Lilly drug chosen for Alzheimer's prevention study

Researchers have chosen an experimental drug by Eli Lilly & Co. for a large federally funded study testing whether it's possible to prevent Alzheimer's disease in older people at high risk of developing it.

The drug, called solanezumab (sol-ah-NAYZ-uh-mab), is designed to bind to and help clear the sticky deposits that clog patients' brains.

Earlier studies found it did not help people with moderate to severe Alzheimer's but it showed some promise against milder disease. Researchers think it might work better if given before symptoms start.

"The hope is we can catch people before they decline," which can come 10 years or more after plaques first show up in the brain, said Dr. Reisa Sperling, director of the Alzheimer's center at Brigham and Women's Hospital in Boston.

She will help lead the new study, which will involve 1,000 people ages 70 to 85 whose brain scans show plaque buildup but who do not yet have any symptoms of dementia. They will get monthly infusions of solanezumab or a dummy drug for three years. The main goal will be slowing the rate of cognitive decline. The study will be done at 50 sites in the U.S. and possibly more in Canada, Australia and Europe, Sperling said.

In October, researchers said combined results from two studies of solanezumab suggested it might modestly slow mental decline, especially in patients with mild disease. Taken separately, the studies missed their main goals of significantly slowing the mind-robbing disease or improving activities of daily living.

Those results were not considered good enough to win the drug approval. So in December, Lilly said it would start another large study of it this year to try to confirm the hopeful results seen patients with mild disease. That is separate from the federal study Sperling will head.

About 35 million people worldwide have dementia, and Alzheimer's is the most common type. In the U.S., about 5 million have Alzheimer's. Current medicines such as Aricept and Namenda just temporarily ease symptoms. There is no known cure.

___

Online:

Alzheimer's info: http://www.alzheimers.gov

Alzheimer's Association: http://www.alz.org

___

Follow Marilynn Marchione's coverage at http://twitter.com/MMarchioneAP

Read More..

Will Obama's order lead to surge in gun research?

MILWAUKEE (AP) — Nearly as many Americans die from guns as from car crashes each year. We know plenty about the second problem and far less about the first. A scarcity of research on how to prevent gun violence has left policymakers shooting in the dark as they craft gun control measures without much evidence of what works.

That could change with President Barack Obama's order Wednesday to ease research restrictions pushed through long ago by the gun lobby. The White House declared that a 1996 law banning use of money to "advocate or promote gun control" should not keep the Centers for Disease Control and Prevention and other federal agencies from doing any work on the topic.

Obama can only do so much, though. Several experts say Congress will have to be on board before anything much changes, especially when it comes to spending money.

How severely have the restrictions affected the CDC?

Its website's A-to-Z list of health topics, which includes such obscure ones as Rift Valley fever, does not include guns or firearms. Searching the site for "guns" brings up dozens of reports on nail gun and BB gun injuries.

The restrictions have done damage "without a doubt" and the CDC has been "overly cautious" about interpreting them, said Daniel Webster, director of the Center for Gun Policy and Research at the Johns Hopkins Bloomberg School of Public Health.

"The law is so vague it puts a virtual freeze on gun violence research," said a statement from Michael Halpern of the Union of Concerned Scientists. "It's like censorship: When people don't know what's prohibited, they assume everything is prohibited."

Many have called for a public health approach to gun violence like the highway safety measures, product changes and driving laws that slashed deaths from car crashes decades ago even as the number of vehicles on the road rose.

"The answer wasn't taking away cars," said Dr. Georges Benjamin, executive director of the American Public Health Association.

However, while much is known about vehicles and victims in crashes, similar details are lacking about gun violence.

Some unknowns:

—How many people own firearms in various cities and what types.

—What states have the highest proportion of gun ownership.

—Whether gun ownership correlates with homicide rates in a city.

—How many guns used in homicides were bought legally.

—Where juveniles involved in gun fatalities got their weapons.

—What factors contribute to mass shootings like the Newtown, Conn., one that killed 26 people at a school.

"If an airplane crashed today with 20 children and 6 adults there would be a full-scale investigation of the causes and it would be linked to previous research," said Dr. Stephen Hargarten, director of the Injury Research Center at the Medical College of Wisconsin.

"There's no such system that's comparable to that" for gun violence, he said.

One reason is changes pushed by the National Rifle Association and its allies in 1996, a few years after a major study showed that people who lived in homes with firearms were more likely to be homicide or suicide victims. A rule tacked onto appropriations for the Department of Health and Human Services barred use of funds for "the advocacy or promotion of gun control."

Also, at the gun group's urging, U.S. Rep. Jay Dickey, a Republican from Arkansas, led an effort to remove $2.6 million from the CDC's injury prevention center, which had led most of the research on guns. The money was later restored but earmarked for brain injury research.

"What the NRA did was basically terrorize the research community and terrorize the CDC," said Dr. Mark Rosenberg, who headed the CDC's injury center at the time. "They went after the researchers, they went after institutions, they went after CDC in a very big way, and they went after me," he said. "They didn't want the data to be collected because they were threatened by what the data were showing."

Dickey, who is now retired, said Wednesday that his real concern was the researcher who led that gun ownership study, who Dickey described as being "in his own kingdom or fiefdom" and believing guns are bad.

He and Rosenberg said they have modified their views over time and now both agree that research is needed. They put out a joint statement Wednesday urging research that prevents firearm injuries while also protecting the rights "of legitimate gun owners."

"We ought to research the whole environment, both sides — what the benefits of having guns are and what are the benefits of not having guns," Dickey said. "We should study any part of this problem," including whether armed guards at schools would help, as the National Rifle Association has suggested.

Association officials did not respond to requests for comment. A statement Wednesday said the group "has led efforts to promote safety and responsible gun ownership" and that "attacking firearms" is not the answer. It said nothing about research.

The 1996 law "had a chilling effect. It basically brought the field of firearm-related research to a screeching halt," said Benjamin of the Public Health Association.

Webster said researchers like him had to "partition" themselves so whatever small money they received from the CDC was not used for anything that could be construed as gun policy. One example was a grant he received to evaluate a community-based program to reduce street gun violence in Baltimore, modeled after a successful program in Chicago called CeaseFire. He had to make sure the work included nothing that could be interpreted as gun control research, even though other privately funded research might.

Private funds from foundations have come nowhere near to filling the gap from lack of federal funding, Hargarten said. He and more than 100 other doctors and scientists recently sent Vice President Joe Biden a letter urging more research, saying the lack of it was compounding "the tragedy of gun violence."

Since 1973, the government has awarded 89 grants to study rabies, of which there were 65 cases; 212 grants for cholera, with 400 cases, yet only three grants for firearm injuries that topped 3 million, they wrote. The CDC spends just about $100,000 a year out of its multibillion-dollar budget on firearm-related research, New York Mayor Michael Bloomberg has said.

"It's so out of proportion to the burden, however you measure it," said Dr. Matthew Miller, associate professor of health policy at the Harvard School of Public Health. As a result, "we don't know really simple things," such as whether tighter gun rules in New York will curb gun trafficking "or is some other pipeline going to open up" in another state, he said.

What now?

CDC officials refused to discuss the topic on the record — a possible sign of how gun shy of the issue the agency has been even after the president's order.

Health and Human Services Secretary Kathleen Sebelius said in a statement that her agency is "committed to re-engaging gun violence research."

Others are more cautious. The Union of Concerned Scientists said the White House's view that the law does not ban gun research is helpful, but not enough to clarify the situation for scientists, and that congressional action is needed.

Dickey, the former congressman, agreed.

"Congress is supposed to do that. He's not supposed to do that," Dickey said of Obama's order. "The restrictions were placed there by Congress.

"What I was hoping for ... is 'let's do this together,'" Dickey said.

___

Follow Marilynn Marchione's coverage at http://twitter.com/MMarchioneAP

Read More..

Large study confirms flu vaccine safe in pregnancy

NEW YORK (AP) — A large study offers reassuring news for pregnant women: It's safe to get a flu shot.

The research found no evidence that the vaccine increases the risk of losing a fetus, and may prevent some deaths. Getting the flu while pregnant makes fetal death more likely, the Norwegian research showed.

The flu vaccine has long been considered safe for pregnant women and their fetus. U.S. health officials began recommending flu shots for them more than five decades ago, following a higher death rate in pregnant women during a flu pandemic in the late 1950s.

But the study is perhaps the largest look at the safety and value of flu vaccination during pregnancy, experts say.

"This is the kind of information we need to provide our patients when discussing that flu vaccine is important for everyone, particularly for pregnant women," said Dr. Geeta Swamy, a researcher who studies vaccines and pregnant women at Duke University Medical Center.

The study was released by the New England Journal of Medicine on Wednesday as the United States and Europe suffer through an early and intense flu season. A U.S. obstetricians group this week reminded members that it's not too late for their pregnant patients to get vaccinated.

The new study was led by the Norwegian Institute of Public Health. It tracked pregnancies in Norway in 2009 and 2010 during an international epidemic of a new swine flu strain.

Before 2009, pregnant women in Norway were not routinely advised to get flu shots. But during the pandemic, vaccinations against the new strain were recommended for those in their second or third trimester.

The study focused on more than 113,000 pregnancies. Of those, 492 ended in the death of the fetus. The researchers calculated that the risk of fetal death was nearly twice as high for women who weren't vaccinated as it was in vaccinated mothers.

U.S. flu vaccination rates for pregnant women grew in the wake of the 2009 swine flu pandemic, from less than 15 percent to about 50 percent. But health officials say those rates need to be higher to protect newborns as well. Infants can't be vaccinated until 6 months, but studies have shown they pick up some protection if their mothers got the annual shot, experts say.

Because some drugs and vaccines can be harmful to a fetus, there is a long-standing concern about giving any medicine to a pregnant woman, experts acknowledged. But this study should ease any worries about the flu shot, said Dr. Denise Jamieson of the Centers for Disease Control and Prevention.

"The vaccine is safe," she said.

___

Online:

Medical journal: http://www.nejm.org

Read More..

Risk to all ages: 100 kids die of flu each year

NEW YORK (AP) — How bad is this flu season, exactly? Look to the children.

Twenty flu-related deaths have been reported in kids so far this winter, one of the worst tolls this early in the year since the government started keeping track in 2004.

But while such a tally is tragic, that does not mean this year will turn out to be unusually bad. Roughly 100 children die in an average flu season, and it's not yet clear the nation will reach that total.

The deaths this year have included a 6-year-old girl in Maine, a 15-year Michigan student who loved robotics, and 6-foot-4 Texas high school senior Max Schwolert, who grew sick in Wisconsin while visiting his grandparents for the holidays.

"He was kind of a gentle giant" whose death has had a huge impact on his hometown of Flower Mound, said Phil Schwolert, the Texas boy's uncle.

Health officials only started tracking pediatric flu deaths nine years ago, after media reports called attention to children's deaths. That was in 2003-04 when the primary flu germ was the same dangerous flu bug as the one dominating this year. It also was an earlier than normal flu season.

The government ultimately received reports of 153 flu-related deaths in children, from 40 states, and most of them had occurred by the beginning of January. But the reporting was scattershot. So in October 2004, the government started requiring all states to report flu-related deaths in kids.

Other things changed, most notably a broad expansion of who should get flu shots. During the terrible 2003-04 season, flu shots were only advised for children ages 6 months to 2 years.

That didn't help 4-year-old Amanda Kanowitz, who one day in late February 2004 came home from preschool with a cough and died less than three days later. Amanda was found dead in her bed that terrible Monday morning, by her mother.

"The worst day of our lives," said her father, Richard Kanowitz, a Manhattan attorney who went on to found a vaccine-promoting group called Families Fighting Flu.

The Centers for Disease Control and Prevention gradually expanded its flu shot guidance, and by 2008 all kids 6 months and older were urged to get the vaccine. As a result, the vaccination rate for kids grew from under 10 percent back then to around 40 percent today.

Flu vaccine is also much more plentiful. Roughly 130 million doses have been distributed this season, compared to 83 million back then. Public education seems to be better, too, Kanowitz observed.

The last unusually bad flu season for children, was 2009-10 — the year of the new swine flu, which hit young people especially hard. As of early January 2010, 236 flu-related deaths of kids had been reported since the previous August.

It's been difficult to compare the current flu season to those of other winters because this one started about a month earlier than usual.

Look at it this way: The nation is currently about five weeks into flu season, as measured by the first time flu case reports cross above a certain threshold. Two years ago, the nation wasn't five weeks into its flu season until early February, and at that point there were 30 pediatric flu deaths — or 10 more than have been reported at about the same point this year. That suggests that when the dust settles, this season may not be as bad as the one only two years ago.

But for some families, it will be remembered as the worst ever.

In Maine, 6-year-old Avery Lane — a first-grader in Benton who had recently received student-of-the-week honors — died in December following a case of the flu, according to press reports. She was Maine's first pediatric flu death in about two years, a Maine health official said.

In Michigan, 15-year-old Joshua Polehna died two weeks ago after suffering flu-like symptoms. The Lake Fenton High School student was the state's fourth pediatric flu death this year, according to published reports.

And in Texas, the town of Flower Mound mourned Schwolert, a healthy, lanky 17-year-old who loved to golf and taught Sunday school at the church where his father was a youth pastor.

Late last month, he and his family drove 16 hours to spend the holidays with his grandparents in Amery, Wis., a small town near the Minnesota state line. Max felt fluish on Christmas Eve, seemed better the next morning but grew worse that night. The family decided to postpone the drive home and took him to a local hospital. He was transferred to a medical center in St. Paul, Minn., where he died on Dec. 29.

He'd been accepted to Oklahoma State University before the Christmas trip. And an acceptance letter from the University of Minnesota arrived in Texas while Max was sick in Minnesota, his uncle said.

Nearly 1,400 people attended a memorial service for Max two weeks ago in Texas.

"He exuded care and love for other people," Phil Schwolert said.

"The bottom line is take care of your kids, be close to your kids," he said.

On average, an estimated 24,000 Americans die each flu season, according to the Centers for Disease Control and Prevention. People who are elderly and with certain chronic health conditions are generally at greatest risk from flu and its complications.

The current vaccine is about 60 percent effective, and is considered the best protection available. Max Schwolert had not been vaccinated, nor had the majority of the other pediatric deaths.

Even if kids are vaccinated, parents should be watchful for unusually severe symptoms, said Lyn Finelli of the CDC.

"If they have influenza-like illness and are lethargic, or not eating, or look punky — or if a parent's intuition is the kid doesn't look right and they're alarmed — they need to call the doctor and take them to the doctor," she advised.

___

CDC advice on kids: http://www.cdc.gov/flu/protect/children.htm

Read More..

Hospitals crack down on workers refusing flu shots

CHICAGO (AP) — Patients can refuse a flu shot. Should doctors and nurses have that right, too? That is the thorny question surfacing as U.S. hospitals increasingly crack down on employees who won't get flu shots, with some workers losing their jobs over their refusal.

"Where does it say that I am no longer a patient if I'm a nurse," wondered Carrie Calhoun, a longtime critical care nurse in suburban Chicago who was fired last month after she refused a flu shot.

Hospitals' get-tougher measures coincide with an earlier-than-usual flu season hitting harder than in recent mild seasons. Flu is widespread in most states, and at least 20 children have died.

Most doctors and nurses do get flu shots. But in the past two months, at least 15 nurses and other hospital staffers in four states have been fired for refusing, and several others have resigned, according to affected workers, hospital authorities and published reports.

In Rhode Island, one of three states with tough penalties behind a mandatory vaccine policy for health care workers, more than 1,000 workers recently signed a petition opposing the policy, according to a labor union that has filed suit to end the regulation.

Why would people whose job is to protect sick patients refuse a flu shot? The reasons vary: allergies to flu vaccine, which are rare; religious objections; and skepticism about whether vaccinating health workers will prevent flu in patients.

Dr. Carolyn Bridges, associate director for adult immunization at the federal Centers for Disease Control and Prevention, says the strongest evidence is from studies in nursing homes, linking flu vaccination among health care workers with fewer patient deaths from all causes.

"We would all like to see stronger data," she said. But other evidence shows flu vaccination "significantly decreases" flu cases, she said. "It should work the same in a health care worker versus somebody out in the community."

Cancer nurse Joyce Gingerich is among the skeptics and says her decision to avoid the shot is mostly "a personal thing." She's among seven employees at IU Health Goshen Hospital in northern Indiana who were recently fired for refusing flu shots. Gingerich said she gets other vaccinations but thinks it should be a choice. She opposes "the injustice of being forced to put something in my body."

Medical ethicist Art Caplan says health care workers' ethical obligation to protect patients trumps their individual rights.

"If you don't want to do it, you shouldn't work in that environment," said Caplan, medical ethics chief at New York University's Langone Medical Center. "Patients should demand that their health care provider gets flu shots — and they should ask them."

For some people, flu causes only mild symptoms. But it can also lead to pneumonia, and there are thousands of hospitalizations and deaths each year. The number of deaths has varied in recent decades from about 3,000 to 49,000.

A survey by CDC researchers found that in 2011, more than 400 U.S. hospitals required flu vaccinations for their employees and 29 hospitals fired unvaccinated employees.

At Calhoun's hospital, Alexian Brothers Medical Center in Elk Grove Village, Ill., unvaccinated workers granted exemptions must wear masks and tell patients, "I'm wearing the mask for your safety," Calhoun says. She says that's discriminatory and may make patients want to avoid "the dirty nurse" with the mask.

The hospital justified its vaccination policy in an email, citing the CDC's warning that this year's flu outbreak was "expected to be among the worst in a decade" and noted that Illinois has already been hit especially hard. The mandatory vaccine policy "is consistent with our health system's mission to provide the safest environment possible."

The government recommends flu shots for nearly everyone, starting at age 6 months. Vaccination rates among the general public are generally lower than among health care workers.

According to the most recent federal data, about 63 percent of U.S. health care workers had flu shots as of November. That's up from previous years, but the government wants 90 percent coverage of health care workers by 2020.

The highest rate, about 88 percent, was among pharmacists, followed by doctors at 84 percent, and nurses, 82 percent. Fewer than half of nursing assistants and aides are vaccinated, Bridges said.

Some hospitals have achieved 90 percent but many fall short. A government health advisory panel has urged those below 90 percent to consider a mandatory program.

Also, the accreditation body over hospitals requires them to offer flu vaccines to workers, and those failing to do that and improve vaccination rates could lose accreditation.

Starting this year, the government's Centers for Medicare & Medicaid Services is requiring hospitals to report employees' flu vaccination rates as a means to boost the rates, the CDC's Bridges said. Eventually the data will be posted on the agency's "Hospital Compare" website.

Several leading doctor groups support mandatory flu shots for workers. And the American Medical Association in November endorsed mandatory shots for those with direct patient contact in nursing homes; elderly patients are particularly vulnerable to flu-related complications. The American Nurses Association supports mandates if they're adopted at the state level and affect all hospitals, but also says exceptions should be allowed for medical or religious reasons.

Mandates for vaccinating health care workers against other diseases, including measles, mumps and hepatitis, are widely accepted. But some workers have less faith that flu shots work — partly because there are several types of flu virus that often differ each season and manufacturers must reformulate vaccines to try and match the circulating strains.

While not 100 percent effective, this year's vaccine is a good match, the CDC's Bridges said.

Several states have laws or regulations requiring flu vaccination for health care workers but only three — Arkansas, Maine and Rhode Island — spell out penalties for those who refuse, according to Alexandra Stewart, a George Washington University expert in immunization policy and co-author of a study appearing this month in the journal Vaccine.

Rhode Island's regulation, enacted in December, may be the toughest and is being challenged in court by a health workers union. The rule allows exemptions for religious or medical reasons, but requires unvaccinated workers in contact with patients to wear face masks during flu season. Employees who refuse the masks can be fined $100 and may face a complaint or reprimand for unprofessional conduct that could result in losing their professional license.

Some Rhode Island hospitals post signs announcing that workers wearing masks have not received flu shots. Opponents say the masks violate their health privacy.

"We really strongly support the goal of increasing vaccination rates among health care workers and among the population as a whole," but it should be voluntary, said SEIU Healthcare Employees Union spokesman Chas Walker.

Supporters of health care worker mandates note that to protect public health, courts have endorsed forced vaccination laws affecting the general population during disease outbreaks, and have upheld vaccination requirements for schoolchildren.

Cases involving flu vaccine mandates for health workers have had less success. A 2009 New York state regulation mandating health care worker vaccinations for swine flu and seasonal flu was challenged in court but was later rescinded because of a vaccine shortage. And labor unions have challenged individual hospital mandates enacted without collective bargaining; an appeals court upheld that argument in 2007 in a widely cited case involving Virginia Mason Hospital in Seattle.

Calhoun, the Illinois nurse, says she is unsure of her options.

"Most of the hospitals in my area are all implementing these policies," she said. "This conflict could end the career I have dedicated myself to."

__

Online:

R.I. union lawsuit against mandatory vaccines: http://www.seiu1199ne.org/files/2013/01/FluLawsuitRI.pdf

CDC: http://www.cdc.gov

___

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

Read More..

Flu more widespread in US; eases off in some areas

NEW YORK (AP) — Flu is now widespread in all but three states as the nation grapples with an earlier-than-normal season. But there was one bit of good news Friday: The number of hard-hit areas declined.

The flu season in the U.S. got under way a month early, in December, driven by a strain that tends to make people sicker. That led to worries that it might be a bad season, following one of the mildest flu seasons in recent memory.

The latest numbers do show that the flu surpassed an "epidemic" threshold last week. That is based on deaths from pneumonia and influenza in 122 U.S. cities. However, it's not unusual — the epidemic level varies at different times of the year, and it was breached earlier this flu season, in October and November.

And there's a hint that the flu season may already have peaked in some spots, like in the South. Still, officials there and elsewhere are bracing for more sickness

In Ohio, administrators at Miami University are anxious that a bug that hit employees will spread to students when they return to the Oxford campus next week.

"Everybody's been sick. It's miserable," said Ritter Hoy, a spokeswoman for the 17,000-student school.

Despite the early start, health officials say it's not too late to get a flu shot. The vaccine is considered a good — though not perfect — protection against getting really sick from the flu.

Flu was widespread in 47 states last week, up from 41 the week before, the Centers for Disease Control and Prevention said on Friday. The only states without widespread flu were California, Mississippi and Hawaii.

The number of hard-hit states fell to 24 from 29, where larger numbers of people were treated for flu-like illness. Now off that list: Florida, Arkansas and South Carolina in the South, the first region hit this flu season.

Recent flu reports included holiday weeks when some doctor's offices were closed, so it will probably take a couple more weeks to get a better picture, CDC officials said Friday. Experts say so far say the season looks moderate.

"Only time will tell how moderate or severe this flu season will be," CDC Director Dr. Thomas Frieden said Friday in a teleconference with reporters.

The government doesn't keep a running tally of adult deaths from the flu, but estimates that it kills about 24,000 people in an average year. Nationally, 20 children have died from the flu this season.

Flu vaccinations are recommended for everyone 6 months or older. Since the swine flu epidemic in 2009, vaccination rates have increased in the U.S., but more than half of Americans haven't gotten this year's vaccine.

Nearly 130 million doses of flu vaccine were distributed this year, and at least 112 million have been used. Vaccine is still available, but supplies may have run low in some locations, officials said.

To find a shot, "you may have to call a couple places," said Dr. Patricia Quinlisk, who tracks the flu in Iowa.

In midtown Manhattan, Hyrmete Sciuto got a flu shot Friday at a drugstore. She skipped it in recent years, but news reports about the flu this week worried her.

During her commute from Edgewater, N.J., by ferry and bus, "I have people coughing in my face," she said. "I didn't want to risk it this year."

The vaccine is no guarantee, though, that you won't get sick. On Friday, CDC officials said a recent study of more than 1,100 people has concluded the current flu vaccine is 62 percent effective. That means the average vaccinated person is 62 percent less likely to get a case of flu that sends them to the doctor, compared to people who don't get the vaccine. That's in line with other years.

The vaccine is reformulated annually, and this year's is a good match to the viruses going around.

The flu's early arrival coincided with spikes in flu-like illnesses caused by other bugs, including a new norovirus that causes vomiting and diarrhea, or what is commonly known as "stomach flu." Those illnesses likely are part of the heavy traffic in hospital and clinic waiting rooms, CDC officials said.

Europeans also are suffering an early flu season, though a milder strain predominates there. China, Japan, the West Bank, the Gaza Strip, Algeria and the Republic of Congo have also reported increasing flu.

Flu usually peaks in midwinter. Symptoms can include fever, cough, runny nose, head and body aches and fatigue. Some people also suffer vomiting and diarrhea, and some develop pneumonia or other severe complications.

Most people with flu have a mild illness. But people with severe symptoms should see a doctor. They may be given antiviral drugs or other medications to ease symptoms.

Some shortages have been reported for children's liquid Tamiflu, a prescription medicine used to treat flu. But health officials say adult Tamiflu pills are available, and pharmacists can convert those to doses for children.

___

Associated Press writers Dan Sewell in Cincinnati, Catherine Lucey in Des Moines, and Malcolm Ritter in New York contributed to this report.

___

Online:

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

Read More..

Q&A: Scramble for vaccine as flu season heats up

WASHINGTON (AP) — Missed flu-shot day at the office last fall? And all those "get vaccinated" ads? A scramble for shots is under way as late-comers seek protection from a miserable flu strain already spreading through much of the country.

Federal health officials said Friday that there is still some flu vaccine available and it's not too late to benefit from it. But people may have to call around to find a clinic with shots still on the shelf, or wait a few days for a new shipment.

"We're hearing of spot shortages," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention.

Colorado offers an example. Kaiser Permanente, which has 535,000 members in the state, stopped giving flu shots this week. But it expected to resume vaccinations when new shipments arrive, expected this weekend.

Some questions and answers about flu vaccines:

Q: Are we running out of vaccine?

A: It's January — we shouldn't have a lot left. The traditional time to get vaccinated is in the fall, so that people are protected before influenza starts spreading.

Indeed, manufacturers already have shipped nearly 130 million doses to doctors' offices, drugstores and wholesalers, out of the 135 million doses they had planned to make for this year's flu season. At least 112 million have been used so far.

The nation's largest manufacturer, Sanofi Pasteur, said Friday that it still has supplies of two specialty vaccines, a high-dose shot for seniors, and an under-the-skin shot for certain adults, available for immediate shipment. But it also is working to eke out a limited supply of its traditional shots — some doses that it initially hadn't packaged into syringes, said spokesman Michael Szumera. They should be available late this month.

And MedImmune, the maker of the nasal spray vaccine FluMist, said it has 620,000 extra doses available.

Q: Can't they just make more?

A: No. Flu vaccine is complicated to brew, with supplies for each winter made months in advance and at the numbers expected to sell. Although health officials recommend a yearly flu vaccination for nearly everybody, last year 52 percent of children and just 39 percent of adults were immunized. Most years, leftover doses have to be thrown out.

Q: Should I still hunt for a vaccine?

A: It does take two weeks for full protection to kick in. Still, health officials say it's a good idea to be vaccinated even this late, especially for older people, young children and anyone with medical conditions such as heart or lung diseases that put them at high risk of dangerous flu complications. Flu season does tend to be worst in January and February, but it can run through March.

Q: I heard that a new flu strain is spreading. Does the vaccine really work?

A: Flu strains constantly evolve, the reason that people need an updated vaccine every year. But the CDC says this year's is a good match to the types that are circulating, including a new kind of the tough H3N2 strain. That family tends to be harsher than other flu types — and health officials warned last fall that it was coming, and meant this winter would likely be tougher than last year's flu season, the mildest on record.

Q: But don't some people get vaccinated and still get sick?

A: Flu vaccine never is 100 percent effective, and unfortunately it tends to protect younger people better than older ones. But the CDC released a study Friday showing that so far this year, the vaccine appears 62 percent effective, meaning it's working about as well as it has in past flu seasons.

While that may strike some people as low, Frieden said it's the best protection available. "It's a glass 62 percent full," he said. "It's well worth the effort."

Q: What else can I do?

A: Wash your hands often, and avoid touching your eyes, nose and mouth. Viruses can spread by hand, not just through the air. Also, cough in your elbow, not your hand. When you're sick, protect others by staying home.

And people who are in those high-risk groups should call a doctor if they develop symptoms, added CDC spokesman Tom Skinner. They might be prescribed antiviral medication, which works best if given within the first 48 hours of symptoms.

___

AP Medical Writers Lindsey Tanner and Mike Stobbe contributed to this report.

Read More..

Flu season puts businesses and employees in a bind

WASHINGTON (AP) — Nearly half the 70 employees at a Ford dealership in Clarksville, Ind., have been out sick at some point in the past month. It didn't have to be that way, the boss says.

"If people had stayed home in the first place, a lot of times that spread wouldn't have happened," says Marty Book, a vice president at Carriage Ford. "But people really want to get out and do their jobs, and sometimes that's a detriment."

The flu season that has struck early and hard across the U.S. is putting businesses and employees alike in a bind. In this shaky economy, many Americans are reluctant to call in sick, something that can backfire for their employers.

Flu was widespread in 47 states last week, up from 41 the week before, the Centers for Disease Control and Prevention said Friday. The only states without widespread flu were California, Mississippi and Hawaii. And the main strain of the virus circulating tends to make people sicker than usual.

Blake Fleetwood, president of Cook Travel in New York, says his agency is operating with less than 40 percent of its staff of 35 because of the flu and other ailments.

"The people here are working longer hours and it puts a lot of strain on everyone," Fleetwood says. "You don't know whether to ask people with the flu to come in or not." He says the flu is also taking its toll on business as customers cancel their travel plans: "People are getting the flu and they're reduced to a shriveling little mess and don't feel like going anywhere."

Many workers go to the office even when they're sick because they are worried about losing their jobs, says John Challenger, CEO of Challenger, Gray & Christmas, an employer consulting firm. Other employees report for work out of financial necessity, since roughly 40 percent of U.S. workers don't get paid if they are out sick. Some simply have a strong work ethic and feel obligated to show up.

Flu season typically costs employers $10.4 billion for hospitalization and doctor's office visits, according to the CDC. That does not include the costs of lost productivity from absences.

At Carriage Ford, Book says the company plans to make flu shots mandatory for all employees.

Linda Doyle, CEO of the Northcrest Community retirement home in Ames, Iowa, says the company took that step this year for its 120 employees, providing the shots at no cost. It is also supplying face masks for all staff.

And no one is expected to come into work if sick, she says.

So far, the company hasn't seen an outbreak of flu cases.

"You keep your fingers crossed and hope it continues this way," Doyle says. "You see the news and it's frightening. We just want to make sure that we're doing everything possible to keep everyone healthy. Cleanliness is really the key to it. Washing your hands. Wash, wash, wash."

Among other steps employers can take to reduce the spread of the flu on the job: holding meetings via conference calls, staggering shifts so that fewer people are on the job at the same time, and avoiding handshaking.

Newspaper editor Rob Blackwell says he had taken only two sick days in the last two years before coming down with the flu and then pneumonia in the past two weeks. He missed several days the first week of January and has been working from home the past week.

"I kept trying to push myself to get back to work because, generally speaking, when I'm sick I just push through it," says Blackwell, the Washington bureau chief for the daily trade paper American Banker.

Connecticut is the only state that requires some businesses to pay employees when they are out sick. Cities such as San Francisco and Washington have similar laws.

Challenger and others say attitudes are changing, and many companies are rethinking their sick policies to avoid officewide outbreaks of the flu and other infectious diseases.

"I think companies are waking up to the fact right now that you might get a little bit of gain from a person coming into work sick, but especially when you have an epidemic, if 10 or 20 people then get sick, in fact you've lost productivity," Challenger says.

___

Associated Press writers Mike Stobbe in Atlanta, Eileen A.J. Connelly in New York, Paul Wiseman in Washington, Barbara Rodriguez in Des Moines, Iowa, and Jim Salter in St. Louis contributed to this report.

Read More..

Flu season strikes early and, in some places, hard

NEW YORK (AP) — From the Rocky Mountains to New England, hospitals are swamped with people with flu symptoms. Some medical centers are turning away visitors or making them wear face masks, and one Pennsylvania hospital set up a tent outside its ER to deal with the feverish patients.

Flu season in the U.S. has struck early and, in many places, hard.

While flu normally doesn't blanket the country until late January or February, it is already widespread in more than 40 states, with about 30 of them reporting some major hot spots. On Thursday, health officials blamed the flu for the deaths of 20 children so far.

Whether this will be considered a bad season by the time it has run its course in the spring remains to be seen.

"Those of us with gray hair have seen worse," said Dr. William Schaffner, a flu expert at Vanderbilt University in Nashville.

The evidence so far points to a moderate season, Schaffner and others say. It looks bad in part because last year was unusually mild and because the main strain of influenza circulating this year tends to make people sicker and really lay them low.

David Smythe of New York City saw it happen to his 50-year-old girlfriend, who has been knocked out for about two weeks. "She's been in bed. She can't even get up," he said.

Also, the flu's early arrival coincided with spikes in a variety of other viruses, including a childhood malady that mimics flu and a new norovirus that causes vomiting and diarrhea, or what is commonly known as "stomach flu." So what people are calling the flu may, in fact, be something else.

"There may be more of an overlap than we normally see," said Dr. Joseph Bresee, who tracks the flu for the Centers for Disease Control and Prevention.

Most people don't undergo lab tests to confirm flu, and the symptoms are so similar that it can be hard to distinguish flu from other viruses, or even a cold. Over the holidays, 250 people were sickened at a Mormon missionary training center in Utah, but the culprit turned out to be a norovirus, not the flu.

Flu is a major contributor, though, to what's going on.

"I'd say 75 percent," said Dr. Dan Surdam, head of the emergency department at Cheyenne Regional Medical Center, Wyoming's largest hospital. The 17-bed emergency room saw its busiest day ever last week, with 166 visitors.

The early onslaught has resulted in a spike in hospitalizations. To deal with the influx and protect other patients from getting sick, hospitals are restricting visits from children, requiring family members to wear masks and banning anyone with flu symptoms from maternity wards.

One hospital in Allentown, Pa., set up a tent this week for a steady stream of patients with flu symptoms. But so far "what we're seeing is a typical flu season," said Terry Burger, director of infection control and prevention for the hospital, Lehigh Valley Hospital-Cedar Crest.

On Wednesday, Boston declared a public health emergency, with the city's hospitals counting about 1,500 emergency room visits since December by people with flu-like symptoms.

All the flu activity has led some to question whether this year's flu shot is working. While health officials are still analyzing the vaccine, early indications are that it's about 60 percent effective, which is in line with what's been seen in other years.

The vaccine is reformulated each year, based on experts' best guess of which strains of the virus will predominate. This year's vaccine is well-matched to what's going around. The government estimates that between a third and half of Americans have gotten the vaccine.

In New York City, 57-year-old Judith Quinones skipped getting a flu shot this season and suffered her worst case of flu-like illness in years. She was laid up for nearly a month with fever and body aches. "I just couldn't function," she said.

But her daughter got the vaccine. "And she got sick twice," Quinones said.

Europe is also suffering an early flu season, though a milder strain predominates there. Flu reports are up, too, in China, Japan, the West Bank, the Gaza Strip, Algeria and the Republic of Congo. Britain has seen a surge in cases of norovirus.

On average, about 24,000 Americans die each flu season, according to the CDC. That's an estimate — the agency does not keep a running tally of adult flu deaths each year, only for children. Some state health departments do keep count, and they've reported dozens of flu deaths so far.

Flu usually peaks in midwinter. Symptoms can include fever, cough, runny nose, head and body aches and fatigue. Some people also suffer vomiting and diarrhea, and some develop pneumonia or other severe complications.

Most people with flu have a mild illness and can help themselves and protect others by staying home and resting. But people with severe symptoms should see a doctor. They may be given antiviral drugs or other medications to ease symptoms.

Flu vaccinations are recommended for everyone 6 months or older. Of the 20 children killed by the flu this season, only two were fully vaccinated.

___

AP Medical Writer Maria Cheng in London contributed to this report.

___

Online:

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

Read More..

Retooling Pap test to spot more kinds of cancer

WASHINGTON (AP) — For years, doctors have lamented that there's no Pap test for deadly ovarian cancer. Wednesday, scientists reported encouraging signs that one day, there might be.

Researchers are trying to retool the Pap, a test for cervical cancer that millions of women get, so that it could spot early signs of other gynecologic cancers, too.

How? It turns out that cells can flake off of tumors in the ovaries or the lining of the uterus, and float down to rest in the cervix, where Pap tests are performed. These cells are too rare to recognize under the microscope. But researchers from Johns Hopkins University used some sophisticated DNA testing on the Pap samples to uncover the evidence — gene mutations that show cancer is present.

In a pilot study, they analyzed Pap smears from 46 women who already were diagnosed with either ovarian or endometrial cancer. The new technique found all the endometrial cancers and 41 percent of the ovarian tumors, the team reported Wednesday in the journal Science Translational Medicine.

This is very early-stage research, and women shouldn't expect any change in their routine Paps. It will take years of additional testing to prove if the so-called PapGene technique really could work as a screening tool, used to spot cancer in women who thought they were healthy.

"Now the hard work begins," said Hopkins oncologist Dr. Luis Diaz, whose team is collecting hundreds of additional Pap samples for more study and is exploring ways to enhance the detection of ovarian cancer.

But if it ultimately pans out, "the neat part about this is, the patient won't feel anything different," and the Pap wouldn't be performed differently, Diaz added. The extra work would come in a lab.

The gene-based technique marks a new approach toward cancer screening, and specialists are watching closely.

"This is very encouraging, and it shows great potential," said American Cancer Society genetics expert Michael Melner.

"We are a long way from being able to see any impact on our patients," cautioned Dr. Shannon Westin of the University of Texas MD Anderson Cancer Center. She reviewed the research in an accompanying editorial, and said the ovarian cancer detection would need improvement if the test is to work.

But she noted that ovarian cancer has poor survival rates because it's rarely caught early. "If this screening test could identify ovarian cancer at an early stage, there would be a profound impact on patient outcomes and mortality," Westin said.

More than 22,000 U.S. women are diagnosed with ovarian cancer each year, and more than 15,000 die. Symptoms such as pain and bloating seldom are obvious until the cancer is more advanced, and numerous attempts at screening tests have failed.

Endometrial cancer affects about 47,000 women a year, and kills about 8,000. There is no screening test for it either, but most women are diagnosed early because of postmenopausal bleeding.

The Hopkins research piggybacks on one of the most successful cancer screening tools, the Pap, and a newer technology used along with it. With a standard Pap, a little brush scrapes off cells from the cervix, which are stored in a vial to examine for signs of cervical cancer. Today, many women's Paps undergo an additional DNA-based test to see if they harbor the HPV virus, which can spur cervical cancer.

So the Hopkins team, funded largely by cancer advocacy groups, decided to look for DNA evidence of other gynecologic tumors. It developed a method to rapidly screen the Pap samples for those mutations using standard genetics equipment that Diaz said wouldn't add much to the cost of a Pap-plus-HPV test. He said the technique could detect both early-stage and more advanced tumors. Importantly, tests of Paps from 14 healthy women turned up no false alarms.

The endometrial cancers may have been easier to find because cells from those tumors don't have as far to travel as ovarian cancer cells, Diaz said. Researchers will study whether inserting the Pap brush deeper, testing during different times of the menstrual cycle, or other factors might improve detection of ovarian cancer.

Read More..

Report: Death rates from cancer still inching down

WASHINGTON (AP) — Death rates from cancer are continuing to inch down, researchers reported Monday.

Now the question is how to hold onto those gains, and do even better, even as the population gets older and fatter, both risks for developing cancer.

"There has been clear progress," said Dr. Otis Brawley of the American Cancer Society, which compiled the annual cancer report with government and cancer advocacy groups.

But bad diets, lack of physical activity and obesity together wield "incredible forces against this decline in mortality," Brawley said. He warned that over the next decade, that trio could surpass tobacco as the leading cause of cancer in the U.S.

Overall, deaths from cancer began slowly dropping in the 1990s, and Monday's report shows the trend holding. Among men, cancer death rates dropped by 1.8 percent a year between 2000 and 2009, and by 1.4 percent a year among women. The drops are thanks mostly to gains against some of the leading types — lung, colorectal, breast and prostate cancers — because of treatment advances and better screening.

The news isn't all good. Deaths still are rising for certain cancer types including liver, pancreatic and, among men, melanoma, the most serious kind of skin cancer.

Preventing cancer is better than treating it, but when it comes to new cases of cancer, the picture is more complicated.

Cancer incidence is dropping slightly among men, by just over half a percent a year, said the report published by the Journal of the National Cancer Institute. Prostate, lung and colorectal cancers all saw declines.

But for women, earlier drops have leveled off, the report found. That may be due in part to breast cancer. There were decreases in new breast cancer cases about a decade ago, as many women quit using hormone therapy after menopause. Since then, overall breast cancer incidence has plateaued, and rates have increased among black women.

Another problem area: Oral and anal cancers caused by HPV, the sexually transmitted human papillomavirus, are on the rise among both genders. HPV is better known for causing cervical cancer, and a protective vaccine is available. Government figures show just 32 percent of teen girls have received all three doses, fewer than in Canada, Britain and Australia. The vaccine was recommended for U.S. boys about a year ago.

Among children, overall cancer death rates are dropping by 1.8 percent a year, but incidence is continuing to increase by just over half a percent a year. Brawley said it's not clear why.

Read More..

Report: Death rates from cancer still inching down

WASHINGTON (AP) — Death rates from cancer are continuing to inch down, researchers reported Monday.

Now the question is how to hold onto those gains, and do even better, even as the population gets older and fatter, both risks for developing cancer.

"There has been clear progress," said Dr. Otis Brawley of the American Cancer Society, which compiled the annual cancer report with government and cancer advocacy groups.

But bad diets, lack of physical activity and obesity together wield "incredible forces against this decline in mortality," Brawley said. He warned that over the next decade, that trio could surpass tobacco as the leading cause of cancer in the U.S.

Overall, deaths from cancer began slowly dropping in the 1990s, and Monday's report shows the trend holding. Among men, cancer death rates dropped by 1.8 percent a year between 2000 and 2009, and by 1.4 percent a year among women. The drops are thanks mostly to gains against some of the leading types — lung, colorectal, breast and prostate cancers — because of treatment advances and better screening.

The news isn't all good. Deaths still are rising for certain cancer types including liver, pancreatic and, among men, melanoma, the most serious kind of skin cancer.

Preventing cancer is better than treating it, but when it comes to new cases of cancer, the picture is more complicated.

Cancer incidence is dropping slightly among men, by just over half a percent a year, said the report published by the Journal of the National Cancer Institute. Prostate, lung and colorectal cancers all saw declines.

But for women, earlier drops have leveled off, the report found. That may be due in part to breast cancer. There were decreases in new breast cancer cases about a decade ago, as many women quit using hormone therapy after menopause. Since then, overall breast cancer incidence has plateaued, and rates have increased among black women.

Another problem area: Oral and anal cancers caused by HPV, the sexually transmitted human papillomavirus, are on the rise among both genders. HPV is better known for causing cervical cancer, and a protective vaccine is available. Government figures show just 32 percent of teen girls have received all three doses, fewer than in Canada, Britain and Australia. The vaccine was recommended for U.S. boys about a year ago.

Among children, overall cancer death rates are dropping by 1.8 percent a year, but incidence is continuing to increase by just over half a percent a year. Brawley said it's not clear why.

Read More..

Your medical chart could include exercise minutes

CHICAGO (AP) — Roll up a sleeve for the blood pressure cuff. Stick out a wrist for the pulse-taking. Lift your tongue for the thermometer. Report how many minutes you are active or getting exercise.

Wait, what?

If the last item isn't part of the usual drill at your doctor's office, a movement is afoot to change that. One recent national survey indicated only a third of Americans said their doctors asked about or prescribed physical activity.

Kaiser Permanente, one of the nation's largest nonprofit health insurance plans, made a big push a few years ago to get its southern California doctors to ask patients about exercise. Since then, Kaiser has expanded the program across California and to several other states. Now almost 9 million patients are asked at every visit, and some other medical systems are doing it, too.

Here's how it works: During any routine check of vital signs, a nurse or medical assistant asks how many days a week the patient exercises and for how long. The number of minutes per week is posted along with other vitals at the top the medical chart. So it's among the first things the doctor sees.

"All we ask our physicians to do is to make a comment on it, like, 'Hey, good job,' or 'I noticed today that your blood pressure is too high and you're not doing any exercise. There's a connection there. We really need to start you walking 30 minutes a day,'" said Dr. Robert Sallis, a Kaiser family doctor. He hatched the vital sign idea as part of a larger initiative by doctors groups.

He said Kaiser doctors generally prescribe exercise first, instead of medication, and for many patients who follow through that's often all it takes.

It's a challenge to make progress. A study looking at the first year of Kaiser's effort showed more than a third of patients said they never exercise.

Sallis said some patients may not be aware that research shows physical inactivity is riskier than high blood pressure, obesity and other health risks people know they should avoid. As recently as November a government-led study concluded that people who routinely exercise live longer than others, even if they're overweight.

Zendi Solano, who works for Kaiser as a research assistant in Pasadena, Calif., says she always knew exercise was a good thing. But until about a year ago, when her Kaiser doctor started routinely measuring it, she "really didn't take it seriously."

She was obese, and in a family of diabetics, had elevated blood sugar. She sometimes did push-ups and other strength training but not anything very sustained or strenuous.

Solano, 34, decided to take up running and after a couple of months she was doing three miles. Then she began training for a half marathon — and ran that 13-mile race in May in less than three hours. She formed a running club with co-workers and now runs several miles a week. She also started eating smaller portions and buying more fruits and vegetables.

She is still overweight but has lost 30 pounds and her blood sugar is normal.

Her doctor praised the improvement at her last physical in June and Solano says the routine exercise checks are "a great reminder."

Kaiser began the program about three years ago after 2008 government guidelines recommended at least 2 1/2 hours of moderately vigorous exercise each week. That includes brisk walking, cycling, lawn-mowing — anything that gets you breathing a little harder than normal for at least 10 minutes at a time.

A recently published study of nearly 2 million people in Kaiser's southern California network found that less than a third met physical activity guidelines during the program's first year ending in March 2011. That's worse than results from national studies. But promoters of the vital signs effort think Kaiser's numbers are more realistic because people are more likely to tell their own doctors the truth.

Dr. Elizabeth Joy of Salt Lake City has created a nearly identical program and she expects 300 physicians in her Intermountain Healthcare network to be involved early this year.

"There are some real opportunities there to kind of shift patients' expectations about the value of physical activity on health," Joy said.

NorthShore University HealthSystem in Chicago's northern suburbs plans to start an exercise vital sign program this month, eventually involving about 200 primary care doctors.

Dr. Carrie Jaworski, a NorthShore family and sports medicine specialist, already asks patients about exercise. She said some of her diabetic patients have been able to cut back on their medicines after getting active.

Dr. William Dietz, an obesity expert who retired last year from the Centers for Disease Control and Prevention, said measuring a patient's exercise regardless of method is essential, but that "naming it as a vital sign kind of elevates it."

Figuring out how to get people to be more active is the important next step, he said, and could have a big effect in reducing medical costs.

___

Online:

Exercise: http://1.usa.gov/b6AkMa

___

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

Read More..

FDA: New rules will make food safer

WASHINGTON (AP) — The Food and Drug Administration says its new guidelines would make the food Americans eat safer and help prevent the kinds of foodborne disease outbreaks that sicken or kill thousands of consumers each year.

The rules, the most sweeping food safety guidelines in decades, would require farmers to take new precautions against contamination, to include making sure workers' hands are washed, irrigation water is clean, and that animals stay out of fields. Food manufacturers will have to submit food safety plans to the government to show they are keeping their operations clean.

The long-overdue regulations could cost businesses close to half a billion dollars a year to implement, but are expected to reduce the estimated 3,000 deaths a year from foodborne illness. The new guidelines were announced Friday.

Just since last summer, outbreaks of listeria in cheese and salmonella in peanut butter, mangoes and cantaloupe have been linked to more than 400 illnesses and as many as seven deaths, according to the federal Centers for Disease Control and Prevention. The actual number of those sickened is likely much higher.

Many responsible food companies and farmers are already following the steps that the FDA would now require them to take. But officials say the requirements could have saved lives and prevented illnesses in several of the large-scale outbreaks that have hit the country in recent years.

In a 2011 outbreak of listeria in cantaloupe that claimed 33 lives, for example, FDA inspectors found pools of dirty water on the floor and old, dirty processing equipment at Jensen Farms in Colorado where the cantaloupes were grown. In a peanut butter outbreak this year linked to 42 salmonella illnesses, inspectors found samples of salmonella throughout Sunland Inc.'s peanut processing plant in New Mexico and multiple obvious safety problems, such as birds flying over uncovered trailers of peanuts and employees not washing their hands.

Under the new rules, companies would have to lay out plans for preventing those sorts of problems, monitor their own progress and explain to the FDA how they would correct them.

"The rules go very directly to preventing the types of outbreaks we have seen," said Michael Taylor, FDA's deputy commissioner for foods.

The FDA estimates the new rules could prevent almost 2 million illnesses annually, but it could be several years before the rules are actually preventing outbreaks. Taylor said it could take the agency another year to craft the rules after a four-month comment period, and farms would have at least two years to comply — meaning the farm rules are at least three years away from taking effect. Smaller farms would have even longer to comply.

The new rules, which come exactly two years to the day President Barack Obama's signed food safety legislation passed by Congress, were already delayed. The 2011 law required the agency to propose a first installment of the rules a year ago, but the Obama administration held them until after the election. Food safety advocates sued the administration to win their release.

The produce rule would mark the first time the FDA has had real authority to regulate food on farms. In an effort to stave off protests from farmers, the farm rules are tailored to apply only to certain fruits and vegetables that pose the greatest risk, like berries, melons, leafy greens and other foods that are usually eaten raw. A farm that produces green beans that will be canned and cooked, for example, would not be regulated.

Such flexibility, along with the growing realization that outbreaks are bad for business, has brought the produce industry and much of the rest of the food industry on board as Congress and FDA has worked to make food safer.

In a statement Friday, Pamela Bailey, president of the Grocery Manufacturers Association, which represents the country's biggest food companies, said the food safety law "can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal."

The new rules could cost large farms $30,000 a year, according to the FDA. The agency did not break down the costs for individual processing plants, but said the rules could cost manufacturers up to $475 million annually.

FDA Commissioner Margaret Hamburg said the success of the rules will also depend on how much money Congress gives the chronically underfunded agency to put them in place. "Resources remain an ongoing concern," she said.

The farm and manufacturing rules are only one part of the food safety law. The bill also authorized more surprise inspections by the FDA and gave the agency additional powers to shut down food facilities. In addition, the law required stricter standards on imported foods. The agency said it will soon propose other overdue rules to ensure that importers verify overseas food is safe and to improve food safety audits overseas.

Food safety advocates frustrated over the last year as the rules stalled praised the proposed action.

"The new law should transform the FDA from an agency that tracks down outbreaks after the fact, to an agency focused on preventing food contamination in the first place," said Caroline Smith DeWaal of the Center for Science in the Public Interest.

Read More..

FDA proposes sweeping new food safety rules

WASHINGTON (AP) — The Food and Drug Administration on Friday proposed the most sweeping food safety rules in decades, requiring farmers and food companies to be more vigilant in the wake of deadly outbreaks in peanuts, cantaloupe and leafy greens.

The long-overdue regulations could cost businesses close to half a billion dollars a year to implement, but are expected to reduce the estimated 3,000 deaths a year from foodborne illness. Just since last summer, outbreaks of listeria in cheese and salmonella in peanut butter, mangoes and cantaloupe have been linked to more than 400 illnesses and as many as seven deaths, according to the federal Centers for Disease Control and Prevention. The actual number of those sickened is likely much higher.

The FDA's proposed rules would require farmers to take new precautions against contamination, to include making sure workers' hands are washed, irrigation water is clean, and that animals stay out of fields. Food manufacturers will have to submit food safety plans to the government to show they are keeping their operations clean.

Many responsible food companies and farmers are already following the steps that the FDA would now require them to take. But officials say the requirements could have saved lives and prevented illnesses in several of the large-scale outbreaks that have hit the country in recent years.

In a 2011 outbreak of listeria in cantaloupe that claimed 33 lives, for example, FDA inspectors found pools of dirty water on the floor and old, dirty processing equipment at Jensen Farms in Colorado where the cantaloupes were grown. In a peanut butter outbreak this year linked to 42 salmonella illnesses, inspectors found samples of salmonella throughout Sunland Inc.'s peanut processing plant in New Mexico and multiple obvious safety problems, such as birds flying over uncovered trailers of peanuts and employees not washing their hands.

Under the new rules, companies would have to lay out plans for preventing those sorts of problems, monitor their own progress and explain to the FDA how they would correct them.

"The rules go very directly to preventing the types of outbreaks we have seen," said Michael Taylor, FDA's deputy commissioner for foods.

The FDA estimates the new rules could prevent almost 2 million illnesses annually, but it could be several years before the rules are actually preventing outbreaks. Taylor said it could take the agency another year to craft the rules after a four-month comment period, and farms would have at least two years to comply — meaning the farm rules are at least three years away from taking effect. Smaller farms would have even longer to comply.

The new rules, which come exactly two years to the day President Barack Obama's signed food safety legislation passed by Congress, were already delayed. The 2011 law required the agency to propose a first installment of the rules a year ago, but the Obama administration held them until after the election. Food safety advocates sued the administration to win their release.

The produce rule would mark the first time the FDA has had real authority to regulate food on farms. In an effort to stave off protests from farmers, the farm rules are tailored to apply only to certain fruits and vegetables that pose the greatest risk, like berries, melons, leafy greens and other foods that are usually eaten raw. A farm that produces green beans that will be canned and cooked, for example, would not be regulated.

Such flexibility, along with the growing realization that outbreaks are bad for business, has brought the produce industry and much of the rest of the food industry on board as Congress and FDA has worked to make food safer.

In a statement Friday, Pamela Bailey, president of the Grocery Manufacturers Association, which represents the country's biggest food companies, said the food safety law "can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal."

The new rules could cost large farms $30,000 a year, according to the FDA. The agency did not break down the costs for individual processing plants, but said the rules could cost manufacturers up to $475 million annually.

FDA Commissioner Margaret Hamburg said the success of the rules will also depend on how much money Congress gives the chronically underfunded agency to put them in place. "Resources remain an ongoing concern," she said.

The farm and manufacturing rules are only one part of the food safety law. The bill also authorized more surprise inspections by the FDA and gave the agency additional powers to shut down food facilities. In addition, the law required stricter standards on imported foods. The agency said it will soon propose other overdue rules to ensure that importers verify overseas food is safe and to improve food safety audits overseas.

Food safety advocates frustrated over the last year as the rules stalled praised the proposed action.

"The new law should transform the FDA from an agency that tracks down outbreaks after the fact, to an agency focused on preventing food contamination in the first place," said Caroline Smith DeWaal of the Center for Science in the Public Interest.

Read More..

CDC: 1 in 24 admit nodding off while driving

NEW YORK (AP) — This could give you nightmares: 1 in 24 U.S. adults say they recently fell asleep while driving.

And health officials behind the study think the number is probably higher. That's because some people don't realize it when they nod off for a second or two behind the wheel.

"If I'm on the road, I'd be a little worried about the other drivers," said the study's lead author, Anne Wheaton of the Centers for Disease Control and Prevention.

In the CDC study released Thursday, about 4 percent of U.S. adults said they nodded off or fell asleep at least once while driving in the previous month. Some earlier studies reached a similar conclusion, but the CDC telephone survey of 147,000 adults was far larger. It was conducted in 19 states and the District of Columbia in 2009 and 2010.

CDC researchers found drowsy driving was more common in men, people ages 25 to 34, those who averaged less than six hours of sleep each night, and — for some unexplained reason — Texans.

Wheaton said it's possible the Texas survey sample included larger numbers of sleep-deprived young adults or apnea-suffering overweight people.

Most of the CDC findings are not surprising to those who study this problem.

"A lot of people are getting insufficient sleep," said Dr. Gregory Belenky, director of Washington State University's Sleep and Performance Research Center in Spokane.

The government estimates that about 3 percent of fatal traffic crashes involve drowsy drivers, but other estimates have put that number as high as 33 percent.

Warning signs of drowsy driving: Feeling very tired, not remembering the last mile or two, or drifting onto rumble strips on the side of the road. That signals a driver should get off the road and rest, Wheaton said.

Even a brief moment nodding off can be extremely dangerous, she noted. At 60 mph, a single second translates to speeding along for 88 feet — the length of two school buses.

To prevent drowsy driving, health officials recommend getting 7 to 9 hours of sleep each night, treating any sleep disorders and not drinking alcohol before getting behind the wheel.

__

Online:

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

Read More..

Brain image study: Fructose may spur overeating

This is your brain on sugar — for real. Scientists have used imaging tests to show for the first time that fructose, a sugar that saturates the American diet, can trigger brain changes that may lead to overeating.

After drinking a fructose beverage, the brain doesn't register the feeling of being full as it does when simple glucose is consumed, researchers found.

It's a small study and does not prove that fructose or its relative, high-fructose corn syrup, can cause obesity, but experts say it adds evidence they may play a role. These sugars often are added to processed foods and beverages, and consumption has risen dramatically since the 1970s along with obesity. A third of U.S. children and teens and more than two-thirds of adults are obese or overweight.

All sugars are not equal — even though they contain the same amount of calories — because they are metabolized differently in the body. Table sugar is sucrose, which is half fructose, half glucose. High-fructose corn syrup is 55 percent fructose and 45 percent glucose. Some nutrition experts say this sweetener may pose special risks, but others and the industry reject that claim. And doctors say we eat too much sugar in all forms.

For the study, scientists used magnetic resonance imaging, or MRI, scans to track blood flow in the brain in 20 young, normal-weight people before and after they had drinks containing glucose or fructose in two sessions several weeks apart.

Scans showed that drinking glucose "turns off or suppresses the activity of areas of the brain that are critical for reward and desire for food," said one study leader, Yale University endocrinologist Dr. Robert Sherwin. With fructose, "we don't see those changes," he said. "As a result, the desire to eat continues — it isn't turned off."

What's convincing, said Dr. Jonathan Purnell, an endocrinologist at Oregon Health & Science University, is that the imaging results mirrored how hungry the people said they felt, as well as what earlier studies found in animals.

"It implies that fructose, at least with regards to promoting food intake and weight gain, is a bad actor compared to glucose," said Purnell. He wrote a commentary that appears with the federally funded study in Wednesday's Journal of the American Medical Association.

Researchers now are testing obese people to see if they react the same way to fructose and glucose as the normal-weight people in this study did.

What to do? Cook more at home and limit processed foods containing fructose and high-fructose corn syrup, Purnell suggested. "Try to avoid the sugar-sweetened beverages. It doesn't mean you can't ever have them," but control their size and how often they are consumed, he said.

A second study in the journal suggests that only severe obesity carries a high death risk — and that a few extra pounds might even provide a survival advantage. However, independent experts say the methods are too flawed to make those claims.

The study comes from a federal researcher who drew controversy in 2005 with a report that found thin and normal-weight people had a slightly higher risk of death than those who were overweight. Many experts criticized that work, saying the researcher — Katherine Flegal of the Centers for Disease Control and Prevention — painted a misleading picture by including smokers and people with health problems ranging from cancer to heart disease. Those people tend to weigh less and therefore make pudgy people look healthy by comparison.

Flegal's new analysis bolsters her original one, by assessing nearly 100 other studies covering almost 2.9 million people around the world. She again concludes that very obese people had the highest risk of death but that overweight people had a 6 percent lower mortality rate than thinner people. She also concludes that mildly obese people had a death risk similar to that of normal-weight people.

Critics again have focused on her methods. This time, she included people too thin to fit what some consider to be normal weight, which could have taken in people emaciated by cancer or other diseases, as well as smokers with elevated risks of heart disease and cancer.

"Some portion of those thin people are actually sick, and sick people tend to die sooner," said Donald Berry, a biostatistician at the University of Texas MD Anderson Cancer Center in Houston.

The problems created by the study's inclusion of smokers and people with pre-existing illness "cannot be ignored," said Susan Gapstur, vice president of epidemiology for the American Cancer Society.

A third critic, Dr. Walter Willett of the Harvard School of Public Health, was blunter: "This is an even greater pile of rubbish" than the 2005 study, he said. Willett and others have done research since the 2005 study that found higher death risks from being overweight or obese.

Flegal defended her work. She noted that she used standard categories for weight classes. She said statistical adjustments were made for smokers, who were included to give a more real-world sample. She also said study participants were not in hospitals or hospices, making it unlikely that large numbers of sick people skewed the results.

"We still have to learn about obesity, including how best to measure it," Flegal's boss, CDC Director Dr. Thomas Frieden, said in a written statement. "However, it's clear that being obese is not healthy - it increases the risk of diabetes, heart disease, cancer, and many other health problems. Small, sustainable increases in physical activity and improvements in nutrition can lead to significant health improvements."

___

Online:

Obesity info: http://www.cdc.gov/obesity/data/trends.html

___

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

Mike Stobbe can be followed at http://twitter.com/MikeStobbe

Read More..

Brain image study: Fructose may spur overeating

This is your brain on sugar — for real. Scientists have used imaging tests to show for the first time that fructose, a sugar that saturates the American diet, can trigger brain changes that may lead to overeating.

After drinking a fructose beverage, the brain doesn't register the feeling of being full as it does when simple glucose is consumed, researchers found.

It's a small study and does not prove that fructose or its relative, high-fructose corn syrup, can cause obesity, but experts say it adds evidence they may play a role. These sugars often are added to processed foods and beverages, and consumption has risen dramatically since the 1970s along with obesity. A third of U.S. children and teens and more than two-thirds of adults are obese or overweight.

All sugars are not equal — even though they contain the same amount of calories — because they are metabolized differently in the body. Table sugar is sucrose, which is half fructose, half glucose. High-fructose corn syrup is 55 percent fructose and 45 percent glucose. Some nutrition experts say this sweetener may pose special risks, but others and the industry reject that claim. And doctors say we eat too much sugar in all forms.

For the study, scientists used magnetic resonance imaging, or MRI, scans to track blood flow in the brain in 20 young, normal-weight people before and after they had drinks containing glucose or fructose in two sessions several weeks apart.

Scans showed that drinking glucose "turns off or suppresses the activity of areas of the brain that are critical for reward and desire for food," said one study leader, Yale University endocrinologist Dr. Robert Sherwin. With fructose, "we don't see those changes," he said. "As a result, the desire to eat continues — it isn't turned off."

What's convincing, said Dr. Jonathan Purnell, an endocrinologist at Oregon Health & Science University, is that the imaging results mirrored how hungry the people said they felt, as well as what earlier studies found in animals.

"It implies that fructose, at least with regards to promoting food intake and weight gain, is a bad actor compared to glucose," said Purnell. He wrote a commentary that appears with the federally funded study in Wednesday's Journal of the American Medical Association.

Researchers now are testing obese people to see if they react the same way to fructose and glucose as the normal-weight people in this study did.

What to do? Cook more at home and limit processed foods containing fructose and high-fructose corn syrup, Purnell suggested. "Try to avoid the sugar-sweetened beverages. It doesn't mean you can't ever have them," but control their size and how often they are consumed, he said.

A second study in the journal suggests that only severe obesity carries a high death risk — and that a few extra pounds might even provide a survival advantage. However, independent experts say the methods are too flawed to make those claims.

The study comes from a federal researcher who drew controversy in 2005 with a report that found thin and normal-weight people had a slightly higher risk of death than those who were overweight. Many experts criticized that work, saying the researcher — Katherine Flegal of the Centers for Disease Control and Prevention — painted a misleading picture by including smokers and people with health problems ranging from cancer to heart disease. Those people tend to weigh less and therefore make pudgy people look healthy by comparison.

Flegal's new analysis bolsters her original one, by assessing nearly 100 other studies covering almost 2.9 million people around the world. She again concludes that very obese people had the highest risk of death but that overweight people had a 6 percent lower mortality rate than thinner people. She also concludes that mildly obese people had a death risk similar to that of normal-weight people.

Critics again have focused on her methods. This time, she included people too thin to fit what some consider to be normal weight, which could have taken in people emaciated by cancer or other diseases, as well as smokers with elevated risks of heart disease and cancer.

"Some portion of those thin people are actually sick, and sick people tend to die sooner," said Donald Berry, a biostatistician at the University of Texas MD Anderson Cancer Center in Houston.

The problems created by the study's inclusion of smokers and people with pre-existing illness "cannot be ignored," said Susan Gapstur, vice president of epidemiology for the American Cancer Society.

A third critic, Dr. Walter Willett of the Harvard School of Public Health, was blunter: "This is an even greater pile of rubbish" than the 2005 study, he said. Willett and others have done research since the 2005 study that found higher death risks from being overweight or obese.

Flegal defended her work. She noted that she used standard categories for weight classes. She said statistical adjustments were made for smokers, who were included to give a more real-world sample. She also said study participants were not in hospitals or hospices, making it unlikely that large numbers of sick people skewed the results.

"We still have to learn about obesity, including how best to measure it," Flegal's boss, CDC Director Dr. Thomas Frieden, said in a written statement. "However, it's clear that being obese is not healthy - it increases the risk of diabetes, heart disease, cancer, and many other health problems. Small, sustainable increases in physical activity and improvements in nutrition can lead to significant health improvements."

___

Online:

Obesity info: http://www.cdc.gov/obesity/data/trends.html

___

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

Mike Stobbe can be followed at http://twitter.com/MikeStobbe

Read More..

Clinton's blood clot an uncommon complication

The kind of blood clot in the skull that doctors say Hillary Rodham Clinton has is relatively uncommon but can occur after an injury like the fall and concussion the secretary of state was diagnosed with earlier this month.

Doctors said Monday that an MRI scan revealed a clot in a vein in the space between the brain and the skull behind Clinton's right ear.

The clot did not lead to a stroke or neurological damage and is being treated with blood thinners, and she will be released once the proper dose is worked out, her doctors said in a statement.

Clinton has been at New York-Presbyterian Hospital since Sunday, when the clot was diagnosed during what the doctors called a routine follow-up exam. At the time, her spokesman would not say where the clot was located, leading to speculation it was another leg clot like the one she suffered behind her right knee in 1998.

Clinton had been diagnosed with a concussion Dec. 13 after a fall in her home that was blamed on a stomach virus that left her weak and dehydrated.

The type of clot she developed, a sinus venous thrombosis, "certainly isn't the most common thing to happen after a concussion" and is one of the few types of blood clots in the skull or head that are treated with blood thinners, said neurologist Dr. Larry Goldstein. He is director of Duke University's stroke center and has no role in Clinton's care or personal knowledge of it.

The area where Clinton's clot developed is "a drainage channel, the equivalent of a big vein inside the skull — it's how the blood gets back to the heart," Goldstein explained.

It should have no long-term consequences if her doctors are saying she has suffered no neurological damage from it, he said.

Dr. Joseph Broderick, chairman of neurology at the University of Cincinnati College of Medicine, also called Clinton's problem "relatively uncommon" after a concussion.

He and Goldstein said the problem often is overdiagnosed. They said scans often show these large "draining pipes" on either side of the head are different sizes, which can mean blood has pooled or can be merely an anatomical difference.

"I'm sure she's got the best doctors in the world looking at her," and if they are saying she has no neurological damage, "I would think it would be a pretty optimistic long-term outcome," Broderick said.

A review article in the New England Journal of Medicine in 2005 describes the condition, which more often occurs in newborns or young people but can occur after a head injury. With modern treatment, more than 80 percent have a good neurologic outcome, the report says.

In the statement, Clinton's doctors said she "is making excellent progress and we are confident she will make a full recovery. She is in good spirits, engaging with her doctors, her family, and her staff."

___

Online:

Medical journal: http://dura.stanford.edu/Articles/Stam_NEJM05.pdf

Read More..

Kenya hospital imprisons new mothers with no money

NAIROBI, Kenya (AP) — The director of the Pumwani Maternity Hospital, located in a hardscrabble neighborhood of downtown Nairobi, freely acknowledges what he's accused of: detaining mothers who can't pay their bills. Lazarus Omondi says it's the only way he can keep his medical center running.

Two mothers who live in a mud-wall and tin-roof slum a short walk from the maternity hospital, which is affiliated with the Nairobi City Council, told The Associated Press that Pumwani wouldn't let them leave after delivering their babies. The bills the mothers couldn't afford were $60 and $160. Guards would beat mothers with sticks who tried to leave without paying, one of the women said.

Now, a New York-based group has filed a lawsuit on the women's behalf in hopes of forcing Pumwani to stop the practice, a practice Omondi is candid about.

"We hold you and squeeze you until we get what we can get. We must be self-sufficient," Omondi said in an interview in his hospital office. "The hospital must get money to pay electricity, to pay water. We must pay our doctors and our workers."

"They stay there until they pay. They must pay," he said of the 350 mothers who give birth each week on average. "If you don't pay the hospital will collapse."

The Center for Reproductive Rights, which filed the suit this month in the High Court of Kenya, says detaining women for not paying is illegal. Pumwani is associated with the Nairobi City Council, one reason it might be able to get away with such practices, and the patients are among Nairobi's poorest with hardly anyone to stand up for them.

Maimouna Awuor was an impoverished mother of four when she was to give birth to her fifth in October 2010. Like many who live in Nairobi's slums, Awuor performs odd jobs in the hopes of earning enough money to feed her kids that day. Awuor, who is named in the lawsuit, says she had saved $12 and hoped to go to a lower-cost clinic but was turned away and sent to Pumwani. After giving birth, she couldn't pay the $60 bill, and was held with what she believes was about 60 other women and their infants.

"We were sleeping three to a bed, sometimes four," she said. "They abuse you, they call you names," she said of the hospital staff.

She said saw some women tried to flee but they were beaten by the guards and turned back. While her husband worked at a faraway refugee camp, Awuor's 9-year-old daughter took care of her siblings. A friend helped feed them, she said, while the children stayed in the family's 50-square-foot shack, where rent is $18 a month. She says she was released after 20 days after Nairobi's mayor paid her bill. Politicians in Kenya in general are expected to give out money and get a budget to do so.

A second mother named in the lawsuit, Margaret Anyoso, says she was locked up in Pumwani for six days in 2010 because she could not pay her $160 bill. Her pregnancy was complicated by a punctured bladder and heavy bleeding.

"I did not see my child until the sixth day after the surgery. The hospital staff were keeping her away from me and it was only when I caused a scene that they brought her to me," said Anyoso, a vegetable seller and a single mother with five children who makes $5 on a good day.

Anyoso said she didn't have clothes for her child so she wrapped her in a blood-stained blouse. She was released after relatives paid the bill.

One woman says she was detained for nine months and was released only after going on a hunger strike. The Center for Reproductive Rights says other hospitals also detain non-paying patients.

Judy Okal, the acting Africa director for the Center for Reproductive Rights, said her group filed the lawsuit so all Kenyan women, regardless of socio-economic status, are able to receive health care without fear of imprisonment. The hospital, the attorney general, the City Council of Nairobi and two government ministries are named in the suit.

___

Associated Press reporter Tom Odula contributed to this report.

Read More..