Guidant, the maker of implantable heart defibrillators and pacemakers, said Tuesday that it had received a warning letter from the U.S. Food and Drug Administration about unresolved issues that arose from an inspection of the company's operations in St. Paul, Minn., according to a company statement.
The letter from the FDA appears to indicate that Guidant has not been able to satisfactorily address the 15 observations the agency cited after a Sept. 1 inspection of the company's operations, The New York Times reported. The FDA's citations were first disclosed on Sept. 22 and the company had said then that it had answered the concerns.
Since June, Guidant has recalled or issued warnings for about 88,000 heart defibrillators and almost 200,000 pacemakers because of reported malfunctions. The company is under investigation by federal and state officials and faces dozens of lawsuits over its recalls, according to the Associated Press.
The latest FDA letter, which Guidant said it received on Dec. 23, says the agency will be demanding further action on its observations and would not grant requests for exportation certificates to foreign governments until those actions have been completed.
News of the letter comes on the heels of a New York Times report that said Guidant officials were aware that its defibrillators had deficiencies that could be "life threatening."
The newspaper, which has been tracking the problems with the defibrillator since the company recalled the model known as the Prizm 2 DR in June, reports that internal documents written in 2002 indicated that some patients might die because of short circuits. But the company never publicized the possible defect because its experts decided that the overall failure rate was acceptable.
The documents became public when they were filed last week in a Texas personal injury lawsuit. Lawsuits have also been filed in Pennsylvania and New York.
China to Produce 1 Billion Doses of Avian Flu Vaccine
China plans to produce 1 billion doses of a newly developed live vaccine and vaccinate all 14.2 billion farm poultry in the country to prevent fresh outbreaks of avian influenza and diminish the risk of a potential pandemic.
China approved the production and storage of the recombinant bivalent vaccine on Dec. 23, according to the Beijing-based Ministry of Agriculture's Web site. The vaccine can be applied by injection, through nasal sprays, eye drops and mixed in drinking water, Bloomberg news reported.
The development of the vaccine took four years for scientists at the Harbin Veterinary Research Institute of the Chinese Academy of Agricultural Sciences, the China Daily reported on its Web site, citing Chief Veterinary Officer Jia Youling.
Avian fluhas infected at least 141 people in Asia since 2003, killing at least 73 of them, the World Health Organization said on its Web site.
China has reportedly vaccinated 6.85 billion birds, with more than 5 billion of them immunized since October.
Grapefruit Fights Gum Disease, Study Shows
Eating two grapefruits a day for two weeks appears to significantly cut gum bleeding for people who have gum disease, new research from Germany shows.
The researchers from Friedrich Schiller University said the grapefruit increases blood levels of vitamin C, which is known to promote wound healing and cut damage by unstable free radical molecules.
The study of 58 people with chronic gum disease, published in the British Dental Journal, showed that eating grapefruit had a positive effect on both smokers and non-smokers, the BBC reported. Smoking is known to increase the risk of gum disease.
At the start of the two-week study, virtually all those taking part had low levels of vitamin C in their blood plasma. On average, smokers' vitamin C level was 29 per cent lower than that for non-smokers. Eating two grapefruits a day raised vitamin C levels for all everyone.
In smokers, the level almost doubled, but because they started from a lower baseline, their average vitamin C level was still lower than that recorded in the non-smokers.
New England Flu Vaccine Distribution Inadequate, Report Says
This season's supply of flu vaccine in New England is probably sufficient, but it's not being distributed properly, according to a story in the Boston Globe.
The newspaper reports that thousands of unused doses of flu shots have been returned by hospitals and clinics and now have to be quickly redistributed if they are going to be effective. As many as 10,000 doses have been returned to the Massachusetts Department of Public Health for redistribution to doctors and facilities that didn't get enough, the Globe reports. Connecticut's health department sent about 950 doses of flu vaccine last month to a Navajo reservation in New Mexico, which had exhausted its supply, the newspaper reports.
Flu vaccine distribution doesn't flow smoothly, the Globe reports, because it isn't controlled by the U.S. government. An aggregate of private companies and some government agencies handle supply and demand. "We've seen proof that leaving something as essential as the flu vaccine supply in the hands almost entirely of the market forces is grossly inadequate and certainly would lead to a great tragedy if we had a truly severe season," the newspaper quotes Dr. Dora Mills, Maine's top health officer, as saying.
Poor Nutrition Hurts Early School Achievement, Study Shows
The lack of proper nutrition plays a negative role in academic development in young children, a Cornell University study says, especially in reading skills.
Published in the December issue of the Journal of Nutrition, the research, which examined what scientists call "food insecurity," found that "reading development, in particular, is affected in girls, though the mathematical skills of food-insecure children entering kindergarten also tend to develop significantly more slowly than other children's," said Edward Frongillo, associate professor of nutritional sciences at Cornell. Frongillo and his colleagues define families with food insecurity as "households having limited or uncertain availability of nutritionally adequate or safe foods."
The research also indicates that young girls in the primary grades whose families once were food secure no longer are have difficulty adjusting socially. "We found that kindergarten girls from food-insecure families tend to gain more weight than other girls, which may put them at risk for obesity as adults," Frongillo said.
The Cornell study was conducted over a four year period, using statistics from the U.S. Department of Education of 21,000 children who started kindergarten in 1998.
Food Fact: Is apple juice healthy?
It's better than soda -- but it still shortchanges you and your kids. Whole apples have lots of fiber that's missing from juice, which is mostly water and sugar. An apple has just 80 calories, making it a great choice to satisfy between-meal hunger.
Fitness Tip of the day: Touch-tone up!
Some of the best opportunities to burn calories arise as you're talking on the phone. Stand up and do front, back or side leg lifts while you chat. Add ankle weights for greater toning and calorie-burning effects. Stand on tip toes for as long as you can until the muscle starts to burn. If you're on a cordless, walk throughout your conversation. Or grab a heavy can of food and do alternating bicep curls for tighter arms. For a firmer butt, lean against the wall and sit on an imaginary chair.
FAQ of the day: Are beans good for weight loss?
If you replace high-calorie proteins such as meat and cheese with legumes, then eating more grain or bean dishes will help you cut your caloric intake. But remember that beans have more calories than green vegetables. A cup of black beans cooked without fat has about 230 calories, while a cup of steamed chopped broccoli has only about 45. So use modest portions of legumes for protein, and bulk up your dinners with fresh vegetables.