Death toll from Philippine typhoon nears 300












NEW BATAAN, Philippines (AP) — Stunned parents searching for missing children examined a row of mud-stained bodies covered with banana leaves while survivors dried their soaked belongings on roadsides Wednesday, a day after a powerful typhoon killed nearly 300 people in the southern Philippines.


Officials fear more bodies may be found as rescuers reach hard-hit areas that were isolated by landslides, floods and downed communications.












At least 151 people died in the worst-hit province of Compostela Valley when Typhoon Bopha lashed the region Tuesday, including 78 villagers and soldiers who perished in a flash flood that swamped two emergency shelters and a military camp, provincial spokeswoman Fe Maestre said.


Disaster-response agencies reported 284 dead in the region and 14 fatalities elsewhere from the typhoon, one of the strongest to hit the country this year.


About 80 people survived the deluge in New Bataan with injuries, and Interior Secretary Mar Roxas, who visited the town, said 319 others remained missing.


“These were whole families among the registered missing,” Roxas told the ABS-CBN TV network. “Entire families may have been washed away.”


The farming town of 45,000 people was a muddy wasteland of collapsed houses and coconut and banana trees felled by Bopha’s ferocious winds.


Bodies of victims were laid on the ground for viewing by people searching for missing relatives. Some were badly mangled after being dragged by raging flood waters over rocks and other debris. A man sprayed insecticide on the remains to keep away swarms of flies.


A father wept when he found the body of his child after lifting a plastic cover. A mother, meanwhile, went away in tears, unable to find her missing children. “I have three children,” she said repeatedly, flashing three fingers before a TV cameraman.


Two men carried the mud-caked body of an unidentified girl that was covered with coconut leaves on a makeshift stretcher made from a blanket and wooden poles.


Dionisia Requinto, 43, felt lucky to have survived with her husband and their eight children after swirling flood waters surrounded their home. She said they escaped and made their way up a hill to safety, bracing themselves against boulders and fallen trees as they climbed.


“The water rose so fast,” she told AP. “It was horrible. I thought it was going to be our end.”


In nearby Davao Oriental, the coastal province first struck by the typhoon as it blew from the Pacific Ocean, at least 115 people perished, mostly in three towns that were so battered that it was hard to find any buildings with roofs remaining, provincial officer Freddie Bendulo and other officials said.


“We had a problem where to take the evacuees. All the evacuation centers have lost their roofs,” Davao Oriental Gov. Corazon Malanyaon said.


The International Federation of Red Cross and Red Crescent Societies issued an urgent appeal for $ 4.8 million to help people directly affected by the typhoon.


The sun was shining brightly for most of the day Wednesday, prompting residents to lay their soaked clothes, books and other belongings out on roadsides to dry and revealing the extent of the damage to farmland. Thousands of banana trees in one Compostela Valley plantation were toppled by the wind, the young bananas still wrapped in blue plastic covers.


But as night fell, however, rain started pouring again over New Bataan, triggering panic among some residents who feared a repeat of the previous day’s flash floods. Some carried whatever belongings they could as they hurried to nearby towns or higher ground.


After slamming into Davao Oriental and Compostela Valley, Bopha roared quickly across the southern Mindanao and central regions, knocking out power in two entire provinces, triggering landslides and leaving houses and plantations damaged. More than 170,000 fled to evacuation centers.


As of Wednesday evening, the typhoon was over the South China Sea west of Palawan province. It was blowing northwestward and could be headed to Vietnam or southern China, according to government forecasters.


The deaths came despite efforts by President Benigno Aquino III’s government to force residents out of high-risk communities as the typhoon approached.


Some 20 typhoons and storms lash the northern and central Philippines each year, but they rarely hit the vast southern Mindanao region where sprawling export banana plantations have been planted over the decades because it seldom experiences strong winds that could blow down the trees.


A rare storm in the south last December killed more than 1,200 people and left many more homeless.


The United States extended its condolences and offered to help its Asian ally deal with the typhoon’s devastation. It praised government efforts to minimize the deaths and damage.


___


Associated Press writers Jim Gomez, Teresa Cerojano and Oliver Teves in Manila contributed to this report.


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100,000 protest at presidential palace


CAIRO (AP) — More than 100,000 Egyptians protested outside the presidential palace in Cairo on Tuesday, fueling tensions over Islamist leader Mohammed Morsi's seizure of nearly unrestricted powers and the adoption by his allies of a controversial draft constitution.


The outpouring of anger across the Egyptian capital, the Mediterranean port of Alexandria and a string of other cities pointed to a prolonged standoff between the president and a newly united opposition.


Morsi's opponents, long fractured by bickering and competing egos, have been re-energized since he announced decrees last month that place him above oversight of any kind, including by the courts, and provide immunity to two key bodies dominated by his allies: The 100-member panel drafting the constitution and parliament's upper chamber.


The decrees have led to charges that Morsi's powers turned him into a "new pharaoh."


The large turnout in Tuesday's protests — dubbed "The Last Warning" by organizers — signaled sustained momentum for the opposition, which brought out at least 200,000 protesters to Cairo's Tahrir Square a week ago and a comparable number on Friday to demand that Morsi rescind the decrees.


The huge scale of the protests have dealt a blow to the legitimacy of the new constitution, which Morsi's opponents contend allows religious authorities too much influence over legislation, threatens to restrict freedom of expression and opens the door to Islamist control over day-to-day life.


What the revived opposition has yet to make clear is what it will do next: campaign for a "no" vote on the draft constitution in a nationwide referendum set for Dec. 15, or call on Egyptians to boycott the vote.


Already, the country's powerful judges have said they will not take on their customary role of overseeing the vote, thus robbing it of much of its legitimacy.


Morsi was in the presidential palace conducting business as usual as the protesters gathered outside. He left for home through a back door as the crowds continued to swell, according to a presidential official who spoke on condition of anonymity because he was not authorized to speak to the media.


The official said Morsi left on the advice of security officials to head off "possible dangers" and to calm the protesters. Morsi's spokesman, however, said the president left the palace at the end of his normal work day, through the door he routinely uses.


The protest was peaceful except for a brief outburst when police used tear gas to prevent demonstrators from removing a barricade topped with barbed wire and converging on the palace.


Soon after, with the president gone, the police abandoned their lines and the protesters surged ahead to reach the palace walls. But there were no attempts to storm the palace, guarded inside by the army's Republican Guard.


Protesters also commandeered two police vans, climbing atop the armored vehicles to jubilantly wave Egypt's red, white and black flag and chant against Morsi. The protesters later mingled freely with the black-clad riot police, as more and more people flocked to the area to join the demonstration.


The protesters covered most of the palace walls with anti-Morsi graffiti and waved giant banners carrying images of revolutionaries killed in earlier protests. "Down with the regime" and "No to Morsi," they wrote on the walls.


"He isn't the president of all Egyptians, only of the Muslim Brotherhood," said protester Mariam Metwally, a postgraduate student of international law. "We don't feel like he is our president."


A giant poster emblazoned with an image of Morsi wearing a Pharaonic crown was hoisted between two street light posts outside the presidential palace. "Down with the president. No to the constitution," it declared.


"The scene at Itihadiya palace is a stab at the president's legitimacy and his constitutional declaration," opposition leader Hamdeen Sabahi told a private TV network. "The scene sends a message to the president that he is running out of time."


The massive gathering was reminiscent of the one outside the palace on Feb. 11, 2011 — the day authoritarian president Hosni Mubarak stepped down in the face of an 18-day uprising that ended his 29-year regime.


Shouts of "Erhal! Erhal!" — Arabic for "Leave! Leave!" — and "The people want to topple the regime!" rose up from the crowd, the same chants used against Mubarak. This time, though, they were directed at his successor, Egypt's first democratically elected president.


"The same way we brought down Mubarak in 18 days, we can bring down Morsi in less," Ziad Oleimi, a prominent rights activist, told the crowds using a loudspeaker.


In Alexandria, some 10,000 opponents of Morsi gathered in the center of the country's second-largest metropolis, chanting slogans against the leader and his Islamic fundamentalist group, the Muslim Brotherhood.


The protests fueled Egypt's worst political crisis since Mubarak's ouster, with the country clearly divided into two camps: Morsi, his Muslim Brotherhood and their ultraconservative Islamist allies, versus an opposition made up of youth groups, liberal parties and large sectors of the public.


Tens of thousands also gathered in Cairo's downtown Tahrir Square, miles away from the palace, to join several hundred who have been camping out there for nearly two weeks. There were other large protests around the city.


Smaller protests by Morsi opponents were staged in the Islamist stronghold of Assiut, as well as in Suez, Luxor, Aswan, Damanhour and the industrial city of Mahallah, north of Cairo.


"Freedom or we die," chanted a crowd of several hundred outside a mosque in Cairo's Abbasiyah district. "Mohammed Morsi, illegitimate! Brotherhood, illegitimate!" they yelled.


Earlier Tuesday, several hundred protesters also gathered outside Morsi's residence in an upscale suburb. "Down with the sons of dogs. We are the power and we are the people," they chanted.


Morsi, who narrowly won the presidency in a June election, appeared to be in no mood for compromise.


A statement by his office said he met Tuesday with his deputy, his prime minister and several top Cabinet members to discuss preparations for the referendum. The statement suggested business as usual at the palace, despite the mass rally outside its doors.


Asked why Morsi did not address the crowds, Muslim Brotherhood spokesman Mahmoud Ghozlan said the protesters were "rude" and included "thugs and drug addicts."


The Islamists responded to the mass opposition protests last week by sending hundreds of thousands of supporters into Cairo's twin city of Giza on Saturday and across much of the country. Thousands also besieged Egypt's highest court, the Supreme Constitutional Court.


The court had been widely expected to declare the constitutional assembly that passed the draft charter illegitimate and to disband parliament's upper house, the Shura Council. Instead, the judges went on strike after they found their building under siege by protesters.


Morsi's Nov. 22 decrees were followed last week by the constitutional panel rushing through the draft constitution in a marathon, all-night session without the participation of liberal and Christian members. Only four women, all Islamists, attended the session.


The charter has been criticized for not protecting the rights of women and minority groups, and many journalists see it as restricting freedom of expression. Critics also say it empowers Islamic religious clerics by giving them a say over legislation, while some articles were seen as tailored to get rid of the Islamists' enemies.


___


Associated Press writer Maggie Michael contributed to this report.


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‘Dr. Phil”s stolen classic Chevy recovered












BURBANK, Calif. (AP) — Los Angeles police say they’ve recovered a stolen 1957 Chevrolet Bel Air Convertible that belongs to talk-show host Phil McGraw.


Detective Jess Corral said Tuesday that investigators recovered McGraw’s classic car, along with 13 others, after law enforcement began targeting auto theft rings.












McGraw is known as television’s “Dr. Phil. His car was stolen from the RODZ shop in Burbank in August, and was found with minor damage.


The car is worth at least $ 80,000.


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Chelsea’s hypotension drug fails to prove efficacy past week one












(Reuters) – Chelsea Therapeutics Inc said its experimental hypotension drug met the main goal of a study by significantly reducing dizziness in patients at week one, but results beyond that period were not statistically significant.


The U.S. Food and Drug Administration declined to approve the drug, Northera, in March, and asked for data that proved it was effective over two to three months.












The company’s shares, which have lost about two-thirds of its value so far this year, fell 22 percent to $ 1.40 in extended trading after closing at $ 1.79 on Tuesday on the Nasdaq.


Chelsea said in August that it would modify the main goal of the ongoing 306B study, though the FDA had said the study was unlikely to provide sufficient data for a marketing application and had suggested the company conduct an additional trial.


The drugmaker said on Tuesday that preliminary data showed that beyond week one, dizziness/lightheadedness and standing blood pressure predominantly favored Northera-treated patients over placebo, although the results were not statistically significant.


The drug, known generically as droxidopa, is designed to treat symptomatic neurogenic orthostatic hypotension — a chronic and often debilitating drop in blood pressure on standing up that is most often associated with Parkinson’s disease.


(Reporting by Vidya P L Nathan in Bangalore; Editing by Anthony Kurian)


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Toshiba’s 10-inch Excite 10 SE tablet sells for $349.99, comes with Jelly Bean












While every other company is busy chasing the 7-inch tablet market, Toshiba (TOSBF) is keeping its eye on people interested in 10-inch tablets. Its new Excite 10 SE Android tablet is fairly similar to its Excite 10 LE, sporting a 10.1-inch 1280 x 800 resolution display, NVIDIA Tegra 3 quad-core processor, 16GB of internal storage, 3-megapixel rear camera, HD front camera, microSD card slot and Android 4.1 Jelly Bean. It doesn’t have the iPad’s eye-popping Retina display or the Samsung (005930) Nexus 10′s crisp 2,560 x 1,600 resolution with 300 pixels per inch, but it’s more than adequate for most basic tablet tasks. And at $ 349.99, it’s not a bad deal for a 10-inch tablet. The Excite 10 SE goes on sale December 6th and will be available from ToshibaDirect.com and select retail stores. Toshiba’s press release follows below.



Toshiba expands excite family of tablets with new 10-inch model












New Excite 10 SE Tablet Powered by Android 4.1 Starting at $ 349.99 MSRP


IRVINE, Calif. — Dec. 4, 2012 — Toshiba’s Digital Products Division (DPD), a division of Toshiba America Information Systems, Inc., today announced the availability of the Excite™ 10 SE tablet, a multimedia-rich tablet with a 10.1-inch touchscreen, powered by Android™ 4.1, Jelly Bean. The Excite 10 SE offers an affordable option for people looking for a powerful and versatile tablet for the home, starting at only $ 349.99 MSRP[i].


“Our Excite family of tablets continues to grow with options to suit a wide range of consumer needs, from portability and gaming to versatility and power,” said Carl Pinto, vice president of marketing of Toshiba America Information Systems, Inc., Digital Products Division. “We designed the Excite 10 SE to be a full featured tablet that offers a pure Android, Jelly Bean experience, while maintaining an attractive price point.”


The Excite 10 SE features Android 4.1, Jelly Bean, which improves on the simplicity and usability of Android 4.0. Moving between customizable home screens and switching between apps is effortless, while the Chrome™ browser and new Google Now intelligent personal assistant and Voice Search apps makes surfing the web fast and fluid.


Slim and light at only 0.4 inches thick and weighing 22.6 ounces[ii], the Excite 10 SE is encased with a textured Fusion Lattice finish, making it comfortable to hold and easy to carry. The tablet offers a vibrant 10.1-inch diagonal AutoBrite™ HD touchscreen display[iii] plus the NVIDIA® Tegra® 3 Super 4-PLUS-1™ quad-core processor[iv] that delivers smooth web browsing and outstanding performance for games, HD movies and more.


Stereo speakers with SRS® Premium Voice Pro create an optimized audio experience for music, video and games, while providing greater clarity for video chatting via the tablet’s HD front-facing camera. The Excite 10 SE also includes a 3 megapixel rear-facing camera with auto-focus and digital zoom for capturing HD video and photos. Featuring a wide range of connectivity, the tablet includes 802.11 b/g/n Wi-Fi®, Bluetooth® 3.0, as well as Micro SD and Micro USB ports for expandability. The tablet also charges conveniently via the Micro USB port.


Availability


The Excite 10 SE will be available starting at $ 349.99 MSRP for the 16GB model at select retailers and direct from Toshiba at ToshibaDirect.com on December 6, 2012.



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WestJet embraces tech to woo business travelers












TORONTO (Reuters) – WestJet Airlines Ltd will use technological innovation, including a new Internet ticket booking system, to help it transform from a no-frills carrier to a lower-cost full-service airline courting lucrative corporate travelers, its chief executive said on Monday.


Canada’s second-biggest airline plans to launch a series of technology systems, most notably the new online booking engine, which will sell three tiers of tickets, in the next two months.












“Companies evolve or they die,” Chief Executive Gregg Saretsky told Reuters in a phone interview from the company’s Calgary head office.


“We’re 16 and going on 17 years old and we can’t stay just as we were 17 years ago. The world has changed. And we are changing to be more relevant for a broader segment of guests.”


The new Internet booking system, which WestJet hopes to launch in late January, will sell economy, mid-tier and premium tickets. That is a major shift from its current system, which sells only the lowest-priced ticket available.


Economy tickets under the new system will continue to sell the lowest available fare, but the cancellation fee for them will jump to C$ 75 ($ 75.48) from C$ 50. Mid-tier tickets will have a C$ 50 cancellation fee.


Premium tickets, unavailable until late March when WestJet finishes reconfiguring its 100 Boeing 737 planes to allow more leg room, will include priority screening and boarding, free cancellations and flexibility on ticket changes.


Pricing for those tickets, which may include free meals and drinks and an extra baggage allowance, has not yet been determined. Fares will be well below half the price for business class at WestJet’s bigger competitor, Air Canada, Saretsky said.


“It’s time for us to be more serious with respect to going after business travelers because frankly, they’re the ones who are booking last-minute and are happy to pay for the conveniences,” Saretsky said.


WestJet will launch its premium economy service with 24 seats per plane, but will consider expansion if it proves “wildly successful,” he added.


POISED FOR CHANGE


WestJet, which has spent about C$ 40 million over the past two years on technology projects, is poised for major changes in 2013 as it readies to launch a new regional airline, Encore.


Saretsky hopes that WestJet’s switch in coming weeks to a new Internet phone system will allow ticket reservation agents to work from home and help make room for Encore staff.


Some 750 reservation agents work at WestJet’s Calgary offices, which house about 2,400 staff. Space will be needed for Encore employees over the next 18 months while their office, hangars and maintenance stores are constructed at the WestJet campus.


Encore will be launch in the second half of 2013, “probably closer to July than December,” Saretsky said, with seven Bombardier Q400 planes.


While WestJet won’t announce Encore’s schedule until Jan 21, the carrier will initially serve only “a handful” of new cities, with ticket prices up to 50 percent below Air Canada’s, he added.


Over the next two months, WestJet will also roll out a guest notification system that alerts travelers via email about their flights, allowing them to check in remotely.


Such self-service technology will be critical as WestJet faces increasing labor costs, Saretsky said.


Wage and benefit costs, which represent about a third of operating costs, have climbed 50 percent since WestJet was founded in 1996.


“You can see that creates a little bit of drag on earnings,” Saretsky said. “We’ve got to find ways of reducing our component costs.”


If WestJet can increase self service options for travelers, that could limit the need for new employees, Saretsky said. Management also wants to improve attendance management, so that fewer employees book off sick around long weekends, and more quickly clean and process planes between flights, he said.


(Reporting By Susan Taylor; Editing by Peter Galloway)


(This story was corrected to show that WestJet is replacing its Internet booking engine, not entire reservation system, in the first and second paragraphs)


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Marine special operations team members honored

CAMP PENDLETON, Calif. (AP) — Navy Secretary Ray Mabus on Monday honored four members of a Marine special operations team in a rare public ceremony for those who have served in the covert forces.

In a ceremony at Camp Pendleton, Calif., Mabus awarded Marine Sgt. William Soutra Jr. the Navy Cross, the Navy's highest honor and the military's second highest honor, for tending to the wounded while guiding the platoon to safety during an attack in Afghanistan's Helmand Province in July 2010 that spanned over two days.

Three others on his team, including a Navy corpsman, were given Silver Stars.

Often the heroic actions of those on special operations teams are only known to each other and the leadership because of their covert work on classified missions.

"This is a chance to recognize people who don't get recognized much," Mabus said.

Soutra was a canine handler with a Marine special operations team when they were ambushed. After the team's assistant leader was fatally wounded by an enemy explosive during the ambush, Soutra jumped into action, repeatedly running into the line of fire as he helped direct troops to defend themselves and fight off the enemy, Mabus said.

At one point, the 27-year-old Marine from Worcester, Mass., placed a tourniquet on a wounded commando, before dragging him to a ditch for cover. He worked tirelessly for more than an hour after the initial blast and helped carry casualties through the sporadic gunfire, officials said.

His military dog stayed attached to his side during the ordeal. The dog had to be put down more than a year ago because it had cancer.

Maj. James Rose, Staff Sgt. Frankie Shinost Jr. and Navy Corpsman Patrick Quill were given Silver Stars for their actions that day.

The four men called it a horrible day because they lost their element leader, Staff Sgt. Chris Antonik.

"Every day I think about Chris," said Soutra, calling him a close friend and great warrior.

Soutra vowed to try to carry on as the kind of warrior that would make Antonik proud.

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Marine special operations team members honored

CAMP PENDLETON, Calif. (AP) — Navy Secretary Ray Mabus on Monday honored four members of a Marine special operations team in a rare public ceremony for those who have served in the covert forces.

In a ceremony at Camp Pendleton, Calif., Mabus awarded Marine Sgt. William Soutra Jr. the Navy Cross, the Navy's highest honor and the military's second highest honor, for tending to the wounded while guiding the platoon to safety during an attack in Afghanistan's Helmand Province in July 2010 that spanned over two days.

Three others on his team, including a Navy corpsman, were given Silver Stars.

Often the heroic actions of those on special operations teams are only known to each other and the leadership because of their covert work on classified missions.

"This is a chance to recognize people who don't get recognized much," Mabus said.

Soutra was a canine handler with a Marine special operations team when they were ambushed. After the team's assistant leader was fatally wounded by an enemy explosive during the ambush, Soutra jumped into action, repeatedly running into the line of fire as he helped direct troops to defend themselves and fight off the enemy, Mabus said.

At one point, the 27-year-old Marine from Worcester, Mass., placed a tourniquet on a wounded commando, before dragging him to a ditch for cover. He worked tirelessly for more than an hour after the initial blast and helped carry casualties through the sporadic gunfire, officials said.

His military dog stayed attached to his side during the ordeal. The dog had to be put down more than a year ago because it had cancer.

Maj. James Rose, Staff Sgt. Frankie Shinost Jr. and Navy Corpsman Patrick Quill were given Silver Stars for their actions that day.

The four men called it a horrible day because they lost their element leader, Staff Sgt. Chris Antonik.

"Every day I think about Chris," said Soutra, calling him a close friend and great warrior.

Soutra vowed to try to carry on as the kind of warrior that would make Antonik proud.

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LeBron James wins Sports Illustrated annual award












(Reuters) – LeBron James of the Miami Heat was named as Sports Illustrated’s Sportsman of the Year for 2012, the U.S. magazine announced on Monday.


In an outstanding year, the 27-year-old James won his first NBA championship, his third league Most Valuable Player (MVP) award, was named MVP of the NBA finals and a won gold medal with the United States at the London Olympics.












He became just the sixth basketballer to win the award, which began in 1954. The most recent was his team-mate Dwyane Wade in 2006.


Two years ago, James became a hate figure for many American sports fans after he announced his decision to sign for Miami live on television after his contract with the Cleveland Cavaliers had expired.


He was booed at courts across the NBA and received intense criticism for his performance as Miami lost the 2011 NBA finals to the Dallas Mavericks.


“Did I think an award like this was possible two years ago? ‘No, I did not,” James said in an interview with the magazine.


“I thought I would be helping a lot of kids and raise $ 3 million by going on TV and saying, ‘Hey, I want to play for the Miami Heat.’ But it affected far more people than I imagined.


“I know it wasn’t on the level of an injury or an addiction, but it was something I had to recover from. I had to become a better person, a better player, a better father, a better friend, a better mentor and a better leader. I’ve changed, and I think people have started to understand who I really am.”


Previous winners of the award include swimmer Michael Phelps (2008), cyclist Lance Armstrong (2002) and golfer Tiger Woods (2000) while the first award was given to British athlete Roger Bannister in 1954 after he became the first person to run a mile in under four minutes.


(Reporting By Simon Evans; Editing by Julian Linden)


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U.S. court voids drug rep’s conviction, cites free speech












NEW YORK (Reuters) – A divided federal appeals court on Monday threw out the conviction of a sales representative for promoting off-label use of a prescription drug, a ruling that could make it harder for the government to police how drugs are marketed and sold.


The 2nd U.S. Circuit Court of Appeals in New York found that the sales representative’s free speech rights under the First Amendment had been violated.












“In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed,” Circuit Judge Denny Chin wrote for a 2-1 majority.


The decision overturned the October 2008 conviction of Alfred Caronia, a sales representative for Orphan Medical Inc, now part of Jazz Pharmaceuticals Plc.


Using drugs “off-label” means that they are taken for conditions other than those for which they received U.S. Food and Drug Administration approval.


Many large healthcare settlements with the U.S. government have involved off-label promotions, including GlaxoSmithKline Plc’s $ 3 billion accord in July over several medicines, and Pfizer Inc’s $ 2.3 billion accord in 2009 over treatments such as the anti-inflammatory drug Bextra.


Matthew Bennett, vice-president of the Pharmaceutical Research and Manufacturers of America, an industry lobby, in a statement said the group was “pleased that the Second Circuit has recognized that the FDA‘s ability to regulate communication about medicines is circumscribed by the rights protected by the First Amendment.”


An FDA spokeswoman declined to comment. The U.S. Justice Department, which prosecuted Caronia, did not immediately respond to a request for comment.


CONSPIRACY CONVICTION


Caronia had appealed his conviction by a Brooklyn, New York, jury on one count of conspiracy for introducing a misbranded drug into interstate commerce, violating the federal Food, Drug & Cosmetic Act.


He was sentenced to one year of probation plus 100 hours of community service for the misdemeanor.


The drug was Xyrem, which won FDA approval in July 2002 to treat patients with narcolepsy, a condition associated with weak muscles, and in November 2005 to treat patients with excessive daytime sleepiness linked to narcolepsy.


Prosecutors said that in October 2005, prior to the second FDA approval, Caronia had improperly promoted Xyrem for “off-label” uses including excessive daytime sleepiness, muscle disorders, chronic pain and fatigue.


But Caronia said it should not be a crime for drug companies and sales representatives to truthfully promote FDA-approved drugs for legal, off-label uses when others, like doctors, may engage in such speech without penalty.


The 2nd Circuit agreed, noting that the U.S. Supreme Court had in 2011 found that speech that aided in drug marketing was a form of constitutionally protected expression.


Chin rejected the government’s contentions that restrictions were needed to stop the non-approved usage of drugs, and preserve the efficacy of the FDA drug approval process.


“The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good,” Chin wrote.


Chin made clear in a footnote that off-label promotion that is false or misleading does not get First Amendment protection.


NO MORE GUESSWORK


Thomas Liotti, a lawyer for Caronia, welcomed the decision.


“If physicians can talk about alternative uses of drugs among themselves, it doesn’t seem to make any sense that others cannot,” he said in a phone interview.


He said the decision “increases the marketability of drugs, and means consumers can be fully informed by sales representatives, manufacturers and their own physicians.”


Chin was joined in the majority by Circuit Judge Reena Raggi.


Circuit Judge Debra Ann Livingston dissented. She called the case indistinguishable from a 2004 case in which a unanimous panel of the federal appeals court in Washington, D.C., including then-judge and current U.S. Chief Justice John Roberts, found no First Amendment protection.


“The majority calls into question the very foundations of our century-old system of drug regulation,” Livingston wrote. “I do not believe that the Supreme Court’s precedents compel such a result.”


The case is U.S. v. Caronia, 2nd U.S. Circuit Court of Appeals, No. 09-cr-5006.


(Reporting by Jonathan Stempel; Additional reporting by David Ingram in Washington, D.C.; Editing by Steve Orlofsky and Vicki Allen)


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