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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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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Fed ties rates to jobs recovery, adds to stimulus

WASHINGTON (Reuters) – The U.S. Federal Reserve, announcing a new round of monetary stimulus, took the unprecedented step on Wednesday of indicating interest rates would remain near zero until unemployment falls to at least 6.5 percent.

It was the latest in a series of unorthodox measures taken by central banks around the world to battle erratic, sub-par recoveries from the financial crisis and recession of 2007-2009.

The Fed expects to hold rates steady until its new threshold on unemployment was reached as long as inflation does not threaten to break above 2.5 percent and inflation expectations are contained. It also replaced an expiring stimulus program with a fresh round of Treasury debt purchases.

The central bank previously said it expected to hold rates near zero through at least mid-2015, but policymakers were uncomfortable making a pledge based on the calendar rather than the economic goals they hope to achieve.

“By tying future monetary policy more explicitly to economic conditions, this formulation of our policy guidance should … make monetary policy more transparent and predictable to the public,” Fed Chairman Ben Bernanke told a news conference.

Importantly, in the eyes of Fed officials, the new framework should help financial markets assess incoming data in a way that helps them better guess were monetary policy is heading.

Right now, the Fed is engaged in an open-ended program of asset purchases, which it bolstered on Wednesday.

Officials committed to buy $ 45 billion in longer-term Treasuries each month on top of the $ 40 billion per month in mortgage-backed bonds they started purchasing in September. They repeated a pledge to keep pumping money into the economy until the outlook for the labor market improves “substantially.”

“The committee remains concerned that, without sufficient policy accommodation, economic growth might not be strong enough to generate sustained improvement in labor market conditions,” the Fed’s policy-setting panel said after a two-day meeting.

BALANCE SHEET ACTION

The Fed will fund the new Treasury purchases with an expansion of its $ 2.8 trillion balance sheet. Under the expiring “Operation Twist” program, the Fed bought an identical amount, but paid for them with proceeds from sales and redemptions of short-term debt.

Some policymakers view actions that expand the Fed’s balance sheet as economically more potent than actions that do not. However, Bernanke said the dose of stimulus would remain about the same, given that the central bank is still purchasing a combined $ 85 billion per month in longer-term securities.

“They see an anemic economy, and they’re doing all they can to get any economic progress,” said Alan Lancz, president of Alan B. Lancz & Associates in Toledo, Ohio.

The Fed’s decision initially gave a small lift to U.S. stock prices, but the major indexes closed mostly unchanged, while government bond prices fell. Oil prices rose and the dollar weakened against the euro.

Fed policymakers voted 11-1 to back the new plan. Jeffrey Lacker, president of the Richmond Federal Reserve Bank, dissented, as he has at every meeting this year, expressing opposition both to the bond buying and the new economic thresholds.

SWEATING A WEAK RECOVERY

The newly unveiled numerical policy guidelines offered the most specific suggestion yet that the Fed is willing to tolerate slightly higher inflation as it tries to juice up a moribund economy and spur stronger job growth.

A drop in the unemployment rate to 7.7 percent in November from 7.9 percent in October was driven by workers exiting the labor force, and therefore did not come close to satisfying the condition the Fed has set for trimming its stimulus.

In response to the financial crisis and recession, the Fed slashed overnight rates to zero almost exactly four years ago and bought some $ 2.4 trillion in mortgage and Treasury securities to keep long-term rates down.

Despite its unconventional and aggressive efforts, U.S. economic growth remains tepid. Gross domestic product grew at a 2.7 percent annual rate in the third quarter, but a Reuters poll published on Wednesday showed economists expect it to expand at just a 1.2 percent pace in the current quarter.

Businesses have hunkered down, fearful of a tightening of fiscal policy as politicians in Washington wrangle over ways to avoid a $ 600 billion mix of spending reductions and expiring tax cuts set to take hold at the start of 2013.

Bernanke has warned that running over this “fiscal cliff” would lead to a new recession. He told reporters the Fed could ramp up its bond buying “a bit,” but emphasized that monetary policy has limits and could not fully offset the impact.

NEW TACK ON RATES

He said the central bank would look at a range of indicators, not just the rates of unemployment and inflation, in determining when to finally push overnight borrowing costs higher, adding that the Fed was not on “auto pilot.”

“Reaching the thresholds will not immediately trigger a reduction in policy accommodation,” Bernanke said. “No single indicator provides a complete assessment of the state of the labor market.”

Bernanke said the new framework was consistent with the earlier calendar guidance, because officials do not expect the jobless rate to reach 6.5 percent until sometime in 2015.

Indeed, a fresh set of economic projections from the Fed put the rate in a 6 percent to 6.6 percent range in the fourth quarter of 2015. At the same time, the projections showed that at no point over that forecast horizon does the central bank see inflation topping its 2 percent target.

Officials held to their assessment that they could eventually push the unemployment rate down to a 5.2 percent to 6 percent range without sparking inflation, although Bernanke cautioned that policy would have to start tightening before it fell so low. In its statement, the Fed said its long-term asset purchase program would end well before any rate increase.

Fed policymakers see GDP expanding between 2.3 percent and 3.0 percent next year. That is down from the 2.5 percent to 3.0 percent they forecast in September, but is still a bit more optimistic than most private forecasters. The Reuters poll of economists found a median U.S. growth estimate of 2.1 percent for next year.

(Writing by Pedro Nicolaci da Costa; Editing by Andrea Ricci, Tim Ahmann, Leslie Adler and Andre Grenon)

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The Hobbit: Richard Armitage Talks Preparations For Playing Thorin Oakenshield

British actor Richard Armitage admitted it wasn’t a walk in the park to play a J.R.R. Tolkien character in Peter Jackson’s reimagining of “The Hobbit,” the first installment of which is on its way into theaters.

Upon touching down in New Zealand, where the trilogy was shot, the cast had a lot of character preparation to do.

PLAY IT NOW: Martin Freeman Discusses The Hobbit’s ‘Good Chemistry’ & Playing Bilbo Baggins

“We arrived in February 2011 and we went straight into a training program, which was called ‘Dwarf Bootcamp,’ which was literally boots — these huge boots. We learned how to walk, we wrestled with each other, we did archery together, we did sword fighting, hammer fighting, horse riding — everything you could possibly think of,” Richard, who plays Thorin Oakenshield in the film told Access Hollywood at the film’s junket.

In addition, the cast, which includes his former “Cold Feet” co-star James Nesbitt as Bofur, found ways to get to know each other better off set.

VIEW THE PHOTOS: The Hobbit: An Unexpected Journey — New York City Premiere

“We went round to each other’s houses and we cooked food together, we went to the pub and got drunk together, so there was an incredibly great bonding time between the dwarves,” he said.

Richard had plenty of experience sword fighting and horse riding in the BBC America series “Robin Hood,” but it was something else that came in handy during the long days on set.

“I’d done a number of shows where I’d had to use sword fighting and I’d also done horse riding. I’d also pulled guns out of my pocket. That was less useful,” he laughed, likely referring to his recent role in the PBS-import series “MI-5,” where he played a British spy. “But, yeah, you draw on everything. I’d worked at the Royal Shakespeare Company, so the vocal work was really useful to kind of pull that from there. I’d worked in a circus, there were… all sorts of things that were really useful, but the one thing that I do have — for lack of talent — is stamina and that’s the one thing I think everybody needed on this job.”

VIEW THE PHOTOS: Meet ‘The Hobbit’ Cast!

An imagination was useful also, but Richard said what turned out on the big screen was still wilder – and more beautiful – than he dreamed of.

“So many moments… Actually, apart from the eagles — which every single time I’ve seen this film absolutely blows my mind and I can barely keep the tears back and [it has] nothing to do with the pathos of the scene, just that feeling of flight moves me — is the throne of Aragorn, in the beginning of the prologue,” he told Access of the moment that moved him most. “When it got to [filming] that scene, I walked on and… it was just a green cross on the floor with a tiny green chair… [But in the film], they just made this incredible, almost space aged, sort of suspended seat in the middle of this stalagmite. It just blows my mind when I see that.”

VIEW THE PHOTOS: The Brit Pack: Hot Shots Of Stars From The UK!

“The Hobbit: An Unexpected Journey” hits theaters on December 14, 2012, followed by “The Hobbit: The Desolation of Smaug,” on December 13, 2013 and “The Hobbit: There and Back Again,” on July 18, 2014.

– Jolie Lash

Copyright 2012 by NBC Universal, Inc. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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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)

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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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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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Asia stocks gain, unfazed by NKorea rocket launch

BANGKOK (AP) — Asian stock markets rose Wednesday as a German business confidence survey alleviated concerns that Europe’s largest economy might fall into recession. Investors brushed off North Korea‘s latest test launch of a long-range rocket.

The ZEW indicator of economic sentiment defied expectations by rising to plus 6.9 points, from minus 15.7 in November. Markets had expected the index to remain mired in negative numbers. Germany’s economy grew a modest 0.2 percent in the third quarter and expectations are for another weak quarter in the last three months of the year.

Wolfgang Franz, head of the ZEW, or Centre for European Economic Research, said Tuesday the survey showed that Germany isn’t facing recession unless the debt crisis afflicting euro countries reignites.

Japan protested North Korea’s launch of a rocket and was convening its security council to analyze the situation. Rocket tests are seen as crucial to advancing North Korea’s nuclear weapons ambitions. Officials in Washington, Seoul, Tokyo and elsewhere have been urging North Korea to cancel the liftoff.

Despite the launch, Japan’s Nikkei 225 index rose 0.5 percent to 9,570.08. Hong Kong’s Hang Seng added 0.6 percent to 22,446.36. South Korea’s Kospi gained 0.2 percent to 1,969.26. Australia’s S&P/ASX 200 added 0.3 percent to 4,592.40.

Among individual stocks, shares of Australian mining giant BHP Billiton rose 1.2 percent after the company announced it has agreed to sell its stake in a proposed Australian gas project to Chinese state-owned energy producer PetroChina for $ 1.6 billion.

Traders also are watching the U.S. Federal Reserve, which began a two-day policy meeting Tuesday. Some economists expect the Fed to Wednesday announce a new bond-buying program, or quantitative easing, to boost the economy.

Wall Street Tuesday as investors hoped U.S. leaders would eventually thrash out a budget deal needed to keep a slew of tax increases and spending cuts from hitting the world’s largest economy. The longer a U.S. deal fails to emerge to avoid the so-called “fiscal cliff” of automatic tax increases and spending cuts at the start of next year, the more fidgety investors are likely to become.

The Dow Jones industrial average rose 0.6 percent to 13,248.44. The S&P 500 gained 0.7 percent to 1,427.84. The Nasdaq composite index rose 1.2 percent to 3,022.30

Benchmark crude for January delivery was up 19 cents to $ 85.98 per barrel in electronic trading on the New York Mercantile Exchange. The contract rose 23 cents to close at $ 85.79 per barrel on the Nymex on Tuesday.

In currencies, the euro rose to $ 1.3009 from $ 1.3003 late Tuesday in New York. The dollar rose to 82.55 yen from 82.50 yen.

___

Follow Pamela Sampson on Twitter at http://twitter.com/pamelasampson

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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)

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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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