Elmo puppeteer Clash resigns following new sex claims
















NEW YORK (Reuters) – Kevin Clash, the puppeteer behind the “Sesame Street” character Elmo, resigned on Tuesday following new allegations that he had sex with an underage boy, adding to an ongoing controversy involving one of America’s most popular children’s brands.


In a lawsuit filed on Tuesday, Cecil Singleton is seeking more than $ 5 million in damages from Clash. Singleton claims he met the then-32-year-old puppeteer in 1993 in a gay chat room when he was 15.













It added that on numerous occasions over a period of years Clash engaged in sexual activity with Singleton.


The news came just a week after another man recanted his claims that Clash had sex with him when he was 16 years old.


Clash, 52, said he was leaving Sesame Workshop, the company behind the television show, after nearly 30 years with a very heavy heart.


“I have loved every day of my 28 years working for this exceptional organization. Personal matters have diverted attention away from the important work Sesame Street is doing and I cannot allow it to go on any longer,” he said in a statement issued by his publicist, Risa B. Heller.


“I am deeply sorry to be leaving and am looking forward to resolving these personal matters privately,” he added.


The New York-based Sesame Workshop said it was a sad day for “Sesame Street,” which premiered in 1969 and has been educating and entertaining children for decades with characters such as Elmo, Big Bird, Bert and Ernie, Oscar the Grouch and Cookie Monster.


“Unfortunately, the controversy surrounding Kevin’s personal life has become a distraction that none of us wants, and he has concluded that he can no longer be effective in his job and has resigned from Sesame Street,” the company said in a statement.


A representative declined further comment.


The unnamed 23-year-old man who first accused Clash recanted his claims last week, saying the relationship was consensual. His lawyers were not immediately available to comment on the lawsuit.


Clash had denied the allegations and acknowledged a past relationship with his first accuser. He added the pair were both consenting adults at the time.


“I am a gay man. I have never been ashamed of this or tried to hide it,” Clash said at the time.


Sesame Workshop said the first allegations involving Clash came to its attention in June when the earlier accuser contacted the company by email.


The Elmo character debuted on “Sesame Street” in 1979. While Clash was the third performer to animate the child-like shaggy red monster, Sesame Workshop credits him with turning Elmo into the international sensation he became.


(Reporting by Patricia Reaney; additional reporting by Steve Gorman; Editing by Ellen Wulfhorst and Cynthia Osterman)


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Ex-hedge fund trader charged in $276M insider ploy
















NEW YORK (AP) — A former hedge fund portfolio manager was arrested Tuesday in what prosecutors called perhaps the most lucrative insider trading scheme of all time — an arrangement to obtain secret, advance results of tests on an experimental Alzheimer’s drug that netted more than $ 276 million for his fund and others.


The case also led authorities to investigate the activities of one of the nation’s wealthiest hedge fund managers, billionaire Steven A. Cohen.













The portfolio manager, Mathew Martoma, was accused in U.S. District Court in Manhattan of using the information to advise other investment professionals to buy shares in the companies developing the drug, then later to dump those investments and place financial bets against the companies when the tests returned disappointing results.


“The charges unsealed today describe cheating coming and going,” U.S. Attorney Preet Bharara said at a news conference. The scheme unfolded “on a scale that has no historical precedent.”


Martoma’s trades helped reap a hefty profit from 2006 through July 2008, while he worked for CR Intrinsic Investors LLC of Stamford, Conn., an affiliate of SAC Capital Advisors, a firm owned by Cohen.


Cohen is not referred to by name in court papers but is frequently alluded to for his dealings with the defendant in the weeks leading up to an announcement about the drug trial.


The government has been scrutinizing SAC since at least November 2010, when the FBI subpoenaed SAC and other influential hedge funds. Martoma is the fourth person associated with SAC Capital to be arrested on insider trading charges in the last four years.


SAC spokesman Jonathan Gasthalter said the company and Cohen “are confident that they have acted appropriately and will continue to cooperate with the government’s inquiry.”


The FBI said the scheme developed after Martoma met a doctor in Manhattan involved in an Alzheimer’s drug trial in October 2006. According to a criminal complaint, he later obtained confidential information related to the final results of a drug trial.


Martoma’s attorney, Charles Stillman, called his client “an exceptional portfolio manager who succeeded through hard work and the dogged pursuit of information in the public domain. What happened today is only the beginning of a process that we are confident will lead to Mr. Martoma’s full exoneration.”


Martoma was arrested at his home in Boca Raton, Fla., and made an initial appearance in federal court in West Palm Beach, Fla., where he was released on $ 5 million bail on charges of conspiracy to commit securities fraud and securities fraud. He was scheduled to return to court Monday in Manhattan.


The defendant will have great incentive to cooperate with the government because the size of the gains would add years, if not decades, to any potential sentence upon conviction, said John Sylvia, co-chairman of the securities litigation practice at the Mintz Levin law firm in Boston.


He said it was clear from reading the court papers that Cohen was referenced frequently and was a likely target of investigators, though they might not be able to build a sufficient case against him.


“There’s little doubt as to where the government’s sights are,” Sylvia said. “I don’t think it takes Sherlock Holmes to figure it out.”


The Securities and Exchange Commission filed civil papers in the case against CR Intrinsic Investors, Mathew Martoma and Dr. Sidney Gilman. The civil complaint said the illegal money was earned in July 2008, when various hedge funds traded ahead of a negative public announcement involving the clinical trial results of an Alzheimer drug being jointly developed by Elan Corp. and Wyeth, both pharmaceutical companies.


The SEC complaint said that Martoma carried out the scheme with Gilman, an 80-year-old professor of neurology at the University of Michigan Medical School who served as chairman of a safety committee overseeing the clinical trial. Gilman was selected by Elan and Wyeth to present the final clinical trial results at a July 29, 2008, medical conference.


Messages left with the University of Michigan Medical School were not immediately returned.


Gilman’s lawyer, Marc Mukasey, said his client is cooperating with the SEC and the U.S. Attorney’s Office, and has entered into a non-prosecution agreement with federal prosecutors.


A copy of the agreement released by federal prosecutors Tuesday showed that Gilman will forfeit nearly $ 187,000 that he received from Elan for consulting work in 2007 and 2008 and from an expert networking firm for consultations between 2006 and 2009 with Martoma’s hedge fund.


Bharara said Martoma gained from “cultivating and corrupting” Gilman, eventually receiving $ 9 million in bonus pay for the year when the trades were made.


Martoma met with the doctor about 42 times, beginning in the summer of 2006, and eventually convinced him to start talking about the drug trial, prosecutors said.


The SEC said leaks by Martoma caused hedge fund portfolios managed by CR Intrinsic and by an affiliated investment adviser to liquidate more than $ 700 million in holdings in Elan and Wyeth.


The massive repositioning, the SEC said, allowed CR Intrinsic and various hedge funds to reap huge illicit profits and avoid steep losses.


“By cultivating and corrupting a doctor with access to secret drug data, Mathew Martoma and his hedge fund benefited from what might be the most lucrative inside tip of all time,” Bharara said.


The prosecutor said the doctor sent him a draft of the 24-page presentation he planned to make at a conference announcing the results.


That is when Martoma “had to do a spectacular about-face because he understood that — with these negative results looming — the hedge fund’s massive $ 700 million stake had become a terrible bet,” Bharara said. “And so, just like that, overnight, Martoma went from bull to bear as he tried to dig his hedge fund out of a massive hole.”


The news caused Elan’s stock price to plunge by more than 40 percent. The price of Wyeth fell about 12 percent.


The bets against the drug developers brought additional profits totaling $ 76.2 million. That is roughly the same amount that prosecutors said former hedge fund manager Raj Rajaratnam made in illegal profits before he was arrested. The one-time billionaire is serving an 11-year prison sentence in what was once considered the biggest insider trading case in U.S. history.


A year later, a hedge fund employee recommended that Martoma be terminated, and he was let go in 2010, Bharara said.


___


AP Business Writer Daniel Wagner in Washington contributed to this report.


Health News Headlines – Yahoo! News



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Securing Gaza cease-fire proves elusive

JERUSALEM (AP) — Israel and the Hamas militant group edged closer to a cease-fire Tuesday to end a weeklong Israeli offensive in the Gaza Strip, but after a day of furious diplomatic efforts involving the U.S. secretary of state, U.N. chief and Egypt's president, a deal remained elusive and fighting raged on both sides of the border.

Israeli tanks and gunboats pummeled targets in Gaza in what appeared to be a last-minute burst of fire, while at least 200 rockets were fired into Israel. As talks dragged on near midnight, Israeli and Hamas officials, communicating through Egyptian mediators, expressed hope that a deal would soon be reached, but cautioned that it was far from certain.

"If there is a possibility of achieving a long-term solution to this problem by diplomatic means, we prefer that. But if not, then I am sure you will understand that Israel will have to take whatever actions are necessary to defend its people," Israeli Prime Minister Benjamin Netanyahu said at a late-night meeting with visiting Secretary of State Hillary Rodham Clinton.

Clinton was hastily dispatched to the region by President Barack Obama to join a high-profile group of world leaders working to halt the violence. Standing alongside the Israeli leader, Clinton indicated it could take some time to iron out an agreement.

"In the days ahead, the United States will work with our partners here in Israel and across the region toward an outcome that bolsters security for the people of Israel, improves conditions for the people of Gaza and moves toward a comprehensive peace for all people of the region," she said.

Clinton expressed sorrow for the heavy loss of life on both sides, but called for the Palestinian rocket attacks on Israel to end and stressed that the American commitment to Israel's security is "rock solid."

"The goal must be a durable outcome that promotes regional stability and advances the security and legitimate aspirations of Israelis and Palestinians alike," she said.

In Washington, State Department spokeswoman Victoria Nuland said Clinton met with Netanyahu and other Israeli officials for two hours.

"They discussed efforts to de-escalate the situation and bring about a sustainable outcome that protests Israel's security and improves the lives of civilians in Gaza," Nuland said. "They also consulted on her impending stops in Ramallah and Cairo, including Egyptian efforts to advance de-escalation."

Israel launched the offensive on Nov. 14 in a bid to end months of rocket attacks out of the Hamas-run territory, which lies on Israel's southern flank. After assassinating Hamas' military chief, it has carried out a blistering campaign of airstrikes, targeting rocket launchers, storage sites and wanted militants.

The campaign has killed more than 130 Palestinians, including dozens of civilians, and wounded hundreds of others. Five Israelis have been killed by rocket fire, including a soldier and a civilian contractor on Tuesday.

With Israel massing thousands of ground troops on the Gaza border, diplomats raced throughout the region in search of a formula to halt the fighting.

In a meeting with Netanyahu, U.N. chief Ban Ki-moon condemned Palestinian rocket attacks, but urged Israel to show "maximum restraint."

"Further escalation benefits no one," he said.

Israel demands an end to rocket fire from Gaza and a halt to weapons smuggling into Gaza through tunnels under the border with Egypt. It also wants international guarantees that Hamas will not rearm or use Egypt's Sinai region, which abuts both Gaza and southern Israel, to attack Israelis.

Hamas wants Israel to halt all attacks on Gaza and lift tight restrictions on trade and movement in and out of the territory that have been in place since Hamas seized Gaza by force in 2007. Israel has rejected such demands in the past.

Egypt's new Islamist government is expected to play a key role in maintaining a deal.

The crisis has thrust Egypt's president, Mohammed Morsi, into the spotlight as he plays a difficult balancing act.

Morsi belongs to the Muslim Brotherhood, Hamas' parent movement, and clearly sympathizes with the Islamic militant group. At the same time, he relies heavily on U.S. aid and is trying to preserve a historic peace agreement with Israel.

Earlier, Morsi raised hopes that a cease-fire was near when he predicted the negotiations would yield "positive results" during the coming hours.

Netanyahu also said his country would be a "willing partner" in a cease-fire agreement.

But as the talks stretched into the evening, it became clear that a deal remained a ways off.

"Most likely the deal will be struck tomorrow. Israel has not responded to some demands, which delayed the deal," Hamas official Izzat Risheq said.

Hamas officials refused to discuss the remaining sticking points.

Israeli media quoted Defense Minister Ehud Barak as telling a closed meeting that Israel wanted a 24-hour test period of no rocket fire to see if Hamas could enforce a truce.

Palestinian officials briefed on the negotiations said Hamas wanted assurances of a comprehensive deal that included new border arrangements — and were resisting Israeli proposals for a phased agreement. The officials spoke on condition of anonymity because they were not authorized to talk to the media.

Although Israel claims it has inflicted heavy damage on militants' capabilities, its roughly 1,550 airstrikes and shelling attacks have failed to halt the rocket fire.

More than 1,400 rockets have been fired at Israel, including about 200 on Tuesday. A U.S.-financed Israeli rocket-defense system has knocked down roughly 400 of the incoming projectiles.

Violence raged on as the talks continued. An airstrike late Tuesday killed two journalists who work for the Hamas TV station, Al-Aqsa, according to a statement from the channel. A third journalist, from Al Quds Educational Radio, a private station, also was killed.

The Al-Aqsa TV cameramen were in a car hit by an airstrike, Gaza health official Ashraf al-Kidra said. Israel claims that many Hamas journalists are involved in militant activities. Earlier this week it targeted the station's offices, saying they served as a Hamas communications post.

Late Tuesday, a Palestinian rocket hit a house in the central Israeli city of Rishon Lezion, wounding two people and badly damaging the top two floors of the building, police spokesman Micky Rosenfeld said.

Minutes before Ban's arrival in Jerusalem from Egypt, Palestinian militants fired a rocket toward Jerusalem, just the second time it has targeted the city. The rocket fell in an open area southeast of the city.

Jerusalem had previously been considered beyond the range of Gaza rockets — and an unlikely target because it is home to the Al-Aqsa Mosque compound, Islam's third-holiest shrine.

Israeli warplanes dropped leaflets on several Gaza neighborhoods asking residents to evacuate and head toward the center of Gaza City along specific roads. The army "is not targeting any of you, and doesn't want to harm you or your families," the leaflets said. Palestinian militants urged residents to ignore the warnings, calling them "psychological warfare."

Israeli security officials acknowledge they rely on a network of Palestinian informants to identify targets. Masked gunmen publicly shot dead six suspected collaborators with Israel in a large Gaza City intersection Tuesday, witnesses said.

An Associated Press reporter saw a mob surrounding five of the bloodied corpses shortly after the killing, and one of the bodies was dragged through the streets by a motorcycle.

Hamas did not provide any evidence against the alleged collaborators.

Clinton was also scheduled to meet with Palestinian President Mahmoud Abbas in the West Bank and Egyptian leaders in Cairo on Wednesday. Turkey's foreign minister and a delegation of Arab League foreign ministers traveled to Gaza on a separate truce mission. Airstrikes continued to hit Gaza even as they entered the territory.

"Turkey is standing by you," Turkish Foreign Minister Ahmet Davutoglu told the Hamas prime minister in Gaza, Ismail Haniyeh. "Our demand is clear. Israel should end its aggression immediately and lift the inhumane blockade imposed on Gaza."

The U.S. considers Hamas, which has killed hundreds of Israelis in suicide and other attacks, to be a terror group and does not meet with its officials. The Obama administration blames Hamas for the latest eruption of violence and says Israel has the right to defend itself. At the same time, it has warned against a ground invasion, saying it could send casualties spiraling.

___

Barzak reported from Gaza City, Gaza Strip. Associated Press writers Hamza Hendawi in Cairo, Karin Laub in Gaza City and Ian Deitch in Jerusalem contributed to this report.

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Turbulence on Cuba-Italy flight leaves 30 bruised
















ROME (AP) — An airliner flying from Havana to Milan abruptly plunged some 1,000 meters (3,300 feet) when it hit unusually strong turbulence over the Atlantic on Monday, terrifying passengers and leaving some 30 people aboard with bruises and scrapes, airline officials said.


The flight continued to Milan’s Malpensa airport after the plane’s captain determined that it suffered no structural damage and two passengers who are physicians found no serious injuries, Giulio Buzzi, head of the pilots division at Neos Air, told Sky TG24 TV.













The ANSA news agency quoted bruised passenger Edoardo De Lucchi as saying meals were being served when suddenly there was “10 seconds of terror.” He recounted how plates went flying and some passengers not wearing seatbelts bounced about.


Buzzi had said that the drop measured some 3,000 meters (10,000 feet) in a cloudless sky. But Milan daily’s Corriere della Sera’s web site, quoting Neos official Davide Martini, later reported that the plane first bounced up some 500 meters (1,650 feet), then dropped some 1,000 meters (3,300 feet) to some 500 meters (1,650 feet) below the original altitude.


Europe News Headlines – Yahoo! News



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Review: Wii U Filled With Potential
















The Nintendo Wii turns six this month, making the video game system past its prime in console years. Nintendo and third-party developers have been slowly grinding Wii titles to a halt as all prepare for its successor, the $ 300 Wii U (say it with us, We-you), to launch today.


WATCH: Wii U Video Review













The latest Nintendo comes with a shiny new console and a shiny new GamePad tablet controller. (They may actually be a little too shiny, as the system and controller easily pick up smudges and fingerprints.) A mess of long cords also come with the system, including the Wii U’s power cord, the GamePad’s charger, the HDMI cord and the motion sensor’s long, thin cord.


The box is packed with contents, but also high expectations.


The Console
The GamePad controller, which we will get to in a second, is one of the biggest changes to the system, but there are a lot of other changes inside the actual console. With an IBM multi-core processor, 2GB of RAM, and an AMD Radeon graphics chip, a Nintendo console is capable for the first time of pushing along full HD, 1080p games on your HDTV. It connects to your HDTV via that aforementioned HDMI cord, which is kindly included in the box.


At least for a brief period we have a Nintendo with better internal organs than the Xbox 360 and Sony PlayStation, though not many expect that to last.


Of note, the graphics processor on the Wii U is far more advanced than its competition, but the computer processor has been hinted to be a little less powerful than both rivals. This means stronger graphics, but potential processing issues when more moving items are presented on screen.


The GamePad
Back to the main event — the Wii U’s GamePad controller. Nintendo’s latest toy takes the best aspects of the company’s top-selling handheld, the Nintendo DS, and has supersized them, putting a larger, 6.2-inch touchscreen in your hands. But that’s not all that is found in the controller. It also has a front-facing camera, stylus, dual analog sticks, an accelerometer and a gyroscope.


At 1.1 pounds the controller is easy to hold and very light. And while it is a bit wide, it is durable enough to avoid much damage when in the hands of an enraged 7-year-old. Yes, I slammed it on a carpeted floor a few times and it withstood the abuse.


There is only one GamePad included in the box and you can expect there to be fighting over it. At the moment, Nintendo isn’t selling GamePads separately, but that’s intentional; there are no games that support dual GamePad experiences at the moment.


Nintendo calls its one-pad approach “asymmetric gameplay,” where the person using the GamePad has a different role in how games are played, equivalent to being “it” in tag or the dungeon master in “Dungeons & Dragons.” For this role, what they see on the controller’s screen is sometimes completely different than what others see on the TV.


For instance, in “Nintendo Land‘s Animal Crossing: Sweet Day,” the person with the GamePad controls two characters while the person with the extra non-GamePad controller controls just one. The person using the GamePad sees their characters on the touchscreen, while the non-GamePad player sees theirs on the TV.


Nintendo is releasing a Pro controller with the Wii U for an extra $ 50. The controller looks very similar to the Xbox 360 controller, and while we do wish it was included for the $ 300 price, you don’t have to buy that controller if you want to add more players. That’s because your original Wii games and Wiimote controllers will work with the new system.


Nintendo sold 97 million Wii consoles in six years and plenty of Nintendo fans have stashes of iconic white wands sitting around the house. All those still in love with motion controls can rest easy, this move means all your past, present and future arm flailing will endure.


Word to the wise: if you haven’t already purchased WiiMotion Plus add-on accessories for your old Wiimotes, now is the time, they’re crucial for games like Zelda Battle Quest in “Nintendo Land.”


Since the Gamepad is wireless, it can be used when away from the TV, but not too far away. You can play a game on it while in another room in the house, but it needs to be in close proximity to the console. You’ll want to make sure you’re in close proximity to the charger, too. All that technology inside the Gamepad takes a hit on battery life; after four hours of continuous gameplay it begins to warn you of its need for juice.


The Games
In 2006, the Wii launched with “Wii Sports,” a game included in the box and built to demonstrate the capabilities of the system. “Wii Sports” was big on simplicity, utilizing just a few buttons and bit of stick waving, making it the ultimate casual gaming experience.


Today’s Wii U’s launch is complimented by “Nintendo Land,” a world that contains 12 mini-games in one. (It comes in the box with the $ 350 Deluxe Wii U version and costs $ 60 on its own.) Some games take advantage of the stylus while others require a mix of the analog sticks, motion capabilities, and the actual touchscreen. The variety is a great showcase but lacks the level of simplicity that made “Wii Sports” an instant hit.


If anything, the Wii U’s sampling of gameplay varieties will get you excited thinking what might be possible with the new hardware. Drawing with the stylus on your GamePad and seeing the end result on a TV screen is extremely satisfying. A possible “Mario Paint” meets “Draw Something” could be gigantic. My colleague Joanna Stern couldn’t get enough of flicking stars on the touch screen in “Takamaru’s Ninja Castle,” I could see a full game centered around that mechanic doing very well.


At launch, there are almost two-dozen titles with various degrees of GamePad integration, spanning almost every genre. It feels like there should be more that directly take advantage of the touchscreen, however. We will be reviewing these over the course of the week, but I will say the $ 60 New Super Mario Bros. U seems like a must-have, just to experience Mario in HD for the first time.


The Social and Media Capabilities
With the Wii U comes a broadening of the Nintendo Network, the structure that has allowed Nintendo 3DS players to compete with each other online. On the Nintendo Network, video chat is now available through the GamePad‘s front-facing camera.


Mii avatars are being more integrated than ever into games, you can expect to be the star of the game more often and to see your Miis interacting with those of your friends, sharing screenshots, messages and accomplishments.


Even with more social networking and revamped cooperative play, the focus of this system is bringing back single players and defining Nintendo as a brand for both social gatherings and “me time,” hence the “U” in Wii U. More “hardcore” single player games will be in the mix as well, reflected at launch with “Call of Duty: Black Ops 2″ and “Batman: Arkham City” availability.


Like the competing consoles, Nintendo is also making moves to bring media capabilities to the console with YouTube, Netflix, Hulu Plus, and Amazon Instant Video integration. Nintendo has also announced TVii, an interface that integrates with those Internet video services and your cable box, but it has been delayed until December.


The Bottom Line
On paper, the Wii U sounds like a simple win. Take Nintendo’s best-selling handheld, their best-selling system (Wii), the graphics of their competitors and mash that up with latest developments in tablet technology. And in many ways it is, combining the best of the last five years in an incredibly unique and well-designed package. That said, there’s a ways to go in terms of games that take advantage of the touchscreen, the GamePad’s battery life, and we really do wish another controller was included in the box.


Wii U has major potential and if Nintendo plays their cards right, the system can become a major player, especially once the media capabilities and game options are fully stocked. The second-generation Wii might not be as game-changing as the orginal, but it certainly is a lot of fun to play with.


Joanna Stern contributed to this review.


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Aussie rockers AC/DC’s music to be sold on iTunes
















NEW YORK (Reuters) – AC/DC‘S entire catalogue, including 20 studio and live albums and three compilations will be available on iTunes for the first time worldwide, Columbia Records and Apple said on Monday.


Until now the Australian heavy metal group that was formed by two brothers, Angus and Malcolm Young, in 1973, had refused to put their music on Apple Inc’s online music store.













“AC/DC’s thunderous and primal rock and roll has excited fans for generations with their raw and rebellious brand of music, which also resonates with millions of new fans discovering AC/DC everyday,” Columbia Records and Apple, said in a statement announcing the deal.


“Their growing legion of fans will now experience the intensity of AC/DC’s music in a way that has never been heard before,” they added.


The group’s 1976 debut album “High Voltage,” its classic “Back In Black” and 2008′s “Black Ice” are among the albums available on iTunes.


All the of music has been mastered for iTunes and fans can download entire albums or individual songs.


(Reporting by Patricia Reaney; editing by Paul Casciato)


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Amid meningitis crisis, critics say Medicare may promote risky drug compounding
















NEW YORK (Reuters) – With 34 deaths and 474 cases of fungal meningitis linked to tainted steroids from a Massachusetts compounding pharmacy, blame has fallen on everyone from the pharmacy to state and federal regulators. Now a new potential culprit has emerged: Medicare, which reimburses for almost all compounded drugs.


“Medicare’s reimbursement policy is certainly relevant in the government’s role in supporting purchases” of compounded drugs, Senator Richard Blumenthal told Reuters, referring to the customized medications meant to be prepared for an individual based on doctor directions.













Medicare is the federal health insurance program for the elderly and disabled. Because it is such a large player in healthcare policy, its coverage decisions have an outsized impact on the market.


As long as a physician has prescribed a compounded drug, Medicare as well as some private insurers cover it even if the Food and Drug Administration has approved a version of the drug from a pharmaceutical manufacturer.


In a letter sent on Monday to U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, the consumer advocacy organization Public Citizen charged that by paying for compounded drugs Medicare “created an economic environment that allowed large-scale drug production by compounding pharmacies to flourish.”


“Medicare played a role in fostering the widespread use of compounded drugs,” Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, said.


In reply, an HHS spokesman told Reuters that if the FDA finds that a company is producing compounded drugs in violation of the law, “Medicare will not reimburse for drugs produced in that facility.” But because the FDA’s authority over compounding pharmacies is severely limited, “we urge Congress to strengthen FDA’s authority to ensure these kinds of outbreaks do not happen again.”


In a letter to Medicare on Monday, Senators Debbie Stabenow, Al Franken, Dianne Feinstein and Blumenthal – all Democrats – also raised concerns about how compounded drugs are “reimbursed at the state and federal level.”


The senators cited a section of Medicare’s policy manual which explains how the program can deny payment for compounded drugs. In addition, they asked how Medicare works with the FDA “to determine which companies have received violations for mass compounding of drugs.”


Medicare pays for compounded medications mostly under what is called Part B, which covers drugs that patients cannot administer themselves, such as spinal injections and intravenous cancer drugs. “These medications are vital and often life-sustaining and should be covered in full,” said David Ball, a spokesman for the International Academy of Compounding Pharmacists.


Also weighing in on compounding on Monday, the Senate Committee on Health, Education, Labor, and Pensions asked all 50 state boards of pharmacy – which, rather than federal regulators, oversee compounding pharmacies – for information on “actions you have taken to address this meningitis outbreak.”


Specifically, the committee asked the boards whether they had reported problems with drugs from New England Compounding Center, the company that produced the tainted steroids, to the FDA, and whether they require compounding pharmacies to report whether they produce large volumes of drugs.


Although traditional pharmacy compounding is small-scale, producing one prescription for one specific patient at a time, the company that produced the tainted steroids in the meningitis outbreak manufactured thousands of doses for hundreds of patients at once, documents show.


OUT OF BUSINESS


The suspicion that Medicare’s payment policy encourages large-scale compounding has arisen in part because in the single instance when Medicare denied payment for an entire class of compounded drugs – respiratory medications used in special inhalers called nebulizers – the decision drove compounders out of that business.


At the time, Medicare said that because compounded drugs are not tested for safety and effectiveness, they have “the potential of putting a patient at increased risk of injury, illness, or death.”


The nebulizer-drugs decision came in 2007, after patient advocates led by Allergy & Asthma Network Mothers of Asthmatics argued to Medicare that the compounded nebulizer drugs had contamination and potency problems, said Sandra Fusco Walker, who led that effort.


That coverage decision “is absolutely relevant” to the question of Medicare’s support for compounding pharmacies, Blumenthal said, “because it reflects an awareness of this issue. Whether that should be a precedent for denying coverage of all such (compounded) drugs is a separate question.”


The Center for Medicare and Medicaid Services (CMS), which is part of HHS and runs the Medicare, regularly decides whether to cover diagnostic tests, medications, surgical procedures and other medical treatments. It bases those decisions on whether the intervention is “reasonable and necessary.” For drugs, that almost always means that the medication has received approval from the FDA.


“We believe that Medicare’s policy manual clearly establishes the agency’s authority to deny coverage for compounded drugs,” said Carome.


But he admits that the manual is “internally contradictory.”


In a section of the manual related to compounded drugs, CMS says that compounded drugs that have not received FDA approval – which describes essentially all compounded drugs – are excluded from Medicare coverage.


“If the FDA has not approved the manufacturing and processing procedures used by these (compounding) facilities, the FDA has no assurance that the drugs these companies are producing are safe and effective,” the manual adds.


But the same section also says that payment for such a drug does not stop unless CMS notifies the local carriers that it contracts with to process Medicare claims “that it is appropriate to do so.”


“Clearly, if compounded drugs weren’t covered to the extent they are, there wouldn’t be an economic environment that allows large-scale compounding to continue,” said Carome.


(Editing by Cynthia Osterman)


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Israel's Gaza offensive was years in the making

JERUSALEM (AP) — With little notice, Israel has launched a blistering air offensive against the Gaza Strip's ruling Hamas militant group. Here's a look at why the violence erupted, the goals of the warring sides and how it may end:

LIGHTNING STRIKE

Israel opened its offensive with a surprise airstrike on Nov. 14 that killed the shadowy leader of Hamas' military wing. Since then, it has carried out hundreds of airstrikes in what it says is a systematic campaign to halt years of rocket attacks launched from Gaza. While Israel claims to have inflicted heavy damage, dozens of rockets have continued to fly out of Gaza each day.

WHY NOW?

Israel launched the operation in response to days of rocket attacks out of Gaza, highlighted by a rare missile strike on an Israeli military jeep that wounded four soldiers. But the operation was actually years in the making. Since a previous Israeli offensive four years ago, Hamas has restocked its arsenal with more sophisticated and powerful weapons smuggled in from Egypt through underground tunnels. After a lull following Israel's previous offensive, rocket fire has steadily climbed the past two years. The Israeli military says more than 700 rockets were launched into Israel this year before it launched the offensive last week. In this environment, Israeli officials have said it was only a matter of time before a new round of fighting broke out.

THE BATTELFIELD

Hamas seized control of Gaza, a densely populated strip of land sandwiched between southern Israel and Egypt's Sinai desert, five years ago from the rival Fatah movement of Palestinian President Mahmoud Abbas. Hamas, a militant group sworn to Israel's destruction, has developed is rocket arsenal to the point where nearly half of Israel's population is in range.

WHY FIRE ROCKETS?

Palestinian militants, led by Hamas, say the rocket fire is a legitimate response to continued Israeli attacks. They also claim they are resisting Israeli occupation of the territory. Israel withdrew from Gaza in 2005, ending a 38-year military occupation. But it has maintained a blockade of the territory in a step it says is needed to prevent arms smuggling. In the murky world of Gaza politics, the attacks also stem from internal rivalries between groups eager to prove their militant credentials. Israeli Prime Minister Benjamin Netanyahu says no country would tolerate repeated missile attacks on its civilians.

RISKY BUSINESS

Prolonged fighting carries great risks for both sides. As Israel presses forward, the number of Palestinian civilian casualties is likely to rise — a scenario that could quickly turn international opinion against it. Israel's previous offensive left hundreds of civilians dead, drawing international condemnation and war crimes accusations. By continuing to fire rockets, Hamas raises the risk of tougher Israeli attacks, including a possible ground offensive. Well aware of these risks, both sides are working through mediators to arrange a cease-fire.

TERMS OF THE DEAL

Israel wants a halt to the rocket attacks and an end to arms smuggling into Gaza, most likely in a deal that is guaranteed by Egypt or other international parties. Hamas wants a halt to Israeli assassinations of its leaders and a lifting of the Israeli blockade. While gaps remain wide, both sides have strong interests in a deal. Bringing quiet to Israel's embattled south will make Netanyahu a national hero, weeks before parliamentary elections. Hamas, branded a terrorist group by Israel and the West, has seen its influence grow as the Arab Spring brings Islamists to power across the region. A cease-fire, particularly an arrangement guaranteed with international partners, would cement Hamas' control of Gaza and give it more of the international recognition it covets so much.

BY THE NUMBERS

—More than 100 Palestinians, half of them civilians, have been killed, according to Palestinian medical officials. Three Israeli civilians have died from rocket fire.

—Israel has attacked more than 1,350 targets in the current offensive, according to the Israeli army. Hamas and smaller armed groups have responded with nearly 600 rockets, the army says.

—Israel says its new "Iron Dome" rocket-defense system has shot down more than 300 incoming projectiles.

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Rebels in Congo reach door of Goma
















GOMA, Congo (AP) — A Rwandan-backed rebel group advanced to within 3 kilometers (1.8 miles) of Goma, a crucial provincial capital in eastern Congo, marking the first time that rebels have come this close since 2008.


Congolese army spokesman Col. Olivier Hamuli said the fighting has been going on since 6 a.m. Sunday and the front line has moved to just a few kilometers (miles) outside the city. After more than nine hours of violent clashes the two sides took a break, with M23 rebels establishing a checkpoint just 100 meters (yards) away from one held by the military in the village of Munigi, exactly 3 kilometers (1.8 miles) outside the Goma city line.













Contacted by telephone on the front line, M23 rebel spokesman Col. Vianney Kazarama said the group will spend the night in Goma.


“We are about to take the town. We will spend the night in Goma tonight,” said Kazarama. “We are confident that we can take Goma and then our next step will be to take Bukavu,” he said mentioning the capital of the next province to the south.


The M23 rebel group is made up of soldiers from a now-defunct rebel army, the National Congress for the Defense of the People, or CNDP, a group made-up primarily of fighters from the Tutsi ethnic group, the ethnicity that was targeted in Rwanda‘s 1994 genocide. In 2008, the CNDP led by Rwandan commando Gen. Laurent Nkunda marched his soldiers to the doorstep of Goma, abruptly stopping just before taking the city.


In the negotiations that followed and which culminated in a March 23, 2009 peace deal, the CNDP agreed to disband and their fighters joined the national army of Congo. They did not pick up their arms again until this spring, when hundreds of ex-CNDP fighters defected from the army in April, claiming that the Congolese government had failed to uphold their end of the 2009 agreement.


Reports, including one by the United Nations Group of Experts, have shown that M23 is actively being backed by Rwanda and the new rebellion is likely linked to the fight to control Congo’s rich mineral wealth.


The latest fighting broke out Thursday and led to the deaths of 151 rebels and two soldiers. On Saturday U.N. attack helicopters targeted M23 positions in eastern Congo.


Also on Saturday, United Nations Secretary-General Ban Ki-Moon had called Rwandan President Paul Kagame “to request that he use his influence on the M23 to help calm the situation and restrain M23 from continuing their attack,” according to peacekeeping chief Herve Ladsous who spoke at the U.N. headquarters in New York on Saturday.


North Kivu governor Julien Paluku said Saturday that the Congolese army had earlier retreated from Kibumba, which is 30 kilometers (19 miles) north of Goma, after thousands of Rwandans, who he says were backing the rebels, attacked early Saturday.


“Rwandan forces bombarded our positions in Kibumba since early this morning and an estimated 3,500 crossed the border to attack us,” he said Saturday.


In downtown Goma, panicked residents had come out to try to get more information on what was happening. A 45-year-old mother of five said that she has nowhere to go.


“I don’t really know what is happening, I’ve seen soldiers and tanks in the streets and that scares me,” said Imaculee Kahindo. Asked if she planned to leave the city, she said: “What can we do? I will probably hide in my house with my children.”


Hamuli, the spokesman for the Congolese army, denied reports that soldiers were fleeing.


In 2008 as Nkunda’s CNDP rebels amassed at the gates of Goma, reporters inside the city were able to see Congolese soldiers running in the opposite direction, after having abandoned their posts. The Congolese army is notoriously dysfunctional with soldiers paid only small amounts, making it difficult to secure their loyalties during heavy fighting.


“We are fighting 3 kilometers from Goma, just past the airport. And our troops are strong enough to resist the rebels,” said Hamuli. “We won’t let the M23 march into our town,” he said. Asked if his troops were fleeing, he added: “These are false rumors. We are not going anywhere.”


U.N. peacekeeping chief Ladsous said that the rebels were very well-equipped, including with night vision equipment allowing them to fight at night.


Reports by United Nations experts have accused Rwanda, as well as Uganda, of supporting the rebels. Both countries strongly deny any involvement and Uganda said if the charges continue it will pull its peacekeeping troops out of Somalia, where they are playing an important role in pushing out the Islamist extremist rebels.


The U.N. Security Council called for an immediate stop to the violence following a two-hour, closed-door emergency meeting. The council said it would add sanctions against M23 rebels and demanded that rebels immediately stop their advance toward the provincial capital of Goma.


“We must stop the M23″ because Goma’s fall “would, inevitably, turn into a humanitarian crisis,” said France‘s U.N. Ambassador, Gerard Araud. He added that U.N. officials would decide in the coming days which M23 leaders to target for additional sanctions.


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Associated Press writer Maria Sanminiatelli at the United Nations and Rukmini Callimachi in Dakar, Senegal, contributed to this report.


Africa News Headlines – Yahoo! News



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Singing stars arrive for American Music Awards
















Pink on a song with Lauryn Hill? The pop star hopes so.


Pink said on the red carpet of the American Music Awards that she’d like to collaborate with the acclaimed singer-rapper.













Cyndi Lauper said her musical playlist includes Pink, Nicki Minaj and Carly Rae Jepsen‘s “Call Me Maybe.” Boy band The Wanted is excited to see “Gangnam Style” star PSY and Colbie Caillat wants to watch No Doubt rock the stage.


The stars walking the red carpet before the AMAs were ready to take their seats as fans. Arrivals included Taylor Swift, 50 Cent, Gloria Estefan, Ludacris, Kelly Rowland, Lady Antebellum, J. Cole, Luke Bryan, the Backstreet Boys and Linkin Park.


“What makes the American Music Awards special is the fans choose the winning artists,” said Chester Bennington of Linkin Park, who is nominated for favorite artist alternative rock and will perform at the show.


Carrie Underwood arrived in a magenta dress and Kerry Washington was in a banana Stella McCartney number Sunday. Heidi Klum and Ginnifer Goodwin were also on the scene.


Along with Rihanna, Minaj is the top nominee at Sunday’s American Music Awards, but the rapper-singer isn’t concerned with her four nominations.


“I don’t do music for awards,” the 29-year-old said in an interview. “It’s so crazy because people always have to remind me that I’m nominated for an award when I go to award shows.”


“I know they’re going to come. I’m sitting here looking at my awards right now,” she continued with a laugh. “I never stress it. I think of myself as ‘I’ll have a career long enough to get all those different awards.’”


In the pop/rock category, Minaj is up for favorite female artist and album for “Pink Friday: Roman Reloaded.” She’s also nominated for favorite artist and album in the hip-hop/rap category, two awards she won last year.


Minaj isn’t up for the night’s top award, though. Rihanna, Maroon 5, Drake, Katy Perry and Justin Bieber will battle it out for artist of the year.


But the American Music Awards are all about performances, and Sunday’s show will be no exception. Taylor Swift and Carrie Underwood will perform. Justin Bieber will share the stage with Minaj. Ludacris and Chris Brown will perform with Swizz Beatz. And Stevie Wonder is set to provide the soundtrack for a tribute to the late Dick Clark.


“I’m really going there to perform ‘Freedom,’” Minaj said of her new single. “I’m very, very proud of the record and I’m happy that people are going to get to hear it. I’m performing a hip-hop song on the AMAs, and I think . that’s just a big look for hip-hop.”


Rae Jepsen, Kelly Clarkson and Usher are also among those set to sing during the three-hour program, which is to be broadcast live on ABC.


Other multiple nominees include Usher, Bieber, Drake, Maroon 5 and One Direction, who have three nods each. Perry, Underwood, Brown, Clarkson, Pitbull, fun., Gotye, J. Cole and Luke Bryan are all double nominees.


American Music Awards nominees were selected based on sales and airplay, and fans chose the winners by voting online.


The 40th anniversary show will also include the tribute to Clark, its creator.


“Dick changed the face of music back in the late ’50s,” producer Larry Klein said. “Dick is the one who made rock ‘n’ roll acceptable to come into people’s homes… We’re paying tribute to Dick because of the legacy that he’s left everybody and also the creativity of what he did on this show.”


___


AP Entertainment Writer Sandy Cohen contributed to this report from Los Angeles. Follow (at)APSandy’s American Music Award updates at www.twitter.com/APEntertainment.


___


Online:


http://beta.abc.go.com/shows/american-music-awards


Entertainment News Headlines – Yahoo! News



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