WHO: Slight cancer risk after Japan nuke accident

LONDON (AP) — Two years after Japan's nuclear plant disaster, an international team of experts said Thursday that residents of areas hit by the highest doses of radiation face an increased cancer risk so small it probably won't be detectable.

In fact, experts calculated that increase at about 1 extra percentage point added to a Japanese infant's lifetime cancer risk.

"The additional risk is quite small and will probably be hidden by the noise of other (cancer) risks like people's lifestyle choices and statistical fluctuations," said Richard Wakeford of the University of Manchester, one of the authors of the report. "It's more important not to start smoking than having been in Fukushima."

The report was issued by the World Health Organization, which asked scientists to study the health effects of the disaster in Fukushima, a rural farming region.

On March 11, 2011, an earthquake and tsunami knocked out the Fukushima plant's power and cooling systems, causing meltdowns in three reactors and spewing radiation into the surrounding air, soil and water. The most exposed populations were directly under the plumes of radiation in the most affected communities in Fukushima, which is about 150 miles (240 kilometers) north of Tokyo.

In the report, the highest increases in risk are for people exposed as babies to radiation in the most heavily affected areas. Normally in Japan, the lifetime risk of developing cancer of an organ is about 41 percent for men and 29 percent for women. The new report said that for infants in the most heavily exposed areas, the radiation from Fukushima would add about 1 percentage point to those numbers.

Experts had been particularly worried about a spike in thyroid cancer, since radioactive iodine released in nuclear accidents is absorbed by the thyroid, especially in children. After the Chernobyl disaster, about 6,000 children exposed to radiation later developed thyroid cancer because many drank contaminated milk after the accident.

In Japan, dairy radiation levels were closely monitored, but children are not big milk drinkers there.

The WHO report estimated that women exposed as infants to the most radiation after the Fukushima accident would have a 70 percent higher chance of getting thyroid cancer in their lifetimes. But thyroid cancer is extremely rare and one of the most treatable cancers when caught early. A woman's normal lifetime risk of developing it is about 0.75 percent. That number would rise by 0.5 under the calculated increase for women who got the highest radiation doses as infants.

Wakeford said the increase may be so small it will probably not be observable.

For people beyond the most directly affected areas of Fukushima, Wakeford said the projected cancer risk from the radiation dropped dramatically. "The risks to everyone else were just infinitesimal."

David Brenner of Columbia University in New York, an expert on radiation-induced cancers, said that although the risk to individuals is tiny outside the most contaminated areas, some cancers might still result, at least in theory. But they'd be too rare to be detectable in overall cancer rates, he said.

Brenner said the numerical risk estimates in the WHO report were not surprising. He also said they should be considered imprecise because of the difficulty in determining risk from low doses of radiation. He was not connected with the WHO report.

Some experts said it was surprising that any increase in cancer was even predicted.

"On the basis of the radiation doses people have received, there is no reason to think there would be an increase in cancer in the next 50 years," said Wade Allison, an emeritus professor of physics at Oxford University, who also had no role in developing the new report. "The very small increase in cancers means that it's even less than the risk of crossing the road," he said.

WHO acknowledged in its report that it relied on some assumptions that may have resulted in an overestimate of the radiation dose in the general population.

Gerry Thomas, a professor of molecular pathology at Imperial College London, accused the United Nations health agency of hyping the cancer risk.

"It's understandable that WHO wants to err on the side of caution, but telling the Japanese about a barely significant personal risk may not be helpful," she said.

Thomas said the WHO report used inflated estimates of radiation doses and didn't properly take into account Japan's quick evacuation of people from Fukushima.

"This will fuel fears in Japan that could be more dangerous than the physical effects of radiation," she said, noting that people living under stress have higher rates of heart problems, suicide and mental illness.

In Japan, Norio Kanno, the chief of Iitate village, in one of the regions hardest hit by the disaster, harshly criticized the WHO report on Japanese public television channel NHK, describing it as "totally hypothetical."

Many people who remain in Fukushima still fear long-term health risks from the radiation, and some refuse to let their children play outside or eat locally grown food.

Some restrictions have been lifted on a 12-mile (20-kilometer) zone around the nuclear plant. But large sections of land in the area remain off-limits. Many residents aren't expected to be able to return to their homes for years.

Kanno accused the report's authors of exaggerating the cancer risk and stoking fear among residents.

"I'm enraged," he said.

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Mari Yamaguchi in Tokyo and AP Science Writer Malcolm Ritter in New York contributed to this report.

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Online:

WHO report: http://bit.ly/YDCXcb

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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.

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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

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

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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."

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Online:

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

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

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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."

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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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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..

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..

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..

Flu shot doing poor job of protecting older people

ATLANTA (AP) — It turns out this year's flu shot is doing a startlingly dismal job of protecting older people, the most vulnerable age group.

The vaccine is proving only 9 percent effective in those 65 and older against the harsh strain of the flu that is predominant this season, the Centers for Disease Control and Prevention said Thursday.

Health officials are baffled as to why this is so. But the findings help explain why so many older people have been hospitalized with the flu this year.

Despite the findings, the CDC stood by its recommendation that everyone over 6 months get flu shots, the elderly included, because some protection is better than none, and because those who are vaccinated and still get sick may suffer less severe symptoms.

"Year in and year out, the vaccine is the best protection we have," said CDC flu expert Dr. Joseph Bresee.

Overall, across the age groups studied, the vaccine's effectiveness was found to be a moderate 56 percent, which means those who got a shot have a 56 percent lower chance of winding up at the doctor with the flu. That is somewhat worse than what has been seen in other years.

For those 65 and older, the vaccine was only 27 percent effective against the three strains it is designed to protect against, the worst level in about a decade. It did a particularly poor job against the tough strain that is causing more than three-quarters of the illnesses this year.

It is well known that flu vaccine tends to protect younger people better than older ones. Elderly people have weaker immune systems that don't respond as well to flu shots, and they are more vulnerable to the illness and its complications, including pneumonia.

But health officials said they don't know why this year's vaccine did so poorly in that age group.

One theory, as yet unproven, is that older people's immune systems were accustomed to strains from the last two years and had more trouble switching gears to handle this year's different, harsh strain.

The preliminary data for senior citizens is less than definitive. It is based on fewer than 300 people scattered among five states.

But it will no doubt surprise many people that the effectiveness is that low, said Michael Osterholm, a University of Minnesota infectious-disease expert who has tried to draw attention to the need for a more effective flu vaccine.

Among infectious diseases, flu is considered one of the nation's leading killers. On average, about 24,000 Americans die each flu season, according to the CDC.

This flu season started in early December, a month earlier than usual, and peaked by the end of year. Hospitalization rates for people 65 and older have been some of the highest in a decade, at 146 per 100,000 people.

Flu viruses tend to mutate more quickly than others, so a new vaccine is formulated each year to target the strains expected to be the major threats. CDC officials have said that in formulating this year's vaccine, scientists accurately anticipated the strains that are circulating this season.

Because of the guesswork involved, scientists tend to set a lower bar for flu vaccine. While childhood vaccines against diseases like measles are expected to be 90 or 95 percent effective, a flu vaccine that's 60 to 70 percent effective in the U.S. is considered pretty good. By that standard, this year's vaccine is OK.

For senior citizens, a flu vaccine is considered pretty good if it's in the 30 to 40 percent range, said Dr. Arnold Monto, a University of Michigan flu expert.

A high-dose version of the flu shot was recently made available for those 65 and older, but the new study was too small to show whether that has made a difference.

The CDC estimates are based on about 2,700 people who got sick in December and January. The researchers traced back to see who had gotten shots and who hadn't. An earlier, smaller study put the vaccine's overall effectiveness at 62 percent, but other factors that might have influenced that figure weren't taken into account.

The CDC's Bresee said there is a danger in providing preliminary results because it may result in people doubting — or skipping — flu shots. But the figures were released to warn older people who got shots that they may still get sick and shouldn't ignore any serious flu-like symptoms, he said.

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Online:

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

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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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Drug overdose deaths up for 11th consecutive year

CHICAGO (AP) — Drug overdose deaths rose for the 11th straight year, federal data show, and most of them were accidents involving addictive painkillers despite growing attention to risks from these medicines.

"The big picture is that this is a big problem that has gotten much worse quickly," said Dr. Thomas Frieden, head of the Centers for Disease Control and Prevention, which gathered and analyzed the data.

In 2010, the CDC reported, there were 38,329 drug overdose deaths nationwide. Medicines, mostly prescription drugs, were involved in nearly 60 percent of overdose deaths that year, overshadowing deaths from illicit narcotics.

The report appears in Tuesday's Journal of the American Medical Association.

It details which drugs were at play in most of the fatalities. As in previous recent years, opioid drugs — which include OxyContin and Vicodin — were the biggest problem, contributing to 3 out of 4 medication overdose deaths.

Frieden said many doctors and patients don't realize how addictive these drugs can be, and that they're too often prescribed for pain that can be managed with less risky drugs.

They're useful for cancer, "but if you've got terrible back pain or terrible migraines," using these addictive drugs can be dangerous, he said.

Medication-related deaths accounted for 22,134 of the drug overdose deaths in 2010.

Anti-anxiety drugs including Valium were among common causes of medication-related deaths, involved in almost 30 percent of them. Among the medication-related deaths, 17 percent were suicides.

The report's data came from death certificates, which aren't always clear on whether a death was a suicide or a tragic attempt at getting high. But it does seem like most serious painkiller overdoses were accidental, said Dr. Rich Zane, chair of emergency medicine at the University of Colorado School of Medicine.

The study's findings are no surprise, he added. "The results are consistent with what we experience" in ERs, he said, adding that the statistics no doubt have gotten worse since 2010.

Some experts believe these deaths will level off. "Right now, there's a general belief that because these are pharmaceutical drugs, they're safer than street drugs like heroin," said Don Des Jarlais, director of the chemical dependency institute at New York City's Beth Israel Medical Center.

"But at some point, people using these drugs are going to become more aware of the dangers," he said.

Frieden said the data show a need for more prescription drug monitoring programs at the state level, and more laws shutting down "pill mills" — doctor offices and pharmacies that over-prescribe addictive medicines.

Last month, a federal panel of drug safety specialists recommended that Vicodin and dozens of other medicines be subjected to the same restrictions as other narcotic drugs like oxycodone and morphine. Meanwhile, more and more hospitals have been establishing tougher restrictions on painkiller prescriptions and refills.

One example: The University of Colorado Hospital in Aurora is considering a rule that would ban emergency doctors from prescribing more medicine for patients who say they lost their pain meds, Zane said.

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Stobbe reported from Atlanta.

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Online:

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

CDC: http://www.cdc.gov

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AP Medical Writer Lindsey Tanner can be reached at http://www.twitter.com

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Hip implants a bit more likely to fail in women

CHICAGO (AP) — Hip replacements are slightly more likely to fail in women than in men, according to one of the largest studies of its kind in U.S. patients. The risk of the implants failing is low, but women were 29 percent more likely than men to need a repeat surgery within the first three years.

The message for women considering hip replacement surgery remains unclear. It's not known which models of hip implants perform best in women, even though women make up the majority of the more than 400,000 Americans who have full or partial hip replacements each year to ease the pain and loss of mobility caused by arthritis or injuries.

"This is the first step in what has to be a much longer-term research strategy to figure out why women have worse experiences," said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families. "Research in this area could save billions of dollars" and prevent patients from experiencing the pain and inconvenience of surgeries to fix hip implants that go wrong.

Researchers looked at more than 35,000 surgeries at 46 hospitals in the Kaiser Permanente health system. The research, published Monday in JAMA Internal Medicine, was funded by the U.S. Food and Drug Administration.

After an average of three years, 2.3 percent of the women and 1.9 percent of the men had undergone revision surgery to fix a problem with the original hip replacement. Problems included instability, infection, broken bones and loosening.

"There is an increased risk of failure in women compared to men," said lead author Maria Inacio, an epidemiologist at Southern California Permanente Medical Group in San Diego. "This is still a very small number of failures."

Women tend to have smaller joints and bones than men, and so they tend to need smaller artificial hips. Devices with smaller femoral heads — the ball-shaped part of the ball-and-socket joint in an artificial hip — are more likely to dislocate and require a surgical repair.

That explained some, but not all, of the difference between women and men in the study. It's not clear what else may have contributed to the gap. Co-author Dr. Monti Khatod, an orthopedic surgeon in Los Angeles, speculated that one factor may be a greater loss of bone density in women.

The failure of metal-on-metal hips was almost twice as high for women than in men. The once-popular models were promoted by manufacturers as being more durable than standard plastic or ceramic joints, but several high-profile recalls have led to a decrease in their use in recent years.

"Don't be fooled by hype about a new hip product," said Zuckerman, who wrote an accompanying commentary in the medical journal. "I would not choose the latest, greatest hip implant if I were a woman patient. ... At least if it's been for sale for a few years, there's more evidence for how well it's working."

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Online:

Journal: http://www.jamainternalmed.com

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Study: Better TV might improve kids' behavior

SEATTLE (AP) — Teaching parents to switch channels from violent shows to educational TV can improve preschoolers' behavior, even without getting them to watch less, a study found.

The results were modest and faded over time, but may hold promise for finding ways to help young children avoid aggressive, violent behavior, the study authors and other doctors said.

"It's not just about turning off the television. It's about changing the channel. What children watch is as important as how much they watch," said lead author Dr. Dimitri Christakis, a pediatrician and researcher at Seattle Children's Research Institute.

The research was to be published online Monday by the journal Pediatrics.

The study involved 565 Seattle parents, who periodically filled out TV-watching diaries and questionnaires measuring their child's behavior.

Half were coached for six months on getting their 3-to-5-year-old kids to watch shows like "Sesame Street" and "Dora the Explorer" rather than more violent programs like "Power Rangers." The results were compared with kids whose parents who got advice on healthy eating instead.

At six months, children in both groups showed improved behavior, but there was a little bit more improvement in the group that was coached on their TV watching.

By one year, there was no meaningful difference between the two groups overall. Low-income boys appeared to get the most short-term benefit.

"That's important because they are at the greatest risk, both for being perpetrators of aggression in real life, but also being victims of aggression," Christakis said.

The study has some flaws. The parents weren't told the purpose of the study, but the authors concede they probably figured it out and that might have affected the results.

Before the study, the children averaged about 1½ hours of TV, video and computer game watching a day, with violent content making up about a quarter of that time. By the end of the study, that increased by up to 10 minutes. Those in the TV coaching group increased their time with positive shows; the healthy eating group watched more violent TV.

Nancy Jensen, who took part with her now 6-year-old daughter, said the study was a wake-up call.

"I didn't realize how much Elizabeth was watching and how much she was watching on her own," she said.

Jensen said her daughter's behavior improved after making changes, and she continues to control what Elizabeth and her 2-year-old brother, Joe, watch. She also decided to replace most of Elizabeth's TV time with games, art and outdoor fun.

During a recent visit to their Seattle home, the children seemed more interested in playing with blocks and running around outside than watching TV.

Another researcher who was not involved in this study but also focuses his work on kids and television commended Christakis for taking a look at the influence of positive TV programs, instead of focusing on the impact of violent TV.

"I think it's fabulous that people are looking on the positive side. Because no one's going to stop watching TV, we have to have viable alternatives for kids," said Dr. Michael Rich, director of the Center on Media and Child Health at Children's Hospital Boston.

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Online:

Pediatrics: http://www.pediatrics.org

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Contact AP Writer Donna Blankinship through Twitter (at)dgblankinship

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UN warns risk of hepatitis E in S. Sudan grows

GENEVA (AP) — The United Nations says an outbreak of hepatitis E has killed 111 refugees in camps in South Sudan since July, and has become endemic in the region.

U.N. refugee agency spokesman Adrian Edwards says the influx of people to the camps from neighboring Sudan is believed to be one of the factors in the rapid spread of the contagious, life-threatening inflammatory viral disease of the liver.

Edwards said Friday that the camps have been hit by 6,017 cases of hepatitis E, which is spread through contaminated food and water.

He says the largest number of cases and suspected cases is in the Yusuf Batil camp in Upper Nile state, which houses 37,229 refugees fleeing fighting between rebels and the Sudanese government.

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UN warns risk of hepatitis E in S. Sudan grows

GENEVA (AP) — The United Nations says an outbreak of hepatitis E has killed 111 refugees in camps in South Sudan since July, and has become endemic in the region.

U.N. refugee agency spokesman Adrian Edwards says the influx of people to the camps from neighboring Sudan is believed to be one of the factors in the rapid spread of the contagious, life-threatening inflammatory viral disease of the liver.

Edwards said Friday that the camps have been hit by 6,017 cases of hepatitis E, which is spread through contaminated food and water.

He says the largest number of cases and suspected cases is in the Yusuf Batil camp in Upper Nile state, which houses 37,229 refugees fleeing fighting between rebels and the Sudanese government.

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Study: Fish in drug-tainted water suffer reaction

BOSTON (AP) — What happens to fish that swim in waters tainted by traces of drugs that people take? When it's an anti-anxiety drug, they become hyper, anti-social and aggressive, a study found. They even get the munchies.

It may sound funny, but it could threaten the fish population and upset the delicate dynamics of the marine environment, scientists say.

The findings, published online Thursday in the journal Science, add to the mounting evidence that minuscule amounts of medicines in rivers and streams can alter the biology and behavior of fish and other marine animals.

"I think people are starting to understand that pharmaceuticals are environmental contaminants," said Dana Kolpin, a researcher for the U.S. Geological Survey who is familiar with the study.

Calling their results alarming, the Swedish researchers who did the study suspect the little drugged fish could become easier targets for bigger fish because they are more likely to venture alone into unfamiliar places.

"We know that in a predator-prey relation, increased boldness and activity combined with decreased sociality ... means you're going to be somebody's lunch quite soon," said Gregory Moller, a toxicologist at the University of Idaho and Washington State University. "It removes the natural balance."

Researchers around the world have been taking a close look at the effects of pharmaceuticals in extremely low concentrations, measured in parts per billion. Such drugs have turned up in waterways in Europe, the U.S. and elsewhere over the past decade.

They come mostly from humans and farm animals; the drugs pass through their bodies in unmetabolized form. These drug traces are then piped to water treatment plants, which are not designed to remove them from the cleaned water that flows back into streams and rivers.

The Associated Press first reported in 2008 that the drinking water of at least 51 million Americans carries low concentrations of many common drugs. The findings were based on questionnaires sent to water utilities, which reported the presence of antibiotics, sedatives, sex hormones and other drugs.

The news reports led to congressional hearings and legislation, more water testing and more public disclosure. To this day, though, there are no mandatory U.S. limits on pharmaceuticals in waterways.

The research team at Sweden's Umea University used minute concentrations of 2 parts per billion of the anti-anxiety drug oxazepam, similar to concentrations found in real waters. The drug belongs to a widely used class of medicines known as benzodiazepines that includes Valium and Librium.

The team put young wild European perch into an aquarium, exposed them to these highly diluted drugs and then carefully measured feeding, schooling, movement and hiding behavior. They found that drug-exposed fish moved more, fed more aggressively, hid less and tended to school less than unexposed fish. On average, the drugged fish were more than twice as active as the others, researcher Micael Jonsson said. The effects were more pronounced at higher drug concentrations.

"Our first thought is, this is like a person diagnosed with ADHD," said Jonsson, referring to attention deficit-hyperactivity disorder. "They become asocial and more active than they should be."

Tomas Brodin, another member of the research team, called the drug's environmental impact a global problem. "We find these concentrations or close to them all over the world, and it's quite possible or even probable that these behavioral effects are taking place as we speak," he said Thursday in Boston at the annual meeting of the American Association for the Advancement of Science.

Most previous research on trace drugs and marine life has focused on biological changes, such as male fish that take on female characteristics. However, a 2009 study found that tiny concentrations of antidepressants made fathead minnows more vulnerable to predators.

It is not clear exactly how long-term drug exposure, beyond the seven days in this study, would affect real fish in real rivers and streams. The Swedish researchers argue that the drug-induced changes could jeopardize populations of this sport and commercial fish, which lives in both fresh and brackish water.

Water toxins specialist Anne McElroy of Stony Brook University in New York agreed: "These lower chronic exposures that may alter things like animals' mating behavior or its ability to catch food or its ability to avoid being eaten — over time, that could really affect a population."

Another possibility, the researchers said, is that more aggressive feeding by the perch on zooplankton could reduce the numbers of these tiny creatures. Since zooplankton feed on algae, a drop in their numbers could allow algae to grow unchecked. That, in turn, could choke other marine life.

The Swedish team said it is highly unlikely people would be harmed by eating such drug-exposed fish. Jonsson said a person would have to eat 4 tons of perch to consume the equivalent of a single pill.

Researchers said more work is needed to develop better ways of removing drugs from water at treatment plants. They also said unused drugs should be brought to take-back programs where they exist, instead of being flushed down the toilet. And they called on pharmaceutical companies to work on "greener" drugs that degrade more easily.

Sandoz, one of three companies approved to sell oxazepam in the U.S., "shares society's desire to protect the environment and takes steps to minimize the environmental impact of its products over their life cycle," spokeswoman Julie Masow said in an emailed statement. She provided no details.

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Online:

Overview of the drug: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682050.html

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Morning-after pill use up to 1 in 9 younger women

NEW YORK (AP) — About 1 in 9 younger women have used the morning-after pill after sex, according to the first government report to focus on emergency contraception since its approval 15 years ago.

The results come from a survey of females ages 15 to 44. Eleven percent of those who'd had sex reported using a morning-after pill. That's up from 4 percent in 2002, only a few years after the pills went on the market and adults still needed a prescription.

The increased popularity is probably because it is easier to get now and because of media coverage of controversial efforts to lift the age limit for over-the-counter sales, experts said. A prescription is still required for those younger than 17 so it is still sold from behind pharmacy counters.

In the study, half the women who used the pills said they did it because they'd had unprotected sex. Most of the rest cited a broken condom or worries that the birth control method they used had failed.

White women and more educated women use it the most, the research showed. That's not surprising, said James Trussell, a Princeton University researcher who's studied the subject.

"I don't think you can go to college in the United States and not know about emergency contraception," said Trussell, who has promoted its use and started a hot line.

One Pennsylvania college even has a vending machine dispensing the pills.

The morning-after pill is basically a high-dose version of birth control pills. It prevents ovulation and needs to be taken within a few days after sex. The morning-after pill is different from the so-called abortion pill, which is designed to terminate a pregnancy.

At least five versions of the morning-after pills are sold in the United States. They cost around $35 to $60 a dose at a pharmacy, depending on the brand.

Since it is sold over-the-counter, insurers generally only pay for it with a doctor's prescription. The new Affordable Care Act promises to cover morning-after pills, meaning no co-pays, but again only with a prescription.

The results of the study were released Thursday by the Centers for Disease Control and Prevention. It's based on in-person interviews of more than 12,000 women in 2006 through 2010. It was the agency's first in-depth report on that issue, said Kimberly Daniels, the study's lead author.

The study also found:

—Among different age groups, women in their early 20s were more likely to have taken a morning-after pill. About 1 in 4 did.

—About 1 in 5 never-married women had taken a morning-after pill, compared to just 1 in 20 married women.

—Of the women who used the pill, 59 percent said they had done it only once, 24 percent said twice, and 17 percent said three or more times.

A woman who uses emergency contraception multiple times "needs to be thinking about a more regular form" of birth control, noted Lawrence Finer, director of domestic research for the Guttmacher Institute, a nonprofit group that does research on reproductive health.

Also on Thursday, the CDC released a report on overall contraception use. Among its many findings, 99 percent of women who've had sex used some sort of birth control. That includes 82 percent who used birth control pills and 93 percent whose partner had used a condom.

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Online:

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

Emergency contraception info: http://ec.princeton.edu/index.html

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Study questions kidney cancer treatment in elderly

In a stunning example of when treatment might be worse than the disease, a large review of Medicare records finds that older people with small kidney tumors were much less likely to die over the next five years if doctors monitored them instead of operating right away.

Even though nearly all of these tumors turned out to be cancer, they rarely proved fatal. And surgery roughly doubled patients' risk of developing heart problems or dying of other causes, doctors found.

After five years, 24 percent of those who had surgery had died, compared to only 13 percent of those who chose monitoring. Just 3 percent of people in each group died of kidney cancer.

The study only involved people 66 and older, but half of all kidney cancers occur in this age group. Younger people with longer life expectancies should still be offered surgery, doctors stressed.

The study also was observational — not an experiment where some people were given surgery and others were monitored, so it cannot prove which approach is best. Yet it offers a real-world look at how more than 7,000 Medicare patients with kidney tumors fared. Surgery is the standard treatment now.

"I think it should change care" and that older patients should be told "that they don't necessarily need to have the kidney tumor removed," said Dr. William Huang of New York University Langone Medical Center. "If the treatment doesn't improve cancer outcomes, then we should consider leaving them alone."

He led the study and will give results at a medical meeting in Orlando, Fla., later this week. The research was discussed Tuesday in a telephone news conference sponsored by the American Society of Clinical Oncology and two other cancer groups.

In the United States, about 65,000 new cases of kidney cancer and 13,700 deaths from the disease are expected this year. Two-thirds of cases are diagnosed at the local stage, when five-year survival is more than 90 percent.

However, most kidney tumors these days are found not because they cause symptoms, but are spotted by accident when people are having an X-ray or other imaging test for something else, like back trouble or chest pain.

Cancer experts increasingly question the need to treat certain slow-growing cancers that are not causing symptoms — prostate cancer in particular. Researchers wanted to know how life-threatening small kidney tumors were, especially in older people most likely to suffer complications from surgery.

They used federal cancer registries and Medicare records from 2000 to 2007 to find 8,317 people 66 and older with kidney tumors less than 1.5 inches wide.

Cancer was confirmed in 7,148 of them. About three-quarters of them had surgery and the rest chose to be monitored with periodic imaging tests.

After five years, 1,536 had died, including 191 of kidney cancer. For every 100 patients who chose monitoring, 11 more were alive at the five-year mark compared to the surgery group. Only 6 percent of those who chose monitoring eventually had surgery.

Furthermore, 27 percent of the surgery group but only 13 percent of the monitoring group developed a cardiovascular problem such as a heart attack, heart disease or stroke. These problems were more likely if doctors removed the entire kidney instead of just a part of it.

The results may help doctors persuade more patients to give monitoring a chance, said a cancer specialist with no role in the research, Dr. Bruce Roth of Washington University in St. Louis.

Some patients with any abnormality "can't sleep at night until something's done about it," he said. Doctors need to say, "We're not sticking our head in the sand, we're going to follow this" and can operate if it gets worse.

One of Huang's patients — 81-year-old Rhona Landorf, who lives in New York City — needed little persuasion.

"I was very happy not to have to be operated on," she said. "He said it's very slow growing and that having an operation would be worse for me than the cancer."

Landorf said her father had been a doctor, and she trusts her doctors' advice. Does she think about her tumor? "Not at all," she said.

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Online:

Kidney cancer info: http://www.cancer.net/cancer-types/kidney-cancer

and http://www.cancer.gov/cancertopics/types/kidney

Study: http://gucasym.org

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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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Pope shows lifetime jobs aren't always for life

The world seems surprised that an 85-year-old globe-trotting pope who just started tweeting wants to resign, but should it be? Maybe what should be surprising is that more leaders his age do not, considering the toll aging takes on bodies and minds amid a culture of constant communication and change.

There may be more behind the story of why Pope Benedict XVI decided to leave a job normally held for life. But the pontiff made it about age. He said the job called for "both strength of mind and body" and said his was deteriorating. He spoke of "today's world, subject to so many rapid changes," implying a difficulty keeping up despite his recent debut on Twitter.

"This seemed to me a very brave, courageous decision," especially because older people often don't recognize their own decline, said Dr. Seth Landefeld, an expert on aging and chairman of medicine at the University of Alabama at Birmingham.

Age has driven many leaders from jobs that used to be for life — Supreme Court justices, monarchs and other heads of state. As lifetimes expand, the woes of old age are catching up with more in seats of power. Some are choosing to step down rather than suffer long declines and disabilities as the pope's last predecessor did.

Since 1955, only one U.S. Supreme Court justice — Chief Justice William Rehnquist — has died in office. Twenty-one others chose to retire, the most recent being John Paul Stevens, who stepped down in 2010 at age 90.

When Thurgood Marshall stepped down in 1991 at the age of 82, citing health reasons, the Supreme Court justice's answer was blunt: "What's wrong with me? I'm old. I'm getting old and falling apart."

One in 5 U.S. senators is 70 or older, and some have retired rather than seek new terms, such as Hawaii's Daniel Akaka, who left office in January at age 88.

The Netherlands' Queen Beatrix, who just turned 75, recently said she will pass the crown to a son and put the country "in the hands of a new generation."

In Germany, where the pope was born, Chancellor Angela Merkel, who is 58, said the pope's decision that he was no longer fit for the job "earns my very highest respect."

"In our time of ever-lengthening life, many people will be able to understand how the pope as well has to deal with the burdens of aging," she told reporters in Berlin.

Experts on aging agreed.

"People's mental capacities in their 80s and 90s aren't what they were in their 40s and 50s. Their short-term memory is often not as good, their ability to think quickly on their feet, to execute decisions is often not as good," Landefeld said. Change is tougher to handle with age, and leaders like popes and presidents face "extraordinary demands that would tax anybody's physical and mental stamina."

Dr. Barbara Messinger-Rapport, geriatrics chief at the Cleveland Clinic, noted that half of people 85 and older in developed countries have some dementia, usually Alzheimer's. Even without such a disease, "it takes longer to make decisions, it takes longer to learn new things," she said.

But that's far from universal, said Dr. Thomas Perls, an expert on aging at Boston University and director of the New England Centenarians Study.

"Usually a man who is entirely healthy in his early 80s has demonstrated his survival prowess" and can live much longer, he said. People of privilege have better odds because they have access to good food and health care, and tend to lead clean lives.

"Even in the 1500s and 1600s there were popes in their 80s. It's remarkable. That would be today's centenarians," Perls said.

Arizona Sen. John McCain turned 71 while running for president in 2007. Had he won, he would have been the oldest person elected to a first term as president. Ronald Reagan was days away from turning 70 when he started his first term as president in 1981; he won re-election in 1984. Vice President Joe Biden just turned 70.

In the U.S. Senate, where seniority is rewarded and revered, South Carolina's Strom Thurmond didn't retire until age 100 in 2002. Sen. Robert Byrd of West Virginia was the longest-serving senator when he died in office at 92 in 2010.

Now the oldest U.S. senator is 89-year-old Frank Lautenberg of New Jersey. The oldest congressman is Ralph Hall of Texas who turns 90 in May.

The legendary Alan Greenspan was about to turn 80 when he retired as chairman of the Federal Reserve in 2006; he still works as a consultant.

Elsewhere around the world, Cuba's Fidel Castro — one of the world's longest serving heads of state — stepped down in 2006 at age 79 due to an intestinal illness that nearly killed him, handing power to his younger brother Raul. But the island is an example of aged leaders pushing on well into their dotage. Raul Castro now is 81 and his two top lieutenants are also octogenarians. Later this month, he is expected to be named to a new, five-year term as president.

Other leaders who are still working:

—England's Queen Elizabeth, 86.

—Abdullah bin Abd al-Aziz al-Saud, king of Saudi Arabia, 88.

—Sabah al-Ahmad al-Jaber al-Sabah, emir of Kuwait, 83.

—Ruth Bader Ginsburg, U.S. Supreme Court associate justice, 79.

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Associated Press writers Paul Haven in Havana, Cuba; David Rising in Berlin; Seth Borenstein, Mark Sherman and Matt Yancey in Washington, and researcher Judy Ausuebel in New York contributed to this report.

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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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What heals traumatized kids? Answers are lacking

CHICAGO (AP) — Shootings and other traumatic events involving children are not rare events, but there's a startling lack of scientific evidence on the best ways to help young survivors and witnesses heal, a government-funded analysis found.

School-based counseling treatments showed the most promise, but there's no hard proof that anxiety drugs or other medication work and far more research is needed to provide solid answers, say the authors who reviewed 25 studies. Their report was sponsored by the federal Agency for Healthcare Research and Quality.

According to research cited in the report, about two-thirds of U.S. children and teens younger than 18 will experience at least one traumatic event, including shootings and other violence, car crashes and weather disasters. That includes survivors and witnesses of trauma. Most will not suffer any long-term psychological problems, but about 13 percent will develop symptoms of post-traumatic stress, including anxiety, behavior difficulties and other problems related to the event.

The report's conclusions don't mean that no treatment works. It's just that no one knows which treatments are best, or if certain ones work better for some children but not others.

"Our findings serve as a call to action," the researchers wrote in their analysis, published online Monday by the journal Pediatrics.

"This is a very important topic, just in light of recent events," said lead author Valerie Forman-Hoffman, a researcher at the University of North Carolina-Chapel Hill.

She has two young children and said the results suggest that it's likely one of them will experience some kind of trauma before reaching adulthood. "As a parent I want to know what works best," the researcher said.

Besides the December massacre at Sandy Hook Elementary School in Connecticut, other recent tragedies involving young survivors or witnesses include the fatal shooting last month of a 15-year-old Chicago girl gunned down in front of a group of friends; Superstorm Sandy in October; and the 2011 Joplin, Mo., tornado, whose survivors include students whose high school was destroyed.

Some may do fine with no treatment; others will need some sort of counseling to help them cope.

Studying which treatments are most effective is difficult because so many things affect how a child or teen will fare emotionally after a traumatic event, said Dr. Denise Dowd, an emergency physician and research director at Children's Mercy Hospitals and Clinics in Kansas City, Mo., who wrote a Pediatrics editorial.

One of the most important factors is how the child's parents handle the aftermath, Dowd said.

"If the parent is freaking out" and has difficulty controlling emotions, kids will have a tougher time dealing with trauma. Traumatized kids need to feel like they're in a safe and stable environment, and if their parents have trouble coping, "it's going to be very difficult for the kid," she said.

The researchers analyzed 25 studies of treatments that included anti-anxiety and depression drugs, school-based counseling, and various types of psychotherapy. The strongest evidence favored school-based treatments involving cognitive behavior therapy, which helps patients find ways to cope with disturbing thoughts and emotions, sometimes including talking repeatedly about their trauma.

This treatment worked better than nothing, but more research is needed comparing it with alternatives, the report says.

"We really don't have a gold standard treatment right now," said William Copeland, a psychologist and researcher at Duke University Medical Center who was not involved in the report. A lot of doctors and therapists may be "patching together a little bit of this and a little bit of that, and that might not add up to the most effective treatment for any given child," he said.

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Pediatrics: http://www.pediatrics.org

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After early start, worst of flu season may be over

NEW YORK (AP) — The worst of the flu season appears to be over.

The number of states reporting intense or widespread illnesses dropped again last week, and in a few states there was very little flu going around, U.S. health officials said Friday.

The season started earlier than normal, first in the Southeast and then spreading. But now, by some measures, flu activity has been ebbing for at least four weeks in much of the country. Flu and pneumonia deaths also dropped the last two weeks, the Centers for Disease Control and Prevention reported.

"It's likely that the worst of the current flu season is over," CDC spokesman Tom Skinner said.

But flu is hard to predict, he and others stressed, and there have been spikes late in the season in the past.

For now, states like Georgia and New York — where doctor's offices were jammed a few weeks ago — are reporting low flu activity. The hot spots are now the West Coast and the Southwest.

Among the places that have seen a drop: Lehigh Valley Hospital-Cedar Crest in Allentown, Pa., which put up a tent outside its emergency room last month to help deal with the steady stream of patients. There were about 100 patients each day back then. Now it's down to 25 and the hospital may pack up its tent next week, said Terry Burger, director of infection control and prevention for the hospital.

"There's no question that we're seeing a decline," she said.

In early December, CDC officials announced flu season had arrived, a month earlier than usual. They were worried, saying it had been nine years since a winter flu season started like this one. That was 2003-04 — one of the deadliest seasons in the past 35 years, with more than 48,000 deaths.

Like this year, the major flu strain was one that tends to make people sicker, especially the elderly, who are most vulnerable to flu and its complications

But back then, that year's flu vaccine wasn't made to protect against that bug, and fewer people got flu shots. The vaccine is reformulated almost every year, and the CDC has said this year's vaccine is a good match to the types that are circulating. A preliminary CDC study showed it is about 60 percent effective, which is close to the average.

So far, the season has been labeled moderately severe.

Like others, Lehigh Valley's Burger was cautious about making predictions. "I'm not certain we're completely out of the woods," with more wintry weather ahead and people likely to be packed indoors where flu can spread around, she said.

The government does not keep a running tally of flu-related deaths in adults, but has received reports of 59 deaths in children. The most — nine — were in Texas, where flu activity was still high last week. Roughly 100 children die in an average flu season, the CDC says

On average, about 24,000 Americans die each flu season, according to the CDC.

According to the CDC report, the number of states with intense activity is down to 19, from 24 the previous week, and flu is widespread in 38 states, down from 42.

Flu is now minimal in Florida, Kentucky, Maine, Montana, New Hampshire and South Carolina.

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CDC: http://www.cdc.gov/flu/

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