In gun debate, video game industry defends itself






WASHINGTON (AP) — The video game industry, blamed by some for fostering a culture of violence, defended its practices Friday at a White House meeting exploring how to prevent horrific shootings like the recent Connecticut elementary school massacre.


Vice President Joe Biden, wrapping up three days of wide-ranging talks on gun violence prevention, said the meeting was an effort to understand whether the U.S. was undergoing a “coarsening of our culture.”






“I come to this meeting with no judgment. You all know the judgments other people have made,” Biden said at the opening of a two-hour discussion. “We’re looking for help.”


The gaming industry says that violent crime, particularly among the young, has fallen since the early 1990s while video games have increased in popularity.


There are conflicting studies on the impact of video games and other screen violence. Some conclude that video games can desensitize people to real-world violence or temporarily quiet part of the brain that governs impulse control. Other studies have concluded there is no lasting effect.


Cheryl Olson, a participant in Biden’s meeting and a researcher of the effect of violent video games, said there was concern among industry representatives that they would be made into a scapegoat in the wake of the Connecticut shooting.


“The vice president made clear that he did not want to do that,” Olson said.


Biden is expected to suggest ways to address violence in video games, movies and on television when he sends President Barack Obama a package of recommendations for curbing gun violence Tuesday. The proposals are expected to include calls for universal background checks and bans on assault weapons and high-capacity ammunition magazines.


Obama appointed Biden to lead a gun violence task force after last month’s shooting at a Newtown, Conn., elementary school that left 20 children and six educators dead.


Gun-safety activists were coalescing around expanded background checks as a key goal for the vice president’s task force. Some advocates said it may be more politically realistic — and even more effective as policy — than reinstating a ban on assault weapons.


The Brady Campaign to Prevent Gun Violence said some 40 percent of gun sales happen with no background checks, such as at gun shows and by private sellers over the Internet or through classified ads.


“Our top policy priority is closing the massive hole in the background check system,” the group said.


While not backing off support for an assault weapons ban, some advocates said there could be broader political support for increasing background checks, in part because that could actually increase business for retailers and licensed gun dealers who have access to the federal background check system.


“The truth is that an assault weapons ban is a very important part of the solution — and it is also much tougher to pass,” said Mark Glaze, director of Mayors Against Illegal Guns.


Restrictions on high-capacity ammunition magazines are also seen by some as an easier lift politically than banning assault weapons.


The National Rifle Association adamantly opposes universal background checks, as well as bans on assault weapons and high-capacity magazines — all measures that would require congressional approval. The NRA and other pro-gun groups contend that a culture that glamorizes violence bears more responsibility for mass shootings than access to a wide range of weapons and ammunition.


In a 2009 report, the American Academy of Pediatrics declared, “The evidence is now clear and convincing: Media violence is one of the causal factors of real-life violence and aggression.”


The report focused on all types of media violence. But for video games in particular, the pediatricians cited studies that found high exposure to violent ones increased physical aggression at least in the short term, and warned that they allow people to rehearse violent acts. On the other hand, it said friendly video games could promote good behavior.


A wide spectrum of the video game industry was represented at the meeting with the vice president, including the makers of violent war video games like “Call of Duty” and “Medal of Honor” and a representative from the Entertainment Software Ratings Board, which sets age ratings that on every video game package released in the United States.


The vice president met Thursday with representatives from the entertainment industry, including Motion Picture Association of America and the National Cable & Telecommunications Association. In a joint statement after the meeting, a half-dozen said they “look forward to doing our part to seek meaningful solutions” but offered no specifics.


Biden, hinting at other possible recommendations to the president, said he is interested in technology that would keep a gun from being fired by anyone other than the person who bought it. He said such technology may have curtailed what happened last month in Connecticut, where the shooter used guns purchased by his mother.


The vice president has also discussed making gun trafficking a felony, a step Obama can take through executive action. And he is expected to make recommendations for improving mental health care and school safety.


“We know this is a complex problem,” Biden said. “We know there’s no single answer.”


The president plans to push for the new measures in his State of the Union address, scheduled for Feb. 12.


___


Associated Press writers Lauran Neergaard and Darlene Superville contributed to this report.


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Rookies rule at the Sony Open


HONOLULU (AP) — Two days into his PGA Tour career, Russell Henley was on his way to breaking a record.


Henley putted for birdie on every hole on his way to a second straight round of a 7-under 63, giving him a two-shot lead over fellow rookie Scott Langley among early starters Friday in the Sony Open. He was 14-under 126, which would break the 36-hole scoring record at this event by two shots.


"It's pretty surreal," Henley said.


In the first full-field event of the season, the rookies were leading the way. All they did on another windy, warm day along the shores of Oahu was trade places atop the leaderboard. Langley opened with a 62 and followed that with a 66. That typically would be enough to stay in the lead.


Langley said he tried to stay aggressive, and then he felt he had no choice. He birdied his last three holes to reach 128.


Unless anyone could catch them in the afternoon, they would play together a third straight time, in the last group going into the weekend. The college grads first were linked when they shared low amateur honors at Pebble Beach in the 2010 U.S. Open.


"It's never easy to back up a really good round, I kind of got off to a little slower start," Langley said. "But it was certainly nice to finish the way I did and kind of get back in it with Russ. He played so well, and I was just trying to keep pace as much as I can. To finish that way was really good."


The previous 36-hole record at the Sony Open was 128 by five players, most recently John Cook in 2002.


Among the late starters was Scott Piercy, who opened with a 64 and already was at 10 under for the tournament as he headed to his back nine.


Dustin Johnson won't get a chance to match Ernie Els as the only players to sweep the two Hawaii events. Johnson, who won last week at Kapalua, withdrew after playing nine holes because of the flu.


Chris Kirk made a pair of tap-in eagles — a 5-iron into the wind to 3 feet on the ninth, a 7-iron with the wind to 2 feet on the 18th — for a 62 that put him at 10-under 130 along with Tim Clark, who had a 66.


Pat Perez, working on his new attitude of seeing silver linings instead of black clouds, ran off three straight birdies early in his round for a 63 and was another shot back.


Henley took over the lead for the first time with a shot into 8 feet to a front pin on No. 2, his 11th hole of the day. With birdies on the fifth and sixth holes, it looked as though he might pull away when he stretched his lead to four shots.


Langley came to life with a 7-iron and a 20-foot birdie putt on the seventh, then a sand wedge into the par-4 eighth and more work than he wanted on the par-5 ninth, when he got up-and-down for birdie from near the hospitality tent to the right of the green.


"This feels like a Monday qualifier," Langley said of the low scores, not to mention the company he has been keeping. Langley and Henley were born two weeks apart.


They became friends after Pebble Beach when they flew together to Royal Portrush for the Palmer Cup, and they helped each other on the practice range when their games were in need of repair.


The difference was their road to the PGA Tour.


Henley won a Nationwide Tour event while still at Georgia, and then he won twice on that tour last year to easily finish among the top 25 on the money list.


Langley, a former NCAA champion from Illinois, went through a bad patch last year when he finished last in the second stage of Q-school and had no status. He kicked around the smaller tours, tried a few Monday qualifiers, and then made his way through Q-school and earned his card with two shots to spare.


They're neck-and-neck going into the weekend, both hopeful they ride their momentum.


The surprise might be Clark, who was runner-up at the Sony Open two years ago until he suffered a mysterious elbow injury that cost him a year of trying to figure out what was wrong and how to get better. He is close to healthy now, and it's starting to show.


"Obviously, I've still got to take care of myself and look after it," Clark said. "But at least coming out to the golf course, I feel like I'm pretty much 100 percent."


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Flu Deaths Reach Epidemic Level, but May Be at Peak





Deaths in the current flu season have officially crossed the line into “epidemic” territory, federal health officials said Friday, adding that, on the bright side, there were also early signs that the caseloads could be peaking.




Officials from the Centers for Disease Control and Prevention, speaking on a telephone news conference, again urged Americans to keep getting flu shots. At the same time, they emphasized that the shots are not infallible: a preliminary study rated this year’s vaccine as 62 percent effective, even though it is a good match for the most worrisome virus circulating. That corresponds to a rating of “moderately” effective — the vaccine typically ranges from 50 percent to 70 percent effective, they said.


Even though deaths stepped — barely — into epidemic territory for the first time last Saturday, the C.D.C. officials expressed no alarm, and said it was possible that new flu infections were peaking in some parts of the country. “Most of the country is seeing a lot of flu and that may continue for weeks,” said Dr. Thomas R. Frieden, the C.D.C.’s director.


New outpatient cases — a measure based on what percentage of doctor visits were for colds or flu — dropped off slightly from the previous week, to 4 percent from 6 percent. The trend was more pronounced in the South, where this year’s season began.


Dr. Frieden cautioned that the new flu figures could be aberrations because they were gathered as the holiday season was ending. Few people schedule routine checkups then, so the percentage of visits for severe illness can be pushed artificially high for a week or two, then inevitably drop.


Deaths from pneumonia and the flu, a wavy curve that is low in summer and high in winter, typically touch the epidemic level for one or two weeks every flu season. How bad a season is depends on how high the deaths climb for how long.


So far this season, 20 children with confirmed flu tests have died, but that is presumably lower than the actual number of deaths because not all children are tested and not all such deaths are reported. How many adults die will not be estimated until after the season ends, said Dr. Joseph Bresee, the chief of prevention and epidemiology for the C.D.C.’s flu branch. Epidemiologists count how many death certificates are filed in a flu year, compare the number with normal years, and estimate what percentage were probably flu-related.


Many people are getting ill this year because the country is also having widespread outbreaks of two diseases with overlapping symptoms, norovirus and whooping cough, and the normal winter surge in common colds. Flu shots have no effect on any of those.


Spot shortages of vaccines have been reported, and there will not be enough for all Americans, since the industry has made and shipped only about 130 million doses. But officials said they would be pleased if 50 percent of Americans got shots; in a typical year, 37 percent do.


Dr. Bresee said that this year’s epidemic resembles that of 2003-4, which also began early, was dominated by an H3N2 strain and killed more Americans than usual.


Nevertheless, more Americans now routinely get flu shots than did then, and doctors are much quicker to prescribe Tamiflu and Relenza, drugs that can lessen a flu’s severity if taken early.


The C.D.C.’s vaccine effectiveness study bore out the point of view of a report released last year by the University of Minnesota’s Center for Infectious Disease Research and Policy. It said that the shot’s effectiveness had been “overpromoted and overhyped,” said Michael T. Osterholm, the center’s director.


Although the report supported getting flu shots, it said that new vaccines offering lifelong protection against all flu strains, instead of annual partial protection against a mix-and-match set, must be created.


“But there’s no appetite to fund that research,” Dr. Osterholm said in an interview Friday.


“To get a vaccine across the ‘Valley of Death’ is likely to cost $1 billion,” he added, referring to the huge clinical trials that would be needed to approve a new type of vaccine. “No government has put more than $100 million into any candidate, and the private sector has no appetite for it because there’s not enough return on investment.”


At the same time, he praised the C.D.C. for measuring vaccine effectiveness in midseason.


“We’re the only ones in the world who have data like that,” he said.


“Vaccine effectiveness” is a very different metric from vaccine-virus match, which is done in a lab. Vaccine efficacy is measured by interviewing hundreds of sick or recovering patients who had positive flu tests and asking whether and when they had received shots.


Only people sick enough to visit doctors get flu tests, said Thomas Skinner, a C.D.C. spokesman, so the metric means the shot “reduces by 62 percent your chance of getting a flu so bad that you have to go to a doctor or hospital.”


During the telephone news conference Friday, Dr. Frieden repeatedly described the vaccine as “far from perfect, but by far the best tool we have to prevent influenza.”


Most vaccinations given in childhood for threats like measles and diphtheria are 90 percent effective or better. But flu viruses mutate so fast that they must be remade annually. Scientists are trying to develop vaccines that target bits of the virus that appear to stay constant, like the stem of the hemagglutinin spike that lets the virus break into lung cells.


During the 2009 swine flu pandemic, many elderly Americans had natural protection, presumably from flus they caught in the 1930s or ’40s.


“Think about that,” Dr. Osterholm said. “Even though they were old, they were still protected. We’ve got to figure out how to capture that kind of immunity — which current vaccines do not.”


At Friday’s news conference, Dr. Bresee acknowledged the difficulties, saying: “If I had the perfect answer as to how to make a better flu vaccine, I’d probably get a Nobel Prize.”


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DealBook: European Regulators Propose Overhaul of Benchmark Interest Rate

LONDON — European regulators called for a major overhaul of a benchmark interest rate on Friday, but stopped short of demanding direct regulatory oversight after a rate-rigging scandal.

The recommended changes to the euro interbank offered rate, or Euribor, come after a $1.5 billion settlement by the Swiss bank UBS, where some traders were found to have altered that rate as well as the London interbank offered rate, or Libor, for financial gain.

The European Banking Authority and European Securities and Markets Authority are pushing to improve the accuracy of the benchmark rate and increase oversight of how banks submit rates to Euribor, which underpins trillions of dollars of global financial products.

European authorities said the system did not require participating banks to have internal governance structures to manage potential conflicts of interest when submitting rates to Euribor. Also, the rate-setting process is not sufficiently assessed against real banking transactions, according to the report.

The recommendations include cutting in half the number of maturities included in the Euribor process, to seven rates. That would leave the focus only on benchmark rates that are supported by a large number of financial transactions.

The change is in response to a drastic reduction of lending among global financial institutions during the financial crisis that reduced the accuracy of firms’ rate submissions. The fall in actual transactions also led a number of traders and senior managers at global banks to manipulate the rate, according to regulatory filings.

On Friday, European authorities did not demand direct regulatory control over Euribor, which continues to be overseen by the European Banking Federation, a trade body. A recent review of Libor by British authorities recommended regulatory oversight of that rate, as well as criminal charges against individuals trying to alter the rate for financial gain.

Despite widespread calls for authorities to take control over global benchmark rates, the European regulatory bodies do not have the legal responsibility to recommend those changes, according to a European Securities and Markets Authority spokesman.

The European Commission is considering changes to how global benchmark rates are set, and is expected to propose legislation later this year.

Other recommendations outlined by European authorities on Friday included regular audits of the rate-setting process by the European Banking Federation, as well as increasing the independence of the board that oversees Euribor. The trade body said it welcomed many of the changes outlined by the European banking and financial market regulators, adding that it was open to regulators participating in the supervision of Euribor.

Greater scrutiny of the benchmark rate is already having an effect.

As more banks continue to be embroiled in the rate-rigging scandal, a number of financial institutions, including Rabobank Groep of the Netherlands and Raiffeisen Bank International of Austria, have left the panel that sets Euribor. Euribor-EBF, the group that oversees the rate, has said other banks could also pull out of the rate-setting process.

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Kurdish Killings in Paris, and Motive Is a Mystery


Thomas Samson/Agence France-Presse — Getty Images


Members of the Kurdish community watched as the body of one of the three Kurdish women shot dead at the Kurdish Institute was carried away on Thursday in Paris.







PARIS — The three Kurdish women were murdered, two with bullets to the head, the third with a shot to the stomach. It was a carefully planned killing in a nondescript building in central Paris.




When the bodies were found early Thursday, the office was locked from the outside. Three bullet casings were found on the floor. Blood was splattered on the door.


One of the dead women was a founder of the Kurdistan Workers Party — or P.K.K. — a Kurdish separatist group that has waged a guerrilla war against Turkey since 1984. The other two were Kurdish activists who may well have died because they were simply in the wrong place at the wrong time.


There were competing theories over who was responsible, and outraged Kurds poured into the street in Paris, blaming Turkey. Officials there said the killings were probably a dispute among Kurds, perhaps intended to derail new peace talks between the government and the P.K.K.’s jailed leader, or to settle a score.


But these were theories. The evidence spoke only to a well-planned job.


“No hypothesis can be excluded at this stage” about the motive, said Agnès Thibault-Lecuivre, a spokeswoman for the Paris prosecutor’s office. Visiting the crime scene on Thursday, Interior Minister Manuel Valls called the killings “intolerable” and said they were “without doubt an execution.”


The shootings took place in the gritty 10th District of the city, near the Gare du Nord railroad station, in a working-class immigrant neighborhood of Turkish kebab shops and African hair salons. The killings prompted outrage, raised fears of violent revenge violence and opened a new chapter in the often murky annals of Kurdish exile life.


The bodies were found around 2 a.m. inside the Kurdish Information Center, which is used to promote Kurds’ political and cultural agendas. Someone would have to have known the office was there; there was no plaque outside. And the front door could only be opened with a digital code or if the occupants buzzed someone in, the manager of the center, Leon Edart, told reporters.


That possibility led to many questions. Did the women know their killer? Did the killer slip into the center behind a welcomed guest? An organization called the Federation of Kurdish Associations in France, representing many of the estimated 150,000 Kurdish exiles in the country, added to the intrigue, saying in a statement that the victims might have been killed with weapons equipped with silencers.


“Why anyone would want to do this is unclear,” said Rusen Werdi, a Kurdish lawyer who knew two of the women. “It was an ambush.”


The bodies, she said, were discovered after friends became concerned about the women because cellphone calls had gone unanswered and none of them had returned home.


Ms. Thibault-Lecuivre said the antiterrorism department of the prosecutor’s office would oversee the investigation.


The authorities confirmed the identities of two of the victims: Leyla Soylemeza, a young Kurdish activist, and Fidan Dogan, the head of the Kurdish Information Center and a representative of the Kurdistan National Congress. News media reports said the third woman was Sakine Cansiz, a founder of the Kurdistan Workers Party.


But for all the intrigue, Ms. Werdi said, it appeared that the target was Ms. Cansiz and that the other two victims might well have been killed because they were with her.


Ms. Werdi said that at least one of the women had been under surveillance by the French police because of her activism. She said that Ms. Cansiz had been keeping a low profile in recent months, and that it was rare for her to be at the information center.


The P.K.K.  is no stranger to infighting and internal strife. Hurriyet, a Turkish daily newspaper, said Ms. Cansiz was “known for her opposition to the alleged head of the P.K.K.’s armed wing, Syrian citizen Ferman Hussein.”


Ms. Cansiz had been in Paris since 2007 after the authorities in Germany arrested and briefly held her before turning down a Turkish request for her extradition. Kurdish activists said she was very close to Abdullah Ocalan, the head of the P.K.K., who has been in prison since 1999. Ms. Cansiz was imprisoned in Turkey in 1979 and freed in 1991, after which they said she became active in the organization. She played a leading role garnering financial and political support for the Kurdish cause in Europe.


Scott Sayare contributed reporting from Paris, and Sebnem Arsu from Istanbul.



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Academy Launches Oscar App on Android, Amazon






LOS ANGELES (TheWrap.com) – The Academy launched its official Oscars app on Android and Amazon on Thursday, expanding its initiative to direct fans’ attention from the television to the second screen.


The app, already available on the iPad and iPhone, was made available for free on the Google Play store and the Amazon app store, the Academy said. According to iTunes, the iPad app was updated earlier on Wednesday.






Developed by the Academy and Disney/ABC Television Group’s digital media arm, the app allows users to see behind-the-scenes videos and stories with host Seth MacFarlane and search information about the nominees. It also features a “My Picks” ballot on which users can organize their dream-team of winners.


On Oscar night on February 24, the app will feature “Backstage Pass,” a live telecast from more than a dozen cameras placed on the Red Carpet and throughout the Dolby Theatre – in the press room, the control room, backstage and elsewhere.


And a ticker on the app will notify when a users’ favorite actor and actress arrives on stage.


“We’re always looking for ways to bring fans closer to the show and this app provides a unique and fun way to do that,” Josh Spector, the managing director of digital media and marketing for the Academy, said in a statement. “More fans than ever will be able to enjoy the full Oscar experience now that our app is available to Droid users.”


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Researchers: NFL's Seau had brain disease


When he ended his life last year by shooting himself in the chest, Junior Seau had a degenerative brain disease often linked with repeated blows to the head.


Researchers from the National Institutes of Health said Thursday the former NFL star's abnormalities are consistent with chronic traumatic encephalopathy, or CTE.


The hard-hitting linebacker played for 20 NFL seasons with San Diego, Miami and New England before retiring in 2009. He died at age 43 of a self-inflicted gunshot in May, and his family requested the analysis of his brain.


"We saw changes in his behavior and things that didn't add up with him," his ex-wife, Gina, told The Associated Press. "But (CTE) was not something we considered or even were aware of. But pretty immediately (after the suicide) doctors were trying to get their hands on Junior's brain to examine it."


The NIH, based in Bethesda, Md., studied three unidentified brains, one of which was Seau's, and said the findings on Seau were similar to autopsies of people "with exposure to repetitive head injuries."


"It was important to us to get to the bottom of this, the truth," Gina Seau added, "and now that it has been conclusively determined from every expert that he had obviously had CTE, we just hope it is taken more seriously. You can't deny it exists, and it is hard to deny there is a link between head trauma and CTE. There's such strong evidence correlating head trauma and collisions and CTE."


In the final years of his life, Seau had wild behavioral swings, according to Gina and to 23-year-old son, Tyler, along with signs of irrationality, forgetfulness, insomnia and depression.


"He emotionally detached himself and would kind of 'go away' for a little bit," Tyler Seau said. "And then the depression and things like that. It started to progressively get worse."


He hid it well in public, they said, but not when he was with family or close friends.


Seau joins a list of several dozen football players who were found to have CTE. Boston University's center for study of the disease reported last month that 34 former pro players and nine who played only college football suffered from CTE.


The NFL faces lawsuits by thousands of former players who say the league withheld information on the harmful effects of concussions. According to an AP review of 175 lawsuits, 3,818 players have sued. At least 26 Hall of Famer members are among the players who have done so.


The National Football League, in an email to the AP, said: "We appreciate the Seau family's cooperation with the National Institutes of Health. The finding underscores the recognized need for additional research to accelerate a fuller understanding of CTE.


"The NFL, both directly and in partnership with the NIH, Centers for Disease Control and other leading organizations, is committed to supporting a wide range of independent medical and scientific research that will both address CTE and promote the long-term health and safety of athletes at all levels."


NFL teams have given a $30 million research grant to the NIH.


The players' union called the NIH report on Seau "tragic."


"The only way we can improve the safety of players, restore the confidence of our fans and secure the future of our game is to insist on the same quality of medical care, informed consent and ethical standards that we expect for ourselves and for our family members," the NFLPA said in a statement.


"This is why the players have asked for things like independent sideline concussion experts, the certification and credentialing of all professional football medical staff and a fairer workers compensation system in professional football," it said.


Seau is not the first former NFL player who killed himself and later was found to have had CTE. Dave Duerson and Ray Easterling are the others.


Before shooting himself, Duerson, a former Chicago Bears defensive back, left a note asking that his brain be studied for signs of trauma. His family filed a wrongful-death suit against the NFL, claiming the league didn't do enough to prevent or treat the concussions that severely damaged his brain.


Easterling played safety for the Falcons in the 1970s. After his career, he suffered from dementia, depression and insomnia, according to his wife, Mary Ann. He committed suicide last April.


Mary Ann Easterling is among the plaintiffs who have sued the NFL.


Tyler Seau played football through high school and for two years in college. He says he has no symptoms of brain trauma.


"I was not surprised after learning a little about CTE that he had it," Tyler said. "He did play so many years at that level. I was more just kind of angry I didn't do something more and have the awareness to help him more, and now it is too late."


Gina Seau's son Jake, now a high school junior, played football for two seasons but has switched to lacrosse and has been recruited to play at Duke.


"Lacrosse is really his sport and what he is passionate about," she said. "He is a good football player and probably could continue. But especially now watching what his dad went through, he says, 'Why would I risk lacrosse for football?'


"I didn't have to have a discussion with him after we saw what Junior went through."


Her 12-year-old son Hunter has shown no interest in playing football.


"That's fine with me," she said.


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F.D.A. Requires Cuts to Dosages of Ambien and Other Sleep Drugs





WASHINGTON — For two decades, millions of Americans have taken Ambien to help them sleep at night. But for years, the Food and Drug Administration has gotten complaints that people felt drowsy the morning after taking the medicine or its successors, and sometimes got into car accidents.




On Thursday, after laboratory studies and driving tests confirming the risks of drowsiness, the agency said that women should be taking half as much.


The new recommendation applies to drugs containing the active ingredient zolpidem, by far the most widely used sleep aid. Using lower doses means less of the drug will remain in the blood in the morning hours, and will reduce the risk that people who use it will be impaired while driving.


Sleeping pills have boomed in popularity with the increasingly frantic pace of modern American life. According to IMS, a health care information and technology company, about 60 million prescriptions were dispensed in 2011, up about 20 percent since 2006. About 40 million were for products containing zolpidem.


The agency’s announcement was focused on women because they take longer to metabolize the drug than men. An estimated 10 percent to 15 percent of women will have a level of zolpidem in their blood that could impair driving eight hours after taking the pill, while only about 3 percent of men do, said Dr. Robert Temple, an official in the agency’s Center for Drug Evaluation and Research.


Reports of aftereffects from sleeping pills have circulated for years, and some doctors questioned why the drug agency took so long to act. Mishaps with sleepy driving — and even strange acts of texting, eating or having sex in the night without any memory of it in the morning — have long been familiar to the medical community.


“In this case, the F.D.A. may be behind the 8-ball,” said Daniel Carlat, an associate clinical professor of psychiatry at Tufts University, referring to residual drowsiness. “This has been a known problem. Few doctors will be surprised hearing about this. They’ll say, ‘Oh yeah, we’ve already seen this in our patients.’ ”


He added that Thursday’s announcement “will be good for public health because it will get patients to ask their doctors about the appropriate dosage.”


Agency officials acknowledged that they had received about 700 reports of driving mishaps with people on zolpidem over the years, with a spike in 2007 after a change in labeling caused more people to call in complaints. But they said it was not easy to draw a direct connection between the reports and the drug. Patients often did not remember what time they took the pill. Sometimes they had been drinking.


It was not until the drug agency reviewed driving simulation studies from controlled trials of the drug Intermezzo, which was approved in 2011 for middle-of-the-night waking, that a more complete picture of the risks emerged. The agency linked the driving simulation information with data from manufacturers on the amount of zolpidem in patients’ blood and determined that levels above about 50 nanograms per milliliter increased the risk of crashing while driving, said Dr. Ellis Unger, an official at the agency’s Center for Drug Evaluation and Research.


Dr. Unger said that all makers of new sleeping drugs would now be asked to conduct driving trials; a spokeswoman clarified that it would not be required.


“A lot of people are wondering about the elephant in the room,” Dr. Unger said. “Why did this take so long? This is science, and our thinking evolves over time.”


The drug agency told manufacturers that the recommended dose for women should be lowered to 5 milligrams from 10 for immediate-release products like Ambien, Edluar and Zolpimist. Doses for extended-release products should be lowered to 6.25 milligrams from 12.5, the agency said. Most sleeping drugs containing zolpidem are now generic.


For men, the agency informed manufacturers that labels should recommend that health care providers should “consider” prescribing lower doses.


Patients taking the higher doses should continue them for the time being, officials said, but should consult with their doctors about lowering them. Doctors can still prescribe the higher dose if the lower one does not work. The lower doses are already commercially available, Dr. Unger said, as they are recommended for older patients.


Sanofi, the manufacturer of Ambien and Ambien CR, said in a statement that it agreed that people taking zolpidem “should always talk to their doctor about the most appropriate dose,” and that the label “provides important information” to determine what that is. The company added that it “stands behind the significant clinical data demonstrating the safety and efficacy of Ambien.”


The drug has also been known to cause sleepwalking incidents, and Dr. Unger said there was evidence that the lower dose might ease such events, though it is weaker than the evidence about next-morning-drowsiness. Dr. Carlat said one of his patients discovered that her weight gain while on the drug was from midnight trips to the kitchen she did not even remember taking.


Dr. Daniel Kripke, professor emeritus of psychiatry at the University of California, San Diego, and a leading critic of sleeping pills, welcomed the move but said the agency was still not doing enough to investigate other possible side effects.


“It’s a very small step in the right direction,” he said. He added that sleeping medications like zolpidem might increase total sleep time by 20 minutes a night, but that most studies suggest that the use of sleeping pills impairs a person’s performance the next day.


Critics of the drug agency said the label on Intermezzo, which very clearly denotes the risks for women, indicate that the agency was aware of these problems earlier.


But Thomas Roth, director of the sleep center at Henry Ford Hospital in Detroit who has been a consultant to sleeping pill makers, said that the drug agency had always been concerned about the potential risks with driving, “but they care about it more now.” He said he believed the lower dose would still be effective for many patients.


Agency officials say all patients are unique and doses will need to be tailored. They say the drugs should be prescribed at the lowest dose required.


Dr. Daniel J. Buysse, professor of psychiatry at the University of Pittsburgh School of Medicine, said he already prescribed the lower dose when he feels it is necessary, by telling patients to cut a tablet in half along the score.


“This just tells me, maybe be a little bit more cautious,” said Dr. Buysse, who has been a consultant for drug companies including the maker of Ambien. “But I do not think it will have a big effect on what I do.”


Andrew Pollack contributed reporting from San Francisco.



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Electronic Records Systems Have Not Reduced Health Costs, Report Says





The conversion to electronic health records has failed so far to produce the hoped-for savings in health care costs and has had mixed results, at best, in improving efficiency and patient care, according to a new analysis by the influential RAND Corporation.







Jim Wilson/The New York Times

Dr. Alvin Rajkomar tracks patient data on a Samsung Galaxy Note. A new report questions whether electronic records reduce health care costs.







Optimistic predictions by RAND in 2005 helped drive explosive growth in the electronic records industry and encouraged the federal government to give billions of dollars in financial incentives to hospitals and doctors that put the systems in place.


“We’ve not achieved the productivity and quality benefits that are unquestionably there for the taking,” said Dr. Arthur L. Kellermann, one of the authors of a reassessment by RAND that was published in this month’s edition of Health Affairs, an academic journal.


RAND’s 2005 report was paid for by a group of companies, including General Electric and Cerner Corporation, that have profited by developing and selling electronic records systems to hospitals and physician practices. Cerner’s revenue has nearly tripled since the report was released, to a projected $3 billion in 2013, from $1 billion in 2005.


The report predicted that widespread use of electronic records could save the United States health care system at least $81 billion a year, a figure RAND now says was overstated. The study was widely praised within the technology industry and helped persuade Congress and the Obama administration to authorize billions of dollars in federal stimulus money in 2009 to help hospitals and doctors pay for the installation of electronic records systems.


“RAND got a lot of attention and a lot of buzz with the original analysis,” said Dr. Kellermann, who was not involved in the 2005 study. “The industry quickly embraced it.”


But evidence of significant savings is scant, and there is increasing concern that electronic records have actually added to costs by making it easier to bill more for some services.


Health care spending has risen $800 billion since the first report was issued, according to federal figures. The reasons are many, from the aging of the baby boomer population, to the cost of medical advances, to higher usage of medical services over all.


Officials at RAND said their new analysis did not try to put a dollar figure on how much electronic record-keeping had helped or hurt efforts to reduce costs. But the firm’s acknowledgment that its earlier analysis was overly optimistic adds to a chorus of concern about the cost of the new systems and the haste with which they have been adopted.


The recent analysis was sharply critical of the commercial systems now in place, many of which are hard to use and do not allow doctors and patients to share medical information across systems. “We could be getting much more if we could take the time to do a little more planning and to set more standards,” said Marc Probst, chief information officer for Intermountain Healthcare, a large health system in Salt Lake City that developed its own electronic records system and is cited by RAND as an example of how the technology can help improve care and reduce costs.


The RAND researchers pointed to a number of other reasons the expected savings had not materialized. The rate of adoption has been slow, they said, and electronic records do not address the fact that doctors and hospitals reap the benefits of high volumes of care.


Many experts say the available systems seem to be aimed more at increasing billing by providers than at improving care or saving money. Federal regulators are investigating whether electronic records make it easier for hospitals and doctors to bill for services they did not provide and whether Medicare and other federal agencies are adequately monitoring the use of electronic records.


Technology “is only a tool,” said Dr. David Blumenthal, who helped oversee the federal push for the adoption of electronic records under President Obama and is now president of the Commonwealth Fund, a nonprofit health group. “Like any tool, it can be used well or poorly.” While there is strong evidence that electronic records can contribute to better care and more efficiency, Dr. Blumenthal said, the systems in place do not always work in ways that help achieve those benefits.


Federal officials say they are drafting new rules to address many of the concerns about the current systems.


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World Briefing | The Americas: Mexico: Killer Dog Case Widens



A pack of feral dogs may be responsible for the deaths of as many as five people in a Mexico City park, the authorities said Wednesday. Last week, the police said dogs had killed four people, including a woman and a baby boy, whose mutilated bodies were found in the park in December. Now, prosecutors are investigating if the wounds found on a fifth person, a 15-year-old girl who died in December, are consistent with dog bites. The authorities have captured several dogs, spurring an online campaign to save them, but it is not clear if any are the culprits.


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