FDA ties newer birth control drugs to blood clots (AP)

WASHINGTON � Safety concerns with the popular birth control pill Yaz increased Thursday as federal health scientists reported that the Bayer drug and other newer birth control treatments appear to increase the risk of dangerous blood clots more than older medications.

A new study released by the Food and Drug Administration reviewed the medical history of more than 800,000 U.S. women taking different forms of birth control between 2001 and 2007. On average, woman taking Yaz had a 75 percent greater chance of experiencing a blood clot than women taking older birth control drugs.

Yaz contains estrogen along with a next-generation synthetic hormone called drospirenone, which is known to increase potassium levels in the blood. FDA compared medical records of women taking the drug with those taking the older drug levonorgestrel.

Yaz, Yasmin and related drospirenone-containing pills were Bayer's second-best-selling franchise last year at $1.6 billion in global sales.

In 2009, the FDA took the unusual step of ordering Bayer to run corrective TV advertisements on Yaz, saying the drugmaker's marketing campaign overstated the drugs' ability to prevent acne and premenstrual syndrome.

Bayer Healthcare, a division of the German conglomerate, said it "is currently evaluating this publication and cannot comment at this point in time."

The agency also reported higher complications in women using the Ortho Evra patch from Johnson & Johnson and the Nuvaring vaginal ring from Merck & Co. Inc. Those drugs combine estrogen, which is present in all birth control pills, with two other synthetic hormones launched in the last decade.

The FDA said it hasn't reached a final conclusion on the drugs' safety but will hold a meeting with scientific advisers Dec. 8.

Consumer safety advocates have criticized the agency for approving newer, more expensive birth control drugs when cheaper, generic drugs with established safety records are widely available.

"At a certain point we have to ask why the FDA continues to approve drugs that are less safe and have no benefit compared to drugs already on the market," said Dr. Diana Zuckerman, president of the National Center for Women and Families, a consumer group for women's health issues. "With all these different birth control options, why take the most expensive one that can also kill you?"

Recent studies have reached differing conclusions on the risks of newer birth control pills.

A study published earlier this week involving more than 1 million Danish women found that women taking Yaz and other newer medications had twice the risk of blood clots as women taking the older hormone levonorgestrel. The findings appeared Tuesday in the British Medical Journal.

However, two studies published in 2007, conducted as part of the postmarketing requirements of the FDA or European regulators, did not find any difference in blood clotting between the two comparable groups.

Birth-control pills that contain drospirenone include Bayer's Yaz, Yasmin, Beyaz, Safyral; Sandoz's Syeda and Loryna; as well as Barr Laboratories' Ocella, Watson Pharmaceuticals' Zarah and Teva Pharmaceuticals' Loryna.

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Pythons' big hearts hold clues for human health (AP)

WASHINGTON � You don't think of pythons as big-hearted toward their fellow creatures. They're better known for the bulge in their bodies after swallowing one of those critters whole.

But the snakes' hearts balloon in size, too, as they're digesting � and now scientists are studying them for clues about human heart health.

The expanded python heart appears remarkably similar to the larger-than-normal hearts of Olympic-caliber athletes. Colorado researchers report they've figured out how the snakes make it happen.

"It's this amazing biology," said Leslie Leinwand, a molecular biologist at the University of Colorado Boulder, whose team reports the findings in Friday's edition of the journal Science. "They're not swelling up. They're building (heart) muscle."

Reptile biologists have long studied the weird digestion of these snakes, especially the huge Burmese pythons that can go nearly a year between meals with no apparent ill effects. When they swallow that next rat or bird � or in some cases deer � something extraordinary happens. Their metabolism ratchets up more than 40-fold, and their organs immediately start growing in size to get the digesting done. The heart alone grows a startling 40 percent or more within three days.

Leinwand, who studies human heart disease, stumbled across that description and saw implications for people. An enlarged human heart usually is caused by chronic high blood pressure or other ailments that leave it flabby and unable to pump well. But months and years of vigorous exercise give some well-conditioned athletes larger, muscular hearts, similar to how python hearts are during digestion.

So Leinwand's team � led by a graduate student who initially was frightened of snakes � ordered a box of pythons and began testing what happens to their hearts.

The first surprise: A digesting python's blood gets so full of fat it looks milky. A type of fat called triglycerides increased 50-fold within a day. In people, high triglyceride levels are very dangerous. But the python heart was burning those fats so rapidly for fuel that they didn't have time to clog anything up, Leinwand said.

The second surprise: A key enzyme that protects the heart from damage increased in python blood right after it ate, while a heart-damaging compound was repressed.

Then the team found that a specific combination of three fatty acids in the blood helped promote the healthy heart growth. If they injected fasting pythons with that mixture, those snakes' hearts grew the same way that a fed python's does.

But did it only work for snakes? Lead researcher Cecilia Riquelme dropped some plasma from a fed python into a lab dish containing the heart cells of rats � and they grew bigger, too. Sure enough, injecting living mice made their hearts grow in an apparently healthy way as well.

Now the question is whether that kind of growth could be spurred in a mammal with heart disease, something Leinwand's team is starting to test in mice with human-like heart trouble. They also want to know how the python heart quickly shrinks back to its original size when digestion's done.

The experiments are "very, very cool indeed," said James Hicks, a biologist at the University of California, Irvine, who has long studied pythons' extreme metabolism and wants to see more such comparisons.

If the same underlying heart signals work in animals as divergent as snakes and mice, "this may reveal a common universal mechanism that can be used for improving cardiac function in all vertebrates, including humans," Hicks wrote in an email. "Only further studies and time will tell, but this paper is very exciting."

The study was funded by the National Institutes of Health and a Boulder biotechnology company that Leinwand co-founded, Hiberna Corp., that aims to develop drugs based on extreme animal biology.

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Keeping it clean: Protesters cope with sanitation (AP)

LOS ANGELES � With thousands of Occupy Wall Street demonstrators roughing it in parks for up to six weeks, garbage, human waste and hygiene are becoming a growing worry in public encampments nationwide.

Poor food storage exacerbated a rat infestation in Oakland. Inspectors found open human waste in Philadelphia. Hypothermia cases developed in Denver after a snowstorm hit.

Disease is the chief concern with so many people living in close proximity without proper sanitation.

"Any time you have a large number of people in an event like this, there's potential for illness to spread rapidly," said Angelo Bellomo, director of environmental health for Los Angeles County. "Conditions can change within an hour or two."

Poor food storage, along with public urination and defecation, led Oakland police to dislodge 200 protesters from a plaza outside City Hall before dawn Tuesday.

In Philadelphia, sanitary conditions have worsened at the 350-tent Occupy Philly camp, said city managing director Richard Negrin. The camp has four portable toilets that have not been cleaned or emptied regularly.

Health officials, who conduct daily inspections of Los Angeles' camp, have directed organizers to dispose of wastewater from portable showers into drains rather than the ground, and to increase the number of portable toilets, have them emptied twice a day and provide water jugs for hand-washing.

Close-quarters living can facilitate the spread of germs through airborne, foodborne or person-to-person contact. Norovirus has caused outbreaks of gastroenteritis on cruise ships, for example, while adenovirus has caused influenza and other respiratory illnesses in military barracks.

So far, no outbreaks of illness have been reported from the grassroots demonstrations that have sprouted nationwide to oppose policies viewed as promoting corporate greed. Medical tents in Los Angeles have only treated minor ailments such as scrapes and colds.

Protesters in Denver, however, said they took two demonstrators to a hospital with symptoms of hypothermia during an snowstorm that started Tuesday night.

Some demonstrators complain that the health issues have been exaggerated as a pretext to crack down on the camps. Authorities did not seem to be concerned about unhygienic conditions that existed before, they said.

"They never go and clean up Skid Row," said Juan Alcala, a camper in Los Angeles, where more than 350 tents are jammed on a lawn around City Hall.

The protesters are taking pains to keep the premises clean but acknowledge it's an ongoing battle to keep up as tents proliferate and attract the attention of public health officials.

Mayor Antonio Villaraigosa told the Los Angeles Times that county health inspectors have expressed concerns over the cleanliness of the camp. The mayor also said the city's lawn and trees are suffering.

"The lawn is dead, our sprinklers aren't working ... our trees are without water," Villaraigosa told the Times.

Although protesters formed a sanitation committee from the start, hygiene issues have gotten more complicated than Occupy LA organizers anticipated.

The camp is largely well kept, although numerous trash bins around the site were overflowing during recent visits. Organizers pay a private hauler $57 a week to collect the rubbish daily after being fined by the city for failing to remove trash.

As the scent of marijuana wafted in the air and drumbeats sounded in a steady rhythm, organizers roamed the camp, urging people to pick up their trash and not to walk barefoot. Most people complied and some pitched in. Alcala seized a large palm frond and swept concrete walkways.

Protesters said overall, people were careful about rubbish. "I smoke and I'm really conscious about not throwing my butts on the ground," said another camper, John Waiblinger.

Personal hygiene has been a more difficult issue.

Many people use showers at homeless shelters in Skid Row, while some have organized bathing trips to homes, said organizer Gia Trimble.

Others said they used the camp showers on site, filling up a plastic bag with solar-heated water or hot water from a City Hall faucet. The bag, which has a tube to spray the water, hangs from a cord.

"I use the solar-heated shower or even those moist towelettes," Alcala said. "We're clean here."

Campers said they weren't worried about illnesses. Nevertheless, some were taking commonsense precautions.

Tommy Schacht, who was brushing his teeth with bottled water on a recent morning, said he goes home to shower and change clothes, and mostly used bathrooms at nearby businesses or public facilities instead of the portable toilets on site.

"I don't worry about that at all, but I try to stay away from people that are dirty," he said.

Some campers' clothing was visibly grubby, although others said they went to friends' homes or Laundromats to do laundry.

Food handling has posed other problems.

The camp shut down its food tent, where volunteers made everything from sandwiches to a tabouli-type salad in blenders, after inspectors noted that it was not in compliance with food handling laws.

Now, donated prepared foods, ranging from cookies to packaged sandwiches, are distributed. Most campers make their own meals, heating up Ramen noodles, canned soup and refried beans on small gas-powered camp stoves.

Schacht, who's been camping out for more than a week, said he was cooking lots of pasta � "anything that can be made with hot water, that's easy."

Organizers said that although they continue to hammer out unforeseen logistical issues, they're trying to keep the political cause paramount.

"It's a very interesting time for us. We're dealing with trying to become self-sufficient," said Trimble. "We don't want the focus to be on their living conditions, we want it to be on the movement."

___

Associated Press writers Marcus Wohlsen in Oakland, Calif., Kristen Wyatt in Denver, and Kathy Matheson in Philadelphia contributed to this report.

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