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Health & Fitness (233)
WASHINGTON (AP) -- The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.
In a warning letter posted online Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of email exchanges." The agency orders 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.
23andMe's saliva-based test kit, launched more than 5 years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.
The letter follows years of back-and-forth between the government and 23andMe, the most visible company among a new field of startups selling personal genetic information. The spread of consumer-marketed DNA tests has troubled doctors and health officials who worry that the products are built on flimsy science.
For years, 23andMe resisted government regulation, arguing that it simply provides consumers with information, not a medical service. But last year the company changed course, submitting several of the disease-specific tests included in its test kit.
A spokeswoman for the Mountain View, Calif.-based company said 23andMe recognizes it has been late responding to FDA questions about the application.
"Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns," said Kendra Cassillo in a statement.
The FDA letter suggests that regulators have gone to great lengths to try and work with the company, citing months of meetings and dozens of letters between the two parties.
"However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated" its technology, states the letter.
The FDA warning, dated Nov. 22, takes issue with a number of claims the company makes for its test kit, particularly calling it a "first step in prevention" against diseases like diabetes, heart disease and breast cancer. Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care. For instance, 23andMe says its test can identify women who carry the BRCA gene mutation that significantly increases the risk of breast and ovarian cancer. But a false result could lead women to undergo unnecessary screening, chemotherapy and surgery.
The FDA gives the company 15 days to respond in writing to the letter's concerns. Warning letters are not legally binding, but the government can take companies to court if they are ignored.
23andMe was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company over the years.
Company executives previously said that they first contacted the FDA in 2007, before launching their product. The agency did not take an interest in the technology until 2010, when it issued letters to several testing companies, warning that their products must be approved as safe and effective.
The FDA already regulates a variety of genetic tests administered by health care providers. The FDA's concern with 23andMe appears to center on its marketing approach, which sidesteps doctors and health professionals.
Consumers order the company's $99 product online. Once the kit arrives by mail they are instructed to spit into a small tube, providing a saliva sample which is sent back to the company for analysis. 23andMe says the customer's DNA is analyzed to determine their likelihood of developing various diseases and responding to various drugs. The test also claims to provide information about ancestral background, though this information is not regulated by the FDA.
PARIS (AP) -- A French contraceptive maker said Tuesday its morning-after pill doesn't work when taken by women who weigh more than 80 kilograms (176 pounds) and plans to change its labels to warn patients.
The decision to change its labels by HRA Pharma is based on a previous study of levonorgestrel, one of the active ingredients in its Norlevo emergency contraceptive, said Frederique Welgryn, HRA Pharma's head of women's health.
Some doctors said heavy women shouldn't assume emergency contraception won't work for them and that they should talk to a health professional or consider alternatives like a copper IUD, a birth control device that can be fitted on the uterus.
Norlevo is not sold in the U.S. but another drug with the same active ingredient is widely available.
Welgryn said a dose of HRA's drug contains 1.5 mg of levonorgestrel, identical to that found in Plan B One-Step, manufactured by Teva Pharmaceuticals in the U.S. Denise Bradley, a spokeswoman for the company, declined to comment.
The Food and Drug Administration is currently reviewing the issue and will determine "what, if any, labeling changes to approved emergency contraceptives are warranted," according to spokeswoman Erica Jefferson in an email.
Welgryn said that while the results of the study conducted by the University of Edinburgh in 2011 were "quite surprising," the last few years have seen much discussion about contraceptives' efficacy in overweight or obese patients.
HRA Pharma Chief Executive Erin Gainer estimated that millions of women across Europe use emergency contraceptives identical to Norlevo. Gainer declined to give sales figures for Norlevo alone.
Anna Glasier, a lead researcher in the 2011 study, said that their research wasn't designed to look specifically at the effect of weight on emergency contraception. She said their study only included about 1,700 women.
"It is not my place to comment as to whether the company's decision to change advice is premature," she said in an email.
She also noted another previous analysis that found there was no solid evidence to show that hormonal contraceptives were less effective in overweight women, but the quality of the studies was low.
The morning-after pill contains a higher dose of the hormone in regular birth control pills. Taking it within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent, but it works best within the first 24 hours. If a woman is already pregnant, the pill, which prevents ovulation or fertilization of an egg, has no effect.
HRA began the process of consulting with French regulators about changing the pill's labeling in 2012 and it has taken until now for Europe's drug regulators to approve the change, Welgryn said.
The new warning also says that the drug's efficacy is reduced in women who weigh more than 75 kilograms (165 pounds), and it is ineffective in women who weigh more than 80 kilograms.
Dr. Diana Mansour, a spokeswoman for Britain's Faculty of Sexual and Reproductive Healthcare, said in overweight and obese women the drug probably gets absorbed into their fat more quickly and doesn't have enough time to work in their bodies.
"It has less of a chance to delay ovulation and there are lower levels (in the blood) of the drug to have an effect," she said. Mansour said there wasn't enough information to know if simply giving obese women a higher dose of the drug would solve the problem.
In the U.K., doctors haven't been given any advice to stop giving overweight or obese women Levonnelle, which contains the same active ingredient as Norlevo.
Lynn Hearton, clinical lead for the FPA sexual health charity, said any overweight or obese women concerned about emergency contraception should speak to a medical professional.
"It is particularly important we don't put some women off taking emergency contraception because they think it won't work anyway," she said.
She said women should consider using an IUD, which can be inserted in the womb up to five days after unprotected sex.
HRA markets Norlevo in about 50 countries worldwide. It began marketing the pill in France in 1999.
It will begin printing the warning on packaging in the first half of 2014.
Cheng reported from London. Associated Press writer Matthew Perrone in Washington contributed to this report.
Follow Greg Keller on Twitter at HTTP://TWITTER.COM/GREG-KELLER
WASHINGTON (AP) -- They are among our most personal daily decisions: what to eat or drink. Maybe what to inhale.
Now that the government's banning trans fat, does that mean it's revving up to take away our choice to consume all sorts of other unhealthy stuff?
What about salt? Soda? Cigarettes?
In the tug-of-war between public health and personal freedom, the Food and Drug Administration's decision to ban trans fats barely rates a ripple.
Hardly anyone defends the icky-sounding artificial ingredient anymore, two decades after health activists began warning Americans that it was clogging their arteries and causing heart attacks.
New York, Philadelphia, a few other localities and the state of California already have banned trans fat from restaurant food.
McDonald's, Taco Bell and KFC dropped it from their french fries, nachos and chicken years ago.
The companies that fill grocery shelves say they already have reduced their use of trans fat by nearly three-fourths since 2005.
Growers are promoting new soybean oils that they say will eliminate, within a few years, the need for partial hydrogenation, the process that creates trans fats still used to enhance the texture of some pie crusts, cookies and margarine.
Mostly, Americans' palates have moved on, and so have their arguments over what's sensible health policy and what amounts to a "nanny state" run amok.
When they aren't feuding over President Barack Obama's health care law, state politicians are busy weighing the wisdom of legalizing marijuana. Already 20 states and the District of Columbia have authorized it for medicinal use. Voters in Colorado and Washington state approved smoking pot just for fun.
The FDA is taking heat for delays in coming out with new rules on regular-old tobacco cigarettes under a law passed in 2009. There are the new e-cigarettes to worry about, too. More than 20 states have banned stores from selling electronic cigarettes to minors, but the federal government has yet to take them on.
New York Mayor Michael Bloomberg's attempt to stop restaurants from selling sodas larger than 16 ounces, and the federal government's efforts to impose healthier lunches on school kids are causing more of an uproar than the trans fat ban.
Still, Jeffrey Levi, executive director of the nonprofit Trust for America's Health, says a national trans fat ban is "a big deal." After all, the FDA estimates it will prevent 20,000 heart attacks and 7,000 deaths a year.
Levi doesn't see it as evidence that federal regulators are suddenly on a roll, however.
"There are other areas where regulation is sort of stuck - everything from nutrition labeling to food safety to the tobacco regulations that have not seen the light of day," Levi said.
Talk of new government regulation typically stirs up libertarians and conservatives. Yet the trans fat ban hasn't provoked much beefing.
Radio host Rush Limbaugh groused that bureaucrats shouldn't regulate what people eat because it's "none of their business" and research on nutrition keeps changing. After all, sticks of margarine made with trans fats used to be recommended as a healthier alternative to butter.
Heritage Foundation research fellow Daren Bakst, who specializes in agriculture issues, blogged that the FDA is "ignoring the most important issue: the freedom of Americans."
A few fans of ready-to-spread cake frostings and microwave popcorn that still contain trans fat griped via Twitter.
They don't have to worry immediately.
The FDA must consider comments from the food industry and the public before it comes up with a timeline for phasing out trans fats, also known as partially hydrogenated oils. It could take years to get them off the market.
Michael Jacobson, executive director of the nonprofit Center for Science in the Public Interest, has been warning about the dangers since the early 1990s. Advocacy by the center helped persuade the government to add trans fat to nutrition labels beginning in 2006.
That created consumer pressure on food companies to find tasty ways to replace partially hydrogenated oil with less harmful fats. The companies' success helped clear the way for the government to consider a trans fat ban, he said.
"It's a little bit of an exception, in that it's so harmful and it was so widely used," Jacobson said, "and there are substitutes so that people can't tell the difference when it's removed."
Next on Jacobson's wish list is something that would be much harder for industry and the FDA to accomplish: reducing the salt in processed foods.
"There are estimates that it's causing around 100,000 deaths prematurely every year in this country," he said. "That is just huge."
Follow Connie Cass on Twitter: HTTPS://TWITTER.COM/CONNIECASS
TRI NGUYEN ISLAND, Vietnam (AP) -- Nguyen Thi Yen rolls up the sleeves of her white lab coat and delicately slips her arms into a box covered by a sheath of mesh netting. Immediately, the feeding frenzy begins.
Hundreds of mosquitoes light on her thin forearms and swarm her manicured fingers. They spit, bite and suck until becoming drunk with blood, their bulging bellies glowing red. Yen laughs in delight while her so-called "pets" enjoy their lunch and prepare to mate.
The petite, grandmotherly entomologist - nicknamed Dr. Dracula - knows how crazy she must look to outsiders. But this is science, and these are very special bloodsuckers.
She smiles and nods at her red-hot arms, swollen and itchy after 10 minutes of feeding. She knows those nasty bites could reveal a way to greatly reduce one of the world's most menacing infectious diseases.
All her mosquitoes have been intentionally infected with bacteria called Wolbachia, which essentially blocks them from getting dengue. And if they can't get it, they can't spread it to people.
New research suggests some 390 million people are infected with the virus each year, most of them in Asia. That's about one in every 18 people on Earth, and more than three times higher than the World Health Organization's previous estimates.
Known as "breakbone fever" because of the excruciating joint pain and hammer-pounding headaches it causes, the disease has no vaccine, cure or specific treatment. Most patients must simply suffer through days of raging fever, sweats and a bubbling rash. For those who develop a more serious form of illness, known as dengue hemorrhagic fever, internal bleeding, shock, organ failure and death can occur.
And it's all caused by one bite from a female mosquito that's transmitting the virus from another infected person.
So how can simple bacteria break this cycle? Wolbachia is commonly found in many insects, including fruit flies. But for reasons not fully understood, it is not carried naturally by certain mosquitoes, including the most common one that transmits dengue, the Aedes aegypti.
The germ has fascinated scientist Scott O'Neill his entire career. He started working with it about two decades ago at Yale University. But it wasn't until 2008, after returning to his native Australia, that he had his eureka moment.
One of his research students figured out how to implant the bacteria into a mosquito so it could be passed on to future generations. The initial hope was that it would shorten the insect's life. But soon, a hidden benefit was discovered: Wolbachia-infected mosquitoes not only died quicker but they also blocked dengue partially or entirely, sort of like a natural vaccine.
"The dengue virus couldn't grow in the mosquito as well if the Wolbachia was present," says O'Neill, dean of science at Monash University in Melbourne. "And if it can't grow in the mosquito, it can't be transmitted."
But proving something in the lab is just the first step. O'Neill's team needed to test how well the mosquitoes would perform in the wild. They conducted research in small communities in Australia, where dengue isn't a problem, and the results were encouraging enough to create a buzz among scientists who have long been searching for new ways to fight the disease. After two and a half years, the Wolbachia-infected mosquitoes had overtaken the native populations and remained 95 percent dominant.
But how would it work in dengue-endemic areas of Southeast Asia? The disease swamps hospitals in the region every rainy season with thousands of sick patients, including many children, sometimes killing those who seek help too late.
The Australians tapped 58-year-old Yen at Vietnam's National Institute of Hygiene and Epidemiology, where she's worked for the past 35 years. Their plan was to test the Wolbachia mosquitoes on a small island off the country's central coast this year, with another release expected next year in Indonesia.
Just getting the mosquitoes to Tri Nguyen Island was an adventure. Thousands of tiny black eggs laid on strips of paper inside feeding boxes had to be hand-carried inside coolers on weekly flights from Hanoi, where Yen normally works, to Nha Trang, a resort city near the island. The eggs had to be kept at just the right temperature and moisture. The mosquitoes were hatched in another lab before finally being transported by boat.
Yen insisted on medical checks for all volunteer feeders to ensure they weren't sickening her mosquitoes. She deemed vegetarian blood too weak and banned anyone recently on antibiotics, which could kill the Wolbachia.
"When I'm sleeping, I'm always thinking about them," Yen says, hunkered over a petri dish filled with dozens of squiggling mosquito pupae. "I'm always worried about temperature and food. I take care of them same-same like baby. If they are healthy, we are happy. If they are not, we are sad."
Recently, there have been several promising new attempts to control dengue. A vaccine trial in Thailand didn't work as well as hoped, proving only 30 percent effective overall, but it provided higher coverage for three of the four virus strains. More vaccines are in the pipeline. Other science involves releasing genetically modified "sterile" male mosquitoes that produce no offspring, or young that die before reaching maturity, to decrease populations.
Wolbachia could end up being used in combination with these and other methods, including mosquito traps and insecticide-treated materials.
"I've been working with this disease now for 40-something years, and we have failed miserably," says Duane Gubler, a dengue expert at the Duke-NUS Graduate Medical School in Singapore who is not involved with the Wolbachia research.
"We are now coming into a very exciting period where I think we'll be able to control the disease. I really do."
Wolbachia also blocks other mosquito-borne diseases such as yellow fever and chikungunya, O'Neill says. Similar research is being conducted for malaria, though that's trickier because the disease is carried by several different types of mosquitoes.
It's unclear why mosquitoes that transmit dengue do not naturally get Wolbachia, which is found in up to 70 percent of insects in the wild. But O'Neill doesn't believe that purposefully infecting mosquitoes will negatively impact ecosystems. He says the key to overcoming skepticism is to be transparent with research while providing independent risk analyses and publishing findings in high-caliber scientific journals.
"I think, intuitively, it makes sense that it's unlikely to have a major consequence of introducing Wolbachia into one more species," O'Neill says, adding that none of his work is for profit. "It's already in millions already."
Dengue typically comes in cycles, hitting some areas harder in different years. People remain susceptible to the other strains after being infected with one, and it is largely an urban disease with mosquitoes breeding in stagnant water.
Laos and Singapore have experienced their worst outbreaks in recent history this season. Thailand has also struggled with a large number of patients. Cases have also been reported in recent years outside tropical regions, including in the U.S. and Europe.
Vietnam has logged lower numbers this year overall, but the country's highest dengue rate is in the province where Yen is conducting her work.
At the area's main hospital in Nha Trang, Dr. Nguyen Dong, director of infectious diseases, says 75 of the 86 patients crammed into the open-air ward are infected with the virus.
Before jabbing his fingers into the stomach of one seriously ill patient to check for pain, he talks about how the dengue season has become much longer in recent years. And despite the government's increased education campaigns and resources, the disease continues to overwhelm the hospital.
If the experiment going on just a short boat ride away from the hospital is successful, it eventually will be expanded across the city and the entire province.
The 3,500 people on Tri Nguyen island grew accustomed to what would be a bizarre scene almost anywhere else: For five months, community workers went house-to-house in the raging heat, releasing cups of newborn mosquitoes.
And the residents were happy to have them.
"We do not kill the mosquitoes. We let them bite," says fisherman Tran To. "The Wolbachia living in the house is like a doctor in the house. They may bite, but they stop dengue."
Specimens collected from traps are taken back to the lab for analysis to determine how well Wolbachia mosquitoes are infiltrating the native population.
The strain of bacteria used on the island blocks dengue 100 percent, but it's also the hardest to sustain. At one point, 90 percent of the mosquitoes were infected, but the rate dropped to about 65 percent after the last batch was released in early September. A similar decrease occurred in Australia as well, and scientists switched to other Wolbachia strains that thrive better in the wild but have lesser dengue-blocking abilities.
The job is sure to keep Yen busy in her little mosquito lab, complete with doors covered by long overlapping netting.
And while she professes to adore these pests nurtured by her own blood, she has a much stronger motivation for working with them: Dengue nearly claimed her own life many years ago, and her career has been devoted to sparing others the same fate.
"I love them," she says, "when I need them."
On the Net: HTTP://WWW.ELIMINATEDENGUE.COM/
Follow Margie Mason on Twitter: twitter.com/MargieMasonAP
WASHINGTON (AP) -- Debating whether to seek a strep test for that sore throat? One day there could be an app for that: Researchers are developing a home scorecard that aims to prevent thousands of unnecessary trips to the doctor for this common complaint.
More than 12 million people make doctors' visits for a sore throat every year. Usually the culprit is a virus that they just have to wait out with a little TLC.
In fact, the risk of strep throat is low enough for adults that doctors may skip testing them, deciding not to bother after running down a list of symptoms. That can leave patients wondering why they spent hours in the waiting room and had to pay the doctor's bill.
"If you could know that your risk was low enough that you wouldn't even be tested, you might actually save yourself a visit," said Dr. Andrew Fine, an emergency physician at Boston Children's Hospital.
The trick: Combine some of the symptoms that doctors look for with a bit of computer data to tell if strep throat is circulating in your geographical region. If the bug's in your neighborhood, that increases the chances that you've caught it, said Dr. Kenneth Mandl, a Harvard professor and informatics specialist with Boston Children's.
As a first step, Fine and Mandl turned to the records of more than 70,000 sore-throat patients who got strep tests and had their symptoms recorded at CVS MinuteClinics in six states between 2006 and 2008. They determined those people's risk of strep using the experimental scorecard approach and checked the computer model's accuracy against the strep test results.
Nationally, identifying those with less than a 10 percent chance of strep throat could save 230,000 doctor visits a year, the team reported Monday in the journal Annals of Internal Medicine.
The method wasn't perfect: It meant 8,500 strep cases would have been missed, or the diagnosis delayed, concluded the government-funded study.
But Mandl said it's unlikely that would lead to lasting harm as most of those infections would clear up on their own, or persisting pain eventually would send patients to the doctor. And he noted that the rapid strep tests that doctors use in their offices can miss cases, too.
Much more research is needed to prove if the method would work in everyday life and if a mobile app or a phone call to the doctor would be the best approach. The Boston team has begun the next step: Parents of kids who come to the hospital's emergency room for a strep test are handed a digital tablet and asked to fill out the scorecard first. Researchers will see how the combination of symptoms and local infection trends compare with actual strep test results.
Sore throats are a challenge. Strep throat, caused by bacteria named Group A streptococcus, is to blame for only about 10 percent of cases in adults, and 30 percent in children.
It's hard to tell who needs a strep test based on symptoms alone, cautioned Dr. Chris Van Beneden of the Centers for Disease Control and Prevention, which helped fund the new research. But what is clear: Doctors should be sure it's strep before prescribing antibiotics because those bacteria-fighting drugs have no effect on viruses.
Yet research published last month in the journal JAMA Internal Medicine found 60 percent of adults who sought care for a sore throat received antibiotics. Unneeded antibiotic use can spur development of drug-resistant germs.
The Boston team looked at the flip side of the issue: Who could safely skip a strep check? Because strep is most common in children ages 5 to 15, doctors usually test youngsters with a sore throat for the bacteria.
For anyone 15 or older, Mandl said doctors may skip a test depending on symptoms. While a cough and runny nose are more typical of a cold virus, strep symptoms might include a fever, enlarged lymph nodes, tonsils with swelling or pus and lack of a cough.
So Fine and Mandl focused first on the over-15 crowd. Because feeling lymph nodes and peeking at tonsils could be difficult for the average layman, their scorecard posed easy questions: Is there a fever? Is there a cough?
Then came the key: The scorecard automatically merged those symptoms with local trends in strep diagnosis.
It's a practice called biosurveillance. Already, hundreds of hospitals, clinics and health departments automatically report certain symptoms and diagnoses to the government. That lets officials track the spread of flu every year, for example - and some web sites now show flu activity by zip code so people can check if influenza has reached their community.
Likewise, results of strep tests are available digitally from testing laboratories, clinics, even large doctors' offices, Mandl said. They just have to be collected and used, which isn't routine.
In an accompanying editorial, Dr. Robert Centor of the University of Alabama, Birmingham, said too many clinics and emergency rooms still give a strep test to every sore throat patient. But he questioned if the home scorecard approach would make a difference, wondering if biosurveillance would be too costly or if average patients even would use it before seeking care.
NEW YORK (AP) — Doctors may one day be able to control a patient's HIV infection in a new way: injecting swarms of germ-fighting antibodies, two new studies suggest.
In monkeys, that strategy sharply reduced blood levels of a cousin of HIV. The results also gave tantalizing hints that someday the tactic might help destroy the AIDS virus in its hiding places in the body, something current drugs cannot do.
The study results "could revolutionize efforts to cure HIV" if the approach is found to work in people, said a commentary published Wednesday by the journal Nature along with the monkey studies.
Antibodies are proteins in the blood that grab onto specific germs and mark them for elimination. People infected with HIV naturally make antibodies to fight the AIDS virus, but they are generally ineffective. The two new studies used lab-made versions of rare antibodies with unusual potency against HIV.
One study of rhesus monkeys showed a profound effect from a single injection of antibodies, said lead author Dr. Dan Barouch of Harvard and the Beth Israel Deaconess Medical Center in Boston.
The 18 animals had been infected with SHIV, a monkey version of HIV. In 13 animals, blood levels of SHIV became undetectable by standard tests within a week of the treatment. After the antibodies petered out, the virus came back. That happened one to three months after treatment.
In three monkeys with the lowest levels of SHIV before treatment, the virus didn't return during an observation period of up to eight months. Barouch said the animals were not cured, but the treatment had apparently improved their immune systems enough to keep the virus in check.
The two other monkeys started with the highest blood levels of SHIV. Treatment lowered those levels but not to the point where they were undetectable.
The second study in Nature, from the National Institutes of Health, showed encouraging results in a smaller group of monkeys.
In people, standard drugs routinely tamp down HIV to undetectable levels in the blood. But the antibody approach may someday help doctors attack virus that's hiding in infected cells, beyond the reach of today's drugs, said the Nature commentary by Dr. Steven Deeks of the University of California, San Francisco, and Dr. Louis Picker of the Oregon Health & Science University in Beaverton.
In theory, antibodies might activate the body's immune system to kill those infected cells, they wrote. Barouch's results hinted at such an effect, they noted. Virus levels dropped faster in the monkeys than they do when people get standard HIV drugs, and when the monkey virus returned, it generally didn't reach its pre-treatment levels. Barouch also found virus levels reduced in cells and tissues after treatment.
The findings of the two studies are "provocative" about prospects for attacking HIV's hiding places, Deeks said in a telephone interview.
"These studies raised more questions than they answered," he said. "But that's how science advances."
Online: Nature: http://www.nature.com/nature
CHICAGO (AP) -- Doctors 2 parents: Limit kids' tweeting, texting & keep smartphones, laptops out of bedrooms. (hash)goodluckwiththat.
The recommendations are bound to prompt eye-rolling and LOLs from many teens but an influential pediatricians group says parents need to know that unrestricted media use can have serious consequences.
It's been linked with violence, cyberbullying, school woes, obesity, lack of sleep and a host of other problems. It's not a major cause of these troubles, but "many parents are clueless" about the profound impact media exposure can have on their children, said Dr. Victor Strasburger, lead author of the new American Academy of Pediatrics policy
"This is the 21st century and they need to get with it," said Strasburger, a University of New Mexico adolescent medicine specialist.
The policy is aimed at all kids, including those who use smartphones, computers and other Internet-connected devices. It expands the academy's longstanding recommendations on banning televisions from children's and teens' bedrooms and limiting entertainment screen time to no more than two hours daily.
Under the new policy, those two hours include using the Internet for entertainment, including Facebook, Twitter, TV and movies; online homework is an exception.
The policy statement cites a 2010 report that found U.S. children aged 8 to 18 spend an average of more than seven hours daily using some kind of entertainment media. Many kids now watch TV online and many send text messages from their bedrooms after "lights out," including sexually explicit images by cellphone or Internet, yet few parents set rules about media use, the policy says.
"I guarantee you that if you have a 14-year-old boy and he has an Internet connection in his bedroom, he is looking at pornography," Strasburger said.
The policy notes that three-quarters of kids aged 12 to 17 own cellphones; nearly all teens send text messages, and many younger kids have phones giving them online access.
"Young people now spend more time with media than they do in school - it is the leading activity for children and teenagers other than sleeping" the policy says.
Mark Risinger, 16, of Glenview, Ill., is allowed to use his smartphone and laptop in his room, and says he spends about four hours daily on the Internet doing homework, using Facebook and YouTube and watching movies.
He said a two-hour Internet time limit "would be catastrophic" and that kids won't follow the advice, "they'll just find a way to get around it."
Strasburger said he realizes many kids will scoff at advice from pediatricians - or any adults.
"After all, they're the experts! We're media-Neanderthals to them," he said. But he said he hopes it will lead to more limits from parents and schools, and more government research on the effects of media.
The policy was published online Monday in the journal Pediatrics. It comes two weeks after police arrested two Florida girls accused of bullying a classmate who committed suicide. Police say one of the girls recently boasted online about the bullying and the local sheriff questioned why the suspects' parents hadn't restricted their Internet use.
Mark's mom, Amy Risinger, said she agrees with restricting kids' time on social media but that deciding on other media limits should be up to parents.
"I think some children have a greater maturity level and you don't need to be quite as strict with them," said Risinger, who runs a communications consulting firm.
Her 12-year-old has sneaked a laptop into bed a few times and ended up groggy in the morning, "so that's why the rules are now in place, that that device needs to be in mom and dad's room before he goes to bed."
Sara Gorr, a San Francisco sales director and mother of girls, ages 13 and 15, said she welcomes the academy's recommendations.
Her girls weren't allowed to watch the family's lone TV until a few years ago. The younger one has a tablet, and the older one has a computer and smartphone, and they're told not to use them after 9 p.m.
"There needs to be more awareness," Gorr said. "Kids are getting way too much computer time. It's bad for their socialization, it's overstimulating, it's numbing them."
Follow AP Medical Writer Lindsey Tanner atHTTP://WWW.TWITTER.COM.LINDSEYTANNER