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.

___

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

__

Online:

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

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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.

___

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

__

Online:

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

Read More..

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

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

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Vt. lye victim gets new face at Boston hospital

BOSTON (AP) — A Vermont nurse disfigured in a 2007 lye attack has received a new face at a Boston hospital.

Carmen Blandin Tarleton's full facial transplant at Brigham & Women's Hospital included transplanting a female donor's facial skin to Tarleton's neck, nose and lips, along with facial muscles, arteries and nerves.

Hospital officials say the 44-year-old Thetford, Vt., woman suffered burns on more than 80 percent of her body after her estranged husband attacked her.

Tarleton's sister said Wednesday she showed "great appreciation" for the gift she's been given.

The donor's family believes their loved one's spirit lives on in Tarleton.

Tarleton has undergone more than 50 surgeries. The latest took 15 hours and included a team of more than 30 medical professionals.

Tarleton once worked as a transplant nurse.

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C. Everett Koop, 'rock star' surgeon general, dies

NEW YORK (AP) — Dr. C. Everett Koop has long been regarded as the nation's doctor— even though it has been nearly a quarter-century since he was surgeon general.

Koop, who died Monday at his home in Hanover, N.H., at age 96, was by far the best known and most influential person to carry that title. Koop, a 6-foot-1 evangelical Presbyterian with a biblical prophet's beard, donned a public health uniform in the early 1980s and became an enduring, science-based national spokesman on health issues.

He served for eight years during the Reagan administration and was a breed apart from his political bosses. He thundered about the evils of tobacco companies during a multiyear campaign to drive down smoking rates, and he became the government's spokesman on AIDS when it was still considered a "gay disease" by much of the public.

"He really changed the national conversation, and he showed real courage in pursuing the duties of his job," said Chris Collins, a vice president of amfAR, the Foundation for AIDS Research.

Even before that, he had been a leading figure in medicine. He was one of the first U.S. doctors to specialize in pediatric surgery at a time when children with complicated conditions were often simply written off as untreatable. In the 1950s, he drew national headlines for innovative surgeries such as separating conjoined twins.

His medical heroics are well noted, but he may be better remembered for transforming from a pariah in the eyes of the public health community into a remarkable servant who elevated the influence of the surgeon general — if only temporarily.

"He set the bar high for all who followed in his footsteps," said Dr. Richard Carmona, who served as surgeon general a decade later under President George W. Bush.

Koop's religious beliefs grew after the 1968 death of his son David in a mountain-climbing accident, and he became an outspoken opponent of abortion. His activism is what brought him to the attention of the administration of President Ronald Reagan, who decided to nominate him for surgeon general in 1981. Though once a position with real power, surgeon generals had been stripped of most of their responsibilities in the 1960s.

By the time Koop got the job, the position was kind of a glorified health educator.

But Koop ran with it. One of his early steps involved the admiral's uniform that is bestowed to the surgeon general but that Koop's predecessors had worn only on ceremonial occasions. In his first year in the post, Koop stopped wearing his trademark bowties and suit jackets and instead began wearing the uniform, seeing it as a way to raise the visual prestige of the office.

In those military suits, he surprised the officials who had appointed him by setting aside his religious beliefs and feelings about abortion and instead waging a series of science-based public health crusades.

He was arguably most effective on smoking. He issued a series of reports that detailed the dangers of tobacco smoke, and in speeches began calling for a smoke-free society by the year 2000. He didn't get his wish, but smoking rates did drop from 38 percent to 27 percent while he was in office — a huge decline.

Koop led other groundbreaking initiatives, but perhaps none is better remembered than his work on AIDS.

The disease was first identified in 1981, before Koop was officially in office, and it changed U.S. society. It destroyed the body's immune system and led to ghastly death, but initially was identified in gay men, and many people thought of it as something most heterosexuals didn't have to worry about.

U.S. scientists worked hard to identify the virus and work on ways to fight it, but the government's health education and policy efforts moved far more slowly. Reagan for years was silent on the issue. Following mounting criticism, Reagan in 1986 asked Koop to prepare a report on AIDS for the American public.

His report, released later that year, stressed that AIDS was a threat to all Americans and called for wider use of condoms and more comprehensive sex education, as early as the third grade. He went on to speak frankly about AIDS in an HBO special and engineered the mailing of an educational pamphlet on AIDS to more than 100 million U.S. households in 1988.

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's speeches and empathetic approach made him a hero to a wide swath of America, including public health workers, gay activists and journalists. Some called him a "scientific Bruce Springsteen." AIDS activists chanted "Koop, Koop" at his appearances and booed other officials.

"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."

Koop 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.

He got static from some staff at the White House for his actions, but Reagan himself never tried to silence Koop. 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.

After his death was reported Monday, the tributes poured forth, including a statement from New York Mayor Michael Bloomberg, who has made smoking restrictions a hallmark of his tenure.

"The nation has lost a visionary public health leader today with the passing of former Surgeon General C. Everett Koop, who was born and raised in Brooklyn," Bloomberg said. "Outspoken on the dangers of smoking, his leadership led to stronger warning labels on cigarettes and increased awareness about second-hand smoke, creating an environment that helped millions of Americans to stop smoking — and setting the stage for the dramatic changes in smoking laws that have occurred over the past decade."

Dr. Anthony Fauci of the National Institutes of Health taught Koop what was known about AIDS during quiet after-hours talks in the early 1980s and became a close friend.

"A less strong person would have bent under the pressure," Fauci said. "He was driven by what's the right thing to do."

Carmona, a surgeon general years later, said Koop was a mentor who preached the importance of staying true to the science in speeches and reports — even when it made certain politicians uncomfortable.

"We remember him for the example he set for all of us," Carmona said.

Koop's nomination originally was met with staunch opposition. Women's groups and liberal politicians complained Reagan had selected him only because of his conservative views, especially his staunch opposition to abortion.

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 as surgeon general after he told a Senate panel he would not use the post to promote his religious ideology. He kept his word and eventually won wide respect with his blend of old-fashioned values, pragmatism and empathy.

Koop was modest about his accomplishments, saying before leaving office in 1989, "My only influence was through moral suasion."

The office declined after that. Few of his successors had his speaking ability or stage presence. Fewer still were able to secure the support of key political bosses and overcome the meddling of everyone else. The office gradually lost prestige and visibility, and now has come to a point where most people can't name the current surgeon general. (It's Dr. Regina Benjamin.)

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."

He maintained his personal opposition to abortion. 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.

Worried that medicine had lost old-fashioned caring and personal relationships between doctors and patients, Koop opened an institute at Dartmouth College in New Hampshire 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 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.

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

He 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.

___

Contributing to this report were Associated Press writers Wilson Ring in Montpelier, Vt.; Jeff McMillan in Philadelphia; and AP Medical Writer Lauran Neergaard in Washington.

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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.

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FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla (kad-SY'-luh) from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a double-shot of anti-tumor poison.

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

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug.

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was co-developed by South San Francisco-based Genentech and ImmunoGen Inc., of Waltham, Mass. ImmunoGen developed the technology that binds the drug ingredients together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 33 cents, or 2.27 percent, to $14.63 in midday trading.

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Flu shot did poor job against worst bug in seniors

ATLANTA (AP) — For those 65 and older, this season's flu shot is only 9 percent effective against the most common and dangerous flu bug, according to a startling new government report.

Flu vaccine tends to protect younger people better than older ones and never works as well as other kinds of vaccines. But experts say the preliminary results for seniors are disappointing and highlight the need for a better vaccine.

For all age groups, the vaccine's effectiveness is moderate at 56 percent, which is nearly as well as other flu seasons, the Centers for Disease Control and Prevention said Thursday.

For those 65 and older, it is 27 percent effective against the three strains in the vaccine, the lowest in about a decade but not far below from what's expected. But the vaccine did a particularly poor job of protecting older people against the harshest flu strain, which is causing most of the illnesses this year. CDC officials say it's not clear why.

Vaccinations are now recommended for anyone over 6 months, and health officials stress that some vaccine protection is better than none at all. While it's likely that older people who were vaccinated are still getting sick, many of them may be getting less severe symptoms.

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

To be sure, the preliminary data for seniors 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. Older people are most vulnerable to flu and its complications, and the nation has seen some of the highest hospitalization rates for people 65 and older in a decade.

Flu viruses tend to mutate more quickly than others, and it's not unusual for multiple strains to be spreading at the same time. A new vaccine is formulated each year targeting the three strains expected to be the major threats. But that involves guesswork.

Because of these challenges, 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. The 56 percent effectiveness figure means people have a 56 percent lower chance of winding up at the doctor for treatment of flu symptoms.

For seniors, 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.

Older people have weaker immune systems that don't respond as well to flu shots. That's why a high-dose version was recently made available for those 65 and older. The new study was too small to show whether that made a difference this year.

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 flu shots and who hadn't. An earlier study put the vaccine's overall effectiveness slightly higher, at 62 percent.

The CDC's Bresee said there's a danger in providing preliminary results because it may result in people doubting — or skipping — flu shots. But the data was 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.

The new data highlights an evolution in how experts are evaluating flu vaccine effectiveness. For years, it was believed that if the viruses in the vaccine matched the ones spreading around the country, then the vaccine would be effective. This year's shot was a good match to the bugs going around this winter, including the harsher H3N2 that tends to make people sicker.

But the season proved to be a moderately severe one, with many illnesses occurring in people who'd been vaccinated.

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Online:

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

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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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UK patient dies from SARS-like coronavirus

LONDON (AP) — A patient being treated for a mysterious SARS-like virus has died, a British hospital said Tuesday.

Queen Elizabeth Hospital in Birmingham, central England, said the coronavirus victim was also being treated for "a long-term, complex unrelated health problem" and already had a compromised immune system.

A total of 12 people worldwide have been diagnosed with the disease, six of whom have died.

The virus was first identified last year in the Middle East. Most of those infected had traveled to Qatar, Saudi Arabia, Jordan or Pakistan, but the person who just died is believed to have caught it from a relative in Britain, where there have been four confirmed cases.

The new coronavirus is part of a family of viruses that cause ailments including the common cold and SARS. In 2003, a global outbreak of SARS killed about 800 people worldwide.

Health experts still aren't sure exactly how humans are being infected. The new coronavirus is most closely related to a bat virus and scientists are considering whether bats or other animals like goats or camels are a possible source of infection.

Britain's Health Protection Agency has said while it appears the virus can spread from person to person, "the risk of infection in contacts in most circumstances is still considered to be low."

Officials at the World Health Organization said the new virus has probably already spread between humans in some instances. In Saudi Arabia last year, four members of the same family fell ill and two died. And in a cluster of about a dozen people in Jordan, the virus may have spread at a hospital's intensive care unit.

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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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Report: Tracking system needed to fight fake drugs

WASHINGTON (AP) — Fighting the problem of fake drugs will require putting medications through a chain of custody like U.S. courts require for evidence in a trial, the Institute of Medicine reported Wednesday.

The call for a national drug tracking system comes a week after the Food and Drug Administration warned doctors, for the third time in about a year, that it discovered a counterfeit batch of the cancer drug Avastin that lacked the real tumor-killing ingredient.

Fake and substandard drugs have become an increasing concern as U.S. pharmaceutical companies move more of their manufacturing overseas. The risk made headlines in 2008 when U.S. patients died from a contaminated blood thinner imported from China.

The Institute of Medicine report made clear that this is a global problem that requires an international response, with developing countries especially at risk from phony medications. Drug-resistant tuberculosis, for example, is fueled in part by watered-down medications sold in many poor countries.

"There can be nothing worse than for a patient to take a medication that either doesn't work or poisons the patient," said Lawrence O. Gostin, a professor of health law at Georgetown University who led the IOM committee that studied how to combat the growing problem.

A mandatory drug-tracking system could use some form of barcodes or electronic tags to verify that a medication and the ingredients used to make it are authentic at every step, from the manufacturing of the active ingredient all the way to the pharmacy, he said. His committee examined fakes so sophisticated that health experts couldn't tell the difference between the packaging of the FDA-approved product and the look-alike.

"It's unreliable unless you know where it's been and can secure each point in the supply chain," Gostin said.

Patient safety advocates have pushed for that kind of tracking system for years, but attempts to include it in FDA drug-safety legislation last summer failed.

The report also concluded that:

—The World Health Organization should develop an international code of practice that sets guidelines for monitoring, regulation and law enforcement to crack down on fake drugs.

—States should beef up licensing requirements for the wholesalers and distributors who get a drug from its manufacturer to the pharmacy, hospital or doctor's office.

__Internet pharmacies are a particularly weak link, because fraudulent sites can mimic legitimate ones. The report urged wider promotion of the National Association of Boards of Pharmacy's online accreditation program as a tool to help consumers spot trustworthy sites.

The Institute of Medicine is an independent organization that advises the government on health matters.

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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 RTI International, a North Carolina-based nonprofit research group.

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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