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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Sharon Osbourne has double mastectomy: magazine

LONDON (Reuters) – British celebrity Sharon Osbourne has had a double mastectomy after discovering she was carrying a gene that increased the risk of her developing breast cancer, she told Hello! magazine in an interview published on Monday.

Osbourne, 60, told the publication that the decision was a “no-brainer” in the end.

“As soon as I found out I had the breast cancer gene, I thought: ‘The odds are not in my favor’,” she said in remarks that also ran in the Daily Mirror tabloid.

“I’ve had cancer before and I didn’t want to live under that cloud: I decided to just take everything off, and had a double mastectomy.”

Osbourne, who put the eccentric life of her family on view in the reality TV series “The Osbournes”, said she did not want to spend the rest of her life with “that shadow hanging over me.

“I want to be around for a long time and be a grandmother to Pearl,” she added, referring to her son Jack’s first child.

“I didn’t even think of my breasts in a nostalgic way, I just wanted to be able to live my life without that fear all the time. It’s not ‘pity me’, it’s a decision I made that’s got rid of this weight that I was carrying around.”

Osbourne raised her profile by appearing as a judge on successful talent shows “The X Factor” and “America’s Got Talent”. She is married to heavy metal singer Ozzy Osbourne.

Her London publicist referred Reuters to the interview which ran in Hello! and the Daily Mirror when asked to confirm the news.

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

Celebrity News Headlines – Yahoo! News

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Exclusive - Amazon to win e-book tussle with Apple

BRUSSELS (Reuters) - European Union regulators are to end an antitrust probe into e-book prices by accepting an offer by Apple and four publishers to ease price restrictions on Amazon, two sources said on Tuesday.

The decision hands online retailer Amazon victory in its attempt to sell e-books cheaper than its rivals in the fast-growing market that publishers hope will boost revenue and increase customer numbers.

Apple and the publishers offered in September to let retailers set their own prices or discounts for a period of two years, and also to suspend "most-favored nation" contracts for five years.

Such clauses bar Simon & Schuster, News Corp. unit HarperCollins, Lagardere SCA's Hachette Livre and Verlagsgruppe Georg von Holtzbrinck, the owner of German company Macmillan, from making deals with rival retailers to sell e-books more cheaply than Apple.

The agreements, which critics say prevent Amazon and other retailers from undercutting Apple's charges, sparked an investigation by the European Commission in December last year.

Pearson Plc's Penguin group, which is also under investigation, did not take part in the offer.

The EU antitrust authority, which in September asked for feedback from rivals and consumers about the proposal, has not asked for more concessions, said one of sources.

"The Commission is likely to accept the offer and announce its decision next month," the source said on Tuesday.

Antoine Colombani, spokesman for competition policy at the European Commission, said: "We have launched a market test in September and our investigation is still ongoing."

Amazon declined to comment, while Apple did not respond to an email for comments.

Companies found guilty of breaching EU rules could be fined up to 10 percent of their global sales, which in Apple's case could reach $15.6 billion, based on its 2012 fiscal year.

FROWNING ON ONLINE TRADE CURBS

Antitrust regulators tend to frown on restrictions on online trade and the case is a good example of this policy, said Mark Tricker, a partner at Brussels-based law firm Norton Rose.

"This case shows the online world continues to be a major focus for the Commission. They are looking at lots of different aspects of e-commerce, as this can have such a significant impact on consumers, development and innovation," he said.

"These markets change very quickly and if you don't stamp down on potential infringements of competition rules, you can have significant consequences."

UBS analysts estimate that e-books account for about 30 percent of the U.S. book market and 20 percent of sales in Britain but are minuscule elsewhere. Amazon created demand for e-books when it launched its e-Kindle reader, charging $9.99 for each book.

Apple's agency model let publishers set prices in return for a 30 percent cut to the maker of iPhone and iPad.

The U.S. Department of Justice is also investigating e-book prices. HarperCollins, Simon & Schuster and Hachette recently settled, but Apple, Penguin Group and Macmillan continue to fight the allegations.

(Editing by Rex Merrifield and David Goodman)

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