FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

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Cyberattacks Bring Attention to Security Reform

Recent accusations of a large-scale cyber crime effort by the Chinese government left many wondering what immediate steps the president and Congress are taking to prevent these attacks from happening again.

On Wednesday, the White House released the administration's Strategy on Mitigating the Theft of U.S. Trade Secrets as a follow-up to the president's executive order. The strategy did not outwardly mention China, but it implied U.S. government awareness of the problem.

"We are taking a whole of government approach to stop the theft of trade secrets by foreign competitors or foreign governments by any means -- cyber or otherwise," U.S. Intellectual Property Enforcement Coordinator Victoria Espinel said in a White House statement.

As of now, the administration's strategy is the first direct step in addressing cybersecurity, but in order for change to happen Congress needs to be involved. So far, the Cyber Intelligence Sharing and Protection Act (CISPA) is the most notable Congressional legislation addressing the problem, despite its past controversy.

Last April, CISPA was introduced by House Intelligence Committee Chairman Mike Rogers, R-Mich., and Rep. Dutch Ruppersberger, D-Md. The act would allow private companies with consumer information to voluntarily share those details with the NSA and the DOD in order to combat cyber attacks.

Peter Parks/AFP/Getty Images

The companies would be protected from any liabilities if the information was somehow mishandled. This portion of the act sounded alarm bells for CISPA's opponents, like the ACLU, which worried that this provision would incentivize companies to share individuals' information with disregard.

CISPA passed in the House of Representatives, despite a veto threat from the White House stemming from similar privacy concerns. The bill then died in the Senate.

This year, CISPA was reintroduced the day after the State of the Union address during which the president declared an executive order targeting similar security concerns from a government standpoint.

In contrast to CISPA, the executive order would be initiated on the end of the government, and federal agencies would share relevant information regarding threats with private industries, rather than asking businesses to supply data details. All information shared by the government would be unclassified.

At the core of both the executive order and CISPA, U.S. businesses and the government would be encouraged to work together to combat cyber threats. However, each option would clearly take a different route to collaboration. The difference seems minimal, but has been the subject of legislative debates between the president and Congress for almost a year, until now.

"My response to the president's executive order is very positive," Ruppersberger told ABC News. "[The president] brought up how important information sharing is [and] by addressing critical infrastructure, he took care of another hurdle that we do not have to deal with."

Addressing privacy roadblocks, CISPA backers said the sharing of private customer information with the government, as long as personal details are stripped, is not unprecedented.

"Think of what we do with HIPAA in the medical professions; [doctors do not need to know] the individual person, just the symptoms to diagnose a disease," Michigan Gov. John Engler testified at a House Intelligence Committee hearing in an attempt to put the problem into context.

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Iran appears to advance in construction of Arak nuclear plant

VIENNA (Reuters) - Iran appears to be advancing in its construction of a research reactor Western experts say could offer the Islamic state a second way of producing material for a nuclear bomb, if it decided to embark on such a course, a U.N. report showed.

Iran has almost completed installation of cooling and moderator circuit piping in the heavy water plant near the town of Arak, the International Atomic Energy Agency (IAEA) said in a confidential report issued to member states late on Thursday.

Nuclear analysts say this type of reactor could yield plutonium for nuclear arms if the spent fuel is reprocessed, something Iran has said it has no intention of doing. Iran has said it "does not have reprocessing activities", the IAEA said.

In its previous report on Iran, in November, the Vienna-based U.N. agency said installation work at Arak was continuing, without giving any indication of how far advanced it was.

Iran rejects Western allegations it seeks to develop a capability to assemble nuclear weapons, saying its atomic program is entirely peaceful and that the Arak reactor will produce isotopes for medical and agricultural use.

Iran says it plans to begin operating the facility in the first quarter of 2014, the IAEA said. Tehran last year postponed the planned start-up from the third quarter of 2013, a target that Western experts said always had seemed unrealistic.

The Arms Control Association, a Washington-based research and advocacy group, said late last year that it was questionable whether Iran would be able to meet the new target date as well, in view of "significant delays and impeded access to necessary materials" because of international sanctions imposed on Iran.

Western worries about Iran are focused largely on uranium enrichment plants at Natanz and Fordow, as such material refined to a high level can provide the fissile core of an atomic bomb. But experts say Arak may also be a proliferation issue.

The Arak facility is a "growing source of concern", said Mark Fitzpatrick, director of the non-proliferation and disarmament program of the International Institute for Strategic Studies (IISS), a London-based think-tank.

Israel, believed to be the Middle East's only nuclear-armed state, sees Iran's nuclear program as a serious danger and has threatened to attack its atomic sites if diplomacy and sanctions fail to resolve the decade-old dispute.

If it does, the nuclear sites at Natanz, Fordow and Arak in central Iran are likely to be targets. Fitzpatrick said it could be Arak that triggers a conflict because attacking it after it is launched could cause an environmental disaster.

TESTING FUEL FOR ARAK REACTOR

Thursday's quarterly IAEA report showed Iran expanding its uranium enrichment program in defiance of tightening Western sanctions, installing advanced centrifuge machines at its main enrichment plant near the town of Natanz.

The report, issued just a few days before six world powers and Iran are due to resume negotiations after an eight-month hiatus, underlined the tough task facing the West in seeking to pressure Tehran to curb its nuclear activities.

Cliff Kupchan, Middle East director at the Eurasia consultancy, said Iran had adopted a defiant policy of pressing ahead with its nuclear program, despite harsh sanctions.

"As a result, Israel and the U.S. Congress will press a receptive U.S. administration to move forward with new and even harsher sanctions," he said in a research note.

Enriched uranium can fuel nuclear power plants, Iran's stated aim, but also provide the explosive core of a nuclear weapon if refined much further. Making plutonium from spent fuel is a second way of obtaining potential bomb material.

The Institute for Science and International Security (ISIS), a U.S. think-tank, noted that Iran planned to use a medical research reactor in Tehran, known as TRR, to test fuel for Arak.

"The TRR is now more than a medical isotope production reactor, Iran's stated use for the reactor, and is necessary for the operation" of Arak, it said in a report.

If operated optimally, the heavy-water plant could produce about nine kilograms (20 pounds) of plutonium a year, or enough for about two nuclear bombs annually, ISIS has said previously.

"Before it could use any of the plutonium in a nuclear weapon, however, it would first have to separate the plutonium from the irradiated fuel," it added on its website.

Iran has repeatedly declared it has no plans to reprocess the spent fuel. But, "similarly sized reactors ostensibly built for research" have been used by India, Israel, North Korea and Pakistan to make plutonium for weapons, Fitzpatrick said.

(Editing by Mark Heinrich)

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Eurozone facing recession right through 2013: EU

BRUSSELS: The eurozone faces another full year of recession in 2013 with unemployment likely to surge above the 20-million mark, and French and Spanish state spending badly overshooting targets, the EU said on Friday.

Economic output across the 17-state currency area is set to shrink by 0.3 percent this year after a 0.6-percent contraction last year, the European Commission said.

That means that millions more people are likely to lose their jobs, with already record unemployment expected to rise markedly right into 2014.

The EU's winter economic forecast said there would not be a return to growth for the debt-laden monetary union -- home to about 340 million people -- until 2014, when growth would return at a rate of 1.4-percent from this low base.

As a result, the unemployment rate would hit 12.2 percent for 2013 after 11.4 percent last year -- which left the number of people unemployed already at nearly 19 million.

Much of the attention was on France where the public deficit is set to be worse than expected in 2013 and 2014, veering up to 3.7 percent of output this year and 3.9 percent next year.

France, with the eurozone's second-biggest economy, was due this year to get back within the European Union's deficit ceiling of 3.0 percent of output, and had been expected to show a deficit of 3.5 percent of gross domestic product.

The gap leaves Socialist President Francois Hollande looking for special leeway from Brussels.

Spain's public deficit meanwhile exploded to 10.2 percent of output in 2012, the Commission said two days after Prime Minister Mariano Rajoy said it had fallen below 7.0 percent of GDP.

The figure for 2014 in the EU's latest economic forecasts would be 7.2 percent, Brussels also said -- although these figures may pre-date those of Rajoy, who said Madrid had avoided an economic "shipwreck" last year.

"We must stay the course of reform and avoid any loss of momentum," EU Economy and Euro commissioner Olli Rehn told a press conference, arguing that the drag on growth and uptick on joblessness was a natural consequence of "the ongoing rebalancing of the European economy."

Across the full, 27-state EU, which also includes Britain and Poland, growth is expected to be 0.1 percent this year and 1.6 percent next year, with the non-eurozone part doing better on unemployment too.

- AFP/al

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Hyderabad blasts: Shinde 'totally disappointing', opposition and UPA allies say

NEW DELHI: Home minister Sushilkumar Shinde on Friday came under sharp attack from opposition as well as UPA allies SP and DMK, which trashed his statement on Hyderabad blasts as "totally disappointing" and "devoid of any concrete and meaningful plan of action". Shinde made a statement in the House on Thursday's blasts saying government will make all possible efforts to apprehend the perpetrators and masterminds.

The opposition was, however, dissatisfied with the statement and accused the government of treating the issue of terror in a "very casual" manner. Leading the attack, BJP leader M Venkaiah Naidu said, "Government's policy seems to be condolence for the dead and compensation for those who survived."

Naidu also said that being a member of the House, Prime Minister Manmohan Singh should have come to the Rajya Sabha and made a statement taking the issue seriously.

The Rajya Sabha earlier witnessed acrimonious scenes as opposition members insisted on a debate before the home minister's statement on the issue. After the home minister read out his statement amid noisy scenes, the House witnessed a verbal spat between Shinde and Naidu with the BJP leader telling the minister that had he been serious on the issue, he would have rushed to the spot immediately after the occurrence last night and come to Parliament in morning.

Shinde countered it saying that after monitoring the issue for the whole night, he went to the spot at 4am drawing angry reactions from Naidu. "You have not done any favour to us. You have done your duty. The incident had happened at 7pm on Thursday. You should have gone there at 8 pm and come back by the morning. That shows your seriousness," Naidu said, who later staged a walkout for a brief period.

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Flu shot doing poor job of protecting older people

ATLANTA (AP) — It turns out this year's flu shot is doing a startlingly dismal job of protecting older people, the most vulnerable age group.

The vaccine is proving only 9 percent effective in those 65 and older against the harsh strain of the flu that is predominant this season, the Centers for Disease Control and Prevention said Thursday.

Health officials are baffled as to why this is so. But the findings help explain why so many older people have been hospitalized with the flu this year.

Despite the findings, the CDC stood by its recommendation that everyone over 6 months get flu shots, the elderly included, because some protection is better than none, and because those who are vaccinated and still get sick may suffer less severe symptoms.

"Year in and year out, the vaccine is the best protection we have," said CDC flu expert Dr. Joseph Bresee.

Overall, across the age groups studied, the vaccine's effectiveness was found to be a moderate 56 percent, which means those who got a shot have a 56 percent lower chance of winding up at the doctor with the flu. That is somewhat worse than what has been seen in other years.

For those 65 and older, the vaccine was only 27 percent effective against the three strains it is designed to protect against, the worst level in about a decade. It did a particularly poor job against the tough strain that is causing more than three-quarters of the illnesses this year.

It is well known that flu vaccine tends to protect younger people better than older ones. Elderly people have weaker immune systems that don't respond as well to flu shots, and they are more vulnerable to the illness and its complications, including pneumonia.

But health officials said they don't know why this year's vaccine did so poorly in that age group.

One theory, as yet unproven, is that older people's immune systems were accustomed to strains from the last two years and had more trouble switching gears to handle this year's different, harsh strain.

The preliminary data for senior citizens is less than definitive. It is based on fewer than 300 people scattered among five states.

But it will no doubt surprise many people that the effectiveness is that low, said Michael Osterholm, a University of Minnesota infectious-disease expert who has tried to draw attention to the need for a more effective flu vaccine.

Among infectious diseases, flu is considered one of the nation's leading killers. On average, about 24,000 Americans die each flu season, according to the CDC.

This flu season started in early December, a month earlier than usual, and peaked by the end of year. Hospitalization rates for people 65 and older have been some of the highest in a decade, at 146 per 100,000 people.

Flu viruses tend to mutate more quickly than others, so a new vaccine is formulated each year to target the strains expected to be the major threats. CDC officials have said that in formulating this year's vaccine, scientists accurately anticipated the strains that are circulating this season.

Because of the guesswork involved, scientists tend to set a lower bar for flu vaccine. While childhood vaccines against diseases like measles are expected to be 90 or 95 percent effective, a flu vaccine that's 60 to 70 percent effective in the U.S. is considered pretty good. By that standard, this year's vaccine is OK.

For senior citizens, a flu vaccine is considered pretty good if it's in the 30 to 40 percent range, said Dr. Arnold Monto, a University of Michigan flu expert.

A high-dose version of the flu shot was recently made available for those 65 and older, but the new study was too small to show whether that has made a difference.

The CDC estimates are based on about 2,700 people who got sick in December and January. The researchers traced back to see who had gotten shots and who hadn't. An earlier, smaller study put the vaccine's overall effectiveness at 62 percent, but other factors that might have influenced that figure weren't taken into account.

The CDC's Bresee said there is a danger in providing preliminary results because it may result in people doubting — or skipping — flu shots. But the figures were released to warn older people who got shots that they may still get sick and shouldn't ignore any serious flu-like symptoms, he said.

___

Online:

CDC report: http://www.cdc.gov/mmwr

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Arias Challenged On Pedophilia Claim

Accused murderer Jodi Arias was challenged today by phone records, text message records, and her own diary entries that appeared to contradict her claim that she caught her ex-boyfriend, Travis Alexander, looking at pictures of naked boys.

Arias had said during her testimony that one afternoon in January 2008, she walked in on Alexander masturbating to pictures of naked boys. She said she fled from the home, threw up, drove around aimlessly, and ignored numerous phone calls from Alexander because she was so upset at what she had seen.

The claim was central to the defense's accusation that Alexander was a "sexual deviant" who grew angry and abusive toward Arias in the months after the incident, culminating in a violent confrontation in June that left Alexander dead.

Arias claimed she killed him in self-defense. She could face the death penalty if convicted of murder.

Catching Up on the Trial? Check Out ABC News' Jodi Arias Trial Coverage

Today, prosecutor Juan Martinez, who has been aggressive in questioning witnesses throughout the trial, volleyed questions at her about the claim of pedophilia, asking her to explain why her and Alexander's cell phone records showed five calls back and forth between the pair throughout the day she allegedly fled in horror. Some of the calls were often initiated Arias, according to phone records.

Jodi Arias Doesn't Remember Stabbing Ex-Boyfriend Watch Video

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She and Alexander also exchanged text messages throughout the afternoon and evening at a time when Arias claims the pedophilia incident occurred. In those messages they discuss logistics of exchanging one another's cars that night. Alexander sends her text messages about the car from a church social event he attended that night that she never mentioned during her testimony.

Arias stuck by her claim that she saw Alexander masturbating to the pictures, and her voice remained steady under increasingly-loud questioning by Martinez.

But Martinez also sparred with Arias on the stand over minor issues, such as when he asked Arias detailed questions about the timing and order of events from that day and Arias said she could not remember them.

"It seems you have problems with your memory. Is this a longstanding thing? Since you started testifying?" Martinez asked.

"No it goes back farther than that. I don't know even know if I'd call it a problem," Arias said.

"How far back does it go? You don't want to call them problems, are they issues? Can we call them issues? When did you start having them?" he asked in rapid succession. "You say you have memory problems, that it depends on the circumstance. Give me the factors that influence that."

"Usually when men like you or Travis are screaming at me," Arias shot back from the stand. "It affects my brain, it makes my brain scramble."

"You're saying it's Mr. Martinez's fault?" Martinez asked, referring to himself in the third person.

"Objection your honor," Arias' attorney finally shouted. "This is a stunt!"

Timeline of the Jodi Arias Trial

Martinez dwelled at one point about a journal entry where Arias wrote that she missed the Mormon baptism of her friend Lonnie because she was having kinky sex with Alexander. He drew attention to prior testimony that she and Alexander used Tootsie Pops and Pop Rocks candy as sexual props.

"You're trying to get across (in the diary entry) that this involved a sexual liaison with Mr. Alexander right?" he asked. "And you're talking about Tootsie Pops and Pop Rocks?"

"That happened also that night," Arias said.

"You were there, enjoying it, the Tootsie Pops and Pop Rocks?" he asked again, prompting a smirk from Arias.

"I enjoyed his attention," Arias said.

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French hostages seized in Cameroon found safe: report

PARIS (Reuters) - Seven French hostages kidnapped in Cameroon have been found alive in a house in northern Nigeria and are safe with Nigerian authorities, French television reported on Thursday.

The hostages, four children and three adults, were captured by Islamist militants this week while on a tourist excursion to the Waza national park near the Nigerian border with Cameroon.

It was the first case of foreigners being seized in the mainly Muslim north of Cameroon, a former French colony, but the region is considered within the operational sphere of Islamist sect Boko Haram and fellow Nigerian Islamist militants Ansaru.

"The hostages are safe and sound and are in the hands of Nigerian authorities," BFMTV quoted an officer from Cameroon's army as saying.

France's minister for veterans' affairs, who told parliament on Thursday that seven hostages abducted from Cameroon had been released, said minutes later there was no official confirmation that they had been freed.

A French diplomatic source said there would be no official confirmation until French authorities had received physical proof the hostages had been freed or they were in French hands.

(Reporting By Emile Picy and Nicholas Vinocur in Paris; Additional reporting by Joe Brock in Abuja; Editing by Pravin Char)

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Man who drowned in NUS pool unlikely to survive despite resuscitation

SINGAPORE: A man who drowned in a pool at the National University of Singapore (NUS) in 2007, would likely not have survived despite resuscitaton efforts, according to a cardiologist during a court hearing on Thursday.

40-year-old Roland Yeo, who was an IT manager with NUS, drowned after suffering a sudden heart attack in the university's pool on June 6, 2007.

His wife is seeking S$1 million in damages from NUS after claiming the university was negligent.

Dr Michael Lim Chun Leng, a medical director with Singapore Heart, Stroke and Cancer Centre, took the stand on Thursday as an expert witness.

He told the court that Yeo had an underlying heart problem where there was "severe" damage of his heart muscle and impairment of the heart pump function.

Coupled with waterlogged lungs, Dr Lim said that Yeo "really had no chance of survival in an acute event."

The court heard that Yeo, a father of two, was a regular swimmer who could "outswim" his friends.

On that fatal day, Yeo had finished more than seven laps when he ran into difficulty.

He was spotted struggling and was semi-conscious when pulled out of the pool.

Efforts by lifeguards to revive him failed and he was later pronounced dead at the National University Hospital.

But Dr Lim emphasised that any resuscitation efforts by lifeguards or using an automated external defibrillator (AED) would have made little difference.

He noted that the exercise could have precipitated the heart attack, as there was not enough oxygen sent to the vital organs.

NUS is contesting the lawsuit and has named the pool operators, Hydro Aquatic Swimming School, as the second defendant.

The operators have in turn included their insurers Overseas Assurance Corporation in the suit to indemnify them for any liabilities.

The case continues on Friday.

- CNA/de

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SC sets up special team to examine contents of Radia tapes

NEW DELHI: A six-member special team comprising five from the CBI and one from the Income Tax department was today constituted by the Supreme Court to examine the contents of tapped telephonic conversations of corporate lobbyist Niira Radia with politicians, corporate honchos and others.

A bench comprising justices G S Singhvi and S J Mukhopadhaya said the working of the team will be supervised by two officers of the CBI who will report to Superintendent of Police, CBI dealing with the 2G matter.

The bench said that the overall supervision will be under the Deputy Inspector General, CBI who is looking after the case.

The bench said that the team shall submit its report in four months from today.

The apex court on February 13 had sought names of officials of CBI, IT department and the Enforcement Directorate for setting up of a team to enquire into the tapped telephonic conversations of Radia with others to ascertain element of criminality.

The court had earlier said that it had gone through some of the tapped conversations and some of them were "innocuous" and hence, the voluminous transcripts were needed to be "scrutinised" to find out elements of "criminality" in them.

It had also made clear that the scrutiny would be limited to those conversations which pertain to criminal element and relating to interest of justice.

Earlier, senior advocate Harish Salve, appearing for Ratan Tata, had submitted that "utmost secrecy" be maintained in the scrutiny of transcripts.

He was referring to various conversations that took place between Tata and Radia which are allegedly personal in nature.

"There are some conversations in public domain and those are hardly personal in nature. They relate to illegality and shed significant light on how government decisions are being influenced and how institutions run in the country," Prashant Bhushan, appearing for Centre for Public Interest Litigation, had said.

Excerpts from the tapes earlier leaked in the media had sparked a political storm with the conversations bringing out the nature of corporate lobbying and also its purported impact on politics.

The income tax department placed transcripts of 5,800 tapped telephone conversations in 50 sealed envelopes.

The conversations were recorded as part of surveillance of Radia's phone on a complaint to Finance Minister on November 16, 2007 alleging that within a span of nine years she had built up a business empire worth Rs 300 crore.

The government had recorded 180 days of Radia's conversations--first from August 20, 2008 onwards for 60 days and then from October 19 for another 60 days. Later, on May 11, 2009, her phone was again put on surveillance for another 60 days following a fresh order given on May 8.

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