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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