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."

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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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Report: Industry decides food ingredient safety (AP)

SAN FRANCISCO � Thousands of ingredients that go into food have been classified as safe by private industry alone, without any government oversight, according to a new report published Wednesday.

Since the early 1960's, private companies and industry trade associations have determined at least 3,000 ingredients are safe, with no federal scrutiny, the study found. The ingredients include everything from artificially synthesized chemicals used in chewing gum to grape seed extract used in cheese and instant coffee.

The peer-reviewed report published in the Comprehensive Reviews in Food Science and Food Safety journal draws on research funded by the Pew Health Group, the health and consumer safety arm of the nonprofit Pew Charitable Trusts.

The Grocery Manufacturers Association says the industry only classifies ingredients as safe after a battery of rigorous biological tests but agrees that more transparency in the vetting process would help build consumer confidence.

"The system is less transparent than it should be so we're looking to open that dialogue," said Leon Bruner, the association's chief science officer, who agreed the study's estimates were reasonable. "We are completely comfortable with increasingly the transparency or the visibility of ingredients that go through the process."

The Federal Food, Drug, and Cosmetic Act makes food manufacturers responsible for ensuring food ingredients are safe. Companies can classify an ingredient as "generally recognized as safe" for use in a specific product but aren't required to tell the Food and Drug Administration about what they find. Some do, through a voluntary notification program that gives the Food and Drug Administration a chance to review the findings.

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Secrets of long life sought in DNA of the elderly (AP)

NEW YORK � George Eberhardt turned 107 last month, and scientists would love to know how he and other older folks like him made it that far. So he's going to hand over some of his DNA.

He's one of 100 centenarians taking part in a project announced Wednesday that will examine some of the oldest citizens with one of the newest scientific tools: whole-genome sequencing, the deciphering of a person's complete collection of DNA.

Scientists think DNA from very old healthy people could offer clues to how they lived so long. And that could one day lead to medicines to help the rest of us stay disease-free longer.

By the time you reach, say, 105, "it's very hard to get there without some genetic advantages," says Dr. Thomas Perls, a geriatrics expert at Boston University.

Perls is helping find centenarians for the Archon Genomics X Prize competition. The X Prize Foundation, best known for a spaceflight competition, is offering $10 million in prize money to researchers who decipher the complete DNA code from 100 people older than 100. The contest will be judged on accuracy, completeness and the speed and cost of sequencing.

The contest is a relaunch of an older competition with a new focus on centenarians, and it's the second sequencing project involving the elderly to be announced this month.

Genome pioneer J. Craig Venter says the centenarian project is just a first step in revealing the genetic secrets of a long and healthy life.

"We need 10,000 genomes, not 100, to start to understand the link between genetics, disease and wellness," said Venter, who is co-chairing the X Prize contest.

The 107-year-old Eberhardt of Chester, N.J., played and taught tennis until he was 94. He said he's participating in the X Prize project because he's interested in science and technology. It's not clear his genes will reveal much. Nobody else in his extended family reached 100, and he thinks only a couple reached 90, he said in a telephone interview.

So why does he think he lived so long? He credits 70 years of marriage to his wife, Marie. She in turn cites his "intense interest in so many things" over a lifetime, from building radios as a child to pursuing a career in electronics research.

But scientists believe there's more to it, and they want to use genome sequencing to investigate. Dr. Richard Cawthon of the University of Utah, who is seeking longevity genes by other means, says it may turn up genetic features that protect against multiple diseases or that slow the process of aging in general.

Protective features of a centenarian's DNA can even overcome less-than-ideal lifestyles, says Dr. Nir Barzilai of the Albert Einstein College of Medicine in New York. His own study of how centenarians live found that "as a group, they haven't done the right things."

Many in the group he studied were obese or overweight. Many were smokers, and few exercised or followed a vegetarian diet. His oldest participant, who died this month just short of her 110th birthday, smoked for 95 years.

"She had genes that protected her against the environment," Barzilai said. One of her sisters died at 102, and one of her brothers is 105 and still manages a hedge fund.

Earlier this month, Scripps Health of San Diego announced a different genome project involving the elderly. The Scripps Wellderly Study will receive the complete genomes of 1,000 people age 80 and older from a sequencing company.

A complete genome reveals not only genes but also other DNA that's responsible for regulating genes. It's "the full monty," showing DNA elements that are key for illness and health, says Dr. Eric Topol, who heads the Wellderly Study.

Participants in that study have an average age of 87 and range up to 108, and they've never had diabetes, heart disease or cancer, or any neurological disease.

"Why are these people Teflon-coated?" Topol asked. "Why don't they get disease?"

The ability to turn out lots of complete genomes is "the new-new thing" in trying to find out, he said.

"There's been too much emphasis on disorders per se and not enough on the people who are exceptionally healthy," to learn from their genomes, Topol said. "Now we have the powerful tools to do that."

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Online:

X Prize competition: http://genomics.xprize.org/

Wellderly Study: http://bit.ly/pHFHDj

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Malcolm Ritter can be followed at http://twitter.com/MalcolmRitter

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Panel: Boys should get HPV vaccine given to girls (AP)

ATLANTA � A vaccine against cervical cancer hasn't been all that popular for girls. It may be even a harder sell for boys now that it's been recommended for them too.

A government advisory panel on Tuesday decided that the vaccine should also be given to boys, in part to help prevent the cancer-causing virus through sex.

Public health officials have tried since 2006 to get parents to have their daughters vaccinated against the human papillomavirus, or HPV, which causes most of the cervical cancer in women.

They have had limited success, hitting a number of hurdles. Some parents distrust the safety of vaccines, especially newer products. Others don't want to think about their daughters having sex one day, or worry that the vaccine essentially promotes promiscuous behavior.

Tuesday's vote by the Advisory Committee on Immunization Practices' was the first to strongly recommend routine vaccination for boys since the vaccine was first approved for them two years ago. Officials acknowledged the low rate in girls encouraged them to take a new, hard look.

Experts say a key benefit of routinely vaccinating boys could be preventing the spread of the virus to others through sex � making up somewhat for the disappointing vaccination rate in girls. But the recommendation is being framed as an important new measure against cancer in males.

"Today is another milestone in the nation's battle against cancer," said Dr. Anne Schuchat, a U.S. Centers for Disease Control and Prevention administrator who oversees the agency's immunization programs.

Federal health officials usually adopt the panel's recommendations and ask doctors and patients to follow them.

The vaccine has been advised for girls since 2006. Just 49 percent of adolescent girls have gotten at least the first of the three HPV shots. Only a third had gotten all three doses by last year.

"Pretty terrible," Schuchat said.

Schuchat attributed the low rates for girls to confusion or misunderstanding by parents that they can wait until their daughter becomes sexually active. It works best if the shots are given before a girl or boy begins having sex.

Some conservatives argue the vaccine could promote promiscuous behavior. It has come up in the GOP presidential campaign. Texas Gov. Rick Perry came under attack for a 2007 executive order requiring adolescent girls to get the vaccine (with an opt-out clause). When conservative lawmakers rebelled, he backed down.

An estimated 75 to 80 percent of men and women are infected with HPV during their life, but most don't develop symptoms or get sick, according to the CDC. Some infections lead to genital warts, cervical cancer and other cancers, including of the head and neck.

The HPV vaccine is approved for use in males and females ages 9 to 26; it is usually given to 11- and 12-year olds when they get other vaccines. The committee also recommended that males 13 to 21 years get vaccinated.

Tuesday's vote follows recent studies that show the vaccine prevents anal cancer in males, and may work against a type of throat cancer. A study that focused on gay men found it to be 75 percent effective against anal cancer.

While anal cancer has been increasing, it's still fairly rare. Only about 7,000 U.S. cases in men each year are tied to the strains targeted in the HPV vaccine. In contrast, about 15,000 vaccine-preventable cervical cancers in women occur annually.

Preventing a cancer that's primarily associated with gay men may not be much of a selling point, said Dr. Ranit Mishori, a family practice doctor in Washington, D.C. and an assistant professor at the Georgetown University School of Medicine.

Some parents may say "`Why are you vaccinating my son against anal cancer? He's not gay! He's not ever going to be gay!' I can see that will come up," said Mishori, who supports the panel's recommendation.

Schuchat indicated the CDC is ready for that kind of argument: "There's no data suggesting that offering a vaccine against HPV will change people's subsequent sexual behavior," she said.

So far, the threat of genital warts hasn't been persuasive: Some data suggest that less than 1.5 percent of adolescent males have gotten the vaccine over the past two years.

Meanwhile, some feel it's unlikely that most parents will agree to get their sons vaccinated primarily to protect girls. A survey of 600 pediatricians last year found that nearly 70 percent of doctors thought families would deem vaccination of their boys as unnecessary.

Experts at the committee meeting noted an earlier analysis that showed vaccinating boys would not be cost-effective if the female vaccination were high.

"If you do reach high coverage of females, will you stop vaccinating males?" asked Dr. David Salisbury, director immunization for the United Kingdom's Department of Health.

There are two vaccines against HPV, but Tuesday's vote applies only to Merck & Co.'s Gardasil, which costs $130 a dose. The other vaccine wasn't tested for males.

The committee's recommendation � and the greater insurance coverage of the vaccine that is expected to follow � will make it easier for more boys to get the shots, said Dr. Mark Feinberg, chief public health and science officer for Merck Vaccines.

Merck officials bristled at the idea that males would see the vaccine as mainly meant for gay men, noting that HPV-caused anal cancers can occur in heterosexual men.

Maura Robbins of Chicago said she's likely to have her 12-year-old son, Cole, vaccinated against HPV � but probably not until he's a little older. "I would just like to see some long-term testing and long-term results," she said.

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AP Medical Writer Lindsey Tanner in Chicago contributed to this report.

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Online:

HPV info: http://www.cdc.gov/hpv/

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