FDA halts Amgen study after teen patient death


WASHINGTON (AP) — Federal health regulators have halted Amgen's studies of its thyroid drug Sensipar after the death of a 14-year-old patient in a company trial.


The Food and Drug Administration said Tuesday it is still gathering information about the death, but has shut down all studies of the drug in children.


Sensipar is approved in adults to treat over-activity of the parathyroid gland. It has been used since 2004 to treat symptoms of chronic kidney disease and parathyroid cancer.


Amgen Inc. had been studying the drug to see whether it works in children.


The Thousand Oaks, Calif.-based company said in a statement that it "is working as rapidly as possible to understand the circumstances of what happened."


The FDA said on its website that it is unclear whether Amgen's drug had a role in the patient's death, but it is reminding doctors to prescribe it carefully.


The drug is known to lower calcium levels, sometimes to a dangerous extent.


The agency says doctors should monitor patients' calcium levels monthly to make sure they don't fall to dangerous levels. Signs of a calcium deficiency include muscle cramping, convulsions and burning or prickling sensations.


The most common side effects of the drug in adults include nausea, vomiting and diarrhea.


Amgen shares fell 7 cents to $89.48 in afternoon trading Tuesday.


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Wall Street rebounds as Bernanke defends policy

NEW YORK (Reuters) - Stocks climbed on Tuesday, rebounding from their worst decline since November after Federal Reserve Chairman Ben Bernanke defended the Fed's bond-buying stimulus before Congress.


Bernanke, in testimony before the Senate Banking Committee, strongly defended the Fed's bond-buying stimulus program and quieted rumblings that the central bank may pull back from its stimulative policy measures, which were sparked by the release of the Fed minutes last week.


Bernanke's testimony helped ease concerns about a stalemate in Italy after a general election failed to give any party a parliamentary majority, posing the threat of prolonged instability and financial crisis in Europe, and sending the S&P 500 to its worst decline since early November in the previous sessions.


Bernanke "certainly said everything the market needed to feel in order to get comfortable again," said Peter Kenny, managing director at Knight Capital in Jersey City, New Jersey.


"The fear is we were going to see a rollover, and the first shot over the bow was what we saw out of Italy yesterday with the elections," Kenny said. "When it came to U.S. markets, we saw some of that bleeding stop because our focus shifted from the Italian political circus to Ben Bernanke."


Gains in homebuilders and other consumer stocks, following strong economic data, lifted the S&P 500 and a 5.6 percent jump in Home Depot to $67.38 boosted the Dow industrials. The PHLX housing sector index <.hgx> rose 3.3 percent.


However, the central bank chairman also urged lawmakers to avoid sharp spending cuts set to go into effect on Friday, which he warned could combine with earlier tax increases to create a "significant headwind" for the economic recovery.


The Dow Jones industrial average <.dji> climbed 109.04 points, or 0.79 percent, to 13,893.21. The Standard & Poor's 500 Index <.spx> gained 8.96 points, or 0.60 percent, to 1,496.81. The Nasdaq Composite Index <.ixic> advanced 13.46 points, or 0.43 percent, to 3,129.71.


Despite the bounce, the S&P 500 also failed to move above 1,500, a closely watched level that was technical support until recently, but it could now become a hurdle.


The uncertainty caused by the Italian elections continues to weigh on stocks in Europe. The FTSEurofirst-300 index of top European shares <.fteu3> closed down 1.4 percent. The benchmark Italian index <.ftmib> tumbled 4.9 percent.


Home Depot gave the biggest boost to the Dow and provided one of the biggest lifts to the S&P 500 after the world's largest home improvement chain reported adjusted earnings and sales that beat expectations. The stock climbed 5.6 percent to $67.47.


Macy's shares gained 3.6 percent to $39.90 after the department-store chain stated it expects full-year earnings to be above analysts' forecasts because of strong holiday sales.


Economic reports that showed strength in housing and consumer confidence also supported stocks. U.S. home prices rose more than expected in December, according to the S&P/Case-Shiller index. Consumer confidence rebounded in February, jumping more than expected, and new-home sales rose to their highest in 4-1/2 years.


(Reporting by Chuck Mikolajczak; Editing by Jan Paschal)



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IHT Rendezvous: Memories of Floating Over Luxor, Now Tinged With the Macabre

My 5-year-old son spent the entire hot-air balloon ride over Luxor crouched in the bottom of the basket, terrified of the flames that kept shooting into the balloon—the flames that produced the hot air that kept us afloat. He missed the glorious views: of the ancient ruins and the quilts of green grass, of the magnificent sunrise and the dancing shadows it created out of the dozens of other hot-air balloons with which we shared the early-morning sky.

We had hardly thought about danger when we booked the ride, a staple of Luxor vacations, worrying only about whether it would be worth the $240 pricetag for our family of four—and the 4:40 a.m. wake-up call. Less than two months later, with Tuesday’s horrific headlines about a crash on one of those very balloons that killed at least 18, it seems my son may have been on to something.

This is not my first there-but-for-the-grace experience. Days after I went skydiving in the Chicago suburbs to celebrate a friend’s 40th birthday, I read that a skydiver who crash-landed into a lake we had flown over had drowned. While covering the small-plane crash that killed Senator Paul Wellstone of Minnesota in 2002, I discovered that the day I had spent with him three weeks earlier was on the very same King Air A-100.

Skydiving and small-plane rides in rural areas are known risks. But a fatal hot-air balloon ride? Did not occur to me. (Maybe it’s that tourist mentality: I never inquired about whether the camels we rode through back roads and villages were insured, either.)

Before this morning, the balloon ride was easily one of the best memories of our weeklong adventure in Luxor and Cairo over New Year’s.

It did not begin well: The hotel failed to make that 4:40 a.m. wake-up call, and we were hopelessly late. That meant we kept a literal boatload of Chinese tourists waiting to cross the Nile. Aboard the rickety wooden boat there was instant coffee, tea, and, oddly, Twinkies. On the other side, we were shuttled in vans to the open field where these huge, colorful balloons were in various stages of life—some lying limp on the ground, others half-filled, some taking flight.

My twins hoped for one of the multicolored balloons, but we ended up in red. Some 20 strangers joined us in the basket, where the kids were just the right height to peer out of the footholds we had used to climb in. My daughter peeked; my son cowered. The blue flames roared, and we were
airborne.

The ride lasted perhaps a half-hour, each minute offering a landscape transformed by the relative height of our balloon, the others, and the emerging sun. It was remarkable, if was not quite peaceful — there were those loud, hot flames shooting up a few feet away every few seconds. It was flames like those that, for the doomed balloon, ignited the stream from a ripped gas hose at landing, sending it bouncing back into the air to explode.

For us, on Dec. 31, the landing was smooth. Once on the ground, each rider was given a signed certificate commemorating the flight. (We passed on the offers to purchase
photographs or video.)

My daughter excitedly pasted her certificate into the vacation journal she was keeping for kindergarten. Now that seems like a macabre piece of memorabilia. We will be waiting a long time to tell our children the postscript to our adventure.

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Mindy McCready Is Laid to Rest in Florida















UPDATED
02/26/2013 at 02:35 PM EST

Originally published 02/26/2013 at 02:20 PM EST



Nine days after troubled country singer Mindy McCready died of a self-inflicted gunshot wound at her lakefront home in Heber Springs, Ark., her family held her funeral in her hometown of Ft. Myers, Fla.

About 400 mourners filled the sanctuary of Crossroads Baptist Church. A white hearse, escorted by two police cars, delivered the singer's wooden casket to the service.

A large portrait of McCready graced the stage, and her casket was adorned with white roses. As McCready's songs were played, photos from her life were displayed on two large video screens on either side of the sanctuary.

The pictures included a glamorous shot of her and her onetime fiancé Dean Cain. Among the songs were "I'm Still Here" and "Ten Thousand Angels."

Attendees, besides being greeted with a handshake form McCready's mother, Gayle Inge, were presented with a program that included a color photo of McCready.

Through tears during the service, Inge told the mourners. "Mindy adored her two children. She wanted them to know that. Through much agony and pain, she went to heaven. She is no longer sick. She is healed. Thank you for all who are here. Please pray for those boys. No matter what, she will always be my little girl, sitting in her car seat, singing into a hairbrush. The world was her stage."

Stepfather Michael Inge played his guitar and sang Bobby Helms's "You Are My Special Angel." Pallbearers included McCready's three brothers – Timothy, Joshua and Skyler – along with some of her cousins.

Gayle Inge, who arranged what was called "A Celebration of Life," told PEOPLE in a statement: "Our family is devastated by the loss of our beautiful and talented daughter. Her life, no matter how brief, touched many, and she will forever be our special angel."

In lieu of flowers, the family is requesting that donations be made to the Mindy McCready Children's Trust, c/o John Ammons, Edison National Bank, 13000 S. Cleveland Ave., Ft. Myers, FL 33907.

McCready, who was 37, will be buried in Ft. Myers. A second memorial service for her professional colleagues to attend is to take place in Nashville in early March.

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Mediterranean-style diets found to cut heart risks


Pour on the olive oil, preferably over fish and vegetables: One of the longest and most scientific tests of a Mediterranean diet suggests this style of eating can cut the chance of suffering heart-related problems, especially strokes, in older people at high risk of them.


The study lasted five years and involved about 7,500 people in Spain. Those who ate Mediterranean-style with lots of olive oil or nuts had a 30 percent lower risk of major cardiovascular problems compared to those who were told to follow a low-fat diet but who in reality, didn't cut fat very much. Mediterranean meant lots of fruit, fish, chicken, beans, tomato sauce, salads, and wine and little baked goods and pastries.


Mediterranean diets have long been touted as heart-healthy, but that's based on observational studies that can't prove the point. The new research is much stronger because people were assigned diets to follow for a long time and carefully monitored. Doctors even did lab tests to verify that the Mediterranean diet folks were consuming more olive oil or nuts as recommended.


Most of these people were taking medicines for high cholesterol and blood pressure, and researchers did not alter those proven treatments, said one study leader, Dr. Ramon Estruch of Hospital Clinic in Barcelona.


But as a first step to prevent heart problems, "we think diet is better than a drug" because it has few if any side effects, Estruch said. "Diet works."


Results were published online Monday by the New England Journal of Medicine and were discussed at a nutrition conference in Loma Linda, Calif.


People in the study were not given rigid menus or calorie goals because weight loss was not the aim. That could be why they found the "diets" easy to stick with — only about 7 percent dropped out within two years. There were twice as many dropouts in the low-fat group than among those eating Mediterranean-style.


Researchers also provided the nuts and olive oil, so it didn't cost participants anything to use these relatively pricey ingredients. The type of oil may have mattered — they used extra-virgin olive oil, which is minimally processed and richer than regular or light olive oil in the chemicals and nutrients that earlier studies have suggested are beneficial.


The study involved people ages 55 to 80, just over half of them women. All were free of heart disease at the start but were at high risk for it because of health problems — half had diabetes and most were overweight and had high cholesterol and blood pressure.


They were assigned to one of three groups: Two followed a Mediterranean diet supplemented with either extra-virgin olive oil (4 tablespoons a day) or with walnuts, hazelnuts and almonds (a fistful a day). The third group was urged to eat a low-fat diet heavy on bread, potatoes, pasta, rice, fruits, vegetables and fish and light on baked goods, nuts, oils and red meat.


Independent monitors stopped the study after nearly five years when they saw fewer problems in the two groups on Mediterranean diets.


Doctors tracked a composite of heart attacks, strokes or heart-related deaths. There were 96 of these in the Mediterranean-olive oil group, 83 in the Mediterranean-nut group and 109 in the low-fat group.


Looked at individually, stroke was the only problem where type of diet made a big difference. Diet had no effect on death rates overall.


The Mediterranean diet proved better even though its followers ate about 200 calories more per day than the low-fat group did. The study leaders now are analyzing how each of the diets affected weight gain or loss and body mass index.


The Spanish government's health research agency initiated and paid for the study, and foods were supplied by olive oil and nut producers in Spain and the California Walnut Commission. Many of the authors have extensive financial ties to food, wine and other industry groups but said the sponsors had no role in designing the study or analyzing and reporting its results.


Rachel Johnson, a University of Vermont professor who heads the American Heart Association's nutrition committee, said the study is very strong because of the lab tests to verify oil and nut consumption and because researchers tracked actual heart attacks, strokes and deaths — not just changes in risk factors such as high cholesterol.


"At the end of the day, what we care about is whether or not disease develops," she said. "It's an important study."


Rena Wing, a weight-loss expert at Brown University, noted that researchers provided the oil and nuts, and said "it's not clear if people could get the same results from self-designed Mediterranean diets" — or if Americans would stick to them more than Europeans who are used to such foods.


Dr. George Bray of the Pennington Biomedical Research Center in Baton Rouge, La., said he would give the study "a positive — even glowing — comment" and called it "the best and certainly one of the largest prospective dietary trials ever done."


"The data are sufficiently strong to convince me to move my dietary pattern closer to the Mediterranean Diet that they outline," he added.


Another independent expert also praised the study as evidence diet can lower heart risks.


"The risk reduction is close to that achieved with statins," cholesterol-lowering drugs, said Dr. Robert Eckel, a diet and heart disease expert at the University of Colorado.


"But this study was not carried out or intended to compare diet to statins or blood pressure medicines," he warned. "I don't think people should think now they can quit taking their medicines."


___


Online:


Journal: http://www.nejm.org


___


Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP


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Wall Street drops on Italian election uncertainty

NEW YORK (Reuters) - Stocks fell on Monday, reversing course from earlier gains as elections in Italy stoked concerns a divided parliament could disrupt the country's fiscal reforms and the euro zone's stability.


Early forecasts of the results were conflicting, as opinion polls indicated the center-left of Pier Luigi Bersani winning the lower house, but projections from RAI state television showed Silvio Berlusconi's center right in front in the Senate - which has equal lawmaking power - but unable to form a majority.


The resulting gridlock in parliament could force new elections and sent the euro currency lower against both the dollar and yen.


"Most likely we are looking at a second election, so it's delayed, but at the margin it is a negative," said Tim Ghriskey, chief investment officer of Solaris Group in Bedford Hills, New York.


"The question is, what happens with Italy and that uncertainty is out there, that is really what you've seen in the sell-off here."


Earlier polls pointing to a center-left victory boosted stocks in Milan and other European markets, as well as helping to lift the S&P 500 to a session high of 1,525.84 on optimism Italy would continue to pay down its debt.


However, the benchmark S&P index remained near highs not seen in five years, as bets on a stronger U.S. economy have given equities support. The S&P 500's slight fall last week was the first weekly drop after a seven-week string of gains to start the year.


Banks and other financial stocks were among the worst performers on worries about the sector's exposure to Italy's massive debt. The KBW Bank Index <.bkx> fell 1.1 percent.


The Dow Jones industrial average <.dji> dropped 92.14 points, or 0.66 percent, to 13,908.43. The Standard & Poor's 500 Index <.spx> dropped 11.65 points, or 0.77 percent, to 1,503.95. The Nasdaq Composite Index <.ixic> dropped 12.65 points, or 0.40 percent, to 3,149.17.


Barnes & Noble Inc shares jumped 10.6 percent to $14.94 after the bookseller's chairman offered to buy its declining retail business.


The Nasdaq received support from Amgen Inc , up 4.9 percent at $91.03, after rival Affymax issued a voluntary recall of its only drug, an anemia treatment that competes with Amgen's top-selling red blood cell booster, Epogen. Affymax shares slumped 84.6 percent to $2.55.


The FTSEurofirst-300 index of top European shares <.fteu3> unofficially closed up 0.04 percent and Italy's main FTSE MIB <.ftmib> ended up 0.7 percent after earlier gaining near 4 percent.


U.S. equities will face a test with the looming debate over so-called sequestration, U.S. government budget cuts that will take effect starting on Friday if lawmakers fail to reach an agreement over spending and taxes. The White House issued warnings about the harm the cuts are likely to inflict on the economy if enacted.


"Sitting out there is the one thousand pound gorilla - the sequester issue - and certainly nothing is happening there," Ghriskey said.


Lowe's Companies Inc lost 1.6 percent to $37.08 after the home improvement retailer posted fourth-quarter earnings.


With 83 percent of the S&P 500 companies having reported results so far, 69 percent beat profit expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters, according to Thomson Reuters data.


Fourth-quarter earnings for S&P 500 companies are estimated to have risen 6 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.


(Editing by Kenneth Barry, Jan Paschal and Nick Zieminski)



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Top British Cardinal Resigns After Accusations of ‘Inappropriate Acts’





VATICAN CITY — Britain’s most senior Roman Catholic cleric announced his resignation on Monday, a day after being accused of “inappropriate acts” with priests, saying he would not attend the conclave to elect a new pope.




The cleric, Cardinal Keith O’Brien, said that he had submitted his resignation months ago, and that the Vatican said Pope Benedict XVI had accepted it on Feb. 18. However, the timing of the announcement — a day after news reports of alleged abuse appeared in Britain — suggested that the Vatican had encouraged the cardinal to stay away from the conclave,


“Everybody’s been struck by how quickly Rome responded,” said Austen Ivereigh, director of the British church advocacy group Catholic Voices. “Clearly Rome saw that there was sufficient substance to the allegations. They would not have told him to stand down unless they thought there was something worth investigating.”


The move leaves Britain without a voting cardinal in the conclave, and is bound to raise questions about other cardinals. It comes amid a campaign by some critics to urge Cardinal Roger M. Mahony of Los Angeles not to attend the conclave because of his role in moving priests accused of abuse to other parishes.


It also comes just days after the Vatican Secretariat of State issued a harsh statement against recent news media reports, including ones alleging a gay sex scandal inside the Vatican. It said that cardinals should not be affected by external pressures when they vote for the next pope. About 115 cardinals are expected to be at the gathering. Cardinal Cormac Murphy-O’Connor, the former archbishop of Westminster, will attend the meetings in Rome before the conclave, according to Mr. Ivereigh, the cardinal’s former spokesman, but is past the voting age cutoff of 80 years.


Vatican watchers said that Cardinal O’Brien’s decision not to attend the conclave was rare.


“It’s quite unprecedented,” said Sandro Magister, a Vatican expert with the Italian weekly L’Espresso. “He made it clear that his resignation came under the pressure of the accusations. His certainly isn’t a frequent case and hasn’t happened in conclaves in recent memory.”


On Monday, Benedict changed the laws governing the conclave to allow cardinals to move up the start date before the traditional 15-to-20-day waiting period after the papacy is vacant. He also met with three cardinals who had conducted a secret investigation into a scandal over leaked documents and ruled that the contents of their report would be known only to his successor, not to the cardinals entering the conclave.


Cardinal O’Brien’s announcement came a day after The Observer reported that four men had made complaints to the pope’s diplomatic representative in Britain, Antonio Mennini, the week before Pope Benedict XVI announced on Feb. 11 that he would be stepping down as of Feb. 28.


The Observer said that the accusations, which dated back to the 1980s, had been forwarded to the Vatican.


Last week, Cardinal O’Brien drew different headlines, telling the BBC that the next pope should consider abandoning the church’s insistence on priestly celibacy, and suggesting that it might be time for the papal conclave to choose a pontiff from Africa or Asia, where church membership has been growing even as it has fallen across Europe and North America.


On Monday, the Vatican spokesman, the Rev. Federico Lombardi, played down the connection between the media reports and Cardinal O’Brien’s resignation, which the pope accepted under a norm of church law that says he had reached the normal retirement age of 75.


A statement issued by the media office of the Roman Catholic Church in Scotland said Cardinal O’Brien had informed the pope some time ago of his intention to resign as archbishop of St. Andrews and Edinburgh as his 75th birthday approached on March 17, but that no date had been set.


The cardinal said in the statement, “The Holy Father has now decided that my resignation will take effect today, 25 February 2013.”


“Looking back over my years of ministry: For any good I have been able to do, I thank God,” he said. “For any failures, I apologize to all whom I have offended.”


“I also ask God’s blessing on my brother cardinals who will soon gather in Rome,” the statement said, adding: “I will not join them for this conclave in person. I do not wish media attention in Rome to be focused on me — but rather on Pope Benedict XVI and on his successor.”


Rachel Donadio reported from Rome and John F. Burns from London. Alan Cowell contributed reporting from London and Laurie Goodstein from New York.



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Music service Spotify hooks up with Ford in first vehicle foray






(Reuters) – Streaming music service Spotify has partnered with Ford Motor Co to allow its subscribers to listen to music in more than one million Ford vehicles in North America.


Owners of Ford models with SYNC AppLink can access Spotify’s catalog of more than 20 million songs through voice activation using its smartphone app.






The deal, announced by both companies on Monday, is Spotify’s first collaboration with an automaker.


Spotify is a free on-demand streaming music service that also offers a subscription package that allows listeners to hear music without interruptions from commercials and gain access to play lists and preferences from any device anytime.


Spotify says it has 20 million active users worldwide, with 25 percent of them paying for subscriptions.


Music services like Spotify and Pandora Media Inc


are striking partnerships with automakers to make their music available to drivers, especially as Internet access improves in vehicles.


Pandora is available in 75 vehicle models and has deals with automakers like General Motors Co , Ford, BMW and Chrysler Group LLC , allowing drivers to plug in their Pandora-enabled mobile devices and use car dashboards to control the service.


More than 1 million people have used Pandora’s dashboard integration, it said.


Separately on Monday, GM said it was switching to AT&T Inc from Verizon Wireless to provide high-speed wireless service for its 2015 vehicle models.


(Reporting by Jennifer Saba in New York; Editing by Jeffrey Benkoe)


Internet News Headlines – Yahoo! News





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Which Oscars Diva Had the Biggest Musical Moment?















02/25/2013 at 01:00 AM EST







From left: Jennifer Hudson, Adele, Barbra Streisand, Shirley Bassey and Kristin Chenoweth


WireImage; Landov; AP; Getty; AP


It was a great night for music at the Academy Awards on Sunday – particularly for the ladies.

But who really knocked it out of the park?

Jennifer Hudson's performance of "And I Am Telling You I'm Not Going" brought the audience to its feet, while Barbra Streisand delivered a wonderful tribute to Marvin Hamlisch with her rendition of "The Way We Were."

Then there were the Bond girls.

Dame Shirley Bassey wowed the crowd with the James Bond classic "Goldfinger." Then Adele sang "Skyfall," which earned her the Oscar for best song this year.

Closing out the evening was Kristin Chenoweth, who got the better of Seth MacFarlane in a salute to the evening's losers.

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