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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Wilmar International's Q4 net profit falls 4.7%






SINGAPORE: Wilmar International's net profit in the fourth quarter fell 4.7 per cent, weighed mainly by lower palm oil prices.

Fourth-quarter net profit was US$476.8 million (S$590 million), down from US$500 million recorded in the same period in 2011.

A decline in crude palm oil prices hit profits in the firm's plantations segment, which were down 23 per cent compared to the previous year.

Fourth-quarter revenue rose 0.9 per cent on year to US$11.6 billion (S$14.4 billion).

Wilmar International's chairman and CEO Kuok Khoon Hong said the Group remains positive on its long term prospects due to "good economic growth" in its main markets of China, India and Indonesia and robust business model.

Separately, Wilmar International and Noble Group also announced a joint venture to develop palm projects in Papua, Indonesia.

In a statement, the companies said Wilmar's subsidiary Newbloom will hold a 53.74 per cent equity stake in the venture while Noble unit Noble Plantations will own a 46.27 per cent stake.

The joint venture owns a majority interest in PT Henrison Inti Persada, which owns 22,953 hectares of land in Papua.

- CNA/ck



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Suspend question hour to discuss blasts: BJP

NEW DELHI: The Bharatiya Janata Party (BJP) Friday demanded that question hour be suspended in both houses to discuss the Hyderabad terror attack.

"We have asked for suspension of question hour and demanded discussion on the terror issue," BJP leader Prakash Javadekar told reporters outside parliament.

He said the country was united at this hour and party president Rajnath Singh had gone to Hyderabad to meet the victims.

"The government is failing in fight against terror and we will raise the matter in parliament," he said.

Sixteen people were killed and more than 100 injured in the twin bomb blasts that rocked Hyderabad Thursday evening.

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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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Syrian opposition says Assad cannot be part of deal


CAIRO (Reuters) - The opposition Syrian National Coalition is willing to negotiate a peace deal to end the country's civil war but President Bashar al-Assad must step down and cannot be a party to any settlement, members agreed after debating a controversial initiative by their president.


The meeting of the 70-member Western, Arab and Turkish-backed coalition began on Thursday before Syrian Foreign Minister Walid al-Moualem is due for talks in Moscow, one of Assad's last foreign allies, and as U.N. mediator Lakhdar Brahimi renews efforts for a deal.


After an angry late night session in which coalition president Moaz Alkhatib came under strong criticism from Islamist and liberal members alike for proposing talks with Assad's government without setting what they described as clear goals, the coalition adopted a political document that demands Assad's removal and trial for the bloodshed, members said.


A draft document seen by Reuters that was circulated for debate said Assad cannot be party to any political solution and has to be tried, but did not directly call for his removal.


"We have adopted the political document that sets the parameters for any talks. The main addition to the draft is a clause about the necessity of Assad stepping step down," said Abdelbasset Sida, a member of the coalition's 12 member politburo who has criticized Alkhatib for acting alone.


"We removed a clause about a need for Russian and U.S. involvement in any talks and added that the coalition's leadership has to be consulted before launching any future initiatives," he added.


Still, the agreement marked a softening of tone by the coalition because previously it had insisted that Assad must step down before any talks with his government could begin.


In an indication that Syria's strongman remains defiant, Brahimi said Assad had told him he will remain president until his term ends in 2014 and then run for re-election.


Brahimi told al-Arabiya television he wants to see a transitional government formed in Syria that would not answer to any higher authority and lasts until U.N.-supervised elections take place in the country.


"I am of the view that U.N. peacekeepers should come to Syria as happened in other countries," Brahimi said.


BOMB, AIR STRIKES


The opposition front convened in Cairo on a day when a car bomb jolted central Damascus, killing 53 people, wounding 200 and incinerating cars on a busy highway close to the Russian Embassy and offices of the ruling Baath Party.


Syrian state television blamed the suicide blast on "terrorists". Central Damascus has been relatively insulated from the 23-month conflict that has killed around 70,000 people, but the bloodshed has shattered suburbs around the capital.


In the southern city of Deraa near the border with Jordan, activists said warplanes bombed the old quarter for the first time since March 2011, when the town set in a wheat-growing plain rose up against Assad, starting a national revolt.


A rebel officer in the Tawheed al-Janoub brigade which led an offensive this week in Deraa said there were at least five air strikes on Thursday. The Syrian Observatory for Human Rights said 18 people were killed, including eight rebel fighters.


Coalition member Munther Makhos, who was forced into exile in the 1970s for his opposition to Assad's father, the late President Hafez al-Assad, said supplies from Iran and Russia were giving government forces an awesome firepower advantage.


"It would be surreal to imagine that a political solution is possible. Bashar al-Assad will not send his deputy to negotiate his removal. But we are keeping the door open," Makhos said.


Makhos is the only Alawite in the Islamist-dominated coalition. The Alawite sect, an offshoot of Shi'ite Islam which accounts for about 10 percent of Syria's population but makes up most of the intelligence apparatus and dominates the army and the political system, has generally remained behind Assad.


With Alawites feeling increasingly threatened by a violent Sunni backlash, Alkhatib, a cleric from Damascus who played a role in the peaceful protest movement against Assad at the beginning of the uprising in 2011, has been calling on Alawites to join the revolution, saying their participation will help preserve the social fabric of the country.


Alkhatib's supporters say the initiative has popular support inside Syria from people who want to see a peaceful departure of Assad and a halt to the war that has increasingly pitted his fellow Alawites against Syria's Sunni Muslim majority.


But rebel fighters on the ground, over whom Alkhatib has little control, are generally against the proposal.


The Syrian Islamic Liberation Front, which represents armed brigades, said in a statement it was opposed to Alkhatib's initiative because it ignored the revolt's goal of "the downfall of the regime and all its symbols".


"We are demanding his accountability for the bloodshed and destruction he has wreaked. I think the message is clear enough," said veteran opposition campaigner Walid al-Bunni, who supports Alkhatib.


Alkhatib formulated the initiative in broad terms last month after talks with the Russian and Iranian foreign ministers in Munich but without consulting the coalition, catching the umbrella organization by surprise.


Among Alkhatib's critics is the Muslim Brotherhood, the only organized group in the political opposition.


A Brotherhood source said the group will not scuttle the proposal because it was confident Assad is not interested in a negotiated exit, which could help convince the international community to support the armed struggle for his removal.


"Russia is key," the source said, speaking on condition of anonymity. "We are showing the international community that we are willing to take criticism from the street but the problem is Assad and his inner circle. They do not want to leave."


PLAY FOR RUSSIA


Russia hopes Alkhatib will visit soon in search of a breakthrough. Bunni said Alkhatib would not go to Moscow without the coalition's approval and that he would not be there at the same time as Moualem.


"In my opinion Alkhatib should not go to Moscow until Russia stops sending arms shipments to the Assad regime," Bunni said.


Formal backing by the coalition for Alkhatib's initiative gives it more weight internationally and undermines Assad supporters' argument that the opposition is too divided to be considered a serious player, opposition sources said.


Coalition members and diplomats based in the region said Brahimi asked Alkhatib in Cairo last week to seek full coalition backing for his plan, which resembles the U.N. envoy's own ideas for a negotiated settlement.


One diplomat in contact with the opposition and the United Nations had said a coalition approval of Alkhatib's initiative could help change the position of Russia, which has blocked several United Nations Security Council resolutions on Syria.


The diplomat said only a U.N. resolution could force Assad to the negotiating table, and a U.N. "stabilization force" may still be needed to prevent an all-out slide into a civil war.


"Brahimi has little hope that Assad will agree to any serious talks," the diplomat said. "Differences are narrowing between the United States and Russia about Syria but Moscow remains the main obstacle for Security Council action."


(Editing by Paul Taylor and Mohammad Zargham)



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Officer in Pistorius case facing 7 attempted murder charges: police






JOHANNESBURG: The lead detective in the Oscar Pistorius murder case is himself facing seven attempted murder charges for shooting at a taxi in 2009 to try to stop it, police said Thursday.

"We were only informed yesterday that attempted murders charges against Hilton Botha have been reinstated," said police spokesman Neville Malila.

Malila said the charges were initially brought against investigating officer Botha in 2009, but later withdrawn.

It is not clear whether he will continue working on the case.

On Wednesday, Botha's evidence came under scrutiny from Pistorius' defence team, forcing him to admit to multiple errors in the case, including not wearing protective clothing when attending to the athlete's house, where the shooting happened.

Under cross-examination, Botha was forced to admit that Pistorius's version of the early morning shooting last Thursday fitted the crime scene, weakening the state's claim that the killing was premeditated.

- AFP/ck



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Kohinoor is ours, won't be returned, British PM David Cameron tells India

AMRITSAR: British Prime Minister David Cameron says a giant diamond his country forced India to hand over in the colonial era that was set in a royal crown will not be returned.

Speaking on the third and final day of a visit to India aimed at drumming up trade and investment, Cameron ruled out handing back the 105-carat Kohinoor diamond, now on display in the Tower of London. The diamond had been set in the crown of the current Queen Elizabeth's late mother.

One of the world's largest diamonds, some Indians - including Mahatma Gandhi's grandson - have demanded its return to atone for Britain's colonial past.

"I don't think that's the right approach," Cameron told reporters on Wednesday after becoming the first serving British prime minister to voice regret about one of the bloodiest episodes in colonial India, a massacre of unarmed civilians in the city of Amritsar in 1919.

"It is the same question with the Elgin Marbles," he said, referring to the classical Greek marble sculptures that Athens has long demanded be given back.

"The right answer is for the British Museum and other cultural institutions to do exactly what they do, which is to link up with other institutions around the world to make sure that the things which we have and look after so well are properly shared with people around the world.

"I certainly don't believe in 'returnism', as it were. I don't think that's sensible."

Britain's then colonial governor-general of India arranged for the huge diamond to be presented to Queen Victoria in 1850.

If Kate Middleton, the wife of Prince William, who is second in line to the throne, eventually becomes queen consort she will don the crown holding the diamond on official occasions.

When Elizabeth II made a state visit to India to mark the 50th anniversary of India's independence from Britain in 1997, many Indians demanded the return of the diamond.

Cameron is keen to tap into India's economic rise, but says he is anxious to focus on the present and future rather than "reach back" into the past.

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Adults get 11 percent of calories from fast food


ATLANTA (AP) — On an average day, U.S. adults get roughly 11 percent of their calories from fast food, a government study shows.


That's down slightly from the 13 percent reported the last time the government tried to pin down how much of the American diet is coming from fast food. Eating fast food too frequently has been seen as a driver of America's obesity problem.


For the research, about 11,000 adults were asked extensive questions about what they ate and drank over the previous 24 hours to come up with the results.


Among the findings:


Young adults eat more fast food than their elders; 15 percent of calories for ages 20 to 39 and dropping to 6 percent for those 60 and older.


— Blacks get more of their calories from fast-food, 15 percent compared to 11 percent for whites and Hispanics.


— Young black adults got a whopping 21 percent from the likes of Wendy's, Taco Bell and KFC.


The figures are averages. Included in the calculations are some people who almost never eat fast food, as well as others who eat a lot of it.


The survey covers the years 2007 through 2010 and was released Thursday by the Centers for Disease Control and Prevention. The authors couldn't explain why the proportion of calories from fast food dropped from the 13 percent found in a survey for 2003 through 2006.


One nutrition professor cast doubts on the latest results, saying 11 percent seemed implausibly low. New York University's Marion Nestle said it wouldn't be surprising if some people under-reported their hamburgers, fries and milkshakes since eating too much fast food is increasingly seen as something of a no-no.


"If I were a fast-food company, I'd say 'See, we have nothing to do with obesity! Americans are getting 90 percent of their calories somewhere else!'" she said.


The study didn't include the total number of fast-food calories, just the percentage. Previous government research suggests that the average U.S. adult each day consumes about 270 calories of fast food — the equivalent of a small McDonald's hamburger and a few fries.


The new CDC study found that obese people get about 13 percent of daily calories from fast food, compared with less than 10 percent for skinny and normal-weight people.


There was no difference seen by household income, except for young adults. The poorest — those with an annual household income of less than $30,000 — got 17 percent of their calories from fast food, while the figure was under 14 percent for the most affluent 20- and 30-somethings with a household income of more than $50,000.


That's not surprising since there are disproportionately higher numbers of fast-food restaurants in low-income neighborhoods, Nestle said.


Fast food is accessible and "it's cheap," she said.


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Online:


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


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