Twin explosions strike southern Syrian city

BEIRUT (AP) — Syria‘s state-run news agency says two large explosions have struck the southern city of Daraa, causing multiple casualties and heavy material damage.

SANA did not immediately give further information or say what the target of Saturday’s explosions was.

The Britain-based Syrian Observatory for Human Rights says the blasts went off near a branch of the country’s Military Intelligence in Daraa.

The Observatory, which relies on a network of activists on the ground, says the explosions were followed by clashes between regime forces and rebels fighting to topple President Bashar Assad.

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Nutella maker says will brave French tax hike

PARIS (Reuters) – The makers of the renowned Nutella food spread say they will not change the lucrative recipe even if France, its biggest market, endorses proposals to quadruple tax on a key ingredient of the gooey mix, palm oil.

Senators in France, where a left-wing government is hiking tax generally to help slash a bloated debt, have proposed a 300 percent tax hike on palm oil on the grounds that its production harms the environment and its consumption fuels obesity.

Frederic Thil, French director for Ferrero, the Italian firm that makes the sugary, chocolate-colored paste, sounded a defiant note in Le Parisien daily.

“The arguments are unfair and the repercussions would be catastrophic,” he told the newspaper.

More than 100 million jars of Nutella were sold in France alone in 2008, according to Ferrero, whose website says the recipe sold in large quantities across the Western world was invented in the backroom of an Italian pastry shop in 1944.

The main ingredients are sugar, milk powder, hazelnuts, cocoa, emulsifier, flavoring and palm oil, on which a tax of almost 100 euros per metric tonne is levied in France at the moment.

That tax would rise to 400 euros a tonne if the proposal floated by a Senate committee earlier this month secures majority backing in the Senate and in the lower house of parliament, the National Assembly.

France, which is keen to find other funding sources for a generous healthcare system in cash-strapped times, has already raised tax on sugary drinks and recently hatched plans to hike tax on beer to help plug the hole in public welfare finances.

Thil said the maker of Nutella, popular in many countries as a breakfast fare smeared onto slices of bread, would do all it could to limit the hit from any tax rise for consumers.

Palm oil, also extensively used in margarine, biscuits and crisps, makes up about 20 percent of the Nutella mix. The 300 percent tax rise, if passed on, would raise the cost of a 1-kilo jar or the spread by 0.06 euros, according to ASEF, an association of doctors that backs the tax hike proposal.

The other argument made for a tax increase is that it will encourage a shift away from intensive production methods that have prompted destruction of forests in countries such as Malaysia, a major exporter of palm oil.

(Reporting By Brian Love; Editing by Toby Chopra)

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Four days later, Obama wins Florida

ST. PETERSBURG, Fla. - President Barack Obama was declared the winner of Florida's 29 electoral votes Saturday, ending a four-day count with a razor-thin margin that narrowly avoided an automatic recount that would have brought back memories of 2000.

No matter the outcome, Obama had already clinched re-election and now has 332 electoral votes to Romney's 206.

The Florida Secretary of State's Office said that with almost 100 per cent of the vote counted, Obama led Republican challenger Mitt Romney 50 per cent to 49.1 per cent, a difference of about 74,000 votes. That was over the half-per cent margin where a computer recount would have been automatically ordered unless Romney had waived it.

There is a Nov. 16 deadline for overseas and military ballots, but under Florida law, recounts are based on Saturday's results. Only a handful of overseas and military ballots are believed to remain outstanding.

It's normal for election supervisors in Florida and other states to spend days after any election counting absentee, provisional, military and overseas ballots. Usually, though, the election has already been called on election night or soon after because the winner's margin is beyond reach.

But on election night this year, it was difficult for officials — and the media — to call the presidential race here, in part because the margin was so close and the voting stretched into the evening.

In Miami-Dade, for instance, so many people were in line at 7 p.m. in certain precincts that some people didn't vote until after midnight.

The hours-long wait at the polls in some areas, a lengthy ballot and the fact that Gov. Rick Scott refused to extend early voting hours has led some to criticize Florida's voting process. Some officials have vowed to investigate why there were problems at the polls and how that led to a lengthy vote count.

If there had been a recount, it would not be as difficult as the lengthy one in 2000. The state no longer uses punch-card ballots, which became known for their hanging chads. All 67 counties now use optical scan ballots where voters mark their selections manually.

Republican George W. Bush won the 2000 contest after the Supreme Court declared him the winner over Democrat Al Gore by a scant 537 votes.

The win gave Obama victories in eight of the nine swing states, losing only North Carolina. In addition to Florida, he won Ohio, Iowa, New Hampshire, Wisconsin, Virginia, Colorado and Nevada.

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“Hunger Games” star Jennifer Lawrence will not diet for role

LOS ANGELES (Reuters) – “The Hunger Games” star Jennifer Lawrence will not be dieting for a role any time soon.

Lawrence, 22, who plays the famished Katniss Everdeen in the life-or-death thriller series, told Elle magazine in an interview to be published on November 13 that dropping a few pounds will not be part of her script.

“I’m never going to starve myself for a part,” Lawrence said, a view out of step with many in diet-obsessed Hollywood.

Lawrence’s figure in “The Hunger Games” raised eyebrows of some critics, who believed the actress looked a little too healthy for a character struggling to eat.

“I don’t want little girls to be like, ‘Oh, I want to look like Katniss, so I’m going to skip dinner,” Lawrence said. “That’s something I was really conscious of during training…I was trying to get my body to look fit and strong – not thin and underfed.”

Suffering for a role by rapidly losing or gaining weight is part of Hollywood lore.

Natalie Portman was applauded for dropping some 20 pounds for her Oscar-winning role as a ballerina in 2010′s “Black Swan”. Likewise Robert De Niro nabbed an Oscar after packing on 60 extra pounds in 1980 boxing film “Raging Bull”.

Lawrence’s figure did not hurt the first installment of the “The Hunger Games” series, which was released in March and has grossed some $ 670 million worldwide. The actress has signed on for three sequels.

(Reporting By Jill Serjeant; Editing by David Gregorio)

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Google says multiple services blocked in China

SAN FRANCISCO (Reuters) – Google Inc said several of its online services have been blocked in China.

Traffic to Google’s services in China dropped sharply beginning Friday evening there, according to an online “Transparency Report” website operated by Google, which provides updates about access to its services in different parts of the world.

Among the sites affected were Google’s search engine and its Gmail web email product.

The disruptions come as China’s once-in-a-decade meeting to appoint new leadership gets underway.

A Google spokeswoman said the company did not know why the disruption was happening. Google said in a statement that it had “checked and there’s nothing wrong on our end.”

Google’s YouTube video service has been inaccessible in China since 2009, while access to other services in China are blocked sporadically.

In 2010 Google relocated its Chinese search engine to Hong Kong after a spat with authorities over censorship and cyber-attacks that Google said originated in China.

(Reporting By Alexei Oreskovic; editing by John Wallace)

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Syria opposition bloc elects Christian as leader

DOHA, Qatar (AP) — Syria‘s main opposition group in exile has elected a Christian Paris-based former geography teacher as its new president.

George Sabra said Friday that his election as head of the Syrian National Council is a sign that the opposition is not plagued by sectarian divisions.

Sabra says the SNC‘s main demand is to receive weapons from the international community. The U.S. and some other foreign backers of rebels fighting the regime of President Bashar Assad have so far refused to send weapons for fear they can fall into the wrong hands.

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Uncle Sam to Start Tracking Tobacco Use in Movies Aimed at Kids

Federal health authorities said Friday they will begin monitoring how well movie studios are doing to reduce depictions of smoking and other tobacco use in youth-rated movies.

Authorities at the Center for Disease Control and Prevention’s Office on Smoking and Health said that voluntary efforts by movie studios to reduce tobacco use in youth-rated movies have been unimpressive. Data on tobacco use in movies will  be added to regular CDC reports to the public on smoking prevalence among youth and adults, total and per-capita cigarette consumption, and progress on tobacco control policies.

“We all have a responsibility to prevent youth from becoming tobacco users, and the movie industry has a responsibility to protect our youth from exposure to tobacco use and other pro-tobacco imagery in movies that are produced and rated as appropriate for children and adolescents,” said the lead author of the paper, Dr. Tim McAfee. “Eliminating tobacco imagery in movies is an important step that should be easy to take.”

MORE: PG-13 Movies May Start Teens Smoking

Understanding what motivates kids to smoke is a high priority of public-health experts. According to the U.S. Department of Health and Human Services, more than 3,800 kids a day smoke their first cigarette. And, while smoking rates fell over the past 40 years, rates in both adults and youths have held steady in more recent years.

Previous research shows that kids who see smoking on television and in the movies are more likely to take up smoking. But depictions of smoking continue to turn up in youth-rated movies. Last year, the number of on-screen smoking scenes increased, according to a study published in the October issue of the journal Preventing Chronic Disease.

The data, from Thumbs Up! Thumbs Down!, a project of  Breathe California-Emigrant Trails, is based on tobacco incidents in top-grossing movies each year rated G, PG and PG-13. The study looked at 134 movies that were among the 10 top-grossing, youth-rated movies last year for at least one week.

The study found the number of tobacco incidents rose 3 percent (1,881 incidents) in 2011 compared to 2010 despite the fact that there were five fewer movies in the 2011 sample. The number of tobacco incidents per movie rose 7 percent over 2010 — 13.1 incidents per movie in 2010 and 14 last year. The biggest increase in smoking depictions occurred in G and PG movies.

MORE: Smoking Rates Around the World Are Astronomical

And, while kids aren’t supposed to see R-rated movies, smoking incidents in those films rose 7 percent in 2011, said the author of the study, Dr. Stanton A. Glantz, a professor of medicine for the Center for Tobacco Control Research and Education at the University of California, San Francisco. Glantz has been studying smoking in the movies for many years.

“There are going to be hundreds or thousands of kids who will take up smoking due to this backsliding,” Glantz told Take Part. “There is a dose response here, too — the more kids see, the more likely they will smoke.”

The uptick in smoking comes at a time when health professionals are unified behind the idea that kids are influenced by such depictions in the media. In a report released earlier this year, U.S. Surgeon General Regina Benjamin identified smoking in movies and tobacco-company advertising as the primary forces that cause kids to take up smoking.

“The evidence is sufficient to conclude that there is a causal relationship between depictions of smoking in the movies and the initiation of smoking among young people,” the Surgeon General’s report noted. Images of smoking in the movies, “are powerful because they can make smoking seem like a normal, acceptable, or even attractive activity. Young people may also look up to movie stars, both on and off screen, and may want to imitate behaviors they see.”

MORE: Teen Smoking an ‘Epidemic,’ Surgeon General Says

Previous studies have also showed that depictions of smoking in the movies are more likely to influence low-risk kids to smoke; “the kids whose parents don’t smoke or kids who do well in school,” Glantz says.

The increase in on-screen smoking is further disappointing because top officials for three studios — Comcast (Universal), Disney and Time Warner — had previously committed to reductions in smoking in their movies, Glantz says. Smoking in youth-rated movies declined from 2005 to 2010.

Among these companies with stated policies discouraging smoking in movies, the percentage of movies that were tobacco-free declined by 17 percent from 2010 to 2011.

“A few studios had taken the lead in reducing the amount of smoking in their films,” Glantz says.  “They accomplished it and showed it could be done. But now there is this serious back-sliding. I don’t know what accounts for that.  These three studios are now about as bad as the studios that hadn’t made a lot of progress. I don’t know what happened.”

The Walt Disney Company “actively seeks to limit the depiction of smoking in

movies marketed to youth,” according to a statement released by the company to Take Part.

MORE: U.S. Appeals Court Strikes Down Graphic Cigarette Warning Labels

“Disney discourages depictions of cigarette smoking in movies produced in the United States for which a Disney entity is the sole or lead producer and which are released either as a Touchstone movie or Marvel movie, and seeks to limit cigarette smoking in those movies that are not rated “R” to: scenes in which smoking is part of the historical, biographical or cultural context of the scene or is important to the character or scene from a factual or creative standpoint, or to scenes in which cigarette smoking is portrayed in an unfavorable light or the negative consequences of smoking are emphasized,” according to the statement.

The company also said it prohibits tobacco product placement and promotions and will  place anti-smoking public service announcements on DVD’s of new and newly re-mastered titles, not rated “R,” that depict cigarette smoking and will work with theater owners to encourage the exhibition of an anti-smoking public service announcement before the theatrical exhibition of any such movie.

But the World Health Organization and other public health groups have recommended formal policies aimed at eliminating smoking in the movies, McAfee noted.

MORE: Teens: Smoking Less, Calling It ‘Scummy’ More

The Glantz study raises “serious concerns about this individual company approach,” he wrote. “This difference suggests that individual company policies may not be sufficient to sustain a reduction in youth exposure to tobacco-use and other pro-tobacco imagery in movies and that more formal, industry-wide policies are needed.”

Glantz has long argued for a modernized rating system to give movies with any tobacco use an R rating, unless the presentation of tobacco “clearly and unambiguously reflects the dangers and consequences of tobacco use,” he says. Other options to discourage smoking are to run anti-smoking messages prior to the movie and persuading movie studies to adopt policies to certify they receive no payments for depicting particular tobacco brands in their movies.

“The MPAA has refused to address this issue in a meaningful way by giving movies with smoking an R rating,” Glantz says. “They have never rated a single movie R for smoking. The goal here is to get smoking out of the movies being shown to kids.”

Question: Should movies that depict smoking receive an R rating? Tell us what you think in the comments.

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Shari Roan is an award-winning health writer based in Southern California. She is the author of three books on health and science subjects.

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CIA director resigns, reportedly over an affair

CIA Director David Petraeus has resigned, Director of National Intelligence James Clapper said in a written statement Friday. The former Army general, who rocketed to global prominence as the man in charge of the "surge" in Iraq, quit over an extramarital affair, MSNBC reported.

"Today, CIA Director David Petraeus submitted his letter of resignation to the President," Clapper wrote. "Dave's decision to step down represents the loss of one of our nation's most respected public servants.

"From his long, illustrious Army career to his leadership at the helm of CIA, Dave has redefined what it means to serve and sacrifice for one's country," continued Clapper, whose statement did not specify a reason for the decision.

Petraeus went to work as CIA chief in September 2011 after heading up the war in Afghanistan. He had drawn fire in the aftermath of the Sept. 11 attack on the American compound in Benghazi, Libya.

White House Press Secretary Jay Carney said President Barack Obama "will address this with a statement later." But he declined to confirm the circumstances of the retired general's departure. "I don't have any details to give to you," he said.

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Andy Summers film documents surviving the Police

LOS ANGELES (Reuters) – Police guitarist Andy Summers has always been a multifaceted artist – musician, songwriter, photographer and author. Now he can add filmmaker to his extensive resume.

“Can’t Stand Losing You: Surviving the Police,” Summers’ 90-minute documentary film that chronicles his musical career and life with supergroup, has its world premiere at the DOC NYC festival in New York on Friday.

Summers, who narrates the film, describes it as “a musical journey” that uses live footage from the 2007-2008 Police reunion world tour, along with lots of archival material from both the early Police days and the London punk scene.

“But it’s not done as a chronological story,” he told Reuters. “We establish the fact we’re doing the reunion tour early on, and then it dips in and out of live Police concert footage, and then starts going back to the earlier days.”

Based on his 2006 memoir “One Train Later,” the documentary also incorporates rare footage dating back to the 1960s, when Summers, now 69, was involved with the early British rock scene and seminal artists including British vocalist and keyboard player Zoot Money and Eric Burdon. The film also features many still photographs that the rock star took along the way.

“I was always interested in photography, so it was very natural for me to document everything, whether it was backstage at some grungy club or on early tours with the Police,” he said.

“So there’s a lot of intimate moments and interesting shots and archival stuff, especially in the first 25 minutes of the film, with the Sex Pistols appearing and so on.”

BUMPING INTO FAME

Following his book’s lead, the film also documents the serendipitous nature of the formation of the Police, one of the biggest bands in rock history, when Summers “just happened to bump into” drummer Stewart Copeland in a London Underground station one day in 1977.

The two decided to have coffee and discuss forming a new band with a then-unknown singer called Sting, whom they had just met.

“One train later, and it all might never have happened,” recalled Summers, “which is why I titled the book ‘One Train Later.’”

He would have preferred that title for the documentary. “It’s much hipper and doesn’t pander to the obvious Police connection,” he said, “so I’m hoping at some point we’ll change it to that.”

Inevitably, the film also focuses on the breakup of the always-combustible and often acrimonious trio.

“It’s obviously a very painful and poignant moment, when we all realize, ‘Well, that’s it,’” Summers said of the 2008 footage documenting the band’s final dissolution.

“The camera lingers on all our faces, and you can see the raw emotion there. It’s very bittersweet.”

As for rumors that the Police may re-form yet again for another tour, Summers does not think that is likely, even though their 30th reunion tour grossed more than $ 350 million.

“But then I never thought we’d get back together to do the last tour, so I never shut the door on anything,” he said. “I personally think that my book was somewhat of a provoking agent in getting the Police reunited, so maybe this film will do the same thing again.”

(Reporting by Iain Blair, Editing by Jill Serjeant, Patricia Reaney and Lisa Von Ahn)

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Social media shakes up solitary online FX trading

LONDON (Reuters) – The solitary world of online foreign exchange trading is emerging from the shadows as solo investors turn to specialist social media networks to link up with their peers and seek market-beating strategies.

Individual or retail trading, estimated at 8-10 percent of the $ 2.5 trillion daily spot FX market, used to conjure an image of a lone trader with little contact with the outside world.

But that is changing. Thanks to specially tailored websites known as social trading networks, users are able to see and even copy the trades of top-ranked rivals, swap ideas and gauge the market mood in online chat with a community of contacts.

“In the world of trading there are a lot of signals but social media gives us the market sentiment and it is ideal for chatting to people across the world for trade ideas,” said Patrick Orini, who has been trading FX online since 2004.

Retail forex traders make their deals using personal accounts through brokers such as Alpari, FxPro and IronFX. Increasingly, traders are hooking up their broker accounts with social trading networks, such as eToro, Currensee and Tradeo.

Traders usually pay a subscription to use the service while the social network and the broker might share revenue on trades.

In a system reminiscent of microblog network Twitter, top players who make their trades visible can gather thousands of followers, some of whom pay to copy their strategies.

Orini’s trading account on a social trading network called Tradeo has 500 followers, of whom around 20 copy his trades.

If online investors do well in their trades, they will attract more followers and will be ranked higher on the trader “leaderboard” posted on the site.

Retail FX has grown over the last decade as brokers allow individual traders to take highly leveraged positions previously accessible only to institutional investors. The largest group of market players is based in Japan.

eToro, one the world’s largest social trading platforms has processed more than 20 million trades since it went live at the beginning of 2012.

Tradeo, a social network for forex traders based in Tel Aviv, launched three months ago and, according to its co-founder and CEO Jonathan Adest, the site has posted up to half a billion dollars of trades from around 10,000 traders since then.

“It’s not a broker, but a network for brokers — a bit like an online trading room,” Adest said.

He said Tradeo also combats a key hazard of online trading — inaccurate or bogus information. Traders often swap ideas on comment boards, but anonymity and low security makes it difficult to weed out spam.

“The idea of creating a niche social network for forex traders is to help verify commentators usually found in chat rooms and comment boards,” Adest said.

In its increased use of social media, online forex trading is catching up with developments in the equities market.

Retail equities trading is estimated to account for up to half of trade in UK small companies. Retail FX’s smaller share of the overall market reflects the fact that most trade is over-the-counter and lack of volatility that make it harder to turn a profit.

TWITTER

In the equities market, analysis of Twitter postings and news headlines has been used to predict stock price movements.

London-based hedge fund firm Derwent Capital is launching a new spread betting application for retail traders in January that will use Twitter’s 350 million daily tweets to create a sentiment indicator covering currency pairs and other assets.

Social media makes existing currency market sentiment models more effective, said John Hardy, head of FX strategy at Saxo Bank.

“It would be a new way to measure “sentiment” in real time, something that banks can do already via how people are actually trading…but the Twitter measures might be able to bring new nuances and sophistication,” he said.

Arguably, solo traders who hook up to social trading networks are seeking an edge in the “wisdom of crowds”.

“The reason why so many people, like myself, do share their activity and ideas is to help each other and build the community,” Orini said. “I got so many valuable ideas from other traders, that I’m more than happy to share my ideas as well.”

(Editing by Nigel Stephenson)

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Myanmar says Obama to visit later this month

YANGON, Myanmar (AP) — President Barack Obama will make a groundbreaking visit later this month to Myanmar, an official said Thursday, following through with his policy of rapprochement to encourage democracy in the Southeast Asian nation.

The Myanmar official speaking from the capital, Naypyitaw, said Thursday that security for a visit on Nov. 18 or 19 had been prepared, but the schedule was not final. He asked not to be named because he was not authorized to give information to the media.

The official said Obama would meet with opposition leader Aung San Suu Kyi as well as government officials including reformist President Thein Sein.

It would be the first-ever visit to Myanmar by an American president. U.S. officials have not yet announced any plans for a visit, which would come less than two weeks after Obama’s election to a second term.

Obama’s administration has sought to encourage the recent democratic progress under Thein Sein by easing sanctions applied against Myanmar’s previous military regime.

Officials in nearby Thailand and Cambodia have already informally announced plans for visits by Obama that same week. Cambodia is hosting a summit meeting of the Association of Southeast Asian Nations, and Thailand is a longtime close U.S. ally.

The visit to Myanmar, also known as Burma, would be the culmination of a dramatic turnaround in relations with Washington as the country has shifted from five decades of ruinous military rule and shaken off the pariah status it had earned through its bloody suppression of democracy.

Obama’s ending of the long-standing U.S. isolation of Myanmar’s generals has played a part in coaxing them into political reforms that have unfolded with surprising speed in the past year. The U.S. has appointed a full ambassador and suspended sanctions to reward Myanmar for political prisoner releases and the election of Nobel laureate Suu Kyi to parliament.

From Myanmar’s point of view, the lifting of sanctions is essential for boosting a lagging economy that was hurt not only by sanctions that curbed exports and foreign investment, but also by what had been a protectionist, centralized approach. Thein Sein’s government has initiated major economic reforms in addition to political ones.

A procession of senior diplomats and world leaders have traveled to Myanmar, stopping both in the remote, opulent capital city, which was built by the former ruling junta, and at Suu Kyi’s dilapidated lakeside villa in the main city of Yangon, where she spent 15 years under house arrest. New Zealand announced Thursday that Prime Minister John Key would visit Myanmar after attending the regional meetings in Cambodia.

The most senior U.S. official to visit was Hillary Rodham Clinton, who last December became the first U.S. secretary of state to travel to Myanmar in 56 years.

The Obama administration regards the political changes in Myanmar as a marquee achievement in its foreign policy, and one that could dilute the influence of China in a country that has a strategic location between South and Southeast Asia, regions of growing economic importance.

But exiled Myanmar activists and human rights groups are likely to criticize an Obama visit as premature, rewarding Thein Sein before his political and economic reforms have truly taken root. The military — still dominant and implicated in rights abuses — has failed to prevent vicious outbreaks of communal violence in the west of the country that have left scores dead.

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Home blood pressure monitors show mixed results

NEW YORK (Reuters Health) – Home blood pressure monitors may be useful to some older adults who’ve suffered a stroke, but little help to others, a new study suggests.

Researchers found that overall, home monitors did not help stroke sufferers get a better handle on their blood pressure over one year.

The exception, though, was patients whose blood pressure was poorly controlled at the study’s start – meaning it was above the standard high blood pressure cutoff of 140/90 mm Hg.

In that case, patients given a home monitor cut an average of 11 points from their systolic blood pressure (the top number in a blood-pressure reading). That compared with just under five points among patients who were not given the devices.

That’s a meaningful difference, said Hayden B. Bosworth, a professor of medicine at Duke University in Durham, North Carolina, who was not involved in the study.

The lack of overall benefit in the study doesn’t mean stroke patients shouldn’t use blood pressure monitors, according to Bosworth, who studies ways to improve people’s management of high blood pressure and other chronic conditions.

“It may be a matter of finding the right people to give them to,” he said.

Sally M. Kerry, the lead researcher on the study, said that many people who’ve had a stroke are “very motivated” to prevent another. So they may already be doing their best to keep their numbers under control.

“The main issue seems to be with those who already have relatively well-controlled blood pressure. Home monitoring is unlikely to improve this, although people do find it reassuring,” Kerry, a researcher at Queen Mary, University of London in the UK, said in an email.

She and her colleagues report their findings in the Canadian Medical Association Journal.

Past studies have found that home monitoring may aid blood pressure control. A 2010 review of 37 clinical trials found that overall, people who used monitors shaved a few extra points from their blood pressure. They were also more likely to cut down on medication compared with patients who stuck with traditional doctor’s office measurements.

The new study focused on patients who’d recently had a stroke – a group, Bosworth noted, that hasn’t really been studied when it comes to home blood pressure monitoring. He said that’s probably in part because there is no real consensus on what stroke survivors’ blood pressure levels should be.

Kerry’s team randomly assigned the patients to either stick with standard care only or get a home monitor – along with instructions on how to use it and periodic phone calls from a nurse to check on how they were doing.

Over the next year, the results were mixed. Among the patients who didn’t seem to benefit were those who’d been left disabled by their stroke. Home monitors showed no effects on their blood pressure, while non-disabled patients cut about four points using a monitor.

“Some patients had difficulty in carrying out monitoring because they did not have a carer who lived with them to help,” Kerry said.

Bosworth pointed out that many people with high blood pressure already have home monitors, and these findings do not mean that stroke survivors can’t benefit.

It may just be that an elderly person left disabled by a stroke is “not the best” candidate, he said.

And for a monitor to benefit anyone, the numbers have to be put to good use, Bosworth said. That means a person’s healthcare provider has to know what the numbers are and make any needed adjustments in the patient’s medication.

Traditionally, people have had to bring their home readings to their doctor at each visit; some monitors automatically record each reading and allow you to print them out. But there is also “telemonitoring,” wherein wired or wireless technology is used to automatically send blood pressure readings to the doctor’s office.

That’s not widely used in the real world yet, but studies have suggested that telemonitoring boosts the effectiveness of home blood pressure measurements.

Home monitors range in cost from about $ 25 to more than $ 100, depending on the features. Experts generally suggest that you choose a monitor that has been validated for accuracy according to international criteria.

Some groups, like the British Hypertension Society and the Association for the Advancement of Medical Instrumentation, test blood pressure monitors’ reliability and keep lists of validated monitors on their websites.

The current study was funded by The Stroke Association, a UK charity.

If you do use a monitor, Kerry cautioned against interpreting the readings on your own and changing your medication dose.

In this study, she noted, some patients using home monitors did take it upon themselves to cut down on medication when they saw that their numbers looked good. And that, Kerry added, might be one reason why patients with fairly good control at the outset did not see a further improvement when they used a monitor.

SOURCE: http://bit.ly/STMwU2 CMAJ, online November 5, 2012.

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Loughner gets life for deadly Ariz. rampage

TUCSON, Ariz. (AP) — Former Congresswoman Gabrielle Giffords, partially blind, her right arm paralyzed and limp, came face to face Thursday with the man who tried to kill her last year, standing beside her husband as he spoke of her struggles to recover from being shot in the head.

"Her life has been forever changed. Plans she had for our family and her career have been immeasurably altered," said astronaut Mark Kelly, both he and his wife staring at the shooter inside a packed courtroom. "Every day is a continuous struggle to do those things she once was so good at."

Jared Lee Loughner, 24, was then ordered to serve seven consecutive life sentences, plus 140 years in federal prison for the January 2011 shooting rampage that killed six people and wounded 13 others, including Giffords, outside a grocery store in Tucson, Ariz.

Loughner pleaded guilty under an agreement that guarantees he will spend the rest of his life in prison without the possibility of parole. He avoids a federal death sentence, although state prosecutors could still decide to try him.

One by one, survivors of the attack at a Giffords political event approached the courtroom podium to address Loughner, each turning toward him where he sat stoic and emotionless at a table with his attorneys.

"You took away my life, my love and my reason for living," said Mavanell Stoddard, who was shot three times and cradled her dying husband in her arms as he lay bleeding on the sidewalk after shielding her from the spray of bullets.

Susan Hileman, who was shot, spoke to him, at times visibly shaking.

"We've been told about your demons, about the illness that skewed your thinking," she said. "Your parents, your schools, your community, they all failed you.

"It's all true," Hileman said. "It's not enough."

"You pointed a weapon and shot me three times," she said, staring directly at Loughner. He looked back at her. "And now I walked out of this courtroom and into the rest of my life and I won't think of you again."

Loughner's parents sat nearby, his mother sobbing.

Some victims, including Giffords, welcomed the plea deal as a way to move on. It spared them and their families from having to go through a potentially lengthy and traumatic trial and locks up the defendant for life.

Giffords didn't speak, but stood by Kelly and kissed her husband when he was done. He grabbed her hand and they walked away, her limping.

Earlier, Loughner told Burns that he would not speak at the hearing.

Both sides reached the deal after a judge declared that Loughner was able to understand the charges against him. After the shooting, he was diagnosed with schizophrenia and underwent forcible psychotropic drug treatments.

Christina Pietz, the court-appointed psychologist who treated Loughner, had warned that although Loughner was competent to plead guilty, he remained severely mentally ill and his condition could deteriorate under the stress of a trial.

When Loughner first arrived at a Missouri prison facility for treatment, he was convinced Giffords was dead, even though he was shown a video of the shooting. He eventually realized she was alive after he was forcibly medicated.

It's unknown whether Pima County prosecutors, who have discretion on whether to seek the death penalty against Loughner, will file state charges against him. Stephanie Coronado, a spokeswoman for Pima County Attorney Barbara LaWall, said Wednesday that no decision had been made.

It's also unclear where Loughner will be sent to serve his federal sentence. He could return to a prison medical facility like the one in Springfield, Mo., where he's been treated for more than a year. Or he could end up in a prison such as the federal lockup in Florence, Colo., that houses some of the country's most notorious criminals, including Oklahoma City bombing conspirator Terry Nichols and "Unabomber" Ted Kaczynski.

Read More..

Look who’s talking! Kirstie Alley calls Travolta “greatest love”

LOS ANGELES (Reuters) – Actress Kirstie Alley described on Wednesday how she fell in love more than 20 years ago with John Travolta, and rejected widespread Hollywood speculation that the “Grease” star is secretly gay.

Alley, former star of the 1980s TV comedy “Cheers,” told ABC television journalist Barbara Walters that she fell for both Travolta and actor Patrick Swayze in the 1980s, although their romances never got physical.

Alley, 61, said she was attracted to Travolta while the pair were making the 1989 movie “Look Who’s Talking,” calling him “the greatest love of my life.”

“Believe me, it took everything I had inside, outside, whatever, to not run off and marry John and be with John for the rest of my life,” Alley told Walters in an interview broadcast on breakfast TV show “Good Morning America.”

Asked by Walters to comment on persistent rumors about Travolta’s sexuality, she said: “I know John with all my heart and soul. He’s not gay.”

Alley added: “I think in some weird way, in Hollywood, if someone gets big enough and famous enough, and they’re not out doing drugs and they’re not womanizing, what do you say about them?”

Travolta was single at the time, but Alley was on her second marriage, so she never pursued her feelings, she explained.

Travolta later married actress Kelly Preston, his wife for the past 20 years. But the actor was the target of two lawsuits earlier this year, which were quickly dropped, from two male masseurs who claimed Travolta made unwanted sexual advances.

Alley, who talks more about her love life in her new book, “The Art of Men,” said she fell for Swayze while they were filming the 1985 Civil War TV miniseries “North and South.”

“We did fall in love. I was more willing to break up my marriage and I wasn’t willing to break up his marriage,” Alley said, explaining why the relationship failed to go further.

Swayze, best known for his lead role in “Dirty Dancing,” died of pancreatic cancer in 2009 at the age of 57. He was married to dancer Lisa Niemi from 1975 until his death.

Alley has been married twice. Her second marriage, to actor Parker Stevenson, ended in 1997.

(Reporting by Jill Serjeant; editing by Matthew Lewis)

Celebrity News Headlines – Yahoo! News

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Exclusive: Google Ventures beefs up fund size to $300 million a year

SAN FRANCISCO (Reuters) - Google will increase the cash it allocates to its venture-capital arm to up to $300 million a year from $200 million, catapulting Google Ventures into the top echelon of corporate venture-capital funds.

Access to that sizeable checkbook means Google Ventures will be able to invest in more later-stage financing rounds, which tend to be in the tens of millions of dollars or more per investor.

It puts the firm on the same footing as more established corporate venture funds such as Intel's Intel Capital, which typically invests $300-$500 million a year.

"It puts a lot more wood behind the arrow if we need it," said Bill Maris, managing partner of Google Ventures.

Part of the rationale behind the increase is that Google Ventures is a relatively young firm, founded in 2009. Some of the companies it backed two or three years ago are now at later stages, potentially requiring larger cash infusions to grow further.

Google Ventures has taken an eclectic approach, investing in a broad spectrum of companies ranging from medicine to clean power to coupon companies.

Every year, it typically funds 40-50 "seed-stage" deals where it invests $250,000 or less in a company, and perhaps around 15 deals where it invests up to $10 million, Maris said. It aims to complete one or two deals annually in the $20-$50 million range, Maris said.

LACKING SUPERSTARS

Some of its investments include Nest, a smart-thermostat company; Foundation Medicine, which applies genomic analysis to cancer care; Relay Rides, a carsharing service; and smart-grid company Silver Spring Networks. Last year, its portfolio company HomeAway raised $216 million in an initial public offering.

Still, Google Ventures lacks superstar companies such as microblogging service Twitter or online bulletin-board company Pinterest. The firm's recent hiring of high-profile entrepreneur Kevin Rose as a partner could help attract higher-profile deals.

Soon it could have even more cash to play around with. "Larry has repeatedly asked me: 'What do you think you could do with a billion a year?'" said Maris, referring to Google chief executive Larry Page.

(Editing by Muralikumar Anantharaman)

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Merkel says Germany, Britain must work together on EU

LONDON (Reuters) – Germany and Britain must cooperate to work round their differences on the European Union‘s long-term spending plans, German Chancellor Angela Merkel said on Wednesday.

“Despite differences that we have it is very important for me that the UK and Germany work together,” Merkel said through a translator before a meeting in London with Prime Minister David Cameron to discuss the EU‘s 2014-2020 budget.

“We always have to do something that will stand up to public opinion back home. Not all of the expenditure that has been earmarked has been used with great efficiency … We need to address that,” she said.

EU leaders meet in Brussels on November 22-23 to try to secure a seven-year budget for the 27-nation bloc amid signs of differences of opinion over what action should be taken.

(Reporting by Peter Griffiths; Editing by Andrew Osborn)

Europe News Headlines – Yahoo! News

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Pediatric clinical trials not going overseas – study

NEW YORK (Reuters Health) – Despite some concerns that medical studies involving children could make an ethically dubious shift to developing nations, a new study suggests that’s not happening.

It’s really only in the last decade that clinical trials – even in the U.S. and Europe – have started to focus on children, said Dr. Dianne Murphy, director of the U.S. Food and Drug Administration (FDA) Office of Pediatric Therapeutics.

Since children cannot give informed consent to enter a study (their parents have to do it), kids have historically been left out of clinical trials testing vaccines, drugs and other therapies.

But that’s a problem, Murphy explained, because children are not small adults, and study results from adults cannot simply be extended to them.

“We don’t know if we’re giving them the right dose, or if it’s even going to be effective,” Murphy explained.

So pediatric clinical trials are necessary. But since most children are, fortunately, healthy, researchers have to cast a wider net for study participants.

“You do have to reach out to more countries and more locations,” Murphy said.

And that has led some to question whether there could be an inappropriate shift to countries where ethical guidelines – like making sure parents give truly informed consent – might not be closely monitored.

In the new study, however, Murphy and her colleagues found that the number of pediatric clinical trials in developing countries has actually declined in recent years. And the U.S. remains, by far, the most common trial location.

Of 346 pediatric trials the FDA reviewed, the U.S. participated in 86 percent, providing three-quarters of the patients. Less developed and transitional countries, like Mexico, Brazil and India, took part in 22 percent and accounted for 10 percent of all kids involved.

The figures come from trials submitted to the FDA in support of therapies approved between 2007 and 2010.

Developing nations, the agency found, played a smaller role in those trials than they had just a few years earlier.

In an earlier study of trials submitted between 2002 and 2007, the FDA found that developing countries took part in 38 percent of trials, and accounted for almost one-quarter of patients.

Those numbers will naturally shift depending on the diseases and treatments being studied in a given time period, Murphy noted.

If there are more trials testing vaccines or treatments for infectious disease, developing nations will tend to be more involved. And that’s appropriate, Murphy said, because those diseases are a far bigger problem in developing countries.

“Children shouldn’t be in a trial unless there’s an opportunity for them to benefit,” Murphy said.

The researchers didn’t find evidence that kids in developing countries were being recruited into trials for diseases that are irrelevant to them. Of children enrolled in Mexico, for example, 97 percent were involved in vaccine trials.

In addition, most trials being done in developing countries (75 percent) were also running in wealthy ones.

Murphy said the FDA is taking steps to ensure that pediatric trials are being done appropriately. “For one,” she noted, “everyone should be aware that we’re reviewing this. That alone is important.”

But she said the agency also offers training to regulators in other countries, and has regular conference calls with officials in developing nations to help them with “in-the-weeds kinds of questions.”

“These conversations, particularly for (trials with) children, are very important,” Murphy said.

Continuing to do trials involving kids is also vital, according to Murphy.

“If we don’t, then your child becomes an experiment of one,” she said, noting that research suggests that products that work for adults’ ills do not work for children about one-fifth of the time.

SOURCE: http://bit.ly/UwOXbC Pediatrics, online November 5, 2012.

Medications/Drugs News Headlines – Yahoo! News

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Boehner, Reid in talks to avert 'fiscal cliff'

WASHINGTON (Reuters) - Fresh off the election, the two top leaders of Congress began tentative discussions on Wednesday aimed at heading off potential economic disaster at year's end, when simultaneous tax increases and spending cuts threaten to throw the United States into a recession.

The leader of the Senate's Democratic majority, Harry Reid, said he had conferred Wednesday morning with his Republican counterpart in the U.S. House of Representatives, Speaker John Boehner, and both had agreed not to "draw any lines in the sand" for the time being.

At the same time, Reid stressed that Democrats were not likely to budge from their standard negotiating position, that tax increases should apply to the wealthy, not those in the middle class or below.

The re-election of President Barack Obama and Democratic gains in the U.S. Senate, Reid said, had validated the party's position on taxes.

"I'm willing to negotiate at any time on any issue ... I want to work together but I want everyone to understand you can't push us around," Reid said

Reid said it was his preference they reach agreement in the post-election session of Congress that begins next week on ways to avoid the so-called "fiscal cliff" - the combination of expiring tax cuts and automatic across-the-board reductions in federal spending due at year's end.

He said would prefer a solution in this year's so-called lame duck session rather than enact a temporary fix for the fiscal cliff and would push the issue into the newly elected Congress, which starts in January.

"I'm not for kicking the can down the road," he told reporters. "We need to solve it."

Boehner, will deliver a statement at 3:30 p.m. EST on Wednesday on the need for a bipartisan deal.

Boehner will make his case a day after American voters gave Obama a second term, but maintained a divided government, with Republicans still in control of the House and Democrats still holding the Senate.

Boehner will argue that Republicans and Democrats must "take steps together," a spokesman said in a press release.

(Reporting By Thomas Ferraro; Editing by Fred Barbash and Jackie Frank)

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A Minute With: Taylor Lautner finding new dawn after “Twilight”

LOS ANGELES (Reuters) – As dusk sets on the “Twilight” saga with the final film, actor Taylor Lautner is looking at a new dawn for the next stage in his career.

Lautner, 20, shot to fame after being cast as werewolf Jacob Black in the “Twilight” films, entangled in a torrid love triangle with Kristen Stewart‘s Bella Swan and Robert Pattinson‘s vampire Edward Cullen. He became a household name and pin-up for his clean-cut good looks and shirtless scenes.

In “Breaking Dawn – Part 2,” out in U.S. theaters on November 16, Lautner’s character finds new love, albeit unusual, and indulges his comedic side as the story comes to an end.

Lautner spoke to Reuters about leaving Jacob and his cast mates behind, and why the final film may leave fans in tears.

Q: What’s different about Jacob in “Breaking Dawn – Part 2″?

A: “He’s always been so stressed and emotional and things aren’t going his way and there was a huge weight lifted off his shoulders in this one, huge. It was nice to play that side of Jacob where he could sit back and relax and have a smile on his face and crack a few funny jokes every now and then.”

Q: Jacob finds his soul mate in Bella and Edward’s daughter Renesmee from the moment she is born. Was it challenging to balance his affection for her without coming across creepy?

A: “It was a challenge, and it is so complicated, but really nobody understands it more than Stephenie Meyer who created it. I was picking her brain all day long about it. She basically told me over and over again, ‘Taylor, stop trying to overthink it, stop trying to take it different places … It’s a life-long bond between two people, that’s it.’ In the movie, (Renesmee) is 10 years old, it’s much more of a protector relationship right now, and of course the relationship will grow but we don’t explore that, but it was important for me to keep it simple.”

Q: What are you going to miss most about your character and the franchise?

A: “These characters have never stopped changing throughout the entire franchise, and that’s what I love about Jacob. Jacob himself has grown up so much and gone through so many hurdles and it was a fantastic character to play. For me, it’ll be tough to say goodbye to spending time with people that I love. We’ve grown so close over the past few years. Our relationships will go on past this but to not have that excuse to spend day after day together while filming or promoting will be different.”

Q: “Twilight” fans are not just interested in your characters, they’re also interested in your personal lives. The past summer has seen a lot of attention on Robert and Kristen’s relationship. How do you handle that level of scrutiny?

A: “It’s unlike anything else because when we do talk about the movies, 90 percent of the time people want to know more about ourselves than the characters and what’s going on. I guess that just comes with a fan base like this, it comes with the job and you try and not let it affect you too much, but I have no complaints … The scrutiny, is it unfortunate? Yeah, but you just got to make your way around it and think about things more.”

Q: Do you feel protective of your cast members?

A: “Yes, I definitely do, we’re so close by this point, I think that it’s hard not to.”

Q: What do you hope “Twilight” fans take away from “Breaking Dawn – Part 2″?

A: “I just hope they’re happy and they’re proud because we really do make these movies for them. They’re the reason we are able to make them, their support is unreal and we’re so proud of this last one. This last one specifically wraps it up so nicely, it’s an amazing movie. During the movie, it’ll keep you on the edge of your seat but by the end, I think more than a few of the fans will be in tears.”

Q: Post-Twilight, where do you want to take your career to, what roles would you like to explore? I hear you have a cameo in the comedy “Grown Ups 2″?

A: “It was great to do (comedy), just hop in and show a different side, do something fun and work with somebody like Adam (Sandler). But now I’m looking forward to doing something different from that. There are a few projects that I’m very excited about that are extremely challenging and dramatic and would be tough.”

(Reporting By Piya Sinha-Roy, editing by Jill Serjeant and Patricia Reaney)

Movies News Headlines – Yahoo! News

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Apple's shares slide 4 percent to five-month low

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Officials: New mass graves found in Ivory Coast

ABIDJAN, Ivory Coast (AP) — Up to 10 new mass graves have been discovered near the site of a July attack on a camp for displaced people, officials said Tuesday, amid allegations that initial casualty totals were downplayed to mask killings carried out by the national army.

Rights groups claim summary executions were carried out by the Republican Forces of Ivory Coast, known by its French acronym of FRCI. Last month, officials found six bodies in a well close to the former campsite in the western town of Duekoue.

Government, army and U.N. officials toured 10 more graves in the same area on Saturday, said Paul Mondouho, vice-mayor of Duekoue. He said the graves had first been identified by civilians, and that officials did not know the number of bodies they contained because they had not yet been properly exhumed.

“People were suspecting the presence of bodies in these graves because of the smell coming out of them and because of the shoes we saw nearby,” Mondouho said.

Prosecutor Noel Dje Enrike Yahau, who is based in the commercial capital of Abidjan, confirmed that multiple new graves had been discovered but could not provide details. U.N. officials and the local prosecutor in charge of investigating the suspected killings could not be reached Tuesday.

U.N. spokeswoman Sylvie van den Wildenberg confirmed that U.N. forces helped Ivorian authorities secure a perimeter around 10 wells “similar to the one in which six bodies were found,” and that “some of those wells are suspected mass graves.”

She stressed that Ivorian authorities were leading the investigation but that the U.N. was able to provide assistance.

Army spokesmen could not be reached Tuesday. The Justice Ministry has previously vowed to investigate the discovery of the initial grave.

On the morning of July 20, a mob descended on the U.N.-guarded Nahibly camp, which housed 4,500 people displaced by violence in Ivory Coast, burning most of the camp to the ground. Officials said at the time that six people were killed.

The attack was prompted by the shooting deaths of four men and one woman on the night of July 19, according to local officials and residents. In response a mob of some 300 people overran the camp on the morning of July 20 after the perpetrators of the shootings reportedly fled there.

The victims in the July 19 attack lived in a district dominated by the Malinke ethnic group, which largely supported President Alassane Ouattara in the disputed November 2010 election. The camp primarily housed members of the Guere ethnic group, which largely supported former President Laurent Gbagbo.

Gbagbo’s refusal to cede office despite losing the election to Ouattara sparked months of violence that claimed at least 3,000 lives.

Albert Koenders, the top U.N. envoy to Ivory Coast, said one week after the attack that U.N. security forces had been inside and outside the camp at the time but that no Ivorian security forces were present. He said the U.N. forces decided not to fire at a large group of people that were attacking the camp in order to avoid “a massacre.”

Several witnesses have said soldiers and traditional hunters, known as dozos, participated in the attack on the camp. Both military and dozo leaders have denied the claims, saying they had tried to protect the camp.

In a statement released Friday, the International Federation for Human Rights, known by its French acronym of FIDH, said it had information — including the preliminary results of autopsies — confirming that the six bodies found in October were men who had been summarily executed by the army.

“The disappearance of dozens of displaced persons after the attack, as well as confirmation of cases of summary and extra-judicial executions, suggest a much higher victim rate than the official figures report,” said the organization, which counts Ivorian civil society groups among its members.

Duekoue was one of the hardest-hit towns during the post-election violence. The U.N. has established that at least 505 people were killed in and around the town, including during a notorious March 2011 massacre that claimed hundreds of lives and was allegedly carried out by fighters loyal to Ouattara.

Duekoue residents belonging to ethnic groups that supported Gbagbo have long complained about abuses carried out by the FRCI, with some pointing to the direct involvement of the local commander, Kone Daouda. FIDH said in its statement that Daouda had been transferred following the discovery of the grave in October, and called for him to be interrogated over the matter.

The group also said two FRCI members were being “actively sought” after failing to return to their barracks on Oct. 16, noting that they are believed to have fled to neighboring Burkina Faso.

Africa News Headlines – Yahoo! News

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Heart devices often approved without comparisons

NEW YORK (Reuters Health) – Many new heart devices, such as valves and stents, are approved for use by the U.S. Food and Drug Administration (FDA) without good studies showing that they offer any benefits beyond existing treatments, according to a new study.

“This really leaves open the question of, ‘are you better off with this new device or whatever conventional therapy is already?’” said Dr. Rita Redberg, one of the authors of the study and a professor at the University of California, San Francisco.

Given that devices often require surgery, “from a patient point of view, you’re taking a lot more risk with a device, so the harms are potentially much greater,” added Redberg, whose team published the work in the Journal of the American Medical Association. “So it’s really very important to know that the device is an improvement over what you could have had.”

High-risk heart devices, which include implanted defibrillators, mechanical pumps and tubes called stents, go through an approval process called “premarket approval,” which includes a more stringent review of the evidence than for less risky devices.

However, the requirements for the approval of devices in general are less strict than for drugs.

The FDA requires two studies comparing the drug to a “control” – typically, the current standard of care or a fake pill called a placebo – before it will approve a drug.

For first-of-a-kind devices, FDA does require controlled trials, FDA spokeswoman Michelle Bolek told Reuters Health by email. However, the agency does not have such demands for devices that aren’t first-of-a-kind, and approval can be given without direct comparisons to controls, depending on the use of the device and the extent of experience doctors have had with it.

The FDA said there are good reasons why comparing new devices to other treatments or older generations of a product might not be feasible or ethical.

“And, requiring them could significantly and unnecessarily delay patient access to critical new technology,” Bolek added.

COMPARATIVE EFFECTIVENESS RESEARCH

Recent studies have found that sometimes patients are given newer and more expensive products without a clear indication that they’re better off for it (see Reuters report of February 28, 2012 and Reuters Health report of July 9, 2012).

The 2010 Patient Protection and Affordable Care Act, commonly called Obamacare, established the Patient-Centered Outcomes Research Institute, which funds research on comparing the effectiveness of different approaches to medical care.

To see how often heart devices are compared to existing therapies as part of the approval process, Redberg and her colleagues collected information from the FDA on all high-risk device approvals from 2000 to 2011.

They found that 40 percent of approved devices had been in studies comparing them to other treatments.

The comparison treatment could be an older generation of the same implant, a medication or a surgical procedure.

The rest of the approved devices relied on either the results from other studies in which controls were used, but the new device was not compared head-to-head with other treatments; from expectations of how well the device should work; or from research with no comparisons.

“We were surprised and disappointed,” said Redberg, who is also editor of the Archives of Internal Medicine and a member of the FDA’s Drug Administration Circulatory System Devices Panel. “We had already seen (in a previous study) there wasn’t as many randomized controlled trials as one would hope for devices, but we didn’t appreciate it until we looked at the data.”

SOMETIMES JUSTIFIABLE?

Some devices were less likely to have been compared to a conventional therapy than others.

Ventricular assist devices, for instance, used in severe cases of heart failure, were approved without any comparison to another therapy, but this could be justified, said Dr. David Brown, a professor at Stony Brook University in New York, who was not involved in the study.

“People are near death when they need the device, and it may not be ethical or practical to design a trial that compares it to something else,” he said.

“However, if you look at most of the devices in the other categories, they’re not anywhere near being performed in people who don’t have other options,” Brown told Reuters Health.

For instance, there are alternatives to new cardiac stents, pacemakers and defibrillators, such as drugs or other versions of the same devices, he pointed out.

Yet only about four out of 10 approvals for these types of devices included studies that compared them to existing treatments.

The FDA’s Bolek said the information Redberg’s group used to evaluate the studies conducted to get a device approved “does not reflect all of the data reviewed by the FDA in a (premarket approval) submission.”

Bolek said FDA weighs the quality of studies and their results, tests performed outside of the clinic and data monitoring committees.

Congress, Bolek said, has authorized the FDA to take the “least burdensome provision” to approve devices, to ensure that patients are not denied early access to new medical technology.

Dr. Ron Waksman, the associate director of the division of cardiology at the MedStar Washington Hospital Center, said the study does not differentiate between new products and slight improvements on already-approved devices.

“You don’t need to…for every change and iteration, do a clinical randomized trial” said Waksman, who was not part of the study but has been a consultant to medical device companies.

Still, Dr. William Boden at the Albany VA Stratton Medical Center said the different requirements for drug and device approvals is “egregious.”

“I think (the study) really elucidates the fact that there is just an unfortunate double standard, where there is a lack of transparency and a critical need for more comparative effectiveness evaluation before these devices come to market,” said Boden, who did not participate in the current research but whose research has been funded by pharmaceutical companies.

Brown said consumers should express their concerns about a lack of comparative effectiveness studies to their representatives in Congress.

SOURCE: http://bit.ly/Uge4Fb Journal of the American Medical Association, online November 5, 2012.

Medications/Drugs News Headlines – Yahoo! News

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If Romney wins, he would begin his first term as a baffling figure

By Walter Shapiro

In the frenetic closing hours of a hard-fought presidential campaign, Mitt Romney has been ballyhooing his bipartisan credentials. It’s part of his final argument to persuadable voters that he’s really Moderate Mitt rather than the “severely conservative” Massachusetts governor of the Republican primaries.

In Sanford, Fla., on Monday, Romney boasted that in Massachusetts, working with “a Democrat legislature—85 percent Democrat—I helped turn my state from deficit to surplus.” And the Republican nominee in his final major campaign speech Friday in West Allis, Wis., pledged, “When I’m elected, I will work with Republicans and Democrats in Congress. I will meet regularly with their leaders.”

All this brings to mind a delicious story from Romney’s first days as governor in 2003. At a closed-to-the-press meeting with top legislative leaders, Romney told them about his private-sector management philosophy from Bain Capital, “My usual approach has been to set out the strategic vision for the enterprise and then work with the executive vice presidents to implement that strategy.”

As Boston Globe reporters Michael Kranish and Scott Helman make clear in their biography, “The Real Romney,” the mostly Democratic legislators were not amused by Romney’s business theories of political governance. Regardless of party, few legislators in Congress or on Beacon Hill in Boston see themselves as second-tier management implementing someone else’s strategic vision.

Romney has matured as a political leader over the past decade, though he has spent more time running for president than serving in public office. And Romney did have legislative victories in Massachusetts, including (shhh!) a health care reform plan eerily similar to the President Barack Obama’s.

The lasting relevance of that Massachusetts anecdote lies in the way it highlights the painful transition from the glib certainties of the campaign trail to the unrelenting demands of actually governing. It’s why it’s still hard to see the relevance to the White House in Romney’s frequent campaign trail claim, “I promise change—and I have a record of achieving it. I built a business, and turned around another.”

If Romney were elected, he would probably have to deal with a divided Congress in which Democrats retain a narrow majority in the Senate while the Republicans are in command of the House. The legislative arithmetic for Romney would revolve around the necessity to pick up about a dozen Democratic votes to overcome any Senate filibuster.

As the 45th president, Romney might well be able to enact a significant portion of his domestic agenda during the post-inaugural honeymoon period thanks to GOP discipline and Democratic skittishness.

Obamacare would almost certainly be eviscerated or eliminated, though in an era of austerity budgeting, it’s hard to imagine what alternatives would be offered to the uninsured. The Bush tax cuts for the wealthy would be made permanent—and business would be granted a permissive regulatory climate.

Far trickier would be enacting Romney’s signature proposal to slash all income tax rates by 20 percent and make up the revenue loss by closing loopholes and ending deductions. The intractable problem is that President Romney would either have to slash popular deductions like mortgage interest or concede that his numbers cannot add up as revenue neutral. Whenever Congress gets into the act on taxes, it is a safe bipartisan prediction that no voting bloc suffers and the deficit soars.

Beyond the bold strokes of his budget-slashing economic agenda, Romney would enter the Oval Office as a baffling political figure. He has reinvented himself politically so many times from his centrist days of his 1994 Senate campaign against Ted Kennedy to the fire-breathing conservatism of the Republican presidential primaries that it’s impossible for an outsider to know what’s real. In fact, Romney himself may be a bit bewildered as to where he stands.

A Romney presidency might be a portrait in schizophrenia.

On one hand, he probably would assign key roles to soft-right Republican advisers like the former Utah governor Mike Leavitt (who heads the transition team) and Beth Myers (who ran the vice-presidential search).

But whatever his personal beliefs, Romney also understands that the right-wing conservatives who dominate the Republican Party have accepted him with reservations. Whether picking Supreme Court nominees or charting his way through the thicket of social issues, President Romney would be keenly aware of the implicit threat of a primary challenge in 2016 if he deviates far from doctrinal purity.

Every new president in his confident, post-election naiveté makes serious errors. In fact, the desk chair in the Oval Office should come with a seat belt and training wheels.

The character test lies in how a new president responds to the discovery that no one, not even a veteran of Bain Capital, is prepared for the rigors of the White House. What he does with that knowledge—rather than his six-year quest for the White House—would be the true measure of the leadership style of Mitt Romney.

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