Thursday, June 30, 2011

Medicare confirms payment for prostate cancer drug (AP)

WASHINGTON � Medicare officials confirmed Thursday that the program will cover the $93,000 price tag for prostate cancer drug Provenge, an innovative therapy that typically gives men suffering from an incurable stage of the disease an extra four months to live.

The decision from the Centers for Medicare and Medicaid essentially reiterates an earlier proposed ruling that the biotech drug, made by Dendreon Corp., is a "reasonable and necessary" medicine. As expected, the government will cover the cost for men who meet the drug's approved criteria: those with prostate disease that has spread throughout the body and has not responded to hormone therapy or radiation. The government will not pay for alternate, or so called "off-label," use.

"We do not believe there is any persuasive evidence for the off-label use," of Provenge, the agency concluded in the ruling, posted online late Thursday.

About 240,000 new cases of prostate cancer are diagnosed each year in the U.S. and the disease claims over 33,000 lives annually, according to the American Cancer Society. The decision ensures that tens of thousands of men will be able to take the drug through the government-backed health care plan that covers seniors. With government reimbursement, analysts estimate Provenge could rack up $1 billion in sales next year. The decision is important for Dendreon because most prostate cancer patients are 65 or older.

The infused drug is a first-of-a-kind treatment in that each dose is customized to work with each individual patient's immune system. The drug is given in three infusions over the course of one month.

Medicare is legally prohibited from considering price when deciding whether to pay for a new treatment. But Provenge's steep price tag had generated debate about the cost of new drugs and the government's role in paying for them, especially against the political backdrop of health care reform and the rising cost of Medicare given the large number of baby boomers.

Seattle-based Dendreon says Provenge's price reflects the more than $1 billion spent researching and developing the drug. And prostate cancer patients point out that the median survival time with Provenge is double that of chemotherapy, which is about two months and is marked by painful side effects.

Each regimen of Provenge must be tailored to the immune system of the individual patient using a time-consuming formulation process. Doctors collect special blood cells from each patient that help the immune system recognize cancer as a threat. The cells are mixed with a protein found on most prostate cancer cells and another substance to rev up the immune system, and then given back to the patient as three infusions two weeks apart.

Provenge is the first federally-approved cancer drug that uses the body's own immune system to fight the disease, offering an alternative to chemotherapy drugs that attack cancerous and healthy cells at the same time.

On Wednesday, Dendreon announced it received federal regulatory approval to open a second manufacturing facility in Los Angeles, in addition to its primary facility in New Jersey. The company hopes to open a third facility in Atlanta by the end of August.

Shares of Dendreon rose 96 cents, or 2.4 percent, to $40.40 in afterhours trading. The stock had closed the regular session down $1.06, or 2.6 percent, at $39.44.



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17 infants die in 48 hours at 1 Indian hospital (AP)

NEW DELHI � At least 17 infants have died in the last 48 hours at a government-run hospital in eastern India and the state is investigating, media reported Thursday.

Television news channels showed images of weeping and wailing parents outside the B.C. Roy Hospital for Children in Kolkata, the capital of West Bengal.

The hospital head D. Pal told Press Trust of India the babies were either premature, suffering from septicemia or had low birth weight problems. He denied any negligence by the hospital.

PTI quoted the state's top elected official, Mamata Banerjee, as saying her government had ordered an investigation.

In 2006, 22 infants died in three days at the same hospital because of prematurity or acute forms of either meningitis, encephalitis or septicemia, the hospital said at the time.

State-run hospitals in India are often overcrowded and ill-equipped to manage the large number of patients that come to them desperate for medical care.

India's infant mortality rate is higher than the world average. It ranks 50th of 222 countries and territories, with about 48 deaths per 1,000 live births estimated this year, according to the CIA World Factbook.



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AP Exclusive: Fuzzy math in health law formula (AP)

WASHINGTON � Older adults of the same age and income with similar medical histories would pay sharply different amounts for private health insurance due to what appears to be an unintended consequence of the new health care law.

Aware of the problem, the administration says it is exploring options to address a potential disparity that could mean added controversy for President Barack Obama's health care overhaul. The law expands coverage to more than 30 million uninsured people and would require most Americans to carry insurance.

The glitch mainly affects older adults who are too young for a Medicare card but have reached 62, when people can qualify for early retirement from Social Security. Sixty-two is the most common age at which Americans start taking Social Security, although their monthly benefit is reduced.

As the health care law is now written, those who take early retirement would get a significant break on health insurance premiums. That's because part or all of their Social Security benefits would not count as income in figuring out whether they can get federal subsidies to help pay for coverage until they become eligible for Medicare at 65.

"There is an equity issue here," said Robert Laszewski, a former health insurance executive turned policy consultant. "If you get a job for 40 hours a week, you're going to pay more for your health insurance than if you don't get a job."

The Obama administration says it is working on the problem.

"We are monitoring this issue and exploring options that would take into account the needs of Social Security beneficiaries, many of whom are disabled or individuals of limited means," Emily McMahon, a top Treasury Department policy official, said in a statement to The Associated Press.

Other officials, speaking on condition of anonymity because the issue is politically sensitive, said the administration is concerned because the situation could create a perception that some people are getting a worse deal compared with their less-industrious peers.

McMahon doubted that what amounts to a hefty health care discount would start a stampede toward early retirement at a time when many experts are urging older Americans to stay on the job longer. Only a "limited number of individuals" would decide they're better off not working, she said.

To see how the Social Security wrinkle would work, consider a hypothetical example of two neighbors on the same block.

They are both 62 and have the same income of $39,500 a year. But one gets all his income from working, while the other gets $20,000 from part-time work and $19,500 from Social Security.

Neither of them gets health insurance on the job. Instead, they purchase it individually.

Starting in 2014, they would get their coverage through a new online health insurance market called an exchange. Millions of people in the exchanges would get federal tax credits to make their premiums more affordable. Less-healthy consumers could not be charged more because of their medical problems.

The neighbor who is getting Social Security would pay an estimated $206 a month in premiums.

Half of his income from Social Security, or $9,750, would not be counted in figuring his federal health insurance tax credit. On paper, he would look poorer. So he would get a bigger tax credit to offset his premiums.

But the neighbor who makes all his income from work would not be able to deduct any of it. He would pay $313 for health insurance, or about 50 percent more.

The estimates were produced using an online calculator from the nonpartisan Kaiser Family Foundation.

The disparities appear to be even greater for married couples and families in which at least one member is getting Social Security. With a bigger household, both the cost of coverage and the federal subsidies involved are considerably larger.

The glitch seems to be the result of an effort by Congress to make things simpler. Lawmakers decided to use the definition of income in the tax code, which protects Social Security benefits from taxation.

"The practical effect is if more of your income is in the form of Social Security benefits, you are going to be eligible for bigger tax credits in the exchange," said Chapin White, a senior researcher at the nonpartisan Center for Studying Health System Change.

It's unclear whether the Obama administration can fix the problem with a regulation, or whether it will have to go back to Congress. In case of the latter, it will have to deal with Republicans eager to repeal the health care law.

The decision to use the tax code's definition of income for the health care law has created other problems.

Medicare's top number-cruncher is warning that up to 3 million middle-class people in households that get at least part of their income from Social Security could suddenly become eligible for nearly free coverage through Medicaid, the federal-state safety net program for the poor. Chief Actuary Richard Fosters says that situation "just doesn't make sense."

___

Online:

Kaiser Health Reform Subsidy Calculator: http://tinyurl.com/ydopqx7



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Study suggests UN force brought cholera to Haiti (AP)

PORT-AU-PRINCE, Haiti � Evidence "strongly suggests" that a United Nations peacekeeping mission brought a cholera strain to Haiti that has killed thousands of people, a study by a team of epidemiologists and physicians says.

The study is the strongest argument yet that newly-arrived Nepalese peacekeepers at a base near the town of Mirebalais brought with them the cholera, which spread through the waterways of the Artibonite region and elsewhere in this impoverished Caribbean country.

The disease has killed more than 5,500 people and sickened more than 363,000 others since it was discovered in October, according to the Haitian government.

"Our findings strongly suggest that contamination of the Artibonite (river) and 1 of its tributaries downstream from a military camp triggered the epidemic," said the report in the July issue of Emerging Infectious Diseases, a journal of the U.S. Centers for Disease Control and Prevention.

The article says there is "an exact correlation" in time and place between the arrival of a Nepalese battalion from an area of its South Asian homeland that was experiencing a cholera outbreak and the appearance of the first cases in the Meille river a few days later.

The remoteness of the Meille river in central Haiti and the absence of other factors make it unlikely that the cholera strain could have come to Haiti in any other way, the report says.

In an email U.N. mission spokeswoman Sylvie Van Den Wildenberg didn't comment on the findings of the article published in the CDC journal, referring only to a study released in May by a U.N.-appointed panel.

That panel's report found that the cholera outbreak was caused by a South Asian strain imported by human activity that contaminated the Meille river where the U.N. base of the Nepalese peacekeepers is located. The study also found that bad sanitation at the camp would've made contamination of the water system possible.

But the U.N. report refrained from blaming any single group for the outbreak. While no other potential source of the bacteria itself was named, the report attributed the outbreak to a "confluence of circumstances," including a lack of water infrastructure in Haiti and Haitians' dependence on the river system.

The panel's report was ordered by U.N. Secretary-General Ban Ki-moon as anti-U.N. protests spread in Haiti and mounting circumstantial evidence pointed to the troops.

Before that, for nearly two months after the outbreak last October, the United Nations, CDC and World Health Organization refused to investigate the origin of the cholera, saying that it was more important to treat patients than to try to figure out the source.

The article published in the CDC journal comes as health workers in Haiti wrestle with a spike in the number of cholera cases brought on by several weeks of rainfall. The aid group Oxfam said earlier this month that its workers were treating more than 300 new cases a day, more than three times what they saw when the disease peaked in the fall.

Cholera is caused by a bacteria that produces severe diarrhea and is contracted by eating or drinking contaminated food or water.

The disease has spread to the neighboring Dominican Republic, where more than 36 deaths have been reported since November.

Epidemiologist Renaud Piarroux, the lead author of the CDC journal article, was initially sent by the French government in late 2010 to investigate the origins of Haiti's outbreak. He authored a report for U.N. and Haitian officials that said the Nepalese peacekeepers likely caused the outbreak, a copy of which was obtained at the time by the AP.

The latest study was more complete and its methodology was reviewed by a group of scientists.

The new study argues it is important for scientists to determine the origin of cholera outbreaks and how they spread in order to eliminate "accidentally imported disease."

Moreover, the study says, figuring out the source of a cholera epidemic would help health workers better treat and prevent cholera by minimizing the "distrust associated with the widespread suspicions of a cover-up of a deliberate importation of cholera."

It also argues that demonstrating an imported origin would compel "international organizations to reappraise their procedures."

After cholera surfaced last fall, many Haitians believed the Nepalese peacekeepers were to blame, straining relations between the population and U.N. personnel and sparking angry protests. On the streets, cholera has become slang for something that must be banished from Haiti.

The new study is acknowledged in a commentary by a pair of public health experts affiliated with the CDC.

"However it occurred, there is little doubt that the organism was introduced to Haiti by a traveler from abroad, and this fact raises important public health considerations," wrote Scott Dowell, director of the CDC's Division of Global Disease Detection and Emergency Response, and Christopher Braden, a medical epidemiologist with the CDC.

___

Associated Press writer Trenton Daniel reported this story from Port-au-Prince and Jonathan M. Katz reported from Mexico City.

___

Trenton Daniel can be followed at http://twitter.com/trentondaniel; Jonathan M. Katz can be followed at http://twitter.com/KatzOnEarth.



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Wednesday, June 29, 2011

E. coli outbreak may be traced to Egypt seeds (AP)

ROME � European food and disease prevention authorities said Wednesday they are investigating whether the E. coli outbreak in Germany and France may be traced back to fenugreek seeds imported from Egypt either in 2009 or last year.

The European Center for Disease Prevention and Control and the European Food Safety Authority said in a joint report that "there is still much uncertainty about whether this is truly the common cause of all the infections."

The report said "fenugreek seeds imported from Egypt either in 2009 and/or 2010 are implicated in both outbreaks." Fenugreek seeds are commonly used in the preparation of pickles and curry powders as well as Indian, Ethiopian and Yemeni cuisine.

However, further investigation was necessary, said the report.

The death toll in Europe's E. coli outbreak has risen by three to at least 47, according to German authorities. Germany's disease control center said earlier this week that 46 deaths have now been reported in the country. One person has died in Sweden.

In France, eight case have been reported so far. Seven people have been hospitalized in the Bordeaux region and another person was released.

The report said that a 2009 lot of fenugreek seeds appeared to be implicated in the outbreak in France and a 2010 lot in the German outbreak. But it said this possible link does not explain the case in Sweden, where no consumption of sprouts has been implicated.

Many questions were still unanswered about the source of the E. coli.

A further 119 cases have been reported in a total of 15 other countries. The source has been traced to a vegetable sprout farm in northern Germany.

The World Health Organization said it considers an outbreak in France separate. But it also said that, of the eight French cases, three of them carried the same bacterial strains as in Germany.

The report said the clinical picture of the French cases was similar to that of German cases.



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Lung cancer scans: False alarms amid lives saved (AP)

Full results of a big study that showed some smokers' lives could be saved by screening with lung scans now reveal more clearly what the risks are: There's a good chance of a false alarm.

Of those who got the recommended annual scans for three years, 4 out of 10 had a suspicious finding on at least one scan and were advised to have a follow-up test or biopsy. And more than 95 percent of them turned out to have nothing wrong.

The results out Wednesday give the first detailed look at the benefits and risks of screening longtime current or former smokers with special X-rays called CT scans. The government stopped the study last fall after seeing the scans were saving lives.

Most insurers don't cover the scans because no major groups currently recommend them.

"No one should rush off and get one of these scans for screening until we've thought more about it," said Dr. Christine Berg of the National Cancer Institute, the study's main sponsor.

But guidance on smoker screening is likely to change with the study's results, which may help the nation's 94 million current and former smokers decide whether to be screened.

"The question has changed to how are we going to do this," not whether we should, said Dr. Harold "Hal" Sox, a Dartmouth professor who used to head the government task force that shapes policy on screening tests. He wrote an editorial with the results, published online Wednesday by the New England Journal of Medicine.

The study tested CT scans versus ordinary chest X-rays in 53,454 people over 55 with more than 30 pack-years of smoking: a pack a day for 30 years or two packs for 15 years. No one knows if younger or less frequent smokers would benefit from screening.

The study used top medical centers around the nation and low-radiation-dose machines. It involved skilled doctors who did less invasive tests in place of many biopsies and had far lower death rates when they did operate for lung cancer than is usual. The lower risk of death among those screened with scans in the study reflects all these things.

"This is what happens when people get screened in the best of centers. When people start getting screened anyplace ... the results may not be, and are likely not to be, as good," warned Dr. Otis Brawley, chief medical officer of the American Cancer Society.

Numbers to know:

_Three. The number of scans, one each year, that showed benefit in this study. No one knows if a single scan or testing less often would help.

_Twenty percent. The reduction in the risk of dying from lung cancer among those given CT scans (356 deaths versus 443 in the X-ray group).

_Seven percent. The reduction in the risk of dying from any cause during the study (1,877 deaths in the CT group versus 2,000 in X-ray group).

_About 320. The number of people who would have to be scanned for three years to prevent a single death from lung cancer. That's impressive when compared to the 1,339 women in their 50s who would need to have mammograms for several years to avoid one breast cancer death. However, mammograms are cheaper and involve less radiation so the risks and benefits aren't quite the same.

_One percent. The odds of dying from surgery for lung cancer among those in the study. In general practice, it's 4 percent.

_$300 to $1,200. The average range of charges for a scan. At some private practices it's up to $2,500 and "there's a group in Hollywood that's charging more than that," said Berg, of the National Cancer Institute.

Researchers plan a cost-effectiveness study and may compare the benefit from scans to smoking cessation efforts.

"People should not take this positive study as `now it is safe to smoke,'" because it isn't, and quitting remains the best way to lower cancer risk, Brawley said.

The cancer society and other medical groups expect to have screening advice for the public "in a matter of months," said Dr. Bruce Johnson, a lung cancer expert at the Dana-Farber Cancer Institute in Boston and a board member of the American Society of Clinical Oncology, doctors who treat the disease.

"Can society afford it? This comes with a substantial cost," he said of screening.

___

Online:

New England Journal: http://www.nejm.org

Study Q&A: http://www.cancer.gov/newscenter/qa/2002/nlstqaQA

Video discussion: http://www.youtube.com/watch?vhY6GQnO75Mo

Screening info: http://www.cancer.gov/cancertopics/types/lung

___

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



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Researchers analyze gene changes in ovarian cancer (AP)

LOS ANGELES � Researchers analyzing the genetic makeup of ovarian cancer tumors have found a gene mutation that is surprisingly frequent, suggesting it plays a key role in driving the cancer.

The finding, appearing in Thursday's issue of the journal Nature, may eventually lead to tests for earlier diagnosis of the disease and to better treatment. Ovarian cancer kills nearly 14,000 women in the United States each year. It's usually not spotted until at an advanced stage.

The gene sequencing was carried out by The Cancer Genome Atlas, a federally funded network of medical centers that analyzed 316 ovarian tumors.

Scientists found that 96 percent of the tumors had mutated TP53 genes. The mutations were not present in normal tissue from the patients, showing they arose within the tumors. Normally, the gene directs the cell how to make a protein that acts as a tumor suppressor, keeping cells from growing and dividing uncontrollably.

Alterations in nine other genes also played a role in ovarian cancer, though to a much lesser extent, the researchers reported. Among them were the BRCA1 and BRCA2 genes, which increase the risk of breast and ovarian cancer.

"In other cancers, there are usually several genes that are involved" on almost equal footing, said one of the study authors, Dr. David Wheeler of Baylor College of Medicine. "This is an unusual pattern."

The new work "is producing impressive insights into the biology" of ovarian cancer, Dr. Francis Collins, who heads the National Institutes of Health, said in a statement.

Among cancers, ovarian is the fifth leading cause of death among women. A regular pelvic exam is considered the best way to detect ovarian cancer early.

The Cancer Genome Atlas was launched in 2006 to unravel the genetic underpinning of cancer. The group mapped the genome of the most common form of brain cancer in 2008 and plans to do the same for 20 other types of cancers.

___

Online:

Nature journal: www.nature.com/nature

The Cancer Genome Atlas: http://cancergenome.nih.gov



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Report: More than 100 million suffer lasting pain (AP)

WASHINGTON � A new report finds at least 116 million U.S. adults experience long-lasting pain � the kind that lingers for weeks to months. Too often, they feel stigma rather than relief from a health care system poorly prepared to treat them.

The Institute of Medicine report shows chronic pain costs the nation even more than heart disease in medical bills, sick days and lost productivity.

The report calls effective pain management a moral imperative, and urges a series of steps to transform the field.

Barriers include health workers not properly trained to handle pain, and insurance that doesn't cover complex care. Law enforcement's fight against abuse of narcotic painkillers plays a role, too, but the report found that those medicines are safe and effective for the right patient.



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Tuesday, June 28, 2011

AIDS drug supplies dwindling in Swaziland (AP)

MBABANE, Swaziland � Cash-strapped Swaziland's state hospitals have only two months' supplies of AIDS drugs, the country's health minister has told parliament in an assessment that AIDS patients and activists took as a death sentence.

State media on Tuesday quoted Health Minister Benedict Xaba as making the remarks to parliament a day before. He blamed the country's economic crisis, linked to a drop in customs revenues amid a worldwide recession.

More than 60,000 Swazis depend on anti-retroviral AIDS drugs, known as ARVs, distributed free at government hospitals.

Swaziland, with a population of about 1 million, has the world's highest percentage of people living with the virus that causes AIDS. More than a quarter of Swazis between the ages of 15 and 49 are believe to carry HIV.

Swaziland is seeking international loans to cope with its budget crisis. Xaba says AIDS patients should not lose hope, but news of dwindling drug supplies has worried patients.

Without AIDS drugs, "we shall die," said Patrick Mngometulu, an AIDS patient who has been on government-supplied drugs since 2003.

"Mothers who take ARVs will be worse affected. ARVs help children not to get HIV infection from their mothers. So if mothers stop taking the ARVs their children are in danger. We lose hope, and the situation will decrease productivity of the infected," Mngometulu said.

Thembi Nkambule, director of the Swaziland National Network of People Living with HIV and AIDS, said the government has made strides in combating AIDS, moving from 15,000 people on ARVs in 2005 to 60,000 today. But now, she fears gains will be lost.

"Swazis will die in numbers. Hope will be lost," Nkambule said.

A pro-democracy movement in Swaziland, southern Africa's last absolute monarchy, has gained some ground since the government announced in March its plan to freeze civil service salaries and sell off state-run companies. But the government has cracked down hard on protests, and reformists have had to contend with reverence for the monarchy among many Swazis.

Activists have criticized King Mswati III of living lavishly while most Swazis live in poverty, and of harassing and jailing pro-democracy activists.



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Monday, June 27, 2011

Too many blood transfusions? New standards urged (AP)

WASHINGTON � Check into the hospital and you may get a blood transfusion you didn't really need.

There's a lot of variation around the country in how quick doctors are to order up a few pints � not in cases of trauma or hemorrhage where infusing blood fast can be life-saving, but for a range of other reasons.

Anemia is common in older patients, for example, who may get a transfusion as an easy boost even when the anemia's too mild to matter or instead of treating the underlying problem. Need open-heart surgery or another complex operation? There are steps surgeons could take to minimize blood loss instead of trying to replace it later.

Now a government advisory committee is calling for national standards on when a transfusion is needed � and how to conserve this precious resource.

All the variability shows "there is both excessive and inappropriate use of blood transfusions in the U.S.," advisers to Health and Human Services Secretary Kathleen Sebelius concluded earlier this month. "Improvements in rational use of blood have lagged."

Blood banks welcome the idea, important as they try to balance how to keep just enough blood on the shelves without it going bad or running short.

"Better patient care is what's being advocated here," says Dr. Richard Benjamin, chief medical officer of the American Red Cross. "If a transfusion is not necessary, all you can do is harm."

The U.S. uses a lot of blood, more than 14 million units of red blood cells a year. Between 1994 and 2008, blood use climbed 40 percent, Benjamin told the HHS Advisory Committee on Blood Safety and Availability. In many years, parts of the country experienced spot shortages as blood banks struggled to bring in enough donors to keep up.

Surprisingly, blood use dropped a bit with the recession, roughly 6 percent over two years, Benjamin says. He couldn't say why. That dip has leveled off, but specialists say demand is sure to rise again in coming years as the population rapidly grays and people who once were prime donors become more ill and frail.

Right now, overall donation levels are good with one exception, Benjamin says: There's a big need for more Type O-negative blood, especially as banks prepare for the usual summertime donor drop. Few donors are Type O negative, but it's compatible with all other blood types and hospitals have begun using more of it in recent years.

What's the evidence for avoidable transfusions?

One study published last fall tracked more than 100,000 people who underwent open-heart surgery, a transfusion-heavy operation. Just 8 percent of those patients received transfusions at some hospitals, while a startling 93 percent did at other hospitals. But survival wasn't significantly different at hospitals that used more blood than at hospitals that used less.

That's important, because transfusions are not risk-free. While the risk of HIV or other viruses is very rare in blood today, people also can experience allergic-style transfusion reactions and other complications, sometimes fatal ones.

Another study last fall examined Medicare patients who received blood for various reasons over a 10-year period, and found those who live in the South are the most likely to get a transfusion and those who live in the West are the least likely.

Overall, the U.S. uses about 49 units of blood for every 1,000 patients, substantially more than Canada or Britain where those transfusion rates are in the 30s, Benjamin says.

One solution that the HHS advisers urged the government to explore: Some hospitals have begun what's called "patient blood management," instituting their own guidelines on when a transfusion is avoidable.

Consider Eastern Maine Medical Center. Transfusion chief Dr. Irwin Gross described how doctors now order blood via a computerized form that warns if they're about to deviate from the guidelines and tracks who uses the most.

Planning a hip replacement? Patients are supposed to be checked for anemia before elective surgery is scheduled, so they can be treated with iron or other therapies beforehand and lower chances of a post-surgery transfusion. For non-surgery patients, other guidelines spell out when anemia is bad enough to warrant a transfusion or when a patient should just be monitored.

In cardiac and back surgeries, equipment captures a patient's own blood and pumps it back right away, reducing the need for post-surgery transfusions.

The program reduced the amount of blood drawn just for laboratory tests, and limited when doctors can order multiple transfusions rather than checking first to see if one did the trick.

The result: The Bangor hospital is giving blood to nearly half as many patients as it did in 2006, the year before the program began. And there are no signs of patient harm, Gross told the HHS committee. He calculated that the hospital saved $5.4 million over four years in the cost of buying blood.

___

EDITOR'S NOTE � Lauran Neergaard covers health and medical issues for The Associated Press in Washington.



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Diabetics receive blood vessels grown in lab (AP)

For the first time, scientists have given several diabetic patients blood vessels grown in a lab from donated skin cells.

The work is a key step toward creating a supply of ready-to-use veins and arteries that could be implanted in dialysis patients, soldiers with damaged limbs, children with heart defects, people having heart bypass surgery and others.

The blood vessels are made by a California company, Cytograft Tissue Engineering Inc. Three dialysis patients in Poland have received them so far, and they are working well two to eight months later. A larger study in Europe is planned.

The research is considered so promising that the American Heart Association featured it Monday in the first of a new series of webcasts about cutting-edge science.



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E. coli death toll up to at least 47 (AP)

BERLIN � The death toll in Europe's E. coli outbreak has risen by three to at least 47, German authorities said Monday, even as new infections continue to tail off.

Germany's disease control center, the Robert Koch Institute, said 46 deaths have now been reported in the country.

One person has died in Sweden, and officials say one death in the U.S. may be linked to the outbreak � but it isn't yet confirmed that the Arizona man, who had visited Germany, was sickened by the same bacterial strain.

The number of new infections has declined significantly over recent weeks but overall numbers are still rising, due largely to delays in notification.

The disease control center said 3,801 people have been reported sick in Germany. That includes 834 suffering from a complication that can lead to kidney failure.

A further 119 cases have been reported in a total of 15 other countries. The source has been traced to a vegetable sprout farm in northern Germany.

Officials still don't know how the sprouts were contaminated, said Nina Bansbach, a spokeswoman for the German Federal Office of Consumer Protection and Food Safety.

The World Health Organization said it considers an E. coli outbreak in France in recent days as separate.

"Investigations are ongoing, but the first findings suggest that locally grown sprouts might be involved," the WHO said in a statement Monday of the outbreak. It said that, of eight French cases so far, three of them carried the same bacteria strains as in Germany.

"Intensive traceback is under way to identify a possible common source of the German and French sprout seeds," it added. But "other potential vehicles are also under investigation."

France has halted the sale of fenugreek, mustard and arugula sprout seeds from British mail order seed and plant company Thompson & Morgan. The company says the link is unsubstantiated.

There was "no direct supply relationship" between the farm in Germany at the center of the outbreak and the British company, German spokeswoman Bansbach said.

______

Kirsten Grieshaber contributed to this report.



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Philip Morris fights Australian packaging rules (AP)

SYDNEY � Tobacco giant Philip Morris launched legal action on Monday against the Australian government over the country's plans to strip company logos from cigarette packages and replace them with grisly images of cancerous mouths, sickly children and bulging, blinded eyes.

The government believes the new rules will make the packages less attractive to smokers and turn Australia into the world's toughest country on tobacco advertising. Several outraged cigarette makers have threatened lawsuits, arguing the move illegally diminishes the value of their trademarks. Philip Morris is the first of those companies to file a claim for compensation.

"We would anticipate that the compensation would amount to billions," Philip Morris spokeswoman Anne Edwards told The Associated Press.

The legislation, which will be introduced to Parliament in July, would ban cigarette makers from printing their logos, promotional text or colorful images on cigarette packs. Brand names will instead be printed in a small, uniform font and feature large health warnings and gruesome, full-color images of the consequences of smoking. The law would be phased in over six months, starting in January 2012.

Hong Kong-based Philip Morris Asia Limited, which owns the Australian affiliate Philip Morris Limited, filed a notice of claim on Monday arguing the legislation violates a bilateral investment treaty between Australia and Hong Kong.

The tobacco company says the treaty protects companies' property, including intellectual property such as trademarks. The plain packaging proposal severely diminishes the value of the company's trademark, Edwards said.

"Our brands are really one of the absolute key valuable assets that we have as a company � it's what helps us compete, it's what enables us to distinguish our products," Edwards said. "This move ... would essentially amount to confiscation of our brand in Australia."

The government denied the plan breaks any laws and said it would not back down.

"Our government is determined to take every step we can to reduce the harm by tobacco," Health Minister Nicola Roxon said. "We won't be deterred by tobacco companies making threats or taking legal action."

Prime Minister Julia Gillard also brushed off Philip Morris' threats. "We're not going to be intimidated by big tobacco's tactics," she told Australian Broadcasting Corp.

The legal notice filed Monday opens up a three-month period of negotiation between the two sides. Philip Morris said if a "satisfactory outcome" isn't achieved by the end of the three months, it will seek arbitration.

Similar steps are being taken in the U.S., where cigarette packs will soon feature new warning labels with graphic images of the negative health effects of smoking, including diseased lungs and the sewn-up corpse of a smoker.

The labels also feature phrases like "Smoking can kill you" and "Cigarettes cause cancer." They will take up the top half � both front and back � of a pack of cigarettes and be featured in advertisements.

The labels are a part of a campaign by the U.S. Food and Drug Administration that aims to convey the dangers of tobacco, which is responsible for about 443,000 deaths in the U.S. a year. The warnings must appear on cigarette packs by the fall of 2012.

The U.S and Australia are following the lead of other countries.

Uruguay's government requires that 80 percent of the front and back of all cigarettes packages be devoted to warnings. In Brazil, labels feature graphic images of dead fetuses, hemorrhaging brains and gangrened feet.



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Sunday, June 26, 2011

France says its E.coli strain same as Germany's (AP)

BORDEAUX, France � France's health minister says experts are "99 percent sure" that the E. coli outbreak that put seven people in the hospital in Bordeaux region is the same strain of bacteria that killed 44 people � all but one in Germany.

Hospital officials say that three of the seven sickened are on dialysis, while a 78-year-old is in critical condition. Another person was released.

Health Minister Xavier Bertrand said that the strain appears to be the same as the one in Germany.

France halted the sale of fenugreek, mustard and arugula sprout seeds from British mail order seed and plant company Thompson & Morgan. The company says the link is unsubstantiated.

German officials attribute deaths there to a sprout farm in northern Germany.



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Saturday, June 25, 2011

Sportsmen monitor gas drilling in Marcellus Shale (AP)

WHITELEY, Pa. � Fishermen are gearing up and hunters are taking aim � for Marcellus Shale gas drilling.

A new coalition of outdoors groups is emerging as a potent force in the debate over natural gas drilling. The Sportsmen Alliance for Marcellus Conservation isn't against the process of fracking for gas, but its members want to make sure the rush to cash in on the valuable resource doesn't damage streams, forests, and the various creatures that call those places home.

The movement grew out of grass-roots anger as passionate outdoorsmen found their questions about drilling and wildlife brought few answers from local or state officials.

"Either we didn't get a response or the answer we got didn't seem feasible or acceptable. It didn't seem like the people who were in charge had their pulse on what was actually happening," said Ken Dufalla of Clarksville, Pa.

Energy companies have identified major reserves of natural gas throughout the Marcellus Shale, which underlies much of New York and Pennsylvania, and parts of Maryland, Ohio and West Virginia.

More than 3,300 wells have been drilled across Pennsylvania in just the last few years. The boom has raised concerns about the use of hydraulic fracturing, or fracking, a drilling technique in which water, sand and a small amount of chemicals are used to open gas-bearing shale formations deep underground.

Already, preliminary water testing by sportsmen is showing consistently high levels of bromides and total dissolved solids in some streams near fracking operations, Dufalla said. Bromide is a salt that reacts with the chlorine disinfectants used by drinking water systems and creates trihalomethanes. The U.S. Environmental Protection Agency says trihalomethanes can be harmful to people who drink water with elevated levels for many years.

Dufalla stands alongside Whiteley Creek, a little mountain stream in Greene County. But something is wrong. The grass is lush and the woods are green, but the water is cloudy and dead-looking.

"It used to be a nice stream," teeming with minnows, crawfish and other aquatic life, he told The Associated Press. No more, said Dufalla, a former deputy game and fish warden for Pennsylvania.

He's worried that nearby gas drilling has damaged the creek, either from improper discharges of waters used in fracking, or from extensive withdrawals of water. The drilling industry says numerous studies have shown fracking is environmentally safe, but Dufalla and other sportsmen want to be sure.

The goal is to build a water quality database that identifies problem areas and makes that information available to the public. Currently, there's little scientific information about whether or how much fracking water impacts wildlife.

Numbers suggest that many people share Dufalla's concerns, in Pennsylvania and throughout the region. Two years ago his local chapter of the Izaak Walton League (a fishing group) had 19 members. Today there are 111.

More than half a dozen existing outdoors groups are part of the Sportsmen Alliance, and collectively they have more than 60,000 members in the states that overlay the Marcellus. Numbers like that mean there's an established grapevine to reach sportsmen and women, and the ties to national groups bring access to experts and funding.

Members of the Sportsmen Alliance are scheduled to meet in July with Michael Krancer, the new secretary of the Pennsylvania Department of Environmental Protection, said Katy Dunlap, a spokeswoman for Trout Unlimited, a national fishing group based in Arlington, Va.

"We are making specific requests with regards to Wilderness trout waters in Pennsylvania," Dunlap said, such as additional review of proposed wells near such waters.

Some areas may be too environmentally sensitive for drilling, and the Sportsmen Alliance is building a list of places that need special protection, Dunlap said. "Places that once you destroy, you can't take back," she said.

Whether the drilling industry would accept additional limits in some areas remains to be seen.

So many wildlife lovers have expressed concern over drilling that the Sportsmen Alliance has moved beyond relying on volunteers.

Earlier this year Dave Sewak began working full-time across Pennsylvania, giving educational talks and training a network of volunteer water testers. "We support the energy development; we just want to see it done right the first time. I think hunters and fishermen are the original environmentalists," said Sewak, a Windber, Pa. resident. He's paid by Trout Unlimited.

There has been considerable public debate over how and if fracking impacts drinking water supplies, but Dufalla and other sportsmen are worried that even low concentrations of fracking chemicals may affect aquatic invertebrates � the tiny water bugs that grow into mayflies and stoneflies, which are in turn eaten by fish and birds.

The sportsmen worry that a stream without bugs could quickly become a stream without fish, and then a valley with fewer birds, and so on up the food chain.

There are signs that both the drilling industry and sportsmen are trying to find common ground. Patrick Creighton, a spokesman for the Marcellus Shale Coalition, a drilling industry business group, told the AP his group has already met with numerous outdoors groups.

"It's a relationship that we're building," he said. They're also working with local groups on a set of "best management practices."

Some pro-drilling outdoorsmen said that's exactly the area that needs work.

Ed Gaw leased drilling rights to a five-acre tract of his 140-acre farm in Evans City, Pa., to the T.W. Phillips Co. and fracking began in the spring of 2009. The next year the drillers did what they considered to be a basic restoration.

"Their idea of reclaiming a site and mine were kind of night and day," said Gaw, who knew when he signed the lease that the landscape would never look as it had before.

But Gaw didn't just complain. He got to work, investing about $20,000 in a restoration that included planting hundreds of spruce and fruit trees. Now there are more deer on the property than before drilling began, he said.

But no one wanted to talk about restoration in the beginning. Gaw remembers telling the drilling company that a beautiful restoration would be in their long-term interest too, but they didn't see the point. "I'm going take you guys kicking and screaming into this model recovery," he recalls saying.

He was right.

Last year, the Pennsylvania Game Commission sponsored a field day on the issue of reclamation at the Gaw Farm, which is about 30 miles north of Pittsburgh. At the time state officials echoed some of Gaw's concerns.

"Landowners have received a wealth of information across the state on leasing, but little attention has been paid to reclamation and habitat recovery," said Tim Hoppe, Northwest Region Wildlife Diversity Biologist for the Game Commission.

Part of the challenge for outdoorsmen and industry is that there isn't much scientific information on how or if fracking impacts wildlife in the Marcellus Shale region.

University of Pennsylvania biologist Margaret Brittingham is just starting such a project, with support from the Pennsylvania Game Commission. The study will look at how drilling changes the forest habitat, and how it could impact wildlife. But it will be a few years before results are in, and that's just one study.

In the meantime, the sportsmen know the value of keeping their hooks sharp and their powder dry, so to speak.

Trout Unlimited and some of the other sportsmen groups have staff attorneys and a history of organizing and funding successful water quality lawsuits.

Dufalla hopes the volunteer water testing database becomes a tool for negotiating with state officials and the drilling industry.

If the testing shows an ongoing pattern of water quality problems near drilling operations the sportsmen may file lawsuits, he said.

"It's the last thing you want to do," Dufalla said.

But some people in rural communities are past accepting assurances by the industry that fracking doesn't cause environmental problems. Some who don't even hunt or fish have joined the effort to patrol waterways.

Waynesburg resident Chuck Hunnell, 68, said a recent public meeting on drilling was the most radical one he's ever been to. But what he sees in the community he grew up in has turned him into an activist monitoring the drilling industry.

"And now until I breathe my last breath, I'm going to be checking on these people," Hunnell said.

___

Online:

http://www.sportsmenalliance.org/index.htm

http://marcelluscoalition.org/



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France halts sales of 3 seeds after E. coli cases (AP)

PARIS � France has halted the sale of three types of seeds linked to a British company after an E. coli outbreak caused the hospitalization of eight people.

French health officials say test results on two of the eight people hospitalized show an infection of the same strain of E. coli that killed 44 people � all but one in Germany � and sickened more than 3,700.

Commerce Minister Frederic Lefevre said late Friday the order involves fenugreek, mustard and arugula seeds linked to a British seed and plant vendor, Thompson & Morgan.

An investigation by France's competition, consumption and fraud prevention agency found two of the eight people hospitalized had consumed sprouts from the three seeds at a school fair in the southwestern town of Begles.



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Friday, June 24, 2011

Europe's E. coli death toll at least 44 (AP)

BERLIN � Germany has reported another death in Europe's E. coli outbreak, bringing the toll to at least 44.

The national disease control center said Friday that 43 deaths have now been reported in Germany, the outbreak's epicenter. Another person has died in Sweden.

In its own update Friday, the World Health Organization included a further death in the United States. However, it cautioned � as U.S. officials also have � that it isn't yet confirmed that the Arizona man, who had visited Germany and died in mid-June, was sickened by the same bacteria strain.

Although the death toll is still rising, the number of new infections peaked on May 22 and has declined significantly over the past two weeks.

The Robert Koch Institute, the disease control center, says 3,717 people have been reported sick in Germany, including 827 suffering from a complication that can lead to kidney failure.

Another 119 cases have been reported in a total of 15 other countries. The fact that overall numbers are continuing to rise is largely due to delays in notification, the WHO said.

The source of the bacteria has been traced to a sprout farm in northern Germany. Officials still don't know how the sprouts were contaminated.



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States stop circumcisions funds amid budget crisis (AP)

DENVER � A nationwide debate about circumcisions for newborn boys, combined with cash-strapped public health budgets, has Colorado taking sides with 17 other states that no longer fund Medicaid coverage of the once widely accepted procedure.

For years, Colorado lawmakers considered doing away with funding for circumcisions under Medicaid � a move that would save the state $186,500 a year. Now facing a seismic budget shortfall estimated to be $1 billion at the beginning of this year, lawmakers finally approved the change, which takes effect July 1.

"We were just looking at virtually every option and trying to decide what was absolutely urgent now," said Republican Sen. Kent Lambert, a member of the budget-writing Joint Budget Committee. "I think 99 percent of it was completely economic."

The matter of circumcisions has gotten contentious in California, where San Francisco will be the first city to hold a public vote in November on whether to ban the practice.

Jewish and Muslim families are challenging that proposal in court, claiming it violates their right to practice their religion and decide what's best for their children. Supporters of the ballot initiative say male circumcision is a form of genital mutilation that parents should not be able to force on their children.

Matthew Hess, the president of the group behind the San Francisco proposal, called the Male Genital Mutilation Bill, applauded Colorado's move and said he hopes it will lead to a drop in the circumcision rate.

"That's a good thing, because paying someone to amputate a healthy functional body part from an unconsenting minor is not just a waste of taxpayer money � it's also a violation of human rights," he said.

South Carolina is one of the most recent states to eliminate Medicaid payments for circumcisions amid budget concerns. The change, which went into effect in February, was expected to save the state about $114,800 a year. States that also no longer fund circumcisions through Medicaid include Arizona, California, Florida, Maine and Louisiana.

Scott Levin, the regional director of the Mountain States office of the Anti-Defamation League, said Jews are unlikely to be affected by the defunding of Medicaid payments for circumcisions. For them, the procedure is not performed by a hospital physician, but a mohel � a specialist trained in Jewish ritual circumcision.

Levin said his group is more concerned about places like San Francisco that are trying to ban the procedure because Jewish people see the ritual as one of their religion's most sacred.

The World Health Organization reported that circumcisions are one of the most common procedures performed on newborn males in the United States, but the practice is not as common in the rest of the world. About 75 percent of baby boys in the U.S. are circumcised, compared to 30 percent elsewhere, the organization said. The figures refer to non-religious circumcisions.

Joanne Zahora, spokeswoman for the Colorado Department of Health Care Policy and Financing, which administers health care programs for low-income families, said the research her organization has seen shows that circumcisions are not medically necessary.

But the procedure retains its supporters. Although the topic never became heated during the Colorado budgetary debate, some lawmakers spoke in favor of keeping the Medicaid funding. Among them was Democratic Sen. Irene Aguilar, a primary care doctor at Denver Health.

"It's really a pretty inexpensive procedure to perform, and so it's just a little penny-wise and dollar-poor," she said.

Aguilar argued that circumcisions reduce the rates of urinary tract infections, penile cancer, and also lower the rates of cervical cancer for men's sexual partners. She also said she worried that doing away with funding for circumcisions would be discriminatory for Jewish and Muslim people on Medicaid.

Lambert, from Colorado's JBC, said the topic is sensitive for most, but the question lawmakers faced really was whether the government has the money to pay for the procedure.

"I think the general answer was no," Lambert said.

___

Associated Press writer Colleen Slevin contributed to this report.

___

Ivan Moreno can be reached at: http://www.twitter.com/ivanmoreno_colo



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Thursday, June 23, 2011

Report: Fight fat even in toddlers, preschoolers (AP)

WASHINGTON � A food pyramid just for the under-2 set? Contrary to popular belief, children don't usually outgrow their baby fat � and a new report urges steps to help prevent babies, toddlers and preschoolers from getting too pudgy too soon.

That's a growing problem: Already, one in five preschoolers � 2- to 5-year-olds � is overweight or obese.

Topping the list of proposed changes: better guidelines to help parents and caregivers know just how much toddlers should eat as they move from baby food to bigger-kid fare. And making sure preschoolers get at least 15 minutes of physical activity for every hour they spend in child care.

Thursday's recommendations, from the Institute of Medicine, aren't about putting the very young on diets. But those early pounds can lead to lasting bad effects on their health as children grow, says the report.

"It's a huge opportunity to instill good habits at a time when you don't have to change old ones," said Leann Birch, director of Pennsylvania State University's Center for Childhood Obesity Research, who chaired the IOM panel.

Consider: Babies drink milk until they're full and then turn away. But children as young as 2 or 3 are sensitive to portion size, important in not inadvertently training them to overeat.

"If you give them larger portions, they eat more," Birch explained.

Pediatricians generally give pretty explicit directions on how to feed babies. And the nation's dietary guidelines include a special section for preschoolers, including information that a portion size generally is about 1 tablespoon of each food type per year of age.

But overall, those national guidelines are aimed at ages 2 and older � though surveys show even very young children eat too few of the fruits and vegetables they need. So the institute called on the government to create consumer-friendly dietary guidelines for birth to age 2.

That would capture the "dramatic dietary transition that occurs, from consuming one single food to, by the time they're 2, ordering up things from McDonald's and, we hope, having also learned to eat a lot of healthy foods," Birch said.

That will be part of the discussion during the next dietary guidelines update in 2015, said Robert Post, deputy director of the Agriculture Department's Center for Nutrition Policy and Promotion, which oversees that process. But developing guidelines for these younger children is complex because their nutrition needs are based in part on developmental stage, he cautioned.

Of course, parents have the biggest influence over whether healthy eating and being active become a child's norm.

But the report makes the case that children's habits are influenced by far more than their parents � and thus it's time to expand obesity prevention to more of the other places youngsters spend time. For example, nearly three-fourths of children ages 2 to 5 spend at least part of their day in some form of child care.

Among the recommendations:

_Day care and preschool operators should be trained in proper physical activity for young children, provide at least 15 minutes of it per hour, and avoid withholding physical activity as a punishment.

_Child care regulations should limit how long toddlers and preschoolers sit or stand still to no more than 30 minutes at a time � and limit holding babies in swings, bouncy seats or other equipment while they're awake.

_Day care and preschools should practice what's called responsive feeding: providing age-appropriate portion sizes, teaching children to serve themselves properly, requiring adults to sit with and eat the same foods as the children and following babies' cues as to when they've had enough.

_Breastfed infants are less likely to become obese later in childhood, so doctors and hospitals should encourage breastfeeding and limit formula samples aimed at new moms.

_At checkups, doctors should consider the parents' weight in assessing which children are at risk of later obesity, and then alert parents early that preventive steps are needed. About 10 percent of infants and toddlers already weigh too much for their length.

_To increase healthful eating among the poorest children, the government should take steps to get more families who are eligible for federal nutrition-assistance programs to sign up.



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Arizona death may be linked to European E. coli (AP)

ATLANTA � Health officials say the death of an Arizona resident who recently traveled to Germany may be linked to the food-poisoning outbreak in Europe.

The Centers for Disease Control and Prevention on Thursday said the death is under investigation. The Arizona resident had a severe E. coli complication that can lead to kidney failure.

If confirmed, it would be the first U.S. death tied to the outbreak.

So far, there have been five confirmed cases in the United States connected to the outbreak. Those cases are in Michigan, Massachusetts, Wisconsin and North Carolina.

Officials have traced the outbreak to raw vegetable sprouts from a farm in northern Germany.



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Wednesday, June 22, 2011

Potato chips are piling on the pounds, study finds (AP)

LOS ANGELES � Blame the potato chip. It's the biggest demon behind that pound-a-year weight creep that plagues many of us, a major diet study found. Bigger than soda, candy and ice cream.

And the reason is partly that old advertising cliche: You can't eat just one.

"They're very tasty and they have a very good texture. People generally don't take one or two chips. They have a whole bag," said obesity expert Dr. F. Xavier Pi-Sunyer of the St. Luke's-Roosevelt Hospital Center in New York.

What we eat and how much of it we consume has far more impact than exercise and most other habits do on long-term weight gain, according to the study by Harvard University scientists. It's the most comprehensive look yet at the effect of individual foods and lifestyle choices like sleep time and quitting smoking.

The results are in Thursday's New England Journal of Medicine.

Weight problems are epidemic. Two-thirds of American adults are overweight or obese. Childhood obesity has tripled in the past three decades. Pounds often are packed on gradually over decades, and many people struggle to limit weight gain without realizing what's causing it.

The new study finds food choices are key. The message: Eat more fruits, vegetables, whole grains and nuts. Cut back on potatoes, red meat, sweets and soda.

"There is no magic bullet for weight control," said one study leader, Dr. Frank Hu. "Diet and exercise are important for preventing weight gain, but diet clearly plays a bigger role."

Doctors analyzed changes in diet and lifestyle habits of 120,877 people from three long-running medical studies. All were health professionals and not obese at the start. Their weight was measured every four years for up to two decades, and they detailed their diet on questionnaires.

On average, participants gained nearly 17 pounds over the 20-year period.

For each four-year period, food choices contributed nearly 4 pounds. Exercise, for those who did it, cut less than 2 pounds.

Potato chips were the biggest dietary offender. Each daily serving containing 1 ounce (about 15 chips and 160 calories) led to a 1.69-pound uptick over four years. That's compared to sweets and desserts, which added 0.41 pound.

For starchy potatoes other than chips, the gain was 1.28 pounds. Within the spud group, french fries were worse for the waist than boiled, baked or mashed potatoes. That's because a serving of large fries contains between 500 to 600 calories compared with a serving of a large baked potato at 280 calories.

Soda added a pound over four years. Eating more fruits and vegetables and other unprocessed foods led to less weight gain, probably because they are fiber-rich and make people feel fuller.

For each four-year period, these factors had these effects on weight:

� An alcoholic drink a day, 0.41-pound increase.

� Watching an hour of TV a day, 0.31-pound increase.

� Recently quitting smoking, 5-pound increase.

People who slept more or less than six to eight hours a night gained more weight.

The study was funded by the National Institutes of Health and a foundation. Several researchers reported receiving fees from drug and nutrition companies.

"Humans naturally like fat and sweet," said Dr. David Heber, director of the UCLA Center for Human Nutrition, who had no role in the study. "That's why we always tell people to eat their fruits and vegetables."

Pi-Sunyer, who also wasn't involved in the research, said the study gives useful advice.

"It's hard to lose weight once you gain it," he said. "Anything that will give people a clue about what might prevent weight gain if they follow through with it is helpful."

The federal government earlier this year issued new dietary guidelines advising people to eat smarter. This month, it ditched the food pyramid � the longtime symbol of healthy eating � in favor of a dinner plate divided into four sections containing fruits, vegetables, protein and grains.

___

Online:

New England Journal of Medicine: http://www.nejm.org

___

Alicia Chang can be followed at: http://twitter.com/SciWriAlicia



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FDA concludes silicone breast implants mostly safe (AP)

WASHINGTON � Federal health officials say the latest data on silicone breast implants show they are relatively safe, despite frequent complications that lead about one in five women to have the implants removed within ten years.

A Food and Drug Administration report issued Wednesday is the agency's first safety assessment of the implants since regulators returned them to the market in 2006. That followed a 14-year ban when only saline-filled implants were widely available.

The FDA pulled silicone implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus.

But the agency returned the implants to the market five years ago after most studies failed to find a link between silicone breast implants and those diseases. Patients and plastic surgeons say the silicone-filled implants look and feel more real than saline versions.

The approval came with conditions, including a requirement that the companies complete studies on women who have received the implants.

The FDA's safety endorsement is primarily based on those studies, conducted by the two U.S. manufacturers of the products, Allergan Inc. and Johnson & Johnson's Mentor unit.

But industry critics point out that most of the studies are incomplete, and many women have already dropped out.

For example, only 58 percent of women enrolled in a 1,000-patient study of Mentor's implants are still accounted for after eight years. Two larger studies of 40,000 women, conducted by both Allergan and Mentor respectively, have each lost a significant number of patients after just two to three years.

Dr. Diana Zuckerman of the National Research Center for Women and Families said most medical journals would not publish the studies cited by FDA because of the missing data.

"Once a medical product is approved, the manufacturers have no incentive to do these required studies properly," Zuckerman said. "So, we end up with useless information, which is what has happened with the largest, most important studies of silicone gel breast implants."

The FDA commented that "both manufacturers have communicated to the FDA the difficulties in following women who have received silicone gel-filled breast implants." The agency said it is working with Allergan and Mentor to increase participation and follow-up.

The most common side effect remains scar tissue which hardens around the implant, warping the shape of the breast. Other problems include implant rupture, wrinkling, and lopsided appearance, according to the report.

"Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use," the agency concludes.

Based on the company data, FDA says 20 to 40 percent of patients who have implants for cosmetic reasons will need another operation to modify or remove them within eight to 10 years. For women with implants for breast reconstruction, the number is even higher, at 40 to 70 percent.

Breast augmentation remains the most popular cosmetic surgery in the U.S., with nearly 300,000 women receiving saline or silicone breast implants last year.



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Big city got you down? Stress study may show why (AP)

NEW YORK � This may come as no surprise to residents of New York City and other big urban centers: Living there can be bad for your mental health.

Now researchers have found a possible reason why. Imaging scans show that in city dwellers or people who grew up in urban areas, certain areas of the brain react more vigorously to stress. That may help explain how city life can boost the risks of schizophrenia and other mental disorders, researchers said.

Previous research has found that growing up in a big city raises the risk of schizophrenia. And there's some evidence that city dwellers are at heightened risk for mood and anxiety disorders, although the evidence is mixed.

In any case, the volunteers scanned in the new study were healthy, and experts said that while the city-rural differences in brain activity were intriguing, the results fall short of establishing a firm tie to mental illness.

The study, done in Germany and published in Thursday's issue of the journal Nature, focused on how the brain reacts to stress caused by other people.

To do that, investigators had volunteers lie in a brain scanner and solve math problems. The volunteers expected easy problems, but they were in fact hard enough that each volunteer ended up getting most of them wrong.

While in the scanner, volunteers heard a researcher criticize their poor performance, saying it was surprisingly bad and disappointing, and telling the volunteers they might not be skilled enough to participate.

An initial study with 32 volunteers found city-urban differences in two brain areas. One was the amygdala, which reacts to threats in one's environment, and the other was circuitry that regulates the amygdala. Researchers found that volunteers from cities of more than 100,000 showed more activation of the amygdala than participants from towns of more than 10,000, and those in turn showed more activation than people from rural areas.

To assess any effect of where the volunteers grew up, the researchers assigned each an "urbanicity" score based on how many years they'd spent by age 15 in a city, town or rural area. The higher the score, the more urban their childhood life was, and the more activity showed up in the amygdala-regulating circuitry during the experiment.

A slightly different stress-producing test produced similar results with a different group of 23 volunteers.

But when a third group of 37 adults did mental tasks without being criticized for poor performance, they showed no urban-rural differences. That shows the effect comes from the criticism rather than just doing the mental task, the researchers said.

The study can't reveal why city life would boost the brain responses, but it could be because of the stress from dealing with other people, said Dr. Andreas Meyer-Lindenberg, director of the Central Institute of Mental Health in Mannheim, Germany, and senior author of the report. Animal studies suggest that early exposure to stress can cause lasting effects, he said.

Jens Pruessner, a study co-author from the Douglas Mental Health University Institute in Montreal, said the study illustrates a new avenue for understanding the risk factors for developing mental illness.

An expert in emotion and the brain who wasn't involved with the study, Elizabeth Phelps of New York University, said it's premature to draw conclusions about what the results mean for mental illness.

"These results are interesting but preliminary," she said. "This will raise a lot of interest in this idea. Whether or not it pans out in future research, who knows, but I think it's worth investigating."

___

Online:

Nature: http://www.nature.com/nature



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Tuesday, June 21, 2011

Transfer delays common for heart attack patients (AP)

CHICAGO � New research suggests hospitals are taking too long to move heart attack patients who need treatment elsewhere. And it says that delay might increase their chances of dying.

Patients with major heart attacks often need emergency procedures to clear clogged arteries. But most U.S. hospitals aren't equipped for that treatment. Guidelines recommend moving those patients to another hospital within a half-hour.

But in the study of more than 14,000 patients, only one in 10 were moved that fast. More deaths occurred in patients who weren't moved within a half-hour. These patients were generally sicker, and the researchers say that might partly explain the results.

The study appears in Wednesday's Journal of the American Medical Association.



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Cigarettes will carry grisly new warning labels (AP)

RICHMOND, Va. � Rotting teeth and gums. Diseased lungs. A sewn-up corpse of a smoker. Cigarette smoke coming out of the tracheotomy hole in a man's neck. Cigarette packs in the U.S. will have to carry these macabre images in nine new warning labels that are part of a campaign by the Food and Drug Administration to use fear and disgust to discourage Americans from lighting up.

The labels, announced on Tuesday, represent the biggest change in cigarette packs in the U.S. in 25 years.

At a time when the drop in the nation's smoking rate has come to a standstill, the government is hoping the in-your-face labels will go further than the current surgeon general warnings toward curbing tobacco use, which is responsible for about 443,000 deaths a year in the U.S.

"These labels are frank, honest and powerful depictions of the health risks of smoking," Health and Human Services Secretary Kathleen Sebelius said in a statement.

The FDA estimates the labels will cut the number of smokers by 213,000 in 2013, with smaller additional reductions through 2031.

Other countries such as Canada and Uruguay have used graphic, even grisly, warnings for years, and various studies suggest they spur people to quit. But exactly how effective they are is a matter of debate, since the warnings are usually accompanied by other government efforts to stamp out smoking.

"I think it's a great deterrent for kids," said Kristen Polland, 24, of Prattville, Ala. "If you start there, you have won half of the battle."

Rhonda Vanover, 43, of Cincinnati, on the other hand, said: "No one is going to stop me __ unless they make it illegal. Cigarettes get me through the day. They are part of my life."

The labels also include images of a smoker wearing an oxygen mask and a mother and baby with smoke swirling nearby. Some images are not graphic at all; one shows a man wearing an "I Quit" T-shirt.

The warnings will take up the entire top half � both front and back � of a pack of cigarettes. They must also appear in advertisements and constitute 20 percent of each ad. Cigarette makers will have to run all nine labels on a rotating basis. They have until the fall of 2012 to comply.

The legality of the new labels is already being challenged in a federal lawsuit bought by some of the major tobacco companies, which argue that the warnings will relegate the brand name to the bottom half of the cigarette package, making it difficult or impossible to see.

A spokesman for Richmond-based Altria Group Inc., parent company of the nation's largest cigarette maker, Philip Morris USA, said the company was looking at the final labels and had no further comment. Altria Group is not a party in the federal lawsuit.

A pack-a-day smoker would see the graphic warnings more than 7,000 times per year.

American Cancer Society CEO John R. Seffrin said the labels have the potential to "encourage adults to give up their deadly addiction to cigarettes and deter children from starting in the first place."

The introduction of graphic warning labels was required in a 2009 law that, for the first time, gave the federal government authority to regulate tobacco. Tuesday's announcement follows reviews of scientific literature, public comments and results from an FDA-contracted study of 36 labels proposed last November.

The U.S. first mandated the use of warning labels stating, "Cigarettes may be hazardous to your health" in 1965. The current warning labels � put on cigarette packs in the mid-1980s � say more explicitly that smoking can cause lung cancer, heart disease and other illnesses. But the warnings contain no pictures; they consist only of text in a small box.

The share of Americans who smoke has fallen dramatically since 1970, from nearly 40 percent to about 20 percent. But the rate has stalled since about 2004, with about 46 million adults in the U.S. smoking cigarettes. It's unclear why it hasn't budged, but some experts have cited tobacco company discount coupons on cigarettes and lack of funding for programs to discourage smoking or to help smokers quit.

In recent years, more than 30 countries or jurisdictions have introduced labels similar to those created by the FDA. The World Health Organization said in a survey done in countries with graphic labels that a majority of smokers noticed the warnings and more than 25 percent said the warnings led them to consider quitting.

In 2000, Canada introduced blunt warning labels that included images of a pregnant woman smoking, a child and parent puffing away, and a drooping cigarette to illustrate the risk of impotence from smoking. Since then, the county's smoking rate has declined from about 26 percent to about 20 percent. How much the warnings contributed is unclear because the country took other steps to reduce smoking.

David Hammond, a health behavior researcher at the University of Waterloo in Canada, who worked with the firm designing the labels for the FDA, said that while the images are graphic, they are necessary.

"This isn't about doing what's pleasant for people," he said.

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Associated Press Writers Lisa Cornwell in Cincinnati and Anna McFall in Montgomery, Ala., contributed to this report.

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Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum.

Online:

New Cigarette Warning Labels: http://1.usa.gov/j2DI5f.



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Sotomayor tells how she deals with diabetes (AP)

WASHINGTON � Supreme Court Justice Sonia Sotomayor was seven years old and living in the South Bronx when she found she was thirsty all the time. Soon after, she started wetting her bed at night.

"I was ashamed," the 56-year-old justice said, as she related how she came to learn that she has diabetes. The audience for the unusually personal glimpse at a justice's life was children who are diabetics, like Sotomayor. And the reason she met with them Tuesday in a Washington ballroom was to assure them that their common affliction is no bar to doing anything they want.

"It's a disease you have to deal with, but you can," she said, as she sat in an armchair with 150 children seated in a semicircle on the carpet in front of her.

Sotomayor said she has the job of her dreams and that coping with it has become second nature. She injects herself with insulin four to six times a day, including often before she takes the bench with her colleagues to hear arguments in Supreme Court cases.

Sotomayor's condition has long been known, but she has not previously spoken so openly about managing diabetes. The appearance was part of the Juvenile Diabetes Research Foundation's Children's Congress.

To one little girl who asked whether having Type 1 diabetes gets easier as an adult, Sotomayor replied, "Absolutely."

Advances in technology have made dealing with diabetes so much easier since she was diagnosed in the early 1960s, she said.

She held her hands about a foot apart to indicate, perhaps with a bit of exaggeration, how big the needle was that a lab technician used to draw blood. Whatever its size, Sotomayor said it was large enough that she ran from the hospital where she was being tested and hid under a car outside.

Instead of the pin pricks used today to check a diabetic's blood sugar levels, Sotomayor recounted using the edge of a razor blade. "It was horrible," she said.

Without disposable needles for insulin injections, Sotomayor had to sterilize a needle every morning, requiring her to climb on a chair to reach the stove. She would fill a pot with water and then wait for it to boil. "It takes forever to get water to boil," she said, recalling how long it seemed to her as a child.

When another child asked her to say something positive about having diabetes, Sotomayor said it taught her discipline, which has helped her as a student and beyond.

"Figuring out how I felt all the time," she said. "All of that taught me discipline."



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