Wednesday, February 15, 2006

Health Headlines - February 15

Genentech Seeks Additional Indication for Herceptin

Drug company Genentech on Thursday filed an supplemental application with the U.S. Food and Drug Administration to approve an additional indication for the drug Herceptin in treating early-stage operable human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Herceptin is already approved in the United States as a first-line treatment for HER2-positive metastatic breast cancer in combination with paclitaxel, or as a single treatment for relapsed or refractory HER-2 positive metastatic breast cancer.

Genentech requested that the FDA give priority review designation to the application, which is based on an analysis of more than 3,000 patients. It found that the addition of Herceptin to chemotherapy improved disease-free survival and overall survival compared to chemotherapy alone and reduced by 52 percent the risk of breast cancer recurrence in women with early-stage HER-2 positive breast cancer.

In other news, the FDA accepted Merck's new drug application for JANUVIA (sitagliptin phosphate), an investigational drug for type 2 diabetes. If the FDA approves the application, the drug would be among the first in a new class of oral medications called DPP-4 inhibitors that enhance the body's own ability to lower elevated blood sugar levels.

Merck said it expects FDA action on the application by mid-October.

Germany Latest Country to Report Bird Flu

Germany is the latest European Union (EU) country to report the presence of bird flu after two wild swans on the Baltic Sea island of Ruegen were found to be infected with the deadly H5N1 virus.

The Swedish government has ordered farmers to keep their poultry indoors in order to protect them from bird flu infection, Bloomberg news reported.

Austria, Greece, Italy, and Slovenia are the other EU countries that have reported cases of the H5N1 virus.

Hungarian officials said tests are being conducted on the body of a duck found in Budapest and the results will be known within seven days, Bloomberg reported.

In other news, Indonesian officials said the number of human cases of bird flu are increasing, with eight reported so far. That's second only to Turkey, which has reported 12 human cases, all contracted via bird-to-human transmission of the virus.

Bird flu is currently present in southeast and central Asia, eastern and central Europe, and western Africa. The continuing spread of the virus increase the risk that it will develop into a form easily transmitted between humans, experts say.

So far, 91 of the 169 people known to have been infected with bird flu have died, according to the World Health Organization.

FDA Defines Whole Grains

In order to help consumers select cereals and breads that have heart-healthy whole grains, the U.S. Food and Drug Administration issued new guidelines Wednesday on what qualifies as "whole grain" on food labels.

The FDA said it considers whole grains to, "include cereal grains that consist of the intact, ground, cracked or flaked fruit of the grains whose principal components - the starchy endosperm, germ and bran - and present in the same relative proportions as they exist in the intact grain. Such grains may include barley, buckwheat, bulgur, corn, millet, rice, rye, oats, sorghum, wheat and wild rice."

It's the first time that the FDA has attempted to define whole grains, the Associated Press reported.

Barbara Schneeman, director of the FDA's office of nutritional products, labeling and dietary supplements, said consumers need a consistent definition for whole grains.

"Using the term multigrain or seven-grain doesn't necessarily mean that product contains whole grains," Schneeman told the AP.

According to U.S. dietary guidelines, three servings of whole grains a day can reduce the risk of heart disease and type 2 diabetes.

Cost May Limit Avastin Use in Breast- and Lung-Cancer Patients

The widely used colon cancer drug Avastin shows promise as an important new treatment for lung and breast cancer, but the price could prove a barrier to widespread use.

Drug maker Genentech says it plans to charge about $100,000 a year for the drug when it's used to treat lung and breast cancer, The New York Times reported. That's about twice the price currently charged for Avastin treatment of colon cancer.

The $100,000 annual cost would put Avastin in the same price range typical of drugs used to treat rare diseases seen in only small numbers of patients. Some doctors say that high price could be a problem.

"Avastin is a superb drug, but its cost is already discouraging patients and doctors from using it," Dr. David Johnson, head of the cancer unit at Vanderbilt University and former president of the American Society of Clinical Oncology, told the Times.

Genentech said if society wants the benefits of life-sustaining therapies, it has to be willing to spend more for treatments like Avastin, the newspaper reported.

On Monday, the company announced that a large test of Avastin in colon-cancer patients had temporarily stopped recruiting volunteers after there were more deaths than expected of people taking the drug in combination with a chemotherapy called XELOX.

And last September, Genentech stopped enrolling ovarian-cancer patients in a clinical study of Avastin because of more frequent instances of gastrointestinal perforations than were seen in previous trials.

Test Rates Your Death Risk

You may not spend a lot of time thinking about how soon you're going to die but, if you're 51 or older and curious about your odds of shuffling off this mortal coil within four years, here's a test for you.

It was developed by researchers at the San Francisco Veterans Affairs Medical Center and appears in the current issue of the Journal of the American Medical Association, the Associated Press reported.

Simply add up your points from each question and then check your score at the end:

Age: If you're 50-59 years old, 0 points; 60-64, 1 point; 65-69, 2 points; 70-74, 3 points; 75-79, 4 points; 80-84, 5 points; 85 and older, 7 points.
If you're male, 2 points.
Too little weight in relation to your height (a health risk for older people), 1 point.
Diabetic, 2 points.
Have cancer -- excluding minor skin cancers, 2 points.
Chronic lung disease that limits activities or requires oxygen use at home, 2 points.
Congestive heart failure, 2 points.
Cigarette smoking in the past week, 2 points.
Difficulty bathing or showering due to memory or health problems, 2 points.
Difficulty paying bills, managing money, or tracking expenses due to health or memory problems, 2 points.
Difficulty walking several blocks due to health problems, 2 points.
Health problems that make it difficult to push or pull large objects, 1 point.
If your score was 0 to 5 points, you have less than a 4 percent risk of dying within four years; 6 to 9 points, 15 percent risk; 10 to 13 points, 42 percent risk; 14 or more points, 64 percent risk.

Food Fact:
Sprig fever!


Parsley isn't just pretty on the plate -- the green herb may help keep you in the pink. Parsley is rich in potassium, vitamins C and A, folic acid, iron and copper. It also contains phytochemicals that may have cancer-fighting and heart-protective properties. Research into these potential health benefits is in its infancy, however, and there's no data directly relating parsley consumption and lowered disease risk. To wash fresh parsley, dunk the leaves in a large bowl of cold water. Shake off the excess, wrap in paper towels and refrigerate in a plastic bag. It'll keep for several days. Add larger quantities to pilafs, potatoes, egg dishes and vegetable sautes shortly before you finish cooking for a nutritious boost that's not just cosmetic.

Fitness Tip of the day:
Get back on track.


Fell off the exercise wagon? It's never too late to get back on! Losing your routine may slow you down, but you can get back on track in short order if you resume regular sessions. Get motivated by setting new goals; when you start back up, reduce by half the difficulty level where you left off.

FAQ of the day:
How do I know if I have Type 2 diabetes?


The initial symptoms of Type 2 diabetes are far less severe than those of Type 1. In fact, it is estimated that half the Americans who have Type 2 diabetes don't even know it. But early diagnosis is extremely important. Left uncontrolled, Type 2 diabetes silently damages the body's large blood vessels. One reason we didn't hear much about Type 2 diabetes in the past was that many deaths related to it were blamed on heart disease. Talk to your doctor, and above all else, strive to maintain a healthy weight.

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