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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Man charged with outraging modesty of girl

SINGAPORE: A man has been charged with outraging the modesty of a 16-year-old girl.

Toh Boon Cheong, 52, is accused of rubbing his groin area against the girl's hip on board the MRT train travelling from Choa Chu Kang station to Bukit Gombak station.

The alleged incident occurred on 15 January, at about 6:50am.

If convicted, Toh faces up to two years' jail and caning.

- CNA/ck

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Hyderabad bomb blast: Rajnath to meet families of blast victims

NEW DELHI: BJP president Rajnath Singh will visit Hyderabad on Friday to meet the injured and family members of those killed in the twin blasts in the city.

Rajnath, accompanied by BJP MP and spokesperson Shahnawaz Hussain and party secretary Murlidhar Rao, is likely to visit the Dilsukhnagar area of Hyderabad where the two blasts took place on Thursday evening.

The BJP leaders will also visit the hospitals where the injured are being treated and later meet the kin of those killed.

In a statement issued on Thursday, Singh had condoled the death of innocent people in the blast and demanded that immediate steps be taken to provide relief to the injured.

14 people were killed and 110 injured, six of them critically when two powerful near simultaneous blasts ripped through a crowded area close to a cluster of bus stands in Dilsukhnagar area in Hyderabad on Thursday.

The blasts triggered by improvised explosive devices (IED) tied to two bicycles took place at two sites 100 metres apart outside a roadside eatery near Konark and Venkatadiri theatres in the area located on the Hyderabad-Vijaywada National Highway in Cyberabad police limits.

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APNewsBreak: Govs to hear Oregon health care plan

SALEM, Ore. (AP) — Oregon Gov. John Kitzhaber will brief other state leaders this weekend on his plan to lower Medicaid costs, touting an overhaul that President Barack Obama highlighted in his State of the Union address for its potential to lower the deficit even as health care expenses climb.

The Oregon Democrat leaves for Washington, D.C., on Friday to pitch his plan that changes the way doctors and hospitals are paid and improves health care coordination for low income residents so that treatable medical problems don't grow in severity or expense.

Kitzhaber says his goal is to win over a handful of other governors from each party.

"I think the politics have been dialed down a couple of notches, and now people are willing to sit down and talk about how we can solve the problem" of rising health care costs, Kitzhaber told The Associated Press in a recent interview.

Kitzhaber introduced the plan in 2011 in the face of a severe state budget deficit, and he's been talking for two years about expanding the initiative beyond his state. Now, it seems he's found people ready to listen.

Hospital executives from Alabama visited Oregon last month to learn about the effort. And the U.S. Department of Health and Human Services announced Thursday that it's giving Oregon a $45 million grant to help spread the changes beyond the Medicaid population and share information with other states, making it one of only six states to earn a State Innovation Model grant.

Kitzhaber will address his counterparts at a meeting of the National Governors Association. His talk isn't scheduled on the official agenda, but a spokeswoman confirmed that Kitzhaber is expected to present.

"The governors love what they call stealing from one another — taking the good ideas and the successes of their colleagues and trying to figure out how to apply that in their home state," said Matt Salo, director of the National Association of Medicaid Directors.

There's been "huge interest" among other states in Oregon's health overhaul, Salo said, not because the concepts are brand new, but because the state managed to avoid pitfalls that often block health system changes.

Kitzhaber persuaded state lawmakers to redesign the system of delivering and paying for health care under Medicaid, creating incentives for providers to coordinate patient care and prevent avoidable emergency room visits. He has long complained that the current financial incentives encourage volume over quality, driving costs up without making people healthier.

Obama, in his State of the Union address this month, suggested that changes such as Oregon's could be part of a long-term strategy to lower the federal debt by reigning in the growing cost of federally funded health care.

"We'll bring down costs by changing the way our government pays for Medicare, because our medical bills shouldn't be based on the number of tests ordered or days spent in the hospital — they should be based on the quality of care that our seniors receive," Obama said.

The Obama administration has invested in the program, putting up $1.9 billion to keep Oregon's Medicaid program afloat over the next five years while providers make the transition to new business models and incorporate new staff and technology.

In exchange, though, the state has agreed to lower per-capita health care cost inflation by 2 percentage points without affecting quality.

The Medicaid system is unique in each state, and Kitzhaber isn't suggesting that other states should adopt Oregon's specific approach, said Mike Bonetto, Kitzhaber's health care policy adviser. Rather, he wants governors to buy into the broad concept that the delivery system and payment models need to change.

That's not a new theory. But Oregon has shown that under the right circumstances massive changes to deeply entrenched business models can gain wide support.

What Oregon can't yet show is proof the idea is working — that it's lowering costs without squeezing on the quality or availability of care. The state is just finishing compiling baseline data that will be used as a basis of comparison.

One factor driving the Obama administration's interest in Oregon's success is the president's health care overhaul. Under the Affordable Care Act, millions more Americans will join the Medicaid rolls after Jan. 1, and the health care system will have to be able to absorb the influx of patients in a logistically and financially sustainable way.

The federal government will pay 100 percent of the costs for those additional patients in the first three years before scaling back to 90 percent in 2020 and beyond.

"There are a lot of governors who are facing the same challenges we're facing in Oregon," Kitzhaber said. "They recognize that the cost of health care is something they're going to have to get their arms around."

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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

Jodi Arias Murder Trial: Testimony About Ex's Death Watch Video

Arias on Ex-Boyfriend's Death: 'I Don't Remember' Watch Video

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 general urges EU to equip "impoverished" Mali army

BAMAKO, Mali (Reuters) - The European Union should complement a mission to train Mali's army, routed by rebels last year, by providing equipment from uniforms to vehicles and communications technology, a French general said on Wednesday.

General Francois Lecointre, appointed to head the EU training mission to Mali (EUTM) that was formally launched this week, said in Bamako equipping the "very impoverished" and disorganized Malian army was as important as training it.

Europe, along with the United States, has backed the French-led military intervention in Mali which since January 11 has driven al Qaeda-allied Islamist insurgents out of the main northern towns into remote mountains near Algeria's border.

European governments have ruled out sending combat troops to join French and African soldiers pursuing the Islamist rebels.

But the EU is providing a 500-strong multinational training force that will give military instruction to Malian soldiers for an initial period of 15 months at an estimated cost of 12.3 million euros ($16.45 million).

While hailing what he called the EU's "courageous, novel, historic" decision to support Mali, Lecointre told a news conference the Malian army's lack of equipment was a problem.

"I know the Malian state is poor, but the Malian army is more than poor," the French general told a news conference, adding that it urgently needed everything from uniforms and weapons to vehicles and communications equipment.

Last year, when Tuareg separatist forces swelled by weapons and fighters from the Libyan conflict swept out of the northern deserts, a demoralized and poorly-led Malian army collapsed and fled before them, abandoning arms and vehicles.

Mali's military was further shaken by a March 22 coup by junior officers who toppled President Amadou Toumani Toure, sowing division among rival army factions. Islamist radicals allied to al Qaeda later hijacked the victorious Tuareg rebellion to occupy the northern half of the country.

In a fast-charging military campaign led by Paris, French and African troops have driven the jihadists out of principal northern towns like Gao and Timbuktu, and are fighting the rebels in the Adrar des Ifoghas mountains.

HUMAN RIGHTS INSTRUCTION

Flanked by Mali's armed forces chief, General Ibrahima Dembele, Lecointre said he was disappointed that a meeting of international donors last month pledged funds for an African military force, known as AFISMA, being deployed in Mali, but included "very few" contributions for the Malian army itself.

"The European Union needs to invest today in the equipping of the Malian army and not just in its training," the general said, adding he would make this point strongly in a report to EU member state representatives early next month.

Asked how much re-equipping the army would cost, he said it would be "much more" than the 12 million euros of EU financing for the training mission, but could not give a precise estimate.

Starting early in April, the EU mission will start instructing Malian soldiers with a plan to train four new battalions of 600-700 members each, formed from existing enlisted men and new recruits.

Lecointre said the EU training would include instruction in human rights. Demands for this increased after allegations by Malian civilians and international human rights groups that Malian soldiers were executing Tuaregs and Arabs accused of collaborating with Islamist rebels.

The European training contingent is drawn from a range of European countries, but the main contributors would be France, Germany, Italy, Spain and Britain, EUTM officers said.

Mali's army has received foreign training before - several battalions that fled before the rebels last year were trained by the U.S. military and the leader of the March 22 coup, Captain Amadou Sanogo, attended training courses in the United States.

Dembele said U.S. training failed to forge cohesion among Malian units and he hoped the EU training would achieve this.

The United States, which halted direct support for the Malian military after last year's coup, could eventually resume aid if planned national elections in July fully restore democracy to the West African country.

Washington is providing airlift, refuelling and intelligence support to the French-led military intervention in Mali. ($1 = 0.7479 euros)

(Reporting by Pascal Fletcher; Editing by Jason Webb)

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Del Piero signs for second season Down Under

MELBOURNE: Italian World Cup winner Alessandro Del Piero has signed on for a second season in Australia's A-League as his Sydney FC side push for a play-off place.

"I'm very happy about this news," the Juventus and Italy legend told a press conference after agreeing to activate the second year of a reported US$2 million-a-season contract.

"For sure it's a great moment for me, for Sydney FC," he said, thanking the club for trusting him.

The 38-year-old said he would not carry on if he could not play at a high level.

"In my age, I want to be very honest. We have to see year by year."

Del Piero has already scored 11 goals in 18 matches, a record haul by a Sydney FC player in a single season and been a hit off the pitch too, helping to boost crowds, shirt sales and television ratings.

Sydney FC has fought back from the bottom of the league to fifth place -- within reach of qualification for the playoffs, largely thanks to Del Piero's goals.

"We have a good position but it's not enough, we have six games remaining but we have to push our energy to take a play-off," he said.

"We want to improve for the next year and do better and better every week," he added.

The team's charge for the finals gathered steam, with a 2-1 win over Adelaide United following the signing of Socceroos captain Lucas Neill on Saturday.

An early-season collapse was halted by the December arrival of former Australia coach Frank Farina, quickly turning Sydney FC into the form team.

- AFP/sf

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Day 2 of nationwide strike: Cops on alert in Noida; several states affected

NEW DELHI: Normal life in several parts of the country continued to remain affected on Day 2 of the nationwide strike called by the trade unions.

Cops in Noida are on high alert, after widespread violence on the first day of the strike. According to TV reports, several schools and offices in Noida have been closed.

The UP government has formed a two-member panel to probe the violence in Noida on the first day of the two-day nationwide shutdown.

The state government late on Wednesday named additional director general of police (Law and Order) Arun Kumar and home secretary Rakesh as members of the probe committee and asked them to submit a fact finding report within three days.

Principal secretary (Home) RM Srivastava told IANS that "toughest action" would be taken against those found guilty of violence.

The committee has been asked to look into the state of preparedness of the Noida police to handle the shutdown and identify district officials guilty of dereliction of duty.

"The government has taken a serious note of the whole episode, wherein properties were gutted, people were beaten up and several vehicles were set on fire. There should be no doubt that the government would crack down on all found guilty," Srivastava said.

Violence erupted on Wednesday in Noida and Greater Noida where factories were targeted and set on fire. Violent clashes took place and several vehicles were set afire.

Officials have started screening the video footage of the violence in order to identify and book the perpetrators.

"We are also exploring possibilities of slapping the National Security Act (NSA) on the rioters," a senior official said.

State government sources said chief minister Akhilesh Yadav was particularly miffed at the Noida violence as he views it as a big blow to his efforts to create a pro-investment climate in Uttar Pradesh.

"The chief minister has taken a serious note of the clashes as it could send a wrong signal that industries are not safe in UP," an official said.

Bank operations hit

Normal banking operations were hit for the second day on Thursday as public sector bank employees continued their strike.

It is, however, business as usual at private sector banks like ICICI Bank and HDFC Bank.

Employees of public sector insurance companies, including LIC and New India Assurance, are also participating in the strike.

Shutdown in Kerala

In Kerala, workers from most sectors ranging from transport to banking keeping away from work.

Reports from across the state said buses and taxis were off the roads and markets remained shut. Train and air services were not affected.

Attendance in government offices was thin and educational institutions remained closed as pro-Left service and teachers unions joined the strike. Universities have cancelled examinations scheduled for the last two days.

Barring stray incidents of minor violence, the state has remained peaceful since Wednesday.

Police in their vehicles facilitated the short-distance travels of train and air passengers, who arrived in the state unaware of the hartal atmosphere.

Emergency services like healthcare, milk supply and media have been exempted from the strike.

Schools, colleges closed in Karnataka

The two-day nationwide strike by trade unions had no major impact in most parts of Karnataka on Thursday.

Though banking services were hit, many buses, taxis and autos plied and shops and hotels remained opened here. However, schools and colleges were closed.

No violence was reported from any part of the state, police said.

Services at many hospitals in the city were not hit, as also in IT companies. Several PSUs including HAL, BHEL and BEL, besides a host of other industrial units in Bangalore were functioning normally.
No impact in Mangalore

In Mangalore, however, there has been no effect of strike on Day 2. The buses are plying normally and the schools are functioning as usual.

(With inputs from PTI, IANS)

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Doc groups issue list of overused tests, therapies

WASHINGTON (AP) — Don't be afraid to question your doctor and ask, "Do I really need that?"

That's the advice from leading medical groups who came up dozens of tests and treatments that physicians too often prescribe when they shouldn't.

No worrisome stroke signs? Then don't screen a healthy person for a clogged neck artery, the family physicians say. It could lead to risky surgery for a blockage too small to matter.

Don't routinely try heartburn medicine for infants with reflux, the pediatric hospitalists say. It hasn't been proven to work in babies, and could cause side effects.

Don't try feeding tubes in people with advanced dementia, say the hospice providers. Helping them eat is a better option.

These are examples of potentially needless care that not only can waste money and time, but sometimes can harm, says the warning being issued Thursday from medical specialty groups that represent more than 350,000 doctors.

Too many people "think that more is better, that more treatment, more testing somehow results in better health care," said Dr. Glen Stream, former president of the American Academy of Family Physicians, which contributed to the list. "That really is not true."

The recommendations are part of a coalition called Choosing Wisely, formed by the American Board of Internal Medicine Foundation. Participating medical societies were asked to identify five tests or treatments that are commonly overused in their specialty. The list is aimed at doctors and includes references to published studies. Consumers Reports and other consumer groups are publicizing the information in more patient-friendly terms.

Last year, the coalition listed 45 overused tests and treatments. It included some of the best known examples, such as too much imaging for back pain and repeating colonoscopies too frequently.

This year's list adds 90 more overused kinds of care. Some are the result of doctors' habits, hard to overcome despite new evidence, Stream said. Others come about because patients demand care they think they need.

Some other examples:

—Don't use opioid painkillers for migraines except as a last resort, say the neurologists. There are better, more migraine-specific drugs available without the addictive risk of narcotics. Plus, frequent use of opioids actually can worsen migraines, a concept known as rebound headache.

—Just because a pregnant woman misses her due date, don't race to induce labor if mom and baby are doing fine, say the obstetricians. Inducing before the cervix is ready often fails, leading to an unneeded C-section. "Just being due by the calendar doesn't mean your body says you're due," Stream notes.

—Don't automatically give a child a CT scan after a minor head injury, say the pediatricians. About half of children who go to the ER with head injuries get this radiation-heavy scan, and clinical observation first could help some who don't really need a CT avoid it.

—And don't leave an implanted heart-zapping defibrillator turned on when a patient is near death, say the hospice providers. This technology clearly saves lives by guarding against an irregular heartbeat. But if someone is dying of something else, or is in the terminal stages of heart disease, it can issue repeated painful shocks, to no avail. Yet fewer than 10 percent of hospices have formal policies on when to switch off the implants.

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