Showing posts with label Health. Show all posts
Showing posts with label Health. Show all posts

Lilly drug chosen for Alzheimer's prevention study

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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.


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Online:


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


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


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


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Food servers more vulnerable to legal threats

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WASHINGTON (AP) — People with severe food allergies have a new tool in their attempt to find menus that fit their diet: federal disabilities law. And that could leave schools, restaurants and anyplace else that serves food more vulnerable to legal challenges over food sensitivities.


A settlement stemming from a lack of gluten-free foods available to students at a Massachusetts university could serve as a precedent for people with other allergies or conditions, including peanut sensitivities or diabetes. Institutions and businesses subject to the Americans With Disabilities Act could be open to lawsuits if they fail to honor requests for accommodations by people with food allergies.


Colleges and universities are especially vulnerable because they know their students and often require them to eat on campus, Eve Hill of the Justice Department's civil rights division says. But a restaurant also could be liable if it blatantly ignored a customer's request for certain foods and caused that person to become ill, though that case might be harder to argue if the customer had just walked in off the street, Hill said.


The settlement with Lesley University, reached last month but drawing little attention, will require the Cambridge, Mass., institution to serve gluten-free foods and make other accommodations for students who have celiac disease. At least one student complained to the federal government after the school would not exempt the student from a meal plan even though the student couldn't eat the food.


"All colleges should heed this settlement and take steps to make accommodations," says Alice Bast, president and founder of the National Foundation for Celiac Awareness. "To our community this is definitely a precedent."


People who suffer from celiac disease don't absorb nutrients well and can get sick from the gluten found in wheat, rye and barley. The illness, which affects around 2 million Americans, causes abdominal pain, bloating and diarrhea, and people who have it can suffer weight loss, fatigue, rashes and other problems. Celiac is a diagnosed illness that is more severe than gluten sensitivity, which some people self-diagnose.


Ten years ago, most people had never heard of celiac disease. But awareness has exploded in recent years, for reasons that aren't entirely clear. Some researchers say it was under-diagnosed, others say it's because people eat more processed wheat products like pastas and baked goods than in past decades, and those items use types of wheat that have a higher gluten content.


Gluten-free diets have expanded beyond those with celiac disease. Millions of people are buying gluten-free foods because they say they make them feel better, even if they don't have a wheat allergy. Americans were expected to spend $7 billion on gluten-free foods last year.


With so many people suddenly concerned with gluten content, colleges and universities have had to make accommodations. Some will allow students to be exempted from meal plans, while others will work with students individually. They may need to do even more now as the federal government is watching.


"These kids don't want to be isolated," Bast says. "Part of the college experience is being social. If you can't even eat in the school cafeteria then you are missing out on a big part of college life."


Under the Justice Department agreement, Lesley University says it will not only provide gluten-free options in its dining hall but also allow students to pre-order, provide a dedicated space for storage and preparation to avoid cross-contamination, train staff about food allergies and pay a $50,000 cash settlement to the affected students.


"We are not saying what the general meal plan has to serve or not," Hill says. "We are saying that when a college has a mandatory meal plan they have to be prepared to make reasonable modifications to that meal plan to accommodate students with disabilities."


The agreement says that food allergies may constitute a disability under the Americans With Disabilities Act, if they are severe enough. The definition was made possible under 2009 amendments to the disability law that allowed for episodic impairments that substantially limit activity.


"By preventing people from eating, they are really preventing them from accessing their educational program," Hill said of the school and its students.


Mary Pat Lohse, the chief of staff and senior adviser to Lesley University's president, says the school has been working with the Justice Department for more than three years to address students' complaints. She says the school has already implemented most parts of the settlement and will continue to update policies to serve students who need gluten-free foods.


"The settlement agreement provides a positive road map for other colleges and universities to follow with regard to accommodating students with food allergies and modifying existing food service plans," Lohse said.


Some say the Justice Department decision goes too far. Hans von Spakovsky, a fellow at the conservative Heritage Foundation who worked in the civil rights division of the Justice Department under President George W. Bush, says food allergies shouldn't apply under the disability act. He adds that the costs could be substantial when schools are already battling backlash from high tuition costs.


"I certainly encourage colleges and universities to work with students on this issue, but the fact that this is a federal case and the Justice Department is going to be deciding what kind of meals could be served in a dining hall is just absurd," he said.


Whether the government is involved or not, schools and other food service establishments are likely to hear from those who want more gluten-free foods. Dhanu Thiyagarajan, a sophomore at the University of Pittsburgh, said she decided to speak up when she arrived at school and lost weight because there were too few gluten-free options in the cafeteria. Like Lesley University, the University of Pittsburgh requires that on-campus students participate in a meal plan.


Thiyagarajan eventually moved off campus so she could cook her own food, but not before starting an organization of students who suffer from wheat allergies like hers. She says she is now working with food service at the school and they have made a lot of progress, though not enough for her to move back on campus.


L. Scott Lissner, the disability coordinator at Ohio State University, says he has seen similar situations at his school, though people with food allergies have not traditionally thought of themselves as disabled. He says schools will eventually have to do more than just exempt students from a meal plan.


"This is an early decision on a growing wave of needs that universities are going to have to address," he said of the Lesley University agreement.


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Large study confirms flu vaccine safe in pregnancy

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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.


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Online:


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


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ER visits tied to energy drinks double since 2007

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SAN FRANCISCO (AP) — A new government survey suggests the number of people seeking emergency treatment after consuming energy drinks has doubled nationwide during the past four years, the same period in which the supercharged drink industry has surged in popularity in convenience stores, bars and on college campuses.


From 2007 to 2011, the government estimates the number of emergency room visits involving the neon-labeled beverages shot up from about 10,000 to more than 20,000. Most of those cases involved teens or young adults, according to a survey of the nation's hospitals released late last week by the Substance Abuse and Mental Health Services Administration.


The report doesn't specify which symptoms brought people to the emergency room but calls energy drink consumption a "rising public health problem" that can cause insomnia, nervousness, headache, fast heartbeat and seizures that are severe enough to require emergency care.


Several emergency physicians said they had seen a clear uptick in the number of patients suffering from irregular heartbeats, anxiety and heart attacks who said they had recently downed an energy drink.


More than half of the patients considered in the survey who wound up in the emergency room told doctors they had downed only energy drinks. In 2011, about 42 percent of the cases involved energy drinks in combination with alcohol or drugs, such as the stimulants Adderall or Ritalin.


"A lot of people don't realize the strength of these things. I had someone come in recently who had drunk three energy drinks in an hour, which is the equivalent of 15 cups of coffee," said Howard Mell, an emergency physician in the suburbs of Cleveland, who serves as a spokesman for the American College of Emergency Physicians. "Essentially he gave himself a stress test and thankfully he passed. But if he had a weak heart or suffered from coronary disease and didn't know it, this could have precipitated very bad things."


The findings came as concerns over energy drinks have intensified following reports last fall of 18 deaths possibly tied to the drinks — including a 14-year-old Maryland girl who died after drinking two large cans of Monster Energy drinks. Monster does not believe its products were responsible for the death.


Two senators are calling for the Food and Drug Administration to investigate safety concerns about energy drinks and their ingredients.


The energy drink industry says its drinks are safe and there is no proof linking its products to the adverse reactions.


Late last year, the FDA asked the U.S. Health and Human Services to update the figures its substance abuse research arm compiles about emergency room visits tied to energy drinks.


The Substance Abuse and Mental Health Services Administration's survey was based on responses it receives from about 230 hospitals each year, a representative sample of about 5 percent of emergency departments nationwide. The agency then uses those responses to estimate the number of energy drink-related emergency department visits nationwide.


The more than 20,000 cases estimated for 2011 represent a small portion of the annual 136 million emergency room visits tracked by Centers for Disease Control and Prevention.


The FDA said it was considering the findings and pressing for more details as it undertakes a broad review of the safety of energy drinks and related ingredients this spring.


"We will examine this additional information ... as a part of our ongoing investigation into potential safety issues surrounding the use of energy-drink products," FDA spokeswoman Shelly Burgess said in a statement.


Beverage manufacturers fired back at the survey, saying the statistics were misleading and taken out of context.


"This report does not share information about the overall health of those who may have consumed energy drinks, or what symptoms brought them to the ER in the first place," the American Beverage Association said in a statement. "There is no basis by which to understand the overall caffeine intake of any of these individuals — from all sources."


Energy drinks remain a small part of the carbonated soft drinks market, representing only 3.3 percent of sales volume, according to the industry tracker Beverage Digest. Even as soda consumption has flagged in recent years, energy drinks sales are growing rapidly.


In 2011, sales volume for energy drinks rose by almost 17 percent, with the top three companies — Monster, Red Bull and Rockstar — each logging double-digit gains, Beverage Digest found. The drinks are often marketed at sporting events that are popular among younger people such as surfing and skateboarding.


From 2007 to 2011, the most recent year for which data was available, people from 18 to 25 were the most common age group seeking emergency treatment for energy drink-related reactions, the report found.


"We were really concerned to find that in four years the number of emergency department visits almost doubled, and these drinks are largely marketed to younger people," said Al Woodward, a senior statistical analyst with the Substance Abuse and Mental Health Services Administration who worked on the report.


Emergency physician Steve Sun said he had seen an increase in such cases at the Catholic hospital where he works on the edge of San Francisco's Golden Gate Park.


"I saw one young man who had mixed energy drinks with alcohol and we had to admit him to the hospital because he was so dehydrated he had renal failure," Sun said. "Because he was young he did well in the hospital, but if another patient had had underlying coronary artery disease, it could have led to a heart attack."


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


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Hospitals crack down on workers refusing flu shots

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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."


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Online:


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


CDC: http://www.cdc.gov


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


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Flu more widespread in US; eases off in some areas

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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.


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


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Online:


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


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Flu more widespread in US; eases off in some areas

Label:

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


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Flu season puts businesses and employees in a bind

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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.


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Flu season strikes early and, in some places, hard

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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


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Retooling Pap test to spot more kinds of cancer

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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.


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Report: Death rates from cancer still inching down

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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

Label:

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

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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


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FDA: New rules will make food safer

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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: New rules will make food safer

Label:

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..

Indian court to rule on generic drug industry

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NEW DELHI (AP) — From Africa's crowded AIDS clinics to the malarial jungles of Southeast Asia, the lives of millions of ill people in the developing world are hanging in the balance ahead of a legal ruling that will determine whether India's drug companies can continue to provide cheap versions of many life-saving medicines.


The case — involving Swiss drug maker Novartis AG's cancer drug Glivec — pits aid groups that argue India plays a vital role as the pharmacy to the poor against drug companies that insist they need strong patents to make drug development profitable. A ruling by India's Supreme Court is expected in early 2013.


"The implications of this case reach far beyond India, and far beyond this particular cancer drug," said Leena Menghaney, from the aid group Doctors Without Borders. "Across the world, there is a heavy dependence on India to supply affordable versions of expensive patented medicines."


With no costs for developing new drugs or conducting expensive trials, India's $26 billion generics industry is able to sell medicine for as little as one-tenth the price of the companies that developed them, making India the second-largest source of medicines distributed by UNICEF in its global programs.


Indian pharmaceutical companies such as Cipla, Cadila Laboratories and Lupin have emerged over the past decade as major sources of generic cancer, malaria, tuberculosis and AIDS drugs for poor countries that can't afford to pay Western prices.


The 6-year-old case that just wrapped up in the Supreme Court revolves around a legal provision in India's 2005 patent law that is aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines — a practice known as "evergreening."


Novartis' argued that a new version of Glivec — marketed in the U.S. as Gleevec — was a significant change from the earlier version because it was more easily absorbed by the body.


India's Patent Controller turned down the application, saying the change was an obvious development, and the new medicine was not sufficiently distinct from the earlier version to warrant a patent extension.


Patient advocacy groups hailed the decision as a blow to "evergreening."


But Western companies argued that India's generic manufacturers were cutting the incentive for major drug makers to invest in research and innovation if they were not going to be able to reap the exclusive profits that patents bring.


"This case is about safeguarding incentives for better medicines so that patients' needs will be met in the future," says Eric Althoff, a Novartis spokesman.


International drug companies have accused India of disregarding intellectual property rights, and have pushed for stronger patent protection that would weaken India's generics industry.


Earlier this year, an Indian manufacturer was allowed to produce a far cheaper version of the kidney and liver cancer treatment sorefinib, manufactured by Bayer Corp.


Bayer was selling the drug for about $5,600 a month. Natco, the Indian company, said its generic version would cost $175 a month, less than 1/30th as much. Natco was ordered to pay 6 percent in royalties to Bayer.


Novartis says the outcome of the new case will not affect the availability of generic versions of Glivec because it is covered by a grandfather clause in India's patent law. Only the more easily absorbed drug would be affected, Althoff said, adding that its own generic business, Sandoz, produces cheap versions of its drugs for millions across the globe.


Public health activists say the question goes beyond Glivec to whether drug companies should get special protection for minor tweaks to medicines that others could easily have uncovered.


"We're looking to the Supreme Court to tell Novartis it won't open the floodgates and allow abusive patenting practices," said Eldred Tellis, of the Sankalp Rehabilitation Centre, a private group working with HIV patients.


The court's decision is expected to be a landmark that will influence future drug accessibility and price across the developing world.


"We're already paying very high prices for some of the new drugs that are patented in India," said Petros Isaakidis, an epidemiologist with Doctors Without Borders. "If Novartis' wins, even older medicines could be subject to patenting again, and it will become much more difficult for us in future to provide medicines to our patients being treated for HIV, hepatitis and drug resistant TB."


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Flu? Malaria? Disease forecasters look to the sky

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NEW YORK (AP) — Only a 10 percent chance of showers today, but a 70 percent chance of flu next month.


That's the kind of forecasting health scientists are trying to move toward, as they increasingly include weather data in their attempts to predict disease outbreaks.


In one recent study, two scientists reported they could predict — more than seven weeks in advance — when flu season was going to peak in New York City. Theirs was just the latest in a growing wave of computer models that factor in rainfall, temperature or other weather conditions to forecast disease.


Health officials are excited by this kind of work and the idea that it could be used to fine-tune vaccination campaigns or other disease prevention efforts.


At the same time, experts note that outbreaks are influenced as much, or more, by human behavior and other factors as by the weather. Some argue weather-based outbreak predictions still have a long way to go. And when government health officials warned in early December that flu season seemed to be off to an early start, they said there was no evidence it was driven by the weather.


This disease-forecasting concept is not new: Scientists have been working on mathematical models to predict outbreaks for decades and have long factored in the weather. They have known, for example, that temperature and rainfall affect the breeding of mosquitoes that carry malaria, West Nile virus and other dangerous diseases.


Recent improvements in weather-tracking have helped, including satellite technology and more sophisticated computer data processing.


As a result, "in the last five years or so, there's been quite an improvement and acceleration" in weather-focused disease modeling, said Ira Longini, a University of Florida biostatistician who's worked on outbreak prediction projects.


Some models have been labeled successes.


In the United States, researchers at Johns Hopkins University and the University of New Mexico tried to predict outbreaks of hantavirus in the late 1990s. They used rain and snow data and other information to study patterns of plant growth that attract rodents. People catch the disease from the droppings of infected rodents.


"We predicted what would happen later that year," said Gregory Glass, a Johns Hopkins researcher who worked on the project.


More recently, in east Africa, satellites have been used to predict rainfall by measuring sea-surface temperatures and cloud density. That's been used to generate "risk maps" for Rift Valley fever — a virus that spreads from animals to people and in severe cases can cause blindness or death. Researchers have said the system in some cases has given two to six weeks advance warning.


Last year, other researchers using satellite data in east Africa said they found that a small change in average temperature was a warning sign cholera cases would double within four months.


"We are getting very close to developing a viable forecasting system" against cholera that can help health officials in African countries ramp up emergency vaccinations and other efforts, said a statement by one of the authors, Rita Reyburn of the International Vaccine Institute in Seoul, South Korea.


Some diseases are hard to forecast, such as West Nile virus. Last year, the U.S. suffered one of its worst years since the virus arrived in 1999. There were more than 2,600 serious illnesses and nearly 240 deaths.


Officials said the mild winter, early spring and very hot summer helped spur mosquito breeding and the spread of the virus. But the danger wasn't spread uniformly. In Texas, the Dallas area was particularly hard-hit, while other places, including some with similar weather patterns and the same type of mosquitoes, were not as affected.


"Why Dallas, and not areas with similar ecological conditions? We don't really know," said Roger Nasci of the Centers for Disease Control and Prevention. He is chief of the CDC branch that tracks insect-borne viruses.


Some think flu lends itself to outbreak forecasting — there's already a predictability to the annual winter flu season. But that's been tricky, too.


Seasonal flu reports come from doctors' offices, but those show the disease when it's already spreading. Some researchers have studied tweets on Twitter and searches on Google, but their work has offered a jump of only a week or two on traditional methods.


In the study of New York City flu cases published last month in the Proceedings of the National Academy of Sciences, the authors said they could forecast, by up to seven weeks, the peak of flu season.


They designed a model based on weather and flu data from past years, 2003-09. In part, their design was based on earlier studies that found flu virus spreads better when the air is dry and turns colder. They made calculations based on humidity readings and on Google Flu Trends, which tracks how many people are searching each day for information on flu-related topics (often because they're beginning to feel ill).


Using that model, they hope to try real-time predictions as early as next year, said Jeffrey Shaman of Columbia University, who led the work.


"It's certainly exciting," said Lyn Finelli, the CDC's flu surveillance chief. She said the CDC supports Shaman's work, but agency officials are eager to see follow-up studies showing the model can predict flu trends in places different from New York, like Miami.


Despite the optimism by some, Dr. Edward Ryan, a Harvard University professor of immunology and infectious diseases, is cautious about weather-based prediction models. "I'm not sure any of them are ready for prime time," he said.


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Brain image study: Fructose may spur overeating

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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."


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Online:


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


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


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


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Clinton receiving blood thinners to dissolve clot

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WASHINGTON (AP) — Doctors treating Secretary of State Hillary Rodham Clinton for a blood clot in her head said blood thinners are being used to dissolve the clot and they are confident she will make a full recovery.


Clinton didn't suffer a stroke or neurological damage from the clot that formed after she suffered a concussion during a fainting spell at her home in early December, doctors said in a statement Monday.


Clinton, 65, was admitted to New York-Presbyterian Hospital on Sunday when the clot turned up on a follow-up exam on the concussion, Clinton spokesman Phillipe Reines said.


The clot is located in the vein in the space between the brain and the skull behind the right ear. She will be released once the medication dose for the blood thinners has been established, the doctors said.


In their statement, Dr. Lisa Bardack of the Mount Kisco Medical Group and Dr. Gigi El-Bayoumi of George Washington University said Clinton was making excellent progress and was in good spirits.


Clinton's complication "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 Dr. Larry Goldstein, a neurologist who is director of Duke University's stroke center. He is not involved in Clinton's care.


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 said.


Blood thinners usually are enough to treat the clot and it should have no long-term consequences if her doctors are saying she has suffered no neurological damage from it, Goldstein said.


Clinton returned to the U.S. from a trip to Europe, then fell ill with a stomach virus in early December that left her severely dehydrated and forced her to cancel a trip to North Africa and the Middle East. Until then, she had canceled only two scheduled overseas trips, one to Europe after breaking her elbow in June 2009 and one to Asia after the February 2010 earthquake in Haiti.


Her condition worsened when she fainted, fell and suffered a concussion while at home alone in mid-December as she recovered from the virus. It was announced Dec. 13.


This isn't the first time Clinton has suffered a blood clot. In 1998, midway through her husband's second term as president, Clinton was in New York fundraising for the midterm elections when a swollen right foot led her doctor to diagnose a clot in her knee requiring immediate treatment.


Clinton had planned to step down as secretary of state at the beginning of President Barack Obama's second term. Whether she will return to work before she resigns remained a question.


Democrats are privately if not publicly speculating: How might her illness affect a decision about running for president in 2016?


After decades in politics, Clinton says she plans to spend the next year resting. She has long insisted she had no intention of mounting a second campaign for the White House four years from now. But the door is not entirely closed, and she would almost certainly emerge as the Democrat to beat if she decided to give in to calls by Democratic fans and run again.


Her age — and thereby health — would probably be a factor under consideration, given that Clinton would be 69 when sworn in, if she were elected in 2016. That might become even more of an issue in the early jockeying for 2016 if what started as a bad stomach bug becomes a prolonged, public bout with more serious infirmity.


Not that Democrats are willing to talk openly about the political implications of a long illness, choosing to keep any discussions about her condition behind closed doors. Publicly, Democrats reject the notion that a blood clot could hinder her political prospects.


"Some of those concerns could be borderline sexist," said Basil Smikle, a Democratic strategist who worked for Clinton when she was a senator. "Dick Cheney had significant heart problems when he was vice president, and people joked about it. He took the time he needed to get better, and it wasn't a problem."


It isn't uncommon for presidential candidates' health — and age — to be an issue. Both in 2000 and 2008, Sen. John McCain, R-Ariz., had to rebut concerns he was too old to be commander in chief or that his skin cancer could resurface.


Two decades after Clinton became the first lady, signs of her popularity — and her political strength — are ubiquitous.


Obama had barely declared victory in November when Democrats started zealously plugging Clinton as their strongest White House contender four years from now, should she choose to take that leap.


"Wouldn't that be exciting?" House Democratic leader Nancy Pelosi declared in December. "I hope she goes. Why wouldn't she?"


Even Republicans concede that were she to run, Clinton would be a force to be reckoned with.


"Trying to win that will be truly the Super Bowl," Newt Gingrich, the former House Speaker and 2012 GOP presidential candidate, said in December. "The Republican Party today is incapable of competing at that level."


Americans admire Clinton more than any other woman in the world, according to a Gallup poll released Monday — the 17th time in 20 years that Clinton has claimed that title. And a recent ABC News/Washington Post poll found that 57 percent of Americans would support Clinton as a candidate for president in 2016, with just 37 percent opposed. Websites have already cropped up hawking "Clinton 2016" mugs and tote bags.


Beyond talk of future politics, Clinton's three-week absence from the State Department has raised eyebrows among some conservative commentators who questioned the seriousness of her ailment after she canceled planned Dec. 20 testimony before Congress on the deadly attack on the U.S. diplomatic mission in Benghazi, Libya.


Clinton had been due to discuss with lawmakers a scathing report she had commissioned on the attack. It found serious failures of leadership and management in two State Department bureaus were to blame for insufficient security at the facility. Clinton took responsibility for the incident before the report was released, but she was not blamed. Four officials cited in the report have either resigned or been reassigned.


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Associated Press writer Ken Thomas in Washington and AP Chief Medical Writer Marilynn Marchione in Milwaukee contributed to this report.


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