Tuesday, October 2, 2012

FOXNews.com: FDA warns Zimmer over manufacturing of hip devices

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FDA warns Zimmer over manufacturing of hip devices
Oct 2nd 2012, 11:35

Published October 02, 2012

Reuters

Zimmer Holdings Inc said it received a warning letter from the U.S. Food and Drug Administration citing problems with manufacturing and testing processes for artificial hip devices made at the company's Ponce, Puerto Rico, plant.

The warning letter, dated September 19, does not restrict production or shipment of the hip devices, called Trilogy Acetabular Systems, or require withdrawal of any products from the market, Zimmer said in a regulatory filing.

The FDA said Zimmer failed to implement a testing mechanism to demonstrate the products met certain design specifications and had not validated the effects of manufacturing operations on products that incorporate metallic spikes.

The warning follows a June inspection of the company's Ponce plant. Zimmer said it temporarily suspended release of the affected products and has since completed the validation process for Trilogy products that do not incorporate metallic spikes.

The company expects to complete validation of Trilogy spiked products within the next few weeks.

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FOXNews.com: 'Active' video games get some kids off the couch

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'Active' video games get some kids off the couch
Oct 2nd 2012, 11:39

Kids may spend too much time in front of the TV, but "active" video games are getting some of them on their feet and moving, according to a study out Monday.

Of more than 1,200 Canadian high schoolers researchers surveyed, one-quarter said they played "exergames." And on average, that translated to almost an hour of exercise on two days out of the week.

That, researchers say, gets kids part-way to the exercise dose experts recommend: an hour of moderate to vigorous activity on most days of the week.

Active video games - like Nintendo's Wii Fit, Dance Dance Revolution, and Sony EyeToy exergames - get kids off the couch and dancing, boxing, doing yoga and playing sports in their living rooms.

Some small studies have found that they can help kids burn calories and possibly shed a little weight.

But it hasn't been clear how often kids use the games in the "real world."

Erin K. O'Loughlin, the lead researcher on the new study, said she was surprised that so many kids use the games.

"And they're exercising at levels that may help them meet guidelines," said O'Loughlin, of the University of Montreal in Quebec, Canada.

"I would never say this should replace regular physical activity," O'Loughlin added. "Kids should still be going outside and playing and getting exercise."

But the reality is that many are not, she said. So if exergames help some kids get off the couch and sweat, that's better than being completely sedentary.

And, O'Loughlin said, the games may help some kids gain confidence in their sports skills - possibly enough that they'll want to start playing sports the old-fashioned way.

More likely stressed about weight

The findings, reported in the journal Pediatrics, are based on a survey of 1,241 Montreal high school students. The kids answered questions on their weight and lifestyle habits, including exergaming.

Overall, girls were more likely to play exergames: 29 percent did, versus 16 percent of boys.

Exergamers were also more likely than other kids to be stressed about their weight, or to spend more than two hours a day watching TV.

O'Loughlin said the games may be especially appealing to some kids who are insecure about their weight and exercise abilities - especially girls.

Video games cost money, of course, and that could be a barrier, O'Loughlin said.

The games themselves run $15 to $20 or more. And the console systems generally range between $100 and $300.

But, O'Loughlin noted, surveys show that most U.S. kids already have video game systems at home. And if parents buy active games instead of traditional sedentary ones, the costs could be minimal.

"If you notice that your kid is spending a lot of time in front of the screen, this might be something you'd want to try," O'Loughlin said.

In general, experts recommend that kids get no more than two hours of "screen time" - TV and computers - each day. So active games would ideally need to replace, not add to, kids' screen time.

In the past, one criticism of active video games has been that kids could advance through them without ever getting on their feet. But newer motion-tracking technology has changed that, O'Loughlin noted.

"You have to actually move to win the game," she said.

The study was funded by the Canadian Cancer Society and the National Institute of Public Health of Quebec. None of the researchers reports any financial interests in the work.

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FOXNews.com: Genetically-engineered cow makes hypoallergenic milk

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Genetically-engineered cow makes hypoallergenic milk
Oct 2nd 2012, 11:48

People allergic to whey may be able to drink newly engineered milk without the unpleasant digestive consequences, according to research released Monday.

A team of New Zealand researchers genetically engineered a cow named Daisy to produce milk free of β-lactoglobulin protein that can cause allergic skin, digestive and respiratory reactions predominantly in infants.

"Since the protein is not produced in human milk, it's not surprising that this protein may be recognized as a foreign protein in infants and cause allergies," study author and scientist at AgResearch in New Zealand Stefan Wagner told LiveScience.

Studies show that about 1 in 12 infants develops an allergic response to whey, but most infants are able to outgrow their allergy.

For decades, food manufacturers have broken up whey protein, a mix of about 10 proteins including β-lactoglobulin, in milk products through a process called hydrolysis in an effort to decrease its allergenicity. [9 Weirdest Allergies]

"Infant formula uses hydrolyzed milk, which is supposed to be much less allergenic, but there is still residual risk to exposure of allergies," Wagner said.

Some outside researchers expressed concern because while the milk produced by Daisy does show much less β-lactoglobulin, it held more of a non-whey protein called casein, which is also responsible for allergies. "We wouldn't think that this has any relevance to milk allergy; whey protein is one of many, many proteins that people can be allergic to," said Robert Wood, allergy and immunology chief at The Johns Hopkins Hospital, who was not involved in the new research. 

Making Daisy

So instead of relying on manufacturing methods, the researchers focused on getting the source material free of whey.

To decrease whey in milk directly, the New Zealand group created a cow free of β-lactoglobulin. To do so, they combined two tools: Nuclear transfer, a technique established during the days of cloning the famous Dolly sheep; and RNA interference, a technique relatively new for livestock used to shut down genes.

The researchers inserted a DNA fragment into cow somatic cell lines, or those not inherited, for cow-lactating tissues; this DNA element shuts down production of β-lactoglobulin in lactating tissues. Researchers then transferred the transgenic nuclei into unfertilized egg cells that, when stimulated, became embryos that were implanted into cows — a total of 57 cloned cow embryos. [Genetics by the Numbers: 10 Tantalizing Tales]

The process resulted in five pregnancies — one of which was terminated to collect cells. Of the four remaining pregnancies, one resulted in offspring.

The whey-reduced milk is years away from market, if it ever makes it to grocery shelves.

"We are nowhere near any clinical tests — what we are currently doing is to show that milk from our transgenic cow is indeed less allergenic," Wagner said.

A ways to go

But why go to all the bother of producing a transgenic cow when manufacturers can reduce whey in postproduction?

"When we process milk with heat or enzymes, we lose some of the nutrients that are essential to our body," Anower Jabed, who completed his doctoral work on the transgenic cow and is currently at the University of Aukland, told LiveScience. "It is a way to solve the problem where we don't have to process every time."

Daisy was born unable to produce the major allergen in whey, but also born four weeks prematurely, and, to the surprise of researchers, without a tail.

"We do have evidence that suggests that the lacking tail is due to an epigenetic defect (that affects gene expression rather than the genes themselves), and we believe it is not related to the genetic modification of the calf, but this must be backed up by more results," Wagner said.

The whey-reduced milk still contained other allergenic proteins and even increased casein, the main protein that coagulates to form cheese.

However, getting cows to produce hypoallergenic milk may be far-fetched, according to some researchers.

"While it's an interesting idea, that's not going to eliminate the allergies," said Hugh Sampson, an immunologist at Mount Sinai School of Medicine, who was not involved in the current study.

Because federal law says transgenic milk can't be consumed, the researchers aren't sure what it tastes like yet.

Jabed hopes that isn't the case in the future.

"When I started this project in 2007, it was my dream to see a hypoallergenic cow, I wish in the future we can produce (hypoallergenic) milk and market it and see it in store shelves," he said.

The journal the Proceedings of the National Academy of Science published the research today.

Follow LiveScience on Twitter @livescience. We're also on Facebook & Google+.

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FOXNews.com: HPV vaccine safe, but may raise risk of fainting and infections

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HPV vaccine safe, but may raise risk of fainting and infections
Oct 2nd 2012, 11:50

The human papillomavirus (HPV) vaccine is generally safe, but may increase the risk of fainting and skin infections shortly after vaccination, a new study finds.

The study included nearly 200,000 girls who received at least one dose of the quadrivalent HPV vaccine, known as Gardasil, which is marketed by Merck & Co. and protects against four strains of HPV.

Researchers found that fainting was six times more likely to occur on the day of vaccination, compared with a period many months after vaccination — there were 24 cases of fainting per 1,000 people on the day of vaccination, compared with an average of four cases per 1,000 people during a time period months after vaccination.

And skin infections were nearly twice as likely to occur within two weeks of vaccination compared with many months after vaccination. There were 3.5 cases of skin infections per 1,000 people during the two weeks after vaccination, compared with 2.2 cases per 1,000 people during the comparison time period, the researchers said.

Because these side effects were somewhat expected, and the study did not find any new safety concerns, the findings "support the general safety of routine vaccination," the researchers said.

HPV viruses are sexually transmitted viruses that usually cause no symptoms, but persistent infections can lead to cervical cancer. Gardasil was approved in 2006, after studies showed it was safe for use in females ages 9 to 26. But because studies conducted before a vaccine's approval are usually too small to detect rare side effects, researchers have continued to monitor the safety of the HPV vaccine.

In the new study, Nicola Klein, of Kaiser Permanente Vaccine Study Center in Oakland, Calif., and colleagues analyzed information from about 189,600 girls and young women, who received a total of 350,000 doses of the HPV vaccine between 2006 and 2008. The researchers calculated the annual rate of each side effect they observed.

The researchers determined how likely participants were to be hospitalized or visit the emergency room for certain conditions in the 60 days after the vaccination, compared with a period many months after vaccination.

Injections in general are known to be linked with fainting, and so this result "is not unexpected," the researchers said.

There is evidence to suggest some of the skin infections seen in the study were actually reactions at the injection site, but the researchers did not have enough information to confirm this.

Unlike some earlier studies, the new study did not find an increased risk of blood clots linked with the vaccine. The researchers made sure to rule out side effects that were due to conditions the patients already had.

Ongoing studies of HPV are still needed to examine the risk of side effects, the researchers said. They noted that future studies should attempt to rule out effects that could be caused by pre-existing conditions.

The study was funded by Merck, and was published Monday in the journal Archives of Pediatrics & Adolescent Medicine.

Pass it on: The HPV vaccine is linked to an increased risk of fainting and skin infections.

 

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FOXNews.com: Overnight dementia 'camp' allows caregivers rest

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Overnight dementia 'camp' allows caregivers rest
Oct 2nd 2012, 11:41

Just after 10 p.m., when most people their age are going to sleep, a group of elderly folks suffering from dementia are just getting started, dancing and shaking tambourines and maracas in a raucous version of "La Bamba."

"It's a party," says an 81-year-old woman, among dozens of patients brought to a Bronx nursing home every night for a structured series of singalongs, crafts and therapy sessions that lasts until dawn.

The program, which appears to be rare, is kind of a "night camp" for dementia victims who don't sleep at night or tend to wake up agitated or become frightened or disoriented by the fall of darkness.

It's meant to provide care and activity - lots of activity - to fill the wee hours for people with Alzheimer's and similar diseases who live at home. And it's meant to provide their caregivers - usually a son or daughter - with a treasured night's sleep.

"Without this program, my father would be lost, and I would be crazy," said Robert Garcia, whose 82-year-old father, Felix, is in the program at the Hebrew Home at Riverdale called ElderServe at Night. "He doesn't sleep. At night he's wide awake, and he needs activity."

Garcia, who lives in a Bronx apartment with his wife and three of their children, said that before his father went into the program he would wake up in the night, loudly, and keep everyone else from sleeping.

"We would all wake up, and my daughter would ask, `Why is Grandpa screaming? Why is he so grumpy?'" Garcia said.

"Now he comes home in the morning, shows me his drawings, tells me what they did all night."

While many nursing homes offer temporary "respite care" so caregivers can catch up on sleep or go on vacation, the overnight-only program at the Hebrew Home fills a niche.

But costs are high, and such programs are rare. An official at the Alzheimer's Association said she knew of no other.

Daniel Reingold, president and CEO of the Hebrew Home, said the nonsectarian overnight program was started in 1998 because anecdotal studies found the biggest reason people gave for admitting loved ones into the nursing home was sleep deprivation of the caregiver.

"Someone with Alzheimer's can be getting up at 3 a.m., banging the pots and pans, thinking they were making dinner, even walking out of the house," Reingold said. "We heard stories of caregivers who were sleeping on mattresses across the front doorway so their loved one couldn't get out."

Most patients' care is covered by Medicaid, which pays the Hebrew Home $140 a night, plus $74 for transportation to and from home.

Dr. Robert Abrams, a geriatric psychiatrist at NewYork-Presbyterian Hospital, said sleep problems are typical in dementia and include the syndrome known as "sundowning," in which the fall of darkness causes confusion and fear. At the Hebrew Home, shades are kept closed.

Abrams says an overnight activity program like the Hebrew Home's is preferable to "fighting nature by insisting that participants try to sleep."

Ruth Drew, director of family services at the Alzheimer's Association in Chicago, said, "Many family members want to care for relatives with Alzheimer's at home, but in order to do that, the caregivers themselves have to remain healthy. You cannot stay healthy if you don't get a good night's sleep."

Many patients sleep a few hours at home during the day.

As the night passed at the Hebrew Home, other activities were offered to the 34 patients, ranging in age from their 60s to their 90s. Most moved on to a "cooking" program, where they were asked to peel and slice a banana, then add grapes and blueberries for a fruit salad.

During the slow process, the patients were asked, in English and Spanish, about colors and shapes. Several downed the fruit as it came their way, before salads could be compiled.

Other nighttime activities include walks through the nearly empty halls of the nursing home and "movie nights" with popcorn. Patients who are up to it are sometimes taken on field trips, for example, to see the neighborhood's Christmas lights.

In quiet rooms, patients with more profound dementia were guided in simple puzzles like putting a peg in a hole. Others had sand or water poured over their hands to stimulate tactile sensations and perhaps reminiscences.

"They haven't been to the beach in years," said program director Deborah Messina. "Maybe it's a fond memory."

One darkened room was filled with recorded sounds of nature, a pleasant aroma and twinkly lights, all meant to provide gentle stimulation.

On occasion, a patient would nod off. There are "resting rooms" for patients who want to sleep, but half-hour naps in their chairs are more common.

"It's like a sleepover," Messina said. "It's a little bit of a party, and like a sleepover, when they come home in the morning, they haven't slept much."

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FOXNews.com: Breast cancer prevention: What every woman should know

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Breast cancer prevention: What every woman should know
Oct 2nd 2012, 11:00

Few diseases stir up fear like breast cancer. 

After all, one in eight women will get it in her lifetime: "We all know someone who's had it," says Dr. Barbara Levy, vice president for health policy for the American College of Obstetricians and Gynecologists (ACOG). But just how scared should we be? And do we really know how to protect ourselves?

To find out, Health magazine—with ACOG's help—conducted an exclusive survey of 753 readers and 1,248 OB-GYNs. What we found was startling: Even smart women like you have big misconceptions about this disease. Here's what you think when it comes to breast cancer, what doctors want you to know—and the news that could save your life.

Surprise finding #1: 63 percent of women think family history is the biggest breast cancer risk factor.
What you should know:
The vast majority of women with breast cancer have no family history.

In fact, aside from being female, your age is the biggest risk factor. "As we get older, our tissue gets older, and the risk of developing disease increases," says Dr. Susan Boolbol, chief of breast surgery at Beth Israel Medical Center in New York City. With age, we've also had more lifetime exposure to estrogen, which may boost breast cancer risk. This helps explain why your chance of being diagnosed jumps from 1 in 233 in your 30s to 1 in 29 in your 60s. That said, there are simple ways to help protect yourself.

And while age is a bigger risk factor, having a family history does up your chances of developing the disease, so be proactive. Tell your doctor if a family member has had breast cancer (or even ovarian, prostate, or pancreatic cancers), so you can consider getting screened earlier, and discuss whether genetic testing or preventive medication might be good ideas for you.
_______________________________________________

More From Health.com:
Breast Cancer Myths Busted

Reduce Your Risk of Breast Cancer

Celebs Who Battled Breast Cancer

_______________________________________________

Surprise finding #2: 40% of women say breast cancer is the cancer they worry about most.
What you should know: Breast cancer is very treatable when caught early.

Though breast cancer is the most common cancer in women, lung cancer actually kills the most women every year. We have a 1 in 20 lifetime risk of dying from lung cancer, and a 1 in 36 lifetime risk of dying from breast cancer. That's because, compared with lung and other hard-to-treat cancers (such as ovarian), breast cancer tends to be caught at earlier, more treatable stages, thanks to screenings like mammograms (which is why it's so important to get one every year, starting at age 40).

Why is breast cancer so feared then? It's the disease we hear about the most through media coverage and fundraising efforts.

Surprise finding #3: 39 percent of women say the most important way to catch breast cancer early is by doing a formal monthly breast self-exam (BSE). In other words, you think it is more crucial than mammograms.
What you should know:
Mammograms are most important, 73 percent of docs say.

As for how often to get them, 85 percent of doctors advise beginning at 40 and going in every year or two after that. Despite the U.S. Preventative Services Task Force's 2009 recommendation that women start mammograms at age 50 (based on research suggesting there is a clearer benefit for older women), there's still good reason to go in at 40: A 2010 study of about 600,000 women in their 40s found that receiving mammos reduced their breast cancer death rate by 29 percent. If you're younger than 50, Levy suggests requesting a digital mammogram, which is better able to detect cancers in dense breasts (the kind that younger women tend to have).

So why do women believe so much in BSEs? For years, our gynos, based on guidelines from major health institutions like the American Cancer Society (ACS) and ACOG, asked us to perform step-by-step, quadrant-by-quadrant self-exams at home to help us find potentially cancerous lumps between screenings. But these groups have since stopped touting BSEs. Several studies have cast BSEs into doubt, including one showing no difference in death rates between women who were instructed to do self-exams and those who weren't—plus, women who did them were more likely to get invasive, stress-inducing biopsies that found no cancer.

"Formal self-exams aren't valuable," Levy concludes. "Now we promote breast self-awareness—knowing how your breasts normally look and feel so if you notice a new lump or bump, you can bring it to your doctor's attention." Rather than a monthly self-exam (which you may or may not remember to do), just feel your breasts from time to time while in the shower or in bed. If they usually feel like, say, sand, and one day you feel a rock, have your doctor take a look.

Surprise finding #4: 4 percent of women say weight has the "biggest effect" on breast cancer risk.
What you should know: Being heavy increases your risk a whole lot—by as much as 40%.

So says one study that showed women who gained 20 to 30 pounds after age 18 had a higher risk of postmenopausal breast cancer than women who gained no more than five pounds. In fact, weight gain is a big enough risk factor that 78 percent of doctors polled recommend patients drop pounds to help fend off the disease.

It's a message many of you are heeding: 32 percent of you say you've shed weight, and 57 percent exercise to lower your odds of getting the disease. Even going for brisk walks can reduce your risk, so start strolling and protect your breasts today.

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Monday, October 1, 2012

FOXNews.com: How to make eating healthy fun for kids

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How to make eating healthy fun for kids
Oct 1st 2012, 20:07

Kids can be picky when it comes to food .  .  .and it's often difficult to get them excited about eating healthy.

Catherine McCord, food blogger and author of Weelicious: One Family, One Meal, wants to make kids great eaters from an early age – and make life in the kitchen easier for parents.

Her book gives parents advice on how to give kids the necessary balance in their diet. She recently sat down with Dr. Manny Alvarez, senior managing health editor of FoxNews.com to discuss how you can make a meal that the whole family can enjoy.

McCord said because kids are not the ones who do the grocery shopping, it's up to the parents to put healthy foods in front of them.

"Kids don't get to make any decisions in their life, and the one thing (you) can control is food," McCord said.

McCord said you should offer your children options and let them design their own meal. For breakfast, instead of serving plain oatmeal, give them a choice of healthy toppings – like granola or raisins.

After breakfast, it's important to keep your child on the right path, especially once they arrive at school and could be exposed to less healthy options. McCord said it's not hard to make a quick and balanced lunch that is appealing to the eye and colorful to keep kids interested.  She suggested letting your kids help you prepare their lunch so they will be excited to eat it.  

Eliminating sweets completely forms a "taboo" in your child's mind and only makes them crave the sugary substance more. Moderate your child's intake and make a conscious decision about what sweets you purchase, she said.

The biggest influence to keep your kids eating healthy is to make it fun, she added.

For example, cooking as a family and growing a garden together teaches kids that green vegetables are actually tasty.

"Nutritious foods are important, but making them as a family is the beginning of great eating down the road," she added.

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