Ranbaxy halts generic Lipitor production after recall: FDA

(Reuters) – Indian generic drugmaker Ranbaxy Laboratories will stop manufacturing its version of Pfizer Inc‘s cholesterol fighter, Lipitor, while it gets to the bottom of the cause of a recent recall, the U.S. Food and Drug Administration said on its website.

Earlier this month, Ranbaxy recalled certain lots of the widely used cholesterol lowering medicine known generically as atorvastatin at doses of 10 milligrams, 20 mg and 40 mg after the company discovered contamination with tiny glass particles.

There have so far been no reports of patients being harmed due to the glass particulates, the FDA said.

The agency said it does not anticipate drug shortages due to the recall as several other companies also produce generic Lipitor, while Pfizer still sells its branded version.

FDA said it was monitoring the situation and working with other manufacturers to ensure adequate supply in order to avoid shortages of atorvastatin as a result of the recall.

During its first six months on the market, when it enjoyed marketing exclusivity, atorvastatin generated sales of nearly $ 600 million for Ranbaxy, according to Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh

FDA said it will continue to oversee the recall process and work with the Ranbaxy to resolve pharmaceutical quality issues.

The recall is the latest in a series of manufacturing problems at Ranbaxy, which is operating under heightened scrutiny due to past problems that nearly derailed it ability to sell atorvastatin in the United States.

In 2008, the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company’s facilities in India, and Ranbaxy was later accused of falsifying data used in drug applications.

Under a proposed settlement earlier this year, Ranbaxy agreed to engage a third party to conduct a review of its facilities, implement procedures to ensure data integrity in its marketing applications, and ensure it meets good manufacturing practices.

(Reporting by Bill Berkrot)

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Taking a page from Louis C.K., Chill launches online store for films, comedy specials

NEW YORK (TheWrap.com) – Chill, a social video platform with close to 20 million users, has launched Chill Direct, a new store for creatives like Maria Bamford and Michael Urie to sell their movies, specials and documentaries directly to fans.

Comedian Louis C.K. sent shockwaves through the entertainment industry this summer by selling a comedy special directly online rather than making a distribution deal with a television network or online service. He made millions, and various others have followed suit, including Jim Gaffigan and Aziz Ansari.

Chill sees an opportunity to enter this emerging market, empowering artists and offering them an opportunity to control the distribution and monetization of their ongoing projects.

“The community gives filmmakers and comedians the ability to distribute premium video directly to fans,” CEO Brian Norgard told TheWrap. “The common analogy is to Louis C.K. and his ‘Live at Beacon Theater.‘ That was a seminal moment in the entertainment business and a lot of things now allow direct-to-fan to become a viable model.”

Artists who choose to sell through Chill also can sell their videos elsewhere, but Chill Direct launches with eight videos exclusive to the site. That slate includes “Maria Bamford: the Special Special Special!,” an hour-long comedy special starring Bamford, “Thank You For Judging,” a documentary from “Ugly Betty” actor Urie about high school speech and debate and “Unknown Sender,” a suspense series from “48 Hrs” and “Die Hard” scribe Stephen E. de Souza.

Starting Thursday, any artist can create a page for a project and has complete creative control over the page, from information about the project to trailers to pricing. Meanwhile, Chill handles distribution across devices as well as payments.

Artists retain rights to their own intellectual property while Chill takes a 30 percent cut of any transaction.

“What Chill does is let anyone build out socially integrated marketing pages – we call them story pages – beautiful, high-resolution tantalizing receptacles of premium videos,” Norgard said.

Chill, funded by WME and Kleiner Perkins Caulfield & Byers and others, has previously enabled frictionless uploading, consumption and sharing of the web’s most popular videos. This maintains a social layer, allowing for commenting and offering bundles that combine the video with other perks like merchandise or meeting the creator.

“The land of premium video is still a very closed marketplace,” Norgard said. “If you have tremendous business development skills or connections to sell a film to Netflix or Hulu, you’re lucky. The ad-supported model doesn’t fit every type of content. There is plenty of stuff out there like documentary films and comedy specials where creators are between a rock and a hard place and wan to get it out there, distribute it, own the right but not put it on a free streaming site like YouTube.”

Selling direct to fans also offers a new revenue stream to a company that until now was mostly luring people a few times a day for videos.

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Rapper PSY wants Tom Cruise to go ‘Gangnam Style’

BANGKOK (AP) — The South Korean rapper behind YouTube’s most-viewed video ever has set what might be a “Mission: Impossible” for himself.

Asked which celebrity he would like to see go “Gangnam Style,” the singer PSY told The Associated Press: “Tom Cruise!”

Surrounded by screaming fans, he then chuckled at the idea of the American movie star doing his now famous horse-riding dance.

PSY’s comments Wednesday in Bangkok were his first public remarks since his viral smash video — with 838 million views — surpassed Justin Bieber‘s “Baby,” which until Saturday held the record with 803 million views.

“It’s amazing,” PSY told a news conference, saying he never set out to become an international star. “I made this video just for Korea, actually. And when I released this song — wow.”

The video has spawned hundreds of parodies and tribute videos and earned him a spotlight alongside a variety of superstars.

Earlier this month, Madonna invited PSY onstage and they danced to his song at one of her New York City concerts. MC Hammer introduced the Korean star at the American Music Awards as, “My Homeboy PSY!”

Even President Barack Obama is talking about him. Asked on Election Day if he could do the dance, Obama replied: “I think I can do that move,” but then concluded he might “do it privately for Michelle,” the first lady.

PSY was in Thailand to give a free concert Wednesday night organized as a tribute to the country’s revered King Bhumibol Adulyadej, who turns 85 next month. He paid respects to the king at a Bangkok shopping mall, signing his name in an autograph book placed beside a giant poster of the king. He then gave an outdoor press conference, as screaming fans nearby performed the pop star’s dance.

Determined not to be a one-hit wonder, PSY said he plans to release a worldwide album in March with dance moves that he thinks his international fans will like.

“I think I have plenty of dance moves left,” he said, in his trademark sunglasses and dark suit. “But I’m really concerned about the (next) music video.”

“How can I beat ‘Gangnam Style’?” he asked, smiling. “How can I beat 850 million views?”

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Associated Press writer Thanyarat Doksone contributed to this report.

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Numbers drawn for record Powerball jackpot

CHICAGO (AP) -- The numbers have been drawn for the record Powerball jackpot and the wait for winners — if any — has begun.

The numbers drawn Wednesday night are: 5, 16, 22, 23, 29 and Powerball of 6.

A lottery official said late Wednesday that the jackpot increased to $579.9 million by the time of the drawing, making the cash option $379.8 million.

Americans went on a ticket-buying spree in recent days, the big money enticing many people who rarely, if ever, play the lottery to purchase a shot at the second-largest payout in U.S. history.

Among them was Lamar Fallie, a jobless Chicago man who said his six tickets conjured a pleasant daydream: If he wins, he plans to take care of his church, make big donations to schools and then "retire from being unemployed."

Tickets were selling at a rate of 130,000 a minute nationwide — about six times the volume from a week ago. That meant the jackpot could climb even higher before the Wednesday night drawing, said Chuck Strutt, executive director of the Multi-State Lottery Association.

The jackpot had already rolled over 16 consecutive times without a winner, but Powerball officials said earlier Wednesday they believed there was a 75 percent chance the winning combination will be drawn this time.

If one ticket hits the right numbers, chances are good that multiple ones will, according to some experts. That happened in the Mega Millions drawing in March, when three ticket buyers shared a $656 million jackpot, which remains the largest lottery payout of all time.

Yvette Gavin, who sold the tickets to Fallie, is only an occasional lottery player herself, but the huge jackpot means she'll definitely play this time. As for the promises she often gets from ticket purchasers, Gavin isn't holding her breath.

"A lot of customers say if they win they will take care of me, but I will have to wait and see," she said.

In the hours before Wednesday's drawing, Associated Press photographers across the nation sought out ticket buyers and asked about their lottery fantasies. Here's a look at what they found:

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When Atlanta barber Andre Williams buys scratch-off tickets, he typically does a dance in his shop for good luck. As a first-time Powerball player, he plans to reprise the dance — and buy a few extra tickets to enhance his chances.

I don't even know if I'll look at it," said Williams, who bought his ticket at a newsstand. "If I win, I might pass out."

Paralegal Pat Powell was buying her first Powerball ticket at another store in Atlanta, even though she acknowledged her odds were probably "zero to zero."

Still, Powell has specific plans should she win: start an Internet cafe in the West Indies and a learning center in Georgia.

"I've been thinking about winning this money and what I'd do with it," Powell said. "There's no ritual, but it's just been on my mind. So it's like, let me just join the hype and just do it."

Atlanta accountant Benita Lewis, who had never played the lottery before, didn't want to be the only one left in her office without a ticket.

"I did feel nervous buying it like I could be the one," she said. "I'm going to retire and pay off all my family's debt."

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In Philadelphia, seafood salesman Billy Fulginiti bought 50 Powerball tickets with co-workers and a few more with a small group. He said he only plays when the jackpot is especially large.

"You go to bed at night wishing you wake up a millionaire," Fulginiti said. He planned to take a long vacation and "help a lot of people, a lot of charities," if any of his tickets turn out to be winners.

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Powerball purchases at the Canterbury Country Store in Canterbury, N.H., have been so steady that the manager has been working extra evening hours to keep up.

Horticulturist Kevin Brags buys tickets at the store two to three times a month. He says he usually picks numbers higher than 32 because so many people use numbers 31 and lower, largely because of birthdays.

The birthday theory didn't scare off Paul Kruzel, a retired doctor who chooses the days his children were born.

Both, however, have the same plans for winning: "make a lot of people happy."

John Olson has a more elaborate idea: He'd like to buy an island.

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At a downtown Detroit convenience store, Ceejay Johnson purchased five Powerball tickets. If she strikes it rich, the analyst from Southfield, Mich., said she would buy a home for her sister in Florida. Then she would "go into hiding" and take care of her family.

"And the IRS," she added.

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Associated Press photographer Jim Cole reported from Canterbury, N.H.

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Associated Press photographers Paul Sancya in Detroit, David Goldman in Atlanta and Matt Rourke in Philadelphia, and AP writers David Pitt in Des Moines, Iowa, and Jeff McMurray in Chicago contributed to this report.

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Cate Blanchett in negotiations for evil stepmother in Disney’s Cinderella film

LOS ANGELES (TheWrap.com) – Cate Blanchett is in negotiations to play the evil stepmother in Disney‘s re-imagining of the classic fairytale Cinderella, the “Untitled Cinderella Story,” an individual with knowledge of the situation told TheWrap.

Blanchett would be the first to be cast in the live-action film. It is being directed by Mark Romanek for the studio based on a script by Chris Weitz.

The film is being produced by Simon Kinberg, who is best-known for the “X-Men” series.

The feature was first set up at Disney in May 2010 based on a pitch by Aline Brosh McKenna (“Devil Wear Prada.”), who wrote the initial draft.

Disney set the project up in the wake of its success with “Alice in Wonderland,” an adaptation of the Lewis C. Carroll book that starred Johnny Depp.

Disney representatives could not be reached for comment.

Blanchett can next be seen on screen in “The Hobbit: An Unexpected Journey” on December 14. She was recently confirmed for George Clooney’s upcoming film “The Monuments Men.” She will also be seen in “The Hobbit: The Desolation of Smaug” and “The Hobbit: There and Back Again.”

Cinderella has been adapted for the big screen dozens of times. In Andy Tennant’s 1998 version “Ever After: A Cinderella Story,” Angelica Houston played the evil stepmother. In the TV movie “Cinderella” in 1997, the role was played by Bernadette Peters. Sigourney Weaver voiced the character in “Happily N’Ever After” in 2006. Disney‘s 1950 version featured Eleanor Audley in the voice role of Lady Tremaine, the wicked stepmother.

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Arizona declines to set up state-based health insurance exchange

PHOENIX (Reuters) – Arizona Governor Jan Brewer said on Wednesday she was rejecting a major provision of President Barack Obama‘s healthcare reform law that calls for creating state-based health insurance markets where consumers can purchase private, federally subsidized coverage.

Citing lingering questions about the plan and operating costs she said would be passed on to families and small businesses, Brewer, a Republican, said Arizona would join at least 16 other states in opting instead for a federally run health insurance exchange.

Such networks are designed to function as online insurance markets where the uninsured can shop for private health plans offered at federally subsidized rates, and are an integral provision of the Affordable Care Act, a centerpiece of Obama’s first term in office.

Brewer, along with many other Republicans, has been an outspoken critic of Obama’s healthcare overhaul initiative, calling it an “overreaching and unaffordable assault on states’ rights and individual liberty.”

Under a newly extended deadline, states have until December 14 to notify the U.S. Health and Human Services Department whether they intend to comply with the insurance exchange mandate or leave it to the federal government to set up and operate exchanges for them.

Seventeen states plus the District of Columbia have told the Obama administration they intend to move ahead with their own exchanges, while Arizona became the latest of 17 states to reject the plan outright in favor of a federally based exchange, according to the Kaiser Family Foundation, which has closely tracked the issue.

Most of those opting out are states in the Midwest or South. Six more states have sought to join with HHS in setting up a hybrid federal-state network, and 10 states remain undecided, the foundation said.

CALLS OPPOSITION ‘UNWAVERING’

“My opposition to the Affordable Care Act is unwavering, as is my belief that it should be repealed and replaced,” Brewer said in a statement announcing her decision. Republican Mitt Romney, who lost to Obama in the November 6 presidential election, had vowed to repeal the law if elected.

Acknowledging that the law had been upheld as constitutional by the U.S. Supreme Court, and despite her advocacy of greater local control, Brewer said her state would be better off ceding management of a system she said would be dominated by the federal government in any case.

“I have come to the conclusion that the state of Arizona would wield little actual authority over its ‘state’ exchange,” she said.

Although startup costs of exchanges are to be borne by the federal government, Brewer said Arizona stood to incur $ 27 million to $ 40 million in operating expenses starting in 2015, and that those costs would be passed along in the form of higher premiums to policy holders.

Brewer, who has clashed sharply with the Obama administration on a number of issues, especially immigration policy, made her intentions known in a one-page letter to HHS on Wednesday.

The state, which also has a Republican-controlled Legislature, had spent millions of dollars in federal grant money over the past several months laying the groundwork for the possible creation of a healthcare exchange.

Brewer faced heavy lobbying from some conservative Republicans who opposed setting up a state-run exchange, while a number of business groups and healthcare organizations favored creating one. State Democrats also strongly support a state-run exchange.

One top Democratic lawmaker criticized Brewer for “an irresponsible decision” that wasted millions of dollars already spent preparing for a state-run exchange.

“The governor is going to throw that all away so she can push an extremist agenda,” state House of Representatives Minority Leader Chad Campbell said. “We’ve come to expect political grandstanding from her, but this is a whole new level.”

Campbell said in a statement the state exchange that Brewer rejected would be a plus for consumers, giving them more of a say over their healthcare decisions.

“The governor just signed over a lot of power to the federal government,” he added.

(Reporting by David Schwartz; Writing by Steve Gorman; Editing by Cynthia Johnston and Peter Cooney)

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Family learns of student’s death on Facebook

ATLANTA (AP) — The parents of a south Georgia college student first learned from Facebook that their daughter had been found dead in a dormitory study room shortly before Thanksgiving. Now, they hope that Facebook and other social media sites can help solve the death of 17-year-old Jasmine Benjamin, which police are investigating as a homicide.

The Valdosta State University freshman was found unresponsive on a study room couch on Nov. 18.

A family friend forwarded the Facebook post about the teen’s death to her parents before they were officially notified by authorities, said A. Thomas Stubbs, an attorney for the victim’s mother, Judith Brogdon, and her stepfather, James Jackson. But many questions remain unanswered about how she died.

The family has hired a private investigator, and a new Facebook site has been set up in hopes that students and others might share tips.

While some Facebook comments have already been turned over to law enforcement officers, the family hopes friends, classmates or others who noticed suspicious comments will also alert authorities.

“Anything that reveals a little more information than what’s publicly known about her death, those are the kind of comments police are looking for as someone who might warrant a closer examination,” Stubbs said.

Also of interest are “unusual comments or unusually timed comments about her death,” he said.

Police detectives have canvassed dormitories and interviewed several students on the campus, located about 250 miles south of the family’s home in Gwinnett County, outside Atlanta.

Benjamin wanted to follow the career path of her mother and become a nurse.

Police say they’re treating the case as a homicide, though autopsy results are not complete and they can’t say for certain whether she was killed. There were no obvious signs of a crime when her body was found, but an autopsy raised questions, authorities have said.

“We’re providing what resources are necessary to assist Valdosta State University police in solving this crime,” Georgia Bureau of Investigation spokesman John Bankhead said. “The crime lab is expediting evidence from this incident.”

Shortly after Benjamin’s parents learned of her death from Facebook, Lawrenceville police officers knocked on the doors of the family home to inform them officially that their daughter was dead, Stubbs said.

“As frustrating as that may be for the family to learn that way, they understand it’s a different world,” Stubbs said.

The family has yet to learn the possible timeframe of when their daughter died, and police have not shared any theories about how she was killed, Stubbs said.

“We know that they have looked at the phone records, video records that they can find in the school,” he said. Beyond that, they’ve been going through legal procedures that are required to obtain records from Facebook Inc.

The family hired Martinelli Investigations Inc. of Lawrenceville to assist in the investigation.

Private investigator Robin Martinelli said Wednesday that any video near the scene, even if may seem insignificant, could prove helpful in the investigation.

“It wouldn’t matter if it was two weeks before, two hours before or 20 minutes before,” she said.

Martinelli said she’s confident that police are working diligently to follow up on leads, but private investigators can often provide valuable assistance, she said.

“On any homicide, they’re going to work around the clock aggressively every minute, and they’re doing that,” she said.

She said Jasmine Benjamin was a strong student who showed great potential. “Her favorite color was purple, her nickname was Jazzy,” she said.

“She wanted to help people, plain and simple,” her stepfather, James Jackson, told WSB-TV. “That was her goal in life. That’s all she talked about since she was young — ‘I want to be able to help people.’”

Valdosta State campus police, city police and the GBI were working together to conduct interviews and collect evidence, the university said in a statement Tuesday. University officials said they couldn’t release any further information.

Martinelli hopes students away at college keep in touch with their parents — and give them the passwords to social networking sites and their cell phones in case anything happens.

“If you have passcodes to your computer, your phone, please tell your parents,” she said. “Don’t tell everybody in the world, but tell your parents your passcodes.”

She said some of the best advice parents can give students is this: “They should listen to their gut,” she said. “If they walk into a situation and it’s not feeling right, leave.”

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Rugby-England add flyhalf Burns to squad for All Blacks’ test

LONDON, Nov 27 (Reuters) – England called up uncapped Gloucester flyhalf Freddie Burns on Tuesday to their squad for Saturday’s test against New Zealand in place of the injured Toby Flood.

Flood sustained ligament damage to a big toe during the 16-15 loss to South Africa at Twickenham last Saturday.

Owen Farrell, whose last start was in the first test in South Africa this year, is set to replace Flood in the starting XV against the world champions.

Lock Courtney Lawes, who missed England’s first three tests of the November series because of a knee injury, has also been included in the 23-man squad. Two other locks, Mouritz Botha and Tom Palmer, have been omitted.

After beating Fiji in their opening match, England have lost to Australia and the Springboks and now face a daunting match against the All Blacks who are unbeaten in 20 tests since the start of their victorious World Cup campaign last year.

“For those in Saturday’s squad the message is clear – last week we went toe to toe with the second best team in the world and felt we should have won,” England head coach Stuart Lancaster said in a statement.

“Now we have a chance to take on the number one side in front of a passionate Twickenham crowd, who have been fantastic throughout the Internationals, and it is a challenge we will meet head on.” (Reporting by John Mehaffey; Editing by Ken Ferris)

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Robbie Williams aims to seal solo legacy with tour

LONDON (Reuters) – Still famous as the in-again/out-again member of chart-topping boyband Take That, British singer Robbie Williams says it is time to get serious as a solo artist and prove his place at the top of the pop pile.

Williams told reporters on Monday he planned a 15-date European stadium tour kicking off in Manchester on June 19, 2013 and concluding in Tallinn, Estonia on August 20.

“I’m buzzing. I’m ready to go. I haven’t done a tour of this size since 2006,” he said in London.

“I think it’s legacy time, because I’m venturing into getting my handicap down at golf and all that business.

“I’m nearly 40, that’s what I’m trying to say. I want to go and seal my place in pop history and go off and deliver a tour of great magnitude while I still can.”

The 38-year-old in fact enjoyed major success after leaving Take That in 1995, producing a string of hit albums and singles including “Angels” and “Millennium” and signing a contract with EMI in 2002 reportedly worth tens of millions.

But by the time his 2006 album “Rudebox” came out followed by “Reality Killed the Video Star” in 2009, he was seen as a dwindling force in British pop who had failed to break the key U.S. market.

Williams rejoined Take That in 2010 and they recorded the hit album “Progress” before touring together in 2011, and the singer said the experience had helped give him confidence to tour large venues again as a solo artist.

“I just ran out of ideas and ran out of a bit of creativity and ran out of energy and did the textbook ‘burnt out’,” he said of the late 2000s.

“But I’ve been working really hard and I needed to do something else, and fortunately it came in the shape of my old band. A lot of demons were vanquished from the past. A lot of wrongs were put to rights.

“That tour last summer was just absolutely incredible. It kick-started my professional career.”

Earlier this month, Williams returned to the top of the album charts with “Take the Crown”.

Asked whether he would consider rejoining Take That again, he replied: “I haven’t officially left … What I do know is that … if we all remain healthy then I will definitely be a part of Take That at some point. It’s joyful being around them.”

Williams conceded it may be too early to talk about his legacy at 38, but added he wanted to “put my stamp down.

“The fact that 40 is looming plays on my mind more than it does on anybody else’s mind. Pop stars cease to be pop stars at 40 and start being old people singing, don’t they?

“There is a forum for a male solo star to get up there in stadiums and own the place and I want that to be me, so I’ve kind of been lethargic for the last couple of albums.”

Williams recently became a father, and said his daughter would accompany him on tour. Olly Murs, who rose to fame on “The X Factor” reality TV show, will support Williams on his tour.

(Reporting by Mike Collett-White, editing by Paul Casciato)

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Flu Symptoms Drove Boston Mayor to Hospital

When Boston Mayor Thomas Menino ended his vacation in Italy short this fall and checked into a Boston hospital complaining of a respiratory infection, it led doctors to find and treat a blood clot in his leg, a fracture in his back, an infection around the fracture and type 2 diabetes.

Cold and flu symptoms from respiratory infections can be a hassle, but sometimes that fever and cough can be good for just getting people to the doctor.

“That’s why every patient needs a careful evaluation because every once in a while, what the patient thinks is the flu or reports as the flu is not,” said Dr. William Schaffner, chairman of preventative medicine at Vanderbilt University in Tennessee. “I would say 99 percent of people who present to the emergency room and doctor’s office with symptoms of influenza – that is cough, fever and the like – are certainly going to have influenza.”

Click here to read about cold- and flu-fighters.

Menino, 69, arrived at Brigham and Women’s Hospital on Oct. 25, complaining of fatigue and a cough, and doctors described him as “extremely washed out” with some “malaise.” In addition to the respiratory infection, doctors found a blood clot that traveled from Menino’s leg to his lungs.

Respiratory illnesses, like the one that initially drove Menino to seek medical attention, can often range from mild to severe, Schaffner said.

“He was feeling poorly enough to end what was supposed to be a very pleasant vacation, and when he got here, he was very weak and very washed out,” Dr. Dale Adler, Menino’s doctor, said during a press conference in mid-November.

Doctors can usually tell whether flu-like symptoms are the result of a respiratory infection or something else soon after the patient is admitted. If not, they can perform a series of tests to find out.

Click here to read about flu fact and fiction.

(The flu can lead to other ailments, the most common of which is pneumonia, or an infection of the lungs, Schaffner said.

About 1.1 million pneumonia patients were hospitalized and discharged in 2009, according to the latest data from the Centers for Disease Control and Prevention. On average, they stayed in the hospital 5.2 days.)

Weeks later, Menino was still in the hospital. Although his illness and clot had been resolved, he was complaining of back pain, which doctors discovered was the result of a compression fracture and an infection around the fracture.

Finally, doctors discovered that Menino had underlying type 2 diabetes, which may have contributed to the infection, Menino’s doctor said during a press conference on Monday.

It’s not clear how Menino’s initial flu-like symptoms tied into his other ailments, but doctors said they are positive about his prognosis. The mayor relocated to a rehabilitation center on Monday.

“It is a run of bad luck,” Morris said of Menino. “He will rebound from this.”

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