have uniquely potent activity in preventing stroke, according to a new study conducted in an animal model.

Whether they used the drug alone or in combination with a different type of antihypertensive medication, ramipril, Weill Cornell Medical College researchers found that rats fed a high-salt, stroke-inducing diet were completely protected from the brain attacks while on telmisartan.

"No other study has ever shown complete protection against stroke in this rat model using normal human drug doses" notes study senior author Dr. Daniel F. Catanzaro, professor of physiology and biophysics and professor of physiology in cardiothoracic surgery at Weill Cornell Medical College.

The study, which was funded by telmisartan's German maker, Boehringer Ingelheim Pharma GmbH & Co., is published online in the Journal of the American Society of Hypertension.

Telmisartan (brand name Micardis) is one of a class of widely used antihypertensive drugs known as angiotensin receptor blockers (ARBs). "These drugs primarily act on the vasculature to relax the small blood vessels," Dr. Catanzaro explains.

Telmisartan stands out from other ARBs in that its molecular structure allows it to more easily pass through the blood-brain barrier and enter the brain-something many drugs cannot do.

Drug Combination Shrinks Breast Cancer Metastases in Brain
A combination of a "targeted" therapy and chemotherapy shrank metastatic brain tumors by at least 50 percent in one-fifth of patients with aggressive HER2-positive breast cancer, according to data presented by Dana-Farber Cancer Institute investigators at the San Antonio Breast Cancer Symposium.

Lapatinib (Tykerb) and capecitabine (Xeloda) were paired in an extension of a Phase 2 clinical trial in which lapatinib given alone shrank brain metastases significantly in six percent of 241 patients.

In the extension trial, capecitabine was added to lapatinib in 49 patients whose metastases - cancerous colonies in the brain spread from their primary cancer - had progressed while on treatment. With the combination therapy, brain metastases shrank by 20 percent or more in 18 patients (37 percent) and shrank by at least 50 percent in 10 patients (20 percent), reported Nancy Lin, MD, of Dana-Farber's Breast Oncology Center.

Green Tea May Protect Brain Cells Against Parkinson's Disease
Does the consumption of green tea, widely touted to have beneficial effects on health, also protect brain cells? Authors of a new study being published in the December 15th issue of Biological Psychiatry share new data that indicates this may be the case.

The authors investigated the effects of green tea polyphenols, a group of naturally occurring chemical substances found in plants that have antioxidant properties, in an animal model of Parkinson's disease.

Parkinson's disease is a progressive, degenerative disorder of the central nervous system, resulting from the loss of dopamine-producing brain cells, and there is presently no cure. According to Dr. Baolu Zhao, corresponding and senior author on this article, current treatments for Parkinson's are associated with serious and important side effects. Their previous research has indicated that green tea possesses neuroprotective effects, leading Guo and colleagues to examine its effects specifically in Parkinson's. The authors discovered that green tea polyphenols protect dopamine neurons that increases with the amount consumed. They also show that this protective effect is mediated by inhibition of the ROS-NO pathway, a pathway that may contribute to cell death in Parkinson's.

Considering the popularity of green tea beverages worldwide, there is enormous public interest in the health effects of its consumption. John H. Krystal, M.D., Editor of Biological Psychiatry and affiliated with both Yale University School of Medicine and the VA Connecticut Healthcare System, reminds us that "many health-related claims have been made for a wide variety of naturally-occurring substances and many of these claims, as in the case of St. John's Wort and Ginko Biloba, have not held up in rigorous clinical studies. Thus, it is extremely important to identify the putative neuroprotective mechanisms in animal models, as Guo and colleagues have begun to do for Parkinson's disease."

New Study Suggests Why Vaccines Directed Against Cancer, HIV Don't Work
Researchers from the University of Missouri and Imperial College London have found evidence suggesting why vaccines directed against the virus that causes AIDS and many cancers do not work. This research is being published in the Dec. 14 edition of The Journal of Biological Chemistry.

In research spanning more than a decade, Gary Clark, associate professor of Obstetrics, Gynecology and Women's Health in the MU School of Medicine, and Anne Dell, an investigator at Imperial College London, found that HIV, aggressive cancer cells, H. pylori, and parasitic worms known as schistosomes carry the same carbohydrate sequences as many proteins produced in human sperm.

"It's our major Achilles heel," Clark said. "Reproduction is required for the survival of our species. Therefore we are 'hard-wired' to protect our sperm and eggs as well as our unborn babies from any type of immune response. Unfortunately, our results suggest that many pathogens and tumor cells also have integrated themselves into this protective system, thus enabling them to resist the human immune response."

During the initial stages of life, the body goes through a process where it "self-identifies," determining which cells and proteins belong in the body, so it can detect those that do not. After this time, anything foreign is deemed as dangerous, unless the immune system is specifically told to ignore those cells and proteins. This situation arises primarily during reproduction.  

Message to the Elderly: It's Never Too Late to Prevent Illness!
A new study by a NewYork-Presbyterian Hospital/Weill Cornell Medical Center physician-scientist has an important message for the elderly: It's not too late to improve your health through diet and exercise, even if you've had an unhealthy lifestyle in the past!

Published in the November issue of the American Journal of Clinical Nutrition, the report surveyed scientific literature and found that adults, 65 and older, can have significant health improvements with simple and realistic lifestyle changes. It found that risk can be reduced for many diseases-including obesity, cancer, cardiovascular disease and osteoporosis.

"I think this is an extremely important and positive message," says the paper's lead symposium editor, Dr. Richard S. Rivlin, professor of medicine at Weill Cornell Medical College and attending physician at NewYork-Presbyterian/Weill Cornell. "Many elderly people feel that it is too late for them to improve their health, but that is simply not true."

Strong Link Between Obesity and Colorectal Cancer
A clear, direct link between obesity and colorectal cancer, the second most common form of cancer in Australia with more than 12,000 new cases each year, has been shown in a new analysis by The George Institute for International Health in Sydney, Australia.

The report, published today in one of the leading cancer journals Cancer Epidemiology, Biomarkers and Prevention, shows that obese individuals (Body Mass Index* (BMI) >30 kg/m2) have a 20% greater risk of developing colorectal cancer compared with those of normal weight (BMI < 25 kg/m2). The analyses also indicated that obese men are at 30% greater risk of developing the cancer compared with obese women. Findings from the study also showed that carrying even a few excess kilos substantially increases the risk of colorectal cancer; for every 5 kg weight gain the risk of developing the cancer increases by 7%.

Dr Rachel Huxley and co-authors at The George Institute reviewed over 70,000 patients in an analysis that included studies all across the globe: "Approximately, one in twenty Australians will develop colorectal cancer in their lifetime and our data clearly indicate that the risk of developing the cancer can be substantially reduced by maintaining a healthy weight" said Dr Huxley.

The new report carries links with the latest report from the World Cancer Research Fund Report**, which provides further support regarding the link between obesity and cancer. Importantly, the primary recommendation of the report is; "Be as lean as possible within the normal range of body weight", supported by a public health goal of 'Median adult body mass index (BMI) to be between 21 and 23'. All eight recommendations made in the report were focused on healthy eating, drinking and physical activity, creating a sincere message of the relationship between diet and cancer risk. "Although the mechanisms that explain the link between excess weight and cancer remain to be elucidated, substantial evidence supports an important role for diet and physical activity" added Dr Huxley.

Both the international and George Institute report stress the increasing levels of obesity in both high income and developing countries. "Currently, around 300 million people across the world are obese. This figure is expected to rise up toward 700 million by 2015. Considering that obesity increases the threat of colorectal cancer by 20%, this means that 10,000 cases each year are due to severe excess weight. The number of cases of colorectal cancer alone, caused by obesity, is likely rise to at least 25,000 by 2015," added Dr Huxley.

The Truth About Plastic Surgery and the Doctors Who Perform It
Reality shows such as "Dr. 90210," "Extreme Makeover" and "The Swan" have made plastic surgery, like home decorating and wardrobe rescue, a new form of entertainment.

But the real world intruded when Donda West, 58, mother of singer Kanye West, died Nov. 10, a day after undergoing multiple surgeries by Dr. Jan Adams, host of Discovery Health Channel's "Plastic Surgery: Before and After."

Deaths occurring at accredited, office-based surgery facilities are rare -- less than one-quarter of 1 percent, according to a 2004 study published in the journal Plastic and Reconstructive Surgery.

Nevertheless, the incident dramatized the fact that surgery is serious business, with media stardom no guarantee of a physician's level of training. Local doctors say that while such shows have made patients better informed, they've soft-pedaled risks, hyped results and misled the public into believing that TV's telegenic doctors must be among the most qualified in their fields.

"These shows have made people forget this is doctoring," said Dr. Robert D. Wallace, chief of the division of plastic surgery at the University of Tennessee Health Science Center. "It's not just make-believe on TV. ... The same issue is right here in Memphis of surgeons who are not trained in the procedures they are doing working in nonaccredited, office-based, surgery facilities."

Believe it or not
Pregnant? Backache? Thank evolution

Pregnant women may stand out a mile away with their characteristic backward-leaning stance, but that clumsy-looking position is a unique adaptation that evolved over millennia, anthropologists said on Wednesday.

Pregnant pre-humans appeared to have stood the same way. And it may save women from even more back pain than they already have, the researchers report in this week's issue of the journal Nature.

The bodies of women do two things when they are pregnant -- they adjust their stance to move the center of gravity to accommodate the growing fetus, and the lower vertebrae have evolved a distinct shape to allow this shifting to take place without damaging the spine, Katherine Whitcome of Harvard University and colleagues found.

"It was one of these things like, 'Oh my god, no one's ever thought of this,' and it looks so obvious," Liza Shapiro of the University of Texas at Austin, who helped supervise the work, said in a telephone interview.

Whitcome and Shapiro followed 19 women through their pregnancy, using digital cameras and motional analysis equipment to map the changes in stance and movement as the months passed.

"What women do when their pregnancy reaches about half of the expected mass ... they shift backwards," Shapiro said.

"If you didn't have any of those mechanisms, the only way to offset a load in front of you is to contract your back muscles. The more you have to use your muscles, the more discomfort you would have. It would be worse otherwise, and there would be more potential damage to the vertebrae."

Without this change in shape, the vertebrae could be subject to shearing forces, with one sliding over another, damaging the fluid-filled discs in between or pulling on ligaments and muscles.

"The shape of the vertebrae allows her to rotate the upper body," Shapiro said.

When she moved to Harvard, Whitcome continued the study and looked at the fossils of pre-humans known as australopithecines, as well as at the bone structure of our nearest living relatives, the chimpanzees.

"These differences are absent in the chimpanzee. So there is something unique about humans," Whitcome said. "We also see some evidence for these adaptations in early australopithecines."

Men do not have this adaptation, either, Shapiro said.

"We can only conclude that men can't resist the forces of their big bellies as well as women. They are at a disadvantage," she said.

"They probably lean back the same way to try and balance that load, but they are kind of putting their vertebrae more at risk. I am sure there has got to be a correlation between having a big beer gut and having back pain," Shapiro laughed.
News From MedWatch
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