Advancing the Promise of Personalized Medicine: Companion Diagnostics

When I was a sophomore in college, my mother unfortunately lost her very short battle with pancreatic cancer, an experience that changed my life forever. During that time I witnessed firsthand the devastating effects caused by the administration of toxic, non-specific treatments which ultimately failed to stop the spread of the cancer, and instead only made my mother extremely sick. Her death, at the young age of 44, profoundly influenced my feelings towards medicine and altered my career path. As a result, I became driven to discover better drugs for treating cancer, with a focus to specifically target diseased cells while leaving healthy tissues unharmed.Thankfully, my passion for developing smarter cancer drugs is shared by many others, and it has been exciting to see the progress made over the years in developing treatments that can be characterized as “personalized medicines”. A commonly cited example that demonstrates the impact of personalized medicine in cancer is the successful development of the breast cancer drug, Herceptin(R), which specifically targets aggressive HER2-positive breast cancer. Importantly, before this medication was developed, women with HER2-expressing breast cancer were less responsive to standard treatments. Now, however, treatment with Herceptin in combination with chemotherapy has amazingly been shown to reduce the recurrence rate of this type of cancer by 52 percent.Building on Biomarkers: Companion DiagnosticsA biomarker is a unique trait of a disease, such as genetic marker or overexpressed protein like HER2. Developing a medicine that targets a specific biomarker can have a positive effect on patient outcome, but this approach is only one part of the therapeutic equation. To truly fulfill the promise of personalized medicine, there must also be a tool available for identifying those patients bearing that biomarker. An agent of this type is called a companion diagnostic. The outcome of this type of test should enable the right drug to be administered, to the right person, at the right time. In this manner, a companion diagnostic helps to identify those patients that may benefit from a given targeted treatment while at the same time identifying patients that will likely not benefit from therapy. Related to the example above, such a test is available to determine if a patient has HER2-positive breast cancer, and it is performed before Herceptin is prescribed.Recently, due to the benefits realized from biomarker testing, interest in developing companion diagnostics has surged. The FDA is very supportive of the development of these patient-selective tests. In fact, one companion diagnostic was approved this year and two within the same month last year to accompany Pfizer’s targeted drug for lung cancer, Xalkori(R), and Roche’s personalized therapeutic for melanoma, Zelboraf(R). Importantly, Roche stated that it aims to have 60 percent of its drugs in development to be accompanied by some form of a companion test, an indication that, like the FDA, the pharmaceutical industry is also embracing the continued development of companion diagnostic agents.There are many reasons for the significant interest in this space that stem from the benefits of identifying patients with companion diagnostics. For example, in the area of cancer, where development of these agents is most advanced, significant delay of tumor growth and increased survival rates have been demonstrated in patients that were preselected using a companion diagnostic. Having the ability to determine whether a patient may or may not respond to a given treatment enables the selection of the best medicine for that individual, without wasting precious time with trial and error approaches.It is precisely this advantage that allows clinical trials to be conducted in a specific patient population, which can decrease the size and related cost of these studies. Lower costs may allow drug developers to use such savings to invest in additional areas of disease research. Furthermore, smaller clinical trial size means that studies can be conducted more quickly, which could accelerate the arrival of these treatments to the market and broaden access to patients. Collectively, these conserved resources translate into savings for the entire healthcare system, which is an important benefit as rising healthcare costs are a significant issue for our nation.It is worth noting that a recent paper published in the New England Journal of Medicine showed that the genetic characteristics of a tumor, such as biomarker expression, can and often do change over time. Thus, in contrast to conventional companion diagnostics that typically utilize tissue samples obtained through biopsy (especially those performed on archived tissue), additional benefits are found with the use of companion diagnostics that are based on whole-body imaging. Results obtained from non-invasive, real-time imaging methodology, therefore, provide the most up-to-date biomarker information possible to inform treatment decision making. But, regardless of the method employed, the impact of patient selection can be substantial.A New ApproachAt Endocyte, we have seen this patient-selective approach translate into positive clinical results. The technology we’re developing consists of targeted therapeutics called small molecule drug conjugates, or SMDCs. Each of these novel compounds consists of a high affinity, cell-specific targeting molecule (the ligand) that is chemically linked to a potent chemotherapy drug. This yields a highly potent, yet selective therapeutic agent; but, this approach also allows us to easily create a companion diagnostic by simply replacing the chemotherapeutic drug in the SMDC construct with an imaging agent.Vintafolide is our most advanced SMDC in development. This therapeutic binds to the folate receptor, which is a confirmed biomarker expressed on many human cancers, including ovarian, lung, breast and colon. Vintafolide’s companion diagnostic imaging agent (etarfolatide) is designed to identify cancer patients that have high levels of the folate receptor expression, which is the exact population of patients expected to respond to this drug.In a previous clinical trial in patients with platinum-resistant ovarian cancer, women identified as “FR-positive” by etarfolatide and then subsequently treated with vintafolide had significantly delayed tumor growth. Based on these unprecedented results, especially in a patient population that fails to adequately respond to any therapy, both etarfolatide and vintafolide are being considered for conditional approval in Europe. This could mean that patients would have access to these agents much sooner than expected. Overall, this exciting opportunity would never have been possible if our companion diagnostic agent was not used to select the right patient population to treat with vintafolide in our clinical trials.A Promising FutureBecause of the numerous benefits companion diagnostics hold for patients, physicians, drug developers and our healthcare system, their continued development and use will only increase in the future. Regulatory agencies worldwide are also embracing this approach, and they continue to encourage drug developers to pursue this path for the treatment of all types of diseases. As the number of companion diagnostics in development continues to grow, we are moving closer each day to truly fulfilling the promise of personalized medicine.

Follow Scientific American on Twitter @SciAm and @SciamBlogs.Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.
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Mall shooter quit job, was going to Hawaii

In the days before he stole a semiautomatic weapon and stormed into an Oregon shopping mall, killing two people in a shooting spree, Jacob Roberts quit his job, sold his belongings and began to seem "numb" to those closest to him.

Roberts' ex-girlfriend, Hannah Patricia Sansburn, 20, told ABC News today that the man who donned a hockey mask and opened fire on Christmas shoppers was typically happy and liked to joke around, but abruptly changed in the week before the shooting.

Roberts unleashed a murderous volley of gunfire on the second floor of the Clackamas Town Center on Tuesday while wearing the mask and black clothing, and carrying an AR-15 semiautomatic weapon and "several" magazines full of ammunition. He ended his barrage by walking down to the first floor of the mall and committing suicide.

READ: Why Mass Shooters Wear Masks

"I don't understand," Sansburn said. "I was just with him. I just talked to him. I didn't believe it was him at all. Not one part of me believed it."

She said that in recent weeks, Roberts quit his job at a gyro shop in downtown Portland and sold all of his belongings, telling her that he was moving to Hawaii. He had even purchased a ticket.

She now wonders if he was really planning to move.

"He was supposed to catch a flight Saturday and I texted him, and asked how his flight went, and he told me, 'oh, I got drunk and didn't make the flight,'" she said. "And then this happens... It makes me think, was he even planning on going to Hawaii? He quit his job, sold all of his things."

Roberts described himself on his Facebook page as an "adrenaline junkie," and said he is the kind of person who thinks, "I'm going to do what I want."

Roberts, who attended Clackamas Community college, posted a picture of himself on his Facebook page firing a gun at a target. His Facebook photo showed graffiti in which the words "Follow Your Dreams" were painted over with the word "Cancelled."

Sansburn said the pair had dated for nearly a year but had broke up over the summer. Throughout their relationship, she had never seen him act violently or get angry.

"Jake was never the violent type. He didn't go out of his way to try to hurt people or upset people. His main goal was to make you laugh, smile, make you feel comfortable. I never would have guessed him to do anything like this ever," she said.

"You can't reconcile the differences. I hate him for what he did, but I can't hate the person I knew because it was nothing like the person who would go into a mall and go on a rampage. I would never associate the two at all."

The last time she saw him, which was last week, he "seemed numb," and she didn't understand why, she said.

"I just talked to him, stayed the night with him, and he just seemed numb if anything. He's usually very bubbly and happy, and I asked him why, what had changed, and said 'nothing.' He just had so much he had to do before he went to Hawaii that he was trying to distance himself from Portland," Sansburn said.

Sansburn said the last message she sent Roberts was a text, asking him to stay, and saying she didn't want him to leave. He replied "I'm sorry," with a sad face emoticon.

Police are still seeking information about what Roberts was doing in the days leading up to the shooting. They said today they believe Roberts stole the gun he used in the rampage from someone he knew. They have searched his home and his car for other clues into his motive.

Read ABC News' full coverage of the Oregon Mall Shooting

Clackamas County Sheriff Craig Roberts said earlier today on "Good Morning America" that he believes Roberts went into the mall with the goal of killing as many people as he could.

"I believe, at least from the information that's been provided to me at this point in time, it really was a killing of total strangers. To my knowledge at this point in time he was really trying, I think, to kill as many people as possible."

Sansburn said she has not talked to police.

Mall Shooter Told Ex-Girlfriend He Was Moving to Hawaii

Roberts' mother, Tami Roberts, released a statement through a friend today saying she had no explanation of her son's behavior.

"Tami Roberts wishes to express her shock and grief at the events at Clackamas Town Center Tuesday," the friend said, reading from a statement outside of Tami Roberts' home.

The friend noted that Tami raised Roberts, but was not his biological mother. Sansburn said that Roberts' biological mother had died when he was very young.

"She has no understanding or explanation for her son's behavior...It's so out of his character," the friend said.

Officials from the Oregon City School District, where Roberts graduated from Oregon City High School, were also surprised at the news.

"This news is very shocking to those who knew Jacob while at OCHS. He was known as a soft spoken and polite young man who was often eager to be helpful. The motive for such a horrific act is likely to remain a mystery to us all," the district said in a statement.

Roberts had attended the school for only his senior year. He spent three years at Milwaukie High School, where officials described him as an "average student with average grades."

He had no disciplinary record at the school, but chose to transfer for his senior year to Oregon City High School, according to Joe Krumm, an administrator at the North Clackamas School District. Krumm did not know why he transferred, and said that in all, Roberts did not stand out in memory for anything in particular.

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Corruption probe shrouds Quebec in new darkness

MONTREAL (Reuters) – Half a century ago, a new crop of Quebec leaders sparked the so-called Quiet Revolution to eradicate the “Great Darkness” – decades of corruption that kept Canada‘s French-speaking province under the dominance of one party and the Catholic church.

The revolution’s reforms, including cleaning up the way lawmakers were elected and secularizing the education system, seemed to work, paving the way for decades of growth, progress and prominence as Canada emerged as a model of democracy.

Fifty years later, a public inquiry into corruption and government bid-rigging suggests the province’s politics are not as clean as Quebecers had hoped or believed.

Since May, when the inquiry opened in Montreal, Canadians have been getting daily doses of revelations of fraud through live broadcasts on French-language television stations. Corruption involving the Mafia, construction bosses and politicians, the inquiry has shown, drove up the average building cost of municipal contracts by more than 30 percent in Montreal, Canada’s second-largest city.

Last month, Montreal Mayor Gerald Tremblay resigned as did the mayor of nearby Laval, Gilles Vaillancourt. Both denied doing anything wrong, but said they could not govern amid the accusations of corruption involving rigging of municipal contracts, kickbacks from the contracts and illegal financing of elections.

Tremblay has not been charged by police. Vaillancourt’s homes and offices have been raided several times by Quebec’s anti-corruption squad, which operates independently of the inquiry, but no charges have been filed against him either. Police said the raids were part of an investigation but they would not release further details.

“Quebecers lived for several years under the impression that they had found the right formula, that their parties were clean,” said Pierre Martin, political science professor at the University of Montreal. Now, he said, “people at all levels are fed up.”

The inquiry must submit its final report to the Quebec government by next October. It has exposed practices worthy of a Hollywood noir thriller – a mob boss stuffing his socks with money, rigged construction contracts, call girls offered as gifts, and a party fundraiser with so much cash he could not close the door of his safe.

“Even though we are in the early days, what is emerging is a pretty troubling portrait of the way public contracts were awarded,” said Antonia Maioni, director of the McGill Institute for the Study of Canada in Montreal.

Quebec’s Liberals, the force behind the Quiet Revolution, launched the inquiry as rumors of corruption swirled. The government then called an election for September, a year ahead of schedule, in what was seen as an attempt to stop damaging testimony hurting its popularity.

The tactic did not help. Jean Charest’s Liberals lost to the Parti Quebecois, whose ultimate aim is to take the French-speaking province, the size of Western Europe, out of Canada.

‘IT WASN’T COMPLICATED’

According to allegations at the inquiry, the corruption helped three main entities: the construction bosses who colluded to bid on contracts, the Montreal Mafia dons who swooped in for their share, and the municipal politicians who received kickbacks to finance campaigns.

In Quebec, the Mafia has been dominated by the Rizzuto family, with tentacles to the rest of Canada and crime families in New York and abroad. But recently the syndicate has been facing challenges from other crime groups in Montreal, according to the Toronto-based Mafia analyst and author Antonio Nicaso.

The reputed godfather of the syndicate, Vito Rizzuto, has been subpoenaed to appear before the commission, but the date for his testimony has not been set.

The hearings have zeroed in on four construction bosses and how their companies worked with the Mafia, bribed municipal engineers and provided funds for mayoralty campaigns in Montreal, the business capital for Quebec’s 8 million people.

“It’s not good for the economy,” said Martin. “It’s not good for any kind of legitimate business that tries to enter into any kind of long-term relationship with the public sector.”

Quebec’s anti-corruption squad has arrested 35 people so far this year, staging well-publicized raids on mayoral offices and on construction and engineering companies. The squad has arrested civil servants and owners of construction companies, among others.

“I now must suffer an unbearable injustice,” Tremblay said in a somber resignation speech earlier this month after a decade as mayor of Montreal, saying he could not continue in office because the allegations of corruption were causing a paralysis at City Hall.

Some of the most explosive allegations at the inquiry, headed by Quebec Superior Court Justice France Charbonneau, came from Lino Zambito, owner of a now bankrupt construction company, and from a top worker for Tremblay’s political party, Union Montreal.

Zambito, who is seen as one of the smaller players and who also faces fraud charges, described a system of collusion between organized crime, business cartels and corrupt civil servants, with payments made according to a predetermined formula.

“The entrepreneurs made money, and there was an amount that was due to the Mafia,” Zambito told the inquiry. “It wasn’t complicated.”

Zambito said the Mafia got 2.5 percent of the value of a contract, 3 percent went to Union Montreal and 1 percent to the engineer tasked with inflating contract prices.

Tremblay did not respond to emails requesting comment on the allegations of corruption at city hall.

A former party organizer, Martin Dumont, alleged the mayor was aware of double bookkeeping used to hide illegal funding during a 2004 election.

Dumont said the mayor walked out of the room during a meeting that explained the double bookkeeping system, saying he did not want to know anything about it.

Dumont also described how he was called into the office of a fundraiser for Union Montreal to help close the door of a safe because it was too full of money.

“I think it was the largest amount I’d ever seen in my life,” Dumont said at the inquiry.

GOLF, HOCKEY, ESCORTS

The inquiry also saw videos linking construction company players with Mafia bosses. In one police surveillance video, a Mafia boss was seen stuffing cash into his socks.

A retired city of Montreal engineer, Gilles Surprenant, described how he first accepted a bribe in the late 1980s after being “intimidated” by a construction company owner. Over the years he said he accepted over $ 700,000 from the owners in return for inflating the price of the contracts.

Another retired engineer, Luc Leclerc, admitted to bagging half a million dollars for the same service. He said the system was well-known to many at city hall and simply part of the “business culture” in Montreal. He also got gifts and paid golf trips to the Caribbean with other businessmen and Mafia bosses.

Gilles Vezina, who is currently suspended from his job as a city engineer, concurred.

“It was part of our business relationships to get advantages like golf, hockey, Christmas gifts” from construction bosses, he told the inquiry in mid-November.

The gifts didn’t stop there. Vezina said he was twice offered the services of prostitutes from different construction bosses in the 1980s or early 1990s, which he said he refused.

The accusations are jarring for a country that prides itself on being one of the least corrupt places in the world, according to corruption watchdog Transparency International. But experts say corruption in Montreal was something of an open secret.

“The alarm signals have been going off here for 20 years and no one has done anything,” said Andre Cedilot, a former journalist who co-wrote a book on the Canadian Mafia.

Quebec’s new government has introduced legislation tasking the province’s securities regulator with vetting businesses vying for public contracts and allowing it to block companies that do not measure up.

Anti-corruption activist Jonathan Brun was not optimistic.

“You’ve got to use modern technology,” said Brun, a co-founder of Quebec Ouvert, a group that wants to make all information about contracts freely available rather than asking regulators to oversee individual companies. “You’ve got to change the entire system if you really want to fight corruption.”

(Writing by Russ Blinch; Editing by Janet Guttsman, Mary Milliken and Prudence Crowther)

Canada News Headlines – Yahoo! News

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Facebook helps FBI bust cybercriminals blamed for $850 million losses

SAN FRANCISCO (Reuters) – Investigators led by the Federal Bureau of Investigation and aided by Facebook Inc, have busted an international criminal ring that infected 11 million computers around the world and caused more than $ 850 million in total losses in one of the largest cybercrime hauls in history.

The FBI, working in concert with the world’s largest social network and several international law enforcement agencies, arrested 10 people it says infected computers with “Yahos” malicious software, then stole credit card, bank and other personal information.

Facebook’s security team assisted the FBI after “Yahos” targeted its users from 2010 to October 2012, the U.S. federal agency said in a statement on its website. The social network helped identify the criminals and spot affected accounts, it said.

Its “security systems were able to detect affected accounts and provide tools to remove these threats,” the FBI said.

According to the agency, which worked also with the U.S. Department of Justice, the accused hackers employed the “Butterfly Botnet”. Botnets are networks of compromised computers that can be used in a variety of cyberattacks on personal computers.

The FBI said it nabbed 10 people from Bosnia and Herzegovina, Croatia, Macedonia, New Zealand, Peru, the United Kingdom, and the United States, executed numerous search warrants and conducted a raft of interviews.

It estimated the total losses from their activities at more than $ 850 million, without elaborating.

Hard data is tough to come by, but experts say cybercrime is on the rise around the world as PC and mobile computing become more prevalent and as more and more financial transactions shift online, leaving law enforcement, cybersecurity professionals and targeted corporations increasingly hard-pressed to spot and ward off attacks.

(Reporting By Edwin Chan; Editing by Matt Driskill)

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Spice Girls take stage at musical premiere

LONDON (Reuters) – The Spice Girls took to the stage on Tuesday after the world premiere of a new musical loosely based on their meteoric rise to fame in the 1990s, earning huge cheers from an audience that only really got going at the encore.

“Viva Forever!” was the brainchild of producer Judy Craymer, whose “Mamma Mia!” musical based on the hits of ABBA has earned nearly $ 2 billion worldwide and spawned a hit movie starring Meryl Streep.

She teamed up with British comedian Jennifer Saunders to create a story about the central character Viva, a sprightly teenager who, along with her friends, gets into the final stages of a TV singing contest closely resembling “The X Factor”.

To boost flagging audience figures – a nod to “The X Factor”s real-life ratings woes in Britain this season – their “mentor” springs a surprise and throws out three members of the band to leave Viva on her own.

What follows is part morality tale examining what is more important – friends, family or fame – and part satire on reality television, including a callous, Simon Cowell-like producer.

“We love you Judy!” said Geri Halliwell at the end of the show, which closed with a romp through some of the Spice Girls‘ biggest hits including “Spice Up Your Life”.

“Thank you for making the Spice Girls‘ dream come true,” Halliwell added.

Halliwell was joined on stage by Victoria Beckham, Melanie Brown, Emma Bunton and Melanie Chisholm, who together stormed the charts in the 1990s and put “girl power” on the map.

Beckham, who arrived at the London premiere after her ex-bandmates, sat with her soccer star husband David and three sons, who clapped along to the music during the final medley.

NATIONAL TREASURES

Now all young mothers in their late 30s and early 40s, The Spice Girls are still affectionately known by the nicknames they adopted in the band – Posh (Beckham), Scary (Brown), Baby (Bunton), Sporty (Chisholm) and Ginger (Halliwell).

They were hailed as modern-day feminists by some and dismissed as vacuous pop princesses by others, but their success is beyond doubt. They sold 55 million records, had nine British No. 1 singles and three back-to-back Christmas No. 1s.

The band broke up around 12 years ago, and internal bickering among the members was long the delight of Britain’s celebrity-obsessed tabloids.

Perhaps surprisingly, given the bust-ups and hissy fits, the group has been united in its backing of the new musical, and underlining the Spice Girls‘ lasting popularity they played a major part in the closing ceremony at the London Olympics.

Paul Taylor, writing in the Independent newspaper, gave the musical two stars out of five in his review.

“The Spice Girls‘ songs, with their clever hooks and catchy rhythms, are better at projecting an attitude than fleshing out a dramatic situation,” he wrote, describing Saunders’ story as “charmless”, “messy” and “lackluster”.

“Not only does her script rarely give you that necessary gleeful sense of expectancy about where the songs are going to be shoe-horned in, but it’s embarrassingly derivative of ‘Mamma Mia!’ and looks way past its sell-by date in its utterly surprise-free satiric swipe at ‘X Factor’.”

Saunders said before the show that she considered herself the “sixth” Spice Girl.

“We used to travel around everywhere to see them and they were so great with my kids,” said the 54-year-old, best known for playing a self-absorbed, eccentric mother in the popular British comedy series “Absolutely Fabulous”.

“The thought of a Spice Girls musical written by somebody else was not acceptable,” she told the Daily Mirror newspaper. “Because I was so close to them, I couldn’t let it slip through my fingers.”

(Reporting by Mike Collett-White, editing by Jill Serjeant)

Music News Headlines – Yahoo! News

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Chavez cancer surgery successful, Venezuela VP says

CARACAS (Reuters) – Venezuelan President Hugo Chavez‘s cancer operation in Cuba on Tuesday was successful, his vice president said, adding it was a complicated procedure that lasted more than six hours.

The third recurrence of the socialist leader’s illness has thrown his 14-year-old presidency into jeopardy and upended politics in the South American OPEC nation.

“Once again, our comandante has shown his strength,” Vice President Nicolas Maduro said in a broadcast on state TV, as members of the government alongside him applauded.

“We thank the Venezuelan people for all the love they dedicated so this operation ended correctly and successfully.”

He said the post-operative phase would last several days, and they would update the public on the 58-year-old president’s recuperation.

Chavez’s surgery in Cuba, a close ally, was his fourth since mid-2011. Doctors found malignant cells again in his pelvic area soon after he won re-election in October, leading him to name a successor in case he has to step down.

Chavez had twice declared himself cured previously. But he retains hope of recovering in time for the January 10 start of his new six-year term in office.

He named Maduro on Saturday as a potential heir to lead his self-styled revolution in a nation of 29 million people with the world’s largest oil reserves.

The move irked some in Venezuela’s opposition, who say voters – not Chavez – would decide who follows him if he were forced to step down and an election was held within 30 days, as required under the constitution.

(Additional reporting by Caracas bureau; Editing by Peter Cooney)

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Gunman kills 2, then self in Oregon mall rampage

A masked gunman opened fire today at Clackamas Town Center, a mall in suburban Portland, Ore., killing two people, injuring one, and then killing himself.

"I can confirm the shooter is dead of an apparent self inflicted gunshot wound," Lt. James Rhodes of the Clackamas County, Ore., Sheriff's Department said today. "By all accounts there were no rounds fired by law enforcement today in the mall."

Police have not released the names of the deceased. Rhodes said authorities are in the process of notifying victims' families. The injured victim has been transported to a local hospital.

Rhodes described the shooter as an adult male.

Witnesses from the shooting rampage said that a young man in a white hockey mask and bulletproof vest tore through the Macy's, food court, and mall hallways firing rounds at shoppers beginning around 3:30 p.m. PT today.

Hundreds of people were evacuated from the busy mall full of holiday shoppers after the shooting began.

READ: Guns in America: A Statistical Look

The gunman entered the mall through a Macy's store, ran through the upper level of Macy's and opened fire near the mall food court, firing multiple shots, one right after another, with what is believed to be a black, semiautomatic rifle, according to witness reports.

Katie Tate said she was in the parking lot of the mall when she saw the shooter run by, wearing a mask and carrying a machine gun, headed for the Macy's.

"He looked like a teenager wearing a gun, like a bullet-proof vest and he had a machine, like an assault rifle and a white mask and he looked at me," she said.

Witnesses described the shooter as being on a mission and determined, looking straight ahead. He then seemed to walk through the mall toward the other end of the building, shooting along the way, according to witness reports.

Those interviewed said that Macy's shoppers and store employees huddled in a dressing room to avoid being found.

"I was helping a customer in the middle of the store, her and her granddaughter and while we were looking at sweatshirts we heard five to seven shots from a machine gun fire just outside my store," Jacob Rogers, a store clerk, told ABC affiliate KATU-TV in Portland.

"We moved everyone into the back room where there's no access to outside but where there's a camera so we can monitor what's going on out front," Rogers said.

Evan Walters, an employee at a store in the mall, told ABC News Radio that he was locked in a store for his safety and he saw two people shot and heard multiple gunshots.

"It was over 20, and it was kind of surreal because we hear pops and loud noises," he said. "We're next to the food court here and we hear pops and loud noises all the time, but we don't -- nothing like that. It was very definite gunshots."

Police are tracing the weapon used in the shooting.

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Egypt army given temporary power to arrest civilians

CAIRO (Reuters) – Egypt’s Islamist president has given the army temporary power to arrest civilians during a constitutional referendum he is determined to push through despite the risk of bloodshed between his supporters and opponents accusing him of a power grab.

Seven people were killed and hundreds wounded last week in clashes between the Islamist Muslim Brotherhood and their critics besieging Mohamed Mursi’s graffiti-daubed presidential palace. Both sides plan mass rallies on Tuesday.

The elite Republican Guard has yet to use force to keep protesters away from the palace, which it ringed with tanks, barbed wire and concrete barricades after last week’s violence.

Mursi, bruised by calls for his downfall, has rescinded a November 22 decree giving him wide powers but is going ahead with a referendum on Saturday on a constitution seen by his supporters as a triumph for democracy and by many liberals as a betrayal.

A decree issued by Mursi late on Sunday gives the armed forces the power to arrest civilians and refer them to prosecutors until the announcement of the results of the referendum, which the protesters want cancelled.

Despite its limited nature, the edict will revive memories of Hosni Mubarak’s emergency law, also introduced as a temporary expedient, under which military or state security courts tried thousands of political dissidents and Islamist militants.

But a military source stressed that the measure introduced by a civilian government would have a short shelf-life.

“The latest law giving the armed forces the right to arrest anyone involved in illegal actions such as burning buildings or damaging public sites is to ensure security during the referendum only,” the military source said.

Presidential spokesman Yasser Ali said the committee overseeing the vote had requested the army’s assistance.

“The armed forces will work within a legal framework to secure the referendum and will return (to barracks) as soon as the referendum is over,” Ali said.

Protests and violence have racked Egypt since Mursi decreed himself extraordinary powers he said were needed to speed up a troubled transition since Mubarak’s fall 22 months ago.

The Muslim Brotherhood has voiced anger at the Interior Ministry’s failure to prevent protesters setting fire to its headquarters in Cairo and 28 of its offices elsewhere.

Critics say the draft law puts Egypt in a religious straitjacket. Whatever the outcome of the referendum, the crisis has polarized the country and presages more instability at a time when Mursi is trying to steady a fragile economy.

On Monday, he suspended planned tax increases only hours after the measures had been formally decreed, casting doubts on the government’s ability to push through tough economic reforms that form part of a proposed $ 4.8 billion IMF loan agreement.

“VIOLENT CONFRONTATION”

Rejecting the referendum plan, opposition groups have called for mass protests on Tuesday, saying Mursi’s eagerness to push the constitution through could lead to “violent confrontation”.

Islamists have urged their followers to turn out “in millions” the same day in a show of support for the president and for a referendum they feel sure of winning with their loyal base and perhaps with the votes of Egyptians weary of turmoil.

The opposition National Salvation Front, led by liberals such as Mohamed ElBaradei and Amr Moussa, as well as leftist firebrand Hamdeen Sabahy, has yet to call directly for a boycott of the referendum or to urge their supporters to vote “no”.

Instead it is contesting the legitimacy of the vote and of the whole process by which the constitution was drafted in an Islamist-led assembly from which their representatives withdrew.

The opposition says the document fails to embrace the diversity of 83 million Egyptians, a tenth of whom are Christians, and invites Muslim clerics to influence lawmaking.

But debate over the details has largely given way to noisy street protests and megaphone politics, keeping Egypt off balance and ill-equipped to deal with a looming economic crisis.

“Inevitability of referendum deepens divisions,” was the headline in Al-Gomhuriya newspaper on Monday. Al Ahram daily wrote: “Political forces split over referendum and new decree.”

Mursi issued another decree on Saturday to supersede his November 22 measure putting his own decisions beyond legal challenge until a new constitution and parliament are in place.

While he gave up extra powers as a sop to his opponents, the decisions already taken under them, such as the dismissal of a prosecutor-general appointed by Mubarak, remain intact.

“UNWELCOME” CHOICE

Lamia Kamel, a spokeswoman for former Arab League chief Moussa, said the opposition factions were still discussing whether to boycott the referendum or call for a “no” vote.

“Both paths are unwelcome because they really don’t want the referendum at all,” she said, but predicted a clearer opposition line if the plebiscite went ahead as planned.

A spokeswoman for ElBaradei, former head of the U.N. nuclear watchdog, said: “We do not acknowledge the referendum. The aim is to change the decision and postpone it.”

Mahmoud Ghozlan, the Muslim Brotherhood’s spokesman, said the opposition could stage protests, but should keep the peace.

“They are free to boycott, participate or say no, they can do what they want. The important thing is that it remains in a peaceful context to preserve the country’s safety and security.”

The army stepped into the conflict on Saturday, telling all sides to resolve their disputes via dialogue and warning that it would not allow Egypt to enter a “dark tunnel”.

A military source said the declaration read on state media did not herald a move by the army to retake control of Egypt, which it relinquished in June after managing the transition from Mubarak’s 30 years of military-backed one-man rule.

The draft constitution sets up a national defense council, in which generals will form a majority, and gives civilians some scrutiny over the army – although not enough for critics.

In August Mursi stripped the generals of sweeping powers they had grabbed when he was elected two months earlier, but has since repeatedly paid tribute to the military in public.

So far the army and police have taken a relatively passive role in the protests roiling the most populous Arab nation.

(Additional reporting by Edmund Blair and Yasmine Saleh; editing by Philippa Fletcher)

World News Headlines – Yahoo! News

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“X Factor” castoff Cheryl Cole files $2.3 million lawsuit against producers

LOS ANGELES (TheWrap.com) – Cheryl Cole, who was originally hired as a judge for the American version of “The X Factor” but was replaced by Pussycat Doll Nicole Scherzinger before the show premiered, is now suing the producers of the show for $ 2.3 million dollars, according to court papers obtained by TheWrap.

In the complaint against Blue Orbit Productions, filed in Los Angeles Superior Court, Girls Aloud singer Cole claims that she entered a pay-or-play agreement with Blue Orbit Productions in April 22, 2011, that guaranteed her $ 1.8 million for the first season of the show, and $ 2 million for the second.

The suit also says that Cole was also due to receive other expenses for housing, wardrobe, styling and general living expenses.

Cole claims that she received the $ 1.8 million for the first season, but the producers didn’t pony up for the wardrobe/styling allowance, housing allowance (which, according to the suit, was $ 15,000 per month) or living allowance.

She also didn’t receive her guaranteed $ 2 million for the second season, the suit claims.

Now Cole wants damages “in excess of $ 2.3 million,” plus interest at the legal rate, and court costs.

TheWrap was unable to reach Blue Orbit Productions for comment.

(Pamela Chelin contributed to this report)

TV News Headlines – Yahoo! News

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Freezing Breast Cancer Tumors Is Better Than Surgery

FIRST PERSON | Surgery for small breast cancer tumors may soon be a thing of the past. A new procedure called cryoablation turns a tumor into a ball of ice. Instead of undergoing surgery to remove the tumor, a doctor can now freeze it. I like that idea.

Freezing tumors

The Telegraph reported on Dec. 10 that doctors are looking into cyroablation as a viable alternative to breast cancer surgery. Cryoablation is available in the United States, but it’s not usually performed on breast cancer tumors. The procedure is simple: A needle is inserted into the tumor and causes it to freeze. There is no need to remove the tumor, as it dies and the body absorbs it.

The needle is hooked up to specialized equipment, which is cooled to a chilly -274 degrees Fahrenheit. A network of tiny tubes deliver liquid nitrogen to the needle, and the physician controls the size of the “ice ball” delivered to the tumor. This allows the doctor to freeze breast cancer tumors as large as a golf ball.

Alternatives to surgery are needed

If cryoablation could be used as an alternative to breast cancer surgery, it would be wonderful. I had two surgeries for breast cancer. The first was a wire-guided surgical biopsy to determine if the tumor was actually cancerous, and then I had a mastectomy of my left breast several months later.

It would have been great to have the choice to opt out of surgery and instead have the tumor frozen. I would still have my left breast, and breast reconstruction would not have been an issue. Instead of undergoing a surgery that took more than 12 hours, I would have had a 15-minute procedure in a doctor’s office. Recovery time from surgery was more than a month. Cryoablation has little to no recovery time.

Hopefully, cryoablation will become a reality for breast cancer patients. Not all women will fall into the guidelines for this procedure, but many will. The medical community should look for any means possible to prevent the disfiguring surgeries current breast cancer treatment requires.

Lynda Altman was diagnosed with breast cancer in November 2011. She writes a series for Yahoo! Shine called “My Battle With Breast Cancer.”

Diseases/Conditions News Headlines – Yahoo! News

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