British doctors protest heart stent plan
Mon, 27 Aug 2007 19:15:39 GMTBy MARIA CHENG, AP Medical Writer
LONDON - British heart doctors are trying to defeat a proposal to end government coverage of drug-coated heart stents, tiny metal-mesh tubes that prop open clogged arteries.
The proposal was made by Britain's National Institute for Health and Clinical Excellence, which has the lead role in deciding what the country's health system pays for.
Tuesday is the deadline for members of the public to submit their comments on the recommendation. Next week, the organization will meet to review the proposal alongside input from the public.
Any new restrictions would further batter the troubled drug-coated heart stents, which have come under increasing attack in the last year. The stents are commonly used in angioplasties, one of the world's most common medical procedures. More than 1 million such procedures are performed in the United States every year.
Through an artery in the leg, doctors snake a tube to blockages that are clogging vessels. A tiny balloon is inflated, and a mesh scaffold called a stent is left behind to prop the artery open.
If the British proposal is adopted, patients would either get a plain, metal stent or be forced to pay for the drug-coated device themselves. Drug-lined stents typically cost about US$2,300 , compared to the approximately US$700 for the bare metal versions. That could even lead some people to choose alternatives to angioplasties, like surgeries or medication.
When drug-coated stents were first introduced in 2003, they became the fastest-selling medical device in recent history. The tiny tubes that leak drugs to prevent tissue regrowth, were heralded by doctors as a revolutionary way of keeping patients' arteries open. Nearly 6 million people worldwide now have the drug-lined versions.
But last year, major worries were raised about the safety of drug-eluting stents. Several studies showed that patients receiving the stents were more likely to develop potentially fatal blood clots months and even years after their surgeries.
"This is a pretty drastic step," said Dr. Gabriel Steg, a cardiologist at Bichat Hospital in Paris and spokesman for the European Society of Cardiology.
"We are seeing the pendulum swing too far the other way," Steg said. "Withdrawing drug-eluting stents altogether is probably not a good idea," he said, explaining that the tiny tubes can still be useful for certain patients.
Steg also worried that the British guidance would send the wrong message to patients who already have had drug-coated stents implanted. "We do not want to say that this is a dangerous device," he said. "We still need to see more data on drug-eluting stents before we can have the final word."
The British Cardiovascular Society said that it was "surprised, disappointed and very concerned" by the guidance. The British Cardiovascular Intervention Society was also troubled by the guidance, calling it "fundamentally flawed." Without drug-coated stents, the society said that some patients would be forced to live with untreatable chest pains.
Since the stent worries arose, sales of drug-coated stents have plummeted. The U.S. market is expected to shrink by US$1 billion. And Johnson & Johnson, a major stent-maker, recently cut 5,000 jobs in response to declining sales.
Some doctors argue that the drug-oozing stents have advantages that cannot be matched by bare-metal stents. Patients given bare-metal stents have an increased risk of developing another blockage after the formation of scar tissue, said Dr. Timothy Gardner, medical director of the Center for Heart and Vascular Health at Christiana Care Health Services in Delaware.
"This is not good news for patients," Gardner said. "You would be penalizing patients so they would not benefit from the latest technologies we have to help them."
In the U.S., a special meeting was held by the Food and Drug Administration last December looking into the safety of drug-coated stents. Officials did not restrict the use of drug-coated stents, but stressed they should only be used for specific purposes. Many angioplasties in the U.S. use the devices for circumstances beyond those for which they were approved.
Other countries have been closely monitoring the use of drug-lined stents, but none have made recommendations similar to Britain's.
Britain's health advisory body said that comments from doctors and the public could still influence their ultimate guidance.
"There is always the possibility that the recommendations could change," said Lucy Betterton, a NICE spokeswoman. "We respond to reasoned arguments and will be looking to the feedback we've had on the draft recommendations."
Dunkin Donuts dumping most trans fats
Mon, 27 Aug 2007 12:07:02 GMTBy MARK JEWELL, AP Business Writer
BOSTON - Dunkin' Donuts, the food-on-the-go chain whose name celebrates a treat that's symbolic of unhealthy eating, is trying to refresh its image by largely eliminating trans fat across its menu.
Dunkin' planned to announce Monday that it has developed an alternative cooking oil and reformulated more than 50 menu items — doughnuts included. The Canton, Mass.-based chain says its menu will be "zero grams trans fat" by Oct. 15 across its 5,400 U.S. restaurants in 34 states.
About 400 locations nationwide that took part in a four-month test already have made the switch to a new blend of palm, soybean and cottonseed oils. That includes all restaurants in New York City and Philadelphia, which are forcing restaurants to phase out their use of artery-clogging trans fat.
The ice cream chain Baskin-Robbins, another unit of Dunkin' Brands Inc., plans to be zero grams trans fat by Jan. 1.
Dunkin' isn't claiming it will become "trans fat free," but does say any trans fat in foods including doughnuts, croissants, muffins and cookies will fall below half a gram per serving. Federal regulations allow food labels to say they've got zero grams of trans fat, provided levels fall below the half-gram threshold.
A nutrition advocacy group welcomed Dunkin's addition to the list of restaurant chains that have recently shifted away from trans fat.
"It's good news that they're dropping most, if not quite all, trans fat," said Jeff Cronin, spokesman for the Center for Science in the Public Interest, a Washington-based nonprofit. "If Dunkin' Donuts can do that, anyone can."
But Cronin cautioned that when it comes to Dunkin's doughnuts, "we're still talking about a food that's mostly white flour, sugar, and fat."
Dunkin' isn't positioning its namesake product as health food — a shift that would involve more disbelief suspension than might be possible for a treat synonymous with portly, doughnut-gobbling Homer from television's "The Simpsons."
"The goal was not to make a healthy doughnut, it was really to create a doughnut that was better," said Joe Scafido, Dunkin's chief creative and innovation officer. "Certainly, we did not create a healthy doughnut."
Although its coffees are by far a bigger seller, the New England-bred, 57-year-old chain was founded on the reputation of its doughnuts. Now, Dunkin' claims to be the first major chain to introduce a zero grams trans fat doughnut, although smaller doughnut makers have already done so. Mainstream doughnut makers' products can have around 5 grams of trans fat apiece.
The main source of trans fats is partially hydrogenated oils, formed when hydrogen is added to liquid vegetable oils to harden them. Evidence suggests that artificial trans fats boost "bad" cholesterol and lower "good" cholesterol, increasing the risk of heart disease and stroke.
Dunkin' is ahead of Krispy Kreme Doughnuts Inc., which has yet to roll out a zero gram trans fat doughnut but hopes to do so. Brian Little, a spokesman for the North Carolina-based chain, said, "We continue to work aggressively with outside supply partners, and our goal is to get to zero trans fatty acids while maintaining great Krispy Kreme taste."
A call seeking comment from another chain, California-based Winchell's Donut House, wasn't immediately returned.
Starbucks Corp., Dunkin's Seattle-based rival in the coffee shop niche, said in May that it would cut artificial trans fats out of its food and drink by year's end in stores in the continental U.S., Alaska and Canada.
Dunkin's announcement follows about four years of research of more than 28 alternative cooking oils and proprietary blends.
This past spring, hundreds of restaurants began taking part in a test to gauge customer reaction to the blend that Dunkin' ultimately selected. Managers at participating stores were split into two groups, with one receiving conventional cooking oil, the other receiving the experimental oil, and neither group knowing which type they received. Dunkin' closely watched sales and customer response at restaurants with the experimental oil.
"We got no negative consumer feedback, and we sold 50 million doughnuts in that time," Scafido said.
Dunkin's 1,900 locations outside the U.S. are expected to begin using the new oil over the next couple years, he said.
Edwards details cancer research plan
Mon, 27 Aug 2007 19:01:57 GMTBy MIKE GLOVER, Associated Press Writer
CEDAR RAPIDS, Iowa - Democrat John Edwards said Sunday he is offering a strategy for dealing with cancer that would bolster research funding, create support networks for people dealing with the disease and encourage lifestyle changes to help keep others from getting it.
Edwards said his wife's battle with breast cancer has driven home the need to make combatting the disease a top priority for the next president.
"It's clear to me that this is a huge priority," Edwards said in a telephone interview. "That has had a huge influence on my thinking."
Edwards plans to spell out his proposals during a forum Monday sponsored by Olympic bicycling champion Lance Armstrong, himself a cancer survivor. Some details of the package were provided to The Associated Press, and Edwards discussed them in the interview, saying it would mark a new focus on battling cancer.
"I'm going to propose a national strategy for cancer survivorship," said Edwards. "It's a new way of thinking about cancer."
He said five-year cancer survivorship now stands at 66 percent, a 50 percent increase over 30 years ago. That's progress, but more needs to be made, he said.
Under the package being outlined by Edwards, he would:
_Push for a substantial increase in funding for cancer research conducted by the National Institutes for Health. He put no specific figure on the increase, but said only two of 10 research projects now get funded by the federal agency.
_Expand testing and reporting of chemicals that may increase cancer risks, as well as monitoring where they may exist.
_Launch a national research program to identify environmental risks, as well as promoting lifestyle changes that could reduce risk. Those include smoking cessation, improving diets at schools and bolstering exercise to combat obesity.
_Increase support for respite care, including home visits from nurses and other health professionals to give caregivers a break. He also calls for an Internet clearinghouse for information about services that are available for families dealing with the disease.
"Enormous burdens are placed on ordinary Americans who provide full-time care for loved ones with debilitating conditions," said Edwards.
Since Edwards and his wife announced earlier this year that her cancer had returned and spread, he has focused his campaign for the Democratic presidential nomination heavily on health issues in general, cancer specifically. He has offered a universal health care plan that he said would serve as a foundation for the battle against cancer by providing screening and testing for all.
"I want any man or woman who faces this diagnosis to have access to the same high-quality health care that Elizabeth has received," said Edwards. "Uninsured cancer patients get half the treatments and have higher mortality rates. We have to have a national strategy."
Both Edwards and his wife previewed the cancer forum with an appearance on CBS' "Face the Nation."
"We understand the seriousness of this diagnosis," Mrs. Edwards said. "We understand that this disease will probably kill me one day."
Edwards said he is using his campaign to bring attention to the issue. "Both of us believe that what we're doing is important," he said. "This is the cause of our lives."
Armstrong is sponsoring a two-day forum on cancer issues, with the Democratic presidential candidates invited on Monday and Republicans on Tuesday.
Edwards is being joined by New York Sen. Hillary Rodham Clinton and New Mexico Gov. Bill Richardson. Kansas Sen. Sam Brownback and former Arkansas Gov. Mike Huckabee have agreed to appear on Tuesday.
Speaking on NBC's "Meet the Press" Armstrong expressed some disappointment that only a handful of candidates agreed to appear.
"I think the future commander in chief needs to show up and talk about what kills 600,000 Americans a year," said Armstrong. "I'm not going to sugar coat it, it's a disappointment, when you can't show up for whatever reason, won't show up and discuss such a devastating illness. Everybody was invited, of course, and I spoke to almost all of them personally."
Bird flu found at German poultry farm
Sun, 26 Aug 2007 11:18:12 GMTBERLIN - Tests have found that birds at a poultry farm in southern Germany died of the H5N1 strain of bird flu, and some 160,000 birds were being slaughtered as a precaution, authorities said.
The virus was detected in ducklings at the farm near Erlangen, in northern Bavaria. A federal lab confirmed that the birds died of the "highly pathogenic" H5N1 variant, the state consumer protection ministry said Saturday.
More than 400 birds had died over a short period of time at the farm, ministry spokeswoman Sandra Brandt said. Authorities planned to start Saturday evening with the slaughter of the 160,000 birds at the farm.
Several cases of the virus have surfaced among wild birds in Germany this year. Last month, it was detected in a domestic goose in the east of the country.
The H5N1 virus has killed more than 190 people worldwide, according to the World Health Organization.
It remains hard for humans to catch, but experts fear it could mutate into a form that spreads easily among people, potentially sparking a global pandemic. So far, most human cases have been traced to contact with infected birds.
Sexually transmitted wart virus ups mouth cancers
Mon, 27 Aug 2007 20:00:02 GMTWASHINGTON - Men should be vaccinated against a sexually transmitted wart virus to protect them against a type of mouth and throat cancer, U.S. researchers said on Monday.
They said the rate of oropharyngeal cancers -- mostly cancers of the tonsil and base of tongue -- appears to be rising in certain populations and the human papilloma virus or HPV transmitted by oral sex is likely to blame.
New vaccines that target HPV may help turn the trend around, the researchers reported in this week's issue of the journal Cancer. The vaccines are recommended for young women in Europe and the United States.
But young men should be offered the vaccines too, said Dr. Erich Sturgis and Paul Cinciripini of the University of Texas M. D. Anderson Cancer Center in Houston.
&; encourage the rapid study of the efficacy and safety of these vaccines in males and, if successful, the recommendation of vaccination of young adult and adolescent males,&; Sturgis and Cinciripini wrote.
There are several strains of HPV, which cause ordinary warts but also genital warts. These in turn can cause cancer in some cases. The researchers looked at various studies and concluded that HPV 16 was especially likely to be linked with certain cancers of the tonsil and base of tongue.
Smoking is a well known risk factor but rates of these cancer are staying fairly steady, despite declines in tobacco use.
In one study cited by Sturgis and Cinciripini, Dr. Maura Gillison of Johns Hopkins University in Baltimore and colleagues studied 100 patients with oral or throat cancer and compared them to 200 healthy people. They found those who had six or more oral sex partners had a high risk of the cancer.
They found evidence of HPV-16 in 72 percent of the tumors.
U.S. health officials estimate that more than a quarter of U.S. girls and women aged 14 to 59 are infected with HPV.
Two vaccines protect people against HPV infection -- Merck and Co's. Gardasil and GlaxoSmithKline's Cervarix. The U.S. Centers for Disease Control and Prevention has recommended vaccination for 30 million women and girls aged 11 to 26 to prevent cervical cancer, which kills about 300,000 women worldwide each year.
Head and neck cancers, which include cancers of the larynx, nose and nasal passages, mouth, pharynx, and salivary glands, are three times more common in men than women, and 45,000 new cases are expected in 2007 in the United States alone.
Statins may help prevent Alzheimer39s study
Mon, 27 Aug 2007 20:33:48 GMTWASHINGTON - Statin drugs may help prevent the brain damage that leads to Alzheimer's disease, U.S. researchers reported on Monday.
Their study, published in the journal Neurology, bolsters a growing body of research that suggests the popular cholesterol-lowering drugs may reduce the risk of Alzheimer's.
Most studies have simply compared people who take statin drugs to those who do not, and track the rate of Alzheimer's.
&;But our study is the first to compare the brains of people who had received statins with those who had not,&; said Dr. Gail Ge Li of the University of Washington School of Medicine in Seattle, who worked on the study.
Li and colleagues examined the brains of 110 people aged 65 to 79 who had donated their brains for research after they died as part of a study when they were still living.
The researchers looked at the brains for evidence of the plaques and tangles that characterize Alzheimer's, an incurable and progressive brain disease that is the leading cause of dementia.
They found significantly fewer tangles in the brains of people who had taken statins than in those who had not.
&;These results are exciting, novel, and have important implications for prevention strategies,&; said Dr. Eric Larson, who helped direct the study.
&;But they need to be confirmed, because is not a randomized controlled trial.&;
Such a trial would be difficult to conduct. It would require randomly assigning people to either take statins or not, watching to see who developed Alzheimer's, and looking at their brains after they died.
Statin drugs lower cholesterol and may also reduce inflammation in the body. The causes of Alzheimer's are not fully understood, but they are closely linked with cholesterol and also inflammation.
&;Statins are probably more likely to help prevent the disease in certain kinds of people than others,&; Li said.
&;Someday we may be able to know more precisely which individuals will benefit from which types of statins for preventing the changes of Alzheimer's disease,&; Larson added in a statement.
Statins -- which include Pfizer Inc's $10 billion-a-year Lipitor, Bristol-Myers Squibb Co's Pravachol and Merck and Co Inc's Zocor -- are the world's best-selling drugs, taken by millions to reduce the risk of heart attack.
