Study Pollution raises exercise risks
Wed, 12 Sep 2007 21:01:15 GMTBy LINDA A. JOHNSON, Associated Press Writer
People with heart disease may want to steer clear of heavy traffic when exercising or simply take their workout indoors to avoid breathing polluted air.
Exercising in areas with high levels of diesel exhaust and microscopic soot particles is especially risky for people with heart disease, according to the first study in which heart patients were directly exposed to pollution.
European researchers found that brief exposure to diluted diesel exhaust during exercise reduced a key anticlotting substance in the blood and worsened exercise-induced ischemia, or insufficient flow of blood and oxygen to the heart — changes that can trigger a heart attack and even death.
"We now have evidence that being exposed to diesel fuel during exercise will cause cardiac ischemia and that if you have heart disease, it can only make things worse," said Dr. Abraham Sanders, a lung specialist at New York-Presbyterian Hospital who was not involved in the study.
The results have big implications: About 16 million Americans have heart disease, according to the American Heart Association. In addition, people with asthma, bronchitis and chronic obstructive pulmonary disease also should use caution and avoid polluted air when exercising, Sanders recommended. But heart and respiratory patients should keep exercising regularly because it is so beneficial to overall health, doctors stress.
Numerous studies have shown a link between short-term and long-term exposure to air pollution and higher rates of hospitalizations and deaths due to poor blood supply to the heart, abnormal heart rhythms, gradual heart failure and stroke.
This study adds to that knowledge about how air pollution harms people and aims to show what pollution is doing in the body, information that might eventually give clues for preventing such problems, said Dr. Howard M. Kipen, director of clinical research at Rutgers University's Environmental and Occupational Health Sciences Institute.
"It's quite amazing, what they found," but not a surprise, he said. Still, "most doctors aren't aware that little bits of pollution can cause heart attacks."
The European study was reported in Thursday's New England Journal of Medicine.
Researchers in Sweden and the United Kingdom tested 20 men aged about 60 who had survived a heart attack at least six months earlier, had blockages cleared and propped open with a stent, and were getting treatment to prevent a second heart attack. The researchers noted they only tested men with stable heart disease and good tolerance for exercise, and monitored each closely to ensure none suffered any health problems.
On two separate occasions, each man was put in an enclosed chamber for an hour and exposed to either diluted diesel exhaust or clean, filtered air. They rode an exercise bike for two 15-minute periods and rested in between. The men had electrodes attached to their bodies to monitor the heart's electrical activity, like what happens in a standard heart stress test.
While exercising and exposed to diesel exhaust, the men experienced drops in the heart's electrical activity two to six times greater than when they were breathing filtered air. Those reductions indicated the heart muscles were not getting enough blood.
While diesel exhaust contains many harmful chemicals, the researchers said they believe that particulates in the exhaust are the main harm to the heart patients.
A 2000 study in six U.S. cities found the strongest association between risk of death in heart patients and air pollution exposure was for microscopic air particulates, such as those in diesel exhaust.
The European researchers noted particulate concentrations can regularly hit 300 micrograms per cubic meter — the level to which the study participants were exposed — in heavy traffic, workplaces such as factories and refineries and in the world's largest cities. Levels of some of the pollutants in the diesel exhaust were far above the limits recommended by the World Health Organization, they noted.
This study only included men, but Sanders said he thinks the findings probably apply to women. A recent report from the federal Women's Health Initiative found exercise in polluted environments causes a temporary reduction in blood flow to the heart muscle.
In an editorial, Dr. Murray A. Mittleman of Beth Israel Deaconess Medical Center in Boston wrote, "these findings may represent the tip of an iceberg" on how spikes in air pollution levels affect cardiovascular risk.
Kipen said his institute also studies health effects of diesel exhaust, generally on healthy people under age 45, but they use a more natural setting rather than an exposure chamber.
"We put them in a car and drive them around on the turnpike at rush hour for two hours," Kipen said.
___
On the Net:
New England Journal: http://www.nejm.org
American Heart Association: http://www.americanheart.org/presenter.jhtml?identifier4419
Panel Aprotinin should remain on market
Wed, 12 Sep 2007 21:21:07 GMTWASHINGTON - A drug used to prevent excessive bleeding during bypass surgery should remain on the market despite being linked to increased risk of death and other serious side effects, federal advisers recommended Wednesday.
The drug is aprotinin, sold by Bayer AG under the brand name Trasylol. The Food and Drug Administration approved it in 1993 to stanch the loss of blood and prevent the need for blood transfusions in surgeries to bypass clogged coronary arteries.
A joint panel of FDA expert advisers voted 16-1, with one abstention, to recommend allowing sales of the drug to continue, an agency spokeswoman said. The FDA is not required to follow the advice of its advisory committees but does so most of the time.
The FDA has been re-evaluating the drug's safety since the January 2006 publication of two studies that linked the drug's use to serious side effects, including kidney problems, heart attacks and strokes.
More recent studies have suggested the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA due to what a company investigation later characterized as a "regrettable human error."
In separate votes later Wednesday, the panelists said there was no need to add details from those newer studies to Trasylol's label, but that the drug merited further study.
The meeting of outside expert advisers was convened to revisit the drug's safety in light of the more recent studies. Last year, before those studies were made public, FDA advisers said the drug was safe and effective.
Bayer said Trasylol has been shown to reduce the risk of blood transfusion. The company allows that the drug appears to be associated with kidney dysfunction, but says any link to kidney failure is less definitive, according to documents released ahead of Wednesday's meeting.
The company said data do not show any increased risk of death in using the drug and cited a continuing study that is examining in part the stroke, heart attack and other risks.
The FDA in December strengthened the already severe "black-box" warnings on the drug to say it should be used only in patients who face an increased risk of blood loss and transfusion during bypass surgery. At the time, it left open the possibility of further warnings.
Trasylol works by blocking enzymes that dissolve blood clots.
Wed, 12 Sep 2007 21:03:11 GMT
By ADRIAN SAINZ, AP Business Writer
MIAMI - Burger King pledged Wednesday to offer healthier fast-food items for children under 12, with plans to sell and market flame-broiled Chicken Tenders and apples cut to resemble thick-cut french fries.
Burger King Holdings Inc., the world's second largest hamburger chain, said it has set nutritional guidelines to follow when targeting children under 12 in advertising, including limiting ads to Kids Meals that contain no more than 560 calories, less than 30 percent of calories from fat and no more than 10 percent of calories from added sugars.
In that vein, Burger King is building a Kids Meal that will contain the flame-broiled Tenders, organic unsweetened applesauce and low-fat milk, for a total of 305 calories and 8.5 grams of fat. It will be available in restaurants sometime in 2008, the company said.
The fast-food chain is also developing what it calls BK Fresh Apple Fries. The red apples are cut to resemble french fries and are served in the same containers as fries, but they are not fried and are served skinless and cold.
"We not only want to better inform parents and kids about these new menu options but also to demonstrate through product innovation that better-for-you foods can be fun and taste good," said John Chidsey, Burger King's chief executive.
The 2.4-ounce serving of Apple Fries will have 35 calories, the company said. A small serving of Burger King french fries has 230 calories and 13 grams of fat, according to Burger King's Web site.
Burger King will use U.S. grown apples that are cut and packaged in a sterile environment and subjected to a pre-wash that contains lemon to keep them from turning brown, said Burger King spokesman Keva Silversmith.
The Miami-based company will continue to offer its fried Chicken Tenders on its menu. The flame-broiled Tenders have 145 calories and 6 grams of fat per four-piece children's serving. A four-piece serving of fried Tenders has 170 calories and 10 fat grams.
Miriam Pappo, a registered dietitian and nutritionist, said the move is part of a trend to offer healthier products at restaurants as people become more aware of nutrition and take interest in exactly what they are eating.
"It's a good trend. The actual ultimate solution is still to eat less fast food," said Pappo, clinical nutrition manager at Montefiore Medical Center in New York. "It will only be successful if it tastes good and it will only be successful if it fills the child up."
Long criticized for a lack of healthier options, several quick-service food chains in recent years have developed items for those seeking fast access to a less-expensive meal that has fewer calories and less fat than a burger, french fries and a soda.
Burger chain leader McDonald's Corp. offers apple slices with a low-fat caramel dip and low-fat milk in its Happy Meals, while offering salads and fruit parfaits on its regular menu. Wendy's International Inc. offers salads, yogurt with granola and mandarin oranges.
Burger King also sells salads and has a veggie burger. It did not reveal a price for its new children's items because food and paper costs have not been set, Silversmith said.
Ronni Litz Julien, a Miami nutritionist and author, praised Burger King but said it was the responsibility of parents to teach their children to eat healthier.
"I'm elated with the idea that they are paying more attention to the children today," Julien said. "The truth of the matter is that children in this country have never been more unhealthy. Fast food has been a big part of that. ... If a parent doesn't encourage this from the get go for their children, whether its 4 years old or 10 years old, it can't possibly be successful."
U.S. failed to boost produce inspections
Wed, 12 Sep 2007 20:33:05 GMTBy GARANCE BURKE, Associated Press Writer
SALINAS, Calif. - Government regulators never acted on calls for stepped-up inspections of leafy greens after last year's deadly E. coli spinach outbreak, leaving the safety of America's salads to a patchwork of largely unenforceable rules and the industry itself, an Associated Press investigation has found.
The regulations governing farms in this central California region known as the nation's "Salad Bowl" remain much as they were when bacteria from a cattle ranch infected spinach that killed three people and sickened more than 200.
AP's review of data obtained through the Freedom of Information Act found that federal officials inspect companies growing and processing salad greens an average of just once every 3.9 years. Some proposals in Congress would require such inspections at least four times a year.
In California, which grows three-quarters of the nation's greens, processors created a new inspection system but with voluntary guidelines that were unable to keep bagged spinach tainted with salmonella from reaching grocery shelves last month.
The AP review found that since last year's E. coli outbreak, California public health inspectors have yet to spot-test for bacteriological contamination at any processing plants handling leafy greens. And some farms in the fertile Salinas Valley are still vulnerable to bacteria-carrying wildlife and other dangerous conditions.
"We have strict standards for lead paint on toys, but we don't seem to take the same level of seriousness about something that we consume every day," said Darryl Howard, whose 83-year-old mother, Betty Howard, of Richland, Wash., died as a result of E. coli-related complications.
She was one of two elderly people to die in the outbreak that began in August 2006 and also included the death of a child and sicknesses reported from more than 200 people from Maine to Arizona.
By mid-September, the U.S. Food and Drug Administration issued a two-week nationwide warning not to eat fresh spinach. Authorities eventually traced the likely source of the E. coli to a cattle ranch about 40 miles east of Salinas.
But a regulatory backlash never happened.
State Sen. Dean Florez, a Central Valley Democrat who sponsored three failed bills to enact mandatory regulations for leafy greens earlier this year, said momentum faded as the E. coli case dropped from the headlines and the industry lobbied hard for self-regulation.
"That legislation was held up waiting for this voluntary approach for food safety to see if it works," said Florez, who is skeptical of that approach.
"It only took one 50-acre parcel to poison 200 people and bring the industry to its knees," he said. "We don't get why the industry would be playing this game of roulette with our food."
Among the AP's other findings:
• Since September 2006, federal Food and Drug Administration staff inspected only 29 of the hundreds of California farms that grow fresh "stem and leaf vegetables," a broad category the agency uses to keep track of everything from cauliflower to artichokes. Agency officials said they did not know how many of those grew leafy greens.
• Since raw vegetables, especially leafy greens, are minimally processed, they have surpassed meat as the primary culprit for food-borne illness. Produce caused nearly twice as many multistate outbreaks than meat from 1990-2004, but the funding has not caught up to this trend. The U.S. Department of Agriculture branch that prevents animal diseases gets almost twice the funding as the FDA receives to safeguard produce.
• California lettuce and spinach have been the source of 13 E. coli outbreaks since 1996. But if salad growers or handlers violate those new guidelines, they are not subject to any fines, are not punishable under state law and may be allowed to keep selling their products.
Last year's outbreak prompted a temporary downturn in sales of salad greens, but more than 5 million bags of salad are now sold each day nationwide, a number the industry says will grow as health-conscious consumers opt for more greens and vegetables.
Much of those sprout near Salinas, where the fog lifted on a recent morning over fields of romaine and iceberg already wilting in the August sun.
Men in sweat shirts and baseball caps cut heads of lettuce from the ground and loaded them into cardboard boxes to be taken to a nearby plant owned by Castroville-based packager Ocean Mist Farms. From there, they would be shipped out to supermarkets and buyers as far away as Japan.
In an attempt to reassure wary customers, Ocean Mist's vice president recently helped organize a group to police food safety, run entirely by the $1.7 billion leafy greens industry. Some 118 salad processors have signed on to the California Leafy Green Products Handler Marketing Agreement, which uses its own voluntary food safety guidelines.
Public health inspectors can impose mandatory food-safety rules on the farm only after an outbreak, said Patrick Kennelly, chief of the food safety section at California's Department of Public Health.
Some scientists question the approach.
"Mandatory measures give a level playing field and make sure everybody responds," said Martin Cole, a food safety expert at the Illinois Institute of Technology.
But in the absence of federal regulations, 10 auditors from the California Department of Food and Agriculture are monitoring the fields, including Roxann Bramlage, who tramped down the rows of lettuce with a checklist.
"When somebody cuts their finger and it bleeds, what will you do?" Bramlage asked foreman Fernando Vasquez, standing next to a harvester machine rolling gently over the beds.
"When he cuts his finger, even if it's a small cut, I take him to the edge of the field," Vasquez said in Spanish. "Then I put a border around the area where he was working and I don't let anyone cut in it."
That was the right answer.
Ocean Mist passed Bramlage's field audit because the company could prove its growers protected their crops against pathogens, which gave them the right to use a state seal telling consumers the product was grown safely. Growers say that seal sends a powerful message to consumers.
"Once they join, there's nothing voluntary about the program," said Scott Horsfall, who oversees the marketing agreement. "If a handler is decertified, buyers will definitely react."
The industry-led approach isn't foolproof, however.
On Aug. 29, Metz Fresh, a grower and shipper in King City, 30 miles south of Salinas, recalled 8,000 cartons of fresh spinach tainted with salmonella. Auditors had visited the company a few weeks before, but inspected a field where the produce was clean. So they noted nothing unusual in their report.
No one knows how the bacteria got into the leaves. But the news rekindled fears among consumers and legislators who say they are skeptical of the government's willingness to let the industry police itself.
"Some will say the system is working and that we are catching the problem and recalling products, but the average consumer wouldn't know that," said U.S. Sen. Tom Harkin, D-Iowa, who chairs the Senate Committee on Agriculture, Nutrition and Forestry. "Last year, it was E. coli; this year, salmonella."
Harkin and Rep. Rosa DeLauro, D-Conn., are both working on bills to develop a set of mandatory national guidelines to supercede the current patchwork of food safety regulations.
Similar proposals were developed a year ago, but none have gone forward.
In March, the Bush Administration issued a draft of its guidance to minimize microbial hazards of fresh-cut fruits and vegetables. Unlike the strict hazard-control program governing meat and poultry, the guidance included no new laws.
Many growers and producers are either unaware of the guidelines or simply aren't complying, according to the Center for Science in the Public Interest, a Washington-based consumer advocacy group.
"Inspection alone isn't going to fix the problem, unless the farmers utilize food-safety plans that are effective for controlling pathogens," said Caroline Smith DeWaal, director of the center's food safety division. "They're not getting at the source of the contamination: on the farm."
___
Associated Press writer Marcus Wohlsen in San Francisco contributed to this report.
