FDA: New rules will make food safer


WASHINGTON (AP) — The Food and Drug Administration says its new guidelines would make the food Americans eat safer and help prevent the kinds of foodborne disease outbreaks that sicken or kill thousands of consumers each year.


The rules, the most sweeping food safety guidelines in decades, would require farmers to take new precautions against contamination, to include making sure workers' hands are washed, irrigation water is clean, and that animals stay out of fields. Food manufacturers will have to submit food safety plans to the government to show they are keeping their operations clean.


The long-overdue regulations could cost businesses close to half a billion dollars a year to implement, but are expected to reduce the estimated 3,000 deaths a year from foodborne illness. The new guidelines were announced Friday.


Just since last summer, outbreaks of listeria in cheese and salmonella in peanut butter, mangoes and cantaloupe have been linked to more than 400 illnesses and as many as seven deaths, according to the federal Centers for Disease Control and Prevention. The actual number of those sickened is likely much higher.


Many responsible food companies and farmers are already following the steps that the FDA would now require them to take. But officials say the requirements could have saved lives and prevented illnesses in several of the large-scale outbreaks that have hit the country in recent years.


In a 2011 outbreak of listeria in cantaloupe that claimed 33 lives, for example, FDA inspectors found pools of dirty water on the floor and old, dirty processing equipment at Jensen Farms in Colorado where the cantaloupes were grown. In a peanut butter outbreak this year linked to 42 salmonella illnesses, inspectors found samples of salmonella throughout Sunland Inc.'s peanut processing plant in New Mexico and multiple obvious safety problems, such as birds flying over uncovered trailers of peanuts and employees not washing their hands.


Under the new rules, companies would have to lay out plans for preventing those sorts of problems, monitor their own progress and explain to the FDA how they would correct them.


"The rules go very directly to preventing the types of outbreaks we have seen," said Michael Taylor, FDA's deputy commissioner for foods.


The FDA estimates the new rules could prevent almost 2 million illnesses annually, but it could be several years before the rules are actually preventing outbreaks. Taylor said it could take the agency another year to craft the rules after a four-month comment period, and farms would have at least two years to comply — meaning the farm rules are at least three years away from taking effect. Smaller farms would have even longer to comply.


The new rules, which come exactly two years to the day President Barack Obama's signed food safety legislation passed by Congress, were already delayed. The 2011 law required the agency to propose a first installment of the rules a year ago, but the Obama administration held them until after the election. Food safety advocates sued the administration to win their release.


The produce rule would mark the first time the FDA has had real authority to regulate food on farms. In an effort to stave off protests from farmers, the farm rules are tailored to apply only to certain fruits and vegetables that pose the greatest risk, like berries, melons, leafy greens and other foods that are usually eaten raw. A farm that produces green beans that will be canned and cooked, for example, would not be regulated.


Such flexibility, along with the growing realization that outbreaks are bad for business, has brought the produce industry and much of the rest of the food industry on board as Congress and FDA has worked to make food safer.


In a statement Friday, Pamela Bailey, president of the Grocery Manufacturers Association, which represents the country's biggest food companies, said the food safety law "can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal."


The new rules could cost large farms $30,000 a year, according to the FDA. The agency did not break down the costs for individual processing plants, but said the rules could cost manufacturers up to $475 million annually.


FDA Commissioner Margaret Hamburg said the success of the rules will also depend on how much money Congress gives the chronically underfunded agency to put them in place. "Resources remain an ongoing concern," she said.


The farm and manufacturing rules are only one part of the food safety law. The bill also authorized more surprise inspections by the FDA and gave the agency additional powers to shut down food facilities. In addition, the law required stricter standards on imported foods. The agency said it will soon propose other overdue rules to ensure that importers verify overseas food is safe and to improve food safety audits overseas.


Food safety advocates frustrated over the last year as the rules stalled praised the proposed action.


"The new law should transform the FDA from an agency that tracks down outbreaks after the fact, to an agency focused on preventing food contamination in the first place," said Caroline Smith DeWaal of the Center for Science in the Public Interest.


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Chavez swearing-in can be delayed: Venezuelan VP


CARACAS (Reuters) - President Hugo Chavez's formal swearing-in for a new six-year term scheduled for January 10 can be postponed if he is unable to attend due to his battle to recover from cancer surgery, Venezuela's vice president said on Friday.


Nicolas Maduro's comments were the clearest indication yet that the Venezuelan government is preparing to delay the swearing-in while avoiding naming a replacement for Chavez or calling a new election in the South American OPEC nation.


In power since 1999, the 58-year-old socialist leader has not been seen in public for more than three weeks. Allies say he is in delicate condition after a fourth operation in two years for an undisclosed form of cancer in his pelvic area.


The political opposition argues that Chavez's presence on January 10 in Cuba - where there are rumors he may be dying - is tantamount to the president's stepping down.


But Maduro, waving a copy of the constitution during an interview with state TV, said there was no problem if Chavez was sworn in at a later date by the nation's top court.


"The interpretation being given is that the 2013-2019 constitutional period starts on January 10. In the case of President Chavez, he is a re-elected president and continues in his functions," he said.


"The formality of his swearing-in can be resolved in the Supreme Court at the time the court deems appropriate in coordination with the head of state."


In the increasing "Kremlinology"-style analysis of Venezuela's extraordinary political situation, that could be interpreted in different ways: that Maduro and other allies trust Chavez will recover eventually, or that they are buying time to cement succession plans before going into an election.


Despite his serious medical condition, there was no reason to declare Chavez's "complete absence" from office, Maduro said. Such a declaration would trigger a new vote within 30 days, according to Venezuela's charter.


RECOVERY POSSIBLE?


Chavez was conscious and fighting to recover, said Maduro, who traveled to Havana to see his boss this week.


"We will have the Commander well again," he said.


Maduro, 50, whom Chavez named as his preferred successor should he be forced to leave office, said Venezuela's opposition had no right to go against the will of the people as expressed in the October 7 vote to re-elect the president.


"The president right now is president ... Don't mess with the people. Respect democracy."


Despite insisting Chavez remains president and there is hope for recovery, the government has acknowledged the gravity of his condition, saying he is having trouble breathing due to a "severe" respiratory infection.


Social networks are abuzz with rumors he is on life support or facing uncontrollable metastasis of his cancer.


Chavez's abrupt exit from the political scene would be a huge shock for Venezuela. His oil-financed socialism has made him a hero to the poor, while critics call him a dictator seeking to impose Cuban-style communism on Venezuelans.


Should Chavez leave office, a new election is likely to pitch former bus driver and union activist Maduro against opposition leader Henrique Capriles, the 40-year-old governor of Miranda state.


Capriles lost to Chavez in the October presidential election, but won an impressive 44 percent of the vote. Though past polls have shown him to be more popular than all of Chavez's allies, the equation is now different given Maduro has received the president's personal blessing - a factor likely to fire up Chavez's fanatical supporters.


His condition is being watched closely by Latin American allies that have benefited from his help, as well as investors attracted by Venezuela's lucrative and widely traded debt.


"The odds are growing that the country will soon undergo a possibly tumultuous transition," the U.S.-based think tank Stratfor said this week.


(Additional reporting by Marianna Parraga; editing by Christopher Wilson)



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Cricketer Herath alive and bowling despite death rumors






SYDNEY (Reuters) – As Mark Twain might have said, rumors of the death of Sri Lankan spinner Rangana Herath which spread like wildfire across social media late on Friday proved to be greatly exaggerated.


Far from lying in a Sydney morgue alongside former test bowler Chaminda Vaas after perishing in a car crash as the reports had suggested, Herath was very much alive when he pitched up for work at the Sydney Cricket Ground on Saturday.






The most prolific wicket-taker in test cricket last year, the 34-year-old leg spinner claimed two Australian wickets to seal a haul of four for 95 and then contributed nine runs with the bat.


Team mate Dimuth Karunaratne told reporters at the conclusion of the day’s play that the team had been dumbfounded by the rumors.


“I heard about it when we having breakfast but I had no idea where that came from,” he said with a laugh.


“Guys from Sri Lanka were calling us asking ‘when is the funeral?’ and stuff like that.


“Rangana is alive,” he added, somewhat unnecessarily.


Herath’s efforts were not enough to prevent Australia taking an iron grip on the third test match on Saturday and move to the brink of a 3-0 series sweep.


That could all change, however, if he and Dinesh Chandimal, who finished the third day unbeaten on 22, are able to dig in on Sunday, inflate their lead beyond the current 87 and give Sri Lanka a decent target to bowl at.


The Sydney track has traditionally offered a lot of turn for spinners in the last couple of days of a test and, as Herath’s 60 wickets last year showed, there are few better spinners operating in test cricket at the moment.


“The wicket is turning a lot now and the Aussie guys are playing the fourth innings, so I think Rangana… can do something,” said Karunaratne.


Vaas has no position with the test team and remains, also unharmed, in Sri Lanka, Sri Lankan reporters said.


(Editing by John O’Brien)


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Courteney Cox: I'll 'Show My Boobs' on the New Season of Cougar Town















01/04/2013 at 08:00 PM EST



Courteney Cox is taking the term "boob tube" literally.

The Cougar Town star, 48, whose show moves from ABC to TBS on Jan. 8, eagerly anticipates more um, revealing scenes once the program makes its way to the cable network.

"You will not see one scene that I don't show my boobs," Cox joked to reporters Friday at the Television Critics Association winter tour, according to Access Hollywood.

"You know what? I'm getting older, so I've decided at this point I'm taking less focus [on] the face, and focusing here," she added, pointing to her chest. "By the time I'm much older, I will just be absolutely nude. I think it's [going to] work for me, I hope."

The show's executive producer, Bill Lawrence, backed up Cox's comments. "There is one difference [with the show going to cable]," he said Friday. "I think I'm allowed to say … Courteney did declare this the year of her cleavage."

Still, the star isn't exactly baring it all. Although there is an episode themed "naked day" for Cox's character Jules and her on-camera hubby Grayson (Josh Hopkins), there will be no actual nudity on the show.

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FDA: New rules will make food safer


WASHINGTON (AP) — The Food and Drug Administration says its new guidelines would make the food Americans eat safer and help prevent the kinds of foodborne disease outbreaks that sicken or kill thousands of consumers each year.


The rules, the most sweeping food safety guidelines in decades, would require farmers to take new precautions against contamination, to include making sure workers' hands are washed, irrigation water is clean, and that animals stay out of fields. Food manufacturers will have to submit food safety plans to the government to show they are keeping their operations clean.


The long-overdue regulations could cost businesses close to half a billion dollars a year to implement, but are expected to reduce the estimated 3,000 deaths a year from foodborne illness. The new guidelines were announced Friday.


Just since last summer, outbreaks of listeria in cheese and salmonella in peanut butter, mangoes and cantaloupe have been linked to more than 400 illnesses and as many as seven deaths, according to the federal Centers for Disease Control and Prevention. The actual number of those sickened is likely much higher.


Many responsible food companies and farmers are already following the steps that the FDA would now require them to take. But officials say the requirements could have saved lives and prevented illnesses in several of the large-scale outbreaks that have hit the country in recent years.


In a 2011 outbreak of listeria in cantaloupe that claimed 33 lives, for example, FDA inspectors found pools of dirty water on the floor and old, dirty processing equipment at Jensen Farms in Colorado where the cantaloupes were grown. In a peanut butter outbreak this year linked to 42 salmonella illnesses, inspectors found samples of salmonella throughout Sunland Inc.'s peanut processing plant in New Mexico and multiple obvious safety problems, such as birds flying over uncovered trailers of peanuts and employees not washing their hands.


Under the new rules, companies would have to lay out plans for preventing those sorts of problems, monitor their own progress and explain to the FDA how they would correct them.


"The rules go very directly to preventing the types of outbreaks we have seen," said Michael Taylor, FDA's deputy commissioner for foods.


The FDA estimates the new rules could prevent almost 2 million illnesses annually, but it could be several years before the rules are actually preventing outbreaks. Taylor said it could take the agency another year to craft the rules after a four-month comment period, and farms would have at least two years to comply — meaning the farm rules are at least three years away from taking effect. Smaller farms would have even longer to comply.


The new rules, which come exactly two years to the day President Barack Obama's signed food safety legislation passed by Congress, were already delayed. The 2011 law required the agency to propose a first installment of the rules a year ago, but the Obama administration held them until after the election. Food safety advocates sued the administration to win their release.


The produce rule would mark the first time the FDA has had real authority to regulate food on farms. In an effort to stave off protests from farmers, the farm rules are tailored to apply only to certain fruits and vegetables that pose the greatest risk, like berries, melons, leafy greens and other foods that are usually eaten raw. A farm that produces green beans that will be canned and cooked, for example, would not be regulated.


Such flexibility, along with the growing realization that outbreaks are bad for business, has brought the produce industry and much of the rest of the food industry on board as Congress and FDA has worked to make food safer.


In a statement Friday, Pamela Bailey, president of the Grocery Manufacturers Association, which represents the country's biggest food companies, said the food safety law "can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal."


The new rules could cost large farms $30,000 a year, according to the FDA. The agency did not break down the costs for individual processing plants, but said the rules could cost manufacturers up to $475 million annually.


FDA Commissioner Margaret Hamburg said the success of the rules will also depend on how much money Congress gives the chronically underfunded agency to put them in place. "Resources remain an ongoing concern," she said.


The farm and manufacturing rules are only one part of the food safety law. The bill also authorized more surprise inspections by the FDA and gave the agency additional powers to shut down food facilities. In addition, the law required stricter standards on imported foods. The agency said it will soon propose other overdue rules to ensure that importers verify overseas food is safe and to improve food safety audits overseas.


Food safety advocates frustrated over the last year as the rules stalled praised the proposed action.


"The new law should transform the FDA from an agency that tracks down outbreaks after the fact, to an agency focused on preventing food contamination in the first place," said Caroline Smith DeWaal of the Center for Science in the Public Interest.


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Wall Street Week Ahead - "Cliff" concerns give way to earnings focus

NEW YORK (Reuters) - Investors' "fiscal cliff" worries are likely to give way to more fundamental concerns, like earnings, as fourth-quarter reports get under way next week.


Financial results, which begin after the market closes on Tuesday with aluminum company Alcoa , are expected to be only slightly better than the third-quarter's lackluster results. As a warning sign, analyst current estimates are down sharply from what they were in October.


That could set stocks up for more volatility following a week of sharp gains that put the Standard & Poor's 500 index <.spx> on Friday at the highest close since December 31, 2007. The index also registered its biggest weekly percentage gain in more than a year.


Based on a Reuters analysis, Europe ranks among the chief concerns cited by companies that warned on fourth-quarter results. Uncertainty about the region and its weak economic outlook were cited by more than half of the 25 largest S&P 500 companies that issued warnings.


In the most recent earnings conference calls, macroeconomic worries were cited by 10 companies while the U.S. "fiscal cliff" was cited by at least nine as reasons for their earnings warnings.


"The number of things that could go wrong isn't so high, but the magnitude of how wrong they could go is what's worrisome," said Kurt Winters, senior portfolio manager for Whitebox Mutual Funds in Minneapolis.


Negative-to-positive guidance by S&P 500 companies for the fourth quarter was 3.6 to 1, the second worst since the third quarter of 2001, according to Thomson Reuters data.


U.S. lawmakers narrowly averted the "fiscal cliff" by coming to a last-minute agreement on a bill to avoid steep tax hikes this weeks -- driving the rally in stocks -- but the battle over further spending cuts is expected to resume in two months.


Investors also have seen a revival of worries about Europe's sovereign debt problems, with Moody's in November downgrading France's credit rating and debt crises looming for Spain and other countries.


"You have a recession in Europe as a base case. Europe is still the biggest trading partner with a lot of U.S. companies, and it's still a big chunk of global capital spending," said Adam Parker, chief U.S. equity strategist at Morgan Stanley in New York.


Among companies citing worries about Europe was eBay , whose chief financial officer, Bob Swan, spoke of "macro pressures from Europe" in the company's October earnings conference call.


REVENUE WORRIES


One of the biggest worries voiced about earnings has been whether companies will be able to continue to boost profit growth despite relatively weak revenue growth.


S&P 500 revenue fell 0.8 percent in the third quarter for the first decline since the third quarter of 2009, Thomson Reuters data showed. Earnings growth for the quarter was a paltry 0.1 percent after briefly dipping into negative territory.


On top of that, just 40 percent of S&P 500 companies beat revenue expectations in the third quarter, while 64.2 percent beat earnings estimates, the Thomson Reuters data showed.


For the fourth quarter, estimates are slightly better but are well off estimates for the quarter from just a few months earlier. S&P 500 earnings are expected to have risen 2.8 percent while revenue is expected to have gone up 1.9 percent.


Back in October, earnings growth for the fourth quarter was forecast up 9.9 percent.


In spite of the cautious outlooks, some analysts still see a good chance for earnings beats this reporting period.


"The thinking is you need top line growth for earnings to continue to expand, and we've seen the market defy that," said Mike Jackson, founder of Denver-based investment firm T3 Equity Labs.


Based on his analysis, energy, industrials and consumer discretionary are the S&P sectors most likely to beat earnings expectations in the upcoming season, while consumer staples, materials and utilities are the least likely to beat, Jackson said.


Sounding a positive note on Friday, drugmaker Eli Lilly and Co said it expects profit in 2013 to increase by more than Wall Street had been forecasting, primarily due to cost controls and improved productivity.


(Reporting By Caroline Valetkevitch; Editing by Kenneth Barry)



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Eleven dead in Damascus gas station blast


AZAZ, Syria (Reuters) - At least 11 people were killed and 40 wounded when a car bomb exploded at a crowded petrol station in the Syrian capital Damascus on Thursday, opposition activists said.


The station was packed with people queuing for fuel that has become increasingly scarce during the country's 21-month-long insurgency aimed at overthrowing President Bashar al-Assad.


The semi-official al-Ikhbariya television station showed footage of 10 burnt bodies and Red Crescent workers searching for victims at the site.


The opposition Revolution Leadership Council in Damascus said the explosion was caused by a booby-trapped car.


There was no immediate indication of who was responsible for the bombing in the Barzeh al-Balad district, whose residents include members of the Sunni Muslim majority and other religious and ethnic minorities.


"The station is usually packed even when it has no fuel," said an opposition activist who did not want to be named. "There are lots of people who sleep there overnight, waiting for early morning fuel consignments."


It was the second time that a petrol station has been hit in Damascus this week. Dozens of people were incinerated in an air strike as they waited for fuel on Wednesday, according to opposition sources.


In northern Syria, rebels were battling to seize an air base in their campaign against the air power that Assad has used to bomb rebel-held towns.


More than 60,000 people have been killed in the uprising and civil war, the United Nations said this week, a much higher death toll than previously thought.


DRAMATIC ADVANCES


After dramatic advances over the second half of 2012, the rebels now hold wide swathes of territory in the north and east, but they cannot protect towns and villages from Assad's helicopters and jets.


Hundreds of rebel fighters were attempting to storm the Taftanaz air base, near the highway that links Syria's two main cities, Aleppo and Damascus.


A rebel fighter speaking from near the Taftanaz base overnight said much of the base was still in loyalist hands but insurgents had managed to destroy a helicopter and a fighter jet on the ground.


The northern rebel Idlib Coordination Committee said the rebels had detonated a car bomb inside the base.


The government's SANA news agency said the base had not fallen and that the military had "strongly confronted an attempt by the terrorists to attack the airport from several axes, inflicting heavy losses among them and destroying their weapons and munitions".


Rami Abdulrahman, head of the opposition-aligned Syrian Observatory for Human Rights which monitors the conflict from Britain, said as many as 800 fighters were involved in the assault, including Islamists from Jabhat al-Nusra, a powerful group that Washington considers terrorists.


Taftanaz is mainly a helicopter base, used for missions to resupply army positions cut off by the rebels, as well as for dropping crude "barrel bombs" on rebel-controlled areas.


Near Minakh, another northern air base that rebels have surrounded, government forces have retaliated by shelling and bombing nearby towns.


NIGHTLY BOMBARDMENTS


In the town of Azaz, where the bombardment has become a near nightly occurrence, shells hit a family house overnight. Zeinab Hammadi said her two wounded daughters, aged 10 and 12, had been rushed across the border to Turkey, one with her brain exposed.


"We were sleeping and it just landed on us in the blink of an eye," she said, weeping as she surveyed the damage.


Family members tried to salvage possessions from the wreckage, men lifting out furniture and children carrying out their belongings in tubs.


"He (Assad) wants revenge against the people," said Abu Hassan, 33, working at a garage near the destroyed house. "What is the fault of the children? Are they the ones fighting?"


Opposition activists said warplanes struck a residential building in another rebel-held northern town, Hayyan, killing at least eight civilians.


Video footage showed men carrying dismembered bodies of children and dozens of people searching for victims in the rubble. The provenance of the video could not be independently confirmed.


In addition to their tenuous grip on the north, the rebels also hold a crescent of suburbs on the edge of Damascus, which have come under bombardment by government forces that control the center of the capital.


On Wednesday, according to opposition activists, dozens of people died in an inferno caused by an air strike on a petrol station in a Damascus suburb where residents were lining up for fuel.


The civil war in Syria has become the longest and bloodiest of the conflicts that rose out of uprisings across the Arab world in the past two years.


Assad's family has ruled for 42 years since his father seized power in a coup. The war pits rebels, mainly from the Sunni Muslim majority, against a government supported by members of Assad's Shi'ite-derived Alawite minority sect and some members of other minorities who fear revenge if he falls.


The West, most Sunni-ruled Arab states and Turkey have called for Assad to step down. He is supported by Russia and Shi'ite Iran.


(Additional reporting by Khaled Yacoub Oweis in Amman and Dominic Evans in Beirut; Writing by Peter Graff; Editing by Ruth Pitchford and Giles Elgood)



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Poll finds people want an ‘iPhone 5S’ with new color options






The latest rumor surrounding Apple’s (AAPL) next-generation “iPhone 5S” is that it will launch in May or June with two different screen sizes and five different color options. So said Topeka Capital Markets analyst Brian White in a research note earlier this week. White has made some good early calls before — he was one of the first to report that Apple was working on the iPad mini — but nothing is official until Apple announces it on stage at a press conference. One thing we can say with some amount of certainty, though, is that a sizable portion of Apple fans would be interested in a next-generation iPhone made available with new color choices.


[More from BGR: Samsung confirms plan to begin inching away from Android]






In a poll published by BGR on Wednesday, 35% of respondents reported that they would purchase the next iPhone in either blue, pink or yellow if Apple were to launch the device in those colors, as suggested by White. Another 28.4% said they would be interested in the new color options, but they would want to see how they look before making a purchasing decision.


[More from BGR: Microsoft called a failing giant that only survives by charging prices that ‘bleed customers dry’]


More than 2,000 people voted in the poll and roughly 85% of respondents live in the United States.


The results are not scientific, however they do suggest that there would be significant demand for an iPhone with new color options in key markets like the U.S. And where the iPhone 4S had Siri and the iPhone 5 had a fresh new design with a larger display, Apple will certainly look to launch its next-generation smartphone with some key points of differentiation.


As they were with the iPod touch, new color options may be among the next iPhone’s key new features when it launches later this year — and if that is indeed the case, it looks like the new colors will be met with significant interest from consumers.


This article was originally published by BGR


Gadgets News Headlines – Yahoo! News





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George Lucas Engaged to Mellody Hobson















01/03/2013 at 07:35 PM EST







George Lucas and Mellody Hobson


Mike Coppola/Getty


George Lucas is following the Force – right down the aisle.

The Star Wars director, 68, is engaged to DreamWorks animation chairman Mellody Hobson, a rep for Lucasfilm confirmed to The Hollywood Reporter on Thursday.

Hobson, 43, has been dating Lucas since 2006. This will be her first marriage and Lucas's second; he previously was married to film editor Marcia Lou Griffin. The exes adopted a daughter Amanda before their 1983 divorce. Lucas went on to adopt two more children.

Lucas's fiancée is also a contributor to Good Morning America's financial segments and has received many honors, including a 2002 listing as one of Esquire's "Best and Brightest" in America.

Lucas has made headlines of his own, recently donating to an education foundation much of the $4 billion from his sale of Lucasfilm to Disney.

According to THR, Lucas said at the time, "As I start a new chapter in my life, it is gratifying that I have the opportunity to devote more time and resources to philanthropy."

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Indian court to rule on generic drug industry


NEW DELHI (AP) — From Africa's crowded AIDS clinics to the malarial jungles of Southeast Asia, the lives of millions of ill people in the developing world are hanging in the balance ahead of a legal ruling that will determine whether India's drug companies can continue to provide cheap versions of many life-saving medicines.


The case — involving Swiss drug maker Novartis AG's cancer drug Glivec — pits aid groups that argue India plays a vital role as the pharmacy to the poor against drug companies that insist they need strong patents to make drug development profitable. A ruling by India's Supreme Court is expected in early 2013.


"The implications of this case reach far beyond India, and far beyond this particular cancer drug," said Leena Menghaney, from the aid group Doctors Without Borders. "Across the world, there is a heavy dependence on India to supply affordable versions of expensive patented medicines."


With no costs for developing new drugs or conducting expensive trials, India's $26 billion generics industry is able to sell medicine for as little as one-tenth the price of the companies that developed them, making India the second-largest source of medicines distributed by UNICEF in its global programs.


Indian pharmaceutical companies such as Cipla, Cadila Laboratories and Lupin have emerged over the past decade as major sources of generic cancer, malaria, tuberculosis and AIDS drugs for poor countries that can't afford to pay Western prices.


The 6-year-old case that just wrapped up in the Supreme Court revolves around a legal provision in India's 2005 patent law that is aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines — a practice known as "evergreening."


Novartis' argued that a new version of Glivec — marketed in the U.S. as Gleevec — was a significant change from the earlier version because it was more easily absorbed by the body.


India's Patent Controller turned down the application, saying the change was an obvious development, and the new medicine was not sufficiently distinct from the earlier version to warrant a patent extension.


Patient advocacy groups hailed the decision as a blow to "evergreening."


But Western companies argued that India's generic manufacturers were cutting the incentive for major drug makers to invest in research and innovation if they were not going to be able to reap the exclusive profits that patents bring.


"This case is about safeguarding incentives for better medicines so that patients' needs will be met in the future," says Eric Althoff, a Novartis spokesman.


International drug companies have accused India of disregarding intellectual property rights, and have pushed for stronger patent protection that would weaken India's generics industry.


Earlier this year, an Indian manufacturer was allowed to produce a far cheaper version of the kidney and liver cancer treatment sorefinib, manufactured by Bayer Corp.


Bayer was selling the drug for about $5,600 a month. Natco, the Indian company, said its generic version would cost $175 a month, less than 1/30th as much. Natco was ordered to pay 6 percent in royalties to Bayer.


Novartis says the outcome of the new case will not affect the availability of generic versions of Glivec because it is covered by a grandfather clause in India's patent law. Only the more easily absorbed drug would be affected, Althoff said, adding that its own generic business, Sandoz, produces cheap versions of its drugs for millions across the globe.


Public health activists say the question goes beyond Glivec to whether drug companies should get special protection for minor tweaks to medicines that others could easily have uncovered.


"We're looking to the Supreme Court to tell Novartis it won't open the floodgates and allow abusive patenting practices," said Eldred Tellis, of the Sankalp Rehabilitation Centre, a private group working with HIV patients.


The court's decision is expected to be a landmark that will influence future drug accessibility and price across the developing world.


"We're already paying very high prices for some of the new drugs that are patented in India," said Petros Isaakidis, an epidemiologist with Doctors Without Borders. "If Novartis' wins, even older medicines could be subject to patenting again, and it will become much more difficult for us in future to provide medicines to our patients being treated for HIV, hepatitis and drug resistant TB."


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