Hope for new AIDS protection seen in mouse study (AP)

NEW YORK � As scientists struggle to find a vaccine to prevent infection with the AIDS virus, a study in mice suggests hope for a new approach � one that doctors now want to test in people.

The treated mice in the study appeared to have 100 percent protection against HIV. That doesn't mean the strategy will work in people. But several experts were impressed.

"This is a very important paper (about) a very creative idea," says the government's AIDS chief, Dr. Anthony Fauci. He didn't take part in the research.

The new study involved injecting mice with a protective gene, an idea that's been tested against HIV infection in animals for a decade.

In the nearly 30 years since HIV was identified, scientists haven't been able to find a vaccine that is broadly effective. One boost came in 2009, when a large study in Thailand showed that an experimental vaccine protected about a third of recipients against infection. That's not good enough for general use, but researchers are now trying to improve it.

Researchers reported the new results in mice online Wednesday in the journal Nature. They hope to test the approach in people in a couple of years. Another research team reported similar success in monkeys in 2009 and hopes to start human tests even sooner.

A traditional vaccine works by masquerading as a germ, training the body's immune system to build specific defenses in case the real germ shows up. Those defenses are generally antibodies, which are proteins in the blood that have just the right shape to grab onto parts of an invading virus. Once that happens, the virus can't establish a lasting infection and is cleared from the body.

Scientists have identified antibodies that neutralize a wide range of HIV strains, but they've had trouble getting people's immune systems to create those antibodies with a vaccine.

The gene-injection goal is straightforward. Rather than trying to train a person's immune system to devise effective antibodies, why not just give a person genes for those proteins? The genes can slip into cells in muscle or some other tissue and make them pump out lots of the antibodies.

The mouse work is reported by David Baltimore and colleagues at the California Institute of Technology.

Ordinary mice don't get infected with HIV, which attacks the immune system. So the research used mice that carried human immune system cells.

Baltimore's team used a harmless virus to carry an antibody gene and injected it once into a leg muscle. The researchers found that the mice made high levels of the antibody for more than a year. The results suggest lifetime protection for a mouse, Baltimore said, although "we simply don't know what will happen in people."

Even when the mice were injected with very high doses of HIV, they didn't show the loss of certain blood cells that results from HIV infection. Baltimore said researchers couldn't completely rule out the possibility of infection, but that their tests found no evidence of it. He said a few hundred mice appeared to be protected.

The work was funded by the federal government and the Bill and Melinda Gates Foundation. Baltimore said his lab has filed for patents.

"I think it's great," said Dr. Philip R. Johnson of the Children's Hospital of Philadelphia, who reported similar results in monkeys in 2009. "It provides additional evidence this is a concept that's worth moving forward."

Johnson said he has discussed doing a human trial with federal regulators and is preparing an application for permission to go ahead. If all goes well, a preliminary experiment to test the safety of the approach might begin in about a year, he said. Baltimore said his group is also planning human experiments that he hopes will start in the next couple years.

Fauci, who is director of the National Institute of Allergy and Infectious Diseases, cautioned that mouse results don't always pan out in human studies. He also said both the gene approach and standard vaccines should be pursued because it's not clear which will work better.

"We're still in the discovery stage of both of them," he said.

Dr. Harris Goldstein, director of the Einstein-Montefiore Center for AIDS Research in New York, who has done similar research in mice, called Baltimore's result a significant advance if it works in humans because it shows a single injection produces high levels of antibodies for a long time.

It might lead not only to preventing infection, but also a treatment for infected people, he said. If it allowed people with HIV to stop or reduce their medications even for temporary periods, they could avoid the inconvenience and side effects of the drugs, he said.

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Online:

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

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Malcolm Ritter can be followed at http://twitter.com/malcolmritter.

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China prepares for big entry into vaccine market (AP)

BEIJING � The world should get ready for a new Made in China product � vaccines.

China's vaccine makers are gearing up over the next few years to push exports in a move that should lower costs of lifesaving immunizations for the world's poor and provide major new competition for the big Western pharmaceutical companies.

However, it may take some time before some parts of the world are ready to embrace Chinese products when safety is as sensitive an issue as it is with vaccines � especially given the food, drug and other scandals the country has seen.

Still, China's entry into this market will be a "game changer," said Nina Schwalbe, head of policy at the GAVI Alliance, which buys vaccines for 50 million children a year worldwide.

"We are really enthusiastic about the potential entry of Chinese vaccine manufacturers," she said.

China's vaccine-making prowess captured world attention in 2009 when one of its companies developed the first effective vaccine against swine flu � in just 87 days � as the new virus swept the globe. In the past, new vaccine developments had usually been won by the U.S. and Europe.

Then, this past March the World Health Organization announced that China's drug safety authority meets international standards for vaccine regulation. It opened the doors for Chinese vaccines to be submitted for WHO approval so they can be bought by U.N. agencies and the GAVI Alliance.

"China is a vaccine-producing power" with more than 30 companies that have an annual production capacity of nearly 1 billion doses � the largest in the world, the country's State Food and Drug Administration told The Associated Press.

But more needs to be done to build confidence in Chinese vaccines overseas, said Helen Yang of Sinovac, the NASDAQ-listed Chinese biotech firm that rapidly developed the H1N1 swine flu vaccine. "We think the main obstacle is that we have the name of 'made in China' still. That is an issue."

China's food and drug safety record in recent years hardly inspires confidence: in 2007, Chinese cough syrup killed 93 people in Central America; one year later, contaminated blood thinner led to dozens of deaths in the United States while tainted milk powder poisoned hundreds of thousands of Chinese babies and killed six.

The government has since imposed more regulations, stricter inspections and heavier punishments for violators. Perhaps because of that, regulators routinely crack down on counterfeit and substandard drugmaking.

While welcoming WHO's approval of China's drug safety authority, one expert said it takes more than a regulatory agency to keep drugmakers from cutting corners or producing fakes.

"In the U.S., we have supporting institutions such as the market economy, democracy, media monitoring, civil society, as well as a well-developed business ethics code, but these are all still pretty much absent in China," said Yanzhong Huang, a China health expert at the Council on Foreign Relations. "For China, the challenge is much greater in building a strong, robust regulative capacity."

Last year, a Chinese newspaper report linked improperly stored vaccines to four children's deaths in northern Shanxi province, raising nationwide concern. The Health Ministry said the vaccines did not cause the deaths, but some remained skeptical.

Meanwhile, Chinese researchers reported in the New England Journal of Medicine earlier this year that a pandemic flu vaccine given to 90 million people in 2009 was safe.

WHO's medical officer for immunization, Dr. Yvan Hutin, said WHO's approval of the Chinese drug regulatory agency is not "a blank check." Each vaccine will be evaluated rigorously, with WHO and Chinese inspectors given access to vaccine plants on top of other safety checks, he said.

Vaccines have historically been a touchy subject in the Western world, rife with safety concerns and conspiracy theories. Worries about vaccine safety resurfaced in the late 1990s triggered by debate over a claimed association between the vaccine for measles, mumps and rubella and autism. The claim was later discredited.

For China, the next few years will be crucial, as biotech companies upgrade their facilities and improve procedures to meet the safety and quality standards � a process that is expected to be costly and challenging. Then they will submit vaccines to the U.N. health agency for approval, which could take a couple of years.

First up is likely to be a homegrown vaccine for Japanese encephalitis, a mosquito-borne disease that can cause seizures, paralysis and death. The vaccine has been used for two decades in China with fewer side effects than other versions. Its manufacturer expects WHO approval for it in about a year. Also in the works are vaccines for polio and diseases that are the top two killers of children � pneumonia and rotavirus, which causes diarrhea.

Vaccines also are a significant part of a $300 million partnership with the Bill & Melinda Gates Foundation for the development of new health and farming products for poor countries.

China's entry into this field is important because one child dies every 20 seconds from vaccine-preventable diseases each year. UNICEF, the children's agency and the world's biggest buyer of vaccines, has been in talks with Chinese companies, said its supply director Shanelle Hall. The fund provides vaccines to nearly 60 percent of the world's children, and last year spent about $757 million.

Worldwide, vaccine sales last year grew 14 percent to $25.3 billion, according to healthcare market research firm Kalorama Information, as drugmakers which face intensifying competition from generic drugs now see vaccines as key areas of growth, particularly in Latin America, China and India.

China's vaccine makers, some of whom already export in small amounts, are confident they will soon become big players in the field.

"I personally predict that in the next five to 10 years, China will become a very important vaccine manufacture base in the world," said Wu Yonglin, vice president of the state-owned China National Biotec Group, the country's largest biological products maker that has been producing China's encephalitis vaccine since 1989.

CNBG will invest more than 10 billion yuan ($1.5 billion) between now and 2015 to improve its facilities and systems to meet WHO requirements, Wu said. The company also intends to submit vaccines to fight rotavirus, which kills half a million kids annually, and polio for WHO approval.

Smaller, private companies are also positioning themselves for the global market.

Sinovac is now testing a new vaccine for enterovirus 71, which causes severe hand, foot and mouth disease among children in China and other Asian countries. It is also preparing for clinical trials on a pneumococcal vaccine Yang says could rival Pfizer's Prevnar, which was the top-selling vaccine worldwide last year with sales of about $3.7 billion.

Pneumococcal disease causes meningitis, pneumonia and ear infection.

"In the short term, everyone sees the exporting opportunities, because outside of China the entire vaccine market still seems to be monopolized by a few Big Pharma (companies)," Yang said.

The entry of Chinese companies is expected to further pressure Western pharmaceutical companies to lower prices. Earlier this year, UNICEF's move to publicize what drugmakers charge it for vaccines showed that Western drugmakers often charged the agency double what companies in India and Indonesia do.

The aid group Doctors Without Borders criticized the vaccine body GAVI for spending hundreds of millions of dollars on anti-pneumonia vaccines from Western companies, saying it could put its buying power to even better use by fostering competition from emerging manufacturers like those in China.

GAVI's Schwalbe said the vaccine body has to buy what is available and negotiates hard for steep discounts. "We need to buy vaccines now to save children's lives now. We can't wait."

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Making sure kidney donors fare as well as promised (AP)

WASHINGTON � More and more people are donating one of their kidneys to a loved one, a friend, even a stranger, and now a move is on to make sure those donors really fare as well as they're promised.

Specialists insist the surgery rarely brings serious complications for the donor. What's less certain is the risk of any long-term health consequences, in part because transplant centers can lose track of donors after they go home.

"Who's taking care of the donor after the surgery? Really, no one is," says kidney donor Krystal McLear, 32, of Indian Head, Md., who serves on a committee for the network that runs the U.S. organ transplant system.

The United Network for Organ Sharing is debating some new policies to change that. Among the proposals: A checklist for evaluating would-be donors and fully explaining the risks � plus requirements to better monitor those donors' health and social stability for two years. Centers would have to track such things as the condition of the remaining kidney, and whether the donor has a hard time getting health or life insurance afterward.

There is reassuring data. A 2009 study from the University of Minnesota, for example, traced the records of nearly 3,700 people who had donated a kidney there dating back four decades. It concluded those donors lived a normal life span and were no more likely than the general population to suffer kidney failure later in life, probably in part because they were so super-healthy to start.

But there have been more than 109,000 living kidney donors nationwide in the past two decades, and they're a bit different today. Donors are getting older. Some transplant centers are accepting donors who would have been turned away not too long ago because they're overweight or have high blood pressure. More African-Americans, who are more prone to kidney disease, are becoming living donors and there's less information about their outcomes. Even if people were the picture of health when they donated, later-in-life obesity, high blood pressure and diabetes can raise the risk of kidney disease.

"We're changing," says Dr. Connie Davis of the University of Washington in Seattle, who heads the UNOS living donor committee. "We really do need to take a look at things again in real time to say, OK, in this current climate what are our risks?"

More than 90,000 people are on the national waiting list for a kidney, and the wait can stretch for years. There are fewer than 17,000 kidney transplants a year. But more than 6,000 of them each year are thanks to living donors.

Surgery always brings risks, but donor deaths are extremely rare. UNOS data shows that since 2000, there have been 13 donor deaths within 30 days of a kidney donation that were not from a clearly unrelated cause. Davis says no more than 5 percent of donors experience surgical complications such as bleeding or blood clots.

What about later? Transplant centers are supposed to do minimal monitoring but a UNOS analysis found they lose track of too many donors. Just a year after donation, they only knew if two-thirds were still alive or dead, and far fewer had had their remaining kidney tested.

"There is this perception out there that donors don't want to be followed up. That's not necessarily the case," says McLear, who insists that her doctors check her kidney and that her blood pressure remains low.

McLear traveled to Michigan in 2008 to donate a kidney to her 26-year-old cousin, and is glad she did � her cousin is thriving. But McLear had trouble finding out what to expect about her own post-surgery health. And a week after the donation, she developed a dangerous pancreas inflammation, a rare complication. She was readmitted to the hospital for seven more days and out of work for 12 weeks, nearly twice as long as she'd expected.

The new proposal: Transplant centers would have to track at least 90 percent of their living kidney donors for two years � not just if they're still alive and having their kidney checked, but if they've had hospital readmissions, developed any other health problems, and had any loss of income or insurance due to their donation.

Separate proposals lay out the first standard informed-consent document to explain the risks, and aim to eliminate variation in how centers test a donor's fitness.

The proposals are open for public comment through late December, before a final decision next year. Among the concerns are donor cooperation and whether transplant centers have the staff and money to do the tracking.

The National Kidney Foundation has long pushed for such monitoring, and some transplant centers that specialize in living donations already try.

New York's Mount Sinai Medical Center, for example, opened a living-donor center two years ago that offers nutrition and other post-donation counseling in addition to health checks.

At Georgetown University Hospital in Washington, Dr. Jennifer Verbesey recently saw a woman who was doing fine medically after donating a kidney to her son, but had post-surgery depression.

"For a lot of people, there are a lot of ethical and emotional issues after transplant," Verbesey says. "If you tell me 99 percent of people will not have a problem, I still want to make sure I'm there to find the one person that might."

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

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Online:

Transplant proposals: http://tinyurl.com/lja8nx

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AP IMPACT: More kids skip school shots in 8 states (AP)

ATLANTA � More parents are opting out of school shots for their kids. In eight states now, more than 1 in 20 public school kindergartners aren't getting all the vaccines required for attendance, an Associated Press analysis found.

That growing trend among parents seeking vaccine exemptions has health officials worried about outbreaks of diseases that once were all but stamped out.

The AP analysis found more than half of states have seen at least a slight rise in the rate of exemptions over the past five years. States with the highest exemption rates are in the West and Upper Midwest.

It's "really gotten much worse," said Mary Selecky, secretary of health for Washington state, where 6 percent of public school parents have opted out.

Rules for exemptions vary by state and can include medical, religious or � in some states � philosophical reasons.

Reasons for skipping some school shots vary. Some parents are skeptical that vaccines are essential. Others fear vaccines carry their own risks. Some find it easier to check a box opting out than the effort to get the shots and required paperwork schools demand. Still others are ambivalent, believing in older vaccines but questioning newer shots against, say, chickenpox.

The number of shots is also giving some parents pause. By the time most children are 6, they will have been stuck with a needle about two dozen times � with many of those shots given in infancy. The cumulative effect of all those shots has not been studied enough, some parents say.

"Many of the vaccines are unnecessary and public health officials don't honestly know what the effect of giving so many vaccines to such small children really are," said Jennifer Margulis, a mother of four and parenting book author in Ashland, Ore.

But few serious problems have turned up over years of vaccinations and several studies have shown no link with autism, a theory from the 1990s that has been widely discredited.

To be sure, childhood vaccination rates remain high overall, at 90 percent or better for several vaccines, including those for polio, measles, hepatitis B and even chickenpox. In many states, exemptions are filed for fewer than 1 percent of children entering school for the first time.

Health officials have not identified an exemption threshold that would likely lead to outbreaks. But as they push for 100 percent immunization, they worry when some states have exemption rates climbing over 5 percent. The average state exemption rate has been estimated at less than half that.

Even more troubling are pockets in some states where exemption rates much higher. In some rural counties in northeast Washington, for example, rates in recent years have been above 20 percent and even as high as 50 percent.

"Vaccine refusers tend to cluster," said Saad Omer, an Emory University epidemiologist who has done extensive research on the issue.

While parents may think it does no harm to others if their kids skip some vaccines, they are in fact putting others at risk, health officials say. No vaccine is completely effective. If an outbreak begins in an unvaccinated group of children, a vaccinated child may still be at some risk of getting sick.

Studies have found communities with higher exemption rates sometimes are places where measles have suddenly re-emerged in outbreaks. Vaccinated kids are sometimes among the cases, or children too young to be vaccinated. Last year, California had more than 2,100 whooping cough cases, and 10 infants died. Only one had received a first dose of vaccine.

"Your child's risk of getting disease depends on what your neighbors do," said Omer.

And while it seems unlikely that diseases like polio and diphtheria could ever make a comeback to the U.S., immunization expert Dr. Lance Rodewald with the federal Centers for Disease Control and Prevention says it could happen.

"Polio can come back. China was polio free for two decades, and just this year, they were infected from Pakistan, and there is a big outbreak of polio China now. The same could happen here," Rodewald said in an email.

He cited outbreaks of Hib, a disease that can lead to meningitis, among the Amish who don't consistently vaccinate their children. Russia had a huge diphtheria outbreak in the early to mid-1990s, he said, because vaccine coverage declined. "Measles is just visible, but it isn't the only concern," Rodewald said.

For its review, the AP asked state health departments for kindergarten exemption rates for 2006-07 and 2010-11. The AP also looked at data states had previously reported to the federal government. (Most states don't have data for the current 2011-12 school year.)

Alaska had the highest exemption rate in 2010-11, at nearly 9 percent. Colorado's rate was 7 percent, Minnesota 6.5 percent, Vermont and Washington 6 percent, and Oregon, Michigan and Illinois were close behind.

Mississippi was lowest, at essentially 0 percent.

The AP found that vaccine exemptions rose in more than half of states, and 10 had increases over the five years of about 1.5 percentage points or more, a range health officials say is troubling.

Those states, too, were in the West and Midwest � Alaska, Kansas, Hawaii, Illinois, Michigan, Montana, Oregon, Vermont, Washington and Wisconsin. Arizona saw an increase that put that state in the same ballpark.

Exemption seekers are often middle-class, college-educated white people, but there are often a mix of views and philosophies. Exemption hot spots like Sedona, Ariz., and rural northeast Washington have concentrations of both alternative medicine-preferring as well as government-fearing libertarians.

Opposition to vaccines "is putting people together that normally would not be together," observed Elizabeth Jacobs, a University of Arizona epidemiologist looking at that state's rising exemption rates.

What many of exemption-seeking parents share, however, is a mental calculation that the dangers to their children of vaccine-preventable diseases are less important than the possible harms from vaccine. Or they just don't believe health officials, putting more stock in alternative sources � often discovered through Internet searches.

"We are being told this by every government official, teacher, doctor that we need vaccines to keep us safe from these diseases. I simply don't believe that to be true. I believe all the diseases in question were up to 90 percent in decline before mass vaccines ever were given. I don't think vaccines are what saved the world from disease. I think effective sewer systems, nutrition, and handwashing (are the reasons)," said Sabrina Paulick, of Ashland, Ore. She's part-time as a caregiver for elderly people in their homes and a mother of a 4-year-old daughter.

Parents say they'd like to reserve the right to decide what vaccinations their children should get, and when. Health officials reply that vaccinations are recommended at an early age to protect children before they encounter a dangerous infection. "If you delay, you're putting a child at risk," said Gerri Yett, a nurse who manages Alaska's immunization program.

Analyzing vaccination exemptions is difficult. States collect data differently; some base their exemption rates on just a small sample of schools � Alaska, for example � while others rely on more comprehensive numbers. So the AP worked with researchers at CDC, which statistically adjusted some states' 2010-11 data for a better comparison.

It's also not clear when an exemption was invoked against all vaccines and when it was used to excuse just one or two shots. CDC officials think the second scenario is more common.

Also, states differ on some of the vaccines required and what's needed to get an exemption: Sometimes only a box on a form needs to be checked, while some states want letters or even signed statements from doctors.

Meanwhile, some parent groups and others have pushed legislators to make exemptions easier or do away with vaccination requirements altogether. The number of states allowing philosophical exemptions grew from 15 to 20 in the last decade.

Some in public health are exasperated by the trend.

"Every time we give them evidence (that vaccines are safe), they come back with a new hypothesis" for why vaccines could be dangerous, said Kacey Ernst, another University of Arizona researcher.

The exemption increases have come during a time when the government has been raising its estimates of how many children have autism and related disorders. Some experts suggest that parents have listened intently to that message, with some believing the growing roster of recommended shots must somehow be related.

"I don't understand how other people don't see that these two things are related," said Stacy Allan, a Summit, N.J., mother who filed religious exemptions and stopped vaccinating her three children.

Several parents said that while they believe many health officials mean well, their distrust of the vaccine-making pharmaceutical industry only continues to grow.

"I wouldn't be one to say I am absolutely certain these things are hurting our children," said Michele Pereira, an Ashland mother of two young girls. She is a registered nurse and married to an anesthesiologist. While her daughters have had some vaccinations, they have not had the full recommended schedule.

"I feel like there are enough questions out there that I don't want to take the chance," she said.

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Associated Press writer Jeff Barnard in Grants Pass, Ore., contributed to this report.

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England study: Low-risk births don't need hospital (AP)

LONDON � A new study in England shows little difference in complications among the babies of women with low-risk pregnancies who delivered in hospitals versus those who gave birth with midwives at home or in birthing centers.

Based on the findings, researchers said women with uncomplicated pregnancies in England should be able to choose where they want to give birth � and one expert said about half of all pregnant women here could potentially safely give birth outside a hospital.

But they sounded a note of caution for first-time mothers and their infants, who may face a higher risk if they choose a home birth.

"I would never say women should give birth in a particular place, but hope this gives women more information to make an informed choice," said Dr. Peter Brocklehurst, director of the Institute for Women's Health at University College Hospital in London, one of the paper's lead authors. He conducted the research while at Oxford University.

"Birth isn't an abnormal process, it's a physiological process," he said. "And if your pregnancy and labor is not complicated, then you don't need a high level of specific expertise."

Brocklehurst added that about 50 percent of pregnant women in England � those who are low-risk � should be able to choose where to have their baby.

More than 90 percent of pregnant women in England now give birth in a hospital. Some officials say the new study should prompt women to consider alternatives.

"This is about giving women a choice," said Mary Newburn of NCT, a U.K. charity for parents, one of the study's authors. She said midwife-run birth centers in England have a more homelike environment, with privacy, sofas and birthing pools.

In Britain, midwives deliver more than 60 percent of babies already. Similar care is provided in the Netherlands, where about a quarter of all births happen at home. Elsewhere in Europe, most births are led by doctors, although midwives may also be involved.

In the United States, however, less than one percent of births happen at home. The American College of Obstetricians and Gynecologists does not support planned home births and warns evidence shows they have a higher risk of newborn death compared to planned hospital births. The training of midwives in the U.S. varies by state � and some have no regulations.

Brocklehurst and colleagues collected data for nearly 65,000 mothers and babies between 2008 and 2010 in England. Of those, there were 19,706 births in hospital obstetric wards, 16,840 births at home, 11,282 births in "freestanding" midwifery units � independent clinics where there are no doctors or access to anesthetics � and 16,710 births in "alongside" midwifery units, often housed within hospitals.

All the pregnancies were low-risk, meaning the mothers were healthy and carried their baby to term. Women planning C-sections or expecting twins or multiple births were excluded from the study.

In the U.K.'s hospital obstetric wards, most low-risk women don't see a doctor during labor and are only treated by midwives.

There didn't appear to be a difference for the infants' health based on where the mothers planned to give birth.

But researchers found a higher risk for first-time mothers planning a home birth. Among those women, there were 9.3 adverse events per 1,000 births, including babies with brain damage due to labor problems and stillbirth. That compared to 5.3 adverse events per 1,000 births for those planning a hospital birth.

The study was published Friday in the medical journal, BMJ. It was paid for by Britain's department of health and another government health research body.

Dr. Tony Falconer, president of the Royal College of Obstetricians & Gynaecologists, said his group supports "appropriately selected home birth." He noted the higher risk of problems among first-time mothers choosing a home birth and said that raised questions about where they should deliver.

For Emily Shaw of Oxfordshire, northwest of London, giving birth in a hospital wasn't appealing. She wanted home births for both her sons but because her first baby was induced into labor, she had to deliver him in a hospital in October 2008.

Shaw delivered her second son at home in April. "I felt much more comfortable there," she said. "Instead of getting into a car to go to the hospital, the midwives came to me."

"It was nice to have the home comforts during labor," she added, saying she could eat in her own kitchen and use her own bathroom. "And unlike the hospital, they didn't kick out my partner in the middle of the night."

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Online:

http://www.bmj.com

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Global Fund for world health halts new programs (AP)

GENEVA � The world's biggest financier in the fight against three killer diseases says it has run out of money to pay for new grant programs for the next two years � a situation likely to hit poor AIDS patients around the world.

An official with the Global Fund to Fight AIDS, Tuberculosis and Malaria said Thursday that its has been forced to cease giving new grants until 2014 because of global economic woes brought on by debt crises in the U.S. and Europe.

An independent panel recommended in September that the fund must adopt tougher financial safeguards after it weathered a storm of criticism and doubts among some of its biggest donors.

The fund created the panel � chaired by former U.S. Health and Human Services Secretary Michael Leavitt and ex Botswana President Festus Mogae � in March to address concern among donors after Associated Press articles in January about the loss of tens of millions of dollars in grant money because of mismanagement and alleged fraud.

Germany, the European Commission and Denmark withheld hundreds of millions of euros in funding pending reviews of the fund's internal controls. Germany � the fund's fourth-largest donor_ has since restored its funding.

The Geneva-based fund was set up in 2002 as a new way to coordinate world efforts against the diseases and to speed up emergency funds from wealthy nations and donors to the places hardest hit. Outside of its donor nations and celebrity backers, the biggest private donor is the Bill & Melinda Gates Foundation that has pledged $1.15 billion and provided it with $650 million so far.

Since its creation, the fund, which is strictly a financing tool, has disbursed some $15 billion for programs � $2.8 billion this year alone, including to pay for treatment for around half the developing world's AIDS sufferers.

With donations now harder to come by, the fund says it can only afford to keep existing AIDS programs going, but not expand its services or add new patients.

"We're not cutting back � we're not expanding," the fund's board chairman, Simon Bland, told The Associated Press from Accra, Ghana, where the board has been meeting this week.

The fund had to make some "tough decisions to protect some of the gains that have already been delivered," he added.

Among those decisions were that $800 million to $900 million in grants planned for China, Brazil, Mexico and Russia will now be used for other purposes, fund officials said.

"It is deeply worrisome that inadvertently the millions of people fighting with deadly diseases are in danger of paying the price for the global financial crisis," the fund's executive director, Dr. Michel Kazatchkine, said in a statement.

But the fund has $4 billion on hand to meet all of its current commitments and the "presumption" is that people in China, Brazil, Mexico and Russia won't suffer because their governments will commit their own resources to take over the next phase of the fund's programs, said Dr. Christoph Benn, the fund's external relations manager.

He said the fund's financing picture for the next two years, however, could affect about 9 to 10 million new patients who are in need of HIV treatment in developing nations.

The board has also decided to create a new general manager position after the panel found unhealthy friction between Kazatchkine and the fund's internal watchdog, Inspector General John Parsons's office, whose teams of auditors and investigators have been documenting losses.

The fund released 12 reports on its website earlier this month that turned up an additional $20 million of mismanagement, alleged fraud and misspending. Earlier probes had detected about $53 million in losses, according to fund documents.

Some of the reports have led to criminal cases, and some countries � mirroring the fund's own efforts � say they have begun putting new financial safeguards in place.

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Merck will pay $950M to settle Vioxx investigation (AP)

NEW YORK � The Department of Justice said Tuesday that drugmaker Merck will pay $950 million to resolve investigations into its marketing of the painkiller Vioxx.

The agency said Merck will pay $321.6 million in criminal fines and $628.4 million as a civil settlement agreement. It will also plead guilty to a misdemeanor charge that it marketed Vioxx as a treatment for rheumatoid arthritis before getting Food and Drug Administration approval.

The government will get $426.4 million from the settlement, and $202 million will be distributed to state Medicaid programs for 43 states and the District of Columbia.

Merck stopped selling Vioxx in September 2004 after evidence showed the drug doubled the risk of heart attack and stroke. In 2007 the company paid $4.85 billion to settle around 50,000 Vioxx-related lawsuits. The Justice Department said the settlement resolves allegations that Merck made false, unproven, or misleading statements about Vioxx's safety to increase sales and made false statements to Medicaid agencies about its safety.

Merck said the settlement does not constitute an admission of any liability or wrongdoing, and it said the government acknowledged that there was no basis to conclude that Merck's upper-level management was involved in the violations.

Merck also entered into an agreement about its sales, marketing, publication, and government pricing activities. The Justice Department said that agreement strengthens oversight of the company. It will require top officials to complete annual compliance certifications, and the company will post information about physician payments on its website.

The Whitehouse Station, N.J., company took a charge of $950 million in the third quarter of 2010 to cover the anticipated settlement payments.

Vioxx was approved by the FDA in May 1999, but the government did not initially approve the drug for use in rheumatoid arthritis. That meant doctors could write prescriptions for Vioxx for rheumatoid arthritis patients, but Merck could not promote the drug for that use. The Justice Department said Merck promoted Vioxx for rheumatoid arthritis for three years and continued to do so after getting an FDA warning letter in September 2001. The drug was approved as a treatment for rheumatoid arthritis in April 2002.

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Giving thanks helps your psychological outlook (AP)

WASHINGTON � Count your blessings this Thanksgiving. It's good for you.

While it seems pretty obvious that gratitude is a positive emotion, psychologists for decades rarely delved into the science of giving thanks. But in the last several years they have, learning in many experiments that it is one of humanity's most powerful emotions. It makes you happier and can change your attitude about life, like an emotional reset button.

Especially in hard times, like these.

Beyond proving that being grateful helps you, psychologists also are trying to figure out the brain chemistry behind gratitude and the best ways of showing it.

"Oprah was right," said University of Miami psychology professor Michael McCullough, who has studied people who are asked to be regularly thankful. "When you are stopping and counting your blessings, you are sort of hijacking your emotional system."

And he means hijacking it from out of a funk into a good place. A very good place. Research by McCullough and others finds that giving thanks is a potent emotion that feeds on itself, almost the equivalent of being victorious. It could be called a vicious circle, but it's anything but vicious.

He said psychologists used to underestimate the strength of simple gratitude: "It does make people happier ... It's that incredible feeling."

One of the reasons why gratitude works so well is that it connects us with others, McCullough said. That's why when you give thanks it should be more heartfelt and personal instead of a terse thank you note for a gift or a hastily run-through grace before dinner, psychologists say.

Chicago area psychologist and self-help book author Maryann Troiani said she starts getting clients on gratitude gradually, sometimes just by limiting their complaints to two whines a session. Then she eventually gets them to log good things that happened to them in gratitude journals: "Gratitude really changes your attitude and your outlook on life."

Gratitude journals or diaries, in which people list weekly or nightly what they are thankful for, are becoming regular therapy tools.

And in those journals, it is important to focus more on the people you are grateful for, said Robert Emmons, a psychology professor at the University of California, Davis. Concentrate on what life would be without the good things � especially people such as spouses � in your life and how you are grateful they are there, he said.

Grateful people "feel more alert, alive, interested, enthusiastic. They also feel more connected to others," said Emmons, who has written two books on the science of gratitude and often studies the effects of those gratitude diaries.

"Gratitude also serves as a stress buffer," Emmons said in an e-mail interview. "Grateful people are less likely to experience envy, anger, resentment, regret and other unpleasant states that produce stress."

Scientists are not just looking at the emotions behind gratitude but the nuts-and-bolts physiology as well.

Preliminary theories look at the brain chemistry and hormones in the blood and neurotransmitters in the brain that are connected to feelings of gratitude, Emmons said. And the left prefrontal cortex of the brain, which is also associated with positive emotions like love and compassion, seems to be a key spot, especially in Buddhist monks, Emmons said.

However it works in the brain, Emmons said there is little doubt that it works.

Emmons, who has conducted several studies on people from ages 12 to 80, including those with neuromuscular disease, asked volunteers to keep daily or weekly gratitude diaries. Another group listed hassles, and others just recorded random events. He noticed a significant and consistent difference. About three-quarters of the people studied who regularly counted their blessings scored higher in happiness tests and some even showed improvements in amounts of sleep and exercise.

Christopher Peterson of the University of Michigan studied different gratitude methods and found the biggest immediate improvement in happiness scores was among people who were given one week to write and deliver in person a letter of gratitude to someone who had been especially kind to them, but was never thanked. That emotional health boost was large, but it didn't last over the weeks and months to come.

Peterson also asked people to write down nightly three things that went well that day and why that went well. That took longer to show any difference in happiness scores over control groups, but after one month the results were significantly better and they stayed better through six months.

Peterson said it worked so well that he is adopted it in his daily life, writing from-the-heart thank you notes, logging his feelings of gratitude: "It was very beneficial for me. I was much more cheerful."

At the University of North Carolina, Sara Algoe studied the interaction between cancer patients and their support group, especially when acts of gratitude were made. Like Peterson, she saw the effects last well over a month and she saw the feedback cycle that McCullough described.

"It must be really powerful," Algoe said.

It has to be potent to combat gloom many may be feeling in such uncertain times.

There have been many Thanksgivings throughout history that might challenge society's ability to be grateful. The first Thanksgiving with the Pilgrims came after about half of the Plymouth colony died in the first year. Thanksgiving became a national holiday in the United States when Abraham Lincoln proclaimed it in 1863 during the Civil War, the deadliest war the country has ever known. And the holiday moved to the fourth Thursday in November during the tail end of the Great Depression.

Emmons actually encourages people to "think of your worst moments, your sorrows, your losses, your sadness and then remember that here you are, able to remember them. You got through the worst day of your life ... remember the bad things, then look to see where you are."

That grace amid difficulty motif may make this Thanksgiving especially meaningful, McCullough said.

"In order to be grateful for something, we have to remember that something good happened," Peterson said. "It's important to remind ourselves that the world doesn't always suck."

___

Online:

Robert Emmons: http://psychology.ucdavis.edu/labs/emmons/PWT/index.cfm

National Association of School Psychologists' tips on fostering gratitude in children: http://bit.ly/rHlqCz

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UN: AIDS epidemic stabilizing, still work to do (AP)

LONDON � The AIDS epidemic is leveling off and the number of people newly infected with the virus that causes it has remained unchanged since 2007, the United Nations said in a report Monday.

Critics say that the body's aim of wiping out the disease is overly optimistic, however, considering there is no vaccine, millions remain untreated and donations have slumped amid the economic crisis.

There were 2.7 million new HIV infections last year, approximately the same figure as in the three previous years, said the report from UNAIDS, the joint United Nations program on HIV and AIDS. The figures largely confirm earlier findings released by the group in June.

At the end of last year, there were about 34 million people with HIV, the virus that causes AIDS. While that is a slight rise from previous years, experts say that's due to people surviving longer. Last year, there were 1.8 million AIDS-related deaths, down from 1.9 million in 2009.

The outbreak continues to hit hardest in southern Africa. But while the number of new infections there has fallen by more than 26 percent since the peak in 1997, the virus is surging elsewhere.

In eastern Europe and central Asia, there has been a 250 percent jump in the number of people infected with HIV in the past decade, due largely to the spread among injecting drug users. In North America and western Europe, the outbreak "remains stubbornly steady," according to the report.

"It's looking promising, but the numbers are still at a scary level," said Sophie Harman, a global health expert at City University in London. She was not connected to the UNAIDS report.

In its strategy for the next few years, UNAIDS says it is working toward zero new HIV infections, zero discrimination and zero AIDS-related deaths. Harman said that was an admirable goal but wasn't sure it was achievable. "They need to get real," she said. "Maybe they need to aim high but if their main goal is eradication, it's highly unlikely that will ever happen."

Dr. Paul De Lay, deputy executive director of UNAIDS, acknowledged the idea of eliminating AIDS infections and deaths is "more of a vision for the future," and would likely not be accomplished without new tools like a vaccine, which could take several decades. Earlier this month, U.S. Secretary of State Hillary Clinton called for an AIDS-free generation and promised more money for programs in Africa.

De Lay said U.N. strategies will focus on more aggressive prevention and treatment policies, like treating people with HIV earlier. In Africa, people with HIV are not usually treated until their immune system reaches a certain threshold, and officials are now increasingly trying to start treatment before patients get too sick.

Future strategies might also include giving medicines to people at high risk even before they get infected. The World Health Organization is considering how to advise countries with major epidemics on giving drugs to healthy people vulnerable to catching the virus, such as prostitutes, gay men and injecting drug users, as a prevention method.

While studies have shown that could dramatically slow AIDS transmission, experts have voiced concerns about healthy people taking AIDS drugs, which have toxic side effects. It could also encourage drug resistance, and there are already millions of people in developing countries who qualify for treatment but are still waiting for it.

Sharonann Lynch, an HIV policy adviser at Doctors Without Borders, said many African countries are anxious to implement more aggressive strategies and that some are redrafting their guidelines even before official U.N. advice is available. But she said the financial crisis is affecting treatment and that enrollment in some clinics, like in Congo, have stalled or even been suspended. That could allow the epidemic to resurge.

"Just at the moment when we know how to manage HIV, we're hitting the brakes," Lynch said. "Without more investment, we'll be squandering the best chance we have of getting ahead of the new wave of infections."

___

Online:

http://www.unaids.org

http://www.msf.org

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Where's the salt? Hidden in your Thanksgiving menu (AP)

WASHINGTON � No need for a salt shaker on the Thanksgiving table: Unless you really cooked from scratch, there's lots of sodium already hidden in the menu.

Stealth sodium can do a number on your blood pressure. Americans eat way too much salt, and most of it comes inside common processed foods and restaurant meals.

The traditional Thanksgiving fixings show how easy sodium can sneak into the foods you'd least expect. Yes, raw turkey is naturally low in sodium. But sometimes a turkey or turkey breast is injected with salt water to plump it, adding a hefty dose of sodium before it even reaches the store � something you'd have to read the fine print to discover.

From the stuffing mix to the green bean casserole to even pumpkin pie, a lot of people can reach their daily sodium allotment or more in that one big meal unless the cook employs some tricks.

"For Thanksgiving or any meal, the more you can cook from scratch and have some control over the sodium that's going in, the better," says the American Dietetic Association's Bethany Thayer, a registered dietitian at the Henry Ford Health Health System in Detroit.

The Food and Drug Administration this month opened deliberations on how to cut enough salt in processed foods for average shoppers to have a good shot at meeting new dietary guidelines. The idea: If sodium levels gradually drop in the overall food supply, it will ease the nation's epidemic of high blood pressure � and our salt-riddled taste buds will have time to adjust to the new flavor.

"Reducing sodium is important for nearly everyone," Dr. Robin Ikeda of the Centers for Disease Control and Prevention told the FDA hearing.

The question is how to make that happen. The prestigious Institute of Medicine and several public health advocates are urging the FDA to order gradual rollbacks, setting different sodium levels for different kinds of foods, a step the government has been reluctant to take.

Food makers want a voluntary approach and say they're reworking their recipes, some as part of a campaign launched by New York City to cut salt consumption by at least 20 percent over five years.

It will take different strategies to remove salt from different foods � and some may need to be a sneak operation, Kraft Foods Vice President Richard Black told the FDA meeting. Ritz crackers labeled low-sodium were a bust until the box was changed to say "Hint of Salt" and those exact same crackers started selling, he said.

In other foods, salt acts as a preservative with a variety of functions. Kraft sells cheese with somewhat less sodium in Britain than in the U.S. Americans melt a lot of cheese and lower-sodium cheese doesn't melt as well, Black said.

In the U.S., the average person consumes about 3,400 milligrams of sodium a day. The nation's new dietary guidelines say no one should eat more than 2,300 milligrams of sodium � about what's in a teaspoon of salt � and half the population should eat even less, just 1,500 milligrams. The smaller limit is for anyone who's in their 50s or older, African-Americans of any age, and anyone suffering from high blood pressure, diabetes or chronic kidney disease.

Why? One in three U.S. adults has high blood pressure, a leading cause of heart attacks, strokes and kidney failure. Being overweight and inactive raises blood pressure, too, but the weight of scientific evidence shows sodium is a big culprit.

People want to eat heart-healthy, but Wal-mart shoppers spend about 19 minutes buying groceries, added Tres Bailey of Wal-mart Stores Inc., which told its vendors to start cutting sodium.

That's not a lot of time for label-reading to find hidden sodium, especially in foods where it's unexpected � like salad dressings that can harbor more than 130 milligrams per tablespoon.

Depending on your choices, Thanksgiving dinner alone can pass 2,000 milligrams: About 600 per serving from stuffing mix, another 270 from gravy. The salt water-added turkey can bring another 320, double that if you saved time and bought it fully-cooked. Use canned beans in the green bean casserole and add another 350. A small dinner roll adds 130. A piece of pumpkin pie could bring as much as 350.

How to cut back? Thayer, the dietitian, has some tips for Thanksgiving and beyond:

_All bread contains sodium, but starting with a homemade cornbread for stuffing could help cut a few hundred milligrams.

_Use low-sodium broth for the gravy, and choose low-sodium soups whenever possible.

_Try onion, garlic and a variety of other herbs in place of salt. Lemon and other citrus also can stand in for salt in some foods.

_Check your spice bottles. Combination products, such as those labeled poultry seasoning, can contain salt.

_Fresh or frozen vegetables have little if any sodium, unless you choose the frozen kind with an added sauce.

_People tend to heavily salt mashed potatoes while sweet potatoes, even dressed up as a souffle, contain very little sodium.

Going suddenly low-salt can startle your palate, "but it adjusts much quicker than I think most people realize," Thayer says.

___

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

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FDA revokes approval of Avastin for breast cancer (AP)

WASHINGTON � The government delivered a blow to some desperate patients Friday as it ruled the blockbuster drug Avastin should no longer be used to treat advanced breast cancer.

Avastin is hailed for treating colon cancer and certain other malignancies. But the Food and Drug Administration said it appeared to be a false hope for breast cancer: Studies haven't found that it helps those patients live longer or brings enough other benefit to outweigh its dangerous side effects.

"I did not come to this decision lightly," said the FDA's commissioner, Dr. Margaret Hamburg. But she said, "Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing."

Avastin remains on the market to treat certain colon, lung, kidney and brain cancers. Doctors are free to prescribe any marketed drug as they see fit. So even though the FDA formally revoked Avastin's approval as a breast cancer treatment, women could still receive it � but their insurers may not pay for it. Some insurers already have quit in anticipation of FDA's long-expected ruling.

However, "Medicare will continue to cover Avastin," said Brian Cook, spokesman for the Centers for Medicare & Medicaid Services. The agency "will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies."

Including infusion fees, a year's treatment with Avastin can reach $100,000.

The ruling disappointed patients who believe Avastin is helping to curb their incurable cancer.

"It's saved my life," said a tearful Sue Boyce, 54, of Chicago. She's taken Avastin in addition to chemotherapy since joining a research study in 2003. Her breast cancer eventually spread to her lungs, liver and brain, but Boyce says she is stable and faring well.

"So I'm hoping the insurance company will grandfather me in to continue taking it," she said.

The Avastin saga began in 2008, when an initial study suggested the drug could delay tumor growth for a few months in women whose breast cancer had spread to other parts of the body. Over the objection of its own advisers and to the surprise of cancer groups, FDA gave Avastin conditional approval � it could be sold for such women while manufacturer Genentech tried to prove it really worked.

The problem: Ultimately, the tumor effect was even smaller than first thought. Across repeated studies, Avastin patients didn't live longer or have a higher quality of life. Yet the drug causes some life-threatening risks, including severe high blood pressure, massive bleeding, heart attack or heart failure and tears in the stomach and intestines, the FDA concluded. In two public hearings � one last year and one this summer � FDA advisers urged the agency to revoke that approval.

"The science is clear: Breast cancer patients are more likely to be harmed than helped by Avastin," said Diana Zuckerman of the National Research Center for Women and Families in Washington.

Genentech had argued the drug should remain available while it conducted more research to see if certain subsets of breast cancer patients might benefit, and some patients and their doctors had argued passionately for the drug.

"There certainly are patients who benefit tremendously," said Boyce's oncologist, Dr. Melody Cobleigh of Rush University Medical Center. "We'll just be battling with the insurance companies."

"For those not fortunate enough to be on Medicare or an insurance plan that covers it, it's a death sentence," Christi Turnage of Madison, Miss., said of the FDA's decision. Her breast cancer had moved into her lungs before she began Avastin three years ago and the spreading stopped, but Turnage said her insurer is ending coverage and she will seek financial help from Genentech's access program.

Hamburg said that she considered those arguments but that scientifically there are no clues yet to identify who those rare Avastin responders would be � putting a lot of people at risk in order for a few to get some as-yet-unknowable benefit. She urged Genentech to do that research, saying the FDA "absolutely" would reconsider if the company could find the right evidence.

Genentech, part of Swiss drugmaker Roche Group, pledged to begin that research.

"We are disappointed with the outcome," said company chief medical officer Dr. Hal Barron. "We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States."

The breast cancer organization Susan G. Komen for the Cure said that it respected the FDA's decision and that it was time for researchers to concentrate on finding so-called biomarkers that would tell which drug is right for which patient.

"Each type of cancer is very different from another in important ways, and in the end it's no surprise that Avastin's effectiveness may not be equivalent against all types of cancer," said Dr. Neal Meropol of University Hospitals Case Medical Center in Cleveland, who has long used Avastin for colon cancer.

___

Associated Press writer Marley Seaman in New York contributed to this report.

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FACT CHECK: GOP senator gasps for facts on asthma (AP)

WASHINGTON � It was a startling claim: Air pollution has no connection to asthma, Kentucky GOP Sen. Rand Paul said on the Senate floor.

But Paul, and a chart he used to make his case against the health benefits of a new federal air pollution rule, relied on some creative sourcing and pseudoscience.

Paul's chart was a graph showing air pollution declining in California as the number of people diagnosed with asthma rose. The chart attributed the data to a May 2003 paper by what was then called the California Department of Health Services. But the department never plotted the relationship between those two factors.

The real source was a 2006 paper "Facts Not Fear on Air Pollution" from the National Center for Policy Analysis, a conservative think tank. The paper, by independent consultant Joel Schwartz, contends that most information on air pollution from environmentalists, regulators, scientists and journalists is exaggerated or wrong. The paper was not subjected to the normal peer-review process demanded for most published science.

Paul, an ophthalmologist and eye surgeon, cited Schwartz in his Nov. 10 remarks, saying: "We have decreased pollution and rising incidence of asthma. Either they are inversely proportional or they are not related at all."

At best, the chart suggests that air pollution alone cannot explain the rise in asthma, a chronic lung disease that inflicts approximately 34 million Americans and whose exact cause is unknown.

It certainly can't be used to say that air pollution plays no role in causing asthma.

"They may think there is a pattern there, but in fact it has no basis," said Dr. Richard Kreutzer, head of environmental and occupational disease control at what is now California's Department of Public Health, the agency cited on Paul's chart. Kreutzer said there is evidence that some pollutants can cause asthma and even more research showing that air pollution aggravates asthma in those who have the disease.

The National Institutes of Health said last year that "recent findings have conclusively demonstrated a link between asthma and air pollution, especially ground-level ozone."

But Schwartz, who now works for Blue Sky Consulting Group, discounts even studies linking pollution to asthma attacks, saying "they are probably not related."

In an interview with The Associated Press, Schwartz defended his work. "The fact that they move in opposite directions shows that air pollution is not a large factor in the cause," he said.

Dan Greenbaum, the president of the nonprofit Health Effects Institute, said such arguments "miss the point." The institute receives funding from both the Environmental Protection Agency and the auto industry.

"No pulmonary doctor has said that the primary reason for the increase in asthma is air pollution. That is not the concern with air pollution and asthma," Greenbaum said. "The concern is that if you have asthma, we have very strong evidence that you are sensitive to air pollution."

___

Follow Dina Cappiello on Twitter (at)dinacappiello

___

Online:

California Department of Public Health paper: http://www.bit.ly/s3RAen

National Center for Policy Analysis paper: http://www.bit.ly/w06uJC

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Is economy best birth control? US births dip again (AP)

ATLANTA � The economy may well be the best form of birth control.

U.S. births dropped for the third straight year � especially for young mothers � and experts think money worries are the reason.

A federal report released Thursday showed declines in the birth rate for all races and most age groups. Teens and women in their early 20s had the most dramatic dip, to the lowest rates since record-keeping began in the 1940s. Also, the rate of cesarean sections stopped going up for the first time since 1996.

Experts suspected the economy drove down birth rates in 2008 and 2009 as women put off having children. With the 2010 figures, suspicion has turned into certainty.

"I don't think there's any doubt now that it was the recession. It could not be anything else," said Carl Haub, a demographer with the Population Reference Bureau, a Washington, D.C.-based research organization. He was not involved in the new report.

U.S. births hit an all-time high in 2007, at more than 4.3 million. Over the next two years, the number dropped to about 4.2 million and then about 4.1 million.

Last year, it was down to just over 4 million, according to the new report from the Centers for Disease Control and Prevention.

For teens, birth rates dropped 9 percent from 2009. For women in their early 20s, they fell 6 percent. For unmarried mothers, the drop was 4 percent.

Experts believe the downward trend is tied to the economy, which officially was in a recession from December 2007 until June 2009 and remains weak. The theory is that women with money worries � especially younger women � feel they can't afford to start a family or add to it.

That's true of Mary Garrick, 27, an advertising executive in Columbus, Ohio. She and her husband, David, married in 2008 and hoped to start having children quickly, in part because men in his family have died in their 40s. But David, 33, was laid off that year from his nursing job and again last year.

He's working again, but worries about the economy linger. "It kind of made us cautious about life decisions, like having a family. It's definitely something that affected us," she said.

Kristi Elsberry, a married 27-year-old mother of two, had her tubes tied in 2009 after she had trouble finding a job and she and her husband grew worried about the financial burden of any additional children. "Kids are so expensive, especially in this day and age. And neither of us think anything's going to get better," said Elsberry, of Leland, N.C.

Many of the report's findings are part of a trend and not surprising. There was a continued decline in the percentage of premature births at less than 37 weeks. And � as in years past � birth rates fell in younger women but rose a little in women 40 and older, who face a closing biological window for having children and may be more worried about that than the economy.

But a few of the findings did startle experts.

One involved a statistic called the total fertility rate. In essence, it tells how many children a woman can be expected to have if current birth rates continue. That figure was 1.9 children last year. In most years, it's more like 2.1.

More striking was the change in the fertility rate for Hispanic women. The rate plummeted to 2.4 from nearly 3 children just a few years ago.

"Whoa!" said Haub, in reaction to the statistic.

The economy is no doubt affecting Hispanic mothers, too, but some young women who immigrated to the United States for jobs or other opportunities may have left, Haub said.

Another shocker: the C-section rate. It rose steadily from nearly 21 percent in 1996 to 32.9 percent in 2009, but dropped slightly to 32.8 last year.

Cesarean deliveries are sometimes medically necessary. But health officials have worried that many C-sections are done out of convenience or unwarranted caution, and in the 1980s set a goal of keeping the national rate at 15 percent.

It's too soon to say the trend has reversed, said Joyce Martin, a CDC epidemiologist who co-authored the new report.

But the increase had slowed a bit in recent years, and assuming the decline was in elective C-sections, that's good news, some experts said.

"It is quite gratifying," said Carol Hogue, an Emory University professor of maternal and child health and epidemiology.

"There are strong winds pushing against C-sections," she said, including new policies and education initiatives that discourage elective C-sections in mothers who have not reached full-term.

Hogue agreed that the economy seems to be the main reason for the birth declines. But she noted that it's possible that having fewer children is now more accepted and expected.

"Having one child may be becoming more `normal,'" she said.

___

Online:

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

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Lower birth rates for young women tied to economy (AP)

ATLANTA � Birth rates for the nation's youngest mothers hit new lows last year � further evidence that few forms of birth control are as effective as the economy.

The national birth rate dropped for the third straight year, with declines for most ages and all races, according to a federal report released Thursday. Teens and women in their early 20s had the most dramatic dip to the lowest rates since record-keeping began in the 1940s.

Also, the rate of cesarean sections stopped going up for the first time since 1996.

Experts suspected the economy drove down birth rates in 2008 and 2009 as women put off having children. With the 2010 figures, suspicion has turned into certainty.

"I don't think there's any doubt now that it was the recession. It could not be anything else," said Carl Haub, a demographer with the Population Reference Bureau, a Washington, D.C.-based research organization. He was not involved in the new report.

U.S. births hit an all-time high in 2007, at more than 4.3 million. Over the next two years, the number dropped to about 4.2 million and then about 4.1 million.

Last year, it was down to just over 4 million, according to the new report from the Centers for Disease Control and Prevention.

For teens, birth rates dropped 9 percent from 2009. For women in their early 20s, they fell 6 percent. For unmarried mothers, the drop was 4 percent.

Experts believe the downward trend is tied to the economy, which officially was in a recession from December 2007 until June 2009 but remains weak. The theory is that women with money worries � especially younger women � feel they can't afford to start a family or add to it.

That's true of Mary Garrick, 27, an advertising executive in Columbus, Ohio. She and her husband, David, married in 2008 and hoped to start having children quickly, in part because men in his family have died in their 40s. But David, 33, was laid off that year from his nursing job and again last year.

He's working again, but worries about the economy linger. "It kind of made us cautious about life decisions, like having a family. It's definitely something that affected us," she said.

Many of the report's findings are part of a trend and not surprising, but a few did startle experts.

One involved a statistic called the total fertility rate. In essence, it tells how many children a woman can be expected to have if current birth rates continue. That figure was 1.9 children last year. In most years, it's more like 2.1.

More striking was the change in the fertility rate for Hispanic women. The rate plummeted to 2.4 from 3 children just a few years ago.

"Whoa!" said Haub, in reaction to the statistic.

The economy is no doubt affecting Hispanic mothers, too, but some young women who immigrated to the United States for jobs or other opportunities may have left, Haub said.

Another shocker: The C-section rate. It rose steadily from nearly 21 percent in 1996 to 32.9 percent in 2009, but it dropped slightly to 32.8 last year.

Cesarean deliveries are sometimes medically necessary. But health officials have worried that many C-sections are done out of convenience or unwarranted caution, and in the 1980s set a goal of keeping the national rate at 15 percent.

It's too soon to say the trend has reversed, said Joyce Martin, a CDC epidemiologist who co-authored the new report.

But the pace of increase had slowed a bit in recent years, and assuming the decline was in elective C-sections, that's good news, some experts said.

"It is quite gratifying," said Carol Hogue, an Emory University professor of maternal and child health and epidemiology.

"There are strong winds pushing against C-sections," she said, including new policies and education initiatives that discourage elective C-sections in mothers who have not reached full-term.

Hogue agreed that the economy seems to be the main reason for the birth declines. But she noted that it's possible that having fewer children is now more accepted and expected.

"Having one child may be becoming more `normal,'" she said.

___

Online:

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

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Women more likely to have 'broken heart syndrome' (AP)

ORLANDO, Fla. � A woman's heart breaks more easily than a man's.

Females are seven to nine times more likely to suffer "broken heart syndrome," when sudden or prolonged stress like an emotional breakup or death causes overwhelming heart failure or heart attack-like symptoms, the first nationwide study of this finds. Usually patients recover with no lasting damage.

The classic case is "a woman who has just lost her husband," said Dr. Mariell Jessup, a University of Pennsylvania heart failure specialist who has treated many such cases.

Cyndy Bizon feared that was happening when her husband, Joel, suffered a massive heart attack in 2005. "May God work through your hands," the Maine woman told the surgeon as her husband was wheeled past her into the operating room. She later collapsed at a nurse's station from "broken heart syndrome" and wound up in coronary care with him. Both survived.

Japanese doctors first recognized this syndrome around 1990 and named it Takotsubo cardiomyopathy; tako tsubo are octopus traps that resemble the unusual pot-like shape of the stricken heart.

It happens when a big shock, even a good one like winning the lottery, triggers a rush of adrenaline and other stress hormones that cause the heart's main pumping chamber to balloon suddenly and not work right. Tests show dramatic changes in rhythm and blood substances typical of a heart attack, but no artery blockages that typically cause one. Most victims recover within weeks, but in rare cases it proves fatal.

Dr. Abhishek Deshmukh of the University of Arkansas had treated some of these cases.

"I was very curious why only women were having this," he said, so he did the first large study of the problem and reported results Wednesday at an American Heart Association conference in Florida.

Using a federal database with about 1,000 hospitals, Deshmukh found 6,229 cases in 2007. Only 671 involved men. After adjusting for high blood pressure, smoking and other factors that can affect heart problems, women seemed 7.5 times more likely to suffer the syndrome than men.

It was three times more common in women over 55 than in younger women. And women younger than 55 were 9.5 times more likely to suffer it than men of that age.

No one knows why, said Dr. Abhiram Prasad, a Mayo Clinic cardiologist who presented other research on this syndrome at the conference.

"It's the only cardiac condition where there's such a female preponderance," he said.

One theory is that hormones play a role. Another is that men have more adrenaline receptors on cells in their hearts than women do, "so maybe men are able to handle stress better" and the chemical surge it releases, Deshmukh said.

Bizon was 57 when her attack occurred; she's now 63. She and her husband are pharmacists and live in Scarborough, Maine.

"I remember grabbing the counter and a black curtain coming down before my eyes," she said in a telephone interview. Her attack was so severe that she went into full cardiac arrest and had to have her heart shocked back into a normal rhythm. Although most such attacks resolve without permanent damage, she later needed to have a defibrillator implanted.

About 1 percent of such cases prove fatal, the new study shows.

"In the old days, we'd say someone was scared to death," said Prasad.

About 10 percent of victims will have a second episode sometime in their lives. And although heart attacks happen more in winter, broken heart syndrome is more common in summer.

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Online:

Heart Association, http://www.americanheart.org

___

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

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Blood type may affect stroke risk, study finds (AP)

ORLANDO, Fla. � Your blood type might affect your risk for stroke. People with AB and women with B were a little more likely to suffer one than people with O blood � the most common type, a study found.

The research can't prove such a link. But it fits with other work tying A, B and AB to more risk of blood clots in the legs and heart attacks. Blood type O also has been tied to an increased risk of bleeding, which implies less chance of clots, the cause of most strokes.

"There's increasing evidence that blood type might influence risk of chronic disease," said one of the study leaders, Dr. JoAnn Manson, chief of preventive medicine at Harvard's Brigham and Women's Hospital.

"It's not at the level where we want to alarm people and we want to make that clear. But it's one more element of risk that people would want to know about," and it could give them one more reason to keep blood pressure and cholesterol in line, she said.

The study, led by Brigham's Dr. Lu Qi, was presented Wednesday at an American Heart Association conference. It involved 90,000 men and women in two observational health studies that have gone on for more than 20 years.

Looking at the 2,901 strokes that have occurred and taking into account other things that can cause them, such as high blood pressure, researchers found:

_Men and women with AB had a 26 percent increased risk of stroke compared to those with type O.

_Women but not men with B blood had a 15 percent greater risk compared to those with O.

What's the explanation?

Blood type depends on proteins on the surface of red blood cells. A pattern of immune system responses forms early in life based on them. Certain blood types may make red cells more likely to clump together and stick to the lining of blood vessels, setting the stage for a blood clot, Manson said.

"You can't change it, and we don't know if it's the blood type per se or other genes that track with it" that actually confers risk, said Dr. Larry Goldstein, director of Duke University's stroke center.

"There are other things that are more important" than blood type for stroke risk, such as smoking, drinking too much and exercising too little, he said.

About 45 percent of whites, 51 percent of blacks, 57 percent of Hispanics and 40 percent of Asians have blood type O, according to the American Red Cross. Such people are called "universal donors" because their blood can safely be used for transfusions to any other blood type.

AB blood type is the least common type, present in 4 percent of whites and blacks, 2 percent of Hispanics and 7 percent of Asians.

B is second least common overall, in 11 percent of whites, 19 percent of blacks, 10 percent of Hispanics and 25 percent of Asians.

A is in 40 percent of whites, 26 percent of blacks, 31 percent of Hispanics and 28 percent of Asians.

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Online:

Heart Association: http://www.americanheart.org

Blood types: http://www.redcrossblood.org/learn-about-blood/blood-types

___

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

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UK doctors call for ban on smoking in cars (AP)

LONDON � The British Medical Association is calling on the government to ban smoking at all times in cars, a step that would go beyond regulations elsewhere.

In research released on Wednesday, the group that represents U.K. doctors said the confined environment in cars exposes drivers and passengers to 23 times more toxins than a smoky bar. Children are particularly vulnerable to second-hand smoke since they absorb more pollutants. Smoke can linger in cars long after cigarettes have been smoked.

In countries including Australia, Canada, and parts of the U.S., smoking in cars is banned when children are present. In the U.K., smoking in public vehicles like buses and trains is banned but there is no law against smoking in private cars.

Dr. Vivienne Nathanson of the association said Wednesday that the government should now take a "bold and courageous step."

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Giffords faces long road, wants to return to Hill (AP)

WASHINGTON � Debating opponents. Negotiating compromises. Raising money. The demands of Congress are great for anyone, much less someone recovering from a gunshot to the head like Rep. Gabrielle Giffords.

Giffords' first televised interview showed a lively woman making good progress in recovering from a devastating brain injury, yet still struggling mightily to pull out the words she wants. Only 10 months after her injury, brain specialists unconnected with Giffords' care say she'll almost certainly continue to improve. But no one can predict how much or how fast.

How the brain rewires itself after trauma � making new connections or recruiting an undamaged area to compensate for a damaged one � is largely a mystery. But most people with severe brain injuries never emerge as exactly the same person they were before, and lingering impairment could make a return to Congress a difficult decision for Giffords and her family.

The stress of the job should get consideration, said Dr. Jordan Grafman, director of the Traumatic Brain Injury Research Laboratory at the Kessler Foundation Research Center in West Orange, N.J.

"A little stress makes us sharp. A lot of stress kills neurons," said Grafman, who has long studied penetrating brain injuries but hasn't examined Giffords. After a severe brain injury, "I really don't think you'd want to be exposed to the level of stress that you'd be exposed to in Congress. I wouldn't want to."

Monday's interview on ABC was the first opportunity for the public to get a detailed look beyond the reassurances of Giffords' friends and physicians about how she's fared since being shot on Jan. 8. It was a chance to see what someone who's making a recovery often called miraculous or remarkable really looks like.

Giffords appeared determined and confident, but she struggled to form multiple-word sentences, much less string them together for a detailed conversation. With the help of her husband, Mark Kelly, she said she wouldn't return to Congress until she was "better." The filing deadline to run to for re-election to her House seat is May 30.

On Tuesday, Giffords' staff released on her Facebook page a more complex, minute-long recording made last week, two weeks after the ABC interview. In it, she says wants to get back to work.

"I'm getting stronger. I'm getting better," Giffords says still somewhat haltingly. She adds, "There is a lot to say. I will speak better."

Giffords read a script for the recording, which required multiple takes "until she was happy with it," said spokesman Mark Kimble.

To independent brain specialists, Giffords' speech thus far is good, considering the bullet passed right by an important speech region in the brain's left side.

"I think she's way ahead of the curve," said Dr. Ross Bullock, chief of neurotrauma at the University of Miami and Jackson Memorial Hospital. "Just as people's faces are different and personalities are different, just where those collections of really important cells are located varies from person to person," making it impossible to say how much her speech region was damaged.

Indeed, video taken by Kelly of his wife's hard slog through rehabilitation showed a hugely common frustration: People with all kinds of brain injuries recall, once they can speak again, that they knew what word they wanted but a completely unrelated one popped out from their brain's tangled wiring. "Spoon," Giffords kept saying to a therapist early on, instead of "chair."

Recovery from a brain injury is most dramatic in the first year, especially in the first three to six months. Much of that early improvement is spontaneous as the brain's networks reorganize themselves, said Dr. Robert Laureno, neurology chairman at Washington Hospital Center.

The recovery can continue for two years although more slowly, the kinds of changes more noticeable to people you don't see often, Grafman said. Rehab helps to spur the brain's continued rewiring, what scientists call plasticity. Giffords' adaptable personality and motivation give her an obvious advantage, he added.

People can return successfully to high-profile jobs after serious brain injuries. Sen. Tim Johnson, D-S.D., suffered a brain hemorrhage in December 2006 and returned to the Senate the following fall. His speech was a bit slurred, and sometimes he used a scooter to get around. He later won re-election and chairs the Banking Committee.

Grafman says patients must adapt to lingering impairments, with the help of families who are best able to tell if they're making good judgments. For Giffords, a supportive congressional staff can do a lot of the work. But at some point, he noted, "people are going to ask hard questions. How is she going to handle them?"

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Associated Press writer Kevin Freking contributed to this report.

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