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FDA rules that Avastin should no longer be used to treat breast cancer November 18, 2011

The drug Avastin should no longer be used in advanced breast cancer patients because there is no proof that it extends their lives or even provides enough temporary benefit to outweigh its dangerous side effects, the US government declared on Friday.

The ruling by the Food and Drug Administration was long expected, but it was certain to disappoint women who say they have run out of other options as their breast cancer spread through their bodies. Impassioned patients had lobbied furiously to preserve Avastin as a last shot.

But repeated studies found the drug had only a small effect on tumor growth.

The research did not show evidence that patients lived any longer or had a better quality of life than if they had taken standard chemotherapy. The FDA concluded that the drug presented an array of risks, including severe high blood pressure, massive bleeding, heart attack or heart failure, along with perforations in the stomach and intestines.

“I did not come to this decision lightly,” said the FDA commissioner, Dr Margaret Hamburg. But, she said, “Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing.”

Avastin is the world’s best-selling cancer drug, and also is used to treat certain forms of colon, lung, kidney and brain cancers. So even though FDA formally revoked its approval of the drug to treat breast cancer, doctors still could prescribe it but insurers may not pay for it. Including infusion fees, a year’s treatment with Avastin can cost $100,000.

Some insurers already had quit covering the drug’s use in breast cancer after FDA’s advisers twice once last year and once this summer urged revoking the approval.

But Medicare said on Friday that it will keep paying for now. In a statement, the agency said it “will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies.”

Hamburg said any woman wishing to remain on Avastin should have an in-depth discussion with her doctor about the risks and what the research into the drug showed.

Avastin manufacturer Genentech, part of Swiss drugmaker Roche Group, had argued that the drug should remain available while it conducted more research to see if certain subsets of breast cancer patients might benefit, perhaps people whose tumors contain certain genetic characteristics. After all, some doctors had argued that they do see a few patients who seem to do better with Avastin than without it.

Hamburg said she considered that argument, but that scientifically there are no clues yet to identify such women. She urged Genentech to do that research, saying FDA “absolutely” would reconsider if the company could find the right evidence.”

“We’re eager to work with the company, and we hope that the science will advance and that we will be able to offer patients with metastatic breast cancer better, safer, more effective treatments for this devastating disease,” Hamburg said.

Genentech pledged to begin such research.

“We are disappointed with the outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States,” said company chief medical officer Dr Hal Barron.

One patient advocacy group called the decision a mistake.

“Any one life is significant. In this case we’re talking about several thousand lives a year,” said Frank Burroughs of the Abigail Alliance, which advocates for access to experimental medicine.

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Teens Who Sleep Less More Likely to Lead Risky Lives September 30, 2011

Teens ages 14 to 18 who get fewer than 8 hours of sleep on school nights—some 70 percent of U.S. high school students—may be more likely to engage in risky behavior, according to a new study released Monday by the Centers for Disease Control.

The study’s authors examined the 2007 national Youth Risk Behavior survey and found that students who averaged less than a full night’s sleep were more likely to use drugs, drink alcohol, be depressed, and be less physically active than well-rested students.

Lela McKnight-Eily, the study’s lead author, says that it’s hard to tell if students are engaging in risky behavior because they’re not getting sufficient sleep, or if they’re not getting sufficient sleep because they’re engaging in risky behavior. She says a change in the brain’s chemistry that occurs during puberty causes the body’s internal clock, or circadian rhythm, to be knocked off track, causing irregular sleep patterns in many teens.

[Learn more about social networking and risky behavior.]

“There’s not a direction implied by this study. What we do know is that during the period of adolescence, there’s a change in biology that causes a two-hour delay in your circadian rhythm,” she says. “Even if they’re not out doing these risk[y] behaviors, they’re going to want to be out later, they’re going to want to wake up later.”

McKnight-Eily says that broad, societal changes are causing teens today to get less sleep than in the past. “The TV doesn’t turn off anymore; they can text; they can use computers,” she says. “I think there’s a combination of factors going on.”

She says that being up late surfing the Internet or watching TV when trying to fall asleep can cause restless nights. She adds that it’s important for teens to have a somewhat regular sleep schedule.

Length of sleep seemed to have the greatest correlation with the following health-risk behaviors:

Insufficient sleepers average fewer than eight hours of sleep per night; sufficient sleepers average at least eight hours of sleep per night.

See how your school stacks up in our rankings of Best High Schools. Have something of interest to share? Send your news to us at highschoolnotes@usnews.com.

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Ongoing cantaloupe outbreak linked to 13 deaths September 29, 2011

(CNN) — An outbreak of illness linked to consumption of tainted cantaloupes has been linked to 13 deaths and 72 illnesses in 18 states, a federal disease agency reported Wednesday.

The outbreak — blamed on the bacteria Listeria monocytogenes — was first reported September 12, when the Centers for Disease Control and Prevention said 15 people in four states had been infected. The illnesses were traced to consumption of Rocky Ford cantaloupes grown at Jensen Farms’ fields in Granada, Colorado.

The deaths reported as of Tuesday morning occurred in Colorado (two), Kansas (one), Maryland (one), Missouri (one), Nebraska (one), New Mexico (four), Oklahoma (one), and Texas (two).

The illnesses occurred in those states as well as in California, Florida, Illinois, Indiana, Montana, North Dakota, Virginia, West Virginia, Wisconsin and Wyoming.

13 dead after eating cantaloupe

New E. coli contamination scare

Listeriosis primarily affects older adults, pregnant women, newborns and adults with weakened immune systems, according to the CDC website.

Learn more about various types of food poisoning

Jensen Farms, which is based in Holly, Colorado, is voluntarily recalling Rocky Ford whole cantaloupes that were shipped between July 29 and September 10 and distributed to Illinois, Wyoming, Tennessee, Utah, Texas, Colorado, Minnesota, Kansas, New Mexico, North Carolina, Missouri, Nebraska, Oklahoma, Arizona, New Jersey, New York and Pennsylvania.

The cantaloupes bear a green-and-white sticker that reads: Product of USA- Frontera Produce-Colorado Fresh-Rocky Ford-Cantaloupe or a gray, yellow, and green sticker that says: Jensen Farms-Sweet Rocky Fords.

Unlabeled whole cantaloupe should be taken to the retailer for sourcing information, the FDA said.

“Jensen Farms continues to stay committed to the highest levels of food safety and maintains many third-party safety audits, as we have for many years,” said Ryan Jensen, a partner at Jensen Farms. “We continually look for ways to enhance our protocol.”


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Listeria outbreak expected to cause more deaths across US in coming weeks

An outbreak of listeria in cantaloupe melons in the US may cause more illness and deaths in coming weeks, say health officials.

So far, the outbreak has caused at least 72 illnesses and up to 16 deaths, in 18 states, making it the deadliest food outbreak in the country in more than a decade.

The Colorado farm where the potentially deadly cantaloupes were traced to, Jensen Farms in Holly, says it shipped fruit to 25 states, and people with illnesses have been discovered in several states that were not on the shipping list.

A spokeswoman for Jensen Farms said the company’s product is often sold and resold, so they do not always know where it ends up.

“If it’s not Jensen Farms, it’s OK to eat,” said Thomas Frieden, director of the US Centres for Disease Control. “But if you can’t confirm it’s not Jensen Farms, then it’s best to throw it out.”

The recalled cantaloupes may be labelled “Colorado Grown,” “Distributed by Frontera Produce,” “Jensenfarms.com” or “Sweet Rocky Fords” but not every recalled cantaloupe is labelled with a sticker, the US Food and Drug Administration said. The company said it shipped out more than 300,000 cases of cantaloupes that contained five to 15 melons each, meaning the recall involved 1.5m to 4.5m pieces of fruit.

Frieden and FDA commissioner Margaret Hamburg said that illnesses are expected for weeks to come because the incubation period for listeria can be a month or even longer. Jensen Farms last shipped cantaloupes on 10 September, and the shelf life is about two weeks. “We will see more cases likely through October,” Hamburg said.

The FDA said Colorado health officials found listeria in cantaloupes taken from grocers’ and from a victim’s home. Matching strains of the disease were found on equipment and cantaloupe samples at Jensen Farms’ packing facility in Granada, Colorado.

Sherri McGarry, a senior adviser in the FDA’s office of foods, said the agency is looking at the farm’s water supply and possible animal intrusions among other things in trying to figure out how the cantaloupes became contaminated. Listeria bacteria grow in moist, muddy conditions and often are carried by animals.

The health officials said this is the first known outbreak of listeria in cantaloupe. Listeria generally is found in processed meats and unpasteurised milk and cheese, although there have been a growing number of outbreaks in produce. Hamburg called the outbreak a surprise and said the agencies were studying it closely to find out how it happened.

Cantaloupe is often the source of other outbreaks, however. Frieden said CDC had identified 10 other cantaloupe outbreaks in the last decade, most of them salmonella.

Listeria is more deadly than well-known pathogens like salmonella and E coli, although those outbreaks generally cause many more illnesses.

Listeria generally affects only the elderly, pregnant women and others with compromised immune systems. The CDC said the median age of those struck with illness is 78 and that one in five who contract the disease can die from it. Symptoms include fever and muscle aches, often with other gastrointestinal symptoms.

Unlike many pathogens, listeria bacteria can grow at room temperatures and even refrigerator temperatures. It is hardy and can linger long after the source of the contamination is gone; health officials say people who may have had the contaminated fruit in their kitchens should clean and sanitise any surfaces it may have touched.

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Listeria outbreak from cantaloupe melons kills 13 people in US September 28, 2011

A listeria outbreak linked to cantaloupes from Colorado has killed 13 people and infected 59 others, US health officials have said.

The foodborne outbreak is the deadliest in the United States in more than a decade, exceeding the 2008-2009 salmonella outbreak from tainted peanuts that killed nine and infected more than 700 people in the United States, according to the Centres for Disease Control (CDC).

So far 18 states had reported infections from one of the four strains of listeria involved, the CDC said.

Of the 13 deaths, four were in New Mexico, two in Colorado, two in Texas and one each in Kansas, Maryland, Missouri, Nebraska and Oklahoma.

The CDC said it had traced the outbreak to cantaloupes grown at Jensen Farms in Granada, Colorado, after finding Listeria monocytogenes in a sample from there.

The company issued a recall on 14 September of its Rocky Ford-brand cantaloupes. The fruit was shipped to at least 17 states.

The Food and Drug Administration has advised consumers to throw out the recalled melons.

Listeria bacteria thrive in low temperatures. Outbreaks are usually associated with deli meats, unpasteurised cheeses and smoked refrigerated seafood.

It is the deadliest listeria outbreak in the US since 1998 when contaminated hot dogs and deli meats killed 32 people and made 101 sick.

People with weakened immune systems are most vulnerable to listeria. Pregnant women are 20 times more likely than healthy adults to get listeriosis and people with Aids are nearly 300 times more likely, the CDC says on its website.

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