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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How I Made It: Attorney Hal Rosner









The gig: Hal Rosner is a partner at San Diego's Rosner, Barry & Babbitt, one of the largest law firms in the country specializing entirely in consumer auto fraud cases. Founded by Rosner in 1985, the firm employs 10 full-time attorneys and reviews 200 to 400 potential cases a month, taking on about 10% of them. To date, Rosner has handled more than 1,000 auto fraud cases in the Golden State, winning millions of dollars for his clients. It has won him begrudging respect from the auto industry; last year the head of the California New Car Dealers Assn. said Rosner "has about every car dealer in the state scared silly."

Born to litigate: Some boys like baseball, some like comics. Rosner went in for arguing. The cake for his fifth birthday party said: "Happy Birthday Lawyer Hal." While other kids read Hardy Boys mysteries, Rosner was diving into biographies of his hero, Clarence Darrow. And when he graduated from high school in San Jose, friends wrote, "good luck suing companies" in Rosner's yearbook. So it came as a surprise to no one when, after graduating from UC Berkeley with a double major in rhetoric and economics, he enrolled in law school at the University of San Diego.

A new mentor: In law school, Rosner traded in his dreams of handling the next Scopes Monkey Trial. Under the tutelage of Bob Fellmeth, a consumer attorney known for his pioneering work with Ralph Nader in the 1960s and '70s, Rosner became captivated with the idea of representing regular folks in fights with big companies. The two were inseparable and even went into practice together, briefly, after Rosner graduated. Fellmeth helped Rosner take on his first auto case, using California's landmark 1983 lemon law. The car in question: Rosner's own.





Today, Rosner is an adjunct professor at UC San Diego and also instructs Marine Corps and Navy attorneys at Camp Pendleton on consumer protection issues. "It's upsetting that almost no law schools teach consumer law these days," Rosner said. "You can get pet law classes, but nothing for consumers."

A breakthrough: For years, Rosner ran a fairly broad practice, taking cases against banks, telephone companies and other utilities. That all went out the window about a dozen years ago, when Rosner took on Thompson vs. 10,000 RV Sales Inc., which involved improper disclosure by the dealer of trade-in value in the sale of a recreational vehicle.

In the case, Rosner dusted off the law books to try an innovative — and risky — strategy, applying California's Automotive Sales Finance Act, a decades-old statute that grants unusually large attorneys' fees and damages with a favorable verdict. If Rosner lost, it could cost him a lot of money, but if he won, he'd be opening the door to take on countless fraud cases involving sums normally too small for lawyers working on contingency to handle. Rosner prevailed. "That changed everything," he said. "It tipped me off to focus my practice on the way vehicles are financed."

At 'war': A huge portion of dealership profits — and some say shenanigans — take place in the windowless finance rooms in the back of every lot. Known as the "F&I Office" or "the box," it's where insurance policies, extended warranties and undercoat are packed into deals, and where Rosner contends that consumers can get robbed blind without realizing it if they're not careful. Few lawyers take on such cases because they're technical and the laws are arcane, but it's fertile terrain for the right lawyer. And that just happens to be Rosner's sweet spot.

"In the last decade I've been in a massive war with the auto industry when it comes to finance issues," Rosner said. "I'm willing to bet that I can find something illegal in 10% to 20% of all car sale contracts."

Making friends: Rosner's aggressive tactics haven't won him many fans among dealers. After a lengthy dispute with a San Diego area dealership over backdated sales contracts, Rosner took the same argument to court against a sister lot owned by the same company in Riverside County. That case, now on appeal, provoked the dealership's general manager to launch a website criticizing Rosner and his tactics: http://www.halrosner.com. Rosner acknowledged he should have grabbed that URL a long time ago, but shrugs off the site. "It goes with the territory," he said.

When court is not in session: The 6-foot-2 Rosner calls himself a "basketball addict" and, at 54 years old, still plays in two tournaments a year. A bruising small forward who likes a lot of contact, he said he "can still touch rim" and works out regularly with his 14-year-old son — when he isn't taking his 12-year-old daughter shopping. Rosner's other hobby is poker; the game has taught him a lot about his day job, which he said benefits from poker-style analysis of changing odds.

"Cases are like Texas hold 'em. I know what my first two cards are, but a bad card can come at any time," Rosner said. "I play poker for fun but I gamble for a living."

ken.bensinger@latimes.com





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Lining up even earlier for Black Friday becomes a shop priority









In a tradition that seems to take a bigger slice of Thanksgiving every year, hordes of deal-sniffing shoppers descended on Southland stores Thursday, elbowing their way in search of toys, video games and that time-honored Black Friday symbol: cut-rate television sets. As nightfall came, they huddled in long lines, clutching coupons and hatching shopping strategies.


Rebecca Abbott, 42, of Torrance had it down to a science Thursday night. The accountant said she was out the door of the local Toys R Us store in 20 minutes with a shopping cart full of Christmas gifts for her two daughters. 


Her fourth time shopping on Black Friday, Abbott had spent a few hours in Toys R Us the day before scoping out her plan of attack. The first item on her list: a Rockstar Mickey Mouse doll, normally priced at $59.99 but selling for just $19.99.





"You have to have a strategy for this Black Friday madness," she said as she headed for the door. "First-timers will walk around all day looking at deals," Abbott said. "I got in, grabbed my stuff and got out." Her cart was overflowing with large toys — primarily Barbie and Mickey Mouse items. 


PHOTOS: Black Friday shoppers hunt for deals


At a Wal-Mart in Panorama City, just after 8 p.m., "it was really crazy, but you could still walk," said Marya Huaman, 23, as she left the store with her dad, her two infant sons and three bags full of Fisher-Price toys.


"No, you couldn't," scoffed her father, Edward Huaman. "I didn't see anyone fighting, but they will be soon. This is madness."


Last year, Thanksgiving night was marred by a pepper spray "shopping rage" incident at a Wal-Mart in Porter Ranch that injured at least seven people and forced employees to evacuate part of the store. One person was hospitalized.


Los Angeles Police Cmdr. Andy Smith said Thursday that the night appeared to be running smoothly across Los Angeles. "In general, I think things have gone really well," he said. "It sounds like the stores have taken proper precautions and everyone is aware of the hazards of Black Friday."


After retailers last year moved the opening bell for Black Friday sales to midnight, this year there were even more customers eager to get a jump on the traditional kickoff to the holiday shopping season. Wal-Mart, Sears and Toys R Us began rolling out their door busters at 8 p.m. on Turkey Day, followed by Target at 9 p.m. Macy's, Kohl's and Best Buy were set to open at midnight.


A handful of chains such as Kmart and Old Navy also had daytime hours on Thursday. And online merchants were touting bargains all day and night.


About 147 million shoppers are expected this all-important holiday weekend, with more logging in for online specials by Cyber Monday, according to the National Retail Federation. In all, the trade group estimated that holidays sales will rise 4.1% this year, to $586 billion.


"Though the Black Friday tradition is here to stay, there's no question that it has changed in recent years," NRF Chief Executive Matthew Shay said in a statement.


Many shoppers were perfectly content to queue up. At Best Buy electronic stores across the Southland, people waited for hours — and sometimes days — in tents before the midnight opening.


But many workers were angry about spending Turkey Day away from loved ones.


Frustrated retail employees and families have taken to creating online petitions at Change.org to beg companies not to cut into Thanksgiving dinners. More than 20 online petitions have popped up in recent weeks. Lines grew throughout the afternoon and into the evening as anxious shoppers surveyed the competition in line.


Throughout Southern California there were reports of lines wrapped around stores. In Glendale, more than 750 shoppers were lined up outside the Target at the Galleria.


For shoppers who just couldn't wait until Thursday night — much less Black Friday — some retailers opened their doors all day on Thanksgiving.


The sales weren't quite as glorious as the Black Friday specials that stores promise to roll out later. But they were pretty good nonetheless, shoppers said.


JoAnne Garcia walked into Kmart in Burbank in search of a roasting pan in which to cook her turkey. She walked out 90 minutes later, having shelled out $491, including $329 for an RCA 39-inch LCD flat-panel TV.


"The roasting pan was $14.99," Garcia said, laughing at how much she spent as she rolled her cart to the parking lot.


To the 53-year-old aerospace machinist, shopping on Thanksgiving made perfect sense.


Standing near a store display touting "Freak Out Pricing," Garcia explained her theory about shopping while cooking. "You get up, throw your turkey in the oven, and you come back and it's all done."


walter.hamilton@latimes.com


joseph.serna@latimes.com


Contributing to this report were staff writers Wesley Lowery, Marisa Gerber, Nicole Santa Cruz and Andrew Khouri.





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Halle Berry's ex arrested after fight at her house

LOS ANGELES (AP) — Halle Berry's ex-boyfriend Gabriel Aubry was arrested for investigation of battery Thursday after he and the Oscar-winning actress's current boyfriend got into a fight at her Hollywood Hills home, police said.

Aubry, 37, was booked for investigation of a battery, a misdemeanor, and released on $20,000 bail, according to online jail records. He's scheduled to appear in court Dec. 13.

Aubry came to Berry's house Thanksgiving morning and police responded to a report of an assault, said Los Angeles Police Officer Julie Boyer. Aubry was injured in the altercation and was taken to a hospital where he was treated and released.

Emails sent to Berry's publicist, Meredith O'Sullivan, and Aubry's family law attorney, Gary Fishbein, were not immediately returned.

Berry and Aubry have been involved in a custody dispute involving their 4-year-old daughter, Nahla. The proceedings were sealed because the former couple are not married. Both appeared in the case as recently as Nov. 9, but neither side commented on the outcome of the hearing.

Berry has been dating French actor Olivier Martinez, and he said earlier this year that they are engaged.

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Lining up even earlier for Black Friday becomes a shop priority









In a tradition that seems to take a bigger slice of Thanksgiving every year, hordes of deal-sniffing shoppers descended on Southland stores Thursday, elbowing their way in search of toys, video games and that time-honored Black Friday symbol: cut-rate television sets. As nightfall came, they huddled in long lines, clutching coupons and hatching shopping strategies.


Rebecca Abbott, 42, of Torrance had it down to a science Thursday night. The accountant said she was out the door of the local Toys R Us store in 20 minutes with a shopping cart full of Christmas gifts for her two daughters. 


Her fourth time shopping on Black Friday, Abbott had spent a few hours in Toys R Us the day before scoping out her plan of attack. The first item on her list: a Rockstar Mickey Mouse doll, normally priced at $59.99 but selling for just $19.99.





"You have to have a strategy for this Black Friday madness," she said as she headed for the door. "First-timers will walk around all day looking at deals," Abbott said. "I got in, grabbed my stuff and got out." Her cart was overflowing with large toys — primarily Barbie and Mickey Mouse items. 


PHOTOS: Black Friday shoppers hunt for deals


At a Wal-Mart in Panorama City, just after 8 p.m., "it was really crazy, but you could still walk," said Marya Huaman, 23, as she left the store with her dad, her two infant sons and three bags full of Fisher-Price toys.


"No, you couldn't," scoffed her father, Edward Huaman. "I didn't see anyone fighting, but they will be soon. This is madness."


Last year, Thanksgiving night was marred by a pepper spray "shopping rage" incident at a Wal-Mart in Porter Ranch that injured at least seven people and forced employees to evacuate part of the store. One person was hospitalized.


Los Angeles Police Cmdr. Andy Smith said Thursday that the night appeared to be running smoothly across Los Angeles. "In general, I think things have gone really well," he said. "It sounds like the stores have taken proper precautions and everyone is aware of the hazards of Black Friday."


After retailers last year moved the opening bell for Black Friday sales to midnight, this year there were even more customers eager to get a jump on the traditional kickoff to the holiday shopping season. Wal-Mart, Sears and Toys R Us began rolling out their door busters at 8 p.m. on Turkey Day, followed by Target at 9 p.m. Macy's, Kohl's and Best Buy were set to open at midnight.


A handful of chains such as Kmart and Old Navy also had daytime hours on Thursday. And online merchants were touting bargains all day and night.


About 147 million shoppers are expected this all-important holiday weekend, with more logging in for online specials by Cyber Monday, according to the National Retail Federation. In all, the trade group estimated that holidays sales will rise 4.1% this year, to $586 billion.


"Though the Black Friday tradition is here to stay, there's no question that it has changed in recent years," NRF Chief Executive Matthew Shay said in a statement.


Many shoppers were perfectly content to queue up. At Best Buy electronic stores across the Southland, people waited for hours — and sometimes days — in tents before the midnight opening.


But many workers were angry about spending Turkey Day away from loved ones.


Frustrated retail employees and families have taken to creating online petitions at Change.org to beg companies not to cut into Thanksgiving dinners. More than 20 online petitions have popped up in recent weeks. Lines grew throughout the afternoon and into the evening as anxious shoppers surveyed the competition in line.


Throughout Southern California there were reports of lines wrapped around stores. In Glendale, more than 750 shoppers were lined up outside the Target at the Galleria.


For shoppers who just couldn't wait until Thursday night — much less Black Friday — some retailers opened their doors all day on Thanksgiving.


The sales weren't quite as glorious as the Black Friday specials that stores promise to roll out later. But they were pretty good nonetheless, shoppers said.


JoAnne Garcia walked into Kmart in Burbank in search of a roasting pan in which to cook her turkey. She walked out 90 minutes later, having shelled out $491, including $329 for an RCA 39-inch LCD flat-panel TV.


"The roasting pan was $14.99," Garcia said, laughing at how much she spent as she rolled her cart to the parking lot.


To the 53-year-old aerospace machinist, shopping on Thanksgiving made perfect sense.


Standing near a store display touting "Freak Out Pricing," Garcia explained her theory about shopping while cooking. "You get up, throw your turkey in the oven, and you come back and it's all done."


walter.hamilton@latimes.com


joseph.serna@latimes.com


Contributing to this report were staff writers Wesley Lowery, Marisa Gerber, Nicole Santa Cruz and Andrew Khouri.





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New California legislators get a warm welcome — from lobbyists









SACRAMENTO — The day after being elected to the state Assembly, several incoming lawmakers were in AT&T's luxury suite at the Sacramento sports arena, watching the Kings with the company's top Capitol executive.


The next day, the California Dental Assn. feted the state's freshman legislators. That was before more than 20 legislators jetted off to Hawaii, China, Brazil, New Zealand and other locales — with some trips paid for in large part by healthcare, energy and communications companies.


"It's the start of lobbyists inculcating them, saying 'Hey guys, line up and receive your gifts,' " said Bob Stern, former chief counsel to the state Fair Political Practices Commission.








It's a new day in Sacramento, with one of the largest-ever freshman classes elected in districts drawn for the first time by an independent, bipartisan commission.


And the lobbying campaign to shape their minds has begun.


The intent of the redistricting — as well as a rule change that allows lawmakers to serve up to 12 years in either legislative house — was to make the Capitol more accountable. In theory, the changes would reduce the influence of lobbyists and give lawmakers more time to gain expertise and independence.


But old traditions die hard.


Following the example of veteran legislative leaders, including Assembly Speaker John Pérez (D-Los Angeles), more than a dozen Democratic freshmen headed off to AT&T's suite at the Sleep Train Arena.


Lawmakers are not allowed to take more than $420 in gifts per year, and they are supposed to report what they receive. But sidestepping the rules is hardly a challenge.


The freshmen who joined Pérez didn't have to report the value of their tickets because the gathering was hosted by the state Democratic Party.


Jose Medina, a newly elected assemblyman from Riverside, said the event was totally appropriate. Spending time with lobbyists is "part of my job,'' he said.


"At the end of the day, I'll make my decision based on what is best for the people I represent," he said.


Jim Frazier, a freshman assemblyman from Oakley, called the evening "a great opportunity to start meeting the people who worked so hard to represent their districts."


Other freshman Democrats in the suite included Ken Cooley of Rancho Cordova, Marc Levine of San Rafael, Phil Ting of San Francisco, Kevin Mullin of South San Francisco, Rudy Salas of Bakersfield, Bill Quirk of Hayward and Reggie Jones-Sawyer of Los Angeles.


Jones-Sawyer was one of 15 legislators who flew a few days later to Maui for a five-day conference at the Fairmont Kea Lani organized by the California Independent Voter Project.


The group, which paid some of the legislators' travel expenses, has been funded over the years by tobacco giant Altria Group Inc., Southern California Edison, Eli Lilly & Co., Pacific Gas & Electric Co., the California Beer & Beverage Distributors, the Pharmaceutical Research and Manufacturers Assn., Chevron Corp. and the state prison guards union.


In between rounds of golf and poolside lounging, the sponsors talked with lawmakers.


"I was learning about the issues," said Jones-Sawyer, the only freshman on the trip. "There were some things I didn't know — such as how businesses really need help to flourish here in California."


Phillip Ung, an advocate with California Common Cause, said he found the explanations bewildering.


"They have obviously convinced themselves that the people's business is best solved poolside with mai tais in hand," he said. "Congress banned this type of travel years ago."


Other lawmakers went to China, Australia, New Zealand or Brazil this month, in some cases paid for by special interests.


Those in Brazil were sponsored by the California Foundation on the Environment and the Economy, which is bankrolled by Chevron, PG&E, the International Brotherhood of Electrical Workers and Southern California Edison, among others.


The sponsors sent representatives to accompany Assemblyman Steven Bradford (D-Gardena), who is chairman of the Assembly Utilities and Commerce Committee, as well as Sens. Anthony Cannella (R-Ceres), Mimi Walters (R-Laguna Niguel), Bill Emmerson (R-Hemet) and Michael Rubio (D-East Bakersfield).


The group paid for airfare, hotels, meals and ground transportation, said P.J. Johnston, a spokesman for the nonprofit foundation.


The lawmakers were there to meet with government and business leaders in Brazil to discuss reducing pollution, setting low-carbon fuel standards, transportation projects and other issues, Johnston said.


"Brazil provides real-world insight into issues California's decision-makers are grappling with, putting them in a larger perspective and offering lessons learned from a country with a rich history of challenges and successes in these areas," he said.


patrick.mcgreevy@latimes.com


Times staff writer Anthony York contributed to this report.





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Samsung wins U.S. court order to access Apple-HTC deal details
















SAN FRANCISCO (Reuters) – A U.S. judge has ordered Apple Inc to disclose to rival Samsung Electronics details of a legal settlement the iPhone maker reached with Taiwan’s HTC Corp, including terms of a 10-year patents licensing agreement.


The Korean electronics giant had earlier filed a motion to compel its U.S. rival — with whom it is waging a bitter legal battle over mobile patents across several countries — to reveal details of the settlement that was reached on November 10 with HTC but which have been kept under wraps.













In August, the iPhone maker won a $ 1.05 billion verdict against Samsung after a U.S. jury found that certain Samsung gadgets violated Apple’s software and design patents.


Now, legal experts say the question of which patents are covered by the Apple-HTC settlement, and licensing details, could be instrumental in Samsung’s efforts to thwart Apple’s subsequent quest for a permanent sales ban on its products.


The Asian company has argued it is “almost certain” that the HTC deal covers some of the same patents involved in its own litigation with Apple.


The court on Wednesday ordered Apple to produce a full copy of the settlement agreement “without delay”, subject to an Attorneys-Eyes-Only designation.


Representatives for the U.S. company could not immediately be reached for comment.


Samsung also requested the California court to add three newly released Apple products — the iPod Touch 5, the iPad 4 and the iPad mini — to the list of devices that it claims to have infringed on some of its patents, according to court documents.


The settlement of Apple and HTC ended their worldwide litigation and brought to a close one of the first major flare-ups in the global smartphone patent wars.


Apple first sued HTC in 2010, setting in motion a legal conflagration that has since circled the globe and engulfed the biggest names in mobile technology, from Samsung to Google Inc’s Motorola Mobility unit.


(Reporting By Edwin Chan; Additional reporting by Miyoung Kim in SEOUL; Editing by Muralikumar Anantharaman)


Tech News Headlines – Yahoo! News



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Chevy Chase is leaving NBC's sitcom 'Community'

LOS ANGELES (AP) — The NBC series "Community" will finish the season without Chevy Chase.

Sony Pictures Television said Wednesday that the actor is leaving the sitcom by mutual agreement with producers.

His immediate departure means he won't be included in the last episode or two of the show's 13-episode season, which is still in production.

Chase had a rocky tenure playing a bored and wealthy man who enrolls in community college. The actor publicly expressed unhappiness at working on a sitcom and feuded last year with the show's creator and former executive producer, Dan Harmon.

The fourth-season premiere of "Community" is Feb. 7, when it makes a delayed return to the 8 p.m. EST Thursday time slot. The show's ensemble cast includes Joel McHale and Donald Glover.

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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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Car review: 2013 Nissan Pathfinder at a glance


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