New Hope For ‘Man on Fire Syndrome’

Pamela Costa has never known a day without agonizing pain in her legs and feet.

At age 11, the Seattle native was diagnosed with inherited erythromelalgia, a genetic condition that causes such severe pain and redness some call it “Man on Fire Syndrome.”

“Think of the feeling that you get when you come in from the cold and your hands and feet are rewarming too fast,” said Costa, 47. “I have that feeling all of the time.”

Inherited erythromelalgia is a disease of small nerves and blood vessels that causes severe pain in response to heat, pressure, exertion or stress.

“These people feel excruciating, scalding pain while putting on shoes or putting on a sweater,” said Dr. Stephen Waxman, a neuroscientist at Yale University and the West Haven Veterans Affairs Hospital. “They will keep their feet on ice to the point of getting gangrene, just to relieve the sensation.”

When Costa was growing up, playing outside would trigger the unbearable burning sensation.

“I used to come in from recess and just hold my hands on the cool metal of my school desk,” said Costa, who has more than two dozen relatives with the same affliction. “I have had cousins suffer devastating injuries from over-cooling themselves.”

Although the disease is rare, researchers are searching for clues to its cause with hopes of uncovering treatments for chronic pain of all kinds. The story starts at the molecular level within tiny nerves that conduct pain signals.

An Overactive Channel Protein

Pain comes in different forms, depending on the type of nerve that senses it. And for chronic pain patients, the pain is not quick and specific, but instead slow and sharp.

This slow pain is transmitted from the limbs and body to the brain along small nerves in the spinal cord called C-fibers. Messages move along these nerve fibers due to the action of special proteins in their membranes called channels. One specific type of channel is the Nav1.7 sodium channel, which is present in great numbers in the C-fibers of the spinal cord.

Work by Waxman and others has shown that patients with inherited erythromelalgia have a defect in their Nav1.7 channels that allows too many sodium ions to enter the C-fibers, causing an increase in the sensitivity of the nerves.

The specific atomic structure of the Nav1.7 channel has been modeled by Waxman’s lab, and the results are detailed in the current issue of Nature Communications. Armed with this new model of the Nav1.7 channel, the lab has been able to show why some patients with inherited erythromelalgia respond well to an anti-epileptic drug called Carbamazepine.

Furthermore, in studying the channel structure in many different people, Waxman and colleagues have found variations in the channel from person to person. These variations may cause some people to be more likely to experience chronic pain than others.

A New Drug Target

Patients with a completely defective Nav1.7 suffer from the opposite condition, known as congenital indifference to pain. These people do not experience pain at all, with case reports of being able to walk on hot coals without pain.

As the role of Nav1.7 in the mechanism for pain sensation becomes clearer, biotechnology and pharmaceutical companies will likely take notice, according to Waxman.

“I anticipate a race to develop Nav1.7 specific blockers,” he said.

Current drug therapies for pain include medicines like morphine, as well as aspirin and ibuprofen. While all of these decrease the sensation of pain, they also interact with other tissues such as the brain, heart and stomach, causing side effects.

Nav1.7 does not appear to be present in large quantities outside of the C-fibers of the spinal cord. As such, new drugs targeting this protein could herald a new class of pain treatments with many fewer side effects than our current drugs for pain.

Costa said she hopes to see a day where such a medicine would be available to her, providing her with full relief for the first time in her life.

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Stock futures rise, helped by Cisco results

NEW YORK (Reuters) – Stock index futures rose on Wednesday, indicating that equities could rebound after a series of weak sessions on strong results from Cisco and two retail chains.

The S&P 500 has fallen 3.8 percent over the past five trading days, with most of the losses driven by uncertainty over the looming U.S. “fiscal cliff” and concerns about Europe‘s economic troubles.

The index closed below its 200-day moving average for a fourth day in a row on Tuesday, a technical indicator that suggests recent declines could gain momentum.

Trading has been volatile, with positive momentum difficult to sustain.

“It seems as if every minor rally we get, gets sold into, a trend that has been both consistent and concerning,” said Christian Wagner, chief executive officer at Longview Capital Management in Wilmington, Delaware. “This could be the new normal until the fiscal cliff gets resolved, and that will make for a difficult environment.”

Economic reports on Wednesday include October retail sales, which are on tap for 8:30 a.m. (1330 GMT) and are seen dropping 0.2 percent. In September, sales climbed 1.1 percent. Also, the minutes from the Federal Reserve’s latest meeting will be released later on Wednesday.

Cisco Systems Inc reported first-quarter earnings and revenue late Tuesday that beat expectations, sending the stock soaring 7.3 percent to $ 18.08 in premarket trading Wednesday. The networking company and Dow component also forecast flat earnings and slower revenue growth for the current quarter.

Cisco, viewed as a harbinger for spending on information technology because of its global reach and customers across all sectors, could lend support to the tech sector.

Technology shares <.GSPT> have dropped almost 10 percent over the past two months, dragged down by earnings disappointments from Google and others. Tech was the worst performing sector on Tuesday.

“For Cisco to beat expectations in an environment like this is great and speaks to the solid management at the company,” Wagner said. “Hopefully this will do something for the tech sector, which has been so hurt by Apple lately.”

Apple , the most valuable U.S. company, has tumbled in recent months by 20 percent from its peak.

S&P 500 futures rose 4 points and were above fair value, a formula that evaluates pricing by taking into account interest rates, dividends and time to expiration on the contract. Dow Jones industrial average futures added 57 points and Nasdaq 100 futures rose 10.5 points.

Macroeconomic issues will likely play a major role in how stocks trade as investors grapple with the impact of Europe‘s debt crisis and the fiscal cliff, a series of large, mandated tax hikes and spending cuts that start to take effect next year.

Analysts say serious fiscal negotiations are still weeks away, but that the failure to reach a deal in Congress could tip the world’s largest economy into recession.

European shares <.FTEU3> were 0.5 percent lower as Greece’s unresolved crisis raised questions about the region’s potential for economic growth, while anti-austerity strikes across southern Europe added to concerns that fiscal reforms would be politically difficult to implement.

International Monetary Fund Managing Director Christine Lagarde said she expected a real solution for Greece rather than a quick fix.

In earnings news, Abercrombie & Fitch Co soared 25 percent to $ 39 before the bell after posting a steep rise in its third quarter. Staples Inc rose 5 percent to $ 11.81 after posting earnings that beat expectations.

U.S. stocks fell in a volatile session Tuesday, pressured by Microsoft Corp which fell after the surprise departure of a key executive. However, retail names outperformed after Home Depot raised its outlook.

(Editing by Kenneth Barry)

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General investigated for emails to Petraeus friend

PERTH, Australia (AP) — In a new twist to the Gen. David Petraeus sex scandal, the Pentagon said Tuesday that the top American commander in Afghanistan, Gen. John Allen, is under investigation for alleged “inappropriate communications” with a woman who is said to have received threatening emails from Paula Broadwell, the woman with whom Petraeus had an extramarital affair.

Defense Secretary Leon Panetta said in a written statement issued to reporters aboard his aircraft, en route from Honolulu to Perth, Australia, that the FBI referred the matter to the Pentagon on Sunday.

Panetta said that he ordered a Pentagon investigation of Allen on Monday.

A senior defense official traveling with Panetta said Allen’s communications were with Jill Kelley, who has been described as an unpaid social liaison at MacDill Air Force Base, Fla., which is headquarters to the U.S. Central Command. She is not a U.S. government employee.

Kelley is said to have received threatening emails from Broadwell, who is Petraeus’ biographer and who had an extramarital affair with Petraeus that reportedly began after he became CIA director in September 2011.

Petraeus resigned as CIA director on Friday.

Allen, a four-star Marine general, succeeded Petraeus as the top American commander in Afghanistan in July 2011.

The senior official, who discussed the matter only on condition of anonymity because it is under investigation, said Panetta believed it was prudent to launch a Pentagon investigation, although the official would not explain the nature of Allen’s problematic communications.

The official said 20,000 to 30,000 pages of emails and other documents from Allen’s communications with Kelley between 2010 and 2012 are under review. He would not say whether they involved sexual matters or whether they are thought to include unauthorized disclosures of classified information. He said he did not know whether Petraeus is mentioned in the emails.

“Gen. Allen disputes that he has engaged in any wrongdoing in this matter,” the official said. He said Allen currently is in Washington.

Panetta said that while the matter is being investigated by the Defense Department Inspector General, Allen will remain in his post as commander of the International Security Assistance Force, based in Kabul. He praised Allen as having been instrumental in making progress in the war.

The FBI’s decision to refer the Allen matter to the Pentagon rather than keep it itself, combined with Panetta’s decision to allow Allen to continue as Afghanistan commander without a suspension, suggested strongly that officials viewed whatever happened as a possible infraction of military rules rather than a violation of federal criminal law.

Allen was Deputy Commander of Central Command, based in Tampa, prior to taking over in Afghanistan. He also is a veteran of the Iraq war.

In the meantime, Panetta said, Allen’s nomination to be the next commander of U.S. European Command and the commander of NATO forces in Europe has been put on hold “until the relevant facts are determined.” He had been expected to take that new post in early 2013, if confirmed by the Senate, as had been widely expected.

Panetta said President Barack Obama was consulted and agreed that Allen’s nomination should be put on hold. Allen was to testify at his confirmation hearing before the Senate Armed Services Committee on Thursday. Panetta said he asked committee leaders to delay that hearing.

NATO officials had no comment about the delay in Allen’s appointment.

“We have seen Secretary Panetta‘s statement,” NATO spokeswoman Carmen Romero said in Brussels. “It is a U.S. investigation.”

Panetta also said he wants the Senate Armed Services Committee to act promptly on Obama’s nomination of Gen. Joseph Dunford to succeed Allen as commander in Afghanistan. That nomination was made several weeks ago. Dunford’s hearing is also scheduled for Thursday.

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Associated Press writer Slobodan Lekic in Kabul, Afghanistan, contributed to this report.

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‘Skyfall’ brings record Bond debut of $88.4M

LOS ANGELES (AP) — James Bond is cashing in at the box office.

“Skyfall,” the 23rd film featuring the British super-spy, pulled in a franchise-record $ 88.4 million in its U.S. debut, bringing its worldwide total to more than $ 500 million since it began rolling out overseas in late October.

The top 20 movies at U.S. and Canadian theaters Friday through Sunday, followed by distribution studio, gross, number of theater locations, average receipts per location, total gross and number of weeks in release, as compiled Monday by Hollywood.com are:

1. “Skyfall,” Sony, $ 88,364,714, 3,505 locations, $ 25,211 average, $ 90,564,714, one week.

2. “Wreck-It Ralph,” Disney, $ 33,012,796, 3,752 locations, $ 8,799 average, $ 93,647,405, two weeks.

3. “Flight,” Paramount, $ 14,785,097, 2,047 locations, $ 7,223 average, $ 47,455,396, two weeks.

4. “Argo,” Warner Bros., $ 6,617,229, 2,763 locations, $ 2,395 average, $ 85,583,187, five weeks.

5. “Taken 2,” Fox, $ 4,012,829, 2,487 locations, $ 1,614 average, $ 131,300,000, six weeks.

6. “Cloud Atlas,” Warner Bros., $ 2,658,250, 2,023 locations, $ 1,314 average, $ 22,844,956, three weeks.

7. “The Man With the Iron Fists,” Universal, $ 2,592,705, 1,872 locations, $ 1,385 average, $ 12,821,030, two weeks.

8. “Pitch Perfect,” Universal, $ 2,573,350, 1,391 locations, $ 1,850 average, $ 59,099,993, seven weeks.

9. “Here Comes the Boom,” Sony, $ 2,522,790, 2,044 locations, $ 1,234 average, $ 39,033,885, five weeks.

10. “Hotel Transylvania,” Sony, $ 2,400,226, 2,566 locations, $ 935 average, $ 140,954,208, seven weeks.

11. “Paranormal Activity 4,” Paramount, $ 1,980,033, 2,348 locations, $ 843 average, $ 52,600,612, four weeks.

12. “Sinister,” Summit, $ 1,524,448, 1,554 locations, $ 981 average, $ 46,578,686, five weeks.

13. “Silent Hill: Revelation,” Open Road Films, $ 1,300,137, 1,902 locations, $ 684 average, $ 16,383,406, three weeks.

14. “The Perks of Being a Wallflower,” Summit, $ 1,132,924, 607 locations, $ 1,866 average, $ 14,614,770, eight weeks.

15. “Lincoln,” Disney, $ 944,308, 11 locations, $ 85,846 average, $ 944,308, one week.

16. “Alex Cross,” Summit, $ 911,973, 1,090 locations, $ 837 average, $ 24,603,042, four weeks.

17. “Fun Size,” Paramount, $ 757,223, 1,301 locations, $ 582 average, $ 8,800,336, three weeks.

18. “Looper,” Sony, $ 582,150, 491 locations, $ 1,186 average, $ 64,669,383, seven weeks.

19. “The Sessions,” Fox, $ 545,550, 128 locations, $ 4,262 average, $ 1,655,222, four weeks.

20. “Seven Psychopaths,” CBS Films, $ 404,812, 356 locations, $ 1,137 average, $ 14,098,469, five weeks.

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Universal and Focus are owned by NBC Universal, a unit of Comcast Corp.; Sony, Columbia, Sony Screen Gems and Sony Pictures Classics are units of Sony Corp.; Paramount is owned by Viacom Inc.; Disney, Pixar and Marvel are owned by The Walt Disney Co.; Miramax is owned by Filmyard Holdings LLC; 20th Century Fox and Fox Searchlight are owned by News Corp.; Warner Bros. and New Line are units of Time Warner Inc.; MGM is owned by a group of former creditors including Highland Capital, Anchorage Advisors and Carl Icahn; Lionsgate is owned by Lions Gate Entertainment Corp.; IFC is owned by AMC Networks Inc.; Rogue is owned by Relativity Media LLC.

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War uproots 2.5 million Syrians, aid groups say

GENEVA (Reuters) – At least 2.5 million Syrians are believed to have fled their homes because of civil war, aid groups said on Tuesday, more than double previous estimates.

The figure comes from the Syrian Arab Red Crescent, whose volunteers are on the frontlines of the 20-month conflict, delivering aid supplies and evacuating wounded.

“The figure they are using is 2.5 million. If anything, they believe it could be more, that this is a very conservative estimate,” Melissa Fleming, chief spokeswoman of the U.N. High Commissioner for Refugees (UNHCR), told a news briefing.

“So people are moving, people are really on the run, hiding. They are difficult to count and to access,” she said.

Aid agencies had previously thought there were around 1.2 million internally displaced Syrians.

Only 5 percent of the 2.5 million are believed to be living in public facilities, including warehouses and schools, said Fleming. The rest are staying with host families, making it more difficult to count them.

In recent days, air strikes on the town of Ras al-Ain near the Turkish border have caused some of the biggest refugee movements of the conflict.

The United Nations said on Friday that up to 4 million people inside Syria will need humanitarian aid by early next year when the country is in the grip of winter, up from 2.5 million now whose needs are not fully met.

For now, the U.N. World Food Programme (WFP) says its food rations are reaching some 1.5 million. The UNHCR aims to provide assistance to 500,000 in Syria by the end of the year, mainly blankets, clothing, cooking kits and jerry cans, Fleming said.

“Unfortunately the recent deliveries have been very difficult, marred by violence and insecurity also spreading to parts of the country that used to be relatively calm,” she said.

A Syrian Arab Red Crescent warehouse in Aleppo was apparently hit by a shell, burning 13,000 blankets, she said. Unknown armed men hijacked a truck carrying 600 blankets on its way to Adra, outside Damascus.

The UNHCR has temporarily withdrawn about half of its 12 staff from north-eastern Hassaka province due to fierce fighting and insecurity, Fleming said.

“We see corresponding movement of populations there, Syrian Kurds for the most part, across the border into Iraq,” she said.

More than 407,000 Syrian refugees have registered or await registration in the surrounding region – Lebanon, Turkey, Jordan and Iraq – and more are fleeing every day, according to UNHCR.

(Editing by Tom Pfeiffer)

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Cisco to meet quarterly target, disappoint on outlook

(Reuters) – Tech investors hoping for good news may have to look further than Cisco Systems Inc‘s quarterly report as analysts expect Chief Executive John Chambers to be pessimistic in his forecast for the coming year.

Cisco, which is expected to meet estimates when it reports its first-quarter results on Tuesday, is seen as harbinger in terms of spending on information technology because of its global reach and customers across all sectors.

Chambers has been warning since April that businesses are reluctant to spend and that conditions will get worse before they get better.

Most analysts expect him to stay conservative given continued financial weakness in Europe and a drop in U.S. federal spending as concerns mount over the so-called fiscal cliff, which refers to a combination of tax hikes and spending cuts that loom at the end of the year and may tip the economy into recession.

JP Morgan analyst Rod Hall said he has changed his investment recommendation on Cisco to neutral from overweight in light of weak corporate and government spending as well as the continued economic pressure in Europe, but also in regard to longer term risks.

“To be clear, we’re not making a call on (fiscal quarter)FQ1’13, but do believe FQ2’13 guidance is likely to disappoint and expect 2013 to be a tough year as macro pressures persist,” he said.

Hall also said he anticipated that Cisco could face some risks by 2014 from technological developments such as software defined networking (SDN).

SDN lets customers create virtual networks that can operate independently of underlying physical networks, which may pose a threat to Cisco’s network dominance.

BMO Capital Markets analyst Tim Long said that in light of a cautious outlook BMO has reduced its 2013 earnings per share outlook to $ 1.94 from $ 1.96 and lowered its sales outlook for Cisco to revenue of $ 48.9 billion from $ 49.2 billion.

“October results should at least meet expectations, though guidance is likely more at risk,” Long said in a note.

Analysts, on average, expect Cisco to post EPS of 46 cents and revenue of $ 11.79 billion in the quarter that runs until end-October, according to Thomson Reuters I/B/E/S.

Wedbush analyst Rohit Chopra said Cisco has proven it can ride out tough times.

“Despite the macroeconomic environment, we believe Cisco is well positioned given its track record in navigating challenging environments, its broad portfolio of products, and continued actions to control its cost structure ahead of its rivals,” Chopra said. “We advise long-term investors looking for a well-capitalized company that can weather an uncertain spending environment to own the stock.”

Cisco shares were up slightly at $ 16.90 on Monday. The stock has lost around 10 percent in the past month and is down 7 percent year-to-date.

(Reporting By Nicola Leske; Editing by Peter Galloway)

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Clarke’s 218 puts Australia on front foot

BRISBANE (Reuters) – Australia captain Michael Clarke scored a brilliant unbeaten double century to give the hosts a remarkable 37-run first innings lead on the fourth day of the first test against South Africa on Monday.

Supported first by a maiden century from opener Ed Cowan in a record stand of 259, and then by Mike Hussey‘s 86 not out, Clarke’s 218 helped lift Australia from 40 for three when he took to the crease on Sunday to 487 for four when stumps were drawn.

It was Clarke’s sixth test century, and his third double hundred, in the 15 tests since he was named captain last year in the wake of the Ashes humiliation and Australia’s quarter-final exit at the World Cup.

Although by no means a chanceless knock, the 31-year-old played with patience when South Africa’s vaunted pacemen got anything out of the Gabba track before punishing anything loose with some fine shot-making.

When he carried his bat back to the pavilion at the end of the day to the raucous cheers of a sparse crowd at the famous Brisbane ground, Clarke had faced 350 balls over 504 minutes and scored 21 fours.

“I’m very happy with that,” Clarke, who accumulated his 1,000 test run of the year during the innings, said in an interview on the boundary.

“I didn’t feel great at the start and I think Ed Cowan batted beautifully.

“We’re in a great position with a 30-odd lead. I’d like another 70 odd runs in the morning and then I want to have a crack with the ball. We’ll see what happens.”

Cowan departed for 136 in heartbreaking fashion just before tea, run out at the non-striker’s end when Dale Steyn got a finger to a Clarke drive that hit the stumps and the opener was caught out of his crease backing up.

RECORD PARTNERSHIP

His partnership with Clarke was an Australian record for the fourth wicket at the Gabba, beating the 245 Clarke and Mike Hussey made against Sri Lanka in 2007.

Cowan’s wicket was the only wicket to fall on the day and Hussey started pouring on the runs as if determined to get the record back for his own partnership with his captain.

The 37-year-old bucked his poor recent form against South Africa by reaching his half century off just 68 balls with a drive through long-off and was closing on a century of his own when play ended.

It was Hussey’s cut four off Morne Morkel with which Australia overhauled South Africa’s first innings tally of 450 and put themselves in with an unlikely chance of even winning a test which lost an entire day to rain on Saturday.

Clarke’s negotiation of the “nervous nineties” for his century had been fraught and he was nearly run out going for a second run that would have brought him to the hundred mark.

There were no such jitters on his approach to the two hundred mark, which he passed by slapping the ball through mid-on for two runs before giving the badge on his helmet another kiss.

Cowan’s century was a retort to those critics who have consistently questioned his place in the team since he made his debut in last year’s Melbourne test against India.

The 30-year-old lefthander reached the mark two overs after lunch by pulling a short Vernon Philander delivery for four to the square leg boundary, beginning his joyous celebrations before the ball hit the rope.

South Africa’s number one test ranking is on the line in the series, which continues with matches in Adelaide and Perth after Brisbane.

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Labels maintain new music spend despite sales slump

LONDON (Reuters) – Record labels say they have maintained high levels of investment in new music despite sweeping changes to their business in the digital age and a decade of falling revenues caused by sliding album sales and online piracy.

According to a new study from industry body IFPI published on Monday, record companies invested $ 4.5 billion in A&R (artists and repertoire) and marketing in 2011.

That was down from $ 5 billion in 2008, partly due to a significant drop in the amount record labels were willing to spend on marketing up-and-coming talent at a time of shrinking income.

But the A&R side fell less sharply to $ 2.7 billion last year versus $ 2.8 billion in 2008 despite a decline of 16 percent in the trade value of the industry globally over the same period.

Presenting the report in London, Max Hole, COO of Universal Music Group International, said he was cautiously optimistic that the music business would return to growth soon, helped by the proliferation of digital platforms.

“The stats are getting better, the rate of decline is slowing,” he told reporters.

“There’s every reason to hope that in the next couple of years we’ll reach the low point and start to go back to growth.”

According to the IFPI, in the first nine months of 2012, global recorded music sales had fallen by around one percent year-on-year after a fall of three percent in 2011.

The industry peaked in 1999 when sales were $ 28.6 billion, but has shrunk every year since, reaching $ 16.6 billion in 2011.

“I just feel that we are at a tipping point of lots and lots of services coming on, and services that really are in touch with the consumer,” Hole said, adding that, crucially, the platforms were more attractive than illegal pirate sites.

BANDS WANT LABELS

The report showed that more than 70 percent of unsigned acts in Britain and Germany wanted a record deal, despite the perception that many artists are keen to go it alone with the help of social networking.

Major labels have been accused of being slow to adjust to the challenges posed by digital music and illegal downloads, and relying too heavily on older, established acts to make money.

But the IFPI report sought to underline their role in unearthing new talent in a notoriously risky business.

Revenues invested in A&R represent around 16 percent of industry turnover, compared with 15.3 percent in the pharmaceuticals and biotech sector and 9.6 percent in software and computing.

The IFPI estimated breaking a pop act in a major market typically costs from $ 750,000 to $ 1.4 million, including a $ 200,000 advance, $ 200-300,000 on recording, $ 50-300,000 on videos, $ 100,000 on touring and $ 200-500,000 on marketing.

The Internet has revolutionized the way record labels go about their business, the report said.

A&R representatives today rely on the Internet as much as they do on attending gigs up and down the country to discover the next best thing, although most still want to see an act live before making up their minds.

According to the report, record labels are providing far more digital content as part of their marketing and promotion, and tend to sign deals with artists which go well beyond the shrinking recorded music business.

Brand partnerships, offering songs for use on television, in film and in commercials, and linking up singers from different regions to generate cross-over interest are just some of the ways they can help establish a new act, the IFPI added.

Hole said the recent merger between Universal, already the world’s largest music label, and EMI, would not lead to less A&R spending, but more.

“We have stated quite categorically that our intention is to reinvest in EMI and boost it and we think it will result in more investment in A&R,” he said.

“We operate a multi-label structure and that was something that had declined at EMI,” he added. “We’re going to reverse that.”

(Editing by Steve Addison)

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Hathaway says ‘Les Mis’ made her feel deprived

NEW YORK (AP) — Anne Hathaway credits her new husband Adam Schulman for helping her get through the grueling filming of the screen adaptation of “Les Miserables.”

In “Les Mis,” the 30-year-old actress plays Fantine, a struggling, sickly mother forced into prostitution in 1800s Paris.

Hathaway lost 25 pounds and cut her hair for the role. She tells the December issue of Vogue, the part left her in a “state of deprivation, physical and emotional.” She felt easily overwhelmed and says Shulman was understanding and supportive.

The couple wed in September in Big Sur, Calif. Hathaway wore a custom gown by Valentino whom she collaborated with on the design. Working with the designer is a memory she says she will “treasure forever.”

The December issue of Vogue hits stores Nov. 20.

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British medical journal slams Roche on Tamiflu

LONDON (AP) — A leading British medical journal is asking the drug maker Roche to release all its data on Tamiflu, claiming there is no evidence the drug can actually stop the flu.

The drug has been stockpiled by dozens of governments worldwide in case of a global flu outbreak and was widely used during the 2009 swine flu pandemic.

On Monday, one of the researchers linked to the BMJ called for European governments to sue Roche.

“I suggest we boycott Roche’s products until they publish missing Tamiflu data,” wrote Peter Gotzsche, leader of the Nordic Cochrane Centre in Copenhagen. He said governments should take legal action against Roche to get the money back that was “needlessly” spent on stockpiling Tamiflu.

Last year, Tamiflu was included in a list of “essential medicines” by the World Health Organization, which often prompts governments or donor agencies to buy the drug.

WHO spokesman Gregory Hartl said the agency recommended the drug be used to treat unusual influenza viruses like bird flu. “We do have substantive evidence it can stop or hinder progression to severe disease like pneumonia,” he said.

In 2009, the BMJ and researchers at the Nordic Cochrane Centre asked Roche to make all its Tamiflu data available. At the time, Cochrane Centre scientists were commissioned by Britain to evaluate flu drugs. They found no proof that Tamiflu reduced the number of complications in people with influenza.

“Despite a public promise to release (internal company reports) for each (Tamiflu) trial…Roche has stonewalled,” BMJ editor Fiona Godlee wrote in an editorial last month.

In a statement, Roche said it had complied with all legal requirements on publishing data and provided Gotzsche and his colleagues with 3,200 pages of information to answer their questions.

“Roche has made full clinical study data…available to national health authorities according to their various requirements, so they can conduct their own analyses,” the company said.

Roche says it doesn’t usually release patient-level data available due to legal or confidentiality constraints. It said it did not provide the requested data to the scientists because they refused to sign a confidentiality agreement.

Roche is also being investigated by the European Medicines Agency for not properly reporting side effects, including possible deaths, for 19 drugs including Tamiflu that were used in about 80,000 patients in the U.S.

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