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.


Read More..

Paroled sex offenders disarming tracking devices









SACRAMENTO — Thousands of paroled child molesters, rapists and other high-risk sex offenders in California are removing or disarming their court-ordered GPS tracking devices — and some have been charged with new crimes including sexual battery, kidnapping and attempted manslaughter.


The offenders have discovered that they can disable the monitors, often with little risk of serving time for it, a Times investigation has found. The jails are too full to hold them.


"It's a huge problem," said Fresno parole agent Matt Hill. "If the public knew, they'd be shocked."





More than 3,400 arrest warrants for GPS tamperers have been issued since October 2011, when the state began referring parole violators to county jails instead of returning them to its packed prisons. Warrants increased 28% in 2012 compared to the 12 months before the change in custody began. Nearly all of the warrants were for sex offenders, who are the vast majority of convicts with monitors, and many were for repeat violations.


The custody shift is part of Gov. Jerry Brown and the legislature's "realignment" program, to comply with court orders to reduce overcrowding in state prisons. But many counties have been under their own court orders to ease crowding in their jails.


Some have freed parole violators within days, or even hours, of arrest rather than keep them in custody. Some have refused to accept them at all.


Before prison realignment took effect, sex offenders who breached parole remained behind bars, awaiting hearings that could send them back to prison for up to a year. Now, the maximum penalty is 180 days in jail, but many never serve that time.


With so little deterrent, parolees "certainly are feeling more bold," said Jack Wallace, an executive at the California Sex Offender Management Board.


Rithy Mam, a convicted child stalker, was arrested three times in two months after skipping parole and was freed almost immediately each time. After his third release, his GPS alarm went off and he vanished, law enforcement records show.


The next day, he turned up in a Stockton living room where a 15-year-old girl was asleep on the couch, police said. The girl told police she awoke to find the stranger staring at her and that he asked "Wanna date?" before leaving the home.


Police say Mam went back twice more that week and menaced the girl and her 13-year-old sister, getting in by giving candy to a toddler, before authorities recaptured him in a local park. He is in custody on new charges of child molestation.


Californians voted in 2006 to require that high-risk sex offenders be tracked for life with GPS monitors strapped to their bodies.


The devices are programmed to record offenders' movements and are intended, at least in part, to deter them from committing crimes. The devices, attached to rubber ankle straps embedded with fiber-optic cable, transmit signals monitored by a private contractor.


They are easy to cut off, but an alarm is triggered when that happens, as it is when they are interfered with in other ways or go dead, or when an offender enters a forbidden area such as a school zone or playground. The monitoring company alerts parole agents by text message or email.


Arrest warrants for GPS tamperers are automatically published online. The Times reviewed that data as well as thousands of jail logs, court documents and criminal histories provided by confidential sources. The records show that the way authorities handle violators can vary significantly by county.


San Bernardino County releases more inmates early from its cramped jails than any other county in California, according to state reports. But sex offenders who violate parole there generally serve their terms. A spokeswoman said the county closely reviews criminal histories, and those with past sex offenses are ineligible for early release.


By contrast, parole violators in San Joaquin County are often set free within a day of arrest.


A review of the county's jail logs shows that nine of the 15 sex offenders arrested for violating parole in December and January were let out within 24 hours, including seven who immediately tampered with their trackers and disappeared. One of the nine, a convicted rapist named Robert Stone, was arrested two weeks later on kidnapping charges and returned to jail, where he remains.


Raoul Leyva, a sex offender with a history of beating women, was arrested in April for fleeing parole and ordered to remain jailed for 100 days. He was out in 16 days and soon bolted again, after allowing the battery on his device to go dead, according to the documents reviewed by The Times.


Less than two weeks later, a drug dealer led police to a Stockton apartment where Leyva's girlfriend, 20-year-old Brandy Arreola, had lain for days on the floor, severely beaten and in a coma. Now brain damaged and confined to a wheelchair, Arreola spends her time watching cartoons.





Read More..

Italy Set to Vote for a New Parliament





ROME — As Italian voters head to the polls on Sunday and Monday to elect a new Parliament and three regional governments, the prevailing mood is one of anger and disillusionment.




The fledgling, anti-establishment parties that campaigned on promises of radical change could benefit from the voters’ discontent, but the lack of a clear winner could also leave Italy mired in uncertainty.


“Italians feel frustration, anger, but also some hope for renewal,” said Nicola Piepoli, who runs a polling company. They are frustrated, he said, because their taxes are rising but they see no improvements in their “economic and social life,” and they are angry because candidates did not address “concrete problems” during the campaign, focusing instead on “futile, absurd things.”


“But many still hope for some change,” Mr. Piepoli added, explaining the growing support for populists like the comedian Beppe Grillo and his Five Star Movement, and for smaller parties like Civil Revolution, led by Antonio Ingroia, a former prosecutor, and Act to Stop the Decline, a movement guided by Oscar Giannino, a journalist.


Mostly though, the mood is dark among Italians fed up with protracted political scandals and disinclined to believe election promises because they are so rarely fulfilled.


(On Friday, former Prime Minister Silvio Berlusconi, campaigning to return to office, made a new promise: he said that if he won, he would personally refund an unpopular property tax paid by Italians in 2012. “I will take four billion euros of my own fortune and give it to Italians,” he said on television, a pledge of about $5.3 billion.)


“There’s no one to vote for, and if I went to the polls I’d choose the least-worst candidate, so I prefer not to vote,” said Concetta Rossi, a recruiter for hotel employees in Rome. “It’s never been this bad.”


The center-left Democratic Party, led by Pier Luigi Bersani, a low-key former industry minister, is expected to place first but is unlikely to win enough seats to govern without a coalition. The centrist movement backing the current prime minister, Mario Monti, is a possible ally, but even together they might not prevail in the Senate because the electoral law allocates seats based on regional votes. Lombardy and Sicily, where polls suggest that the right is strong, are crucial.


For the past year, Mr. Bersani, a former Communist who has played up his Catholic upbringing, has supported Mr. Monti’s reformist agenda, though sometimes grudgingly. He has backed Mr. Monti’s commitments to the European Union for greater fiscal responsibility, but would review policies that might have hurt workers and retirees.


Investors and economic analysts have their own concerns about the potential instability that could emerge in the absence of a strong government.


In its 15 months in office, Mr. Monti’s technocratic government tried to pass much-needed reforms, but it failed to stimulate the economic growth required to pull Italy out of a persistent recession. On Friday, the European Commission said in its winter forecast that Italy’s economy would shrink by 1 percent in 2013, double its November estimate.


Gains made by anti-establishment parties, including the Five Star Movement, could stall Mr. Monti’s overhauls, and a strong showing by the center-right party led by Mr. Berlusconi could derail the austerity measures meant to keep Italy on a fiscally responsible track.


“The fear remains that the general election produces a significant no-confidence vote on the current austerity plan and the need to reform further,” Raj Badiani, an economist with IHS Global Insight, wrote in a research report last week. “Without the prospect of a stable coalition government with a credible reform agenda, Italy could be forced to reconstruct a technocratic government to keep the markets at bay.”


Alessandro Amadori, the director of Coesis, which conducts marketing and opinion polls, said the “emotional mapping” of Italy highlighted the population’s “disenchantment and rage,” and even its resignation. “People don’t think that much will change. They hope for a sign, but they don’t have high expectations.”


Mr. Amadori added: “These elections will probably mark a moment of transition, rather than long-term change. Italians are looking for something that will shake things up, but what will emerge, we still don’t know.”


Read More..

Mindy McCready: A Country Star's Tragic Life and Death






Cover Story








02/23/2013 at 12:40 PM EST



Alone and adrift, Mindy McCready seemed to have little concept of time in the blurry month following the apparent suicide of her boyfriend, songwriter David Wilson, on Jan. 13 at the lakefront home they shared in quiet Heber Springs, Ark.

"She would call you at 2 in the morning and then would call you 20 minutes later and act like she hadn't spoken to you in a week," says a friend of the long-troubled country singer, who had left a court-ordered rehab facility after just one day on Feb. 7.

She didn't talk much about her two sons, 10-month-old Zayne and 6-year-old Zander – both boys had been placed in foster care when she was admitted for treatment – because the subject brought her to tears.

Upset over speculation about her role in Wilson's death, McCready had been spending her days sleeping and her nights drinking and was screaming "about everything," according to a Feb. 6 petition filed by her father, Tim, to have her committed to rehab. But even as her world imploded, McCready sounded resolutely hopeful after watching the Feb. 10 Grammy Awards. Recalls the friend: "She said, 'I'll be there next year. That's a promise.' "

But as with much of McCready's deeply tumultuous life, the moment of optimism was short-lived. Just five days later McCready, 37, was plunged into despair after being served with court papers proposing that her sons be sent to live with her long-estranged mother, Gayle Inge, in Florida.

"The most important thing are my babies must come home," she wrote in an e-mail on Feb. 16 to L.A. private investigator Danno Hanks, who stayed in touch with McCready after working with her during her 2010 stint on VH1's Celebrity Rehab. "She lost all hope," says Hanks. "She said, 'I'm losing my kids. I can't live without my kids!' "

At her request, Hanks had made a video advocating suicide prevention with the song "I'll See You Yesterday," in which she sings, "If tomorrow's gonna be the same/ I'll see you yesterday." Says Hanks: "Mindy told me that it was exactly what she wanted. Then I asked her if I could post it. And Mindy's answer was, 'You'll know when it's right.' "

The next day, McCready shot herself in the mouth on the porch of her home – the very same spot where Wilson, 34, had been found dead, according to a police source.

The suicide marked a brutal end for a singer who had once been among Nashville's brightest stars before a toxic spiral of reckless relationships, arrests, addiction and family fights played out publicly for nearly a decade.

Read More..

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.


Read More..

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





Read More..

Russia Sends Aid to Mali as Fighting Flares





MOSCOW — Russia sent a planeload of food, blankets and other aid to war-stricken Mali on Friday, a day after Foreign Minister Sergey V. Lavrov warned about the spread of terrorism in North Africa, which the Russian government has linked to Western intervention in Libya.




Mr. Lavrov met on Thursday with the United Nations special envoy for the region, Romano Prodi, to discuss the situation in Mali, where Russia has supported the French-led effort to oust Islamic militants. But Russia has also blamed the West for the unrest and singled out the French in particular for arming the rebels who ousted the Libyan leader, Col. Muammar el-Qaddafi.


“Particular concern was expressed about the activity of terrorist organizations in the north, a threat to regional peace and security,” the Russian Foreign Ministry said in a statement after the meeting. “The parties agreed that the uncontrolled proliferation of arms in the region in the wake of the conflict in Libya sets the stage for an escalation of tension throughout the Sahel.” The Sahel is a vast region stretching more than 3,000 miles across Africa, from the Atlantic in the west to the Horn of Africa in the east.


In a television interview earlier this month, Mr. Lavrov said, “France is fighting against those in Mali whom it had once armed in Libya against Qaddafi.”


French forces quickly drove Islamist fighters out of the population centers of northern Mali — Timbuktu and Gao, in particular — when France began a military intervention in the country last month. Those dispersed fighters, who are members of Al Qaeda in the Islamic Maghreb and several allied groups, have now begun a small campaign of harassment and terror, dispatching suicide bombers, attacking guard posts, infiltrating liberated cities or ordering attacks by militants hidden among civilians.


On Friday, suicide attackers detonated two car bombs near the town of Tessalit, in Mali’s far north, according to news reports, while Islamist fighters clashed with Malian soldiers further south in Gao, where fighting has flared in recent days.


The twin suicide bombings in Tessalit killed three fighters for the M.N.L.A., an ethnic Tuareg armed group that has allied with the French forces, a spokesman for the group told Agence France-Presse. The attackers were killed as well. On Thursday, a guard and an attacker were killed in a car bombing in Kidal, south of Tessalit, that appeared to target a civilian fuel depot, France’s Defense Ministry said in a statement.


Responsibility for that attack was claimed by the Movement for Oneness and Jihad in West Africa, an offshoot of Al Qaeda in the Islamic Maghreb. The group said it would continue to press its fight, and also intended to retake Gao, hundreds of miles to the south.


“More explosions will happen across our territory,” a group spokesman, Abu Walid Sahraoui, told A.F.P. “Our troops have been ordered to attack,” he said. “If the enemy is stronger, we’ll pull back only to return stronger, until we liberate Gao.”


In central Gao late Thursday morning, Malian and French forces killed about 15 militants from “infiltrated terrorist groups” that had seized the town hall and court, according to France’s Defense Ministry. The initial firefight involved only Malian soldiers and militant fighters, the ministry statement said, but several French armored vehicles and two helicopters were later involved.


Two militants were killed outside a checkpoint north of the city after “sporadically” attacking the Nigerien soldiers standing guard, the Defense Ministry said. As many as six Malian soldiers were reported wounded.


On Friday, sporadic gunfire and at least two rebel rocket attacks were reported in Gao, according to a Malian officer cited by The Associated Press. Most of the militants fled to the east of the city aboard seven vehicles, the officer said.


Russian officials have pointed repeatedly to the unrest in North Africa and political turmoil in Egypt as evidence that the Western-supported Arab Spring has created a dangerous and chaotic situation and potential breeding grounds for terrorists. Russia has also used the examples of Libya and Egypt to justify its opposition to any Western effort to oust the government of President Bashar al-Assad in Syria.


Russia voted in favor of a United Nations Security Council resolution authorizing the deployment of African troops in Mali, but Russia has also stressed that the resolution required the consent of the Malian government.


Russia’s state-controlled weapons company, Rosoboronexport, has been selling small arms to the Malian government and is considering a request to buy additional matériel, including armor and helicopters.


The plane dispatched to the Malian capital, Bamako, by Russian’s Emergency Situations Ministry was carrying about 36 tons of aid cargo, including 45 tents, 2,000 blankets, canned food, cereals and rice.


David Herszenhorn reported from Moscow and Scott Sayare from Paris.



Read More..

Jack Nicholson, Dustin Hoffman to Present at Academy Awards









02/22/2013 at 12:40 PM EST







Dustin Hoffman (left) and Jack Nicholson


AP; Getty


Jack's back – at the Oscars.

Legendary actor Nicholson will join Dustin Hoffman as presenters at Sunday's Academy Awards. Both stars are 75.

"Between the two of them, Jack Nicholson and Dustin Hoffman have created more iconic characters than any other pair of actors in the world," says a statement from show producers Craig Zadan and Neil Meron. "Their participation in this year's Oscars completes a list of presenters and performers that truly represents that great breadth and depth of acting talent in film today."

Other presenters include Sandra Bullock, Nicole Kidman, Reese Witherspoon, Salma Hayek Pinault, Melissa McCarthy, Liam Neeson and John Travolta.

Performers for this year's show include Adele, Dame Shirley Bassey, Norah Jones and Barbra Streisand.

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.

Read More..

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.


Read More..

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





Read More..