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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Huge study: 5 mental disorders share genetic links

WASHINGTON (AP) — The largest genetic study of mental illnesses to date finds five major disorders may not look much alike but they share some gene-based risks. The surprising discovery comes in the quest to unravel what causes psychiatric disorders and how to better diagnose and treat them.

The disorders — autism, attention deficit-hyperactivity disorder or ADHD, bipolar disorder, major depressive disorder and schizophrenia — are considered distinct problems. But findings published online Wednesday suggest they're related in some way.

"These disorders that we thought of as quite different may not have such sharp boundaries," said Dr. Jordan Smoller of Massachusetts General Hospital, one of the lead researchers for the international study appearing in The Lancet.

That has implications for learning how to diagnose mental illnesses with the same precision that physical illnesses are diagnosed, said Dr. Bruce Cuthbert of the National Institute on Mental Health, which funded the research.

Consider: Just because someone has chest pain doesn't mean it's a heart attack; doctors have a variety of tests to find out. But there's no blood test for schizophrenia or other mental illnesses. Instead, doctors rely on symptoms agreed upon by experts. Learning the genetic underpinnings of mental illnesses is part of one day knowing if someone's symptoms really are schizophrenia and not something a bit different.

"If we really want to diagnose and treat people effectively, we have to get to these more fine-grained understandings of what's actually going wrong biologically," Cuthbert explained.

Added Mass General's Smoller: "We are still in the early stages of understanding what are the causes of mental illnesses, so these are clues."

The Psychiatric Genomics Consortium, a collaboration of researchers in 19 countries, analyzed the genomes of more than 61,000 people, some with one of the five disorders and some without. They found four regions of the genetic code where variation was linked to all five disorders.

Of particular interest are disruptions in two specific genes that regulate the flow of calcium in brain cells, key to how neurons signal each other. That suggests that this change in a basic brain function could be one early pathway that leaves someone vulnerable to developing these disorders, depending on what else goes wrong.

For patients and their families, the research offers no immediate benefit. These disorders are thought to be caused by a complex mix of numerous genes and other risk factors that range from exposures in the womb to the experiences of daily life.

"There may be many paths to each of these illnesses," Smoller cautioned.

But the study offers a lead in the hunt for psychiatric treatments, said NIMH's Cuthbert. Drugs that affect calcium channels in other parts of the body are used for such conditions as high blood pressure, and scientists could explore whether they'd be useful for psychiatric disorders as well.

The findings make sense, as there is some overlap in the symptoms of the different disorders, he said. People with schizophrenia can have some of the same social withdrawal that's so characteristic of autism, for example. Nor is it uncommon for people to be affected by more than one psychiatric disorder.

___

Online:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60223-8/abstract

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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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Koop, who transformed surgeon general post, dies

With his long silver beard and uniform with braided trim, former Surgeon General 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.

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.

"A lot of people don't realize what an important role he 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," said Chris Collins, a vice president of amFAR, the Foundation for AIDS Research.

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 — Allen, Norman, David and Elizabeth. David, their youngest son, was killed in a mountain climbing accident when he was 20.

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

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

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

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

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

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

___

Ring reported from Montpelier, Vt. Cass reported from Washington. AP Medical Writer Lauran Neergaard in Washington 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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Scientists use 3-D printing to help grow an ear

WASHINGTON (AP) — Printing out body parts? Cornell University researchers showed it's possible by creating a replacement ear using a 3-D printer and injections of living cells.

The work reported Wednesday is a first step toward one day growing customized new ears for children born with malformed ones, or people who lose one to accident or disease.

It's part of the hot field of tissue regeneration, trying to regrow all kinds of body parts. Scientists hope using 3-D printing technology might offer a speedier method with more lifelike results.

If it pans out, "this enables us to rapidly customize implants for whoever needs them," said Cornell biomedical engineer Lawrence Bonassar, who co-authored the research published online in the journal PLoS One.

This first-step work crafted a human-shaped ear that grew with cartilage from a cow, easier to obtain than human cartilage, especially the uniquely flexible kind that makes up ears. Study co-author Dr. Jason Spector of Weill Cornell Medical Center is working on the next step — how to cultivate enough of a child's remaining ear cartilage in the lab to grow an entirely new ear that could be implanted in the right spot.

Wednesday's report is "a nice advancement," said Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest Baptist Medical Center, who wasn't involved in the new research.

Three-dimensional printers, which gradually layer materials to form shapes, are widely used in manufacturing. For medicine, Atala said the ear work is part of broader research that shows "the technology now is at the point where we can in fact print these 3-dimensional structures and they do become functional over time."

Today, people who need a new ear often turn to prosthetics that require a rod to fasten to the head. For children, doctors sometimes fashion a new ear from the stiffer cartilage surrounding ribs, but it's a big operation. Spector said the end result seldom looks completely natural. Hence the quest to use a patient's own cells to grow a replacement ear.

The Cornell team started with a 3-D camera that rapidly rotates around a child's head for a picture of the existing ear to match. It beams the ear's geometry into a computer, without the mess of a traditional mold or the radiation if CT scans were used to measure ear anatomy.

"Kids aren't afraid of it," said Bonassar, who used his then-5-year-old twin daughters' healthy ears as models.

From that image, the 3-D printer produced a soft mold of the ear. Bonassar injected it with a special collagen gel that's full of cow cells that produce cartilage — forming a scaffolding. Over the next few weeks, cartilage grew to replace the collagen. At three months, it appeared to be a flexible and workable outer ear, the study concluded.

Now Bonassar's team can do the process even faster by using the living cells in that collagen gel as the printer's "ink." The 3-D technology directly layers the gel into just the right ear shape for cartilage to cover, without having to make a mold first.

The next step is to use a patient's own cells in the 3-D printing process. Spector, a reconstructive surgeon, is focusing on children born without a fully developed external ear, a condition called microtia. They have some ear cartilage-producing cells in that tissue, just not enough. So he's experimenting with ways to boost those cells in the lab, "so we can grow enough of them from that patient to make an ear," he explained.

That hurdle aside, cartilage may be the tissue most amenable to growing with the help of 3-D printing technology, he said. That's because cartilage doesn't need blood vessels growing inside it to survive.

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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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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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States' choices set up national health experiment

WASHINGTON (AP) — President Barack Obama's health care overhaul is unfolding as a national experiment with American consumers as the guinea pigs: Who will do a better job getting uninsured people covered, the states or the feds?

The nation is about evenly split between states that decided by Friday's deadline they want a say in running new insurance markets and states that are defaulting to federal control because they don't want to participate in "Obamacare." That choice was left to state governments under the law: Establish the market or Washington will.

With some exceptions, states led by Democrats opted to set up their own markets, called exchanges, and Republican-led states declined.

Only months from the official launch, exchanges are supposed to make the mind-boggling task of buying health insurance more like shopping on Amazon.com or Travelocity. Millions of people who don't have employer coverage will flock to the new markets. Middle-class consumers will be able to buy private insurance, with government help to pay the premiums in most cases. Low-income people will be steered to safety net programs like Medicaid.

"It's an experiment between the feds and the states, and among the states themselves," said Robert Krughoff, president of Consumers' Checkbook, a nonprofit ratings group that has devised an online tool used by many federal workers to pick their health plans. Krughoff is skeptical that either the feds or the states have solved the technological challenge of making the purchase of health insurance as easy as selecting a travel-and-hotel package.

Whether or not the bugs get worked out, consumers will be able to start signing up Oct. 1 for coverage that takes effect Jan. 1. That's also when two other major provisions of the law kick in: the mandate that almost all Americans carry health insurance, and the rule that says insurers can no longer turn away people in poor health.

Barring last-minute switches that may not be revealed until next week, 23 states plus Washington, D.C., have opted to run their own markets or partner with the Obama administration to do so.

Twenty-six states are defaulting to the feds. But in several of those, Republican governors are trying to carve out some kind of role by negotiating with federal Health and Human Services Secretary Kathleen Sebelius. Utah's status is unclear. It received initial federal approval to run its own market, but appears to be reconsidering.

"It's healthy for the states to have various choices," said Ben Nelson, CEO of the National Association of Insurance Commissioners. "And there's no barrier to taking somebody else's ideas and making them work in your situation." A former U.S. senator from Nebraska, Nelson was one of several conservative Democrats who provided crucial votes to pass the overhaul.

States setting up their own exchanges are already taking different paths. Some will operate their markets much like major employers run their health plans, as "active purchasers" offering a limited choice of insurance carriers to drive better bargains. Others will open their markets to all insurers that meet basic standards, and let consumers decide.

Obama's Affordable Care Act remains politically divisive, but state insurance exchanges enjoy broad public support. Setting up a new market was central to former Republican presidential candidate Mitt Romney's health care overhaul as governor of Massachusetts. There, it's known as the Health Connector.

A recent AP poll found that Americans prefer to have states run the new markets by 63 percent to 32 percent. Among conservatives the margin was nearly 4-1 in favor of state control. But with some exceptions, including Idaho, Nevada and New Mexico, Republican-led states are maintaining a hands-off posture, meaning the federal government will step in.

"There is a sense of irony that it's the more conservative states" yielding to federal control, said Sandy Praeger, the Republican insurance commissioner in Kansas, a state declining to run its own exchange. First, she said, the law's opponents "put their money on the Supreme Court, then on the election. Now that it's a reality, we may see some movement."

They're not budging in Austin. "Texas is not interested in being a subcontractor to Obamacare," said Lucy Nashed, spokeswoman for Gov. Rick Perry, who remains opposed to mandates in the law.

In Kansas, Praeger supported a state-run exchange, but lost the political struggle to Gov. Sam Brownback. She says Kansans will be closely watching what happens in neighboring Colorado, where the state will run the market. She doubts that consumers in her state would relish dealing with a call center on the other side of the country. The federal exchange may have some local window-dressing but it's expected to function as a national program.

Christine Ferguson, director of the Rhode Island Health Benefits Exchange, says she expects to see a big shift to state control in the next few years. "Many of the states have just run out of time for a variety of reasons," said Ferguson. "I'd be surprised if in the longer run every state didn't want to have its own approach."

In some ways, the federal government has a head start on the states. It already operates the Medicare Plan Finder for health insurance and prescription plans that serve seniors, and the Federal Employees Health Benefits Program. Both have many of the features of the new insurance markets.

Administration officials are keeping mum about what the new federal exchange will look like, except that it will open on time and people in all 50 states will have the coverage they're entitled to by law.

Joel Ario, who oversaw planning for the health exchanges in the Obama administration, says "there's a rich dialogue going on" as to what the online shopping experience should look like. "To create a website like Amazon is a very complicated exercise," said Ario, now a consultant with Manatt Health Solutions.

He thinks consumers should be able to get one dollar figure for each plan that totals up all their expected costs for the year, including premiums, deductibles and copayments. Otherwise, scrolling through pages of insurance jargon online will be a sure turn-off.

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Clues to why most survived China melamine scandal

WASHINGTON (AP) — Scientists wondering why some children and not others survived one of China's worst food safety scandals have uncovered a suspect: germs that live in the gut.

In 2008, at least six babies died and 300,000 became sick after being fed infant formula that had been deliberately and illegally tainted with the industrial chemical melamine. There were some lingering puzzles: How did it cause kidney failure, and why wasn't everyone equally at risk?

A team of researchers from the U.S. and China re-examined those questions in a series of studies in rats. In findings released Wednesday, they reported that certain intestinal bacteria play a crucial role in how the body handles melamine.

The intestines of all mammals teem with different species of bacteria that perform different jobs. To see if one of those activities involves processing melamine, researchers from the University of North Carolina at Greensboro and Shanghai Jiao Tong University gave lab rats antibiotics to kill off some of the germs — and then fed them melamine.

The antibiotic-treated rats excreted twice as much of the melamine as rats that didn't get antibiotics, and they experienced fewer kidney stones and other damage.

A closer look identified why: A particular intestinal germ — named Klebsiella terrigena — was metabolizing melamine to create a more toxic byproduct, the team reported in the journal Science Translational Medicine.

Previous studies have estimated that fewer than 1 percent of healthy people harbor that bacteria species. A similar fraction of melamine-exposed children in China got sick, the researchers wrote. But proving that link would require studying stool samples preserved from affected children, they cautioned.

Still, the research is pretty strong, said microbiologist Jack Gilbert of the University of Chicago and Argonne National Laboratory, who wasn't involved in the new study.

More importantly, "this paper adds to a growing body of evidence which suggests that microbes in the body play a significant role in our response to toxicity and in our health in general," Gilbert said.

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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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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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Online:

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

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Southern diet, fried foods, may raise stroke risk

Deep-fried foods may be causing trouble in the Deep South. People whose diets are heavy on them and sugary drinks like sweet tea and soda were more likely to suffer a stroke, a new study finds.

It's the first big look at diet and strokes, and researchers say it might help explain why blacks in the Southeast — the nation's "stroke belt" — suffer more of them.

Blacks were five times more likely than whites to have the Southern dietary pattern linked with the highest stroke risk. And blacks and whites who live in the South were more likely to eat this way than people in other parts of the country were. Diet might explain as much as two-thirds of the excess stroke risk seen in blacks versus whites, researchers concluded.

"We're talking about fried foods, french fries, hamburgers, processed meats, hot dogs," bacon, ham, liver, gizzards and sugary drinks, said the study's leader, Suzanne Judd of the University of Alabama in Birmingham.

People who ate about six meals a week featuring these sorts of foods had a 41 percent higher stroke risk than people who ate that way about once a month, researchers found.

In contrast, people whose diets were high in fruits, vegetables, whole grains and fish had a 29 percent lower stroke risk.

"It's a very big difference," Judd said. "The message for people in the middle is there's a graded risk" — the likelihood of suffering a stroke rises in proportion to each Southern meal in a week.

Results were reported Thursday at an American Stroke Association conference in Honolulu.

The federally funded study was launched in 2002 to explore regional variations in stroke risks and reasons for them. More than 20,000 people 45 or older — half of them black — from all 48 mainland states filled out food surveys and were sorted into one of five diet styles:

—Southern: Fried foods, processed meats (lunchmeat, jerky), red meat, eggs, sweet drinks and whole milk.

—Convenience: Mexican and Chinese food, pizza, pasta.

—Plant-based: Fruits, vegetables, juice, cereal, fish, poultry, yogurt, nuts and whole-grain bread.

—Sweets: Added fats, breads, chocolate, desserts, sweet breakfast foods.

—Alcohol: Beer, wine, liquor, green leafy vegetables, salad dressings, nuts and seeds, coffee.

"They're not mutually exclusive" — for example, hamburgers fall into both convenience and Southern diets, Judd said. Each person got a score for each diet, depending on how many meals leaned that way.

Over more than five years of follow-up, nearly 500 strokes occurred. Researchers saw clear patterns with the Southern and plant-based diets; the other three didn't seem to affect stroke risk.

There were 138 strokes among the 4,977 who ate the most Southern food, compared to 109 strokes among the 5,156 people eating the least of it.

There were 122 strokes among the 5,076 who ate the most plant-based meals, compared to 135 strokes among the 5,056 people who seldom ate that way.

The trends held up after researchers took into account other factors such as age, income, smoking, education, exercise and total calories consumed.

Fried foods tend to be eaten with lots of salt, which raises blood pressure — a known stroke risk factor, Judd said. And sweet drinks can contribute to diabetes, the disease that celebrity chef Paula Deen — the queen of Southern cuisine — revealed she had a year ago.

The National Institute of Neurological Disorders and Stroke, drugmaker Amgen Inc. and General Mills Inc. funded the study.

"This study does strongly suggest that food does have an influence and people should be trying to avoid these kinds of fatty foods and high sugar content," said an independent expert, Dr. Brian Silver, a Brown University neurologist and stroke center director at Rhode Island Hospital.

"I don't mean to sound like an ogre. I know when I'm in New Orleans I certainly enjoy the food there. But you don't have to make a regular habit of eating all this stuff."

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

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New whooping cough strain in US raises questions

NEW YORK (AP) — Researchers have discovered the first U.S. cases of whooping cough caused by a germ that may be resistant to the vaccine.

Health officials are looking into whether cases like the dozen found in Philadelphia might be one reason the nation just had its worst year for whooping cough in six decades. The new bug was previously reported in Japan, France and Finland.

"It's quite intriguing. It's the first time we've seen this here," said Dr. Tom Clark of the Centers for Disease Control and Prevention.

The U.S. cases are detailed in a brief report from the CDC and other researchers in Thursday's New England Journal of Medicine.

Whooping cough is a highly contagious disease that can strike people of any age but is most dangerous to children. It was once common, but cases in the U.S. dropped after a vaccine was introduced in the 1940s.

An increase in illnesses in recent years has been partially blamed on a version of the vaccine used since the 1990s, which doesn't last as long. Last year, the CDC received reports of 41,880 cases, according to a preliminary count. That included 18 deaths.

The new study suggests that the new whooping cough strain may be why more people have been getting sick. Experts don't think it's more deadly, but the shots may not work as well against it.

In a small, soon-to-be published study, French researchers found the vaccine seemed to lower the risk of severe disease from the new strain in infants. But it didn't prevent illness completely, said Nicole Guiso of the Pasteur Institute, one of the researchers.

The new germ was first identified in France, where more extensive testing is routinely done for whooping cough. The strain now accounts for 14 percent of cases there, Guiso said.

In the United States, doctors usually rely on a rapid test to help make a diagnosis. The extra lab work isn't done often enough to give health officials a good idea how common the new type is here, experts said.

"We definitely need some more information about this before we can draw any conclusions," the CDC's Clark said.

The U.S. cases were found in the past two years in patients at St. Christopher's Hospital for Children in Philadelphia. One of the study's researchers works for a subsidiary of Johnson & Johnson, which makes a version of the old whooping cough vaccine that is sold in other countries.

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JournaL: http://www.nejm.org

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