Anemia Drug May Raise Stroke Risk in Kidney Patients

SATURDAY, Oct. 31 (HealthDay News) -- A drug designed to fight anemia appears to double the risk of stroke in patients with diabetes and kidney disease without substantially improving their quality of life, a new study finds.

Darbepoetin alfa, marketed as Aranesp and known as an erythropoiesis-stimulating agent (ESA), is often prescribed for diabetic patients with chronic kidney disease and mild anemia.

"The benefits we assumed we would have by treating anemia were less striking and the risks were more striking," said lead researcher Dr. Marc A. Pfeffer, a professor of medicine in the cardiovascular division of Brigham and Women's Hospital in Boston.

"This provides new data for doctors and patients to make their own risk-benefit assessment," he said. "There was a perception that treating anemia would make people feel so much better that we'll take risks, but the benefit in quality of life was not as great as we thought, and there was a clear doubling of your risk for a stroke."

The report was published in the Oct. 30 online edition of the New England Journal of Medicine to coincide with its scheduled presentation at the annual meeting of the American Society of Nephrology in San Diego.

For the study, Pfeffer's team randomly assigned more than 4,000 patients with diabetes, chronic kidney disease and anemia to receive Aranesp or placebo. During the study, 632 patients receiving Aranesp died or suffered a cardiovascular event, compared to 602 of the patients receiving placebo.

As well, 101 patients taking Aranesp had a fatal or non-fatal stroke compared with 53 of the placebo patients, the researchers found. In addition, patients taking Aranesp reported only a modest improvement in their fatigue, the researchers noted.

In earlier studies, Aranesp and a similar drug, epoetin alfa, marketed as Procrit or Epogen, were linked to increased risk of death in cancer and stroke patients.

Pfeffer believes that people with more severe kidney disease, such as those on dialysis, might still find Aranesp beneficial and the risk acceptable.

"People on dialysis generally feel even worse and generally have even more severe anemia, and this class of therapy has been very helpful to them," he said.

Because the drug was beneficial to these patients, doctors assumed it would help less severely anemic patients, Pfeffer said.

"But this use of ESAs exceeded the data," he said. "Now we have the data, and we will revisit how the drug is used now."

Dr. Phillip Marsden, a professor of medicine at the University of Toronto and author of an accompanying journal editorial, said these findings mean that doctors and patients will have to discuss whether or not to start the medication.

"For most of these patients, the modest improvement in quality of life will not be enough to subject themselves to the increased risk of stroke and death," he said.

ESAs have been used for two decades, Marsden noted. "It is a bit shocking that it took us 20 years to address whether or not these drugs were safe -- and now we know more."

Dr. Ajay Singh, clinical chief of the renal division and director of dialysis at Brigham and Women's Hospital, said this "landmark study" raises the fundamental question of whether epoetin or darbepoetin should routinely be used in treating anemia of chronic kidney disease.

"Earlier studies raised the specter of increased risk with ESA treatment. This study definitively confirms that there is meaningful risk with routine use of ESAs," said Singh, also an associate professor of medicine at Harvard Medical School.

"In my own practice, I will be cautious in using ESAs for most patients with chronic kidney disease, balancing risk with benefits and reserving treatment largely for patients who need frequent blood transfusions or who are candidates for a kidney transplant," he said.

More information

For more information on ESAs, visit the U.S. Food and Drug Administration.

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Neurotic? It could lead to asthma

NEW YORK (Reuters Health) – People who are neurotic -- they tend to worry a lot and to have emotional ups and downs -- seem to be at increased risk of developing asthma, a new study hints. Those who suffer through a divorce or other relationship conflict are also at risk for asthma, according to the study.

Animal studies have shown that chronic stress alters hormone levels, which can inflame airways making it difficult to breathe. Researchers believe that neurotic character traits may exert similar effects. If so, then helping neurotic people to calm down or "chill out" could, theoretically, reduce their risk of asthma.

Dr. Adrian Loerbroks from Heidelberg University, Germany and colleagues explored associations between neuroticism, stressful life events and asthma by surveying a sample of 5,114 men and women aged 40 to 65 years from Heidelberg and its surroundings.

Right from the start, they noticed a link between asthma and neuroticism in men, and between asthma and unemployment in both sexes. In women, having broken off a life relationship was associated with having asthma.

Among the 4,520 individuals reported to be free of asthma at the start of the study, 63 or about 2 percent, developed asthma during a median follow-up of more than 8 years, they report in the latest issue of the journal Allergy.

According to the investigators, individuals who were highly neurotic were three times more likely to develop asthma than those who were less neurotic, and breaking off a life partnership increased the risk of asthma development by more than twofold.

The link between high neuroticism and the development of asthma was present in women and men, whereas breaking off a life relationship increased asthma risk only in women.

Unemployment and death of a close person were not significantly associated with the development of asthma, the researchers note.

The researchers call for more study on personality traits, stress and asthma.

"The physiological mechanisms by which personality, stress, and emotions might influence the development or course of asthma," they note, "are still not well known."

SOURCE: Allergy, October 2009.

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New York study says menu labeling affects behavior

WASHINGTON (Reuters) – New York's mandate that fast-food restaurants post calorie information on their menus has changed consumer habits, the city said on Monday, contradicting a recent independent study showing no effect.

The city's Department of Health and Mental Hygiene released preliminary data showing evidence that people bought food with fewer calories at nine of the 13 fast-food and coffee chains included in a study on the effects of menu-labeling laws that went into effect in 2008.

Researchers surveyed more than 10,000 customers at 275 locations in early 2007 and another 12,000 this year.

They found statistically significant decreases at four chains -- McDonald's, Au Bon Pain, KFC and Starbucks -- and said diners who saw and acted on calorie information bought food containing 106 fewer calories on average than those who did not notice the postings.

All told, 56 percent of fast-food customers reported seeing the calorie information, researchers told the annual meeting of the Obesity Society in Washington.

The earlier study by researchers at New York University and Yale University, which included 1,156 adults who ate at Burger King, KFC, McDonald's and Wendy's immediately before and after the rule went into effect, found no change to consumer habits in low-income neighborhoods.

The city's researchers said their study was more representative of dining habits because it included more people over a longer period of time and not limited to outlets in low-income neighborhoods.

In July 2008, New York became the first U.S. city to require fast food restaurants to post calorie counts in large type on menu boards.

The system has since become a model for similar rules intended to combat obesity and promote good nutrition in California, other parts of New York state, the cities of Seattle and Portland, and elsewhere.

Health advocates see menu labeling as a tool for fighting obesity. About one-third of U.S. adults are obese, a condition that increases the risk of heart disease, diabetes, cancer and other medical problems, and another one-third are overweight.

Both the city and New York University studies were funded by the nonprofit Robert Wood Johnson Foundation.

Lynn Silver, assistant commissioner for New York's Bureau of Chronic Disease Prevention and Control, said government findings show diners are noticing and acting on the labels.

"Dietary change is likely to come gradually; it will start with consumers interested in making informed, healthy eating decisions and we hope industry will respond by offering more healthier choices and appropriate portion sizes," she said in a statement.

But city researchers also found that the labeling laws' influence can be overcome by restaurant marketing.

The privately held Subway restaurant chain, which has promoted its menu as a vehicle for weight loss and healthy eating, posted calorie information on some of its menus before the labeling laws went into effect in 2008.

The number of calories purchased at Subway more than doubled during the study period, which coincided with an advertising campaign to promote larger 12-inch sandwiches. The calorie gain at Subway was roughly the same as losses at seven other food chains, researchers said.

(Editing by Philip Barbara)

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Scientists identify new lethal virus in Africa

ATLANTA – Scientists have identified a lethal new virus in Africa that causes bleeding like the dreaded Ebola virus. The so-called "Lujo" virus infected five people in Zambia and South Africa last fall. Four of them died, but a fifth survived, perhaps helped by a medicine recommended by the scientists.

It's not clear how the first person became infected, but the bug comes from a family of viruses found in rodents, said Dr. Ian Lipkin, a Columbia University epidemiologist involved in the discovery.

"This one is really, really aggressive" he said of the virus.

A paper on the virus by Lipkin and his collaborators was published online Thursday on in PLoS Pathogens.

The outbreak started in September, when a female travel agent who lives on the outskirts of Lusaka, Zambia, became ill with a fever-like illness that quickly grew much worse.

She was airlifted to Johannesburg, South Africa, where she died.

A paramedic in Lusaka who treated her also became sick, was transported to Johannesburg and died. The three others infected were health care workers in Johannesburg.

Investigators believe the virus spread from person to person through contact with infected body fluids.

"It's not a kind of virus like the flu that can spread widely," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which helped fund the research.

The name given to the virus — "Lujo" — stems from Lusaka and Johannesburg, the cities where it was first identified.

Investigators in Africa thought the illness might be Ebola, because some of the patients had bleeding in the gums and around needle injection sites, said Stuart Nichol, chief of the molecular biology lab in the CDC's Special Pathogens Branch. Other symptoms include include fever, shock, coma and organ failure.

Genetic extracts of blood and liver from the victims were tested at Columbia University in New York, and additional testing was done at CDC in Atlanta. Tests determined it belonged to the arenavirus family, and that it is distantly related to Lassa fever, another disease found in Africa.

The drug ribavirin, which is given to Lassa victims, was given to the fifth Lujo virus patient — a Johannesburg nurse. It's not clear if the medicine made a difference or if she just had a milder case of the disease, but she fully recovered, Nichol said.

The research is a startling example of how quickly scientists can now identify new viruses, Fauci said. Using genetic sequencing techniques, the virus was identified in a matter of a few days — a process that used to take weeks or longer.

Along with Fauci's institute, the National Heart, Lung, and Blood Institute and Google also helped fund the research.

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On the Net:

PLoS Pathogens: http://www.plospathogens.org/home.action

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Stroke group expands time for clot-busting drugs

DALLAS – A change to stroke treatment guidelines is expanding the time that some patients can get clot-busting drugs. Current recommendations limit the use of the medicine to within three hours after the start of stroke symptoms. That treatment window is now being lengthened to 4 1/2 hours for some patients.

But the committee that made the change stressed that the earlier the treatment, the better for stroke victims.

"They should call the ambulance straight away and get moving," said Dr. Gregory del Zoppo, of the University of Washington School of Medicine in Seattle, who headed the committee for the American Heart Association Stroke Council.

The update, published online Thursday in the heart group's journal Stroke, comes after a European study last fall found stroke sufferers still benefited from getting the medicine an hour or so beyond the three-hour window.

The new guideline is expected to increase the number of people who get the treatment. Only about a third of stroke sufferers get help within three hours, and only about 5 percent get the drug now. Many people don't recognize the signs of a stroke: numbness or weakness in the face, arm or leg; trouble speaking, seeing or walking; a sudden, severe headache.

Stroke is the third leading cause of death in the U.S., with about 795,000 people suffering a new or recurrent stroke each year and more than 140,000 people dying. Strokes caused by blood clots are the most common; the clot blocks an artery supplying blood to the brain, which starves brain cells of oxygen. The drug TPA breaks up the clot and opens the artery.

Another member of the committee, Dr. Jeffrey Saver, of the University of California at Los Angeles, said some hospitals extended the time for using the clot dissolver after the European study, while many have been waiting for national guidelines.

He said the change could increase the number of people who get the drug by a third, to 7 or 8 percent of stroke victims.

Dr. Mark D. Johnson, a stroke specialist at the University of Texas Southwestern Medical Center in Dallas, said that the expanded time frame is good news but the emphasis is still on getting treatment sooner rather than later.

"If you were to arrive in 30 minutes, the chances of a better outcome are higher than if you arrive in four hours," said Johnson.

The new guideline notes that some patients should still be restricted to treatment within the three-hour period: people older than 80, those suffering from a severe stroke or with a history of stroke and diabetes or those taking anti-clotting drugs.

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On the Net:

American Stroke Association: http://www.strokeassociation.org

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CDC says October soonest for swine flu shots

ATLANTA – A U.S. health official said a swine flu vaccine could be available as early as October, but only if vaccine production and testing run smoothly this summer.

Dr. Anne Schuchat (Shook-it) of the U.S. Centers for Disease Control and Prevention said the agency began shipping virus samples to manufacturers in the past several days. The government will have to review the safety and effectiveness of what's produced, and decide if a vaccination campaign is warranted. October is about the time seasonal flu vaccine campaigns generally get rolling.

CDC officials reported more than 8,500 probable and confirmed cases in the U.S., including 12 deaths and more than 500 hospitalizations.

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Congress can learn from Mass., Tenn. health plans

Laid off from her job in Massachusetts, Danielle Marks thought immediately about losing her health insurance. How could she afford the medication and physical therapy she needed to heal after shoulder surgery?

Valerie Nash, laid off in Tennessee, thought about her diabetes. Could she stock up enough test strips and insulin before her coverage expired?

The two women, both briefly uninsured, got covered again thanks to their home states' 3-year-old experiments in expanding health insurance coverage. And while both are mostly pleased with the coverage and low cost of their new state-backed plans, their futures hold plenty of doubt.

Congressional lawmakers can look north to Massachusetts and south to Tennessee for guidance as they craft a national plan to restrain costs and cover the nation's estimated 50 million uninsured.

In Massachusetts, nearly every resident has health insurance, but doctors are turning away new patients, costs to the state are climbing and thousands have paid tax penalties for being uninsured. In Tennessee, that state's much smaller program hasn't cramped the budget, but few people are buying the new insurance even though premiums are as cheap as a monthly cell phone bill.

"The belief that we should all have health insurance coverage is broadly held," said Alan Weil of the nonpartisan National Academy for State Health Policy. "But there are tremendous differences around the country in beliefs on how to achieve that goal."

A Massachusetts-style requirement for individuals to obtain health insurance is likely to emerge as part of the health overhaul taking shape in Congress, although details remain unsettled. A variation of Tennessee's practice of charging higher premiums to smokers and those who are overweight also may emerge; some in Congress are discussing a lifestyle tax on alcohol and sugar-sweetened drinks to help finance the national plan.

In Plymouth, Mass., Marks and her husband, Tad, now pay just $78 a month for state-subsidized insurance that covers doctor visits, prescriptions and hospital stays. Because she's pregnant, Marks, who worked as an administrative assistant until her layoff, pays nothing for her checkups, medicine and vitamins.

But pared-down benefits may lie ahead in Massachusetts because throngs of the newly insured swelled costs of Commonwealth Care to $628 million last year.

And the demand for care is outstripping the number of doctors. One in five Massachusetts adults said a doctor's office or clinic told them they weren't taking new patients with their type of insurance, or they weren't accepting new patients at all, according to a new study published Thursday in the journal Health Affairs.

Massachusetts chose to cover virtually everyone. It set high standards for minimum health insurance and decided to deal with costs later. Soon a state commission expects to call for fundamental changes in the way doctors and hospitals are paid, a plan that amounts to putting them on a financial diet.

"Once you start down the moral path to universal coverage, you inevitably confront costs," said Jon Kingsdale, who directs the board that oversees the state's plan. He and others said Congress can learn the Massachusetts way: coverage first, then cost control.

"If you get everybody covered first, it's easier to deal with costs," Kingsdale said. "If you're going to hold the uninsured hostage to containing costs, you have more than doubled the height to get up this hill."

Tennessee, on the other hand, chose to get just a few more people bare-bones insurance at a budget price with limits on how much plans would pay for hospital stays.

In Chattanooga, Tenn., Nash, who had worked at a car dealership, and her husband, Larry, now pay $193 a month for their state-subsidized coverage, called CoverTN. Their doctor visits and generic drugs are covered, but the plan pays only $10,000 a year on hospital bills. A serious medical crisis could bankrupt them.

"My husband and I barely squeak by as it is now," Valerie Nash said. "It would be a devastating blow."

Compared to Massachusetts, Tennessee is similar in population size, but has more uninsured adults of working age and higher rates of diabetes, childhood obesity, low birth weight and smoking.

What set the stage for Tennessee's go-slow approach was the state's history with expanding health insurance during the 1990s, said Gov. Phil Bredesen.

A state program built around Medicaid, called TennCare, "got totally out of control. It was growing at 15 percent a year. Tennessee had the most expensive Medicaid program in the country," Bredesen said. "Our experience with trying to do universal coverage ended up being a disaster."

When Bredesen took office in 2003, he inherited soaring state health care spending. In 2005, he cut 170,000 adults from TennCare. He reduced benefits for thousands more.

His new initiative, CoverTN, takes "baby steps" toward covering more people. It targets workers at small businesses, the self-employed and the recently unemployed. The cost of monthly premiums is shared by the state, the individual and employers. No one is forced to participate.

Bredesen said the plan design reflects what uninsured Tennesseans want — primary care, not catastrophic care — in a trimmed-down package. Only eight people have exceeded the annual maximum for inpatient hospital costs since the program began.

"This is not the insurance for someone who's going to get into a motorcycle accident," Bredesen said.

The program costs less than anticipated and a fraction of Massachusetts' cost — $10.9 million last year, in part because only about 19,000 have signed up so far.

"I've dreamed about 100,000," Bredesen said. "I'm always amazed, however, when you actually charge someone for health insurance, how many fewer people are willing to sign up for it, than are willing to demand affordable health care."

Mostly it's the "young invincibles" who are staying away. Those are young adults who "don't feel like they're going to get sick," said Laurie Lee, who directs CoverTN and other state health benefits programs. "We've been surprised by that," she said. Older people with chronic conditions are signing up.

Massachusetts officials boast of adding 432,000 to the insured population; 187,000 of those got insurance through their employers or individual purchase. A state survey last year found fewer than 4 percent of working age adults remained uninsured.

Tennessee's uninsured rate for working-age adults probably is not much lower than it was before CoverTN, roughly 20 percent. New census data on the uninsured comes out later this year.

"We learn from Massachusetts that a bold objective matters. If it can be sustained, that's terrific," said Weil, who's lived in both states and said the plans reflect the states' different political cultures. "It would be nice if you had a southern state that had achieved universal coverage and did it in a different way, but we don't have that."

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Associated Press writers Bill Poovey in Chattanooga, Tenn., and Steve LeBlanc in Boston contributed to this report.

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US prescription drug use fell in 2008, study says

NEW YORK – Prescription drug use in the U.S. fell last year, although total spending on drugs increased as prices rose sharply on brand-name products, pharmacy benefits manager Medco Health Solutions said Wednesday.

Medco said the overall decline in prescriptions was the first in a decade. The company, which handles drug benefits covering about 60 million people, said total prescription use was down because few new drugs were launched last year, former blockbuster drugs like Zyrtec became available without a prescription, and some drugs faced safety issues that led to decreased use.

Those factors had a bigger impact on prescriptions than the recession, the company said.

Total spending grew 3.3 percent, Medco said, mainly due to greater use of "specialty" drugs, which often treat chronic or complex illnesses. The strongest growth came from diabetes drugs, and use of specialty treatments for cancer, along rheumatological disease, seizure disorders and antiviral drugs also increased. The average price of brand-name pharmaceuticals rose more than 8 percent in 2008, the fastest increase in five years.

Medco said specialty drug prices are rising more quickly than those for other drugs. Specialty drugs often require special handling that is not needed for other drugs, like refrigeration or protection from light, and many must be administered by a doctor or nurse instead of the patient.

Drugmakers tend to raise the price of a product as the date of its patent expiration approaches. After the key patents supporting a drug expire, generic versions usually reach the market and are available for a fraction of the price.

Several drugmakers cited higher prices in their first-quarter earnings reports. Bristol-Myers Squibb, which makes the anti-clotting drug Plavix, said higher prices were responsible for half its revenue growth in the first quarter of 2009.

Medco projects prescriptions will rise no more than 1 percent in 2009 and in 2010 as well. But it believes higher prices will lift total spending by 3 to 5 percent this year and 4 to 6 percent next year.

Franklin Lakes, N.J.-based Medco is the largest pharmacy benefits manager in the U.S. The company filled almost 800 million prescriptions last year.

Revenue from specialty drugs rose almost 16 percent for the year. Medco said growing use of low-cost generic drugs reduced the growth in total spending: 64 percent of all prescriptions were filled with generic drugs. Medco and other pharmacy benefits managers make a larger profit when generic drugs are substituted for brand-name ones. They encourage health plans to develop ways to increase use of generics and 90-day mail-order prescriptions.

Some drugs that were previously available only with a prescription became over-the-counter in 2008, reducing total prescriptions. The biggest names were Zyrtec, an allergy medication, and the laxative Miralax. Drug use was essentially flat with 2008 if Zyrtec and Miralax are excluded, Medco said.

Prescriptions for people 19 and under grew faster than for any other age group. Medco said that was due to rising rates of diabetes among the young, and more prescriptions for attention deficit disorder and similar problems.

Several billion dollar-selling drugs took hits due to potential safety issues last year. Sales of the diabetes treatment Avandia fell after the Food and Drug Administration added new warnings to its labeling, pointing out concerns about heart problems. Sales of the cholesterol drug Vytorin fell after a study released in January showed it was no better than an older drug, Zocor, at reducing plaque buildup in neck arteries. Zocor is available in generic form for about 80 percent less.

Sales of Amgen's Aranesp and other drugs used to treat chemotherapy-induced anemia have been sliding for two years, since studies connected the drugs to the faster growth of some tumors. Medco said safety issues also affected sales of osteoporosis drugs and hormone replacement therapies, and product recalls hurt sales of migraine and cough and cold therapies.

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Births to unwed moms rising, N. Europe beats US

ATLANTA – The percentage of births to unmarried women in the United States has been rising sharply, but it's way behind Northern European countries, a new U.S. report on births shows.

Iceland is the leader with 6 in 10 births occurring among unmarried women. About half of all births in Sweden and Norway are to unwed moms, while in the U.S., it's about 40 percent.

France, Denmark and the United Kingdom also have higher percentages than the United States, according to the report from the U.S. Centers for Disease Control and Prevention.

The U.S. and at least 13 other industrialized nations have seen significant jumps in the proportion of unmarried births since 1980, said Stephanie Ventura of the CDC's National Center for Health Statistics.

Rates have doubled and even tripled in these countries, according to the CDC report released Wednesday.

"Basically we're seeing the same patterns," Ventura said, noting the trend has accelerated in the last five years.

Experts are not certain what's causing the trend but say there seems to be greater social acceptance of having children outside of marriage.

"The values surrounding family formation are changing and women are more independent than they used to be. And young people don't feel they have to live under the same social rules that their parents once did," said Carl Haub, a demographer at the Population Reference Bureau in Washington, D.C.

But there are differences in how unmarried pregnancies are viewed in different countries.

In the United States, unmarried mothers are more likely to be on their own and — traditionally — they are more likely to be poor and uneducated, experts said.

In northern Europe, men and women more often live together in unmarried, long-term, stable relationships, Haub said. Because of declining birth rates in some European countries, people tend to be more focused on whether the baby is born healthy instead of whether the mother is married, Haub said.

He predicted that the total number of births internationally will decline — that's already happening in some European countries — because of faltering economies. But he expects trends in the percentage of mothers who are unmarried will persist.

The CDC previously has reported on the percentage of U.S. births to unmarried mothers. The new report gathers previously released information from other countries to make an international comparison.

The report shows trends from 1980 to the most recent years available — 2007 for the United States and most of the other countries, but 2006 for six nations.

Japan had the lowest percentage of unmarried births, with 2 percent in 2007, up from 1 percent in 1980.

Increases were much more dramatic in the other countries, with Italy rising from 4 percent to 21 percent, Ireland from 5 percent to 33 percent, Canada from 13 to 30 percent, and the United Kingdom from 12 percent to 44 percent.

The U.S. proportion of unmarried births rose from 18 percent to 40 percent during that period, according to the report.

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On the Net:

The CDC report: http://www.cdc.gov/nchs

(This version CORRECTS U.S. number to 40 percent in last graf.)

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Swine flu fears evident as world's cases top 6,000

MEXICO CITY – In China, mask-wearing police cordoned off more hotels Wednesday, quarantining anyone who came in contact with swine flu patients, no matter how mild their symptoms. Not so in Mexico, where the health secretary encouraged tourists to come relax in their favorite vacation spots despite a growing swine flu caseload.

The global outbreak appears mild, but skittishness is evident. Not long after Switzerland lifted its advisory against travel to Mexico and the United States, the Japanese national women's soccer team canceled a tour to North America, where most swine flu cases have been reported.

And in China, hundreds of people have been quarantined inside hotels, hospitals and homes after they came in contact with several infected plane or train travelers from Canada and U.S. The U.S. Embassy said Americans are among those quarantined.

There are now 33 countries reporting an estimated total of 6,080 confirmed swine flu cases, including 3,009 in 45 U.S. states, 2,446 in Mexico and 358 in Canada. But the death total is relatively low — 65, of which 60 were in Mexico, three in the U.S., one in Canada and one in Costa Rica.

Health Secretary Jose Angel Cordova said Wednesday that Mexico has tested about 9,000 sick people, working through a backlog of samples taken before and after the virus was identified as swine flu — and found that Mexico's dead represents 2.5 percent of confirmed cases, suggesting the virus is not as deadly as intitially feared.

Pneumonia, often brought on by regular seasonal flu, may be much more deadly, Cordova said — killing 9,500 people in Mexico last year. The last death from swine flu was on May 7, he said.

Cordova also addressed Mexico's hard-hit tourism industry, saying there are "very few" cases in tourist destinations — including 7 in Cancun.

"There is no risk for tourists — they can return to these relaxing vacation spots," he said.

There is a danger the virus will mutate into something more dangerous — perhaps by combining with the more deadly but less easily spread bird flu virus circulating in Asia and Africa, according to experts at the U.S. Centers for Disease Control and Prevention.

Another concern is that it will combine with the northern winter's seasonal H1N1 virus. While not unusually virulent, it was resistant to Tamiflu, and health officials worry it could make the new swine flu resistant to Tamiflu as well.

With swine flu still spreading around the globe, the World Health Organization is warning countries to limit the use of antiviral drugs to ensure adequate supplies.

European countries have been using antiviral drugs such as Tamiflu and Relenza much more aggressively than the U.S. and Mexico, administering them whenever possible in an attempt to contain the virus before it spreads more widely.

Officials from EU and Latin American nations, including Mexico, were meeting in Prague on Wednesday to discuss the threat.

A WHO medical expert, Dr. Nikki Shindo, said the U.N. agency thinks antivirals should be targeted mainly at people already suffering from other diseases or complications — such as pregnancy — that can lower a body's defenses against flu.

The CDC also said pregnant women should take the drugs if diagnosed with swine flu — even though the effects on the fetus are not completely known.

Pregnant women are more likely to suffer pneumonia when they catch flu, and flu infections have raised the risk of premature birth in past flu epidemics. A pregnant Texas woman with swine flu died last week, and at least 20 other pregnant women with swine flu have been hospitalized in the U.S., including some with severe complications.

For all these reasons, risks from the virus are greater than the unknown risks to the fetus from Tamiflu and Relenza, said Dr. Anne Schuchat of the CDC.

"We really want to get the word out about the likely benefits of prompt antiviral treatment" for pregnant women, she said.

Mexico now gives Tamiflu to anyone who has had direct contact with a person infected with swine flu, Cordova said. And now that schools are back in session, authorities plan to give it to any children who show symptoms and are suspected of being infected.

In Mexico's Baja California state, on the U.S. border, 5,689 children were turned away from schools when classes resumed because they had symptoms like runny noses, headaches or sore throats, the state education department reported Tuesday.

Swiss pharmaceuticals company Roche Holding AG announced it was donating enough Tamiflu for 5.65 million more people to WHO. A further 650,000 packets containing smaller doses of the drug will be used to create a new stockpile for children.

Mexican authorities had enough Tamiflu for 1 million people at the start of the outbreak and have received more, building reserves of 1.5 million courses.

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Medicare won't cover 'virtual colonoscopy'

WASHINGTON – Medicare won't pay for the so-called virtual colonoscopy procedure, concluding Tuesday that there's inadequate evidence to support the cheaper, less intrusive alternative to the dreaded colonoscopy.

Some experts had hoped that popularizing the X-ray procedure would boost screening for colon cancer, the country's second leading cancer killer. Screening to spot early cancer or precancerous growths has resulted in fewer deaths over the last two decades.

But in a decision posted on its Web site, the Centers for Medicare and Medicaid Services said that the test does not qualify for Medicare coverage. The memo noted that the procedure is performed on people without symptoms and cannot, in itself, rid a patient of precancerous growths, like a regular colonoscopy can.

Medicare does cover regular colonoscopies, in which a long, thin tube equipped with a small video camera is snaked through the large intestine to view the lining. Any growth can be removed during the procedure.

CT colonography, also known as virtual colonoscopy, is a super X-ray of the colon that is quicker, cheaper and easier on the patient, but involves radiation. Both procedures involve preparation to clean out the bowels.

The Medicare memo notes that the virtual colonoscopy has shown better precision in detecting larger polyps than smaller ones.

There's been some division of opinion in the medical community over the virtual colonoscopy. Some doctors question its utility since, if a polyp is found, a regular colonoscopy would typically have to follow, anyway.

Others support it, saying it can result in early cancer detection. The American Cancer Society recommends it as an alternative to a regular colonoscopy.

A concern for Medicare officials, according to their decision Tuesday, was the effectiveness of the procedure for the Medicare population — people 65 and older — as opposed to younger patients. More data is needed to answer that, Medicare said.

The U.S. Preventive Services Task Force opted last fall not to give its stamp of approval to the virtual colonoscopy, citing the risk of radiation among other factors. Medicare said it took that decision into account in reaching Tuesday's determination, which is final.

Some private insurers cover the virtual procedure but others don't. Colonoscopies cost up to $3,000 while the X-ray test costs $300 to $800.

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On the Net:

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Flu drug advised for pregnant women with swine flu

ATLANTA – Pregnant women should take prescription flu medicines if they are diagnosed with the new swine flu, health officials said Tuesday. So far, the swine flu has not proven to be much more dangerous than seasonal influenza, and it's not clear whether or not pregnant women catch swine flu more often than other people. But in general, flu poses added risks for pregnant women, said Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention.

Pregnancy weakens a woman's immune system, so that she's more likely to suffer pneumonia when she catches the flu. In earlier flu pandemics, infection also raised the risk of a premature birth, said Schuchat.

Risks from the virus are greater than the unknown risks to the fetus from the drugs Tamiflu and Relenza, Schuchat said at a press conference Tuesday.

"We really want to get the word out about the likely benefits of prompt antiviral treatment" for pregnant women, she said.

Still, the flu medicines' effectiveness is somewhat limited, studies have shown. They can relieve symptoms and shorten the disease by about a day. They only work if started within 48 hours of first symptoms, and little is known about whether they cut the chances of serious flu complications. Most people recover from the flu with no medical treatment.

But a pregnant Texas woman who had swine flu died last week, and at least 20 other pregnant women have swine flu, including some with severe complications.

In total, about 3,000 U.S. cases of swine flu have been confirmed through lab testing so far, most of them ages 18 and under. Officials think the actual number of infections is much higher, and that infections are still occurring.

CDC officials said the swine flu may seem to be mild now, but they worry the virus will mutate into something more dangerous. One concern is that it will combine with the more deadly but less easily spread bird flu virus that has been circulating in Asia and other parts of the world.

Another concern is that it will combine with the seasonal H1N1 virus that went around over the winter. That virus was not unusually virulent, but it was resistant to Tamiflu — the current first-line defense against the new swine flu. If the two virus strains combine, it's possible the swine flu will become resistant to Tamiflu as well, health officials worry.

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On the Net:

CDC swine flu web site: http://www.cdc.gov/h1n1flu/

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As swine flu spreads, who should get Tamiflu?

MEXICO CITY – The swine flu epidemic may seem mild now, with relatively few deaths even as the virus infects thousands in at least 33 countries. But experts worry it could mutate into something more dangerous — making the question of who should get antiviral therapy ever more important.

The World Health Organization said Tuesday that countries should save antiviral drugs for those patients most at risk, and the U.S. Centers for Disease Control and Prevention added that pregnant women in particular should take the drugs if they are diagnosed with swine flu — even though the effects on the fetus are not completely known.

European countries have been using antiviral drugs such as Tamiflu and Relenza much more aggressively than the United States and Mexico — administering it whenever possible in an attempt to contain the virus before it spreads more widely.

Instead, the WHO recommends that antivirals be targeted mainly at people already suffering from other diseases or complications — such as pregnancy — that can lower a body's defenses against flu, WHO medical expert Dr. Nikki Shindo said.

Pregnant women are more likely to suffer pneumonia when they catch flu, and flu infections raised the risk of premature birth in past epidemics. A pregnant Texas woman who had swine flu died last week, and at least 20 other pregnant women have swine flu, including some with severe complications.

For all these reasons, risks from the virus are greater than the unknown risks to the fetus from Tamiflu and Relenza, said Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention.

"We really want to get the word out about the likely benefits of prompt antiviral treatment" for pregnant women, she said.

Mexico is now giving Tamiflu to anyone who has had direct contact with a person infected with swine flu, Health Secretary Jose Angel Cordova said. And now that schools are back in session, authorities plan to give Tamiflu to any children who show symptoms and are suspected of being infected.

CDC officials said the swine flu may seem to be mild now, but they worry the virus will mutate into something more dangerous — perhaps by combining with the more deadly but less easily spread bird flu virus circulating in Asia and Africa.

Another concern is that it will combine with the northern winter's seasonal H1N1 virus. While not unusually virulent, it was resistant to Tamiflu, and health officials worry that it could make the new swine flu resistant to Tamiflu as well.

The nearly 6,000 confirmed cases worldwide so far have included 63 deaths, and Mexico's death toll rose by two on Tuesday to 58, with 2,282 confirmed infections. But Cordova said the worst appears over — and the more cases the country confirms, the less deadly the virus appears. The increasing toll reflects a testing backlog, Cordova said, with the last confirmed case on May 8.

The U.S. has the world's highest caseload, at more than 3,000 infections in 45 U.S. states, but many countries have focused their energy on containing the spread from Mexico, rather than the U.S. Cuba, Thailand and Finland reported their first cases Tuesday, all in people who had returned from Mexico, and criticism of Mexico's handling of the crisis continues.

Cuba's first case — a Mexican student attending a Cuban medical school — came despite strict restrictions on flights and travelers, prompting former president Fidel Castro to accuse Mexico of hiding the epidemic until after President Barack Obama visited last month.

Mexico has denied hiding anything — and the timeline supports this: Obama's April 16 visit came a week before Canadian and U.S. scientists identified swine flu in Mexican patients, at which point Mexico quickly imposed an unprecedented shutdown of most aspects of public life for days.

"The response by Mexico's health care system and the country's transparency in the way it conducted itself has allowed all nations ... to be able to take preventive measures in a timely manner so they could combat this illness," President Felipe Calderon said Tuesday.

China said it has tracked down and quarantined most passengers who shared flights with the mainland's first known swine flu sufferer — a Chinese graduate student from the U.S. who is said to be improving.

"We must attach great importance to the fact that the flu epidemic is still spreading in some countries and regions, and that China has discovered one case," said President Hu Jintao.

About 260 people were quarantined in Beijing, including 70 foreigners, the China Daily reported. In Sichuan province, the government said another 95 people were being isolated.

With the virus now spreading worldwide, Swiss pharmaceuticals company Roche Holding AG announced it is donating enough Tamiflu for 5.65 million more people to WHO. A further 650,000 packets containing smaller doses of the drug will be used to create a new stockpile for children.

At the start of the outbreak, Mexico had enough Tamiflu for 1 million people, and has since received more, building reserves of 1.5 million courses.

Each country's health experts must decide if infected people should immediately be treated with antivirals, Shindo said — a decision that also must take into account how many antivirals are available.

"As part of pandemic preparedness plans, we urge countries to plan for prioritization," Shindo said.

Mexico's overburdened health system has been strained. Dozens of government doctors and nurses marched and blocked streets in the Gulf coast city of Jalapa to demand higher pay and better working conditions.

Mexico also is trying to revive its economy after the epidemic pummeled tourism, the country's third-largest source of legal foreign income. Cordova said there have been no swine flu cases in five top Mexican vacation spots, including Los Cabos, Puerto Vallarta, Cozumel, Mazatlan and Zihuatanejo.

But with incoming flights virtually empty of tourists, Tourism Secretary Rodolfo Elizondo said a $90 million publicity campaign would focus on encouraing Mexicans to vacation at home.

Promoting trips by foreigners now, he said, "would be like throwing money away."

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Associated Press writers Michael Stobbe in Atlanta; Maria Cheng in London; and Gillian Wong in Beijing contributed to this report.

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Senators weigh tax hikes to pay for health care

WASHINGTON – Senators are considering limiting — but not eliminating — the tax-free status of employer-provided health benefits to help pay for President Barack Obama's plan to provide coverage to 50 million uninsured Americans.

Finance Committee Chairman Max Baucus, D-Mont., said Tuesday that there are no easy options. Senators began grappling with how to finance guaranteed coverage, a cornerstone of Obama's plan to overhaul the health care system. Independent experts put the costs at about $1.5 trillion over 10 years.

Obama sees a world in which doctors and hospitals compete to offer quality service at lower costs, and the savings help cover the uninsured. Turning that vision into reality remains the biggest challenge for the president and his backers, because hard cash — not just ideas — is required to cover upfront costs of expanding coverage.

The president put health care industry leaders on notice Tuesday that he expects them to fulfill their dramatic offer of $2 trillion in savings over 10 years. "I will hold you to your pledge to get this done," Obama said in a letter released by the White House that went to groups representing insurers, hospitals, doctors, drug makers and others.

But those savings — even if the industry delivers every penny — won't all accrue to the government. So the financing package for Obama's plan is likely to include a mix of tax increases and spending cuts in federal health programs.

Among the possibilities: tax increases on alcoholic beverages, tobacco products and sugary soft drinks, and restrictions on other health care-related tax breaks, such as flexible spending accounts.

But some taxes don't seem to be on the table, such as a federal sales levy to pay for health care or a new payroll tax.

Congressional leaders say they want to pass legislation in the Senate and House this summer.

On the controversial question of taxing health benefits, Baucus is staking out a position that could put him at odds with Obama.

The president adamantly opposed such taxes during the campaign, arguing they would undermine job-based coverage. Obama's aides now say he's open to suggestions from Congress, even if he criticized Republican presidential rival John McCain for proposing a sweeping version of the same basic idea.

Baucus said he wants to modify the tax break, not abolish it.

"We are not going to repeal it," he said.

Baucus suggested that the benefit could be limited by taxing health insurance provided to high-income individuals, although he did not specify at what income levels. He also said that plans offering rich benefits — for example, no co-payments or deductibles — might be taxed once their value exceeded a yet-to-be-determined threshold.

White House press secretary Robert Gibbs resisted being drawn into the congressional debate. "We're not going to get into a daily scorekeeping of each idea and proposal," he said.

Employer-provided health insurance is considered part of workers' compensation, but unlike wages, it is not taxed. The forgone revenue to the federal government amounts to about $250 billion a year.

Proponents of repealing the benefit say it encourages lavish health insurance plans that only add to waste in the health care system. And they argue that the benefit is unfair, since self-employed people don't get as big a tax break for health care.

Many experts say that Congress won't be able to come up with the kind of money needed to provide coverage for all unless limitations on the health care tax break are part of the mix.

"I don't see how you're going to put a package together ... unless you touch the exclusion," said Robert Greenstein, director of the Center on Budget and Policy Priorities, which advocates for low-income people. In government jargon, the tax-free status of health insurance is called the "tax exclusion."

Obama has proposed to pay for the plan with a 50-50 mix of tax increases and spending cuts. On the tax side, the president would limit income tax deductions for families making more than $250,000 a year, raising $267 billion over 10 years. Baucus said Tuesday that idea deserves consideration.

The ranking Republican on the Finance Committee, Sen. Charles Grassley of Iowa, said lawmakers should try to squeeze wasteful spending out of the system before imposing new taxes. But Grassley ridiculed the health care industry's pledge of $2 trillion in savings through voluntary efforts to hold down costs.

"I'm sure we will be waiting for some time before this fairy dust becomes real gold," he said.

One option for lawmakers would be to codify the industry's cost reduction offer in federal law, giving it some teeth by applying it to federal health insurance programs.

Protesters who back government-run health care disrupted the Finance Committee hearing. Police ejected five doctors and nurses after they interrupted Baucus and Grassley at the start of the session.

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Associated Press writer Erica Werner contributed to this report.

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Miami VA: Steps taken to prevent contamination

MIAMI – The top Veterans Affairs official in Miami said Tuesday she has taken steps locally to prevent the kind of problems that exposed patients to contaminated medical equipment at VA hospitals in three states.

Mary D. Berrocal, director of the Miami VA Healthcare System, told The Associated Press she has hired someone in Miami to supervise training, make sure biomedical equipment works properly there and ensure the problems aren't repeated.

"We have truly scrutinized our systems to ensure that doesn't happen," she said. "We truly, truly are on it ... We've really, really, really expended every effort possible to make sure that this is an isolated situation."

But she declined to discuss specifics about the contamination problems or say how they went undetected for so long.

Five patients have tested positive for HIV — three of them in Miami — and 33 have tested positive for hepatitis since February, when the VA started notifying more than 11,000 people treated at three VA medical centers to get follow-up blood checks because they could have been exposed to infectious body fluids. The equipment is used for colonoscopies and ear, nose and throat procedures.

The hospitals are in Miami, Murfreesboro, Tenn., and Augusta, Ga.

Berrocal, who has been praised by some Miami veterans in the aftermath of the scandal, said that when she first heard about the situation: "I was heartbroken, you know."

The problems with cleaning equipment — and possibly co-mingling infectious body fluids — went on for five years at the Miami and Murfreesboro hospitals and about a year in Augusta.

Berrocal said she couldn't discuss the specifics because of a continuing investigation by the VA and its inspector general.

U.S. Rep. Kendrick Meek, D-Fla., was informed Monday that the VA inspector general's report will be issued within weeks or days to the House Veterans' Affairs Committee, Meek's spokesman Adam Sharon said.

Meek called for congressional hearings when the scandal broke out. Sharon said those hearings are expected to take place shortly after the report is issued.

North Carolina Sen. Richard Burr, the top Republican on the Senate Veterans' Affairs Committee, has also called for hearings on the subject.

The endoscopic equipment is made by Center Valley, Pa.-based Olympus American Inc., and the company has said its recommended cleaning procedures are clear. Berrocal said it's "very complicated equipment."

She said a series of experts have reviewed the processes and the systems and improved them.

She added, "I think our quest has to be about doing everything possible, everything that we can to minimize the potential for error and to take care of our patients. We have to constantly be vigilant"

The VA has stressed that the positive tests are "not necessarily linked" to medical treatment at its hospitals, and infections don't always cause symptoms and can go undetected for years.

No matter where the patients contracted the illnesses, Berrocal said the VA will treat them.

"Miami has a very high percentage of those illnesses anyway. It is very hard to tell whether they contracted it from this or not," she said. "To me, it just doesn't matter how they got it. If we found it, we are going to treat it."

Berrocal said the discovery of the problems at the VA may have helped improve health care nationwide.

"It's really unfortunate that this happened, however, I believe that it has increased awareness across the country about this piece of equipment. It's not only used in VA," she said.

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