Beijing Air Pollution Off the Charts


Alexander F. Yuan/Associated Press


Fashionably masked women on Saturday outside an amusement park in Beijing. The World Health Organization has standards that judge an air-quality score above 500 to be more than 20 times the level of particulate matter in the air deemed safe.







BEIJING — One Friday more than two years ago, an air-quality monitoring device atop the United States Embassy in Beijing recorded data so horrifying that someone in the embassy called the level of pollution “Crazy Bad” in an infamous Twitter post. That day the Air Quality Index, which uses standards set by the United States Environmental Protection Agency, had crept above 500, which was supposed to be the top of the scale.




So what phrase is appropriate to describe Saturday’s jaw-dropping reading of 755 at 8 p.m., when all of Beijing looked like an airport smokers’ lounge? Though an embassy spokesman said he did not immediately have comparative data, Beijing residents who follow the Twitter feed said the Saturday numbers appeared to be the highest recorded since the embassy began its monitoring system in 2008.


The embassy’s @BeijingAir Twitter feed said the level of toxicity in the air was “Beyond Index,” the terminology for levels above 500; the “Crazy Bad” label was used just once, in November 2010, by an embassy employee using the Twitter account. According to the Environmental Protection Agency, levels between 301 and 500 are “Hazardous,” meaning people should avoid all outdoor activity. The World Health Organization has standards that judge a score above 500 to be more than 20 times the level of particulate matter in the air deemed safe.


In online conversations, Beijing residents tried to make sense of the latest readings.


“This is a historic record for Beijing,” Zhao Jing, a prominent Internet commentator who uses the pen name Michael Anti, wrote on Twitter. “I’ve closed the doors and windows; the air purifiers are all running automatically at full power.”


Other Beijing residents online described the air as “postapocalyptic,” “terrifying” and “beyond belief.”


The municipal government reported levels as high as 478 on Saturday in central Beijing, according to The Associated Press. It was not immediately clear why the number was lower, but even that level is considered hazardous according to the United States Environmental Protection Agency standards. (By comparison, the air quality index in New York City, using the same standard, was 19 at 6 a.m. on Saturday.)


Pollution levels in Beijing had been creeping up for days, and readings were regularly surging above 300 by midweek. The interior of the gleaming Terminal 3 of the Beijing Capital International Airport was filled with a thick haze on Thursday. The next day, people working in office towers in downtown Beijing found it impossible to make out skyscrapers just a few blocks away. Some city residents scoured stores in search of masks and air filters.


Still, there was little warning that the United States Embassy reading would jump above 700 on Saturday. Some people speculated that the monitoring system, which measures fine particles called PM 2.5 because they are 2.5 microns in diameter or smaller, might have malfunctioned once it got beyond 500.


But Nolan Barkhouse, an embassy spokesman, said the monitor was operating correctly.


It was unclear exactly what was responsible for the rise in levels of particulate matter, beyond the factors that regularly sully the air here. Factories operating in neighboring Hebei Province ring this city of more than 20 million. The number of cars on Beijing’s streets has been multiplying at an astounding rate. And Beijing sits on a plain flanked by hills and escarpments that can trap pollution on days with little wind. Meanwhile, one person hiking at the Great Wall in the hills at Mutianyu, north of Beijing, took photographs of crisp blue skies there.


Xinhua, the state news agency, reported on Dec. 31 that Beijing’s air quality had improved for 14 years straight, and the level of major pollutants had decreased. A municipal government spokesman told Xinhua that the annual average concentration of PM 10, or particles 10 microns in diameter or smaller, had dropped by 4 percent in 2012, compared with one year earlier.


Chinese officials prefer to publicly release air pollution measurements that give only levels of PM 10, although foreign health and environmental experts say PM 2.5 can be deadlier and more important to track.


There has been a growing outcry among Chinese for municipal governments to release fuller air quality data, in part because of the United States Embassy Twitter feed. As a result, Beijing began announcing PM 2.5 numbers last January. Major Chinese cities have had the equipment to track those levels, but had refused for a long time to release the data.


The existence of the embassy’s machine and the @BeijingAir Twitter feed have been a diplomatic sore point for Chinese officials. In July 2009, a Chinese Foreign Ministry official, Wang Shu’ai, told American diplomats to halt the Twitter feed, saying that the data “is not only confusing but also insulting,” according to a State Department cable obtained by WikiLeaks. Mr. Wang said the embassy’s data could lead to “social consequences.”


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Aaron Swartz, Internet Activist, Dies at 26





Aaron Swartz, a wizardly programmer who as a teenager helped develop code that delivered ever-changing Web content to users and who later became a steadfast crusader to make that information freely available, was found dead on Friday in his New York apartment..




An uncle, Michael Wolf, said that Mr. Swartz, 26, had apparently hanged himself, and that a friend of Mr. Swartz’s had discovered the body.


At 14, Mr. Swartz helped create RSS, the nearly ubiquitous tool that allows users to subscribe to online information. He later became an Internet folk hero, pushing to make many Web files free and open to the public. But in July 2011, he was indicted on federal charges of gaining illegal access to JSTOR, a subscription-only service for distributing scientific and literary journals, and downloading 4.8 million articles and documents, nearly the entire library.


Charges in the case, including wire fraud and computer fraud, were pending at the time of Mr. Swartz’s death, carrying potential penalties of up to 35 years in prison and $1 million in fines.


“Aaron built surprising new things that changed the flow of information around the world,” said Susan Crawford, a professor at the Cardozo School of Law in New York who served in the Obama administration as a technology adviser. She called Mr. Swartz “a complicated prodigy” and said “graybeards approached him with awe.”


Mr. Wolf said he would remember his nephew, who had written in the past about battling depression and suicidal thoughts, as a young man who “looked at the world, and had a certain logic in his brain, and the world didn’t necessarily fit in with that logic, and that was sometimes difficult.”


The Tech, a newspaper of the Massachusetts Institute of Technology, reported Mr. Swartz’s death early Saturday.


Mr. Swartz led an often itinerant life that included dropping out of Stanford, forming companies and organizations, and becoming a fellow at Harvard University’s Edmond J. Safra Center for Ethics.


He formed a company that merged with Reddit, the popular news and information site. He also co-founded Demand Progress, a group that promotes online campaigns on social justice issues — including a successful effort, with other groups, to oppose a Hollywood-backed Internet piracy bill.


But he also found trouble when he took part in efforts to release information to the public that he felt should be freely available. In 2008, he took on PACER, or Public Access to Court Electronic Records, the repository for federal judicial documents.


The database charges 10 cents a page for documents; activists like Carl Malamud, the founder of public.resource.org, have long argued that such documents should be free because they are produced at public expense. Joining Mr. Malamud’s efforts to make the documents public by posting legally obtained files to the Internet for free access, Mr. Swartz wrote an elegant little program to download 20 million pages of documents from free library accounts, or roughly 20 percent of the enormous database.


The government shut down the free library program, and Mr. Malamud feared that legal trouble might follow even though he felt they had violated no laws. As he recalled in a newspaper account, “I immediately saw the potential for overreaction by the courts.” He recalled telling Mr. Swartz: “You need to talk to a lawyer. I need to talk to a lawyer.”


Mr. Swartz recalled in a 2009 interview, “I had this vision of the feds crashing down the door, taking everything away.” He said he locked the deadbolt on his door, lay down on the bed for a while and then called his mother.


The federal government investigated but did not prosecute.


In 2011, however, Mr. Swartz went beyond that, according to a federal indictment. In an effort to provide free public access to JSTOR, he broke into computer networks at M.I.T. by means that included gaining entry to a utility closet on campus and leaving a laptop that signed into the university network under a false account, federal officials said.


Mr. Swartz turned over his hard drives with 4.8 million documents, and JSTOR declined to pursue the case. But Carmen M. Ortiz, a United States attorney, pressed on, saying that “stealing is stealing, whether you use a computer command or a crowbar, and whether you take documents, data or dollars.”


Founded in 1995, JSTOR, or Journal Storage, is nonprofit, but institutions can pay tens of thousands of dollars for a subscription that bundles scholarly publications online. JSTOR says it needs the money to collect and to distribute the material and, in some cases, subsidize institutions that cannot afford it. On Wednesday, JSTOR announced that it would open its archives for 1,200 journals to free reading by the public on a limited basis.


Mr. Malamud said that while he did not approve of Mr. Swartz’s actions at M.I.T., “access to knowledge and access to justice have become all about access to money, and Aaron tried to change that. That should never have been considered a criminal activity.”


Mr. Swartz did not talk much about his impending trial, Quinn Norton, a close friend, said on Saturday, but when he did, it was clear that “it pushed him to exhaustion. It pushed him beyond.”


Recent years had been hard for Mr. Swartz, Ms. Norton said, and she characterized him “in turns tough and delicate.” He had “struggled with chronic, painful illness as well as depression,” she said, without specifying the illness, but he was still hopeful “at least about the world.”


Cory Doctorow, a science fiction author and online activist, posted a tribute to Mr. Swartz on BoingBoing.net, a blog he co-edits. In an e-mail, he called Mr. Swartz “uncompromising, principled, smart, flawed, loving, caring, and brilliant.”


 “The world was a better place with him in it,” he said.


Mr. Swartz, he noted, had a habit of turning on those closest to him: “Aaron held the world, his friends, and his mentors to an impossibly high standard — the same standard he set for himself.” Mr. Doctorow added, however, “It’s a testament to his friendship that no one ever seemed to hold it against him (except, maybe, himself).”


In a talk in 2007, Mr. Swartz described having had suicidal thoughts during a low period in his career. He also wrote about his struggle with depression, distinguishing it from sadness.


“Go outside and get some fresh air or cuddle with a loved one and you don’t feel any better, only more upset at being unable to feel the joy that everyone else seems to feel. Everything gets colored by the sadness.”


When the condition gets worse, he wrote, “you feel as if streaks of pain are running through your head, you thrash your body, you search for some escape but find none. And this is one of the more moderate forms.”


Ravi Somaiya contributed reporting.



This article has been revised to reflect the following correction:

Correction: January 12, 2013

An earlier version of this article incorrectly identified the police who arrested Mr. Swartz, and when they did so. The police were from Cambridge, Mass., not the Massachusetts Institute of Technology campus force, and the arrest occurred two years before Mr. Swartz’s suicide, but not two years to the day.



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City Room: Cuomo Declares Public Health Emergency Over Flu Outbreak

With the nation in the grip of a severe influenza outbreak that has seen deaths reach epidemic levels, New York State declared a public health emergency on Saturday, making access to vaccines more easily available.

There have been nearly 20,000 cases of flu reported across the state so far this season, officials said. Last season, 4,400 positive laboratory tests were reported.

“We are experiencing the worst flu season since at least 2009, and influenza activity in New York State is widespread, with cases reported in all 57 counties and all five boroughs of New York City,” Gov. Andrew M. Cuomo said in a statement.

Under the order, pharmacists will be allowed to administer flu vaccinations to patients between 6 months and 18 years old, temporarily suspending a state law that prohibits pharmacists from administering immunizations to children.

While children and older people tend to be the most likely to become seriously ill from the flu, Mr. Cuomo urged all New Yorkers to get vaccinated.

On Friday, the Centers for Disease Control and Prevention in Atlanta said that deaths from the flu had reached epidemic levels, with at least 20 children having died nationwide. Officials cautioned that deaths from pneumonia and the flu typically reach epidemic levels for a week or two every year. The severity of the outbreak will be determined by how long the death toll remains high or if it climbs higher.

There was some evidence that caseloads may be peaking, federal officials said on Friday.

In New York City, public health officials announced on Thursday that flu-related illnesses had reached epidemic levels, and they joined the chorus of authorities urging people to get vaccinated.

“It’s a bad year,” the city’s health commissioner, Dr. Thomas A. Farley, told reporters on Thursday. “We’ve got lots of flu, it’s mainly type AH3N2, which tends to be a little more severe. So we’re seeing plenty of cases of flu and plenty of people sick with flu. Our message for any people who are listening to this is it’s still not too late to get your flu shot.”

There has been a spike in the number of people going to emergency rooms over the past two weeks with flulike symptoms – including fever, fatigue and coughing – Dr. Farley said.

Mayor Michael R. Bloomberg and Mr. Cuomo made a public display of getting shots this past week.

In a briefing with reporters on Friday, officials from the C.D.C. said that this year’s vaccine was effective in 62 percent of cases.

As officials have stepped up their efforts encouraging vaccinations, there have been scattered reports of shortages. But officials said plenty of the vaccine was available.

According to the C.D.C., makers of the flu vaccine produced about 135 million doses for this year. As of early this month, 128 million doses had been distributed. While that would not be enough for every American, only 37 percent of the population get a flu shot each year.

Federal health officials said they would be happy if that number rose to 50 percent, which would mean that there would be more than enough vaccine for anyone who wanted to be immunized.

Two other diseases – norovirus and whooping cough – are also widespread this winter and are contributing to the number of people getting sick.

The flu can resemble a cold, though the symptoms come on more rapidly and are more severe.

Read More..

City Room: Cuomo Declares Public Health Emergency Over Flu Outbreak

With the nation in the grip of a severe influenza outbreak that has seen deaths reach epidemic levels, New York State declared a public health emergency on Saturday, making access to vaccines more easily available.

There have been nearly 20,000 cases of flu reported across the state so far this season, officials said. Last season, 4,400 positive laboratory tests were reported.

“We are experiencing the worst flu season since at least 2009, and influenza activity in New York State is widespread, with cases reported in all 57 counties and all five boroughs of New York City,” Gov. Andrew M. Cuomo said in a statement.

Under the order, pharmacists will be allowed to administer flu vaccinations to patients between 6 months and 18 years old, temporarily suspending a state law that prohibits pharmacists from administering immunizations to children.

While children and older people tend to be the most likely to become seriously ill from the flu, Mr. Cuomo urged all New Yorkers to get vaccinated.

On Friday, the Centers for Disease Control and Prevention in Atlanta said that deaths from the flu had reached epidemic levels, with at least 20 children having died nationwide. Officials cautioned that deaths from pneumonia and the flu typically reach epidemic levels for a week or two every year. The severity of the outbreak will be determined by how long the death toll remains high or if it climbs higher.

There was some evidence that caseloads may be peaking, federal officials said on Friday.

In New York City, public health officials announced on Thursday that flu-related illnesses had reached epidemic levels, and they joined the chorus of authorities urging people to get vaccinated.

“It’s a bad year,” the city’s health commissioner, Dr. Thomas A. Farley, told reporters on Thursday. “We’ve got lots of flu, it’s mainly type AH3N2, which tends to be a little more severe. So we’re seeing plenty of cases of flu and plenty of people sick with flu. Our message for any people who are listening to this is it’s still not too late to get your flu shot.”

There has been a spike in the number of people going to emergency rooms over the past two weeks with flulike symptoms – including fever, fatigue and coughing – Dr. Farley said.

Mayor Michael R. Bloomberg and Mr. Cuomo made a public display of getting shots this past week.

In a briefing with reporters on Friday, officials from the C.D.C. said that this year’s vaccine was effective in 62 percent of cases.

As officials have stepped up their efforts encouraging vaccinations, there have been scattered reports of shortages. But officials said plenty of the vaccine was available.

According to the C.D.C., makers of the flu vaccine produced about 135 million doses for this year. As of early this month, 128 million doses had been distributed. While that would not be enough for every American, only 37 percent of the population get a flu shot each year.

Federal health officials said they would be happy if that number rose to 50 percent, which would mean that there would be more than enough vaccine for anyone who wanted to be immunized.

Two other diseases – norovirus and whooping cough – are also widespread this winter and are contributing to the number of people getting sick.

The flu can resemble a cold, though the symptoms come on more rapidly and are more severe.

Read More..

Treasury Will Not Mint $1 Trillion Coin to Raise Debt Ceiling





WASHINGTON — The Treasury Department said Saturday that it will not mint a trillion-dollar platinum coin to head off an imminent battle with Congress over raising the government’s borrowing limit.


“Neither the Treasury Department nor the Federal Reserve believes that the law can or should be used to facilitate the production of platinum coins for the purpose of avoiding an increase in the debt limit,” Anthony Coley, a Treasury spokesman, said in a written statement.


The Obama administration has indicated that the only way for the country to avoid a cash-management crisis as soon as next month is for Congress to raise the “debt ceiling,” which is the statutory limit on government borrowing. The cap is $16.4 trillion.


“There are only two options to deal with the debt limit: Congress can pay its bills, or it can fail to act and put the nation into default,” Jay Carney, the White House press secretary, said in a statement. “Congress needs to do its job.”


In recent weeks, some Republicans have indicated that they would not agree to raise the debt limit unless Democrats agreed to make cuts to entitlement programs like Social Security.


The White House has said it would not negotiate spending cuts in exchange for Congressional authority to borrow more, and it has insisted that Congress raise the ceiling as a matter of course, to cover expenses already authorized by Congress. In broader fiscal negotiations, it has said it would not agree to spending cuts without commensurate tax increases.


The idea of minting a trillion-dollar coin drew wide if puzzling attention recently after some bloggers and economic commentators had suggested it as an alternative to involving Congress.


By virtue of an obscure law meant to apply to commemorative coins, the Treasury secretary could order the production of a high-denomination platinum coin and deposit it at the Federal Reserve, where it would count as a government asset and give the country more breathing room under its debt ceiling. Once Congress raised the debt ceiling, the Treasury secretary could then order the coin destroyed.


Mr. Carney, the press secretary, fielded questions about the theoretical tactic at a news conference last week. But the idea is now formally off the table.


The White House has also rejected the idea that it could mount a challenge to the debt ceiling itself, on the strength of the Fourteenth Amendment to the Constitution, which holds that the “validity of the public debt” of the United States “shall not be questioned.”


The Washington Post earlier published a report that the Obama administration had rejected the platinum-coin idea.


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Rebels Agree to Cease-Fire in Central African Republic


Joel Bouopda Tatou/Associated Press


President François Bozizé of Central African Republic, right, who will finish out his term, with Michel Djotodia, a rebel leader, after talks Friday in Gabon.







Bringing a tentative close to an uprising that brought the Central African Republic to the brink of civil war, the government and rebel fighters seeking to oust the president signed a deal on Friday for a weeklong cease-fire that could mature into a peace plan.




Under the agreement, President François Bozizé will not cede power, but a coalition government will be formed and an opposition leader will be named prime minister, according to participants in the negotiations, held in nearby Gabon. Those changes will come only after several other rebel demands have been met, including the release of political prisoners taken by the government during the uprising — their number is unclear — and the departure of soldiers from South Africa and Angola who were sent to bolster the tottering government.


The rebels, an alliance of several groups called the Seleka coalition, swept through the north of the country in December toward the capital city, Bangui. They are still not convinced of Mr. Bozizé’s good will. Should the coalition’s conditions not be met within one week, the cease-fire will not be honored, said Col. François Florian Njadder-Bedaya, a rebel spokesman.


“He’s quite cunning, Bozizé,” Colonel Njadder-Bedaya said. “We want to judge words, speech, with acts.”


A former military officer, Mr. Bozizé seized power in 2003 and has since been elected twice, though there are doubts about the legitimacy of his electoral success. The rebels say he has overseen torture and illegal executions, has not given the country’s north a voice in government and has failed to honor the terms of peace agreements signed with rebels beginning in 2007. Mr. Bozizé’s current term is set to end in 2016, and the agreement signed Friday will allow him to complete it.


Bangui was calm on Friday afternoon. Small groups of government soldiers remain posted in the city, but only at strategic locations; a nightly curfew is not strictly enforced.


In one month of fighting, the rebels seized control of several northern cities and swept south before being stopped at Damara, the final strategic city on the road to Bangui. Hundreds of soldiers from a multinational African peacekeeping force had massed there to prevent the rebels from reaching the capital.


The agreement signed Friday does not require the rebels to retreat from their current positions, and they will not, Colonel Njadder-Bedaya said. Rather, they will await the formation of the coalition government, and will be integrated into the national army, he said.


The coalition government, which participants in the peace talks called a “national unity” government, is to include representatives of Mr. Bozizé’s political group, the Kwa Na Kwa — “Work, Nothing but Work” in Sango, the national language — the opposition, armed groups and civil society.


The National Assembly, which Mr. Bozizé’s opponents dismiss as a corrupt mouthpiece for his government, will be dissolved and replaced by a transitional council. Legislative elections are to be held in 12 months, though the date could be later. Presidential elections will be held at the end of Mr. Bozizé’s term.


“This is a way to accompany Mr. Bozizé toward an honorable exit,” Colonel Njadder-Bedaya said.


The rebels had earlier insisted that there would be no cease-fire without the president’s immediate departure. That demand, however, was rejected early in talks as being unconstitutional.


“Within the constitutional framework, it wasn’t possible,” said Bruno Hyacinthe Gbiégba, a lawyer and the president of an antitorture group who served as an observer at the talks.


Should Mr. Bozizé fail to meet the agreed conditions, the rebels will call upon other nations to intervene, Colonel Njadder-Bedaya said, though this seems an unlikely outcome.


“We’re not in a military situation; we’re in a diplomatic situation,” the colonel said. Still, he added, “I admit to you, things might blow up.”


Christian Panika contributed reporting from Bangui, Central African Republic.



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Bits Blog: Windows 8 Failed to Reverse PC Slump During Holidays

For weeks, there have been signs that the public was not buying new PCs over the holidays in the numbers many had hoped. Now add to them new figures from IDC, one of the best-known scorekeepers for the market, showing that worldwide PC shipments declined 6.4 percent in the fourth quarter from a year earlier.

That decline was worse than the 4.4 percent drop that IDC had previously forecast for the fourth quarter. It was also a sign that the biggest thing to happen to the PC business in years — Microsoft’s release of the Windows 8 operating system and the millions of dollars that went into promoting it — did not rescue an industry that suffered a nasty sales slump for most of last year.

Collectively, PC companies shipped 89.8 million computers over the fourth quarter, compared to 95.9 million a year earlier.

The challenges of the PC business lately have been well documented, all factors causing the soft holiday sales, including the inclination of people to buy tablets like the iPad instead of laptops.

But the PC market also appeared to be hurt by a mismatch between the touch capabilities in Windows 8 that Microsoft advertised so heavily and the types of PCs on most store shelves, many of which did not have touch screens. Loren Loverde, an analyst at IDC, said in an interview that Microsoft and its hardware partners needed to introduce newer PC designs that could more fully exploit Windows 8.

“It would really behoove the PC industry to get out there and deliver a consistent message,” he said.

IDC does not include sales of tablet computers in its PC shipment numbers, even devices like Surface, the first version of which runs a variation of Windows 8 called Windows RT. But sales of Surface and other Windows tablets were estimated to be modest enough over the holidays that they probably would not have made a significant change in the numbers of the PC business had IDC included them, according to Mr. Loverde. IDC has not yet released its estimates for tablet sales over the holidays.

Another research firm, Canalys, painted a bleaker outlook for the PC market with a report released earlier in the day. “The launch of Windows 8 did not reinvigorate the market in 2012, and is expected to have a negative effect as we move into 2013,” said Tom Evans, a Canalys analyst, said in the report. “Windows 8 is so different to previous versions that most consumers will be put off by the thought of having to learn a new OS.”

Unlike other research firms, Canalys includes tablets in its estimates of PC market shipments. As more people buy tablets made by Apple and devices running various flavors of Google’s Android operating system, Canalys estimated that the share of PCs running Windows and Intel chips would fall to 65 percent in 2013 from 72 percent last year.

Microsoft and Intel will suffer further, with the Wintel PC market share expected to decline to 65 percent in 2013, from 72 percent in 2012.

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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.”


Read More..

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.”


Read More..

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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Visit by Google Chairman May Benefit North Korea





BEIJING — As a work of propaganda, the images that North Korea circulated this week showing Google’s executive chairman, Eric E. Schmidt, touring a high-tech incubation center are hard to beat.







David Guttenfelder/Associated Press

Eric E. Schmidt, Google’s executive chairman, standing center, with Bill Richardson, standing right, and North Korean soldiers Wednesday at the Grand People’s Study House in Pyongyang.







With former Gov. Bill Richardson of New Mexico at his side, Mr. Schmidt, who is fond of describing the Internet as the enemy of despots, toured what was presented as the hub of the computer industry in one of the world’s most pitiless police states. Both men gazed attentively as a select group of North Koreans showed their ability to surf the Web.


It is unclear what the famously hermetic North Koreans hoped to accomplish by allowing the visit. But the photos of the billionaire entrepreneur taking the time to visit the nation’s computer labs were bound to be useful to a new national leader whom analysts say needs to show his people that their impoverished nation is moving forward.


It will matter little, those experts say, that the visitors were bundled against the cold, indoors — a sign of the country’s extreme privation — or that the vast majority of North Koreans have no access to computers, much less the Web beyond their country’s tightly controlled borders.


The men’s quixotic four-day trip ended Thursday much the way it began, with some analysts calling the visit hopelessly naïve and others describing it as valuable back-channel diplomacy at a time when Washington and Pyongyang are not on speaking terms (again).


“I’m still spinning my wheels to figure out a plausible motivation for why they went,” said Daniel Pinkston, a North Korea specialist at the International Crisis Group.


Mr. Schmidt and Mr. Richardson insist they accomplished some good — showing the world has not forgotten the plight of an American detained in the North, and at least trying to nudge the tightly sealed nation a bit closer to the fold of globally connected nations.


“As the world becomes increasingly connected, their decision to be virtually isolated is very much going to affect their  physical world, their economic growth and so forth,” Mr. Schmidt told reporters after arriving at Beijing International Airport. “We made that alternative very, very clear.”


The unofficial visit, however, raised hackles in Washington, and provided rich fodder for commentators and comedians. Even before the Americans left Pyongyang, someone created an account on Tumblr, the popular social blogging site, called “Eric Schmidt looking at things,” that parodied sites (themselves parodies) featuring the country’s leaders earnestly inspecting livestock, soldiers or leather insoles. (Mr. Schmidt is shown looking intently at computer screens, “the back of a North Korean Student,” and Mr. Richardson.)


Others were less kind. Senator John McCain, Republican of Arizona, took to Twitter to call the self-appointed delegation “useful idiots,” and John R. Bolton, a former United Nations ambassador, said the delegation was unwittingly feeding the North Korean propaganda mill as it sought to burnish the credentials of Kim Jung-un, the nation’s leader, who is in his 20s.


“Pyongyang uses gullible Americans for its own purposes,” Mr. Bolton wrote in The New York Daily News.


The State Department, meanwhile, called the visit “not particularly helpful” given efforts by the United States to rally international support for tougher sanctions following North Korea’s recent launching of a rocket that intelligence experts say could help in the development of missiles that could one day reach the United States.


As if on cue, the North Korean news media hailed the visit by “the Google team” — which included Jared Cohen, who leads Google’s think tank — highlighting their visit to the mausoleum where Mr. Kim’s grandfather and father lie in state. There, Mr. Richardson and Mr. Schmidt “expressed admiration and paid respect to Comrade Kim Il-sung and Comrade Kim Jong-il,” the North’s main party newspaper, Rodong Sinmun, said.


Choe Sang-Hun contributed reporting from Seoul, South Korea, Claire Cain Miller from San Francisco, and Edward Wong from Beijing.



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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.



Read More..

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.



Read More..

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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Delegation to North Korea Urges More Access to Internet and Cellphones





PYONGYANG, North Korea (AP) — A private delegation to North Korea that includes Google’s executive chairman, Eric E. Schmidt, is urging North Korea to allow more open Internet access and cellphones, although it is unclear how that message is being heard by a leadership that has long depended on a near-total ban on outside information to maintain its totalitarian rule.




Bill Richardson, the former New Mexico governor leading the delegation, said Wednesday in an interview in Pyongyang, the North’s capital, that his nine-member group had also called on North Korea to put a moratorium on missile launchings and nuclear tests that have prompted United Nations sanctions.


He said the group had also asked for “fair and humane treatment” for Kenneth Bae, a naturalized American citizen born in South Korea who was detained by the North in November and charged with unspecified “hostile acts.”


The delegation’s visit has been criticized as appearing to hijack United States diplomacy and bolster North Korea’s profile after its latest, widely condemned rocket launching less than a month ago.


The State Department characterized the trip as unhelpful at a time when the United States is rallying support for sanctions by the United Nations Security Council as a response to the launching.


North Korea has shown no inclination to back off its nuclear program or to stop the launchings that it depicts as needed to send satellites into orbit, but that Western countries believe are tests for technology to create missiles that could eventually be used to deliver nuclear weapons.


Mr. Schmidt is the highest-profile American business executive to visit North Korea since Kim Jong-un took power a year ago. A vocal proponent of Internet freedom and openness, Mr. Schmidt has not said publicly what he hopes to get out of the visit. On Wednesday, he toured the frigid brick building in central Pyongyang that was presented as the heart of North Korea’s computer industry, at one point briefly donning a pair of 3-D goggles.


Mr. Kim has emphasized the importance of computerizing factories, many of which have fallen into disrepair in the years since the collapse of the former Soviet Union deprived the country of its main provider of technology. But he also has vowed in recent weeks to crack down on the “enemy’s ideological and cultural infiltration,” apparently a reference to the growing flow of information over the border with China.


That flow has been driven in part by North Koreans who sneak into China to bring much-needed food and goods back home, but who also bring back news of the outside world and sometimes DVDs and thumb drives containing banned South Korean dramas.


Mr. Richardson, who has described the delegation as a private humanitarian mission, said the members were bringing a message that more openness would benefit North Korea. Almost no one in the impoverished country owns computers, and even many of the computers that are allowed are not hooked up to the Internet, according to analysts who study the North. They say that even the small number of North Koreans allowed onto the Web — a group said to include party loyalists and computer science students — are severely restricted in what they can access.


On Tuesday, Mr. Schmidt, Mr. Richardson and other delegation members chatted with students who have permission to access the Internet for research at the elite Kim Il-sung University in Pyongyang.


On Wednesday, the group toured the main library in Pyongyang, the Grand People’s Study House, where people were crowded into drafty, unheated halls at computers with intranet access to the library’s archive of books, documents and newspapers.


Later, the delegation visited the Korea Computer Center, the hub of North Korea’s efforts to develop software, where a quote from the current leader’s father and predecessor as leader, Kim Jong-il, reads: “Now is the era for science and technology. It is the era of computers.”


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Pap Test May Prove Useful at Detecting More Types of Cancer, Study Suggests





The Pap test, which has prevented countless deaths from cervical cancer, may eventually help to detect cancers of the uterus and ovaries as well, a new study suggests.




For the first time, researchers have found genetic material from uterine or ovarian cancers in Pap smears, meaning that it may become possible to detect three diseases with just one routine test.


But the research is early, years away from being used in medical practice, and there are caveats. The women studied were already known to have cancer, and while the Pap test found 100 percent of the uterine cancers, it detected only 41 percent of the ovarian cancers. And the approach has not yet been tried in women who appear healthy, to determine whether it can find early signs of uterine or ovarian cancer.


On the other hand, even a 41 percent detection rate would be better than the status quo in ovarian cancer, particularly if the detection extends to early stages. The disease is usually advanced by the time it is found, and survival rates are poor. About 22,280 new cases were expected in the United States in 2012, and 15,500 deaths. Improved tests are urgently needed.


Uterine cancer has a better prognosis, but still kills around 8,000 women a year in the United States.


These innovative applications of the Pap test are part of a new era in which advances in genetics are being applied to the detection of a wide variety of cancers or precancerous conditions. Scientists are learning to find minute bits of mutant DNA in tissue samples or bodily fluids that may signal the presence of hidden or incipient cancers.


Ideally, the new techniques would find the abnormalities early enough to cure the disease or even prevent it entirely. But it is too soon to tell.


“Is this the harbinger of things to come? I would answer yes,” said Dr. Bert Vogelstein, director of the Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins University, and a senior author of a report on the Pap test study published on Wednesday in the journal Science Translational Medicine. He said the genomes of more than 50 types of tumors had been sequenced, and researchers were trying to take advantage of the information.


Similar studies are under way or are being considered to look for mutant DNA in blood, stool, urine and sputum, both to detect cancer and also to monitor the response to treatment in people known to have the disease.


But researchers warn that such tests, used for screening, can be a double-edged sword if they give false positive results that send patients down a rabbit hole of invasive tests and needless treatments. Even a test that finds only real cancers may be unable to tell aggressive, dangerous ones apart from indolent ones that might never do any harm, leaving patients to decide whether to watch and wait or to go through surgery, chemotherapy and radiation with all the associated risks and side effects.


“Will they start recovering mutations that are not cancer-related?” asked Dr. Christopher P. Crum, a professor at Harvard Medical School who was not involved in the research.


But he also called the study a “great proof of principle,” and said, “Any whisper of hope to women who suffer from endometrial or ovarian cancer would be most welcome.”


DNA testing is already performed on samples from Pap tests, to look for the human papillomavirus, or HPV, which causes cervical cancer. Dr. Vogelstein and his team decided to try DNA testing for cancer. They theorized that cells or DNA shed from cancers of the ovaries and the uterine lining, or endometrium, might reach the cervix and turn up in Pap smears.


The team picked common mutations found in these cancers, and looked for them in tumor samples from 24 women with endometrial cancer and 22 with ovarian cancer. All the cancers had one or more of the common mutations.


Then, the researchers performed Pap tests on the same women, and looked for the same DNA mutations in the Pap specimens. They found the mutations in 100 percent of the women with endometrial cancer, but in only 9 of the 22 with ovarian cancer. The test identified two of the four ovarian cancers that had been diagnosed at an early stage.


Finally, the team developed a test that would look simultaneously for cancer-associated mutations in 12 different genes in Pap samples. Used in a control sample of 14 healthy women, the test found no mutations — meaning no false-positive results.


Dr. Luis A. Diaz, the other senior author of the report and an associate professor of oncology at Johns Hopkins, called the research a step toward a screening test that at first blush appears very effective at detecting endometrial cancer, though obviously less so at finding ovarian cancer.


“Probably one of the most exciting features of this approach,” Dr. Diaz said, “is that we wanted a test that would seamlessly integrate with routine medical practice that could be utilized with the same test that women get every day all over the world, the Pap smear.”


But, he added: “We can’t say it’s ready for prime time. Like all good science, it needs to be validated.”


He and other members of the team said it might be possible to improve the detection rate for ovarian cancer by looking for more mutations and by changing the technique of performing Pap tests to increase the likelihood of capturing cells from the ovary. The change might involve timing the test to a certain point in a woman’s monthly cycle, using a longer brush to collect cells from deeper within the cervix or prescribing a drug that would raise the odds of cells being shed from the ovary.


The technique also needs to be tested in much larger groups of women, including healthy ones, to find out whether it works, particularly at finding cancers early enough to improve survival. And studies must also find out whether it generates false positive results, or identifies cancers that might not actually need to be treated.


Michael H. Melner, a program director in molecular genetics and biochemistry for the American Cancer Society, called the research “very promising,” in part because it is based on finding mutations.


“It tells you not just that cancer is there, but which mutation is there,” Dr. Melner said. “As we learn more and more about which mutations are associated with more or less severe forms of cancer, it’s more information, and possibly more diagnostic.”


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