Drug Makers Challenge Pill Disposal Law in California

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Brand name drug makers and their generic counterparts rarely find themselves on the same side of an issue, but now they are making an exception. They have teamed up to fight a local law in California, the first in the nation, that makes them responsible for running — and paying for — a program that would allow consumers to turn in unused medicines for proper disposal.




Such so-called drug take-back programs are gaining in popularity because of a growing realization that those leftover pills in your medicine cabinet are a potential threat to public health and the environment.


Small children might accidentally swallow them and teenagers will experiment with them, advocates of the laws say. Prescription drug abusers can, and are, breaking into homes in search of them. Unused pills are sometimes flushed down the toilet, so pharmaceuticals are now polluting waterways and even drinking water. One study found the antidepressant Prozac in the brains of fish.


Most such take-back programs are run by local or other government agencies. But increasingly there are calls to make the pharmaceutical industry pay.


“We feel the industry that profits from the sales of these products should have the financial responsibility for proper management and disposal,” said Miriam Gordon, California director of Clean Water Action, an advocacy group.


In July, Alameda County, Calif., which includes Oakland and Berkeley, became the first locality to enact such a requirement. Drug companies have to submit plans for accomplishing it by July 1, 2013.


But the industry plans to file a lawsuit in United States District Court in Oakland on Friday, hoping to have the law struck down. The suit is being filed by the Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents brand-name drug companies, the Generic Pharmaceutical Association and the Biotechnology Industry Organization.


James M. Spears, general counsel of PhRMA, said the Alameda ordinance violated the Constitution in that a local government was interfering with interstate commerce, a right reserved for Congress.


“They are telling a company in New Jersey that you have to come in and design and implement and pay for a municipal service in California,” he said in an interview.


“This program is one where the cost is shifted to companies and individuals who are not located in Alameda County and who won’t be served by it.”


Mr. Spears, who is known as Mit, said that the program would cost millions of dollars a year to run and that pharmaceutical companies were “not in the waste disposal business.” He said it would be best left to sanitation departments and law enforcement agencies, which must be involved if narcotics, like pain pills, were to be transported.


Nathan A. Miley, the president of the Alameda County Board of Supervisors and the champion of the legislation, said late Thursday, “It’s just unfortunate that PhRMA would fight this because it would be pennies for them.”


“We will win legally and will win in the court of public opinion as well,” Mr. Miley said.


The battle in Alameda could set the direction for other states and localities. Legislators in seven states have introduced bills to require drug companies to pay for take-back programs in the last few years, said Scott Cassel, founder and chief executive of the Product Stewardship Institute, a nonprofit group that advocates such programs. But none of the bills have passed.


Mr. Cassel said about 70 similar “extended producer responsibility” laws have been enacted in 32 states for other products, like electronic devices, mercury-containing thermometers, fluorescent lamps, paint and batteries. He said he was not aware that any had been struck down on constitutional grounds.


The pharmaceutical industry already pays for take-back programs in some other countries. The law in Alameda is modeled partly on the system in British Columbia and two other Canadian provinces. There, the industry formed the Post-Consumer Pharmaceutical Stewardship Association, which runs the programs.


Consumers can take unused drugs back to pharmacies, from which they are periodically collected. Drug companies pay for the program in proportion to their market share, said Ginette Vanasse, executive director of the association. The program for British Columbia, with a population over four million, costs about $500,000 a year, she said.


The extent of the problem of unused pills and how best to handle them are matters of debate.


The United States Geological Survey has found various drugs, including antidepressants, antibiotics, heart medicines and hormones, in waterways it has sampled. Sewage treatment plants and drinking water treatment plants are not meant to remove pharmaceuticals.


Still, it is not known what effect the chemicals might have. “It’s a hard-to-pin-down problem,” said Sonya Lunder, a senior analyst at the Environmental Working Group, an advocacy group. It is thought that trace amounts in drinking water are probably not harmful. But larger amounts found in wastewater could be having an impact on wildlife.


It is also unclear whether take-back programs will help. Experts generally agree that the bigger source of pollution is urine and feces containing the remnants of drugs that are ingested, not the unused pills flushed down the toilet.


PhRMA also argues that take-back programs will not help much with the problem of drug abuse either. Mr. Spears said that it was better to have consumers tie up unused pills in a plastic bag and throw them in the trash. That is more effective, he said, because people would not have to travel to a collection point. Such collection points could become targets for thieves and drug abusers.


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The New Old Age Blog: A Son Lost, a Mother Found

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My friend Yvonne was already at the front door when I woke, so at first I didn’t realize that my mother was missing.

It was less than a week after my son Spencer died. Since that day, a constant stream of friends had been coming and going, bringing casseroles and soup, love, support and chatter. Mom hated it.

My 94-year-old mother, who has vascular dementia, has been living in my home in upstate New York for the past few years. Like many with dementia, mom is courteous but, underneath, irascible. Pride defines her, especially pride in her Phi Beta Kappa intellect. She hates to be confronted with how she has become, as she calls it, “stupid.”

The parade of strangers confused her. She had to be polite, field solicitous questions, endure mundane comments. She could not remember what was going on or why people were there. It must have been stressful and annoying.

That night, like every night since the state troopers brought the news, I woke hourly, tumbling in panic. As if it were not too late to save my son. Mom knew something was wrong, but she could not remember what. As I overslept that morning, she must have decided enough was enough. She was going home.

In a cold sky, the sun blazed over tall pines. As I opened the door, the dogs raced out to greet Yvonne and her two housecleaners. Yvonne often brags about her cleaning duo. They were her gift to me. They were going to clean my house before the funeral reception, which was scheduled for later that week. This was a very big gift because, like my mother before me, I am a very bad housekeeper.

Mom’s door was shut. I cautioned the housecleaners to avoid her room as I showed them around. Yvonne went to the kitchen to listen to the 37 unheard messages on my answering machine; the housecleaners went out to their van to get their instruments of dirt removal.

I ducked into Mom’s room to warn her about the upcoming noise. The bed was unmade; the floor was littered with crumpled tissues; the room was empty.

Normally, I would have freaked out right then. I knew Mom was not in the house, because I had just shown the whole house to the cleaners. Although Mom doesn’t wander like some dementia patients, she does on occasion run away. But I could not muster a shred of anxiety.

“Yvonne,” I called, “did you see my mother outside?”

Yvonne popped her head into the living room, eyebrows raised.“Outside? No!” She was alarmed. “Is she missing?”

“Yeah,” I said wearily, “I’ll look.” I stepped out onto the front porch, tightening the belt of my bathrobe and turning up the collar. Maybe she had walked off into the woods. The dogs danced around my legs, wanting breakfast.

I had no space left in my body to care. Either we would find her, or we would not. Either she was alive, or she was not. My child was gone. How could I care about anything ever again?

Then I saw my car was missing. My mouth fell open and my eyeballs rolled up to the right, gazing blindly at the abandoned bird’s nest on top of the porch light: What had I done with the keys?

Mom likes to run away in the car when she is angry. She used to do it a lot when my father was still alive — every time they fought. Since Mom took off in my car almost a year ago, after we had had a fight, I’d kept the keys hidden. Except for this week; this week, I had forgotten.

I was reverting to old habits. I had left the doors unlocked and the keys in the cupholder next to the driver’s seat. Exactly like Mom used to do.

“Uh-oh,” I said aloud. Mom was still capable of driving, even though she did not know where she was going. I just really, really hoped that she didn’t hurt anybody on the road. I pulled out my cellphone, about to call the police.

“Celia!” Yvonne shouted from the kitchen. She hurried up behind me, excited. “They found your mother. There are two messages on your machine.”

At that very moment, Mom was holed up at the College Diner in New Paltz, a 20-minute drive over the mountain, through the fields, left over the Wallkill River and away down Main Street.

Yvonne called the diner. They promised to keep the car keys until someone arrived. By that time, Yvonne had to go to work. She drove my friend Elizabeth to the diner, and Elizabeth drove Mom home in my car.

Half an hour later, they walked in the front door. Mom’s cheeks were rouged by the chill air and her eyes sparkled, her white hair riffing with static electricity. “Hello, hello,” she sang out. “Here we are.” She was wearing the flannel nightgown and robe I had dressed her in the night before. It was covered by her oversized purple parka, and her bare feet were shoved into sneakers.

I started laughing as soon as I saw her. I couldn’t help it. Elizabeth and Mom started laughing too. “You had a big adventure,” I said, hugging them both. “How are you?”

“I’m just marvelous,” said my mother. Mom always feels great after doing something rakish. We settled her on the sofa with her feet on the ottoman. By the time I got her blanket tucked in around her shoulders, she had fallen asleep.

Elizabeth couldn’t stop laughing as she described the scene. “Your mother was holding court in this big booth. She was sitting there in her nightgown and her parka, talking to everybody, with this plate of toast and coffee and, like, three of the staff hovering around her.”

The waitress said Mom seemed “a little disoriented” when she got there. Mom said she was meeting a friend for breakfast, but since she was wearing a nightgown and didn’t know whom she was meeting or where she lived, the staff thought there might be a problem. They convinced Mom to let them look in the glove compartment of the car, where they found my name and number.

It was then that I realized I was laughing – something I’d thought I would never be able to do again. “Elizabeth, Elizabeth, I’m laughing,” I said.

“Ha, ha, ha,” laughed Elizabeth, holding her belly.

“Ha, ha, ha,” I laughed, rolling on the floor.

And she who gave me life, who had suffered the death of my child and the extinction of her own intellect, snoozed on: oblivious, jubilant, still herself, still mine.

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The New Old Age Blog: A Son Lost, a Mother Found

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My friend Yvonne was already at the front door when I woke, so at first I didn’t realize that my mother was missing.

It was less than a week after my son Spencer died. Since that day, a constant stream of friends had been coming and going, bringing casseroles and soup, love, support and chatter. Mom hated it.

My 94-year-old mother, who has vascular dementia, has been living in my home in upstate New York for the past few years. Like many with dementia, mom is courteous but, underneath, irascible. Pride defines her, especially pride in her Phi Beta Kappa intellect. She hates to be confronted with how she has become, as she calls it, “stupid.”

The parade of strangers confused her. She had to be polite, field solicitous questions, endure mundane comments. She could not remember what was going on or why people were there. It must have been stressful and annoying.

That night, like every night since the state troopers brought the news, I woke hourly, tumbling in panic. As if it were not too late to save my son. Mom knew something was wrong, but she could not remember what. As I overslept that morning, she must have decided enough was enough. She was going home.

In a cold sky, the sun blazed over tall pines. As I opened the door, the dogs raced out to greet Yvonne and her two housecleaners. Yvonne often brags about her cleaning duo. They were her gift to me. They were going to clean my house before the funeral reception, which was scheduled for later that week. This was a very big gift because, like my mother before me, I am a very bad housekeeper.

Mom’s door was shut. I cautioned the housecleaners to avoid her room as I showed them around. Yvonne went to the kitchen to listen to the 37 unheard messages on my answering machine; the housecleaners went out to their van to get their instruments of dirt removal.

I ducked into Mom’s room to warn her about the upcoming noise. The bed was unmade; the floor was littered with crumpled tissues; the room was empty.

Normally, I would have freaked out right then. I knew Mom was not in the house, because I had just shown the whole house to the cleaners. Although Mom doesn’t wander like some dementia patients, she does on occasion run away. But I could not muster a shred of anxiety.

“Yvonne,” I called, “did you see my mother outside?”

Yvonne popped her head into the living room, eyebrows raised.“Outside? No!” She was alarmed. “Is she missing?”

“Yeah,” I said wearily, “I’ll look.” I stepped out onto the front porch, tightening the belt of my bathrobe and turning up the collar. Maybe she had walked off into the woods. The dogs danced around my legs, wanting breakfast.

I had no space left in my body to care. Either we would find her, or we would not. Either she was alive, or she was not. My child was gone. How could I care about anything ever again?

Then I saw my car was missing. My mouth fell open and my eyeballs rolled up to the right, gazing blindly at the abandoned bird’s nest on top of the porch light: What had I done with the keys?

Mom likes to run away in the car when she is angry. She used to do it a lot when my father was still alive — every time they fought. Since Mom took off in my car almost a year ago, after we had had a fight, I’d kept the keys hidden. Except for this week; this week, I had forgotten.

I was reverting to old habits. I had left the doors unlocked and the keys in the cupholder next to the driver’s seat. Exactly like Mom used to do.

“Uh-oh,” I said aloud. Mom was still capable of driving, even though she did not know where she was going. I just really, really hoped that she didn’t hurt anybody on the road. I pulled out my cellphone, about to call the police.

“Celia!” Yvonne shouted from the kitchen. She hurried up behind me, excited. “They found your mother. There are two messages on your machine.”

At that very moment, Mom was holed up at the College Diner in New Paltz, a 20-minute drive over the mountain, through the fields, left over the Wallkill River and away down Main Street.

Yvonne called the diner. They promised to keep the car keys until someone arrived. By that time, Yvonne had to go to work. She drove my friend Elizabeth to the diner, and Elizabeth drove Mom home in my car.

Half an hour later, they walked in the front door. Mom’s cheeks were rouged by the chill air and her eyes sparkled, her white hair riffing with static electricity. “Hello, hello,” she sang out. “Here we are.” She was wearing the flannel nightgown and robe I had dressed her in the night before. It was covered by her oversized purple parka, and her bare feet were shoved into sneakers.

I started laughing as soon as I saw her. I couldn’t help it. Elizabeth and Mom started laughing too. “You had a big adventure,” I said, hugging them both. “How are you?”

“I’m just marvelous,” said my mother. Mom always feels great after doing something rakish. We settled her on the sofa with her feet on the ottoman. By the time I got her blanket tucked in around her shoulders, she had fallen asleep.

Elizabeth couldn’t stop laughing as she described the scene. “Your mother was holding court in this big booth. She was sitting there in her nightgown and her parka, talking to everybody, with this plate of toast and coffee and, like, three of the staff hovering around her.”

The waitress said Mom seemed “a little disoriented” when she got there. Mom said she was meeting a friend for breakfast, but since she was wearing a nightgown and didn’t know whom she was meeting or where she lived, the staff thought there might be a problem. They convinced Mom to let them look in the glove compartment of the car, where they found my name and number.

It was then that I realized I was laughing – something I’d thought I would never be able to do again. “Elizabeth, Elizabeth, I’m laughing,” I said.

“Ha, ha, ha,” laughed Elizabeth, holding her belly.

“Ha, ha, ha,” I laughed, rolling on the floor.

And she who gave me life, who had suffered the death of my child and the extinction of her own intellect, snoozed on: oblivious, jubilant, still herself, still mine.

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Obama’s Tax Plan Would Spare Many Affluent Families

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President Obama’s insistence that marginal tax rates rise for families making more than $250,000 has convinced millions of affluent Americans that they are likely to be writing larger checks to the government next year.


But many of those families have no reason to fret.


A close look at the president’s plan shows that a large majority of families making up to $300,000 – as well as hundreds of thousands of families with even larger incomes – would not pay taxes at a higher marginal rate.


Because the complexity of the tax code makes it difficult to draw clean lines, they are the beneficiaries of choices the administration has made to ensure that families earning less than $250,000 do not pay higher rates.


Some of those affluent households still would pay higher taxes next year under other parts of the president’s tax plan and increases imposed by the Affordable Care Act, but not under the centerpiece, the part most frequently promote by the president and most bitterly opposed by Congressional Republicans.


John Boudreau, the president of a Connecticut construction firm who expects to make about $300,000 this year, said that was a welcome surprise. He voted for Mr. Obama and said he was ready to pay taxes at a higher rate. But he’d rather not.


“I’m willing to, but if it works that I’m not, so be it,” he said. “I will not be a person that’s going to stick an extra check in my tax bill as my donation to my country.”


Unless the White House and Congress are able to reach an agreement, federal taxes are scheduled to rise sharply next year for a large majority of Americans. Tax cuts first passed in 2001 and 2003 under President George W. Bush are scheduled to expire. So are cuts passed during Mr. Obama’s first term.


The president’s plan would prevent most of the scheduled increase for those below an income threshold Mr. Obama generally describes as $250,000. The Senate has passed similar legislation. But Democrats remain at loggerheads with House Republicans, who want to prevent scheduled increases for the most affluent households, too. And the parties disagree about how to prune federal spending.


The number that now divides the parties was introduced by Mr. Obama in 2007, in the early days of the presidential campaign, when he promised to extend the Bush tax cuts for families that made less than that amount.


“I can make a firm pledge,” Mr. Obama said in September 2008. " Under my plan, no family making less than $250,000 a year will see any form of tax increase. Not your income tax, not your payroll tax, not your capital gains taxes, not any of your taxes.”


When policy makers talk about income, however, they don’t mean the amount of money a family earns; they mean the portion subject to taxes. The government does not tax contributions to retirement plans, interest payments on mortgages or charitable donations, among other things. As a result, two families with the same incomes will most likely have different taxable incomes.


To guarantee that tax rates do not increase for any family making less than $250,000, the Obama administration proposed in 2009 to raise marginal rates on taxable income above roughly $230,000 – because the minimum amount of income a family is entitled to shelter from taxation is roughly $20,000.


But the average amount families in that income range are entitled to shelter from taxation is much larger, closer to $60,000. In other words, families with taxable income of $230,000 on average earned about $290,000 in 2009.


“They wanted to be able to say that ‘Absolutely nobody making less than $250,000 could possibly pay higher taxes under our plan,'” said Bob McIntyre, the director of Citizens for Tax Justice, a liberal advocacy group “So they had to assume the most ridiculous assumptions, that even if you’re a childless couple with no itemized deductions making $250,001, your taxes still won’t go up. They figured that if this couple existed and their taxes went up, somebody would find them and jump on ‘em.”


Furthermore, to remain consistent with the president’s original promise, the administration has adjusted the original numbers for inflation. When Mr. Obama says $250,000, the White House says he means “in 2009 dollars.” It is now proposing to raise marginal rates on families with taxable incomes above $246,000 – meaning, on average, families earning more than about $305,000.


While the president has said that he wants to raise tax rates for the top 2 percent, only about 1 percent of taxpayers will face higher marginal rates, according to an analysis by the Tax Policy Center, a widely respected research group.


The restoration of the other provisions temporarily suspended by the Bush tax cuts, including limits on deductions and higher taxes on investment income, still would raise taxes for only about 32 percent of families with income between $250,000 and $300,000, according to an analysis by Citizens for Tax Justice. About 77 percent of families with income between $300,000 and $350,000 would face an increase.


Neera Tanden, domestic policy director for Mr. Obama’s 2008 general election campaign, said the president might not have succeeded in rallying popular support for any tax increase if he had not made the $250,000 promise.


But Ms. Tanden, now president of the left-leaning Center for American Progress, said the administration should reconsider that commitment.


She co-authored a deficit-reduction plan released earlier this week recommending modest tax increases on households making as little as $100,000.


“We think it’s reasonable to ask a couple more dollars from people who make $150,000,” she said.


Some of the beneficiaries see good reasons why their taxes should not rise.


“I wouldn’t exactly say I’m disappointed,” said Ryan Ruby, 36, of Bothell, Wash., after learning that the president’s tax plan probably wouldn’t affect him even though he and his wife make between $250,000 and $300,000 a year. “I do think our tax rates should go up eventually, but right now I think the need for people to have disposable income to get the economy moving is probably more important than broadening the base.”


Most affluent households still will pay higher taxes next year for other reasons.


A two-year-old payroll tax break is scheduled to lapse at the end of this year. That would increase Social Security taxes by 2 percentage points on wage income below $113,700.


And the Affordable Care Act levies new taxes specifically targeting married couples earning more than $250,000 and singles earning more than $200,000 in adjusted gross income.


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Well: Running in Reverse

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This column appears in the Dec. 9 issue of The New York Times Magazine.

Backward running, also known as reverse or retro running, is not as celebrated as barefoot running and will never be mistaken for the natural way to run. But a small body of science suggests that backward running enables people to avoid or recover from common injuries, burn extra calories, sharpen balance and, not least, mix up their daily routine.

The technique is simple enough. Most of us have done it, at least in a modified, abbreviated form, and probably recently, perhaps hopping back from a curb as a bus went by or pushing away from the oven with a roasting pan in both hands. But training with backward running is different. Biomechanically, it is forward motion’s doppelgänger. In a study published last year, biomechanics researchers at the University of Milan in Italy had a group of runners stride forward and backward at a steady pace along a track equipped with force sensors and cameras.

They found that, as expected, the runners struck the ground near the back of their feet when going forward and rolled onto the front of their feet for takeoff. When they went backward though, they landed near the front of their feet and took off from the heels. They tended to lean slightly forward even when running backward. As a result, their muscles fired differently. In forward running, the muscles and tendons were pulled taut during landing and responded by coiling, a process that creates elastic energy (think rubber bands) that is then released during toe-off. When running backward, muscles and tendons were coiled during landing and stretched at takeoff. The backward runners’ legs didn’t benefit from stored elastic energy. In fact, the researchers found, running backward required nearly 30 percent more energy than running forward at the same speed. But backward running also produced far less hard pounding.

What all of this means, says Giovanni Cavagna, a professor at the University of Milan who led the study, is that reverse running can potentially “improve forward running by allowing greater and safer training.”

It is a particularly attractive option for runners with bad knees. A 2012 study found that backward running causes far less impact to the front of the knees. It also burns more calories at a given pace. In a recent study, active female college students who replaced their exercise with jogging backward for 15 to 45 minutes three times a week for six weeks lost almost 2.5 percent of their body fat.

And it aids in balance training — backward slow walking is sometimes used as a therapy for people with Parkinson’s and is potentially useful for older people, whose balance has grown shaky.

But it has drawbacks, Cavagna says — chiefly that you can’t see where you’re going. “It should be done on a track,” he says, “or by a couple of runners, side by side,” one facing forward.

It should be implemented slowly too, because its unfamiliar motion can cause muscle fatigue. Intersperse a few minutes periodically during your regular routine, Cavagna says. Increase the time you spend backward as it feels comfortable.

The good news for serious runners is that backward does not necessarily mean slow. The best recorded backward five-kilometer race time is 19:31, faster than most of us can hit the finish line with our best foot forward.

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Well: Running in Reverse

Label:

This column appears in the Dec. 9 issue of The New York Times Magazine.

Backward running, also known as reverse or retro running, is not as celebrated as barefoot running and will never be mistaken for the natural way to run. But a small body of science suggests that backward running enables people to avoid or recover from common injuries, burn extra calories, sharpen balance and, not least, mix up their daily routine.

The technique is simple enough. Most of us have done it, at least in a modified, abbreviated form, and probably recently, perhaps hopping back from a curb as a bus went by or pushing away from the oven with a roasting pan in both hands. But training with backward running is different. Biomechanically, it is forward motion’s doppelgänger. In a study published last year, biomechanics researchers at the University of Milan in Italy had a group of runners stride forward and backward at a steady pace along a track equipped with force sensors and cameras.

They found that, as expected, the runners struck the ground near the back of their feet when going forward and rolled onto the front of their feet for takeoff. When they went backward though, they landed near the front of their feet and took off from the heels. They tended to lean slightly forward even when running backward. As a result, their muscles fired differently. In forward running, the muscles and tendons were pulled taut during landing and responded by coiling, a process that creates elastic energy (think rubber bands) that is then released during toe-off. When running backward, muscles and tendons were coiled during landing and stretched at takeoff. The backward runners’ legs didn’t benefit from stored elastic energy. In fact, the researchers found, running backward required nearly 30 percent more energy than running forward at the same speed. But backward running also produced far less hard pounding.

What all of this means, says Giovanni Cavagna, a professor at the University of Milan who led the study, is that reverse running can potentially “improve forward running by allowing greater and safer training.”

It is a particularly attractive option for runners with bad knees. A 2012 study found that backward running causes far less impact to the front of the knees. It also burns more calories at a given pace. In a recent study, active female college students who replaced their exercise with jogging backward for 15 to 45 minutes three times a week for six weeks lost almost 2.5 percent of their body fat.

And it aids in balance training — backward slow walking is sometimes used as a therapy for people with Parkinson’s and is potentially useful for older people, whose balance has grown shaky.

But it has drawbacks, Cavagna says — chiefly that you can’t see where you’re going. “It should be done on a track,” he says, “or by a couple of runners, side by side,” one facing forward.

It should be implemented slowly too, because its unfamiliar motion can cause muscle fatigue. Intersperse a few minutes periodically during your regular routine, Cavagna says. Increase the time you spend backward as it feels comfortable.

The good news for serious runners is that backward does not necessarily mean slow. The best recorded backward five-kilometer race time is 19:31, faster than most of us can hit the finish line with our best foot forward.

Read More..

Apple to Resume U.S. Manufacturing

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For the first time in years, Apple will manufacture computers in the United States, the chief executive of Apple, Timothy D. Cook, said in interviews with NBC and Bloomberg Businessweek.




“Next year, we will do one of our existing Mac lines in the United States,” he said in an interview to be broadcast Thursday on “Rock Center With Brian Williams” on NBC.


Apple, the biggest company in the world by market value, moved most of its manufacturing to Asia in the late 1990s. As an icon of American technology success and innovation, the California-based company has been criticized in recent years for outsourcing jobs abroad.


“I don’t think we have a responsibility to create a certain kind of job,” Mr. Cook said in the Businessweek interview. “But I think we do have a responsibility to create jobs.”


The company plans to spend $100 million on the American manufacturing in 2013, according to the interviews, a small fraction of its overall factory investments and an even tinier portion of its available cash.


In the interviews, Mr. Cook suggested the company would work with partners and that the manufacturing would be more than just the final assembly of parts. He noted that parts of the company’s ubiquitous iPhone, including the “engine” and the glass screen, were already made in America. The processor is manufactured by Samsung in Texas, while Corning makes the glass screen in Kentucky.


Over the last few years, sales of the iPhone, iPod and iPad have overwhelmed Apple’s line of Macintosh computers, the basis of the company’s early business. Revenue from the iPhone alone made up 48 percent of the company’s total revenue for its fiscal fourth quarter ended Sept. 30.


But as recently as October, Apple introduced a new, thinner iMac, the product that pioneered the technique of building the computer innards inside the flat screen.


Mr. Cook did not say in the interviews where in the United States the new manufacturing would occur. But he did defend Apple’s track record in American hiring.


“When you back up and look at Apple’s effect on job creation in the United States, we estimate that we’ve created more than 600,000 jobs now,” Mr. Cook told Businessweek. Those jobs include positions at partners and suppliers.


Steve Dowling, a spokesman for Apple, declined on Thursday to provide additional details on Apple’s plans, referring to Mr. Cook’s interviews.


Apple has for years done the final assembly of some Macs in the United States, mainly systems that customers buy with custom configurations, like bigger hard drives and more memory than on standard machines.


Mr. Cook’s statements suggested Apple is planning to build more of the Mac’s ingredients domestically, although with partners. He told Businessweek that the plan “doesn’t mean that Apple will do it ourselves, but we’ll be working with people, and we’ll be investing our money.”


While Apple’s products are typically made in Asian factories owned by other companies, Apple itself often purchases the sophisticated manufacturing equipment required to make its cutting-edge designs, spending billions of dollars a year on such machines.


Foxconn Technology, which manufactures more than 40 percent of the world’s electronics, is one of Apple’s main overseas manufacturing contractors. Based in Taiwan, Foxconn is China’s largest private employer, with 1.2 million workers, and it has come under intense scrutiny over working conditions inside its factories.


In March, Foxconn pledged to sharply curtail the number of working hours and significantly increase wages. The announcement was a response to a far-ranging inspection by the Fair Labor Association, a monitoring group that found widespread problems — including numerous instances where Foxconn violated Chinese law and industry codes of conduct.


Apple, which recently joined the labor association, had asked the group to investigate plants manufacturing iPhones, iPads and other devices. A growing outcry over conditions at overseas factories prompted protests and petitions, and several labor rights organizations started scrutinizing Apple’s suppliers.


Almost all of the 70 million iPhones, 30 million iPads and 59 million other products Apple sold in 2011 were manufactured overseas. Apple employs 43,000 people in the United States and 20,000 overseas. An additional 700,000 people engineer, build and assemble iPads, iPhones and Apple’s other products, mostly abroad.


At a meeting with Silicon Valley executives in 2011, President Obama asked Steven P. Jobs, then the Apple chief executive, what it would take to make iPhones in the United States. Mr. Jobs, who died later that year, told the president, “Those jobs aren’t coming back.”


Nick Wingfield contributed reporting.


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Wider Chaos Feared as Syrian Rebels and Kurds Clash

Label:

Lynsey Addario for The New York Times


Syrian Kurds in Ras al-Ain are seeking refuge across the border in Ceylanpinar, Turkey.







CEYLANPINAR, Turkey — In plain view of the patrons at an outdoor cafe here in this border town, the convoy of gun trucks waving the flag of the Syrian rebels whizzed through the Syrian village of Ras al-Ain. They had not come to fight their primary enemy, the soldiers of Bashar al-Assad’s government. They had rushed in to battle the ethnic Kurds.








Lynsey Addario for The New York Times

Turkish and Syrian civilians watched the fighting across the border in Ras al-Ayn, Syria, after two government jets bombed the village.






The confrontation spoke not only to the violence that has enveloped Syria, but also to what awaits if the government falls. The fear — already materializing in these hills — is that Syria’s ethnic groups will take up arms against one another in a bloody, post-Assad contest for power.


The Kurdish militias in northern Syria had hoped to stay out of the civil war raging in Syria. They were focused on preparing to secure an autonomous enclave for themselves within Syria should the rebels succeed in toppling the government. But slowly, inexorably, they have been dragged into the fighting and now have one goal in mind, their autonomy, which also means the balkanization of the state.


“We want to have a Kurdish nation,” said Divly Fadal Ali, 18, who fled the fighting and was recently staying in a local community center here for Kurdish refugees. “We want our own schools, our own hospitals. We want the government to admit our existence. We want recognition of our Kurdish identity.”


These skirmishes between Kurds and Arabs take on a darker meaning for Syria as the rebels appear each day to gain momentum, and the government appears less and less able to restore control. The rebels have taken over military bases, laid siege to Damascus and forced the shutdown of the airport.


But the rebels are largely Sunni Arabs, and the most effective among them are extremists aligned with Al Qaeda, a prospect that worries not only the West, but the Christians, Shiites, Druze — and Kurds — of Syria.


The fighting in Ras al-Ain, which came after a fierce battle between rebel and government forces last month, demonstrated the complexity of a bloody civil war that has already claimed more than 40,000 lives. Like the sectarian battles in Iraq after the American invasion, the recent violence between Arabs and Kurds in Syria indicates the further unraveling of a society whose mix of sects, identities and traditions were held together by the yoke of a dictator.


Analysts fear this combustible environment could presage a bloody ethnic and sectarian conflict that will resonate far beyond Syria’s borders, especially if it involves the Kurds. There is concern that Iraq’s Kurds, who are already training Syrian Kurds to fight, may jump into the Syria fight to protect their ethnic brethren. That could also pull in Turkey, which fears that an autonomous Kurdish region in Syria would become a haven for Kurdish militants to carry out cross-border attacks in the Kurdish areas in southeastern Turkey.


“The fear that an Arab-Kurdish confrontation has been ignited might lead the Kurds to ask for additional security forces to protect their lands,” said Maria Fantappie, Iraq analyst at the International Crisis Group, who is helping to prepare a report on the Syrian Kurds.


She said that the Syrian Kurdish fighters being trained in northern Iraq were on standby and could be sent to Syria, which would escalate the situation.


Before the uprising in Syria, the Kurds in Ras al-Ain lived peacefully with their Arab neighbors, they say. But the war has shredded those old bonds just as surely as the revolutions in the region have prompted the Kurds to dream of an independent nation uniting the Kurds in Syria, Iraq, Turkey and Iran, and put their own stamp on the great contest for power under way in the Middle East.


“Our time has come after so much suffering and persecution,” said Barham Salih, the former prime minister of Iraq’s regional Kurdish government. “The 20th century was cruel to the Kurds. Our rights, identity and culture were brutally suppressed.”


Sebnem Arsu contributed reporting from Ceylanpinar, and an employee of The New York Times contributed reporting from Ras al-Ain, Syria.



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Euro Watch: Spending Data Point to Continuing Woes in Euro Zone

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PARIS — European consumers continue to cut back on spending, official data showed Wednesday, indicating that the region’s financial crisis and ailing job market were weighing on hopes of an economic recovery.




Retail sales in the 17-nation euro zone fell 1.2 percent in October from September, and were down 3.6 percent from a year earlier, Eurostat, the statistical agency of the European Union, reported Wednesday.


For the entire 27-nation European Union, sales declined 1.1 percent from September and 2.4 percent from October 2011, Eurostat said.


The big dip in retail sales was partly a result of front-loading of purchases before value-added taxes rose in some countries, said James Nixon, an economist in London for Société Générale.


The fiscal crisis in the euro zone and the austerity measures employed to combat it have made companies reticent about hiring, helping to drive the euro zone into recession in the third quarter. That has created a vicious circle, in which falling consumer spending is expected to weigh further on the economy.


A reading Wednesday on euro zone activity from a private data and analysis firm also suggested the economy continued to contract. Markit Economics’ composite purchasing managers’ index for November came in at 46.5. That was a bump upward from the 40-month low of 45.7 in October, but the 10th straight month below 50, a level that suggests shrinking output.


On Friday, Eurostat reported that unemployment in the euro zone rose to a record 11.7 percent in October from 11.6 percent a month earlier, and that the jobless rate among those under 25 years of age was 23.9 percent.


The European Commission on Wednesday expressed grave concern about the problem of youth unemployment, noting that just the immediate cost to governments — in terms of lost revenue and social outlays — worked out to an estimated €150 billion, or $196 billion, a year, or 1.2 percent of E.U. gross domestic product.


It recommended a new program to address the problem, with measures including job guarantees for young people, labor market changes to reduce obstacles to hiring across European borders, and further efforts to provide high-quality training and apprenticeship programs.


The European commissioner for employment and social affairs, Laszlo Andor, said in a statement that the cost of failing to help put young people to work would be “catastrophic.”


The European Central Bank and its British counterpart, the Bank of England, will hold policy meetings Thursday, and though signs of weakness would appear to give the central banks scope for action, neither is believed to be planning any major changes to current monetary policy.


Economists expect the E.C.B. to leave its main refinancing rate at 0.75 percent, while the Bank of England is expected to stand pat at 0.5 percent.


Action by the central banks has helped to calm markets and relieve the pressure on the euro, but conditions remain unsettled. As an indication of the stresses that have sent investors scurrying for the perceived safety of major sovereign bonds, yields on France’s 10-year sovereign debt fell on Wednesday to around 2 percent, the lowest level on record.


The dismal retail sales data came as the European Stability Mechanism, the euro zone’s permanent new bailout fund, said it had issued about €39.5 billion in bonds to cover the recapitalization of Spain’s banking sector.


Euro zone leaders agreed in June to provide up to €100 billion to help Spanish banks, which have been battered in the aftermath of a property bubble collapse and economic dislocation caused by austerity measures. The funds were originally raised by the bloc’s temporary bailout fund, the European Financial Stability Facility, and the transaction Wednesday represented an effective transfer of that money from the old facility to the permanent one.


The fund said that €37 billion would be handed over some time in December to the Spanish government’s own banking rescue fund, the FROB, to cover the needs of BFA-Bankia, Catalunya Banc, NCG Banco and Banco de Valencia. The FROB will use the remaining €2.5 billion to capitalize Spain’s “bad bank,” a company called Sareb that is being used to sift through soured assets.


The action Wednesday “is an important event as the E.S.M. has now started to actively fulfill its role as the permanent rescue mechanism for the euro zone,” Klaus Regling, the head of the European Stability Mechanism, said in a statement.


Mr. Nixon, of Société Générale, predicted that the euro zone economy would shrink in the fourth quarter at an annualized 1.2 percent rate, but said he expected some of the northern European economies, including Germany, to start pulling away from the laggards in 2013.


“We may have reached a bottom,” Mr. Nixon said, citing an easing of tension in the market for sovereign debt and smoother financing conditions. “At least things aren’t getting worse any faster.”


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Study Raises Questions on Coating of Aspirin

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While aspirin may prevent heart attacks and strokes, a commonly used coating to protect the stomach may obscure the benefits, leading doctors to prescribe more expensive prescription drugs, according to a study published Tuesday in the journal Circulation.




The conclusion about coated aspirin was only one finding in the study, whose main goal was to test the hotly disputed idea that aspirin does not help prevent heart attacks or stroke in some people.


For more than a decade, cardiologists and drug researchers have posited that anywhere from 5 to 40 percent of the population is “aspirin resistant,” as the debated condition is known. But some prominent doctors say that the prevalence of the condition has been exaggerated by companies and drug makers with a commercial interest in proving that aspirin — a relatively inexpensive, over-the-counter drug whose heart benefits have been known since the 1950s — does not always work.


The authors of the new study, from the University of Pennsylvania, claim that they did not find a single case of true aspirin resistance in any of the 400 healthy people who were examined. Instead, they claim, the coating on aspirin interfered with the way that the drug entered the body, making it appear in tests that the drug was not working.


The study was partly financed by Bayer, the world’s largest manufacturer of brand-name aspirin, much of which is coated.


Aside from whether coating aspirin conceals its effects in some people, there is little evidence that it protects the stomach better than uncoated aspirin, said Dr. Garret FitzGerald, chairman of pharmacology at the University of Pennsylvania and one of the study’s authors.


“These studies question the value of coated, low-dose aspirin,” he said in a statement accompanying the article. “This product adds cost to treatment, without any clear benefit. Indeed, it may lead to the false diagnosis of aspirin resistance and the failure to provide patients with an effective therapy.”


In a statement, Bayer took issue with some of the study’s conclusions and methods and said previous studies of coated aspirin, also called enteric-coated aspirin, have been shown to stop blood platelets from sticking together — which can help prevent heart attacks and stroke — at levels comparable to uncoated aspirin. Bayer also noted that the price difference between its coated and uncoated aspirin was negligible, although Dr. FitzGerald argued there was no reason patients should use anything other than uncoated generic aspirin, which is cheaper.


“When used as directed,” the company said, “both enteric and nonenteric coated aspirin provides meaningful benefits, is safe and effective and is infrequently associated with clinically significant side effects.”


Although researchers had long observed that, as is true with most drugs, aspirin’s effects varied among patients, the existence of “aspirin resistance” gained currency in the 1990s and early 2000s. One often-cited study, published in 2003, found that about 5 percent of cardiovascular patients were aspirin-resistant and that that group was more than three times as likely as those not aspirin-resistant to suffer a major event like a heart attack.


But some said the popularity of aspirin resistance got a boost in part because of the development of urine and blood tests to measure it and the arrival on the market of drugs like Plavix, a more expensive prescription drug sold by Bristol-Myers Squibb that also thins the blood.


In the most recent study, the patients who initially tested positive for aspirin resistance later tested negative for it and by the end of the study, Dr. FitzGerald said, none of the patients showed true resistance. “Nobody had a stable pattern of resistance that was specific to coated aspirin,” he said. If resistance to aspirin exists, he said, “I think that the incidence is vanishingly small.”


Dr. Eric Topol, one of the authors of the 2003 study, said he strongly disagreed with Dr. FitzGerald’s conclusions, noting that it looked only at healthy volunteers, “which is very different than studying people who actually have heart disease or other chronic illnesses who are taking various medications.” Those conditions or medications could affect the way aspirin works in the body, he said.


But Dr. Topol and Dr. FitzGerald did agree that there was little value in testing for whether someone was aspirin-resistant, in part because there was little evidence that knowing someone is resistant to aspirin will prevent a heart attack or stroke.


Representatives for Accumetrics, which sells a blood test, and Corgenix, which sells a urine test, maintained that there was value in determining how well aspirin worked in individual patients, and said more recent research on the issue has moved away from a stark determination of whether someone is resistant to aspirin. “This whole concept of drug resistance has moved past that term and moved into the level of response that someone has,” said Brian Bartolomeo, market development manager at Accumetrics.


Read More..

Study Raises Questions on Coating of Aspirin

Label:




While aspirin may prevent heart attacks and strokes, a commonly used coating to protect the stomach may obscure the benefits, leading doctors to prescribe more expensive prescription drugs, according to a study published Tuesday in the journal Circulation.




The conclusion about coated aspirin was only one finding in the study, whose main goal was to test the hotly disputed idea that aspirin does not help prevent heart attacks or stroke in some people.


For more than a decade, cardiologists and drug researchers have posited that anywhere from 5 to 40 percent of the population is “aspirin resistant,” as the debated condition is known. But some prominent doctors say that the prevalence of the condition has been exaggerated by companies and drug makers with a commercial interest in proving that aspirin — a relatively inexpensive, over-the-counter drug whose heart benefits have been known since the 1950s — does not always work.


The authors of the new study, from the University of Pennsylvania, claim that they did not find a single case of true aspirin resistance in any of the 400 healthy people who were examined. Instead, they claim, the coating on aspirin interfered with the way that the drug entered the body, making it appear in tests that the drug was not working.


The study was partly financed by Bayer, the world’s largest manufacturer of brand-name aspirin, much of which is coated.


Aside from whether coating aspirin conceals its effects in some people, there is little evidence that it protects the stomach better than uncoated aspirin, said Dr. Garret FitzGerald, chairman of pharmacology at the University of Pennsylvania and one of the study’s authors.


“These studies question the value of coated, low-dose aspirin,” he said in a statement accompanying the article. “This product adds cost to treatment, without any clear benefit. Indeed, it may lead to the false diagnosis of aspirin resistance and the failure to provide patients with an effective therapy.”


In a statement, Bayer took issue with some of the study’s conclusions and methods and said previous studies of coated aspirin, also called enteric-coated aspirin, have been shown to stop blood platelets from sticking together — which can help prevent heart attacks and stroke — at levels comparable to uncoated aspirin. Bayer also noted that the price difference between its coated and uncoated aspirin was negligible, although Dr. FitzGerald argued there was no reason patients should use anything other than uncoated generic aspirin, which is cheaper.


“When used as directed,” the company said, “both enteric and nonenteric coated aspirin provides meaningful benefits, is safe and effective and is infrequently associated with clinically significant side effects.”


Although researchers had long observed that, as is true with most drugs, aspirin’s effects varied among patients, the existence of “aspirin resistance” gained currency in the 1990s and early 2000s. One often-cited study, published in 2003, found that about 5 percent of cardiovascular patients were aspirin-resistant and that that group was more than three times as likely as those not aspirin-resistant to suffer a major event like a heart attack.


But some said the popularity of aspirin resistance got a boost in part because of the development of urine and blood tests to measure it and the arrival on the market of drugs like Plavix, a more expensive prescription drug sold by Bristol-Myers Squibb that also thins the blood.


In the most recent study, the patients who initially tested positive for aspirin resistance later tested negative for it and by the end of the study, Dr. FitzGerald said, none of the patients showed true resistance. “Nobody had a stable pattern of resistance that was specific to coated aspirin,” he said. If resistance to aspirin exists, he said, “I think that the incidence is vanishingly small.”


Dr. Eric Topol, one of the authors of the 2003 study, said he strongly disagreed with Dr. FitzGerald’s conclusions, noting that it looked only at healthy volunteers, “which is very different than studying people who actually have heart disease or other chronic illnesses who are taking various medications.” Those conditions or medications could affect the way aspirin works in the body, he said.


But Dr. Topol and Dr. FitzGerald did agree that there was little value in testing for whether someone was aspirin-resistant, in part because there was little evidence that knowing someone is resistant to aspirin will prevent a heart attack or stroke.


Representatives for Accumetrics, which sells a blood test, and Corgenix, which sells a urine test, maintained that there was value in determining how well aspirin worked in individual patients, and said more recent research on the issue has moved away from a stark determination of whether someone is resistant to aspirin. “This whole concept of drug resistance has moved past that term and moved into the level of response that someone has,” said Brian Bartolomeo, market development manager at Accumetrics.


Read More..

Video Games: Little Inferno; Hitman; Assassin’s Creed III; Persona 4 Golden; Angry Birds Star Wars; My Little Pony

Label:

Ubisoft


Ratonhnhaké:ton is a half-British, half-Mohawk assassin in Revolutionary America.





Released on Nov. 18


Developed by Tomorrow Corporation


For PC, Mac, Linux and Wii U


Rated T for Teen (drug reference and crude humor)


Here’s an odd one. Little Inferno is an interactive fireplace. It’s an emotional, interactive fireplace with a story line and some notions about the dangers of amusing ourselves with distracting trifles.


At first this strange creation appears to be a simple puzzle game consisting of little more than a fireplace, a catalog of items to burn and 99 clues that challenge the player to burn these things in proper combinations. One clue is “Movie Night.” Burn the popcorn. Burn the TV. A weirder one is “Bike Pirate.” Burn the wooden bike. Burn the pirate.


As you play, an unseen character begins to send letters. They burn, too, but something seems off. The messages are alternately cheerful and sad, a wee bit wicked and increasingly desperate.


The purpose of the pyromaniac pastime becomes smoky with doubt. Why are we doing this? What are we missing? It’s odd enough to play a new video game that questions our decision to play video games. That it’s an interactive fireplace game that does this is all the stranger and more wonderful. It’s a yule log for our times.


HITMAN


Absolution


Released on Nov. 20


Developed by IO Interactive


Published by Square Enix


For PC, Xbox 360 and


PlayStation 3


Rated M for Mature (intense violence, partial nudity and strong language)


It’s a vile, dangerous world in Hitman: Absolution. Nearly everyone is in need of a good killing, and Agent 47, the depilated murder machine at the center of the long-running Hitman franchise, is just the man for the job.


Absolution is consistent with the setup of past Hitman games: At the start of a level, 47 is given an assassination target, and he must make his way through semi-open areas by any of a number of possible routes. The reactive artificial intelligence keeps things enjoyably unpredictable, and the best levels feel like a buffet of sadistic improvisation.


The story is pure B-movie hogwash. It’s mostly enjoyable in a certain exploitive way, but it often feels as if the writers were trying too hard.


When it gets cooking, Hitman: Absolution evokes the feeling of a deadly, measured dance. It’s a tango between you and the computer, with each party alternately taking the lead through arenas that shift and upset expectations.


ASSASSIN’S CREED III


Released on Oct. 30


Developed and published by Ubisoft


For PlayStation 3, Xbox 360, Wii U and PC


Rated M for Mature (blood, intense violence, sexual themes and strong language)


Assassin’s Creed III is really the fifth major Assassin’s Creed game. The numbering signifies that this new historical epic is a shift, as this Ubisoft series about the ancestral lives of a man named Desmond Miles leaps to its third era. Finished with the 12th-century crusades and 15th-century Renaissance Italy, Assassin’s Creed now lets us do interactive historical tourism in Boston, New York and the nearby woods of Revolutionary America.


Assassin’s Creed games are lavish action-adventure blockbusters. In this new one, we primarily play as a young, bitter, half-British, half-Mohawk greenhorn assassin named Ratonhnhaké:ton, who finds himself crossing paths and sometimes doing the bidding of Sam Adams, Paul Revere, George Washington and other real figures. Most of the bad guys are red coats with slow-firing muskets. We’re best with a tomahawk and a bow and arrow.


The new game involves a lot of climbing and killing across a sprawling landscape of bustling cities and gorgeous frontier. Add in a mix of awkwardly instituted horseback riding, homestead building, trading, trapping, hunting and, at the wheel of your own tall-masted warship, epic naval combat. There is much to do and witness in a ripped-from-the-history-books adventure that is refreshingly unwilling to ignore the unsavory aspects of America’s birth. A lengthy production cycle didn’t spare the game from a wealth of bugs that are only now being patched out.


The series’s low-key multiplayer games of competitive assassination return, but the star of this epic is something that might seem almost quaint: Assassin’s Creed III is easily the best tree-climbing simulator in history.


PERSONA 4 GOLDEN


Released on Nov. 20


Developed and published by Atlus


For PlayStation Vita


Rated M for Mature (violence, alcohol reference and partial nudity)


Persona 4 Golden is part turn-based role-playing game, part high school simulator and a rerelease of a celebrated PlayStation 2 game on the portable Vita.


These edited and condensed reviews are from the writers and editors of the gaming Web site Kotaku.com. Full reviews are at kotaku.com/nytselects.



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World Briefing | Asia: Chinese Lingerie Factory Fire Kills 14 in Guangdong

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A fire at a lingerie factory killed 14 people in Shantou, a city in the southeastern Chinese province of Guangdong, on Tuesday, official news media said. The Chinese authorities said the police had made an arrest. The Southern Metropolis Daily, a newspaper in Guangzhou, reported that a worker had started the fire as part of a pay dispute, but there was no government confirmation of that.


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Ruling in Off-Label Marketing Case Is a Win for Drug Makers

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In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative’s freedom of speech.


The 2-to-1 decision by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan addresses a long-running and costly issue for the industry, which has paid billions of dollars in penalties to the federal government in recent years after being accused of marketing blockbuster drugs for off-label uses.


In July, for example, the British drug maker GlaxoSmithKline agreed to pay $3 billion in fines, in part for promoting antidepressants and other drugs for unapproved uses; a month later, Johnson & Johnson announced that its pharmaceutical unit had reached a $181 million consumer fraud settlement with 36 states and the District of Columbia over its marketing of Risperdal, an antipsychotic drug.


“Most if not all of these cases have been based on a central premise: that it is unlawful for a company and one of its employees to be promoting a drug or a medical device off-label,” said John R. Fleder, a director at the law firm Hyman, Phelps & McNamara who represented the F.D.A. while working at the Justice Department. “And this decision hits at the heart of the government’s theory.”


The ruling, in United States v. Caronia, involved the conviction of Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive daytime sleepiness, known as narcolepsy. He was accused of promoting it to doctors as a treatment for insomnia, fibromyalgia and other conditions. He became the target of a federal investigation in 2005 and was caught on an audiotape discussing the unapproved uses of the drug with a doctor who was a government informant. He was convicted by a jury in 2008.


Mr. Caronia appealed the conviction, arguing that his right to free speech under the First Amendment was being illegally restricted. The appellate court decision applies only to the Second Circuit, which comprises New York, Connecticut and Vermont, but some lawyers said that the government was likely to appeal and that the case could find its way to the Supreme Court.


Under the Food, Drug and Cosmetic Act, which gives the F.D.A. the authority to regulate drugs, selling a “misbranded drug,” or one that is intended to be used for purposes not listed in the label, is illegal. Doctors, on the other hand, are free to prescribe a drug for any use. The agency has argued that off-label promotion of drugs is evidence that a sales representative or company intended to sell misbranded drugs.


In its decision, the court said this view violated the First Amendment and cited as precedent a 2011 Supreme Court decision, Sorrell vs. IMS Health. In that case, the high court, citing freedom of speech, overturned a Vermont law restricting pharmaceutical companies from using prescription data for marketing purposes.


“The government clearly prosecuted Caronia for his words — for his speech,” the majority wrote, concluding later “the government cannot prosecute pharmaceutical manufacturers and their representatives under the F.D.C.A. for speech promoting the lawful, off-label use of an F.D.A.-approved drug.”


The lone dissenting judge, Judge Debra Ann Livingston, vigorously disagreed, arguing that by throwing out Mr. Caronia’s conviction “the majority calls into question the very foundations of our century-old system of drug regulation.” She argued that if drug companies “were allowed to promote F.D.A.-approved drugs for nonapproved uses, they would have little incentive to seek F.D.A. approval for those uses.”


Gerald Masoudi, a former chief counsel of the F.D.A., said the ruling made a distinction between truthful discussion of off-label uses of drugs, many of which are considered legitimate by the medical community, and those that are misleading or false. He noted that “anyone on the planet” could discuss off-label uses of drugs, except for pharmaceutical companies.


“It’s very significant,” he said, “because it’s going to make F.D.A., in its promotion cases, focus on the kinds of speech that are more likely to harm consumers, such as false or misleading marketing versus something that is not approved.”


In a statement, the trade group for the pharmaceutical industry, Pharmaceutical Research and Manufacturers of America, said it was pleased with the ruling.


“PhRMA believes that truthful and nonmisleading communication between biopharmaceutical companies and health care professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments,” the statement said.


A spokeswoman for the F.D.A. said the agency did not comment on active litigation.


Lawyers said the government would most likely ask for a rehearing before the circuit court’s full panel of judges and after that, it could be taken up by the Supreme Court.


Because pharmaceutical companies market their drugs nationally and the ruling applies only within the Second Circuit, the ruling is not likely to lead drug makers to change their marketing policies. Rather, some said, the F.D.A. will be unlikely to pursue convictions in similar cases until the legal issues are resolved.


Read More..

Sign Language Researchers Broaden Science Lexicon

Label:



Science in Sign:
Lydia Callis, a sign language interpreter, translates a shortened version of an article by Douglas Quenqua, explaining how new signs are being developed that may enhance scientific communication.







Imagine trying to learn biology without ever using the word “organism.” Or studying to become a botanist when the only way of referring to photosynthesis is to spell the word out, letter by painstaking letter.




For deaf students, this game of scientific Password has long been the daily classroom and laboratory experience. Words like “organism” and “photosynthesis” — to say nothing of more obscure and harder-to-spell terms — have no single widely accepted equivalent in sign language. This means that deaf students and their teachers and interpreters must improvise, making it that much harder for the students to excel in science and pursue careers in it.


“Often times, it would involve a lot of finger-spelling and a lot of improvisation,” said Matthew Schwerin, a physicist with the Food and Drug Administration who is deaf, of his years in school. “For the majority of scientific terms,” Mr. Schwerin and his interpreter for the day would “try to find a correct sign for the term, and if nothing was pre-existing, we would come up with a sign that was agreeable with both parties.”


Now thanks to the Internet — particularly the boom in online video — resources for deaf students seeking science-related signs are easier to find and share. Crowdsourcing projects in both American Sign Language and British Sign Language are under way at several universities, enabling people who are deaf to coalesce around signs for commonly used terms.


This year, one of those resources, the Scottish Sensory Centre’s British Sign Language Glossary Project, added 116 new signs for physics and engineering terms, including signs for “light-year,”  (hold one hand up and spread the fingers downward for “light,” then bring both hands together in front of your chest and slowly move them apart for “year”), “mass” and “X-ray” (form an X with your index fingers, then, with the index finger on the right hand, point outward). 


The signs were developed by a team of researchers at the center, a division of the University of Edinburgh in Scotland that develops learning tools for students with visual and auditory impairments. The researchers spent more than a year soliciting ideas from deaf science workers, circulating lists of potential signs and ultimately gathering for “an intense weekend” of final voting, said Audrey Cameron, science adviser for the project. (Dr. Cameron is also deaf, and like all non-hearing people interviewed for this article, answered questions via e-mail.)


Whether the Scottish Sensory Centre’s signs will take hold among its audience remains to be seen. “Some will be adopted, and some will probably never be accepted,” Dr. Cameron said. “We’ll have to wait and see what happens.”


Ideally, the standardization of signs will make it easier for deaf students to keep pace with their hearing classmates during lectures. “I can only choose to look at one thing at a time,” said Mr. Schwerin of the F.D.A., recalling his science education, “and it often meant choosing between the interpreter, the blackboard/screen/material, or taking notes. It was like, pick one, and lose out on the others.”


The problem doesn’t end at graduation. In fact, it only intensifies as new discoveries add unfamiliar terms to the scientific lexicon. “I’ve had numerous meetings where I couldn’t participate properly because the interpreters were not able to understand the jargon and they did not know any scientific signs,” Dr. Cameron said.


One general complaint about efforts to standardize signs for technical terms is the idea that, much like spoken language, sign language should be allowed to develop organically rather than be dictated from above.


“Signs that are developed naturally — i.e., that are tested and refined in everyday conversation — are more likely to be accepted quickly by the community,” said Derek Braun, director of the molecular genetics laboratory at Gallaudet University in Washington, D.C., which he said was the first biological laboratory designed and administered by deaf scientists.


This article has been revised to reflect the following correction:

Correction: December 4, 2012

An earlier version of this article misstated the origin of the ASL-STEM Forum.  It was developed by researchers at the University of Washington, not Gallaudet University.  Researchers at Gallaudet and the National Technical Institute for the Deaf at Rochester Institute of Technology work with the University of Washington to provide content and help the forum grow.

This article has been revised to reflect the following correction:

Correction: December 4, 2012

An earlier version of a correction with this article misstated the name of an institute that works on the ASL-STEM Forum. It is the National Technical Institute for the Deaf at Rochester Institute of Technology not the National Institute for the Deaf. 



Read More..

Sign Language Researchers Broaden Science Lexicon

Label:



Science in Sign:
Lydia Callis, a sign language interpreter, translates a shortened version of an article by Douglas Quenqua, explaining how new signs are being developed that may enhance scientific communication.







Imagine trying to learn biology without ever using the word “organism.” Or studying to become a botanist when the only way of referring to photosynthesis is to spell the word out, letter by painstaking letter.




For deaf students, this game of scientific Password has long been the daily classroom and laboratory experience. Words like “organism” and “photosynthesis” — to say nothing of more obscure and harder-to-spell terms — have no single widely accepted equivalent in sign language. This means that deaf students and their teachers and interpreters must improvise, making it that much harder for the students to excel in science and pursue careers in it.


“Often times, it would involve a lot of finger-spelling and a lot of improvisation,” said Matthew Schwerin, a physicist with the Food and Drug Administration who is deaf, of his years in school. “For the majority of scientific terms,” Mr. Schwerin and his interpreter for the day would “try to find a correct sign for the term, and if nothing was pre-existing, we would come up with a sign that was agreeable with both parties.”


Now thanks to the Internet — particularly the boom in online video — resources for deaf students seeking science-related signs are easier to find and share. Crowdsourcing projects in both American Sign Language and British Sign Language are under way at several universities, enabling people who are deaf to coalesce around signs for commonly used terms.


This year, one of those resources, the Scottish Sensory Centre’s British Sign Language Glossary Project, added 116 new signs for physics and engineering terms, including signs for “light-year,”  (hold one hand up and spread the fingers downward for “light,” then bring both hands together in front of your chest and slowly move them apart for “year”), “mass” and “X-ray” (form an X with your index fingers, then, with the index finger on the right hand, point outward). 


The signs were developed by a team of researchers at the center, a division of the University of Edinburgh in Scotland that develops learning tools for students with visual and auditory impairments. The researchers spent more than a year soliciting ideas from deaf science workers, circulating lists of potential signs and ultimately gathering for “an intense weekend” of final voting, said Audrey Cameron, science adviser for the project. (Dr. Cameron is also deaf, and like all non-hearing people interviewed for this article, answered questions via e-mail.)


Whether the Scottish Sensory Centre’s signs will take hold among its audience remains to be seen. “Some will be adopted, and some will probably never be accepted,” Dr. Cameron said. “We’ll have to wait and see what happens.”


Ideally, the standardization of signs will make it easier for deaf students to keep pace with their hearing classmates during lectures. “I can only choose to look at one thing at a time,” said Mr. Schwerin of the F.D.A., recalling his science education, “and it often meant choosing between the interpreter, the blackboard/screen/material, or taking notes. It was like, pick one, and lose out on the others.”


The problem doesn’t end at graduation. In fact, it only intensifies as new discoveries add unfamiliar terms to the scientific lexicon. “I’ve had numerous meetings where I couldn’t participate properly because the interpreters were not able to understand the jargon and they did not know any scientific signs,” Dr. Cameron said.


One general complaint about efforts to standardize signs for technical terms is the idea that, much like spoken language, sign language should be allowed to develop organically rather than be dictated from above.


“Signs that are developed naturally — i.e., that are tested and refined in everyday conversation — are more likely to be accepted quickly by the community,” said Derek Braun, director of the molecular genetics laboratory at Gallaudet University in Washington, D.C., which he said was the first biological laboratory designed and administered by deaf scientists.


This article has been revised to reflect the following correction:

Correction: December 4, 2012

An earlier version of this article misstated the origin of the ASL-STEM Forum.  It was developed by researchers at the University of Washington, not Gallaudet University.  Researchers at Gallaudet and the National Technical Institute for the Deaf at Rochester Institute of Technology work with the University of Washington to provide content and help the forum grow.

This article has been revised to reflect the following correction:

Correction: December 4, 2012

An earlier version of a correction with this article misstated the name of an institute that works on the ASL-STEM Forum. It is the National Technical Institute for the Deaf at Rochester Institute of Technology not the National Institute for the Deaf. 



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Austrian Group Plans Suit Over Facebook Privacy Policies

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BERLIN — An Austrian student group said Tuesday that it planned to challenge Facebook’s privacy policies in Irish court, alleging that the social networking giant had failed, despite repeated requests and formal complaints made by its members, to adapt to the restrictions of European data protection law.


The group, which calls itself Europe vs. Facebook, said it would begin collecting donations to challenge the policy in Ireland, where the company’s European business is incorporated. Max Schrems, an Austrian law student at the University of Vienna who organized the effort, said Facebook had no interest in adapting its service to meet stricter European privacy requirements.


“We have been pursing this for more than a year with Facebook, but the company has done only about 10 percent of what we had asked them to do,” said Mr. Schrems, 25. “Therefore, we are preparing to go to court.”


Facebook, in a statement, said its European privacy policy had been vetted and approved by Irish regulators and was in compliance with European law.


“The way Facebook Ireland handles personal data has been subject to thorough review by the Irish Data Protection Commissioner over the past year,” the company said. “Nonetheless, we have some vocal critics who will never be happy whatever we do and whatever the D.P.C. concludes.”


Mr. Schrems’s group, which he said was made up of about 10 students at the University of Vienna, filed 22 complaints in 2010 with the Office of the Data Protection Commissioner in Ireland, which regulates Facebook’s European business because it is incorporated there.


As a result of those complaints, the regulator conducted a public audit of Facebook’s privacy policies. In September it announced an agreement with the company that required, among other changes, that Facebook shorten the time it retained consumer data and refrain from building a photo archive on individuals without their prior consent.


But Mr. Schrems said in an interview that Facebook was still violating European law in many areas, including a requirement that Facebook provide users who request it with a full copy of all the data the company has collected on them. Mr. Schrems, a Facebook user since 2007, said he requested his own summary file from Facebook in 2010.


The company, whose global headquarters is in Menlo Park, California, responded by creating a self-service tool for users to extract the data, which Mr. Schrems said supplied him only with information going back to 2010. In addition, he alleged that Facebook’s privacy policy, which users are required to agree to before they can use the service, is too broad and violates European law.


“It is basically a collection of American legalese, which is intentionally vague and gives the company adequate leeway to do basically anything they want with your data,” Mr. Schrems said.


Thilo Weichert, the data protection supervisor for the German state of Schleswig-Holstein, which has also brought legal action against Facebook, said he supported the Austrian student group’s efforts.


“Facebook’s policy is much too vague and broad and does not conform with German or European law,” Mr. Weichert said in an interview. “We think that European privacy officials need to take common action on this.”


Mr. Weichert issued an administrative order in August 2011 that barred businesses in the state, which is located along Germany’s northern border with Denmark, from using Facebook’s social plug-ins like the Like button and Fan pages. The rationale for the order: Those applications collect information on users without their consent by inserting cookies, which track individual computers, through a user’s Web browser.


In November of last year, Mr. Weichert sued several local business organizations, including the state’s own Industrie- und Handelskammer, the equivalent of the local chamber of commerce, for creating their own fan pages on Facebook. The chamber and businesses that have not been identified have challenged that suit, which is pending in court in Kiel.


The privacy policies of Facebook, Google and some other U.S.-based Web companies have come under increasing criticism in Europe.


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Mortar Attack Kills at Least 9 People at Syrian School

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Narciso Contreras/Associated Press


People walked past damaged homes during heavy fighting between rebel fighters and government forces on Tuesday in Aleppo, Syria.







BEIRUT, Lebanon — Syrian forces continued to press an intense counteroffensive against rebels in the Damascus suburbs on Tuesday, as the government blamed rebels for a mortar attack that hit a school, and the United Nations warned that the increasingly dangerous situation in the country was making it hard to provide enough food to displaced Syrians.




SANA, the state news agency, reported that 29 people at the school, including one teacher and numerous children, were killed by a mortar shell fired by “terrorists,” its term for its opponents, in Bteeha, a small town north of Damascus on the road to the central city of Homs. Antigovernment activist groups confirmed the attack but said only nine people were killed at the school, at the Wafideen refugee camp. The road to Homs and on to the commercial hub of Aleppo has been strongly contested in recent fighting.


The Local Coordinating Committees, a network of rebel groups, reported the mortar attack without comment, implying that it was carried out by the government. But an activist reached in Damascus said it was unclear who had fired the shell.


Tecent bombs and mortar attacks by rebels that have killed civilians have angered both supporters and opponents of the government in recent weeks, as even some who support the rebels express concern that the violence has spiraled out of control.


An activist in the Damascus suburbs who gave only her first name, Leena, said activists were surprised that there was an attack in Bteeha, which is usually very calm, and that information had been hard to come by because there were very few activist reporters in Bteeha. She said residents were refugees who fled the Golan Heights in 1967 when Israel occupied the territory. Displaced people, mostly from the Sunni Muslim sect that makes up the bulk of the Syrian uprising, have recently moved there, she said.


“Many Golani people are actually with the revolution, and they even have their own brigades in the Free Syrian Army,” she added, referring to the loose-knit rebel umbrella group.


On Tuesday, there were more signs of concern on the diplomatic front as well.


At a meeting in Brussels, NATO ministers expressed “grave concern” about reports that the Syrian government might be getting ready to use its chemical weapons. The remarks followed a warning by President Obama telling Syria not to use chemical weapons against its own people and vowing to hold accountable anyone who did, even as American intelligence officials picked up signs that such arms might be deployed in the fighting there.


“Any such action would be completely unacceptable and a clear breach of international law,” the NATO secretary general, Anders Fogh Rasmussen, said at a news conference.


In another reflection of how the conflict in Syria is spilling over its borders, NATO agreed to deploy Patriot surface-to-air missiles in Turkey, which had requested the installations as a defense against cross-border violence.


More evidence emerged on Tuesday that the situation in the country was deteriorating, a day after the United Nations and the European Union announced they were curtailing activities and pulling staff members out of Damascus, the capital. Fighting raged in an arc around Damascus on Monday, from the southwest to the northeast, and most commercial flights continued to stay away from the Damascus Airport.


The United Nations’ World Food Program, which is feeding 1.5 million people in Syria, 85 percent of them displaced by the fighting, issued a report warning that food shortages were intensifying because of rising bread prices and indiscriminate attacks on United Nations vehicles that made food distribution difficult.


The roads are so dangerous, the agency said, that it is trying to obtain more armored vehicles to allow its provincial offices to continue to monitor food distribution.


The agency, along with other United Nations organizations, has suspended its operations outside Damascus and sent home nonessential foreign staff members, further hampering its work, it said. Most food distribution is done by local partners, mainly the Syrian Arab Red Cross. Still, the World Food Program maintains 20 foreign and 100 local employees in Syria.


“I can absolutely confirm to you that we will continue our work,” Muhannad Hadi, the country director, said in an interview from Jordan, where he traveled on business with plans to return to Syria.


Food shortages are increasing, especially in Aleppo, where bread prices are 50 percent higher than in the rest of the country, the agency statement said, adding, “Food consumption is particularly low among displaced families taking refuge in schools and public buildings, due to the lack of access to cooking facilities.”


Rebels and government forces continued to clash around a strategic air base at Wadi al-Deif, near Maarat al-Noaman, a crossroads town on the road between Damascus and Aleppo, as government airstrikes around Damascus continued for a fourth day with no sign of abating and neither side apparently able to win.


Even as the government was bringing overwhelming force to bear, it was still unable to quell the rebels, who have managed to disrupt the airport and force a counteroffensive to seal off the city center from the restive suburbs. Yet although rebels have managed to put pressure on the government around Damascus in recent weeks, several fighters interviewed said the fighting had become exhausting and there was no coordinated strategy.


Hania Mourtada contributed reporting from Beirut, and Christine Hauser from New York.



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