Friday, October 28, 2011

Program urges smokers switch to smokeless tobacco (AP)

In the smoker-heavy state of Kentucky, a cancer center is suggesting something that most health experts won't and the tobacco industry can't: If you really want to quit, switch to smoke-free tobacco.

The James Graham Brown Cancer Center and the University of Louisville are aiming their "Switch and Quit" campaign at the city of Owensboro. It uses print, radio, billboard and other advertising to urge smokers to swap their cigarettes for smokeless tobacco and other products that do not deliver nicotine by smoke.

Supporters say smokers who switch are more likely to give up cigarettes than those who use other methods such as nicotine patches, and that smokeless tobacco carries less risk of disease than cigarettes do.

"We need something that works better than what we have," said Dr. Donald Miller, an oncologist and director of the James Graham Brown Cancer Center, which supports the effort along with the University of Louisville. "This is as reasonable a scientific hypothesis as anybody has come up with and it needs to be tried."

The campaign runs counter to the prevailing opinion of the public health community, which holds that there is no safe way to use tobacco. Federal researchers, however, have begun to at least consider the idea that smokers might be better off going smokeless.

The National Cancer Institute at the National Institutes of Health says on its website that the use of all tobacco products "should be strongly discouraged," and that there is "no scientific evidence that using smokeless tobacco can help a person quit smoking." But this year it approved funding for a study that might provide some of that very evidence.

"Switch and Quit" is directed by Brad Rodu, a professor of medicine at the University of Louisville. He analyzed the 2000 National Health Interview Survey and found that male smokers who switched to smokeless tobacco were more likely to quit smoking than those who used nicotine patches or gum.

"Americans are largely misinformed about the relative risks. ... They think smokeless tobacco is just as dangerous," Rodu said. "This level of misinformation is an enormous barrier to actually accomplishing tobacco-harm reduction because if people believe that the products have equal risk, there's not a real incentive."

The program is funded through Rodu's research money, which includes grants from the tobacco industry. Grants through the University of Louisville are unrestricted, which the program says "ensures the scientific independence and integrity of research projects and activities."

"There's absolutely no influence whatsoever," Rodu said. "I decide, along with my colleagues, how we use the money, for what projects, and this is entirely the case. I would not have a situation where there was some control over the kind of projects I undertake."

Tobacco companies want to market more smokeless tobacco and other cigarette alternatives to make up for falling cigarette sales. Some have introduced "snus" � small pouches like tea bags that users stick between the cheek and gum � and dissolvable tobacco � finely milled tobacco shaped into orbs, sticks and strips.

But they're barred by federal law from explicitly marketing them as less risky than cigarettes � at least for now. That means the "Switch and Quit" program can do something the tobacco industry itself cannot: claim that smokeless tobacco has a health benefit when compared to smoking.

The program says smoking kills about 220 adults a year in and around Owensboro. The state of Kentucky, a leading tobacco grower, has the nation's highest smoking and lung cancer rates.

Owensboro and the surrounding area consume about 3 million cigarettes a week, according to the program. That amounts to well over a pack for every man, woman and child in the community of about 115,000 people.

Owensboro resident Vernon Goode had smoked for about 10 years before he recently traded his Marlboros for dissolvable tobacco tablets. The campaign didn't inspire him to quit, but he said he thought it was a good idea.

"I was just wanting to quit because, you know, I could feel it in my lungs," Goode said. "I'll smoke a cigarette every once in a while, but not very often. I want to quit altogether and I'm just using this right here as I guess what you'd call a stepping stone."

The Owensboro program has raised concerns among some in the public health community who say organizers are claiming smokeless tobacco is a healthier alternative to smoking without approval from the Food and Drug Administration.

A 2009 law gives the FDA authority to evaluate health risks of tobacco products and approve those that could be marketed as safer than what's currently for sale. None have been given the OK yet. The FDA also plans to regulate electronic cigarettes, battery-powered plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that users inhale.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the program "a giant experiment with the people of Owensboro without rules or guidance designed to protect individuals from experimental medicine."

Smokeless tobacco isn't a safe alternative to cigarettes, according to the Centers for Disease Control and Prevention. Health warnings on the products required by the FDA state the same thing.

However, some studies, including a 2007 report from the Royal College of Physicians in London titled "Harm Reduction in Nicotine Addiction," suggest that some smokeless tobacco products are about 90 percent less harmful than cigarettes.

"The worst that you can say about smokeless tobacco is that it's the lesser of two evils," said Dr. Randall Thomas, an oncologist with the Owensboro Medical Health System. The health system, the community's largest employer, is going smoke-free in 2013 and is offering Rodu's program as one of a variety of quit-smoking tools for its employees.

"I don't think we have any problem in telling a person that drinks a six-pack a day that if they could cut it back to two beers a day or two drinks a day that their health risks are greatly reduced," Thomas said. "Finding a way to let people have their nicotine that carries less risk, it's the realistic solution."

The Owensboro program doesn't suggest pharmaceutical nicotine replacement gum or patches. That's because they are regulated to provide very small doses of nicotine and are recommended for only a short period of time, while smokeless tobacco can be used as long as a smoker needs, Rodu said.

Myers, of the Campaign for Tobacco-Free Kids, said more research is needed before anyone should suggest that the nation's 46 million smokers would be better off using smokeless tobacco. In the meantime, he said, there are a host of FDA-approved products that can help people give up smoking.

"There's a right way and a wrong way to determine whether smokeless tobacco can and should be marketed as a way to help people quit," Myers said.

The National Cancer Institute approved funding earlier this year for a nationwide 1,250-person study to look at whether being given a snus product changes the habits of smokers who are not motivated to quit.

The tobacco industry sees smokeless tobacco as its future, said Matthew J. Carpenter, a psychology professor at the Medical University of South Carolina who is conducting the yearlong study.

Carpenter said the snus study will examine what smokers do when given smokeless tobacco. He won't look at the health effects, or advise smokers to use the snus to quit.

"They are probably safer than conventional cigarettes, if for no other reason than you're not burning anything, you're not smoking anything, you're not inhaling any smoke," he said.

"If you compare it to conventional cigarettes, they're probably a little bit better. If you compare it to quitting, they're absolutely worse."

___

Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum.



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Gov't considers testing anthrax vaccine in kids (AP)

WASHINGTON � A government advisory panel is considering whether the anthrax vaccine should be tested in children.

Health experts worry that terrorists could one day use the potentially deadly bacteria in an attack on the United States.

There's plenty of vaccine stockpiled just in case, and it's been widely tested on adults.

But since it's never been tested on youngsters, the question is whether to do research now so doctors would know if and how well children respond to the shots � or just wait and, if there is an attack, offer the vaccine experimentally at that time.

That question is before the National Biodefense Science Board on Friday. The board gives advice to the Department of Health and Human Services on preparations for chemical, biological and nuclear emergencies.



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Thursday, October 27, 2011

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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Wednesday, October 26, 2011

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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