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."

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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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