Medicare paid $5.1B for poor nursing home care


SAN FRANCISCO (AP) — Medicare paid billions in taxpayer dollars to nursing homes nationwide that were not meeting basic requirements to look after their residents, government investigators have found.


The report, released Thursday by the Department of Health and Human Services' inspector general, said Medicare paid about $5.1 billion for patients to stay in skilled nursing facilities that failed to meet federal quality of care rules in 2009, in some cases resulting in dangerous and neglectful conditions.


One out of every three times patients wound up in nursing homes that year, they landed in facilities that failed to follow basic care requirements laid out by the federal agency that administers Medicare, investigators estimated.


By law, nursing homes need to write up care plans specially tailored for each resident, so doctors, nurses, therapists and all other caregivers are on the same page about how to help residents reach the highest possible levels of physical, mental and psychological well-being.


Not only are residents often going without the crucial help they need, but the government could be spending taxpayer money on facilities that could endanger people's health, the report concluded. The findings come as concerns about health care quality and cost are garnering heightened attention as the Obama administration implements the nation's sweeping health care overhaul.


"These findings raise concerns about what Medicare is paying for," the report said.


Investigators estimate that in one out of five stays, patients' health problems weren't addressed in the care plans, falling far short of government directives. For example, one home made no plans to monitor a patient's use of two anti-psychotic drugs and one depression medication, even though the drugs could have serious side effects.


In other cases, residents got therapy they didn't need, which the report said was in the nursing homes' financial interest because they would be reimbursed at a higher rate by Medicare.


In one example, a patient kept getting physical and occupational therapy even though the care plan said all the health goals had been met, the report said.


The Office of Inspector General's report was based on medical records from 190 patient visits to nursing homes in 42 states that lasted at least three weeks, which investigators said gave them a statistically valid sample of Medicare beneficiaries' experiences in skilled nursing facilities.


That sample represents about 1.1 million patient visits to nursing homes nationwide in 2009, the most recent year for which data was available, according to the review.


Overall, the review raises questions about whether the system is allowing homes to get paid for poor quality services that may be harming residents, investigators said, and recommended that the Centers for Medicare & Medicaid Services tie payments to homes' abilities to meet basic care requirements. The report also recommended that the agency strengthen its regulations and ramp up its oversight. The review did not name individual homes, nor did it estimate the number of patients who had been mistreated, but instead looked at the overall number of stays in which problems arose.


In response, the agency agreed that it should consider tying Medicare reimbursements to homes' provision of good care. CMS also said in written comments that it is reviewing its own regulations to improve enforcement at the homes.


"Medicare has made significant changes to the way we pay providers thanks to the health care law, to reward better quality care," Medicare spokesman Brian Cook said in a statement to AP. "We are taking steps to make sure these facilities have the resources to improve the quality of their care, and make sure Medicare is paying for the quality of care that beneficiaries are entitled to."


CMS hires state-level agencies to survey the homes and make sure they are complying with federal law, and can require correction plans, deny payment or end a contract with a home if major deficiencies come to light. The agency also said it would follow up on potential enforcement at the homes featured in the report.


Greg Crist, a Washington-based spokeswoman for the American Health Care Association, which represents the largest share of skilled nursing facilities nationwide, said overall nursing home operators are well regulated and follow federal guidelines but added that he could not fully comment on the report's conclusions without having had the chance to read it.


"Our members begin every treatment with the individual's personal health needs at the forefront. This is a hands-on process, involving doctors and even family members in an effort to enhance the health outcome of the patient," Crist said.


Virginia Fichera, who has relatives in two nursing homes in New York, said she would welcome a greater push for accountability at skilled nursing facilities.


"Once you're in a nursing home, if things don't go right, you're really a prisoner," said Fichera, a retired professor in Sterling, NY. "As a concerned relative, you just want to know the care is good, and if there are problems, why they are happening and when they'll be fixed."


Once residents are ready to go back home or transfer to another facility, federal law also requires that the homes write special plans to make sure patients are safely discharged.


Investigators found the homes didn't always do what was needed to ensure a smooth transition.


In nearly one-third of cases, facilities also did not provide enough information when the patient moved to another setting, the report found.


___


On the Web:


The OIG report: http://1.usa.gov/VaztQm


The Medicare nursing home database: http://www.medicare.gov/NursingHomeCompare/search.aspx?bhcp=1&AspxAutoDetectCookieSupport=1


___


Follow Garance Burke on Twitter at —http://twitter.com/garanceburke.


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World powers and Iran end talks, sides to meet again


ALMATY (Reuters) - World powers ended two days of talks with Iran on Wednesday with no sign of a breakthrough, and the two sides have agreed to meet at expert level in Istanbul next month and to hold further high-level negotiations in Kazakhstan in April.


At the talks that ended in the Kazakh city of Almaty, the six world powers - France, Germany, the United States, China Russia and Britain - offered to lift some sanctions if Iran scaled back nuclear activity the West fears could be used to build bombs. Tehran denies seeking nuclear weapons.


Hopes of a significant easing of the deadlock in the decade-old dispute were dented when Russian media cited a source close to the talks as saying there had been no clear progress.


"So far there is no particular rapprochement. There is an impression that the atmosphere is not very good," Interfax news agency quoted the source as saying shortly before the talks ended.


Iran said the expert-level talks between the two sides would be held in Istanbul on March 18 and another round of political negotiations in Almaty on April 5-6.


Russia's negotiator, Deputy Foreign Minister Sergei Ryabkov, said the Istanbul meeting would take place on March 17-18 and gave the same dates as Iran of April 5-6 for the Almaty talks.


The meeting in Almaty that ended on Wednesday was the first between the world powers and Iran in eight months. Western officials described the first day of the talks as "useful". Iranian state television described the atmosphere in the discussions as "very serious".


The outcome will be closely watched in Israel, which has strongly hinted that it could attack Iran's nuclear sites if diplomacy and sanctions fail to stop Tehran's uranium enrichment program.


Iran says Israel's assumed nuclear arsenal is the main threat to peace and denies Western allegations it is seeking to develop the capability to make atomic bombs. It says it is only aiming to produce nuclear energy so that it can export more oil.


In their latest attempt to break years of stalemate in the dispute, the powers are offering Iran a relaxation of some of the sanctions that are taking a heavy toll on its economy.


Western officials have confirmed the offer includes some limited sanctions easing if Iran closes a underground site where it carries out its most controversial uranium enrichment work.


Diplomats had seen scant chances of a conclusive deal with Iran before a June presidential election - with the political elite preoccupied with domestic issues - but they had hoped to hold follow-up talks soon.


(Additional reporting by Yeganeh Torbati in Almaty, Zahra Hosseinian in Zurich, Gabriela Baczynska in Moscow, Dan Williams in Jerusalem and Marcus George in Dubai; Writing by Timothy Heritage and Fredrik Dahl; Editing by Pravin Char)



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Bobby Brown Sentenced to 55 Days in Jail in Drunk Driving Case















02/26/2013 at 09:30 PM EST



Bobby Brown has been sentenced to 55 days in jail and four years probation in his most recent drunk driving arrest.

Brown, 44, was pulled over in Studio City, Calif., on Oct. 24 for driving erratically and was arrested when the officer detected "a strong scent of alcohol." He was charged with DUI and driving on a suspended license.

He was also arrested for driving under the influence in March of 2012.

Brown pled no contest to the charges on Tuesday, reports TMZ. He was also ordered to complete an 18-month alcohol treatment program.

The singer, who married Alicia Etheredge in Hawaii in June of 2012, must report to jail by March 20.

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Advanced breast cancer edges up in younger women


CHICAGO (AP) — Advanced breast cancer has increased slightly among young women, a 34-year analysis suggests. The disease is still uncommon among women younger than 40, and the small change has experts scratching their heads about possible reasons.


The results are potentially worrisome because young women's tumors tend to be more aggressive than older women's, and they're much less likely to get routine screening for the disease.


Still, that doesn't explain why there'd be an increase in advanced cases and the researchers and other experts say more work is needed to find answers.


It's likely that the increase has more than one cause, said Dr. Rebecca Johnson, the study's lead author and medical director of a teen and young adult cancer program at Seattle Children's Hospital.


"The change might be due to some sort of modifiable risk factor, like a lifestyle change" or exposure to some sort of cancer-linked substance, she said.


Johnson said the results translate to about 250 advanced cases diagnosed in women younger than 40 in the mid-1970s versus more than 800 in 2009. During those years, the number of women nationwide in that age range went from about 22 million to closer to 30 million — an increase that explains part of the study trend "but definitely not all of it," Johnson said.


Other experts said women delaying pregnancy might be a factor, partly because getting pregnant at an older age might cause an already growing tumor to spread more quickly in response to pregnancy hormones.


Obesity and having at least a drink or two daily have both been linked with breast cancer but research is inconclusive on other possible risk factors, including tobacco and chemicals in the environment. Whether any of these explains the slight increase in advanced disease in young women is unknown.


There was no increase in cancer at other stages in young women. There also was no increase in advanced disease among women older than 40.


Overall U.S. breast cancer rates have mostly fallen in more recent years, although there are signs they may have plateaued.


Some 17 years ago, Johnson was diagnosed with early-stage breast cancer at age 27, and that influenced her career choice to focus on the disease in younger women.


"Young women and their doctors need to understand that it can happen in young women," and get checked if symptoms appear, said Johnson, now 44. "People shouldn't just watch and wait."


The authors reviewed a U.S. government database of cancer cases from 1976 to 2009. They found that among women aged 25 to 39, breast cancer that has spread to distant parts of the body — advanced disease — increased from between 1 and 2 cases per 100,000 women to about 3 cases per 100,000 during that time span.


The study was published Tuesday in the Journal of the American Medical Association.


About one in 8 women will develop breast cancer in their lifetime, but only 1 in 173 will develop it by age 40. Risks increase with age and certain gene variations can raise the odds.


Routine screening with mammograms is recommended for older women but not those younger than 40.


Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer, said the results support anecdotal reports but that there's no reason to start screening all younger women since breast cancer is still so uncommon for them.


He said the study "is solid and interesting and certainly does raise questions as to why this is being observed." One of the most likely reasons is probably related to changes in childbearing practices, he said, adding that the trend "is clearly something to be followed."


Dr. Ann Partridge, chair of the federal Centers for Disease Control and Prevention's advisory committee on breast cancer in young women, agreed but said it's also possible that doctors look harder for advanced disease in younger women than in older patients. More research is needed to make sure the phenomenon is real, said Partridge, director of a program for young women with breast cancer at the Harvard-affiliated Dana-Farber Cancer Institute.


The study shouldn't cause alarm, she said. Still, Partridge said young women should be familiar with their breasts and see the doctor if they notice any lumps or other changes.


Software engineer Stephanie Carson discovered a large breast tumor that had already spread to her lungs; that diagnosis in 2003 was a huge shock.


"I was so clueless," she said. "I was just 29 and that was the last thing on my mind."


Carson, who lives near St. Louis, had a mastectomy, chemotherapy, radiation and other treatments and she frequently has to try new drugs to keep the cancer at bay.


Because most breast cancer is diagnosed in early stages, there's a misconception that women are treated, and then get on with their lives, Carson said. She and her husband had to abandon hopes of having children, and she's on medical leave from her job.


"It changed the complete course of my life," she said. "But it's still a good life."


____


Online:


JAMA: http://jama.ama-assn.org


CDC: http://www.cdc.gov/cancer/breast/index.htm


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The Bachelor's Sean Lowe Reveals Final Two






The Bachelor










02/25/2013 at 10:30 PM EST







From left: AshLee, Lindsay and Catherine


Kevin Foley/ABC(3)


And then there were two.

After three incredible dates in Thailand with the remaining women, The Bachelor's Sean Lowe faced a difficult decision at the end of Monday's episode: Would he send home AshLee, Catherine or Lindsay?

Keep reading to find out who got a rose – and who was left heartbroken ...

Sean said goodbye to early favorite AshLee in a surprising elimination that left her virtually speechless.

Visibly upset, AshLee left Sean's side without saying goodbye. She even asked him to not walk her to the waiting car that would take her away.

But Sean did get to explain. "I thought it was you from the very beginning," he said. "This was honestly the hardest decision I've ever had to make ... I think the world of you. I did not want to hurt you."

"This wasn't a silly game for me," AshLee said as the car drove away. "This wasn't about a joy ride. It wasn't about laughing and joking and having fun."

She added: "It's hard to say goodbye to Sean because I let him in ... It's the ultimate [rejection]."

Check back Tuesday morning for Sean Lowe's blog post to read all about his Thailand dates and why he chose to send AshLee home

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Koop, who transformed surgeon general post, dies


With his striking beard and starched uniform, former Surgeon General Dr. C. Everett Koop became one of the most recognizable figures of the Reagan era — and one of the most unexpectedly enduring.


His nomination in 1981 met a wall of opposition from women's groups and liberal politicians, who complained President Ronald Reagan selected Koop, a pediatric surgeon and evangelical Christian from Philadelphia, only because of his conservative views, especially his staunch opposition to abortion.


Soon, though, he was a hero to AIDS activists, who chanted "Koop, Koop" at his appearances but booed other officials. And when he left his post in 1989, he left behind a landscape where AIDS was a top research and educational priority, smoking was considered a public health hazard, and access to abortion remained largely intact.


Koop, who turned his once-obscure post into a bully pulpit for seven years during the Reagan and George H.W. Bush administrations and who surprised both ends of the political spectrum by setting aside his conservative personal views on issues such as homosexuality and abortion to keep his focus sharply medical, died Monday at his home in Hanover, N.H. He was 96.


An assistant at Koop's Dartmouth College institute, Susan Wills, confirmed his death but didn't disclose its cause.


Dr. Richard Carmona, who served as surgeon general a decade ago under President George W. Bush, said Koop was a mentor to him and preached the importance of staying true to the science even if it made politicians uncomfortable.


"He set the bar high for all who followed in his footsteps," Carmona said.


Although the surgeon general has no real authority to set government policy, Koop described himself as "the health conscience of the country" and said modestly just before leaving his post that "my only influence was through moral suasion."


A former pipe smoker, Koop carried out a crusade to end smoking in the United States; his goal had been to do so by 2000. He said cigarettes were as addictive as heroin and cocaine. And he shocked his conservative supporters when he endorsed condoms and sex education to stop the spread of AIDS.


Chris Collins, a vice president of amFAR, the Foundation for AIDS Research, said many people don't realize what an important role Koop played in the beginning of the AIDS epidemic.


"At the time, he really changed the national conversation, and he showed real courage in pursuing the duties of his job," Collins said.


Even after leaving office, Koop continued to promote public health causes, from preventing childhood accidents to better training for doctors.


"I will use the written word, the spoken word and whatever I can in the electronic media to deliver health messages to this country as long as people will listen," he promised.


In 1996, he rapped Republican presidential hopeful Bob Dole for suggesting that tobacco was not invariably addictive, saying Dole's comments "either exposed his abysmal lack of knowledge of nicotine addiction or his blind support of the tobacco industry."


Although Koop eventually won wide respect with his blend of old-fashioned values, pragmatism and empathy, his nomination met staunch opposition.


Foes noted that Koop traveled the country in 1979 and 1980 giving speeches that predicted a progression "from liberalized abortion to infanticide to passive euthanasia to active euthanasia, indeed to the very beginnings of the political climate that led to Auschwitz, Dachau and Belsen."


But Koop, a devout Presbyterian, was confirmed after he told a Senate panel he would not use the surgeon general's post to promote his religious ideology. He kept his word.


In 1986, he issued a frank report on AIDS, urging the use of condoms for "safe sex" and advocating sex education as early as third grade.


He also maneuvered around uncooperative Reagan administration officials in 1988 to send an educational AIDS pamphlet to more than 100 million U.S. households, the largest public health mailing ever.


Koop personally opposed homosexuality and believed sex should be saved for marriage. But he insisted that Americans, especially young people, must not die because they were deprived of explicit information about how HIV was transmitted.


Koop further angered conservatives by refusing to issue a report requested by the Reagan White House, saying he could not find enough scientific evidence to determine whether abortion has harmful psychological effects on women.


Koop maintained his personal opposition to abortion, however. After he left office, he told medical students it violated their Hippocratic oath. In 2009, he wrote to Senate Majority Leader Harry Reid, urging that health care legislation include a provision to ensure doctors and medical students would not be forced to perform abortions. The letter briefly set off a security scare because it was hand delivered.


Koop served as chairman of the National Safe Kids Campaign and as an adviser to President Bill Clinton's health care reform plan.


At a congressional hearing in 2007, Koop spoke about political pressure on the surgeon general post. He said Reagan was pressed to fire him every day, but Reagan would not interfere.


Koop, worried that medicine had lost old-fashioned caring and personal relationships between doctors and patients, opened his institute at Dartmouth to teach medical students basic values and ethics. He also was a part-owner of a short-lived venture, drkoop.com, to provide consumer health care information via the Internet.


Koop was born in the New York City borough of Brooklyn, the only son of a Manhattan banker and the nephew of a doctor. He said by age 5 he knew he wanted to be a surgeon and at age 13 he practiced his skills on neighborhood cats.


He attended Dartmouth, where he received the nickname Chick, short for "chicken Koop." It stuck for life.


Koop received his medical degree at Cornell Medical College, choosing pediatric surgery because so few surgeons practiced it.


In 1938, he married Elizabeth Flanagan, the daughter of a Connecticut doctor. They had four children, one of whom died in a mountain climbing accident when he was 20.


Koop was appointed surgeon-in-chief at Children's Hospital in Philadelphia and served as a professor at the University of Pennsylvania School of Medicine.


He pioneered surgery on newborns and successfully separated three sets of conjoined twins. He won national acclaim by reconstructing the chest of a baby born with the heart outside the body.


Although raised as a Baptist, he was drawn to a Presbyterian church near the hospital, where he developed an abiding faith. He began praying at the bedside of his young patients — ignoring the snickers of some of his colleagues.


Koop's wife died in 2007, and he married Cora Hogue in 2010.


He was by far the best-known surgeon general and for decades afterward was still a recognized personality.


"I was walking down the street with him one time" about five years ago, recalled Dr. George Wohlreich, director of the College of Physicians of Philadelphia, a medical society with which Koop had longstanding ties. "People were yelling out, 'There goes Dr. Koop!' You'd have thought he was a rock star."


___


Ring reported from Montpelier, Vt. Cass reported from Washington. AP Medical Writers Lauran Neergaard in Washington and Mike Stobbe in New York contributed to this report.


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Bernanke to face Fed critics in testimony to Congress


WASHINGTON (Reuters) - Federal Reserve Chairman Ben Bernanke faces the first of two days of congressional testimony that will subject the Fed's controversial bond-buying program to tough scrutiny and gauge his confidence in the resilience of the U.S. economy.


Coming just a week after the Fed's meeting minutes sent U.S. stocks reeling by suggesting the central bank could pull back its economic stimulus earlier than had been expected, and a day after another sharp stock market drop, investors are certain to hang on every word.


Beginning with the U.S. Senate Banking Committee on Tuesday, the scholarly Fed chief will be quizzed by some bitter critics of the aggressive steps he has championed to spur growth. On Wednesday, he will appear before the House Financial Services Committee.


"His opinion remains that there is still not enough growth, that high unemployment is a cyclical issue, that there is not enough inflation," economists at TD Securities in New York said in a note to clients. "He will keep the pedal to the metal deep into 2013."


The Fed chairman's prepared testimony is scheduled to be released at 10 a.m. (1500 GMT) on Tuesday, followed by a lengthy question-and-answer session. By tradition, he will issue the same statement on Wednesday before facing the House panel.


FIRST, DO NO HARM


Lawmakers in both chambers will seek his comment on the likely impact of $85 billion in across-the-board government spending cuts that are set to take effect on March 1.


Bernanke is likely to repeat his line that the indiscriminate axe they take to the budget will hurt the recovery, and argue that it would be better to cut the deficit over time and avoid the risk of a near-term fiscal shock.


Lawmakers will also question him about the Fed's bold bond- buying program, which has tripled the size of the central bank's balance sheet to $3 trillion since 2008.


The Fed, which cut overnight interest rates to near zero more than four years ago, is currently buying $85 billion a month in government and mortgage-backed bonds to keep longer- term borrowing costs low and spur the economy's recovery. The Fed has said it would continue to purchase bonds until it sees a substantial improvement in the outlook for the labor market.


That still appears a long way off. In January, the jobless rate ticked up a tenth of a percentage point to 7.9 percent.


Many Republicans have criticized the Fed's aggressive easing of monetary policy for risking inflation and asset bubbles, and for facilitating excessive government spending by keeping the nation's borrowing costs low.


Some of the same concerns have resonated within the central bank.


Minutes of the Fed's January 29-30 policy meeting, released last week, showed that a number of officials felt the potential risks posed by buying bonds could warrant tapering or ending the program before hiring picks up. However, several others argued there was a danger in halting it prematurely.


Financial markets are keen to find out where Bernanke stands. Expectations that he would offer reassuring words, coupled with fears that Europe's debt crisis could grow worse, led on Monday to the biggest drop in the yield on the benchmark 10-year U.S. Treasury note since November.


"You are probably going to hear a message that does not lean so heavily on the costs" of bond buying," said Michael Feroli, an economist with JPMorgan in New York.


(Reporting by Alister Bull; Editing by Tim Ahmann and Jan Paschal)



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Relive the Best One-Liners and Tweets from the Oscars!









02/25/2013 at 12:00 AM EST



Jennifer Lawrence tumbled – to a standing ovation. Ben Affleck tearfully won Best Picure for Argo. And you all loved – or loved to hate – Oscar host Seth MacFarlane.

Yep, the Oscars are over, but it doesn't mean we're done talking about it! You can relive the best of the night! Check out what celebs, readers (and you!) had to say about the musical numbers, speeches – and a certain reigning Sexiest Man Alive! – on Twitter last night.

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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 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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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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