FDA Seeks $2.2 Million Penalty from Hearing Aid Maker
Hearing aid maker Advanced Bionics LLC is being penalized $2.2 million by the U.S. Food and Drug Administration for alleged violations including failing to adhere to manufacturing standards and for failing to notify the agency that it had changed suppliers, the FDA said Friday.
The Sylmar, Calif., company makes a device called the HiRes90k Implantable Cochlear Stimulator. The device is surgically implanted behind the ear to treat profound hearing loss in both adults and children.
The agency's legal complaint alleges that the company exposed device users to unnecessary health risks by failing to follow standard manufacturing procedures and by distributing devices that contained a component provided by an unapproved vendor.
The complaint says Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. At least some of the alleged violations occurred after a 2001 inspection, which had found similar failures that the company had promised to correct, the agency said.
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Brain Changes Affect Teen Behavior
Natural changes in adolescents' brains affect their cognition, emotion and behavior, say U.S. National Institute of Mental Health researchers, who used MRI to examine the brains of volunteers.
The researchers found that brain gray matter increases in volume until the early teens, then decreases until old age. The findings appear in the April issue of the Journal of Adolescent Health.
"Adolescence is a time of substantial neurobiological and behavioral change, but the teen brain is not a broken or defective adult brain," wrote researcher Dr. Jay N. Giedd.
The findings come from the NIMH Longitudinal Brain Imaging Project, which began in 1989.
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New Test Recommended to Determine Cardiovascular Disease Risk
The way doctors treat patients at risk for cardiovascular disease may change after Friday's release of new guidelines from the American Diabetes Association and the American College of Cardiology.
The guidelines say an additional test should be added to the standard cholesterol test used to determine cardiovascular disease risk. The guidelines endorse the use of advanced lipoprotein testing by nuclear magnetic resonance (NMR) as a more accurate method to determine risk and to check whether LDL ("bad") cholesterol-lowering therapies are having an effect in patients.
NMR lipoprotein testing measures the number of LDL particles, which carry cholesterol through the body, rather than cholesterol levels alone. Studies have shown that it's the number of lipoprotein particles present in the blood, not the amount of cholesterol carried by these particles, that form blockages inside arteries.
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Stroke Hospitalizations Higher Among U.S. Blacks
Black Americans and people living in the Southeast have the highest rates of stroke hospitalizations among Medicare beneficiaries in the United States, says a report released Friday by the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services.
The report -- Atlas of Stroke Hospitalizations Among Medicare Beneficiaries -- also found that a large number of beneficiaries live in counties where there is no access to care, or inadequate choices for emergency care when they suffer a stroke.
About 21 percent of counties had no hospital, 31 percent had a hospital without an emergency department, and 77 percent had a hospital with no neurology services.
The atlas provides county-level maps of stroke hospitalizations for blacks, whites and Hispanics. It showed the that stroke hospitalization rate for blacks is 27 percent higher than for the U.S. population in general, 30 percent higher than for whites, and 36 percent higher than for Hispanics.
"The atlas highlights that where you live can determine how you live, regarding your ability to take part in activities that reduce your risk of stroke," study lead author Michele Casper, an epidemiologist at the CDC's Division for Heart Disease and Stroke Prevention, said in a prepared statement.
"Examples of community conditions that can influence a person's risk for stroke include the availability of affordable healthy food, safe options for physical activity, access to high quality health care, and anti-smoking legislation and polices," Casper said.
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CF Drug Shows Promise
An investigational oral drug called VX-770 showed promising results in treating cystic fibrosis (CF) patients who carry the G551D mutation of CF, the Cystic Fibrosis Foundation said.
The drug is being co-developed by the foundation and Vertex Pharmaceuticals Inc.
A 14-day phase 2a trial of 20 patients found that they showed significant improvements in several key indicators of CF, including lung function, nasal potential difference measurements, and sweat chloride (salt) levels. The findings suggest that the drug improves function of what is known as the CFTR protein.
This is the first time any potential therapy has been shown to improve abnormal sweat chloride levels in CF patients. Excessive sweat chloride is a key clinical indicator of CF.
"These early results are an extraordinary endorsement of our hypothesis -- that small molecules can correct the basic defect and affect the clinical indicators of cystic fibrosis," Robert J. Beall, president and CEO of the foundation, said in a prepared statement.
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FDA Issues Warning About 'Total Body Formula' and 'Total Body Mega Formula' Supplements
Consumers should not buy or consume the Tropical Orange and Peach Nectar flavors of "Total Body Formula" or the Orange/Tangerine flavor of "Total Body Mega Formula" because these liquid dietary supplements may cause problems including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue, says the U.S. Food and Drug Administration.
The products have been recalled by the distributor, Total Body Essential Nutrition of Atlanta, and the FDA is analyzing samples of the products to identify the cause of the problems. It's suspected the products contain excessive amounts of selenium, which can cause the symptoms shown by some consumers. Only small amounts of selenium -- a trace mineral -- are needed for good health.
The FDA received reports from the Florida Department of Health about 23 people who suffered serious reactions seven to 10 days after using these products. The FDA is also investigating reports of similar cases in Tennessee.
Consumers with these products should stop using them and throw them away. Anyone who has had adverse reactions after taking the products should consult a health care professional, the FDA said.
For more information, call the FDA's Food Safety Hotline at 1-888-SAFEFOOD.
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Brain Able to Detect Calorie Content of Food: Study
Even when the brain can't sense taste, it can still detect the calorie content of food, say Duke University researchers, who genetically altered the brains of mice so that they lost their ability to taste the "sweetness" in foods.
When the mice were given a choice of two solutions -- one sweetened with sugar, the other with the non-caloric sweetener sucralose -- they showed a strong preference for the sugar solution, CBC News reported.
This suggests that calorie content, not taste, guided their choice, said the researchers, who also found that consuming the sugar solution activated reward circuits in the brains of the mice. The study appears in the journal Neuron.
"Our findings suggest that calorie-rich nutrients can directly influence brain reward circuits that control food intake independently of palatability or functional taste transduction," the researchers wrote.
The study results may help in efforts to treat obesity, CBC News reported.
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