White House Presses for Drone Rule Book





WASHINGTON — Facing the possibility that President Obama might not win a second term, his administration accelerated work in the weeks before the election to develop explicit rules for the targeted killing of terrorists by unmanned drones, so that a new president would inherit clear standards and procedures, according to two administration officials.




The matter may have lost some urgency after Nov. 6. But with more than 300 drone strikes and some 2,500 people killed by the Central Intelligence Agency and the military since Mr. Obama first took office, the administration is still pushing to make the rules formal and resolve internal uncertainty and disagreement about exactly when lethal action is justified.


Mr. Obama and his advisers are still debating whether remote-control killing should be a measure of last resort against imminent threats to the United States, or a more flexible tool, available to help allied governments attack their enemies or to prevent militants from controlling territory.


Though publicly the administration presents a united front on the use of drones, behind the scenes there is longstanding tension. The Defense Department and the C.I.A. continue to press for greater latitude to carry out strikes; Justice Department and State Department officials, and the president’s counterterrorism adviser, John O. Brennan, have argued for restraint, officials involved in the discussions say.


More broadly, the administration’s legal reasoning has not persuaded many other countries that the strikes are acceptable under international law. For years before the Sept. 11, 2001, attacks, the United States routinely condemned targeted killings of suspected terrorists by Israel, and most countries still object to such measures.


But since the first targeted killing by the United States in 2002, two administrations have taken the position that the United States is at war with Al Qaeda and its allies and can legally defend itself by striking its enemies wherever they are found.


Partly because United Nations officials know that the United States is setting a legal and ethical precedent for other countries developing armed drones, the U.N. plans to open a unit in Geneva early next year to investigate American drone strikes.


The attempt to write a formal rule book for targeted killing began last summer after news reports on the drone program, started under President George W. Bush and expanded by Mr. Obama, revealed some details of the president’s role in the shifting procedures for compiling “kill lists” and approving strikes. Though national security officials insist that the process is meticulous and lawful, the president and top aides believe it should be institutionalized, a course of action that seemed particularly urgent when it appeared that Mitt Romney might win the presidency.


“There was concern that the levers might no longer be in our hands,” said one official, speaking on condition of anonymity. With a continuing debate about the proper limits of drone strikes, Mr. Obama did not want to leave an “amorphous” program to his successor, the official said. The effort, which would have been rushed to completion by January had Mr. Romney won, will now be finished at a more leisurely pace, the official said.


Mr. Obama himself, in little-noticed remarks, has acknowledged that the legal governance of drone strikes is still a work in progress.


“One of the things we’ve got to do is put a legal architecture in place, and we need Congressional help in order to do that, to make sure that not only am I reined in but any president’s reined in terms of some of the decisions that we’re making,” Mr. Obama told Jon Stewart in an appearance on “The Daily Show” on Oct. 18.


In an interview with Mark Bowden for a new book on the killing of Osama bin Laden, “The Finish,” Mr. Obama said that “creating a legal structure, processes, with oversight checks on how we use unmanned weapons, is going to be a challenge for me and my successors for some time to come.”


The president expressed wariness of the powerful temptation drones pose to policy makers. “There’s a remoteness to it that makes it tempting to think that somehow we can, without any mess on our hands, solve vexing security problems,” he said.


Despite public remarks by Mr. Obama and his aides on the legal basis for targeted killing, the program remains officially classified. In court, fighting lawsuits filed by the American Civil Liberties Union and The New York Times seeking secret legal opinions on targeted killings, the government has refused even to acknowledge the existence of the drone program in Pakistan.


But by many accounts, there has been a significant shift in the nature of the targets. In the early years, most strikes were aimed at ranking leaders of Al Qaeda thought to be plotting to attack the United States. That is the purpose Mr. Obama has emphasized, saying in a CNN interview in September that drones were used to prevent “an operational plot against the United States” and counter “terrorist networks that target the United States.”


But for at least two years in Pakistan, partly because of the C.I.A.’s success in decimating Al Qaeda’s top ranks, most strikes have been directed at militants whose main battle is with the Pakistani authorities or who fight with the Taliban against American troops in Afghanistan.


In Yemen, some strikes apparently launched by the United States killed militants who were preparing to attack Yemeni military forces. Some of those killed were wearing suicide vests, according to Yemeni news reports.


“Unless they were about to get on a flight to New York to conduct an attack, they were not an imminent threat to the United States,” said Micah Zenko, a fellow at the Council on Foreign Relations who is a critic of the strikes. “We don’t say that we’re the counterinsurgency air force of Pakistan, Yemen and Somalia, but we are.”


Then there is the matter of strikes against people whose identities are unknown. In an online video chat in January, Mr. Obama spoke of the strikes in Pakistan as “a targeted, focused effort at people who are on a list of active terrorists.” But for several years, first in Pakistan and later in Yemen, in addition to “personality strikes” against named terrorists, the C.I.A. and the military have carried out “signature strikes” against groups of suspected, unknown militants.


Originally that term was used to suggest the specific “signature” of a known high-level terrorist, such as his vehicle parked at a meeting place. But the word evolved to mean the “signature” of militants in general — for instance, young men toting arms in an area controlled by extremist groups. Such strikes have prompted the greatest conflict inside the Obama administration, with some officials questioning whether killing unidentified fighters is legally justified or worth the local backlash.


Many people inside and outside the government have argued for far greater candor about all of the strikes, saying excessive secrecy has prevented public debate in Congress or a full explanation of their rationale. Experts say the strikes are deeply unpopular both in Pakistan and Yemen, in part because of allegations of large numbers of civilian casualties, which American officials say are exaggerated.


Gregory D. Johnsen, author of “The Last Refuge: Yemen, Al Qaeda and America’s War in Arabia,” argues that the strike strategy is backfiring in Yemen. “In Yemen, Al Qaeda is actually expanding,” Mr. Johnsen said in a recent talk at the Brookings Institution, in part because of the backlash against the strikes.


Shuja Nawaz, a Pakistan-born analyst now at the Atlantic Council in Washington, said the United States should start making public a detailed account of the results of each strike, including any collateral deaths, in part to counter propaganda from jihadist groups. “This is a grand opportunity for the Obama administration to take the drones out of the shadows and to be open about their objectives,” he said.


But the administration appears to be a long way from embracing such openness. The draft rule book for drone strikes that has been passed among agencies over the last several months is so highly classified, officials said, that it is hand-carried from office to office rather than sent by e-mail.


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New Zealand Wants a Hollywood Put on Its Map





WELLINGTON, New Zealand — Standing by his desk in New Zealand’s distinctive round Parliament building, known locally as the Beehive, Prime Minister John Key proudly brandished an ornately engraved sword. It was used, he said, by Frodo Baggins, the protagonist of the “Lord of the Rings” trilogy, and in the films it possesses magical powers that cause it to glow blue in the presence of goblins.




“This was given to me by the president of the United States,” said Mr. Key, marveling that President Obama’s official gift to New Zealand was, after all, a New Zealand product.


In Mr. Key’s spare blond-wood office — with no goblins in sight — the sword looked decidedly unmagical. But it served as a reminder that in New Zealand, the business of running a country goes hand in hand with the business of making movies.


For better or worse, Mr. Key’s government has taken extreme measures that have linked its fortunes to some of Hollywood’s biggest pictures, making this country of 4.4 million people, slightly more than the city of Los Angeles, a grand experiment in the fusion of film and government.


That union has been on enthusiastic display here in recent weeks as “The Hobbit: An Unexpected Journey,” the first of three related movies by the director Peter Jackson, approached its world premiere on Wednesday in Wellington (and on Dec. 14 in the United States). Anticipation in New Zealand has been building, and there are signs everywhere of the film’s integration into Kiwi life — from the giant replica of the movie’s Gollum creature suspended over the waiting area at Wellington Airport to the gift shops that are expanding to meet anticipated demand for Hobbit merchandise (elf ears, $14).


But the path to this moment has been filled with controversy. Two years ago, when a dispute with unions threatened to derail the “Hobbit” movies — endangering several thousand jobs and a commitment of some $500 million by Warner Brothers — Mr. Key persuaded the Parliament to rewrite its national labor laws.


It was a breathtaking solution, even in a world accustomed to generous public support of movie projects, and a substantial incentive package was included: the government agreed to contribute $99 million in production costs and add $10 million to the studio’s marketing budget. And its tourism office will spend about $8 million in its current fiscal year, and probably more in the future, as part of a promotional campaign with Time Warner that is marketing the country as a film-friendly fantasyland.


For a tiny nation like New Zealand, where plans to cut $35 million from the education budget set off national outrage earlier this year (and a backtrack from the government), the “Hobbit” concessions were difficult for many to swallow, especially since the country had already provided some $150 million in support for the three “Lord of the Rings” movies.


Now, even amid the excitement of the “Hobbit” opening, skepticism about the government’s film-centric strategy remains. And recently it has become entangled with new suspicions: that Mr. Key’s government is taking cues from America’s powerful film industry in handling a request by United States officials for the extradition of Kim Dotcom, the mogul whose given name was Kim Schmitz, so he can face charges of pirating copyrighted material.


New Zealand’s political scene erupted in September, as Mr. Key publicly apologized to Mr. Dotcom for what turned out to be illegal spying on him by the country’s Government Communications Security Bureau. The Waikato Times, a provincial paper, taunted Mr. Key, accusing him of making New Zealand the “51st state,” while others suggested that a whirlwind trip by Mr. Key to Los Angeles in early October was somehow tied to the Dotcom case.


“No studio executive raised it with me,” Mr. Key said in an interview last month. He spoke the day after a private dinner where he lobbied executives from Disney, Warner Brothers, Fox and other companies for still more New Zealand film work, with Mr. Jackson, a New Zealander, joining by video link.


Mr. Key has been sharply criticized for cozying up to Mr. Jackson in what some consider unseemly ways. Last year, a month before elections in which he and his National Party were fighting to keep control of the government, Mr. Key skipped an appointment with Queen Elizabeth II in Australia to visit the Hobbiton set. He also interviewed Mr. Jackson on a radio show, prompting an outcry from the opposition.


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Scientists See Advances in Deep Learning, a Part of Artificial Intelligence


Hao Zhang/The New York Times


A voice recognition program translated a speech given by Richard F. Rashid, Microsoft’s top scientist, into Mandarin Chinese.







Using an artificial intelligence technique inspired by theories about how the brain recognizes patterns, technology companies are reporting startling gains in fields as diverse as computer vision, speech recognition and the identification of promising new molecules for designing drugs.




The advances have led to widespread enthusiasm among researchers who design software to perform human activities like seeing, listening and thinking. They offer the promise of machines that converse with humans and perform tasks like driving cars and working in factories, raising the specter of automated robots that could replace human workers.


The technology, called deep learning, has already been put to use in services like Apple’s Siri virtual personal assistant, which is based on Nuance Communications’ speech recognition service, and in Google’s Street View, which uses machine vision to identify specific addresses.


But what is new in recent months is the growing speed and accuracy of deep-learning programs, often called artificial neural networks or just “neural nets” for their resemblance to the neural connections in the brain.


“There has been a number of stunning new results with deep-learning methods,” said Yann LeCun, a computer scientist at New York University who did pioneering research in handwriting recognition at Bell Laboratories. “The kind of jump we are seeing in the accuracy of these systems is very rare indeed.”


Artificial intelligence researchers are acutely aware of the dangers of being overly optimistic. Their field has long been plagued by outbursts of misplaced enthusiasm followed by equally striking declines.


In the 1960s, some computer scientists believed that a workable artificial intelligence system was just 10 years away. In the 1980s, a wave of commercial start-ups collapsed, leading to what some people called the “A.I. winter.”


But recent achievements have impressed a wide spectrum of computer experts. In October, for example, a team of graduate students studying with the University of Toronto computer scientist Geoffrey E. Hinton won the top prize in a contest sponsored by Merck to design software to help find molecules that might lead to new drugs.


From a data set describing the chemical structure of 15 different molecules, they used deep-learning software to determine which molecule was most likely to be an effective drug agent.


The achievement was particularly impressive because the team decided to enter the contest at the last minute and designed its software with no specific knowledge about how the molecules bind to their targets. The students were also working with a relatively small set of data; neural nets typically perform well only with very large ones.


“This is a really breathtaking result because it is the first time that deep learning won, and more significantly it won on a data set that it wouldn’t have been expected to win at,” said Anthony Goldbloom, chief executive and founder of Kaggle, a company that organizes data science competitions, including the Merck contest.


Advances in pattern recognition hold implications not just for drug development but for an array of applications, including marketing and law enforcement. With greater accuracy, for example, marketers can comb large databases of consumer behavior to get more precise information on buying habits. And improvements in facial recognition are likely to make surveillance technology cheaper and more commonplace.


Artificial neural networks, an idea going back to the 1950s, seek to mimic the way the brain absorbs information and learns from it. In recent decades, Dr. Hinton, 64 (a great-great-grandson of the 19th-century mathematician George Boole, whose work in logic is the foundation for modern digital computers), has pioneered powerful new techniques for helping the artificial networks recognize patterns.


Modern artificial neural networks are composed of an array of software components, divided into inputs, hidden layers and outputs. The arrays can be “trained” by repeated exposures to recognize patterns like images or sounds.


These techniques, aided by the growing speed and power of modern computers, have led to rapid improvements in speech recognition, drug discovery and computer vision.


Deep-learning systems have recently outperformed humans in certain limited recognition tests.


Last year, for example, a program created by scientists at the Swiss A. I. Lab at the University of Lugano won a pattern recognition contest by outperforming both competing software systems and a human expert in identifying images in a database of German traffic signs.


The winning program accurately identified 99.46 percent of the images in a set of 50,000; the top score in a group of 32 human participants was 99.22 percent, and the average for the humans was 98.84 percent.


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Gadgetwise Blog: Having a Beer With a Smartphone





Drinking beer used to be simple. But the exploding popularity of craft beer over the past several years has changed that, giving beer drinkers a new world of possibilities — and a range of hard decisions.




Predictably, the ever-expanding roster of oatmeal stouts and vanilla porters has been accompanied by the creation of dozens of beer-related apps. These include local guides to the best pints, inane games, beery social networks and recommendation engines that determine which beers you might like based on what you have enjoyed in the past.


An app released this month, Craft Beer New York, gives local connoisseurs an excellent guide to the city’s bars, breweries and bottle shops ($1.99 for iPhones and other iOS devices; you must be 17 years old to download this and the other Apple beer apps). Its developer, Blue Crow Media, also makes attractive apps focused on coffee. The content for this app comes from Joshua M. Bernstein, a beer writer living in Prospect Heights, Brooklyn, and the author of Brewed Awakening, a book about the craft beer movement.


The app rates 122 bars, 34 shops and 22 breweries. I first tested it out in Astoria, Queens, where I live, and it seemed to get things right without just picking the most obvious places to drink. There were short entries on half a dozen establishments, including specific recommendations on which beers to order.


It is worth noting that this app is different from a guide to bars. Good spots will not show up if they have pedestrian beer selections. At the same time, bars do not automatically get good ratings for having lots of choices. Mr. Bernstein acknowledges that the Beer Authority, a 70-tap bar that recently opened on a stretch of Eighth Avenue in Midtown Manhattan, is “a life preserver for folks working around the Port Authority.” But the app still sticks it with a 2 out of 5 rating because of its unimaginative décor, high prices and a tendency to play lame music.


Mr. Bernstein updates the app with newly opened establishments, and it also has a news tab that includes bulletins on things like how to ensure that an I.P.A. is fresh, or how to help out beer-related businesses affected by Hurricane Sandy. An Android version is due out in early 2013.


One of the more popular beer apps is Untappd, a location-based social-networking app for beer drinkers (free and available for Android and iOS). The app is designed to get people to share their impressions of beers, keeping track of what they liked while also guiding friends and strangers to good bars and brews. The app has an active community, but like any crowdsourced project there is a lot to sift through to find anything useful.


Another way to find new beers to try is to tell an algorithm what you drink and have it determine what else you might like. BrewGene is a nice version of this idea (free and available for Android, iOS or on the Web). It has a truly extensive database. I recently ordered a Goose Island I.P.A. from a bar, but when I went to enter it into the app found that there were five different beers with that name. I rated a few beers from the app’s top 100 list, and it began generating credible suggestions for me. The app’s ability to point me toward an establishment that would serve me these beers is lacking, however. Its “Places” function pulled in a seemingly random selection of nearby bars, bodegas and restaurants. There’s supposed to be a beer menu for each establishment, but all the ones I got were blank.


Have a favorite New York City app? Send tips via e-mail to appcity@nytimes.com or via Twitter to @joshuabrustein.



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Roadside Bomb Kills at Least 7 in Pakistan





ISLAMABAD, Pakistan — A roadside bomb in northwestern Pakistan killed at least seven people early Saturday, including four children, police officials said, as the government struggled to control sectarian violence in the country.




Militants targeted a procession of Shiite Muslims in Dera Ismail Khan, a town on the edge of the restive tribal region in Khyber-Pakhtunkhwa Province. At least 30 people were wounded when the bomb, which was remotely detonated, ripped through the procession as it passed, the police officials said.


The authorities in Pakistan have installed strict security measures in an effort to thwart attacks by extremist Sunni groups on Shiites, who are observing Ashura, an annual 10-day mourning period that ends Sunday. More than a dozen people had already been killed during processions before Saturday’s bombing.


Thousands of police officials have been deployed across Pakistan to protect Shiite processions as they march through the cities, clad in black mourning dresses, and whip themselves to mourn the killing of a grandson of the Prophet Muhammad, Imam Hussein, in the battle of Karbala in 680.


Cellular networks had been suspended for several hours across 46 cities over the weekend after bomb attacks on Shiites were set off by cellphones, officials said. The interior minister, Rehman Malik, described the suspension as essential in foiling terrorist bombings. Intelligence reports, he said, have warned of terrorist attempts in several major cities, including Karachi and Quetta.


Second riders on motorbikes have also been banned in major cities.


The security challenge facing the government was evident when President Asif Ali Zardari met Friday with the army chief, Gen. Ashfaq Parvez Kayani. Officials said both leaders had discussed the worsening security situation in the country.


Shiites and Sunni Muslims generally live in harmony in the country, but Sunni militants have repeatedly targeted Shiites in the last decade through suicide attacks and bombings. A banned Sunni militant group affiliated with Al Qaeda, Lashkar-e-Jhangvi, is one of the main instigators of violence against Shiites.


Mr. Zardari strongly condemned the Saturday bombing and reiterated the government’s resolve “to continue its struggle against the militants till its logical conclusion.”


“Such nefarious acts cannot deter the people and the government in their fight against the scourge of militancy,” he said in a statement.


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The Lede Blog: Vignettes of Black Friday

With promotions, discounts and doorbusters already well under way on Thanksgiving Day itself, many big-box retailers are making Black Friday stretch longer than ever. The Lede is checking out the mood of American consumers in occasional vignettes Thursday and Friday as the economically critical holiday shopping season kicks off.

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Documents Show F.D.A.’s Failures in Meningitis Outbreak





Newly released documents add vivid detail to the emerging portrait of the Food and Drug Administration’s ineffective and halting efforts to regulate a Massachusetts company implicated in a national meningitis outbreak that has sickened nearly 500 people and killed 34.




In the documents, released on Tuesday in response to a Freedom of Information Act request, the agency would threaten to bring the full force of its authority down on the company, only to back away, citing lack of jurisdiction.


The company, the New England Compounding Center, at times cooperated with F.D.A. inspectors and promised to improve its procedures, and at other times challenged the agency’s legal authority to regulate it, refused to provide records and continued to ship a drug in defiance of the agency’s concerns.


Some of the documents were summarized last week by Congressional committees that held hearings on the meningitis outbreak. Republicans and Democrats criticized the F.D.A. for failing to act on information about unsafe practices at the company as far back as March 2002.


By law, compounding pharmacies are regulated primarily by the states, but the pharmacies have grown over the years into major suppliers of some of the country’s biggest hospitals. The F.D.A. is asking Congress for stronger, clearer authority to police them, but Republicans have said the agency already has enough power.


Records show that the agency was sometimes slow in pursuing its own inspection findings. In one case involving the labeling and marketing of drugs, the agency issued a warning letter to New England Compounding 684 days after an inspection, a delay that the company’s chief pharmacist complained was so long that some of the letter’s assertions no longer applied to its operations.


The agency said in a statement Wednesday that it “was not the timeline we strive for,” but that much of the delay was because of “our limited, unclear and contested authority in this area.” Because of litigation, it said, there was “significant internal discussion about how to regulate compounders.”


The agency first inspected the company in April 2002 after reports that two patients had become dizzy and short of breath after being injected with a steroid made by the company.


 On the first day of the inspection, Barry Cadden, the chief pharmacist, was cooperative, but the next day, the agency inspectors wrote, Mr. Cadden “had a complete change in attitude & basically would not provide any additional information either by responding to questions or providing records,” adding that he challenged their legal authority to be at his pharmacy at all.


The F.D.A. was back at New England Compounding in October 2002 because of possible contamination of another of its products, methylprednisolone acetate, the same drug involved in the current meningitis outbreak.


 While the F.D.A. had the right to seize an adulterated steroid, officials at the time said that action alone would not resolve the company’s poor compounding practices. In a meeting with Massachusetts regulators, F.D.A. officials left authority in the hands of the state, which “would be in a better position to gain compliance or take regulatory action,” according to a memo by an F.D.A. official summarizing the meeting.


 David Elder, compliance branch director for the F.D.A.’s New England District, warned at the meeting that there was the “potential for serious public health consequences if N.E.C.C.’s compounding practices, in particular those relating to sterile products, are not improved.”


 The company fought back hard, repeatedly questioning the F.D.A.’s jurisdiction. In a September 2004 inspection over concerns that the company was dispensing trypan blue, a dye used for some eye surgeries that had not been approved by the F.D.A., Mr. Cadden told the agency inspector that he had none in stock.


But in the clean room, the inspector noticed a drawer labeled “Trypan Blue,” which contained 189 vials of the medicine.


A few days later, Mr. Cadden was defiant. He told the agency that he was continuing to dispense trypan blue and that there was nothing in the law saying a compounder could not dispense unapproved products.


 The conversation turned testy. “Don’t answer any more questions!” Mr. Cadden told another pharmacy executive, according to the F.D.A.’s report.


Mr. Cadden rejected many of the assertions in the warning letter that finally came in December 2006. The next correspondence from the agency did not come until almost two years later, in October 2008, saying that the agency still had “serious concerns” about the company’s practices, and that failing to correct them could result in seizure of products and an injunction against the company and its principals.


It is not known whether any corrective actions were taken. The agency did not conduct another inspection until the recent meningitis outbreak.


Denise Grady contributed reporting.



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Documents Show F.D.A.’s Failures in Meningitis Outbreak





Newly released documents add vivid detail to the emerging portrait of the Food and Drug Administration’s ineffective and halting efforts to regulate a Massachusetts company implicated in a national meningitis outbreak that has sickened nearly 500 people and killed 34.




In the documents, released on Tuesday in response to a Freedom of Information Act request, the agency would threaten to bring the full force of its authority down on the company, only to back away, citing lack of jurisdiction.


The company, the New England Compounding Center, at times cooperated with F.D.A. inspectors and promised to improve its procedures, and at other times challenged the agency’s legal authority to regulate it, refused to provide records and continued to ship a drug in defiance of the agency’s concerns.


Some of the documents were summarized last week by Congressional committees that held hearings on the meningitis outbreak. Republicans and Democrats criticized the F.D.A. for failing to act on information about unsafe practices at the company as far back as March 2002.


By law, compounding pharmacies are regulated primarily by the states, but the pharmacies have grown over the years into major suppliers of some of the country’s biggest hospitals. The F.D.A. is asking Congress for stronger, clearer authority to police them, but Republicans have said the agency already has enough power.


Records show that the agency was sometimes slow in pursuing its own inspection findings. In one case involving the labeling and marketing of drugs, the agency issued a warning letter to New England Compounding 684 days after an inspection, a delay that the company’s chief pharmacist complained was so long that some of the letter’s assertions no longer applied to its operations.


The agency said in a statement Wednesday that it “was not the timeline we strive for,” but that much of the delay was because of “our limited, unclear and contested authority in this area.” Because of litigation, it said, there was “significant internal discussion about how to regulate compounders.”


The agency first inspected the company in April 2002 after reports that two patients had become dizzy and short of breath after being injected with a steroid made by the company.


 On the first day of the inspection, Barry Cadden, the chief pharmacist, was cooperative, but the next day, the agency inspectors wrote, Mr. Cadden “had a complete change in attitude & basically would not provide any additional information either by responding to questions or providing records,” adding that he challenged their legal authority to be at his pharmacy at all.


The F.D.A. was back at New England Compounding in October 2002 because of possible contamination of another of its products, methylprednisolone acetate, the same drug involved in the current meningitis outbreak.


 While the F.D.A. had the right to seize an adulterated steroid, officials at the time said that action alone would not resolve the company’s poor compounding practices. In a meeting with Massachusetts regulators, F.D.A. officials left authority in the hands of the state, which “would be in a better position to gain compliance or take regulatory action,” according to a memo by an F.D.A. official summarizing the meeting.


 David Elder, compliance branch director for the F.D.A.’s New England District, warned at the meeting that there was the “potential for serious public health consequences if N.E.C.C.’s compounding practices, in particular those relating to sterile products, are not improved.”


 The company fought back hard, repeatedly questioning the F.D.A.’s jurisdiction. In a September 2004 inspection over concerns that the company was dispensing trypan blue, a dye used for some eye surgeries that had not been approved by the F.D.A., Mr. Cadden told the agency inspector that he had none in stock.


But in the clean room, the inspector noticed a drawer labeled “Trypan Blue,” which contained 189 vials of the medicine.


A few days later, Mr. Cadden was defiant. He told the agency that he was continuing to dispense trypan blue and that there was nothing in the law saying a compounder could not dispense unapproved products.


 The conversation turned testy. “Don’t answer any more questions!” Mr. Cadden told another pharmacy executive, according to the F.D.A.’s report.


Mr. Cadden rejected many of the assertions in the warning letter that finally came in December 2006. The next correspondence from the agency did not come until almost two years later, in October 2008, saying that the agency still had “serious concerns” about the company’s practices, and that failing to correct them could result in seizure of products and an injunction against the company and its principals.


It is not known whether any corrective actions were taken. The agency did not conduct another inspection until the recent meningitis outbreak.


Denise Grady contributed reporting.



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Bits Blog: Amazon’s Diminishing Discounts

Is it just my imagination, or is the price of physical books on Amazon going up? I have no evidence beyond what I see as I browse through the retailer’s virtual shelves, where I have routinely been noticing books selling for the same price they cost in the rest of the world. Selling at full price is not the sort of value proposition that propelled Amazon to its current perch as one of the country’s biggest and most feared retailers.

A few examples of books published in the last year or two that Amazon is offering at zero discount from list price: “Liebling’s War: World War II Dispatches of A.J. Liebling.” Brian Boyd, “Stalking Nabokov.” Gerald Suttles, “Front Page Economics.” Deborah Kohn, “The Latin American Literary Boom and U.S. Nationalism During the Cold War.” Sandra Messinger Cypess, “Uncivil Wars: Elena Garro, Octavio Paz and the Battle for Cultural Memory.” Others are only marginally discounted: Ira Wood’s “You’re Married to Her,” published by Leapfrog in August, is available at a whopping 4 percent discount. I could get the book $2 cheaper directly from Leapfrog. Juan Rulfo’s “The Plain in Flames” is off 3 percent.

(Here are some caveats: These are all new books sold by Amazon itself, not by third parties that may have damaged or used or other copies for cheaper. Books published by university presses are often available at a smaller discount than books from trade publishers. And yes, there are doubtless many popular books on Amazon at big discounts. But like many readers, I go to Amazon for the long tail — little-known books that are unavailable in even the best-stocked bookshop.)

The issue of pricing on Amazon matters for more than my pocketbook. The central question about the company has always been: How will it choose to make money? It has invested for the future for 18 years now, in the process demolishing much of the competition while giving it one of the priciest stocks on Wall Street. But at some point, somehow, it will have to become a normal business, which means selling things for more than it paid. One way to do that: erase discounts on books that readers cannot easily get anywhere else.

Another possibility: Amazon is intentionally pricing its books higher so buyers will instead purchase from the cheaper third-party sellers, which are more profitable for Amazon. In other words, Amazon would rather run a mall or bazaar than try and be Wal-Mart.

In response to a query, Amazon said, rather generally, that it wasn’t raising prices.

Amazon executives say the price of a book falls as it sells faster, but the site has always seemed more mysterious than that. Here’s one example of a book dropping so fast it seemed to be falling out of the sky, but I doubt it was because people were gobbling up copies. In July, Arcade published an omnibus of the works of the Nobel laureate Octavio Paz. List price: $40. Over the rest of the summer and into the fall, the price tumbled. By Nov. 12, it was down to $1.32 — a 97 percent drop. Mr. Paz is dead and out of fashion, so it seemed as if he was on a rather quick trip to the recycling bin. I finally took pity on the book and bought it. As a Prime member, I got it shipped for free.

The book arrived promptly but was damaged. So I complained, and Amazon of course said it would send another and refund my postage. Now presumably Amazon is still paying the standard rate to Arcade for the book — about $18. (Arcade didn’t get back to me.) Amazon’s total revenue from me on this deal was $1.32. It had to send me the book twice and refund my return $3.99 shipping. Overall I’d guess that Amazon lost about $30 on this transaction.

Perhaps because I bought a copy, the book didn’t last at $1.32. It is now back up to $11.34. Who ever thought that buying a physical book would have all the mystery and excitement of buying a plane ticket?

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Military Analysis: For Israel, Gaza Conflict Is Test for an Iran Confrontation


Menahem Kahana/Agence France-Presse — Getty Images


An Israeli missile is launched from a battery. Officials said their antimissile system shot down 88 percent of all assigned targets.







WASHINGTON — The conflict that ended, for now, in a cease-fire between Hamas and Israel seemed like the latest episode in a periodic showdown. But there was a second, strategic agenda unfolding, according to American and Israeli officials: The exchange was something of a practice run for any future armed confrontation with Iran, featuring improved rockets that can reach Jerusalem and new antimissile systems to counter them.




It is Iran, of course, that most preoccupies Prime Minister Benjamin Netanyahu and President Obama. While disagreeing on tactics, both have made it clear that time is short, probably measured in months, to resolve the standoff over Iran’s nuclear program.


And one key to their war-gaming has been cutting off Iran’s ability to slip next-generation missiles into the Gaza Strip or Lebanon, where they could be launched by Iran’s surrogates, Hamas, Hezbollah and Islamic Jihad, during any crisis over sanctions or an Israeli strike on Iran’s nuclear facilities.


Michael B. Oren, the Israeli ambassador to the United States and a military historian, likened the insertion of Iranian missiles into Gaza to the Cuban missile crisis.


“In the Cuban missile crisis, the U.S. was not confronting Cuba, but rather the Soviet Union,” Mr. Oren said Wednesday, as the cease-fire was declared. “In Operation Pillar of Defense,” the name the Israel Defense Force gave the Gaza operation, “Israel was not confronting Gaza, but Iran.”


It is an imprecise analogy. What the Soviet Union was slipping into Cuba 50 years ago was a nuclear arsenal. In Gaza, the rockets and parts that came from Iran were conventional, and, as the Israelis learned, still have significant accuracy problems. But from one point of view, Israel was using the Gaza battle to learn the capabilities of Hamas and Islamic Jihad — the group that has the closest ties to Iran — as well as to disrupt those links.


Indeed, the first strike in the eight-day conflict between Hamas and Israel arguably took place nearly a month before the fighting began — in Khartoum, the capital of Sudan, as another mysterious explosion in the shadow war with Iran.


A factory said to be producing light arms blew up in spectacular fashion on Oct. 22, and within two days the Sudanese charged that it had been hit by four Israeli warplanes that easily penetrated the country’s airspace. Israelis will not talk about it. But Israeli and American officials maintain that Sudan has long been a prime transit point for smuggling Iranian Fajr rockets, the kind that Hamas launched against Tel Aviv and Jerusalem over recent days.


The missile defense campaign that ensued over Israeli territory is being described as the most intense yet in real combat anywhere — and as having the potential to change warfare in the same way that novel applications of air power in the Spanish Civil War shaped combat in the skies ever since.


Of course, a conflict with Iran, if a last-ditch effort to restart negotiations fails, would look different than what has just occurred. Just weeks before the outbreak in Gaza, the United States and European and Persian Gulf Arab allies were practicing at sea, working on clearing mines that might be dropped in shipping lanes in the Strait of Hormuz.


But in the Israeli and American contingency planning, Israel would face three tiers of threat in a conflict with Iran: the short-range missiles that have been lobbed in this campaign, medium-range rockets fielded by Hezbollah in Lebanon and long-range missiles from Iran.


The last of those three could include the Shahab-3, the missile Israeli and American intelligence believe could someday be fitted with a nuclear weapon if Iran ever succeeded in developing one and — the harder task — shrinking it to fit a warhead.


A United States Army air defense officer said that the American and Israeli militaries were “absolutely learning a lot” from this campaign that may contribute to a more effective “integration of all those tiered systems into a layered approach.”


The goal, and the challenge, is to link short-, medium- and long-range missile defense radar systems and interceptors against the different types of threats that may emerge in the next conflict.


Even so, a historic battle of missile versus missile defense has played out in the skies over Israel, with Israeli officials saying their Iron Dome system shot down 350 incoming rockets — 88 percent of all targets assigned to the missile defense interceptors. Israeli officials declined to specify the number of interceptors on hand to reload their missile-defense batteries.


Before the conflict began, Hamas was estimated to have amassed an arsenal of 10,000 to 12,000 rockets. Israeli officials say their pre-emptive strikes on Hamas rocket depots severely reduced the arsenal of missiles, both those provided by Iran and some built in Gaza on a Syrian design.


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