Exclusive - Amazon to win EU e-book pricing 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.

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

"Faced with years of court battles and uncertainty I can understand why some of these guys decided to fold their cards and take the whipping," said Mark Coker, founder of Smashwords, an ebook publisher and distributor that works with Apple.

"It's certainly another win for Amazon," he added. "I have not seen the terms of the final settlement, but my initial reaction is that it places restrictions on what publishers can do, slowing them down just when they need to be more nimble."

A spokesman at the EU Commission said its investigation was not yet finished. Amazon and Apple declined to comment.

In September, Apple and the publishers offered to let retailers set 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 seeking comment.

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.

AGGREGATE PRICING

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. When Amazon launched its Kindle e-reader, it charged $9.99 per 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 investigating e-book prices. HarperCollins, Simon & Schuster and Hachette have settled, but Apple, Pengin Group and Macmillan have not.

The DOJ settlement required that retailers must at least break even selling all ebooks from a publisher's available list, according to Coker and Joe Wikert, general manager and publisher at O'Reilly Media Inc.

It was not clear if EU regulators will include a similar requirement, which would prohibit Amazon from pricing all ebooks at a loss, said Wikert, a former publishing executive.

In the United States, Amazon will likely price popular titles at a loss and try to make up the difference on a publisher's other ebooks, he said.

Coker said any such rule could be dangerous in Europe, which still has distinct markets.

"It could allow a single retailer to charge full price in a large market like the U.K., and then sell below cost or for free in multiple smaller markets as a strategy to kill regional ebook retailing upstarts before they take root," Coker said.

FROWNING ON ONLINE TRADE CURBS

Antitrust regulators tend to frown on restrictions on online trade and the case is a good example, 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," 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."

(Additional reporting by Alistair Barr in San Francisco; Editing by Rex Merrifield, David Goodman and David Gregorio)

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Renowned special effects firm is “Star Wars” bonus for Disney

LOS ANGELES (Reuters) – “Star Wars” was the force behind Walt Disney’s $ 4 billion purchase of producer George Lucas’s Lucasfilm entertainment holdings. Not so far, far away is Lucas’ Industrial Light and Magic, his award-winning special effects shop that will likely save Disney millions of dollars in costs for its big-budget movies.

ILM, started by Lucas in 1975 when he couldn’t find a special effects house he liked for “Star Wars,” has provided computer-generated dinosaurs, space ships and action characters for a roster of films that includes “Avatar,” “Mission Impossible” and the “Harry Potter” series.

As much as one-third of the cost of films with budgets of $ 200 million and more are for special effects, according to Janney Montgomery Scott analyst Tony Wible, who estimates ILM last year generated at least $ 100 million in revenue. Disney uses ILM‘s computer animators for its “Pirates of the Caribbean” series of films and Marvel-inspired characters for films like “The Avengers.”

ILM is among the companies producing special effects for the Disney film “The Lone Ranger,” a 2013 release estimated to cost more than $ 200 million to produce.

By bringing ILM in-house, Disney can shave as much as $ 20 million a year from its films’ special effects budgets, a welcome savings at a time when all major studios are trying to rein in production spending, Wible said.

“It’s one of the underappreciated aspects of this deal,” he said, along with Skywalker Sound, a Lucas sound production company that will also become part of the Disney empire.

Disney executives, in a conference call with Wall Street analysts, scarcely mentioned ILM in explaining the company’s valuation of Lucasfilm, instead describing its estimate of the company’s rights to its consumer products and the declining value of DVD sales.

Chief Executive Bob Iger praised ILM’s work for Disney and other studios. “Our current thinking is that we would let it remain as-is. They do great work,” Iger said.

A Disney spokesman said the company could not comment further about ILM or the rest of the acquisition until it is cleared by regulators.

The effects house is headquartered in San Francisco at the Letterman Digital Arts Center, a Lucasfilm campus where a statue of Yoda perches atop an outdoor fountain. The effects company employs about 1,000 people between that location and sites in Singapore and Vancouver.

The studio provides effects for as many as 18 projects per year, working with all the major Hollywood studios that compete with Disney. That outside work beyond “Star Wars” will give Disney another revenue source from ILM.

“We can handle quite a slate of films,” Lucasfilm spokesman Miles Perkins said of ILM. “We look forward to continuing that.”

ILM also generates money by supplying effects for commercials by big-name brands Coca-Cola, Budweiser and others.

For Disney’s Iger, who prides his company as being among Hollywood’s most forward thinking on new technology, the Lucasfilm buy might also provide another front for the media giant. Its computer-wielding artists could work with Disney’s Imagineering unit, which creates many of the technologies the company uses at its theme parks.

Lucasfilm engineers created THX, which was designed to help theaters create the best sound for movies through a system that the Lucas company certifies meets its technical standards. THX, which was spun off from Lucasfilms in 2001, also certifies home entertainment systems, consumer electronic products and automobile sound systems.

Hollywood studios have a generally poor record owning effects companies, said Scott Ross, a former general manager of ILM and one of the founders of effects company Digital Domain.

Disney bought Dream Quest Images in 1996 and shuttered it five years later. Warner Bros. also has shut or sold off effects companies it acquired. Only Sony Corp has found success with its Imageworks effects unit.

Studios usually discover that running an effects business is costly and foreign competitors can do the job cheaper, Ross said. “They come to the conclusion that running a visual effects company is not a profitable business,” Ross said.

Iger, in announcing the deal to Wall Street analysts, praised ILM’s work and said he had no immediate plans to change it. “It’s been a decent business for Lucasfilm and one we have every intention of staying in,” he said.

(Reporting By Lisa Richwine and Ronald Grover; Editing by Steve Orlofsky)

Movies News Headlines – Yahoo! News

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Global Update: Polio Eradication Efforts in Pakistan Focus on Pashtuns

Michael Kamber for The New York Times

Polio will never be eradicated in Pakistan until a way is found to persuade poor Pashtuns to embrace the vaccine, according to a study released by the World Health Organization.

A survey of 1,017 parents of young children found that 41 percent had never heard of polio and 11 percent refused to vaccinate their children against it. The survey was done in Karachi, Pakistan’s largest city and the only big city in the world where polio persists; it was published in the agency’s November bulletin.

Parents from poor families “cited lack of permission from family elders,” said Dr. Anita Zaidi, who teaches pediatrics at the Aga Khan University in Karachi. Some rich parents also disdained the vaccine, saying it was “harmful or unnecessary,” she added.

Pashtuns account for 75 percent of Pakistan’s polio cases even though they are only 15 percent of the population. Wealthy children are safer because the virus travels in sewage, and their neighborhoods may have covered sewers and be less flood-prone.

Pashtuns are the largest ethnic group in next-door Afghanistan, where polio has also never been wiped out. Most Taliban fighters are Pashtun, and some Taliban threatened to kill vaccinators earlier this year. Two W.H.O. vaccinators were shot in Karachi in July.

Rumors persist that the vaccine is a plot to sterilize Muslims. But the eradication drive is recruiting Pashtuns as vaccinators and asking prominent religious leaders from various sects to make videos endorsing the vaccine.

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Suzuki, Small-Car Maker, Gives Up on U.S. Market

TOKYO — For all of Suzuki’s tough talk about its “brush-busting” Samurai off-roader, the Japanese automaker never made it big in the United States. Its cars were too small, its safety record iffy and its branding a bit too comical (Suzuki Sidekick, anyone?).

So it came as little surprise to most analysts when Suzuki announced late Monday that it would stop selling automobiles in the United States and put its American unit into Chapter 11 bankruptcy.

“The United States was ultimately a tough market to crack,” said Kentaro Arita, auto analyst and industry research division manager at Mizuho Corporate Bank. “Its exit was a matter of time.”

Still, despite Suzuki’s retreat in North America, the company has made spectacular inroads into emerging markets over the last decade. The low-cost, compact cars sold by Suzuki’s India unit have the top share in that fast-growing market, and the automaker also has a growing presence in Southeast Asia.

Back home in Japan, Suzuki is a leader in a category of small cars called kei vehicles that enjoy preferential tax treatment by meeting limits on length, width, engine size and horsepower. The kei category, created in Japan’s lean postwar years to help ordinary Japanese buy cars, has stayed popular as a cheap option fit for navigating the country’s claustrophobic roads.

One of the company’s kei cars, the long-selling Wagon R, is less than 14 feet long, about 5 feet wide and 6 feet high, and its engine size is limited to two-thirds of a liter, or motorcycle-caliber. Last month, almost as many units were sold in Japan as Toyota’s Prius hybrid.

Suzuki’s decision to pull out of the United States, whose market is dominated by larger models, was a sensible step to focus on its strengths, said Koji Endo, an auto industry analyst and managing director at Advanced Research, an equity research firm in Tokyo. The strong yen also made it difficult to profit by making cars in Japan and shipping them to the United States, he said.

“Basically, Suzuki does not need the United States, and the United States didn’t need Suzuki,” Mr. Endo said.

The American Suzuki Motor Corporation, the sole distributor of Suzuki vehicles in the United States, filed for Chapter 11 bankruptcy on Monday with $346 million in debt, the company said. In a statement, Suzuki said that various challenges led to its withdrawal from the American market, including low sales volume, the limited number of models in its lineup and unfavorable foreign exchange rates.

Suzuki also blamed “the high costs associated with growing and maintaining an automotive distribution system in the continental United States,” as well as “the disproportionately high” costs associated with meeting increasingly stringent state and federal regulatory requirements.

The company said it would sell its remaining inventory through its dealer network, honor existing warranties and continue to supply replacement parts for its vehicles. The company also intends to continue selling motorcycles, all-terrain vehicles and marine products in the United States.

Suzuki shares gained 0.65 percent to 1,847 yen (about $23.02) in Tokyo after the announcement, against a 0.36 percent decline in the benchmark Nikkei index.

While an exit makes sense for Suzuki’s bottom line, it does represent another disappointing failure by Japan’s second tier of automakers in their attempts to follow Toyota, Honda and Nissan into the American market.

A foray by Daihatsu, another Japanese manufacturer of compact cars, lasted only four years before it withdrew in 1992. (Subaru, manufactured by Fuji Heavy Industries, has fared better.)

Suzuki also had big hopes for its Japan-made Samurai 4-wheel-drive vehicle, introduced in the United States in 1985. A $30 million television advertising campaign urged American car owners to try the lightweight yet “rough, tough and brush-busting” off-roader.

The Samurai found a small but loyal following as a low-cost off-roader. But it also suffered early setbacks, including a drawn-out legal battle with Consumer Reports over whether the vehicles were prone to flipping over.

Suzuki later introduced several other models to the United States, including its Swift compact, and its executives spoke of selling 200,000 vehicles a year in the American market.

A partnership with General Motors proved beneficial for both sides, giving the American company access to expertise in smaller cars, while allowing Suzuki to tap G.M.’s dealership network to sell its cars.

But just as Suzuki’s sales were gaining traction in the United States, topping 100,000 in the mid-2000s for the first time, the global financial crisis hit, decimating Japanese exports.

General Motors, scrambling for cash, sold off its stake in Suzuki, and the Japanese manufacturer withdrew from a joint manufacturing venture in Canada.

Since then, Suzuki’s sales in the United States have dwindled. In the first 10 months of 2012, it sold just 21,000 vehicles. A budding partnership with Volkswagen also grew acrimonious, forcing Suzuki to regroup.

Experts said that Suzuki was likely to concentrate its managerial resources on strengthening its grip on markets like India, where it has been hit by worker strife in recent months.

This article has been revised to reflect the following correction:

Correction: November 6, 2012

An earlier version of this article misstated a description Suzuki used to promote its Samurai off-roader. It is “brush-busting,” not “bush-busting.”

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Column a catalyst for debate on race and politics

I knew I'd be navigating a minefield in my Saturday column, which dealt with two combustible topics: race and politics.

I said that the Republican campaign, in the run-up to Tuesday's presidential vote, has resorted to a not-so-subtle nativist appeal that relies on racial animus and fears.

All that "It's time to take our country back" rhetoric you hear at GOP rallies makes me wonder just whose country they think this is. I know race-baiting when I hear it.

INTERACTIVE: Battleground states map

The response to the column on public comment boards tended toward the ugly — as anonymous forums often do.

But the hundreds of emails I received revealed a divided but thoughtful populace, harboring fears and resentments as real as my own.

My column accused the campaign's rhetoric of creating a haven for prejudice, promoting Barack Obama's other-ness as a socially acceptable proxy for racial prejudice.

VOTER GUIDE: Central issues of Election 2012

Dozens of voters objected. Many took the column to mean that I think that anyone voting for Mitt Romney is either hateful or a racist.

That's not what I wrote, and not what I meant. But the implication offended readers, who accused me of race-baiting.

"I do not yet know who I will vote for, but to suggest that if I lean toward Romney it is racist is inappropriate," wrote Sam Wild. "Please appreciate that there are idiots, morons, imbeciles and just plain dopes in the fringes of both parties, and to focus only on the Romney jerks is polarizing."

::

Readers in that camp insist that opposition to Obama is not about race. It's about a bad economy, broken promises and the incumbent's liberal agenda.

"Because of the actions of a very small percentage of Americans, you used a broad brush and stereotype to classify whites as being racist and not voting for President Obama because of his race," wrote Vahak Petrossian of Glendale. He is not voting for Obama because "he broke his promise after the election" to acknowledge the Armenian genocide.

But some readers, in trying to call me out, actually validated the column's claim.

"You want to make it about a black man," wrote Gary Marquis of Orange County. "I didn't vote for Obama because I think he is a liberal Marxist … a man with more Arabic genes than black genes, [who] has failed at the job."

And then there was the guy who "hates your idiot Muslim president" because he caters to "radical libs."

Other readers endorsed my perspective, and said they too were disturbed by what they saw as unfair treatment of Obama — the candidate and the president.

"The ugly treatment afforded this president is an embarrassment for our country and me personally," wrote Sue Masengale of Rancho Palos Verdes. "As a 71-year-old I've seen a few presidents come and go. But at no time have I witnessed this degree of ugliness and lack of respect."

But others said that this kind of bare-knuckle brawl is par for the course in such a close race, with so much at stake.

Read More..

Apple sells three million iPads over first weekend

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Springsteen Sandy telethon raises $23 million, ABC more than $10 million

(Reuters) – Bruce Springsteen, Billy Joel, Mary Blige and dozens of other musicians and celebrities helped raise some $ 23 million for victims of Hurricane Sandy on NBC television, while a Day of Giving on ABC TV networks raised more than $ 10 million.

The American Red Cross said the one-hour NBC telethon on Friday, featuring performances by celebrities with strong New York and New Jersey connections, generated a record number of individual donations by phone, text and online for victims of Sandy.

The preliminary amount raised was nearly $ 23 million, the Red Cross said in a statement.

On ABC on Monday, viewers and celebrities had raised more than $ 10 million, also for the American Red Cross, midway through a day-long fundraiser for victims of last week’s storm, which devastated the U.S. Northeast and killed more that 100 people.

Journalist Barbara Walters made a personal donation of $ 250,000 and manned phone lines during breakfast show “Good Morning America” along with Katie Couric, actor Ben Stiller and “Jersey Shore” star Nicole “Snooki” Polizzi, ABC said. Donations are expected to rise further during the day-long event.

(Reporting by Jill Serjeant in Los Angeles; Editing by Richard Chang)

Music News Headlines – Yahoo! News

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Unlikely Model for H.I.V. Prevention: Adult Film Industry

Stephanie Diani for The New York Times

INDUSTRY DATABASE Shylar Cobi, right, a film producer, confirmed test results of the actors who perform as James Deen and Stoya.

LOS ANGELES — Before they take off all their clothes, the actors who perform as James Deen and Stoya go through a ritual unique to the heterosexual adult film industry.

First, they show each other their cellphones: Each has an e-mail from a laboratory saying he or she just tested negative for H.I.V., syphilis, chlamydia and gonorrhea.

Then they sit beside the film’s producer, Shylar Cobi, as he checks an industry database with their real names to confirm that those negative tests are less than 15 days old.

Then, out on the pool terrace of the day’s set — a music producer’s hilltop home with a view of the Hollywood sign — they yank down their pants and stand around joking as Mr. Cobi quickly inspects their mouths, hands and genitals for sores.

“I’m not a doctor,” Mr. Cobi, who wears a pleasantly sheepish grin, says. “I’m only qualified to do this because I’ve been shooting porn since 1990 and I know what looks bad.”

Bizarre as the ritual is, it seems to work.

The industry’s medical consultants say that about 350,000 sex scenes have been shot without condoms since 2004, and H.I.V. has not been transmitted on a set once.

Outside the world of pornography, the industry’s testing regimen is not well known, and no serious academic study of it has ever been done. But when it was described to several AIDS experts, they all reacted by saying that there were far fewer infections than they would have expected, given how much high-risk sex takes place.

“I don’t think there’s any question that it works,” said Dr. Allan Ronald, a Canadian AIDS specialist who did landmark studies of the virus in prostitutes in a Nairobi slum. “I’m a little uncomfortable, because it’s giving the wrong message — that you can have multiple sex partners without condoms — but I can’t say it doesn’t work.”

Despite the regimen’s apparent success, California health officials and an advocacy group, the AIDS Healthcare Foundation, are trying to make it illegal to shoot without condoms. They argue that other sexually transmitted diseases are rampant in the industry, though the industry trade group disputes that.

In January, the city of Los Angeles passed a law requiring actors to wear condoms. A measure to do the same for the whole county is on the ballot on Tuesday.

Producers say the condom requirement will drive them out of business since consumers will not buy such films. Local newspapers like The Los Angeles Times oppose the ballot measure, calling it well-intentioned but unenforceable, and warning that it could drive up to 10,000 jobs out of state.

Very frequent testing makes it almost impossible for an actor to stay infected without being caught, said Dr. Jacques Pepin, the author of “The Origins of AIDS” and an expert on transmission rates. “And if you are having sex mostly with people who themselves are tested all the time, this must further reduce the risk.”

When the virus first enters a high-risk group like heroin users, urban prostitutes or habitués of gay bathhouses, it usually infects 30 to 60 percent of the cohort within a few years, studies have shown. The same would be expected in pornography, performers can have more than a dozen partners a month, but the industry says self-policing has prevented it..

“Our talent base has sex exponentially more than other people, but we’re all on the same page about keeping it out,” said Steven Hirsch, the founder of Vivid Entertainment, one of the biggest studios.

Performers have to test negative every 28 days, although some studios recently switched to every 14.

If a test is positive, all the studios across the country that adhere to standards set by the Free Speech Coalition, an industry trade group, are obliged to stop filming until all the on-screen partners of that performer, all their partners, and all their partners’ partners, are found and retested. In 2004, the industry shut down for three months to do that.

It has had briefer shutdowns in each of the last four years.

In 2009 and 2010, no other infected performers were found. Coalition representatives said an infected woman in 2009, from Nevada, may have had an infected boyfriend, and offered evidence that a man infected in 2010 in Florida had worked outside the industry as a prostitute. The 2011 test was a false positive.

A shutdown in August came after several actors got syphilis, not H.I.V. All performers were given a choice: Take antibiotics, or pass two back-to-back syphilis tests 14 days apart.

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New Drugs for Lipids Set Off Race

LOS ANGELES — A new class of powerful cholesterol-reducing drugs is showing promising results, potentially offering a new option for people who do not respond to medication now on the market, according to studies presented at a conference of heart specialists here on Monday.

Although the final word on the effectiveness of the drugs is still a few years away, the results so far are so promising that pharmaceutical companies are racing to bring them to market.

In early- and middle-stage trials, use of the experimental drugs reduced so-called bad cholesterol by about 40 to 70 percent in a matter of weeks, equivalent to the reduction achieved by the most effective statins like Lipitor. But it appears that the new drugs can be used along with statins, lowering cholesterol even further.

“With these drugs, together with statins, you can get virtually everyone to the goal,” Dr. Frederick Raal of the University of the Witwatersrand, in Johannesburg, South Africa, who presented one of several studies on these new drugs at the American Heart Association’s scientific meeting here.

The most advanced of the drugs, which as a class are called PCSK9 inhibitors, is only now entering the final stages of clinical trials and is not likely to get to market until 2015 at the earliest.

And there are still some caveats. One is that while the drugs lower cholesterol, it has not yet been shown that they actually reduce the risk of heart attacks, strokes or other cardiovascular problems.

Furthermore, many of the studies so far have lasted no more than 12 weeks and involved fewer than 200 people. Far longer and larger studies are needed to show that the drugs would keep working over a lifetime and would be safe.

So far, however, the studies show “quite good safety,” Dr. Peter Wilson of Emory University said in a presentation here discussing the studies. “This is extremely promising.”

The drugs have to be injected, typically every two to four weeks. That means that the PCSK9 inhibitors are not likely to be widely used for “garden variety high cholesterol,” said Dr. Gordon Tomaselli, chief of cardiology at Johns Hopkins.

Still, millions of Americans cannot lower their cholesterol sufficiently using statins alone, providing a market that could reach billions of dollars in annual sales for a successful drug.

Leading the race so far is the team of Sanofi, the big French drug company, and Regeneron Pharmaceuticals, a biotechnology company in Tarrytown, N.Y.

The companies announced Monday that they were beginning a Phase 3 trial — usually the last step before filing for approval — involving 18,000 patients with a recent heart attack or worsening chest pain who cannot lower their cholesterol with statin therapy alone. The patients will inject themselves once every two weeks with either the drug or a placebo, while continuing to take statins.

The study, which will take at least two years, will determine whether the drug, known by the awkward code name SAR236553/REGN727, can reduce the rate of heart attacks, strokes and other cardiovascular problems.

In a midstage study published recently in The New England Journal of Medicine, patients who took the Sanofi drug plus a high dose of atorvastatin, the generic equivalent of Lipitor, had a mean 73 percent reduction in low-density lipoprotein cholesterol, the so-called bad cholesterol, compared with a 17 percent reduction for those taking only the high dose of the statin.

Amgen seems to be next in line, saying it plans to begin Phase 3 trials early next year. Pfizer and Roche have drugs in midstage clinical trials. Others in pursuit include Eli Lilly & Company and Alnylam.

Dr. Evan A. Stein of the Metabolic and Atherosclerosis Research Center in Cincinnati, said that about 10 to 20 percent of patients could not tolerate statins at all, or at least could not tolerate doses high enough to lower cholesterol sufficiently. Their main alternative now is Merck’s Zetia, which reduces cholesterol about 18 percent.

Dr. Stein, who is a consultant to Amgen, presented the results on Monday of a trial of Amgen’s drug, AMG 145, in such patients.

Patients receiving AMG 145 experienced an average reduction in LDL cholesterol after 12 weeks of 41 to 51 percent, depending on the dose. Those who received both AMG 145 and Zetia had an even greater average reduction — 63 percent. By contrast, those who received Zetia and a placebo had a drop in bad cholesterol of only 15 percent.

After 12 weeks, only 7 percent of the patients on Zetia alone reduced LDL to 100 milligrams per deciliter, which is the goal for many people. About 61 percent of those on the highest dose of AMG 145 did so, as did 90 percent on both AMG 145 and Zetia. The trial results were also published online by The Journal of the American Medical Association.

LDL cholesterol is removed from the blood when it binds to LDL receptors on the surface of liver cells, and then is taken inside the cells. PCSK9 — which stands for proprotein convertase subtilisin/kexin type 9 — also binds to the LDL receptor, and when it does so, the receptor is destroyed along with the LDL.

But if PCSK9 does not bind, the receptor can return to the surface of the cell and remove more cholesterol. The drugs, which in general are proteins known as monoclonal antibodies, block PCSK9 from binding to the receptor.

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Keeping 007 relevant in a changed world

NEW YORK — Early in "Skyfall," Judi Dench's M pulls aside our embattled hero, played once again with suave ennui by Daniel Craig, and wonders whether the world still needs either of their services. As Bond wraps his head around that idea, he looks searchingly at his boss. "So this is it?" he wonders. "We're both played out?"

Questions about relevance dangle throughout the new James Bond movie, which opens in the U.S., after a crescendo of marketing, on Nov 9. Field agents are of diminishing importance in an era of cyber-spying and drone warfare, and the uniqueness of Bond's gadgets has been diluted at a time when everyone and their great-aunt carries an iPhone.

PHOTOS: James Bond through the years

Yet as the film franchise turns 50 (yes, someone born the year "Dr. No" came out is now eligible to join AARP) themes of retirement and sell-by dates aren't simply screenplay fodder — they pertain to the franchise itself.

After strong early reviews and solid overseas business, the latest Bond adventure sweeps into theaters with blockbuster expectations. But even if the Sony release blows the doors off the box office like, well, 007 making a grand entrance, it can't hide what those who worked on it quietly acknowledge — making this movie was a more difficult and delicate undertaking than ever.

No longer is a successful Bond movie simply a matter of dialing up clever dialogue and dazzling set pieces. Facing a world that would be unrecognizable to those behind the early Ian Fleming adaptations, Bond filmmakers and actors grapple on many levels with how to keep the series fresh.

They must find ways for a tuxedo-wearing, martini-swilling protagonist to stay relatable while a global downturn rages. They need to project a contemporary degree of villainy in a world where the threat of Islamist terrorism is, for a variety of reasons, not as easily portrayed as the enemies and fears of the Cold War.

They want to retain at least a hint of gravitas after years of Austin Powers and Johnny English.

Maybe most important, they struggle with how to avoid what might be called the quaintness trap — staying relevant in a cinema culture that has seen the rise of splashy CG action movies on the one hand and modern truth-seekers a la Jason Bourne on the other.

"The theme of our story is that we have to question if the old classic things still work," said Javier Bardem, who plays the villain in "Skyfall," directed by Sam Mendes. "It's implied in every character in this movie. But it's also the question about the James Bond franchise."

New obstacles

For years, Barbara Broccoli, the longtime producer and steward of the spy series (total box office: about $5 billion), knew that she wanted a film for the franchise's 50th anniversary. "Bond 23," as "Skyfall" soon became known, was a way of honoring her late father, Albert "Cubby" Broccoli, who died in 1996 and was heavily responsible for putting Fleming's work on the screen. It also offered a third act in the Craig-led Bond.

About three years ago, with the blessing of studio MGM, Broccoli and stepbrother/fellow producer Michael Wilson hired the longtime Bond writers Neal Purvis and Robert Wade, along with "The Queen" scribe Peter Morgan. At nearly the same time they brought on Mendes, the British director of "American Beauty" who was in a slump after his young-marrieds drama "Away We Go" flopped in 2009.

Then MGM filed for bankruptcy, and suddenly everyone was frozen in place. (To avoid legal action from creditors, Mendes was retained off the books as a "consultant.")

PHOTOS: The Bond girls

"It was a nightmare," Broccoli recalled. "This was one of those situations that's really frustrating — when all the delays have nothing to do with the making of the movie." Craig's attitude was even more bleak. "I thought OK, we might have to say goodbye to this," he said in an interview in New York several weeks ago. "And that made me really sad." In the hiatus, Morgan left, replaced by the veteran John Logan ("Hugo").

MGM was finally reconstituted with new owners. But now came another problem: how to make Bond dramatically relevant again. The franchise wasn't just long in the tooth — it was coming off a disappointing entry in 2008's "Quantum of Solace." Craig acknowledged in the interview that the movie wasn't "satisfying." Wilson said that, after witnessing the critical reception, he thought, "Oh God, we really screwed this up."

A big reason for that was Bond's nemesis. During the decades that the series provided a catharsis for the Soviet threat, it was easy to put a face on the menace. But since the Iron Curtain fell — and especially after the attacks of Sept. 11 — that was a lot tougher.

In "Casino Royale," Craig's initiation, filmmakers used a clever work-around: They channeled the demons that would normally reside in the villain into the hero. Craig's Bond was grimmer and darker, which not only made for a compelling character but for some juicy zeitgeist stuff, Bond's beleaguered air matching our post-Sept. 11 anxiety.

In "Quantum," writers essentially opted out, creating villains and stakes that had little to do with the headlines (they involved a Bolivian coup and the arcana of water rights.) The film was rushed into production after the writers strike — "you shouldn't try to rewrite whole sections of the story while you're shooting," Craig noted dryly — and the results were wobbly.

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