Monday, August 29, 2011

Need a C-section? Protection from blood clot urged (AP)

WASHINGTON � New advice for pregnant women: If you're getting a C-section, special inflating boots strapped on your legs may lower the risk of a blood clot.

Hospitals already use these compression devices for other major operations, such as hip replacements, and a growing number have begun offering them for at least some of their cesarean deliveries, too.

Now guidelines for the nation's obstetricians say it's time to make the step routine for most C-sections, which account for nearly a third of U.S. births.

The new recommendations promise to raise awareness of what is a silent threat not just for pregnant women but for thousands of other people, too: Blood clots in veins that can masquerade as simple leg pain.

Called a DVT, for deep vein thrombosis, this kind of clot usually starts in the leg or groin. But it can kill if it moves up to the lungs, where it's called a pulmonary embolism.

These clots make headlines every few years when seemingly healthy people collapse after long airplane flights or similar prolonged inactivity. Certain surgeries also can trigger a DVT. Earlier this year, tennis star Serena Williams was treated for clots in her lungs discovered after foot surgery and cross-country travel.

Obesity, some types of injuries, even some birth control pills can increase the risk, too.

A woman's risk of a DVT jumps during pregnancy and the six weeks afterward. That's partly because of slower blood flow from the weight gain, and because mom is less active in the last trimester and during those first few weeks of recovery from childbirth.

It's also because pregnancy temporarily changes blood to make it clot more easily.

"This is a consequence of nature's protecting women against the bleeding challenges of childbirth," explains Dr. Andra James of Duke University, who co-authored the new guidelines from the American College of Obstetricians and Gynecologists.

Add a C-section and, like any major surgery, it further increases that risk.

As many as two of every 1,000 pregnant women will experience a DVT, James says. Fortunately, pregnancy-related deaths are very rare in this country, but when they happen, those clots are one of the leading reasons.

Yet too few people even know the warning signs, she says: Pain or swelling in one leg, especially the calf or thigh. Redness or warmth in one spot on the leg. If the clot has reached the lung, shortness of breath or chest pain.

The new guidelines urge obstetricians to closely monitor their patients for DVTs � and to check if they have additional factors that would put them at extra risk. Women who've had a DVT earlier in life, or whose close relatives had one � or who have certain inherited clotting disorders � may need anti-clotting medicines throughout the pregnancy, say the recommendations, published in the September issue of the journal Obstetrics & Gynecology.

Then there are those compression devices, which slip over each leg and regularly inflate and deflate, sort of like a massage, to help blood flow more briskly.

The obstetricians' group acknowledges that there haven't been large studies with C-sections to prove how much difference the gadgets could make. But it decided to recommend them anyway because in other types of surgery, the devices can cut the clot risk by two-thirds, James says.

The guidelines recommend strapping them on before the C-section begins, unless there's no time before an emergency operation or the woman is taking anti-clotting medication.

Mount Sinai Medical Center in New York began using the devices for C-sections a few years ago, and deputy chief medical officer Dr. Erin DuPree says they add $14 to the cost of care. Women typically remove and replace them as they ease out of bed throughout the first day after surgery, and no longer need them by the second day, she says.

"It's an easy thing to do that really does not cause harm and could potentially help," she says.

James stresses that leg compression shouldn't lull a woman into thinking she can rest in bed rather than push herself to walk � and a new mom should remain alert to symptoms when she goes home because half of pregnancy-related DVTs occur in those weeks after childbirth.

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

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Online:

DVT info: http://www.cdc.gov/ncbddd/dvt/index.html



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New HIV case causes LA porn industry shutdown (AP)

LOS ANGELES � A porn industry group says an adult film performer has tested positive for HIV, resulting in a production moratorium in Southern California while the organization investigates to see if the virus has spread.

Free Speech Coalition executive director Diane Duke told The Los Angeles Times ( http://lat.ms/mX0vin) on Monday that her group became aware of the HIV case Saturday.

Duke declined to release the performer's name, age or gender. She also declined to tell the Times how her group learned of the case.

According to Duke, the case was found in an out-of-state clinic that doesn't report to California state officials. Duke says the performer is being retested to confirm the HIV.

The group is working to identify others who had sex with the performer.



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UN warns of bird flu resurgence, new Asian strain (AP)

ROME � The United Nations warned Monday of a possible resurgence of the deadly bird flu virus, saying wild bird migrations had brought it back to previously virus-free countries and that a mutant strain was spreading in Asia.

A mutant strain of H5N1, which can apparently sidestep defenses of existing vaccines, is spreading in China and Vietnam, Tthe U.N. Food and Agriculture Organization said in a statement Monday. It urged greater surveillance to ensure that any outbreaks are contained.

Last week, the World Health Organization reported that a 6-year-old Cambodian girl had died Aug. 14 from bird flu, the eighth person to die from H5N1 avian influenza this year in Cambodia.

Vietnam suspended its springtime poultry vaccination this year, FAO said. Most of the northern and central parts of the country where the virus is endemic have been invaded by the new strain.

Elsewhere, FAO says bird migrations over the past two years have brought H5N1 to countries that had been virus-free for several years, including Israel, the Palestinian territories, Bulgaria, Romania, Nepal and Mongolia.

"Wild birds may introduce the virus, but people's actions in poultry production and marketing spread it," said FAO's chief veterinary office Juan Lubroth in urging greater preparedness and surveillance.

WHO says globally there have been 331 human deaths from 565 confirmed bird flu cases since 2003 when it was first detected.

The virus was eliminated from most of the 63 countries infected at its peak in 2006, but it remained endemic in six countries: Bangladesh, China, Egypt, India, Indonesia and Vietnam.

The number of outbreaks in poultry and wild bird populations shrank from a high of 4000 to 302 in mid-2008, but outbreaks have risen progressively since, with almost 800 cases reported in 2010-2011, FAO said.

"The general departure from the progressive decline in 2004-2008 could mean that there will be a flare-up of H5N1 this fall and winter, with people unexpectedly finding the virus in their backyard," Lubroth said in a statement.



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Taiwan hospital transplants 5 HIV-infected organs (AP)

TAIPEI, Taiwan � One of Taiwan's best regarded hospitals transplanted organs from an HIV carrier into five patients, a hospital official said Monday, in what appears to be one of the most egregious examples of medical negligence in the island's modern history.

The five are now being treated with anti-AIDS drugs, said the official at National Taiwan University Hospital in Taipei.

The official spoke on condition of anonymity because she is not authorized to deal with the media.

In a posting on its website over the weekend, the hospital said the mistake occurred because a transplant staffer believed he heard the English word "non-reactive" on the donor's standard HIV test, which means negative, while the word "reactive" was actually given.

The hospital added that the information on the test result was given over the telephone and was not double-checked, as required by standard operating procedures.

"We deeply apologize for the mistake," the hospital said.

Shih Chung-liang, a Health Department official, said a department team will look into the mistaken transplants and decide on possible penalties for NTUH.

The donor was a 37-year-old man who fell into a coma on Aug. 24 and his heart, liver, lungs and two kidneys were transplanted to five patients on the same day. The heart transplant was conducted at another hospital, while the four other transplants were conducted at NTUH, according to NTUH.

The donor's mother, who was not identified, told cable news stations that she felt terrible about the transplants and had not been aware of her son's ailment. She said he died after "falling from a high spot," without providing details.

Yao Ke-wu, who heads the health department of Hsinchu city, where the donor resided, decried the NTUH transplants as "appalling negligence."

He said NTUH staffers could have avoided the mistake by asking his department about the donor's medical history in advance, and deplored that such inquiries were not mandatory in Taiwan.

Yao said the five organ receivers will very likely contract HIV, and their anti-AIDS treatment will be further complicated because they also have to take medication to modify rejection of the new organs.

There are also concerns among the physicians and nurses who conducted the transplants that they too may contract HIV.

Lee Nan-yao, a physician with the National Chengkung University Hospital, which performed the heart transplant, told the United Daily News that some physicians and nurses who had conducted the transplant "were depressed, and on the verge of panic."

(This version CORRECTS Adds details, byline. Updates with authorities investigating transplants. Corrects how mistake was made.)



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Saturday, August 27, 2011

FDA approves gene-targeting lung cancer drug (AP)

WASHINGTON � The Food and Drug Administration has approved a new Pfizer drug for a subset of lung cancer patients with a particular genetic mutation.

The twice-a-day pill, called Xalkori, is part of a new wave of personalized medications that fight disease by targeting specific genes found in certain patients. Last week, the FDA approved another drug that uses similar gene targeting technology to treat two rare forms of lymph node cancer.

Xalkori is approved to treat a small subset of non-small cell lung cancer patients, less than 7 percent, who have an abnormal gene that stimulates cancer cells and causes tumor growth. It works by blocking proteins produced by the gene.

"It's another example of how we're using molecular medicine to subtype lung cancer into more specific and treatable diseases," said Dr. Roy Herbst, a lung cancer expert who is chief of medical oncology at Yale University.

Including previously approved targeted therapies, "we have specific therapies now that we can offer for about 18 percent of lung cancer patients that are far superior to chemotherapy and that in many cases can cause their tumors to melt away with few side effects," Herbst said.

The FDA said it also approved a genetic test to screen for the mutation, known as an abnormal anaplastic lymphoma kinase gene. The test is made by Abbott Laboratories.

About 187,000, or 85 percent, of the 220,000 lung cancer cases diagnosed each year are non-small cell lung cancer. Roughly three-fourths of patients aren't diagnosed until tumors have spread, and only 6 percent of those patients live five years.

"It's pretty exciting," said Dr. David Carbone, a lung cancer specialist at Vanderbilt University, one of the sites that tested the drug. Only a small share of lung cancer patients have the gene mutation this drug targets, "but for those people it makes a huge difference," he said.

Analysts predict Xalkori could be a blockbuster product for Pfizer, eventually reaping more than $2 billion in annual sales by 2021.

The FDA approved the drug under its accelerated approval program, which speeds up the clearance of therapies that show promising early results.

Pfizer released follow-up data on the drug in June, reporting that 88 percent of patients in one study saw their tumors shrink at least somewhat after one year on Xalkori. In a second study, 54 percent of patients had their tumors shrink by about a third or more and 83 percent had tumors shrink somewhat. Most patients had only mild side effects, but two of the nine patient deaths during that study were considered treatment-related.

The most common side effects of the drug include vision disorders, nausea, diarrhea and inflammation.

The FDA's accelerated approval program has come under criticism in the last year after follow-up studies showed the best-selling cancer drug Avastin did not extend the lives of patients with breast cancer. The FDA granted the drug accelerated approval because a single study suggesting it slowed tumor growth. The FDA is now in the process of trying to remove the drug's indication, though the drug maker, Roche, has appealed the decision.

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AP Medical Writer Marilyn Marchione contributed reporting from Milwaukee.



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Thursday, August 25, 2011

Report: Vaccines generally safe, some side effects (AP)

WASHINGTON � Vaccines can cause certain side effects but serious ones appear very rare � and there's no link with autism and Type 1 diabetes, the Institute of Medicine says in the first comprehensive safety review in 17 years.

The report released Thursday isn't aimed at nervous parents. And the side effects it lists as proven are some that doctors long have known about, such as fever-caused seizures and occasional brain inflammation.

Instead, the review comes at the request of the government's Vaccine Injury Compensation Program, which as the name implies, pays damages to people who are injured by vaccines. Federal law requires this type of independent review as officials update side effects on that list to be sure they agree with the latest science.

"Vaccines are important tools in preventing serious infectious disease across the lifespan, from infancy through adulthood. All health care interventions, however, carry the possibility of risk and vaccines are no exception," said pediatrician and bioethicist Dr. Ellen Wright Clayton of Vanderbilt University, who chaired the institute panel.

Still, the report stresses that vaccines generally are safe, and it may help doctors address worries from a small but vocal anti-vaccine movement. Some vaccine-preventable diseases, including measles, are on the rise.

"I am hopeful that it will allay some people's concerns," Clayton said.

The review echoed numerous other scientific reports that dismiss an autism link.

But it found convincing evidence of 14 side effects:

_Fever-triggered seizures, which seldom cause long-term consequences, from the measles-mumps-rubella, or MMR, vaccine.

_MMR also can cause a rare form of brain inflammation in some people with immune problems.

_The varicella vaccine against chickenpox sometimes triggers that viral infection, resulting in widespread chickenpox or a painful relative called shingles. It also occasionally can lead to pneumonia, hepatitis or meningitis.

_Six vaccines � MMR and the chickenpox, hepatitis B, meningococcal and tetanus-containing vaccines � can cause severe allergic reactions known as anaphylaxis.

_Vaccines in general sometimes trigger fainting or a type of shoulder inflammation.

There's suggestive evidence but not proof of a few other side effects, including anaphylaxis from the human papillomavirus, or HPV, vaccine and short-term joint pain in some women and children from the MMR vaccine.

On the other hand, the report cleared flu shots of blame for two long-suspected side effects: Bell's palsy and worsening of asthma.

That doesn't mean there aren't other side effects � the review couldn't find enough evidence to decide about more than 100 other possibilities. Some vaccines are just too new to link to something really rare. Another example: Flu shots have long come with a caution about rare, paralyzing Guillain-Barre syndrome, but Clayton said research hasn't settled if that's a coincidence since the disorder is more common during the winter.

The Health Resources and Services Administration, which runs the vaccine compensation program, is reviewing the report but said it's too early to predict if it will prompt changes to the injury list.



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