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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New toll lanes open on 10 Freeway









Los Angeles County's venture into toll roads advanced early Saturday with the opening of 14 miles of express lanes on the San Bernardino Freeway — the second project of its type to begin operation in the region since November.


At 12:01 a.m., the Los Angeles County Metropolitan Transportation Authority allowed drivers to travel the 10 Freeway's new high occupancy toll lanes — so-called HOT lanes — between Interstate 605 in El Monte and Alameda Street in downtown Los Angeles.


"This shows we are willing to address traffic, gridlock and congestion in the region," said Los Angeles Mayor and MTA board member Antonio Villaraigosa at a dedication ceremony in El Monte on Friday. "Other cities are going to do this across the county. We are going to see smarter use of highways."





The two westbound and two eastbound "Metro ExpressLanes" will be open to solo motorists who pay a toll, but they will be free for cars carrying at least two passengers.


During peak travel times, however, only carpools of three or more people will be able to use the lanes without paying. Van pools and motorcyclists also can enter the lanes toll free.


Using congestion pricing, motorists will pay anywhere from $0.25 a mile during off-peak periods to $1.40 a mile during the height of rush hour. MTA officials estimate that the average one-way cost should range between $4 and $7.


Setting tolls based on the volume of traffic is designed to maintain speeds of no less than 45 mph in the lanes. If the speed falls below that level, solo motorists will be prohibited from entering the lanes until the minimum speed resumes.


Motorists interested in the express lanes must open a FasTrak account with the MTA and make a $40 deposit to obtain a transponder, an electronic device that automatically bills their accounts whenever the lanes are used. Drivers can adjust the transponder to show how many people are in the vehicle, so the charges can be adjusted. Information is available online at metroexpresslanes.net.


The county marked its entry into the use of tollways on Nov. 10, when the MTA opened its first express lanes along 11 miles of the Harbor Freeway between Adams Boulevard in Los Angeles and the Harbor Gateway Transit Center in the South Bay.


The lanes on both freeways are part of a $210-million demonstration project funded largely by the federal government. It includes upgrading transit and rail stations, 59 new clean-fuel buses, the $60-million El Monte Bus Station, highway ramp improvements and 100 new vanpools.


MTA officials said the express lanes on the 10 and 110 will cost $7 million to $10 million a year to operate, but should generate $18 million to $20 million in revenue, money that can be reinvested in both freeway corridors. So far, more than 100,000 people have obtained transponders for the lanes, officials said.


During the next year, the express-lane projects will be evaluated to determine whether the program should be continued and expanded to other freeways in the county.


"We expect it will be totally successful," said Victor Mendez, head of the Federal Highway Administration. "The project offers commuters a variety of choices, not just the highway."


dan.weikel@latimes.com





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India Ink: Image of the Day: Feb. 22

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Renée Zellweger Puckers Up with Doyle Bramhall II in Hawaii: Photo















02/22/2013 at 11:30 AM EST







Doyle Bramhall II and Renée Zellweger


AKM-GSI


Renée Zellweger was feeling the love – and the surf – during her recent Hawaiian vacation.

Zellweger, 43, joined her boyfriend, musician Doyle Bramhall II, 44, for some kayaking, paddle-boarding and romantic kissing on the beach. Wearing matching black beachwear, the Texas natives were not shy about their happiness, holding hands and smiling broadly as they vacationed together.

But soon it's back to work for Zellweger, who's set to appear on the Oscar telecast Sunday in Los Angeles. The Academy Award winner will reportedly join her Chicago cast as presenters, marking the 10th anniversary of their musical film earning Best Picture honors.

Bramhall, a guitarist and songwriter who toured with Roger Waters and Eric Clapton, was last linked to Sheryl Crow in 2011.

The 85th annual Academy Awards will air live on ABC starting at 7 p.m. ET/4 p.m. PT on Sunday, Feb. 24, from the Dolby Theatre in Hollywood.

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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 (kad-SY'-luh) 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 double-shot of anti-tumor poison.


Cancer researchers say the drug may offer a clear advantage over older drugs because it delivers more medication with fewer side effects.


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.


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.


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 co-developed by South San Francisco-based Genentech and ImmunoGen Inc., of Waltham, Mass. ImmunoGen developed the technology that binds the drug ingredients 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 33 cents, or 2.27 percent, to $14.63 in midday trading.


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Eric Garcetti's role in L.A. budget fixes is in dispute









Pressed in the race for mayor of Los Angeles to say how he would fix a persistent budget gap that has led to the gutting of many city services, Eric Garcetti urges voters to look at what he has done in the past.


The onetime City Council president claims credit for reforms that he said cut the City Hall shortfall to just over $200 million from more than $1 billion. He sees "tremendous progress," principally in reducing pension and healthcare costs, and asserts: "I delivered that."


But the truth is in dispute. Although there is not a singular view about any aspect of the city's troubled finances, most of those in the thick of recent budget fights depict Garcetti not as a fiscal hard-liner but as a conciliator who used his leadership position to chart a middle ground on the most significant changes.





Mayor Antonio Villaraigosa, city administrative officer Miguel Santana and one of Garcetti's rivals in the mayoral race, Councilwoman Jan Perry, were among those who pushed for bigger workforce reductions and larger employee contributions toward pensions and healthcare. Labor leaders and their champions on the City Council, including Paul Koretz and Richard Alarcon, sought to cushion the blow for workers.


Garcetti and his supporters say he moderated between those extremes. His critics said he worried too much about process and airing every viewpoint rather than focusing relentlessly on shoring up the city's bottom line.


"It was through the mayor's persistence and steadfast position that we got ongoing concessions," said Santana, the chief budget official for Los Angeles. "It was in collaboration with the council leadership that we finally reached agreements with labor."


The $1-billion-plus deficit Garcetti speaks of shrinking refers not to a single year but to the total of budget gaps that confronted Los Angeles over four years if no corrective action had been taken. The city's fiscal crisis worsened during that time because Garcetti and his fellow council members — including Perry and mayoral candidate Wendy Greuel — approved a city employee pay raise of 25% over five years just before the country stumbled into the recession. (Greuel left the council in 2009 when she was elected city controller.)


Although Garcetti focuses on his role, a portion of the financial improvements were outside his control. The state's elimination of redevelopment agencies in 2012 returned millions to L.A.'s general fund. Tax revenue also ticked upward with the economic recovery.


Garcetti's position as council president from 2006 through 2011 did put him at the center of debate about annual shortfalls that ranged to more than $400 million.


In 2009, he supported an early retirement plan that knocked 2,400 workers off the payroll. "I really pushed that through," the councilman said in an interview. Two participants in confidential contract talks at the heart of the deal had diametrically opposed views. "He made it happen, period," one said; the other offered: "I wouldn't say he was a major mover."


The plan saves the city a maximum of $230 million a year in salary and pension reductions in the short run. But Los Angeles borrowed to spread the costs of the program over 15 years, with current employees and retirees expected to shoulder the cost of the early exits.


The early retirements are expected to do nothing to resolve the long-term "structural deficit" — the $200 million to $400 million a year that Los Angeles spends above what it takes in. And early retirements could even be a net negative in the long run if, as city revenue recovers, new employees are put in those 2,400 empty positions too quickly.


In 2010 the city completed a budget fix that did attack the structural imbalance.


Garcetti's initial proposal called for upping the retirement age for new city employees to 60 from 55 and requiring workers to contribute a minimum of 2% of salary toward their retiree health care.


Budget chief Santana offered a markedly tougher plan. It required a 4% retiree health contribution, halved the health subsidy for retirees and capped pension benefits at 75% of salary instead of 100%. Santana's plan, also for new employees, became the basis of the reform.


Some who served with Garcetti on the council committee that leads employee negotiations pushed for even greater sacrifices. But Garcetti fought against ratcheting up demands on workers, saying it would be useless to approve a plan that would not survive subsequent union votes.


The councilman's greatest contribution may have come after city leaders set their position on pensions. Garcetti took the unusual step of visiting groups of workers. Some employees booed. Some asked him why city lawmakers, among the highest paid in the nation at $178,000 a year, didn't cut their own salaries.


"There was a lot of anger," said a labor leader who spoke on condition of anonymity because that union has not endorsed in the race. "But Eric talked to people as if they were adults and stayed until he answered all their questions. People appreciated him ... taking that kind of heat."


Matt Szabo, a former deputy mayor who helped negotiate with labor, said Garcetti deserved "every bit of credit" he has claimed for deficit reduction. "He knew he was running for mayor, and he was doing the right thing, but it was something that was going to cost him later" in terms of union support, said Szabo, who is running to replace Garcetti on the council.


Most of the employee groups that have endorsed thus far in the mayor's race have come out for Greuel. One political advantage for the controller: She left the council in 2009, before the city began making its toughest demands on workers.


Garcetti found himself stuck the middle again with another 2010 vote, this one over the elimination of 232 jobs — most of them in libraries and day care operations at city parks. Garcetti voted for the layoffs. Later he voted to reconsider, though he said recently that he intended only to re-air the issue, not to keep the workers on the job.


Labor leaders faulted Garcetti for giving the appearance he might be ready to save the jobs when he really wasn't. The reductions remain a sore point, because a "poison pill" in the contract required that any layoffs be accompanied by immediate pay raises for remaining city employees. Fierce disagreement remains over whether the layoffs saved the city any money.


"That became part of the negative picture" of Garcetti, said one labor leader, who asked not to be named out of concern about alienating a possible future mayor. The candidate said in an interview that he frequently found himself hewing a middle ground between some colleagues "who simply hope more revenue would come in" and others who wanted to use an "ax," making indiscriminate cuts. He added: "To me, both views were equally unacceptable."


Critics find Garcetti too malleable, ready to shift to the last argument he has heard. But others appreciate his quest for the middle, saying the fact he sometimes irritated both budget hard-liners and unions showed he had taken a reasoned approach.


"The criticism of Eric is also sort of the good news," said one of the union reps. "He has this very process-y, kumbaya, can't-we-all-get-along style. It drove us all crazy. But now I really miss it because it seems to be all politics over policy."


james.rainey@latimes.com





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India Ink: Image of the Day: Feb. 21

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Taylor Swift Channels Beyoncé at Brit Awards















02/21/2013 at 11:40 AM EST



Does Sasha Fierce have a pop-country cousin?

During a sassy performance of "I Knew You Were Trouble" at Wednesday's Brit Awards, Taylor Swift shed a white wedding dress to reveal a black embellished jumpsuit, sexy boots – and some familiar moves.

Striking a pose, tossing her hair and even falling to her knees to belt out the hit song, Swift, 23, resembled Beyoncé in her highly buzzed-about Super Bowl halftime performance on Feb. 3. Flip through a carousel of photos from the performance above.

At the awards ceremony at London's O2 arena, Swift handed out the best British female prize to soulful Scottish singer and songwriter Emeli Sandé, who also took home the best album prize for her debut, Our Version of Events.

A nominee for international female solo artist, Swift lost in that category to another American, Lana Del Rey.

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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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Doctor sexually assaulted unconscious patients, police say



Yashwant Balgiri GiriAn Orange County anesthesiologist convicted of sexually assaulting three unconscious female patients  has been sentenced to six months in jail and five years probation, despite the objections of prosecutors who wanted state prison time.


Yashwant Balgiri Giri, 60, pleaded guilty to a court offer to multiple felony counts related to the sexual battery of patients, including a 16-year-old, according to a statement from the Orange County district attorney's office.


Giri will have to register as a lifetime sex offender and will have his medical license revoked, in addition to the jail time and probation.


Prosecutors sought a state prison sentence, citing a violation of his "position of power and trust" with the women at a particularly vulnerable time.


Giri, who lives in Cypress, was working at Placentia-Linda Hospital at the time of the crimes, prosecutors said. He previously worked at several hospitals in Anaheim and Lakewood.


Through a spokeswoman, Placentia-Linda Hospital declined to comment.


Prosecutors said that in February 2009,  while a 16-year-old was unconscious from medication, Giri assaulted the girl when a scrub nurse preparing surgery tools had her back turned. The nurse witnessed the assault, prosecutors said, and reported it immediately to a hospital official.


Prosecutors allege that the hospital did not report the incident to police at the time.


In March 2011, prosecutors said, a hospital employee witnessed Giri fondling the breasts of a 36-year-old woman while she was under anesthesia for an outpatient surgery procedure.


An employee allegedly witnessed the incident  Prosecutors said the fondling continued for an extended period of time, as his actions were concealed from the surgeon and nurse.






The alleged assault was reported to a hospital official and then to Placentia police, prosecutors said.

Soon after an investigation began, Giri resigned from his duties at the hospital.


After he was arrested in May 2011, a third alleged victim stepped forward, saying she had been assaulted by Giri.


In April 2010, prosecutors said, Giri assaulted a 27-year-old woman while she was being put under anesthesia but before she was unconscious. Prosecutors said he touched the woman under the pretense of performing an examination, although it had no legitimate medical purpose.


During a sentencing hearing, a statement from the then-36-year-old woman, who was fondled, was read by prosecutors.


"His actions make me question every single doctor, nurse, medical decision and procedure I encounter within my everyday life," she said. "I not only fear for myself, I fear for my child, my friends, my family. This is a burden caused by the perverted actions of this predator."


ALSO:


 O.C. shootings: Listen to frantic 911 call


Hollywood Park Casino might lay off all 600 workers


San Diego sheriff confident 2 wounded deputies will fully recover


-- Rick Rojas


Photo: Yashwant Balgiri Giri. Credit: Orange County district attorney's office.


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