Wall Street ends flat as wary investors stay defensive

NEW YORK (Reuters) - Stocks were little changed on Thursday as the prospect of a drawn-out battle over impending tax and spending changes made investors wary of getting into the water, while retailer Wal-Mart tumbled after disappointing sales.


The S&P 500 is down nearly 2 percent for the week, adding to last week's selloff and eroding more of the market's gains for the year.


What had looked like a stellar 2012 for stocks has turned into merely an average year, and as 2012 draws to a close, investors are becoming more inclined to protect the gains they have.


The worry is the economy could contract again if no deal is reached in Washington to avoid the "fiscal cliff" - large, automatic budget cuts and tax hikes that begin to take effect in the new year.


Combined with the euro zone debt crisis, the uncertain outlook for corporations makes it hard to know how much a stock is worth, said Alan Lancz, president of Alan B. Lancz & Associates in Toledo, Ohio.


"Valuation is going to be uncertain because you don't know what the growth will be," said Lancz. "That is definitely not a good scenario for someone to step up to the plate and do a lot of buying."


The euro zone relapsed into its second recession since 2009 in the third quarter as the region was hurt by its debt problems.


Wal-Mart fell 3.6 percent to $68.72 and was the biggest drag on the Dow as frugal consumers hurt the company's quarterly sales.


Investors will be watching Friday's meeting at the White House between President Barack Obama and Republican and Democratic leaders of Congress over deficit reduction for any sign the two sides are moving closer.


The memory of last year's political impasse over raising the debt ceiling has also made analysts nervous.


"(There is) uncertainty of whether we're going to have a functioning government going forward. That is a weight that sits on markets right now," said Troy Logan, managing director and senior economist at Warren Financial Service in Exton, Pennsylvania.


Even if the economy avoids an outright recession, there are fears a lengthy political dispute could sap business investment and consumer spending.


The Dow Jones industrial average <.dji> slipped 28.49 points, or 0.23 percent, to 12,542.46. The Standard & Poor's 500 Index <.spx> lost 2.16 points, or 0.16 percent, to 1,353.33. The Nasdaq Composite Index <.ixic> was off 9.87 points, or 0.35 percent, to 2,836.94.


The S&P 500 sunk to a 3 1/2-month closing low and was well below its 200-day moving average, which it pierced last week.


Data on Thursday showed new claims for unemployment benefits surged last week, while factory activity in the mid-Atlantic region unexpectedly shrank in November as the economy felt the effects of superstorm Sandy.


A flare-up in violence in the Middle East added to market unease as Israeli warplanes bombed targets in and around Gaza city for a second day, while two rockets fired from the Gaza Strip targeted Tel Aviv.


Apple Inc shares dragged the Nasdaq lower, falling 2.1 percent to $525.62 and down about 25 percent since September's high.


Also in the tech sector, shares of Dell Inc fell in after-hours trading after it reported revenue that was shy of Wall Street's expectations. Dell was down 2.2 percent at $9.35.


Target Corp bucked the trend, rising 1.7 percent to $62.44 after it reported a profit that beat expectations.


Volume was roughly 7.26 billion shares on the New York Stock Exchange, the Nasdaq and the NYSE MKT, topping the year-to-date average daily closing volume of around 6.5 billion.


Decliners outnumbered advancers on the NYSE by 2,069 to 975 on the New York Stock Exchange. Decliners also had the upper hand on the Nasdaq, outpacing advancers 1,506 to 948.


(Editing by Kenneth Barry)


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Israel hammers Hamas in Gaza offensive

GAZA (Reuters) - Israel launched a major offensive against Palestinian militants in Gaza on Wednesday, killing the military commander of Hamas in an air strike and threatening an invasion of the enclave that the Islamist group vowed would "open the gates of hell".


The onslaught shattered hopes that a truce mediated on Tuesday by Egypt could pull the two sides back from the brink of war after five days of escalating Palestinian rocket attacks and Israeli strikes at militant targets.


Operation "Pillar of Defence" began with a surgical strike on a car carrying the commander of the military wing of Hamas, the Iranian-armed Islamist movement which controls Gaza and dominates a score of smaller armed groups.


Within minutes of the death of Ahmed Al-Jaabari, big explosions shook Gaza as the Israeli air force struck at selected targets just before sundown, blasting plumes of smoke and debris high above the crowded city.


Panicking civilians ran for cover and the death toll mounted quickly. Ten people including three children were killed, the health ministry said, and about 40 were wounded. Also among the dead were an 11-month-old baby and a woman pregnant with twins.


Army tanks shelled border areas of Gaza in south and the Israeli navy shelled a Hamas security position from the sea.


Hamas stuck back, firing at least four Grad rockets at the southern city of Beersheba in what it called its initial response. Israel reported damage but no casualties. Its 'Iron Dome' interceptor defence knocked out a dozen rockets in flight.


The escalation in Gaza came in a week when Israel fired at Syrian artillery positions it said had fired into the Israeli-annexed Golan Heights amid a civil war in Syria that has brought renewed instability to neighboring Lebanon.


Egypt, whose new Islamist government pledged to honor the 1979 peace treaty with Israel, condemned the raids as a threat to regional security, recalled its ambassador from Israel and called for an emergency session of the U.N. Security Council.


Egyptian President Mohamed Mursi's predecessor Hosni Mubarak twice withdrew his ambassador, with no lasting effect. But Israel will be watching for signs of a more aggressive approach by the Islamist leader that could imperil their ties.


Mursi has said of the Palestinians that "our blood is their blood" and Egypt may not "accept what was accepted before".


Russia called for an end to the raids. Arab League foreign ministers planned to meet on Saturday to discuss the crisis.


DOZENS OF TARGETS


A second Gaza war has loomed on the horizon for months as waves of Palestinian rocket attacks and Israeli strikes grew increasingly more intense and frequent.


Israel's Operation Cast Lead in 2008-2009 began with a week of air attacks and shelling, followed by a land invasion of the blockaded coastal strip, sealed off at sea by the Israeli navy. Some 1,400 Palestinians were killed and 13 Israelis died.


The Israel Defence Forces said it had targeted dozens of Hamas's medium range (up to 40km) underground rocket launch and infrastructure sites in Wednesday's strikes.


"This has significantly damaged the rocket launch capabilities as munitions warehouses owned by Hamas and other terror organizations were targeted. In addition, Israeli Navy soldiers targeted several Hamas terror sites stationed along the shoreline of the Gaza Strip," it said in a statement.


The Hamas internal security headquarters in southern Gaza was destroyed. There were no injuries because it had been evacuated. After dark, Gaza looked like a ghost city, with no traffic and no people in the streets, no shops open, no electric lights on.


KILLED IN HIS CAR


Hamas said Jaabari, who ran the organization's armed wing, Izz el-Deen Al-Qassam, died along with a Hamas photographer when their car was blown apart by an Israeli missile.


The charred wreckage of a car could be seen belching flames, as emergency crews picked up what appeared to be body parts.


Israel confirmed it had carried out the attack and announced there was more to come. Reuters witnesses saw Hamas security compounds and police stations blasted apart.


"Today we relayed a clear message to the Hamas organization and other terrorist organizations," Prime Minister Benjamin Netanyahu said. "And if there is a need, the IDF (Israel Defence Forces) is prepared to broaden the operation. We will continue to do everything in order to protect our citizens."


Immediate calls for revenge were broadcast over Hamas radio.


"The occupation has opened the gates of hell," Hamas's armed wing said. Smaller groups also vowed to strike back.


"Israel has declared war on Gaza and they will bear the responsibility for the consequences," Islamic Jihad said.


Southern Israeli communities within rocket range of Gaza were on full alert, and schools were ordered closed for Thursday. About one million Israelis live in range of Gaza's relatively primitive but lethal rockets, supplemented in recent months by longer-range, more accurate systems.


"The days we face in the south will, in my estimation, prove protracted," Brigadier-General Yoav Mordechai, Israel's chief military spokesman, told Channel 2 TV.


The Israeli cabinet gave preliminary authorization for the mobilization of military reserves if required, Netanyahu's office said.


Asked if Israel might send in ground forces, Mordechai said: "There are preparations, and if we are required to, the option of an entry by ground is available."


OBAMA BRIEFED


Israeli President Shimon Peres briefed U.S. President Barack Obama on the operation, Peres's office said. He told Obama that Jaabari was a "mass-murderer" and his killing was Israel's response to Palestinian rocket attacks from Gaza.


"Israel is not interested in stoking the flames, but for the past five days there has been constant missile fire at Israel and mothers and children cannot sleep quietly at night," said Peres, who visited the border town of Sderot earlier.


In the flare-up that was prelude to Wednesday's offensive, more than 115 missiles were fired into southern Israel from Gaza and Israeli planes launched numerous strikes.


Seven Palestinians, three of them gunmen, were killed. Eight Israeli civilians were hurt by rocket fire and four soldiers wounded by an anti-tank missile.


The leader of Hamas in the Gaza Strip, Ismail Haniyeh, called on Arab states, especially Egypt, to halt the assault. The six-nation Gulf Cooperation Council said the U.N. Security Council should put pressure on Israel to stop its attacks.


Israel holds a general election on January 22 and Netanyahu has pledged to retaliate harshly against Hamas. But Israel is also wary of the reaction from Mursi's Egypt, whose ruling Muslim Brotherhood is the spiritual mentor of Hamas.


Hamas has been emboldened by its rise to power, viewing Mursi as a "safety net" who will not permit a second Israeli thrashing of Gaza, home to 1.7 million Palestinians.


Hamas is also supported by Iran, which Israel regards as a rising threat to its own existence due to its nuclear program.


Helped by the contraband trade through tunnels from Egypt, Gaza militias have smuggled in longer-range rockets.


But their estimated 35,000 Palestinian fighters are still no match for Israel's F-16 fighter-bombers, Apache helicopter gun ships, Merkava tanks and other modern weapons systems in the hands of a conscript force of 175,000, with 450,000 in reserve.


(Additional reporting by Dan Williams, Crispian Balmer and Ori Lewis in Jerusalem; Writing by Douglas Hamilton; Editing by Giles Elgood)


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Hope Solo Weds Jerramy Stevens Amid Assault Allegations?















11/14/2012 at 06:35 PM EST







Jerramy Stevens and Hope Solo


NFL/Getty; Jeff Vinnick/Getty


One day after former Seattle Seahawks tight end Jerramy Stevens was arrested on suspicion of assaulting his fiancée, U.S. women's soccer team goalkeeper Hope Solo, the pair reportedly tied the knot.

"Confirmed," Sportsradio 950 AM and 102.9 FM radio host Dave Mahler Tweeted on Tuesday. "Jerramy Stevens and Hope Solo were married tonight. Events of yesterday morning didn't change plans."

The pair, who had only been dating for about two months, applied for a marriage license last Thursday. According to court documents, the athletes were arguing over whether to wed in Florida or Washington State.

Stevens, 33, was reportedly released from custody by a Kirkland, Wash., Municipal Court judge on Tuesday after determining there wasn't enough evidence to hold the former football star.

All of the former Dancing with the Stars contestant's social media pages have gone silent since Nov. 6., and calls to her rep have not been returned.

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New gene triples risk for Alzheimer's disease

Scientists have identified a new gene variant that seems to strongly raise the risk for Alzheimer's disease, giving a fresh target for research into treatments for the mind-robbing disorder.

The problem gene is not common — less than 1 percent of people are thought to have it — but it roughly triples the chances of developing Alzheimer's compared to people with the normal version of the gene. It also seems to harm memory and thinking in older people without dementia.

The main reason scientists are excited by the discovery is what this gene does, and how that might reveal what causes Alzheimer's and ways to prevent it. The gene helps the immune system control inflammation in the brain and clear junk such as the sticky deposits that are the hallmark of the disease. Mutations in the gene may impair these tasks, so treatments to restore the gene's function and quell inflammation may help.

"It points us to potential therapeutics in a more precise way than we've seen in the past," said Dr. William Thies, chief medical and scientific officer of the Alzheimer's Association, which had no role in the research. Years down the road, this discovery will likely be seen as very important, he predicted.

It is described in a study by an international group published online Wednesday by the New England Journal of Medicine.

About 35 million people worldwide have dementia, and Alzheimer's is the most common type. In the U.S., about 5 million have Alzheimer's. Medicines such as Aricept and Namenda just temporarily ease symptoms. There is no known cure.

Until now, only one gene — ApoE — has been found to have a big impact on Alzheimer's risk. About 17 percent of the population has at least one copy of the problem version of this gene but nearly half of all people with Alzheimer's do. Other genes that have been tied to the disease raise risk only a little, or cause the less common type of Alzheimer's that develops earlier in life, before age 60.

The new gene, TREM2, already has been tied to a couple other forms of dementia. Researchers led by deCODE Genetics Inc. of Iceland honed in on a version of it they identified through mapping the entire genetic code of more than 2,200 Icelanders.

Further tests on 3,550 Alzheimer's patients and more than 110,000 people without dementia in several countries, including the United States, found that the gene variant was more common in Alzheimer's patients.

"It's a very strong effect," raising the risk of Alzheimer's by three to four times — about the same amount as the problem version of the ApoE gene does, said Dr. Allan Levey, director of an Alzheimer's program at Emory University, one of the academic centers participating in the research.

Researchers also tested more than 1,200 people over age 85 who did not have Alzheimer's disease and found that those with the variant TREM2 gene had lower mental function scores than those without it. This adds evidence the gene variant is important in cognition, even short of causing Alzheimer's.

"It's another piece in the puzzle. It suggests the immune system is important in Alzheimer's disease," said Andrew Singleton, a geneticist with the National Institute on Aging, which helped pay for the study.

One prominent scientist not involved in the study — Dr. Rudolph Tanzi, a Harvard Medical School geneticist and director of an Alzheimer's research program at Massachusetts General Hospital — called the work exciting, but added a caveat.

"I would like to see more evidence that this is Alzheimer's" rather than one of the other dementias already tied to the gene, Tanzi said. Autopsy or brain imaging tests can show whether the cases attributed to the gene variant are truly Alzheimer's or misdiagnosed, he said.

___

Online:

Medical journal: http://www.nejm.org

Alzheimer's info: http://www.alzheimers.gov

Alzheimer's Association: http://www.alz.org

___

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

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Wall Street drops on deficit, Middle East concerns

NEW YORK (Reuters) - Stocks slid on Wednesday with declines accelerating after President Barack Obama set up a drawn-out fight over the fiscal cliff when he stuck to his pledge to raise taxes on the wealthy, and as violence increased in the Middle East.


Obama, in his first press conference since re-election, held to his position that marginal tax rates will have to rise to tackle the nation's deficits.


With talks over solving the U.S. "fiscal cliff" in early stages, investors are reacting to the uncertainty by shedding positions.


"I think we will have a last-minute cliffhanger solution," said Michael Cheah, portfolio manager at SunAmerica Asset Management in Jersey City, New Jersey, about a deal to avoid the so-called cliff.


"In the meantime, the market is going to get punched every day."


Without a deal, a series of mandated tax hikes and spending cuts will start to take effect early next year that could push the U.S. economy into a recession.


Taxes on capital gains and dividends could rise as part of the negotiations, pushing investors to sell this year and pay lower taxes on their gains.


Adding to the selling pressure, Israel launched a major offensive against Palestinian militants in Gaza, killing the military commander of Hamas in an air strike and threatening an invasion of the enclave. Egypt said it recalled its ambassador from Israel in response.


"We know Europe's in trouble, China's slowing down ... and now you've got the Middle East flaring up again. It's all hitting at once, and obviously, the market is taking a 'sell first, ask questions later' approach," said Ryan Detrick, senior technical strategist at Schaeffer's Investment Research in Cincinnati.


Industrial shares led the decline, dragged lower in part by a 1 percent spike in crude prices after the Israeli offensive on Gaza. The S&P industrial sector index <.gspi> fell 2.5 percent.


Wall Street had opened higher after Dow component Cisco Systems Inc reported first-quarter earnings and revenue late Tuesday that beat expectations, driving its stock up 4.8 percent to $17.66. But the positive momentum was short-lived.


The Dow Jones industrial average <.dji> fell 185.23 points, or 1.45 percent, to 12,570.95 at the close. The S&P 500 <.spx> dropped 19.04 points, or 1.39 percent, to 1,355.49. The Nasdaq Composite <.ixic> lost 37.08 points, or 1.29 percent, to 2,846.81.


Both the Dow industrials and the Nasdaq ended at their lowest levels since late June.


The S&P 500 has fallen 5.1 percent in the six sessions since election night. Wednesday marked the benchmark index's lowest close since July 25.


The Russell 2000 <.rut> tumbled 2 percent. The Dow Jones Transportation average <.djt> slid 2.6 percent. FedEx Corp shares dropped 3.7 percent to $87.12. Bank of America shares lost 3.6 percent to $8.99.


In contrast, Facebook shares jumped 12.6 percent to $22.36 as investors were relieved that expiring trading restrictions on a huge block of shares did not trigger an immediate wave of insider selling.


Teen clothing retailer Abercrombie & Fitch Co jumped 34.4 percent to $41.92 after the company reported unexpectedly improved third-quarter results and a full-year outlook that exceeded Wall Street's forecasts.


About 7.53 billion shares changed hands on the New York Stock Exchange, the Nasdaq and NYSE MKT, more than the daily average so far this year of about 6.51 billion shares.


On the NYSE, decliners outnumbered advancers by a ratio of almost 9 to 1. On the Nasdaq, about four stocks fell for every one that rose.


(Reporting by Rodrigo Campos; Additional reporting by Steven C. Johnson and Leah Schnurr; Editing by Jan Paschal)


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France recognizes new Syria opposition

CAIRO/PARIS (Reuters) - France became the first European power to recognize Syria's new opposition coalition as the sole representative of its people and said on Tuesday it would look into arming rebels against President Bashar al-Assad once they form a government.


Twenty months into their bloody uprising against Assad, fragmented Syrian opposition groups struck a deal in Qatar on Sunday to form a broad coalition and their leader immediately appealed for European backing.


"I announce today that France recognizes the Syrian National Council as the sole legitimate representative of the Syrian people and as future government of a democratic Syria making it possible to bring an end to Bashar al-Assad's regime," French President Francois Hollande said, breaking ranks with European allies. Six Gulf Arab states took a similar step on Monday.


The question of arming the rebels would be looked at as soon as the rebel coalition formed a transitional government, Hollande told a news conference in Paris.


Arab League and EU foreign ministers meeting in Cairo on Tuesday welcomed the formation of the coalition as an important step forward, although their communiqué showed they had not reached a unanimous decision to recognize it as Syria's sole authority.


The French announcement came just hours after Syria's newly installed opposition leader urged European states to back the opposition so it could buy weapons.


Paris, one of Assad's harshest critics, had previously ruled out arming rebel forces, concerned that weapons could get into the hands of radical Islamists.


Speaking to Reuters as Arab and European ministers met to discuss Syria at the Arab League in Cairo, Mouaz Alkhatib, the Damascus preacher elected unopposed on Sunday to lead the new group, had asked for diplomatic backing.


"I request European states to grant political recognition to the coalition as the legitimate representative of the Syrian people and to give it financial support," he said.


"When we get political recognition, this will allow the coalition to act as a government and hence acquire weapons and this will solve our problems," added Alkhatib, who has been described by supporters as a moderate noted for his embrace of Syria's religious and ethnic minorities.


So far, concerted action on Syria has been thwarted by divisions within the opposition, as well as by big power rivalries and a regional divide between Sunni Muslim foes of Assad and his Shi'ite allies in Iran and Lebanon.


Russia and China, which have lent Assad diplomatic support since the uprising erupted in March last year, have shown no sign of warming towards his Western- and Arab-backed opponents.


"STEP FORWARD"


Cajoled by Qatar and the United States, the ineffectual Syrian National Council, previously the main opposition body based abroad, agreed to join a wider coalition on Sunday.


Britain's foreign minister, William Hague, said the coalition must show it had support within Syria before London would acknowledge it as the rightful government.


"If they have this, yes, we will then recognize them as the legitimate representative of the Syrian people," he told reporters at the Arab-European meeting in Cairo.


The opposition had hoped its new-found unity would clear the way for outside powers to arm the rebels, but Western nations fear such weapons could reach the hands of Islamist militants.


Western concern has also been heightened by documented reports of atrocities by ill-disciplined insurgents.


"Syria's newly created opposition front should send a clear message to opposition fighters that they must adhere to the laws of war and human rights law, and that violators will be held accountable," New York-based Human Rights Watch said.


BORDER VIOLENCE


Assad, whose family has ruled Syria for 42 years, has vowed to fight to the death in a conflict that has already killed an estimated 38,000 people and risks sucking in other countries.


His warplanes again struck homes in Ras al-Ain, a town on the northern border seized by rebels last week. Civilians fled over the border dividing it from the Turkish town of Ceylanpinar and thick plumes of smoke billowed upwards.


Syrian jets and artillery hit the town of Albu Kamal on the frontier with Iraq, where rebels have seized some areas, according to the mayor of the Iraqi border town of Qaim.


Tension also remained high on the Golan Heights, where Israeli gunners have retaliated against stray Syrian mortar fire landing on the occupied plateau in the previous two days.


Twenty months of conflict have created a vast humanitarian crisis, with more than 408,000 Syrians fleeing to neighboring countries and up to four million expected to need aid by early next year, according to the United Nations.


Fighting has also displaced 2.5 million civilians inside Syria, the Syrian Arab Red Crescent estimates.


"If anything, they believe it could be more; this is a very conservative estimate," Melissa Fleming, chief spokeswoman of the U.N. High Commissioner for Refugees, said in Geneva.


"So people are moving, really on the run, hiding," she told a news briefing. "They are difficult to count and access."


In Cairo, Arab League chief Nabil Elaraby urged opposition factions to join Alkhatib's group, formally known as the Syrian National Coalition for Opposition and Revolutionary Forces.


But although six Gulf Arab nations recognized the coalition as Syria's only legitimate representative on Monday, Iraq, Algeria and Lebanon prevented the League from following suit.


Iraq and Lebanon, with influential Shi'ite populations, have generally maintained better relations with Iran and with Assad, whose minority Alawite sect is an offshoot of Shi'ite Islam.


(Additional reporting by Shaimaa Fayed in Cairo and Jonathon Burch in Ceylanpinar, Turkey; Writing by Giles Elgood; Editing by Peter Graff)


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FTC chief: Kids’ Internet privacy rules done by year’s end
















WASHINGTON (Reuters) – Regulators will likely finish a long-awaited update to rules protecting children’s online privacy by the end of the year, the head of the Federal Trade Commission said on Tuesday.


The original rules were developed when most computers were large beige boxes sitting under office desks instead of smartphones slung into backpacks and permeating most aspects of daily life.













FTC Chairman Jon Leibowitz said the agency was moving forward on two issues: self-regulatory “do not track” guidance, and regulations to update the Children’s Online Privacy Protection Act, or COPPA.


The law requires that website and online service operators obtain verifiable consent from parents before collecting information about children.


Leibowitz, who is thought keen to leave the agency within months, said he was more confident of finishing an update of COPPA’s rules, which were written following the 1998 legislation.


Under revised rules, the FTC would make websites, mobile apps and data brokers all responsible for getting parental consent before collecting data about children aged 12 and younger. Currently it is unclear who has the responsibility.


Data brokers buy and sell consumer data.


Speaking at the Wall Street Journal’s annual CEO Conference in Washington, Leibowitz said the process would most likely be done by the end of the year.


“We are looking at all the comments that came in and weighing how to tweak the regulation,” he said.


Leibowitz was slightly less optimistic about the fate of “do not track,” an effort to allow Internet users to tell companies they did not want to be tracked online.


Some large technology companies, like Microsoft and Google, have agreed to let consumers opt out of being tracked, but advertisers have pushed back hard.


“We’re still making forward progress,” Leibowitz said when asked if the efforts would be done by the end of the year. “We continue to be optimistic. It’s not a certainty though.”


(Reporting By Diane Bartz; Editing by Ros Krasny and Kenneth Barry)


Internet News Headlines – Yahoo! News



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Dancing Eliminates Two More Couples















11/13/2012 at 09:05 PM EST







Kirstie Alley and Maksim Chmerkovskiy


Craig Sjodin/ABC


It was another week of double trouble on Dancing with the Stars.

Two all-star couples got the boot on Tuesday night, following Monday's Veteran's Day tribute.

Combining their scores from Monday and the previous elimination-free week, Kirstie Alley and Maksim Chmerkovskiy were again in the bottom spot, just below Apolo Ohno and Karina Smirnoff.

Gilles Marini and Peta Murgatroyd were uncharacteristically in the bottom three.

Read on to find out of any of these couples were among the two who were forced to hang up their dancing shoes:

The first to go were Alley and Chmerkovskiy.

"The second time around was very special to me," said Alley. "I learned more about dancing, believe it or not."

They were followed by a mild shock, with the departure of usually high-scoring Marini and Murgatroyd, who couldn't overcome the recent rough patch.

"In the end, it was just an incredible experience," said Marini.

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Report: FDA wanted to close Mass pharmacy in 2003

WASHINGTON (AP) — Nearly a decade ago, federal health inspectors wanted to shut down the pharmacy linked to a recent deadly meningitis outbreak until it cleaned up its operations, according to congressional investigators.

About 440 people have been sickened by contaminated steroid shots distributed by New England Compounding Center, and more than 32 deaths have been reported since the outbreak began in September, according to the Centers for Disease Control and Prevention. That has put the Framingham, Mass.-based pharmacy at the center of congressional scrutiny and calls for greater regulation of compounding pharmacies, which make individualized medications for patients and have long operated in a legal gray area between state and federal laws.

The House Energy and Commerce Committee released a detailed history of NECC's regulatory troubles on Monday, ahead of a meeting Wednesday meeting to examine how the outbreak could have been prevented. The 25-page report summarizes and quotes from FDA and state inspection memos, though the committee declined to release the original documents.

The report shows that after several problematic incidents, Food and Drug Administration officials in 2003 suggested that the compounding pharmacy be "prohibited from manufacturing" until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections.

The congressional report also shows that in 2003 the FDA considered the company a pharmacy. That's significant because in recent weeks public health officials have charged that NECC was operating more as a manufacturer than a pharmacy, shipping thousands of doses of drugs to all 50 states instead of small batches of drugs to individual patients. Manufacturers are regulated by the FDA and are subject to stricter quality standards than pharmacies.

The report offers the most detailed account yet of the numerous regulatory complaints against the pharmacy, which nearly date back to its founding in 1998. Less than a year later, the company was cited by the state pharmacy board for providing doctors with blank prescription pads with NECC's information. Such promotional items are illegal in Massachusetts and the pharmacy's owner and director, Barry Cadden, received an informal reprimand, according to documents summarized by the committee.

Cadden was subject to several other complaints involving unprofessional conduct in coming years, but first came to the FDA's attention in 2002. Here are some key events from the report highlighting the company's early troubles with state and federal authorities:

__ In March of 2002 the FDA began investigating reports that five patients had become dizzy and short of breath after receiving NECC's compounded betamethasone repository injection, a steroid used to treat joint pain and arthritis that's different from the one linked to the current meningitis outbreak.

FDA inspectors visited NECC on April 9 and said Cadden was initially cooperative in turning over records about production of the drug. But during a second day of inspections, Cadden told officials "that he was no longer willing to provide us with any additional records," according to an FDA report cited by congressional investigators. The inspectors ultimately issued a report citing NECC for poor sterility and record-keeping practices but said that "this FDA investigation could not proceed to any definitive resolution," because of "problems/barriers that were encountered throughout the inspection."

__ In October of 2002, the FDA received new reports that two patients at a Rochester, N.Y., hospital came down with symptoms of bacterial meningitis after receiving a different NECC injection. The steroid, methylprednisolone acetate, is the same injectable linked to the current outbreak and is typically is used to treat back pain. Both patients were treated with antibiotics and eventually recovered, according to FDA documents cited by the committee.

When officials from the FDA and Massachusetts Board of Pharmacy visited NECC later in the month, Cadden said vials of the steroid returned by the hospital had tested negative for bacterial contamination. But when FDA scientists tested samples of the drug collected in New York they found bacterial contamination in four out of 14 vials sampled. It is not entirely clear whether FDA tested the same lot shipped to the Rochester hospital.

__ At a February 2003 meeting between state and federal officials, FDA staff emphasized "the potential for serious public consequences if NECC's compounding practices, in particular those relating to sterile products, are not improved." The agency issued a list of problems uncovered in its inspection to NECC, including a failure to verify if sterile drugs met safety standards.

But the agency decided to let Massachusetts officials take the lead in regulating the company, since pharmacies are typically regulated at the state level. It was decided that "the state would be in a better position to gain compliance or take regulatory action against NECC as necessary," according to a summary of the meeting quoted by investigators.

The FDA recommended the state subject NECC to a consent agreement, which would require the company to pass certain quality tests to continue operating. But congressional investigators say Massachusetts Board of Pharmacy did not take any action until "well over a year later."

__ In October 2004, the board sent a proposed consent agreement to Cadden, which would have included a formal reprimand and a three-year probationary period for the company's registration. The case ended without disciplinary action in 2006, when NECC agreed to a less severe consent decree with the state.

Massachusetts officials indicated Tuesday they are still investigating why NECC escaped the more severe penalty.

"I will not be satisfied until we know the full story behind this decision," the state's interim health commissioner Lauren Smith said in a transcript of her prepared testimony released a day ahead of delivery. Smith is one of several witnesses scheduled to testify Wednesday, including FDA Commissioner Margaret Hamburg.

The committee will also hear from the widow of 78-year-old Eddie C. Lovelace, a longtime circuit court judge in southern Kentucky. Autopsy results confirmed Lovelace received fungus-contaminated steroid injections that led to his death Sept. 17.

Joyce Lovelace will urge lawmakers to work together on legislation to stop future outbreaks caused by compounded drugs, according to a draft of her testimony.

"We now know that New England Compounding Pharmacy, Inc. killed Eddie. I have lost my soulmate and life's partner with whom I worked side by side, day after day for more than fifty years," Lovelace states.

Barry Cadden is also scheduled to appear at the hearing, after lawmakers issued a subpoena to compel him to attend.

The NECC has been closed since early last month, and Massachusetts officials have taken steps to permanently revoke its license. The pharmacy has recalled all the products it makes, including 17,700 single-dose vials of a steroid that tested positive for the fungus tied to the outbreak.

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Microsoft leads Wall Street lower, but retailers gain

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