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Health & Fitness (231)

LONDON (AP) -- About a third of women worldwide have been physically or sexually assaulted by a former or current partner, according to the first major review of violence against women.

In a series of papers released on Thursday by the World Health Organization and others, experts estimated nearly 40 percent of women killed worldwide were slain by an intimate partner and that being assaulted by a partner was the most common kind of violence experienced by women.

"Violence against women is a global health problem of epidemic proportions," WHO Director-General Dr. Margaret Chan said in a statement.

WHO defined physical violence as being slapped, pushed, punched, choked or being attacked with a weapon. Sexual violence was defined as being physically forced to have sex, having sex because you were afraid of what your partner might do and being compelled to do something sexual that was humiliating or degrading.

The report also examined rates of sexual violence against women by someone other than a partner and found about 7 percent of women worldwide had previously been a victim.

In conjunction with the report, WHO issued guidelines for authorities to spot problems earlier and said all health workers should be trained to recognize when women may be at risk and how to respond appropriately.

Globally, the WHO review found 30 percent of women are affected by domestic or sexual violence by a partner. The report was based largely on studies from 1983 to 2010. According to the United Nations, more than 600 million women live in countries where domestic violence is not considered a crime.

The rate of domestic violence against women was highest in Africa, the Middle East and Southeast Asia, where 37 percent of women experienced physical or sexual violence from a partner at some point in their lifetime. The rate was 30 percent in Latin and South America and 23 percent in North America. In Europe and Asia, it was 25 percent.

Some experts said screening for domestic violence should be added to all levels of health care, such as obstetric clinics.

"It's unlikely that someone would walk into an ER and disclose they've been assaulted," said Sheila Sprague of McMaster University in Canada, who has researched domestic violence in women at orthopedic clinics. She was not connected to the WHO report.

"Over time, if women are coming into a fracture clinic or a pre-natal clinic, they may tell you they are suffering abuse if you ask," she said.

For domestic violence figures, scientists analyzed information from 86 countries focusing on women over the age of 15. They also assessed studies from 56 countries on sexual violence by someone other than a partner, though they had no data from the Middle East. WHO experts then used modeling techniques to fill in the gaps and to come up with global estimates for the percentage of women who are victims of violence.

In a related paper published online in the journal Lancet, researchers found more than 38 percent of slain women are killed by a former or current partner, six times higher than the rate of men killed by their partners. Heidi Stoeckl, one of the authors at the London School of Hygiene and Tropical Medicine, said the figures were likely to be an underestimate. She and colleagues found that globally, a woman's highest risk of murder was from a current or ex-partner.

Stoeckl said criminal justice authorities should intervene at an earlier stage.

"When a woman is killed by a partner, she has often already had contact with the police," she said.

Stoeckl said more protective measures should be in place for women from their partners, particularly when he or she has a history of violence and owns a gun.

"There are enough signs that we should be watching out for that," she said. "We certainly should know if someone is potentially lethal and be able to do something about it."

© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Thursday, 20 June 2013 10:22
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ATLANTA (AP) -- A vaccine against a cervical cancer virus cut infections in teen girls by half in the first study to measure the shot's impact since it came on the market. The results impressed health experts and a top government top health official called them striking.

The research released Wednesday echoes studies done before the HPV vaccine became available in 2006. But the new study is the first evidence of just how well it works now that it is in general use.

Only about half of teen girls in the U.S. have gotten at least one dose of the expensive vaccine, and just a third of teen girls have had all three shots, according to the latest government figures.

"These are striking results and I think they should be a wake-up call that we need to increase vaccination rates," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention.

Cervical cancer is caused by certain types of the common sexually transmitted virus called HPV, for human papillomavirus. The vaccine, which costs about $130 per dose, protects against a few of those strains, including two blamed for 70 percent of cervical cancers. The shots work best if given before someone is sexually active so the emphasis has been on giving the shots to 11- and 12-year olds.

The CDC study compared infection rates in girls ages 14 to 19 before and after the vaccine became available. The proportion infected with the targeted HPV strains dropped 56 percent, from about 12 percent before the vaccine was sold to 5 percent. That result was for all teens after it was on the market, whether or not they were vaccinated.

Among girls who had gotten the vaccine, the drop in HPV infections was higher - 88 percent.

There are two vaccines against HPV, but the study mainly reflects the impact of Gardasil, the Merck & Co. vaccine that came on the market in 2006. A second vaccine approved in 2009 - GlaxoSmithKline's Cervarix - probably had relatively little bearing on the results, said the CDC's Dr. Lauri Markowitz, the study's lead author.

Both vaccines are approved for use in males and females - in ages 9 to 26 for females, and 9 to 21 in males. The vaccine was only recommended for boys in late 2011, and the CDC has not yet reported data on how many boys have gotten the shot since then. HPV vaccination requires three shots over 6 months.

An estimated 75 to 80 percent of men and women are infected with HPV during their lifetime. Most don't develop symptoms and clear it on their own. But some infections lead to genital warts, cervical cancer and other cancers. The study didn't look at cervical cancer rates. It can take many years for such cancers to develop, and not enough time has passed to know the vaccine's impact on cancer rates, CDC officials said.

The study involved interviews and physical examinations of nearly 1,400 teen girls in 2003 through 2006 and of 740 girls in 2007 through 2010.

The vaccine's impact was seen even though only 34 percent of the teens in the second group had received any vaccine. That could be due to "herd immunity" - when a population is protected from an infection because a large or important smaller group is immune.

Only about 20 percent of those vaccinated got all three doses. That result will likely feed an ongoing discussion about whether all three doses are necessary, Markowitz said.

Overall, the study found no significant change over time in the proportion of teens who'd ever had sex and in those who had multiple sex partners. However, it did find that a higher percentage of vaccinated teens said they'd had three or more sex partners.

That could have driven down infection rates, Markowitz noted, if the teens who got vaccinated were the ones at highest risk of getting an infection and spreading it.

The research was released online by the Journal of Infectious Diseases.

--- Online: HPV info: HTTP://WWW.CDC.GOV/HPV/ © 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Thursday, 20 June 2013 10:20
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WASHINGTON (AP) -- Medicare begins a major change next month that could save older diabetics money and time when they buy crucial supplies to test their blood sugar - but it also may cause some confusion as patients figure out the new system.

On July 1, Medicare opens a national mail-order program that will dramatically drop the prices the government pays for those products but patients will have to use designated suppliers. The goal is to save taxpayers money but seniors should see their copays drop, too.

Don't care about the convenience of mail delivery? Just over half of the 4.2 million diabetics with traditional Medicare coverage used mail-order last year, but starting July 1 beneficiaries also can get the new lower price at drugstores enrolled in the Medicare program.

"Those who like the face-to-face interaction with the pharmacist have that choice," stressed Jonathan Blum, Medicare deputy administrator. "We want to preserve both options."

It's the biggest expansion yet of a larger, and somewhat controversial, initiative that's predicted to save taxpayers nearly $26 billion over the next decade by cracking down on waste and fraud in the medical equipment industry. Diabetics aren't the only Medicare patients affected. Depending on where they live, patients who rent home oxygen gear and hospital beds, or who need power wheelchairs, walkers and certain other equipment also could see changes in their suppliers and lower prices as a pilot test of this so-called competitive bidding program expands from nine metro areas to a total of 100 on July 1. Medicare is supposed to apply the lower pricing nationally by 2016.

The diabetes initiative is the first to go nationwide - and Blum said it should put an end to unscrupulous practices such as shipping cartons of supplies to diabetics who haven't run out yet and billing Medicare for the cost.

The concern: Potentially hundreds of thousands of older patients may have to switch mail-order suppliers. The American Diabetes Association worries they won't get the word before their supplies run short - or might be pressured to switch to a cheaper brand of blood-sugar monitor and the matching supplies even though that's against the rules.

"We're sort of torn, truthfully," said Krista Maier, the association's associate director of public policy. "It will save the Medicare program money, which is good for its sustainability. The challenge is ensuring that beneficiaries' testing of their blood glucose isn't disrupted."

Here are some questions and answers about the program:

Q: What's the big change?

A: Until now, hundreds of mail-order companies could bill Medicare for the test strips, lancets and other supplies that diabetics use to measure and track their blood sugar. Under the new national program, Medicare patients can order from only 18 mail-order companies that won government contracts and will be subject to more oversight. (The change doesn't apply to Medicare Advantage patients.)

Check the list at HTTP://WWW.MEDICARE.GOV/SUPPLIER or by calling 1-800-MEDICARE. Some companies operate under multiple names.

Q: What if the new companies don't sell my brand?

A: Medicare's list shows different suppliers sell a mix of top-selling brands as well as generics - and you're not required to change your existing monitor. But you may need to shop around or get a doctor's note that specifies you need a specific type, so plan ahead.

Q: What's the price difference?

A: Medicare has paid about $78 for 100 test strips and lancets, just over a month's supply for someone who tests his or her blood sugar three times a day. Remarkably, that rate was higher than other insurers typically pay. Starting July 1, that reimbursement will drop to about $22. The patient copay is 20 percent, so it will drop from about $15 to less than $5.

Q: What if I want to buy at my local drugstore instead?

A: Ask if it accepts "Medicare assignment," meaning it has to honor the July 1 prices. Some large chains are reassuring customers that they're participating. But pharmacies that aren't enrolled in Medicare are allowed to charge patients more.

Q: How did the program work in the nine test cities?

A: Medicare says patients had plenty of supplies. But surprisingly, mail-order claims dropped the first year. The Department of Health and Human Services' inspector general discovered that some suppliers were billing Medicare for drugstore-sold supplies - which at the time were reimbursed at a higher rate - even though they actually shipped cheaper mail-order supplies. Congress later closed that loophole, mandating the same reimbursement for drugstores and mail-order starting July 1.

Q: What's happening with other medical equipment?

A: That part of the initiative has hit some bumps. Medicare had awarded contracts to nearly 800 suppliers of those items but it turned out that some didn't have certain licenses required by state authorities. Medicare says it has voided 30 of 96 supplier contracts in Tennessee, but that enough remain to do the job. It is investigating the situation in Maryland.

The home supply industry's American Association for Homecare, which opposes Medicare's competitive bidding program, says the licensing issue is a symptom of broader problems. Members of Congress last week asked Medicare to delay the program's expansion, but that's not expected to happen.

© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Wednesday, 19 June 2013 11:32
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CHICAGO (AP) -- A nonprofit group helping to spread the word about President Barack Obama's health care overhaul launched a campaign Tuesday that will target states with high numbers of uninsured Americans and tackle their skepticism with straightforward messages.

The "Get Covered America" campaign will include door-to-door visits by volunteers, brochures handed out at farmers markets and churches and, possibly, partnerships with sports leagues and celebrities, said Anne Filipic, a former White House official who recently became president of Enroll America, the group sponsoring the campaign.

The group's research shows 78 percent of uninsured adults don't know about opportunities that will be available to them in 2014 under the Affordable Care Act, Filipic said Tuesday during a phone call with reporters. The campaign is expected to cost tens of millions of dollars, including a seven-figure media ad buy.

"If they don't know about it, then they won't enroll," Filipic said. "We've done our research. We know people want to know what the law means for them in a `just the facts' sort of way."

Health and Human Services Secretary Kathleen Sebelius has drawn criticism from Republicans for making fundraising calls for Enroll America. Earlier this month, Sebelius told members of Congress she made five phone calls for Enroll America, two of which involved actual fundraising solicitations, to Robert Wood Johnson Foundation and H&R Block, entities not regulated by HHS.

She also called three health care companies to "suggest that the entities take a look at the organization (Enroll America)" but did not make a fundraising solicitation to those three. They were Johnson & Johnson, Ascension Health and Kaiser Permanente.

Sebelius said the HHS secretary has the legal authority to raise money for initiatives that support government health programs.

The federal government itself will spend millions on marketing and advertising about the health law, but the spending will vary greatly across the nation because some Republican-led states haven't sought federal dollars for ad campaigns.

Enroll America's campaign will start with 50 events in 18 states, Filipic said. The group has staff on the ground in eight states, including Texas and Florida and others where government officials have resisted key parts of Obama's health law such as the expansion of Medicaid.

"We know that most of the uninsured don't know about the new coverage options coming this fall, let alone whether or not their state is expanding Medicaid," Filipic said. "Many of the uninsured are eligible for Medicaid today but have not enrolled, and those who are not eligible for Medicaid may qualify for coverage through the marketplace."

Obama's national health law requires that nearly all Americans have health insurance beginning in 2014 or pay a penalty. New insurance marketplaces are scheduled to be operating in every state by Oct. 1. People who are uninsured will be able to comparison-shop for affordable health plans on these websites and many will qualify for tax credits to help them pay for coverage.

The organization is building a predictive model to determine where to target the uninsured and will track which of its tactics are most effective, Filipic said.

"We're going to be doing a lot of testing to see what works," she said. "What moves someone to attend an event or call a phone number? We'll be doing a lot of work to test and analyze that."

In a parallel effort, a group called Doctors for America plans to host training sessions for doctors and print posters and brochures for medical waiting rooms.

Skepticism about the law's benefits is widespread. Enroll America's January survey of 1,814 adults found that most people are skeptical they'll be able to find affordable health insurance that covers their needs. When presented with a specific premium amount they might pay, less than a third of respondents felt that the premium was in the affordable range.

"Survey results suggest using a specific premium amount may actually turn away just as many people as it might motivate," according to the survey report on Enroll America's website.

Broader statements - such as "You might be able to get financial help to pay for a health insurance plan" and "If you have a pre-existing condition, insurance plans cannot deny you coverage" - tested better with the survey group.

Enroll America has staff on ground in Texas, Florida, Ohio, Arizona, Michigan, New Jersey, North Carolina and Pennsylvania. It soon will add staff in Illinois and Georgia.

Kicking off the campaign this week, the Get Covered America team and its community partners plan to host more than 50 events in Arizona, Arkansas, California, Delaware, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Tennessee and Texas.
Wednesday, 19 June 2013 11:29
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NEW YORK (AP) -- By the time 10-year-old Sarah Murnaghan finally got a lung transplant last week, she'd been waiting for months, and her parents had sued to give her a better shot at surgery.

Her cystic fibrosis was threatening her life, and her case spurred a debate on how to allocate donor organs. Lungs and other organs for transplant are scarce.

But what if there were another way? What if you could grow a custom-made organ in a lab?

It sounds incredible. But just a three-hour drive from the Philadelphia hospital where Sarah got her transplant, another little girl is benefiting from just that sort of technology. Two years ago, Angela Irizarry of Lewisburg, Pa., needed a crucial blood vessel. Researchers built her one in a laboratory, using cells from her own bone marrow. Today the 5-year-old sings, dances and dreams of becoming a firefighter - and a doctor.

Growing lungs and other organs for transplant is still in the future, but scientists are working toward that goal. In North Carolina, a 3-D printer builds prototype kidneys. In several labs, scientists study how to build on the internal scaffolding of hearts, lungs, livers and kidneys of people and pigs to make custom-made implants.

Here's the dream scenario: A patient donates cells, either from a biopsy or maybe just a blood draw. A lab uses them, or cells made from them, to seed onto a scaffold that's shaped like the organ he needs. Then, says Dr. Harald Ott of Massachusetts General Hospital, "we can regenerate an organ that will not be rejected (and can be) grown on demand and transplanted surgically, similar to a donor organ."

That won't happen anytime soon for solid organs like lungs or livers. But as Angela Irizarry's case shows, simpler body parts are already being put into patients as researchers explore the possibilities of the field.

Just a few weeks ago, a girl in Peoria, Ill., got an experimental windpipe that used a synthetic scaffold covered in stem cells from her own bone marrow. More than a dozen patients have had similar operations.

Dozens of people are thriving with experimental bladders made from their own cells, as are more than a dozen who have urethras made from their own bladder tissue. A Swedish girl who got a vein made with her marrow cells to bypass a liver vein blockage in 2011 is still doing well, her surgeon says.

In some cases the idea has even become standard practice. Surgeons can use a patient's own cells, processed in a lab, to repair cartilage in the knee. Burn victims are treated with lab-grown skin.

In 2011, it was Angela Irizarry's turn to wade into the field of tissue engineering.

Angela was born in 2007 with a heart that had only one functional pumping chamber, a potentially lethal condition that leaves the body short of oxygen. Standard treatment involves a series of operations, the last of which implants a blood vessel near the heart to connect a vein to an artery, which effectively rearranges the organ's plumbing.

Yale University surgeons told Angela's parents they could try to create that conduit with bone marrow cells. It had already worked for a series of patients in Japan, but Angela would be the first participant in an American study.

"There was a risk," recalled Angela's mother, Claudia Irizarry. But she and her husband liked the idea that the implant would grow along with Angela, so that it wouldn't have to be replaced later.

So, over 12 hours one day, doctors took bone marrow from Angela and extracted certain cells, seeded them onto a 5-inch-long biodegradable tube, incubated them for two hours, and then implanted the graft into Angela to grow into a blood vessel.

It's been almost two years and Angela is doing well, her mother says. Before the surgery she couldn't run or play without getting tired and turning blue from lack of oxygen, she said. Now, "she is able to have a normal play day."

This seed-and-scaffold approach to creating a body part is not as simple as seeding a lawn. In fact, the researchers in charge of Angela's study had been putting the lab-made blood vessels into people for nearly a decade in Japan before they realized that they were completely wrong in their understanding of what was happening inside the body.

"We'd always assumed we were making blood vessels from the cells we were seeding onto the graft," said Dr. Christopher Breuer, now at Nationwide Children's Hospital in Columbus, Ohio. But then studies in mice showed that in fact, the building blocks were cells that migrated in from other blood vessels. The seeded cells actually died off quickly. "We in essence found out we had done the right thing for the wrong reasons," Breuer said.

Other kinds of implants have also shown that the seeded cells can act as beacons that summon cells from the recipient's body, said William Wagner, director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. Sometimes that works out fine, but other times it can lead to scarring or inflammation instead, he said. Controlling what happens when an engineered implant interacts with the body is a key challenge, he said.

So far, the lab-grown parts implanted in people have involved fairly simple structures - basically sheets, tubes and hollow containers, notes Anthony Atala of Wake Forest University whose lab also has made scaffolds for noses and ears. Solid internal organs like livers, hearts and kidneys are far more complex to make.

His pioneering lab at Wake Forest is using a 3-D printer to make miniature prototype kidneys, some as small as a half dollar, and other structures for research. Instead of depositing ink, the printer puts down a gel-like biodegradable scaffold plus a mixture of cells to build a kidney layer by layer. Atala expects it will take many years before printed organs find their way into patients.

Another organ-building strategy used by Atala and maybe half a dozen other labs starts with an organ, washes its cells off the inert scaffolding that holds cells together, and then plants that scaffolding with new cells.

"It's almost like taking an apartment building, moving everybody out ... and then really trying to repopulate that apartment building with different cells," says Dr. John LaMattina of the University of Maryland School of Medicine. He's using the approach to build livers. It's the repopulating part that's the most challenging, he adds.

One goal of that process is humanizing pig organs for transplant, by replacing their cells with human ones.

"I believe the future is ... a pig matrix covered with your own cells," says Doris Taylor of the Texas Heart Institute in Houston. She reported creating a rudimentary beating rat heart in 2008 with the cell-replacement technique and is now applying it to a variety of organs.

Ott's lab and the Yale lab of Laura Niklason have used the cell-replacement process to make rat lungs that worked temporarily in those rodents. Now they're thinking bigger, working with pig and human lung scaffolds in the lab. A human lung scaffold, Niklason notes, feels like a handful of Jell-O.

Cell replacement has also worked for kidneys. Ott recently reported that lab-made kidneys in rats didn't perform as well as regular kidneys. But, he said, just a "good enough organ" could get somebody off dialysis. He has just started testing the approach with transplants in pigs.

Ott is also working to grow human cells on human and pig heart scaffolds for study in the laboratory.

There are plenty of challenges with this organ-building approach. One is getting the right cells to build the organ. Cells from the patient's own organ might not be available or usable. So Niklason and others are exploring genetic reprogramming so that, say, blood or skin cells could be turned into appropriate cells for organ-growing.

Others look to stem cells from bone marrow or body fat that could be nudged into becoming the right kinds of cells for particular organs. In the near term, organs might instead be built with donor cells stored in a lab, and the organ recipient would still need anti-rejection drugs.

How long until doctors start testing solid organs in people? Ott hopes to see human studies on some lab-grown organ in five to 10 years. Wagner calls that very optimistic and thinks 15 to 20 years is more realistic. Niklason also forecasts two decades for the first human study of a lung that will work long-term.

But LaMattina figures five to 10 years might be about right for human studies of his specialty, the liver.

"I'm an optimist," he adds. "You have to be an optimist in this job."

--- Michael Rubinkam in Lewisburg, Pa., and Allen Breed in Winston-Salem, N.C., contributed to this story.
Monday, 17 June 2013 11:28
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PHILADELPHIA (AP) -- A 10-year-old girl with cystic fibrosis was recovering from a transplant of adult lungs after a judge's ruling expanded her options for lifesaving surgery.

Sarah Murnaghan underwent a six-hour surgery Wednesday at Children's Hospital of Philadelphia, a procedure her aunt said resulted because of the larger list of available organs.

"It was a direct result of the ruling that allowed her to be put on the adult list," Sharon Ruddock said after her niece's surgery was completed successfully. "It was not pediatric lungs. She would have never gotten these lungs otherwise."

She said the donor lungs came through "normal channels" and not through the public appeals the family made in its bid to find a compatible donor. No other details about the donor lungs are known.

The Murnaghan family's quest to qualify their daughter for an organ transplant spurred public debate over how donor organs are allocated.

Her family and the family of another cystic fibrosis patient at the same hospital challenged existing transplant policy that made children under 12 wait for pediatric lungs to become available, or be offered lungs donated by adults only after adolescents and adults on the waiting list had been considered. They said pediatric lungs are rarely donated.

Sarah's health was fading when U.S. District Judge Michael Baylson in Philadelphia ruled June 5 that Sarah and 11-year-old Javier Acosta of New York City should be eligible for adult lungs.

Critics warned there could be a downside to having judges intervene in the organ transplant system's allocation policy. Lung transplants are difficult procedures and some say child patients tend to have more trouble with them than adults.

During double lung transplants, surgeons must open up the patient's chest. Complications can include rejection of the new lung and infection.

"Her doctors are very pleased with both her progress during the procedure and her prognosis for recovery," the family said in a statement. "The surgeons had no challenges resizing and transplanting the donor lungs - the surgery went smoothly, and Sarah did extremely well. She is in the process of getting settled in the ICU and now her recovery begins. We expect it will be a long road, but we're not going for easy, we're going for possible."

Ruddock said the family was optimistic about Sarah's recovery.

"If everything goes perfectly, she could be out in a couple of weeks, running down the hall," Ruddock said. "It could take a couple of months, it could take three weeks."

The Murnaghan family noted that Sarah's successful surgery was the result of another family's loss:

"We are elated this day has come, but we also know our good news is another family's tragedy. That family made the decision to give Sarah the gift of life - and they are the true heroes today."

On Wednesday, in a posting on her Facebook page, Janet Murnaghan said she and the family were "overwhelmed with emotions" and thanked all her supporters. She said the donor's family "has experienced a tremendous loss, may God grant them a peace that surpasses understanding."

Ruddock said Sarah doesn't yet know the full extent of the impact her case has had.

"She really wanted to Google herself the other day and we were like, no."

The Organ Procurement and Transplantation Network - the national organization that manages organ transplants - added Sarah to the adult waiting list after Baylson's ruling. Her transplant came just two days before a hearing was scheduled on the family's request for a broader injunction.

The network has said 31 children under age 11 are on the waiting list for a lung transplant. Its executive committee held an emergency meeting this week but resisted making emergency rule changes for children under 12 who are waiting for lungs, instead creating a special appeal and review system to hear such cases.

Murnaghan's family "did have a legitimate complaint" about the rule that limited her access to adult lungs, said medical ethicist Arthur Caplan of the NYU Langone Medical Center in New York.

"When the transplant community met, they didn't want to change that rule without really thinking carefully about it," he said. The appeals process that was established this week was "built on evidence, not on influence."

He added: "In general, the road to a transplant is still to let the system decide who will do best with scarce, lifesaving organs. And it's important that people understand that money, visibility, being photogenic ... are factors that have to be kept to a minimum if we're going to get the best use out of the scarce supply of donated cadaver organs."

---

Ritter, an AP science writer, reported from New York. Associated Press Writer Maryclaire Dale in Philadelphia also contributed to this report.

© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Thursday, 13 June 2013 11:29
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NEW YORK (AP) -- After setting off a storm of criticism from abortion rights groups upset that a Democratic president had sided with social conservatives, the Obama administration said it will comply with a judge's order to allow girls of any age to buy emergency contraception without prescriptions.

But in doing so, at least one opponent of easy access to the contraception thinks the president is buckling to political pressure, rather than making the health of girls a priority.

The Justice Department notified U.S. District Judge Edward Korman on Monday that it will submit a plan for compliance. If he approves it, the department will drop its appeal of his April ruling.

According to the department's letter to the judge, the Food and Drug Administration has told the maker of the pills to submit a new drug application with proposed labeling that would permit it to be sold "without a prescription and without age or point-of-sale prescriptions." The FDA said that once it receives the application, it "intends to approve it promptly."

Advocates for girls' and women's rights said the federal government's decision to comply with the judge's ruling could be a move forward for "reproductive justice" if the FDA acts quickly and puts emergency contraception over the counter without restriction.

"It's about time that the administration stopped opposing women having access to safe and effective birth control," Annie Tummino, coordinator of the National Women's Liberation and lead plaintiff in a lawsuit over unrestricted access to the morning-after pill, said in an emailed statement.

She said women and girls should have "the absolute right to control our bodies without having to ask a doctor or a pharmacist for permission."

NARAL Pro-Choice America President Ilyse Hogue welcomed the decision by the Obama administration.

"By making emergency contraception available to women of all ages, the FDA is taking an important step to reduce unintended pregnancies and put women in control of their futures," Hogue said in a statement.

But an opponent of the contraception plan, at the anti-abortion Family Research Council, criticized the government for not sticking with its decision to appeal.

"We're very concerned and disappointed at the same time because what we see here is the government caving to political pressure instead of putting first the health and safety of girls (and) parental rights," said Anna Higgins, director of the council's Center for Human Dignity.

The government had appealed the judge's underlying April 5 ruling, which ordered emergency contraceptives based on the hormone levonorgestrel be made available without a prescription, over the counter and without point-of-sale or age restrictions.

It had asked the judge to suspend the effect of that ruling until the appeals court could decide the case. But the judge declined, saying the government's decision to restrict sales of the morning-after pill was "politically motivated, scientifically unjustified and contrary to agency precedent." He also said there was no basis to deny the request to make the drugs widely available.

The government had argued that "substantial market confusion" could result if the judge's ruling were enforced while appeals were pending, only to be later overturned.

Last week, an appeals court dealt the government a setback by saying it would immediately permit unrestricted sales of the two-pill version of the emergency contraception until the appeal was decided.

The morning-after pill contains a higher dose of the female hormone progestin than is in regular birth control pills. Taking it within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent, but it works best within the first 24 hours. If a girl or woman already is pregnant, the pill, which prevents ovulation or fertilization of an egg, has no effect.

The FDA was preparing in 2011 to allow over-the-counter sales of the morning-after pill with no limits when Health and Human Services Secretary Kathleen Sebelius overruled her own scientists in an unprecedented move.

The FDA announced in late April that Plan B One-Step, the newer version of emergency contraception, the same drug but combined into one pill instead of two, could be sold without a prescription to those age 15 or older. Its maker, Teva Women's Health, plans to begin those sales soon. Sales had previously been limited to those who were at least 17.

The judge later ridiculed the FDA changes, saying they established "nonsensical rules" that favored sales of the Plan B One-Step morning-after pill and were made "to sugarcoat" the government's appeal.

He also said they placed a disproportionate burden on blacks and the poor by requiring a prescription for less expensive generic versions of the drug bought by those under age 17 and by requiring those age 17 or over to show proof-of-age identification at pharmacies. He cited studies showing that blacks with low incomes are less likely than other people to have government-issued IDs.

Reluctant to get drawn into a messy second-term spat over social issues, White House officials have argued that the FDA and the Department of Justice were acting independently of the White House in deciding how to proceed. That approach continued Monday, with the White House referring all questions about the decision to Health and Human Services.

Still, Obama has made clear in the past that he feels strongly about the limits, and he said in 2011 he supported Sebelius' decision to impose them despite the advice of her scientists.

"As the father of two daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine," Obama said then. ---

Associated Press Writer Josh Lederman in Washington contributed to this report.

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Tuesday, 11 June 2013 11:39
Published in Health & Fitness
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