Friday, September 30, 2011

Fear in Colo. town at heart of Listeria outbreak (AP)

HOLLY, Colo. � Eric Jensen surveys his dusty cantaloupe field and seems equally stunned and puzzled at the fate that has befallen his crop: row upon row of melons rotting on the vine.

Jensen is the co-owner of the Colorado farm where health officials say a national listeria outbreak originated, making his withering fields the epicenter of a food scare that has sickened dozens of people from Wyoming to Maryland and caused 16 deaths.

The farm has recalled more than 300,000 cases of cantaloupes and on Thursday three states � Indiana, Louisiana and Wisconsin � were added to the recall list. Spokeswoman Amy Philpott said that trucking records show that cantaloupes originally intended for other locations ended up in those states but that the buyers were notified as part of the original Sept. 14 recall.

Jensen has no idea how his cantaloupes became infected, and neither do the Food and Drug Administration investigators who have intermittently been in this town of 800 people near the Kansas border since the outbreak started earlier this month.

Regardless of how it happened, the situation has left the town and farm reeling and in fear. Jensen had to quit growing and shipping cantaloupes after the outbreak was discovered � a staggering blow to a region where cantaloupe has always been a proud local tradition.

Until the listeria infections started showing up, Holly's field workers would bring melons into town to share, just as they have for generations. And it wasn't uncommon for Holly residents to stop by Jensen Farms to buy freshly picked cantaloupe. Now, not even the local grocery store has any of the fruit.

No one in Holly has been sickened, but people are frightened by the prospect of contracting listeria. The bacteria can have an incubation period of a month or more, and it principally affects the elderly and those with compromised immune systems.

"I ate that cantaloupe, and I gave some of it to my 97-year-old mother,'" said Wanda Watson, co-owner of the Tasty House Cafe. "I'm watching her real close. It's scary because it could be up to two months before you get sick."

Sherri McGarry, a senior adviser in the FDA's Office of Foods, said the agency is looking at the farm's water supply and the possibility that animals wandered into Jensen Farms' fields, among other things, in trying to figure out how the cantaloupes became contaminated. Listeria bacteria grow in moist, muddy conditions and are often carried by animals.

The water supply for farms in the Holly area comes from wells and irrigation ditches that tap the nearby Arkansas River. There's no shortage of thoughts around town about the potential causes.

"Well water? I doubt it. Ditch water? Well, there's some probability, but it's low," said Jim Cline, a retired construction worker. "Animal intrusion? Well, OK, what kind of animal? Deer? Coons? Coyotes? What kind of animal wants to get into a melon field?"

At Jensen Farms, workers have stopped picking cantaloupes because of a recall of its product. There's no need to irrigate the crop anymore, and the melons are drying up in the rock-hard fields. As Eric Jensen surveyed his lost crop, workers ripped up plastic that's laid down in rows to help the cantaloupe grow.

He could not discuss the outbreak, citing a likely raft of pending litigation.

"There are a lot of things I'd like to say right now, but now is not the time," Jensen said.

It's the latest blow to Holly, a town that has seen its share of hard times.

In late 2006, Holly was pummeled by a blizzard that cut off the town from the outside world so badly that helicopters had to drop feed to stranded cattle. Just as people were digging out of the blizzard, a tornado blasted through Holly, killing three people and destroying and damaging dozens of homes.

The Sept. 10 recall of Jensen Farms' cantaloupes came toward the end of a harvesting season made difficult by a severe drought that has rendered swaths of southeast Colorado, Kansas, Texas and Oklahoma federal disaster areas.

Residents talk about conditions so dry that some corn stalks have no ears of corn on them. Yields in wheat fields � usually between 40 to 50 bushels an acre � have dropped to about 20.

"We just haven't had any luck around here," said Watson.

Holly is about a 90-minute drive from the town of Rocky Ford, home to Colorado's revered cantaloupe growing region. Cantaloupes from the Arkansas River Valley are prized for their sweetness and are such a big deal that farms like Jensen's � 70 miles away � carry the brand name "Rocky Ford Cantaloupe."

The listeria scare has some residents wondering about the future for their Rocky Ford brand of cantaloupe � and cantaloupe farming in Colorado for that matter. They're hopeful this outbreak eventually will fade from the public's memory, like others involving spinach or ground meat contaminated by E. coli bacteria or salmonella.

"You think beef recalls, you think spinach in California," said Michael Daskam, who works in the local soil conservation office. "But heck, I was eating spinach and beef right after."

The same goes for locally grown cantaloupe.

"I'm not afraid of eating cantaloupe. I'd eat one right now," Holly Mayor Viola Welcher said. "We've all eaten it and no one in our area has gotten sick."

___

Online:

http://www.cdc.gov/listeria/index.html

http://1.usa.gov/rr2j1d



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Thursday, September 29, 2011

Killer cantaloupe, scary sprouts ? what to do? (AP)

MILWAUKEE � Avoid foreign produce. Wash and peel your fruit. Keep it refrigerated. None of these common tips would have guaranteed your safety from the deadliest food outbreak in a decade, the one involving cantaloupes from Colorado.

Whether it's sprouts or spinach, turkey or hamburger; whether the government doubled, tripled or quadrupled inspections, the truth is that no food will ever be completely free of risk.

And a few foods have become so risky that certain people such as children, pregnant women and the elderly may do best to avoid them altogether until growers and the government figure out how to make them safer, some food experts say.

An unappetizing fact: Although the current cantaloupe outbreak has been tied to just one farm in Colorado, it's at least the 19th outbreak involving that melon since 1984. It's also the first one caused by listeria, a germ that actually likes to be in the refrigerator and thrives in this fruit, which cannot be cooked unless you want to eat melon mush.

Listeria also prompted a California farm to recall bags of chopped romaine lettuce on Thursday because of possible contamination, though no illnesses have been reported. The greens from Salinas-based True Leaf Farms went to an Oregon distributor and possibly at least two other states � Washington and Idaho.

So what should you do if you see cantaloupe on a salad bar or at the grocery store? Can you be sure all of the tainted stuff has been pulled from the market, since the last bad melons were shipped on Sept. 10? What if no one knows where the cantaloupe was grown?

"If the store can't tell them or the restaurant can't tell them, I would not buy it at all," said Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America.

Laura Anderko, a Georgetown University public health expert, went a step further.

"Honestly, as a nurse, I would tell people don't eat the cantaloupe until this thing resolves itself," she said. "This stuff happens because our system is not as tight as it needs to be."

The federal Centers for Disease Control and Prevention, which has confirmed 13 deaths and 72 illnesses in the outbreak so far, has not told people to stop buying cantaloupe. However, the CDC and the Food and Drug Administration cannot even say where all of the tainted melon went, because it was sold and resold to many distributors across the nation.

"When in doubt, throw it out," is the CDC's advice to consumers who have any cantaloupe whose origins they can't determine.

"Even if the cantaloupe is gone, you need to wash the drawer or shelf it may have been on" to make sure other foods don't become contaminated, said Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest.

Beyond that, each outbreak brings fresh lessons on how to make produce safer. And while some of these things aren't guarantees, they can cut the odds you'll lose at the food safety lottery.

Some new tips food experts offered Thursday:

� Shop more often and consume fresh fruits and vegetables within a few days. This gives germs less chance to multiply and gives you more nutrients from your food, too.

� Don't just wash a melon. Scrub it under running water to rinse off any dislodged germs, and let it dry. If you cut it while it's still wet, "you may be sliding the pathogens more easily from the outside to the inside" on the knife, DeWaal said.

� Keep the fridge cold, 40 degrees or lower. Higher than that can let germs grow.

� Don't get a false sense of security if you buy organic produce. That just means less pesticide � not necessarily fewer germs.

� Consider dropping especially risky foods from your diet. Bean sprouts are not safe for children, pregnant women or people with weak immune systems and certain diseases, but that doesn't mean they're OK for everyone else, said Michael Doyle, a microbiologist who heads the University of Georgia's Center for Food Safety.

Doyle also consults for a lot of food companies, including a major spinach producer that sought help after outbreaks involving that vegetable. He has chaired a food safety advisory council for McDonald's for many years.

"I don't eat sprouts at all," he said. If harmful bacteria are in the seeds "they grow in the sprouting process, and there's nothing to kill them unless you cook them."

You can go too far with this, though. Even Dr. Robert Tauxe, the CDC's top food-germ sleuth, once confessed over lunch that he refused to live in fear of the fork, and that there were only a few foods he absolutely wouldn't eat, such as raw oysters and unpasteurized milk.

Beyond that, safe handling and cooking can generally keep most foods safe, he said.

The big picture is important, said Robert Gravani, a food scientist at Cornell University.

A gazillion pounds of produce are consumed each day, and only a tiny fraction cause problems, he said.

"I have a hard time saying, `Don't eat produce,' because of all of the health benefits," he said. "Everything we do has some degree of risk attached to it."

___

Online:

Food safety tips: www.cspinet.org, http://www.fightbac.org

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP



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If you're happy and you know it, did you tweet? (AP)

WASHINGTON � Twitter confirms it: People tend to wake up in a good mood and are happiest on weekends. The fast-paced forum is offering scientists a peek at real-time, presumably little-filtered human behavior and thoughts. Cornell University researchers turned to the microblog to study mood and found a pretty consistent pattern.

The researchers analyzed English-language tweets from 2.4 million people in 84 countries, more than 500 million of the brief, conversation-like exchanges sent over two years. They used a computer program that searched for words indicating positive mood � happy, enthusiastic, brilliant � or negative mood � sad, anxious, fear.

What they found: Unless you're a night owl, a positive attitude peaks early in the morning and again near midnight, but starts to dip midmorning before rising again in the evening.

Aha, you might think, going to work and related hassles like traffic explain that pattern. After all, there was more positive tweeting on the weekend, even though the morning peak of happy tweets occurred two hours later, probably because people slept late.

Not quite. Work-related stress may play some role but it can't explain why that same midday dip occurs on the weekend, too, said lead researcher Scott Golder, a Cornell graduate student. Instead, the pattern probably is due to the effects of sleep and our 24-hour biological clock, the so-called circadian rhythms that signal when it's time to sleep and to wake, Golder and Cornell sociologist Michael Macy reported. Their study appears in Friday's edition of the journal Science.

The researchers also examined tweets in the United Arab Emirates, where Friday and Saturday are considered the weekend. Sure enough, they found the same daily pattern, even though the workday tends to begin earlier there than in the West, and the same weekend pattern.

Previous research has linked the biological clock and mood, but was based mostly on small studies of American college students. There are cautions about studying Twitter postings, too: Their authors tend to be younger than the general population, and may be more affluent, better educated and different in yet-to-be-discovered ways.

Still, the study's bigger message is about the scientific potential of social media, Macy said.

Other researchers have turned to Twitter to study political campaigning, to blog postings and Twitter feeds to study emotions, and to Google searches of flu symptoms to predict outbreaks.

"It illustrates a new opportunity for doing social and behavioral science in ways that were really unimaginable even five years ago," Macy said.

___

Science: http://www.sciencemag.org/



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CDC: Miners, construction, food workers smoke most (AP)

ATLANTA � A new government report says construction workers, miners and food service workers are the occupations that smoke the most. Experts say that may have as much to do with education levels as the jobs themselves.

The Centers for Disease Control and Prevention study found 19.6 percent of working adults smoke, but as many as 30 percent in the mining, construction and food service industries smoke. Librarians and teachers smoked the least, at less than 9 percent.

Also, people who work outdoors are less likely to face indoor smoking bans seen in other workplaces.

The study is based on in-person interviews of more than 113,000 working adults in the years 2004 through 2010.

___

Online:

CDC report: http://www.cdc.gov/mmwr



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Wednesday, September 28, 2011

Cantaloupe illnesses and deaths expected to rise (AP)

WASHINGTON � Federal health officials said Wednesday more illnesses and possibly more deaths may be linked to an outbreak of listeria in cantaloupe in coming weeks.

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

The heads of the Centers for Disease Control and Prevention and the Food and Drug Administration said consumers who have cantaloupes produced by Jensen Farms in Colorado should throw them out. If they are not sure where the fruit is from, they shouldn't eat it.

Neither the government nor Jensen Farms has supplied a list of retailers who may have sold the fruit. Officials say consumers should ask retailers about the origins of their cantaloupe. If they still aren't sure, they should get rid of it.

"If it's not Jensen Farms, it's OK to eat," said Thomas Frieden, director of the CDC. "But if you can't confirm it's not Jensen Farms, then it's best to throw it out."

Jensen Farms of Holly, Colo. says it shipped cantaloupes to 25 states, though the FDA has said it may be more, and 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 went.

The recalled cantaloupes may be labeled "Colorado Grown," `'Distributed by Frontera Produce," `'Jensenfarms.com" or "Sweet Rocky Fords." Not all of the recalled cantaloupes are labeled with a sticker, the FDA said. The company said it shipped out more than 300,000 cases of cantaloupes that contained five to 15 melons, meaning the recall involved 1.5 million to 4.5 million pieces of fruit.

The FDA said none of the cantaloupes had been exported, reversing an earlier statement that some of the tainted melons had been shipped abroad.

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. That means that someone who ate contaminated cantaloupe last week may not get sick until next month. Jensen Farms last shipped cantaloupes on Sept. 10. The shelf life is about two weeks.

"We will see more cases likely through October," Hamburg said.

The Food and Drug Administration said state health officials found listeria in cantaloupes taken from Colorado grocery stores and from a victim's home that were grown at Jensen Farms. Matching strains of the disease were found on equipment and cantaloupe samples at Jensen Farms' packing facility in Granada, Colo.

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 are often carried by animals.

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

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

Listeria is more deadly than well-known pathogens like salmonella and E. coli, though those outbreaks generally cause many more illnesses. Twenty-one people died in an outbreak of listeria poisoning in 1998 traced to contaminated hot dogs and possibly deli meats made by Bil Mar Foods, a subsidiary of Sara Lee Corp. Another large listeria outbreak, in 1985, killed 52 people and was linked to Mexican-style soft cheese.

Listeria generally only sickens the elderly, pregnant women and others with compromised immune systems. The CDC said the median age of those sickened is 78 and that 1 in 5 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 sanitize any surfaces it may have touched.

The CDC said Tuesday that 13 deaths are linked to the tainted fruit. State and local officials say they are investigating three additional deaths that may be connected.

The death toll released by the CDC Tuesday surpassed the number of deaths linked to an outbreak of salmonella in peanuts almost three years ago. Nine people died in that outbreak. The CDC reported four deaths in New Mexico, two deaths each in Colorado and Texas and one death each in Kansas, Missouri, Nebraska, Oklahoma and Maryland.

New Mexico officials said Tuesday they are investigating a fifth death, while health authorities in Kansas and Wyoming said they too are investigating additional deaths possibly linked to the tainted fruit.

The CDC reported the 72 illnesses and deaths in 18 states. Cases of listeria were reported in California, Colorado, Florida, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, Nebraska, New Mexico, North Dakota, Oklahoma, Texas, Virginia, West Virginia, Wisconsin, and Wyoming. The most illnesses were reported in Colorado, which has seen 15 sickened. Fourteen illnesses were reported in Texas, 10 in New Mexico and eight in Oklahoma.

While most healthy adults can consume listeria with no ill effects, it can kill the elderly and those with compromised immune systems. It is also dangerous to pregnant women because it easily passes through to the fetus. The CDC's Frieden said that two of those sickened were pregnant women but they have since recovered.

___

Online:

CDC on cantaloupe outbreak: http://www.cdc.gov/listeria/index.html

FDA on cantaloupe recall: http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm

Center for Science and the Public Interest, "Super Safe Your Kitchen": http://www.cspinet.org/new/pdf/safekitchen.pdf

___

Find Mary Clare Jalonick on Twitter at http://twitter.com/MCJalonick



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Dementia patients suffer dubious hospitalizations (AP)

One-fifth of Medicare nursing home patients with advanced Alzheimer's or other dementias were sent to hospitals or other nursing homes for questionable reasons in their final months, often enduring tube feeding and intensive care that prolonged their demise, a new study found.

Nursing homes may feel hospital care is warranted when a frail, elderly patient develops swallowing problems, pneumonia or a serious infection, but researchers suspect a different motive for many transfers: money. Medicare pays about three times the normal daily rate for nursing homes to take patients back after a brief hospitalization.

"I think that's unfortunately a factor in what's happening here," said Dr. Joan Teno, a palliative care physician and health policy professor at Brown University. "A lot of this care just feels like in and out, in and out. You really have to question, is the health care system doing a good job or not."

She is a co-author of the study, published in Thursday's New England Journal of Medicine and done with researchers from Harvard University and Dartmouth Medical School.

Among the nearly 475,000 patients studied, 19 percent were moved for questionable reasons. The study provided no evidence that money motivated such transfers or that there was wrongdoing involved. However, the large variation that researchers saw from state to state suggests money may be playing a role.

Rates of such transfers varied from 2 percent in Alaska to more than 37 percent in Louisiana. In McAllen, Texas, 26 percent of study participants had multiple hospitalizations for urinary infections, pneumonia or dehydration � conditions that usually can be treated in a nursing home. That compares to just 1 percent of patients in Grand Junction, Colo.

The researchers used Medicare records from 2000 through 2007 to identify "burdensome" transitions of care: moving patients in the last three days of life, moving them multiple times in the last three months of life, or moving them so they landed in a new nursing home afterward.

Medicaid pays on average $175 per day, depending on the state, for long-term care, but Medicare will pay three times that for skilled nursing care after a patient returns from three days or more in a hospital.

"If you have a nursing home that is operating on a margin, it adds up. It can be a tremendous incentive to hospitalize these people," Teno said.

Researchers found that patients who had a dubious transfer were more likely to have a feeding tube inserted, to spend time in intensive care in the last month of life, to have a severe bedsore or to be enrolled in hospice late (three days or less before they died).

Dubious transfers were more common with black patients, Hispanics and those without advance directives, legal documents spelling out care wishes.

The National Institute on Aging sponsored the study. One author consults for a nursing home system and owns stock in a long-term care information services company.

The study is important because more than 1.6 million Americans live in nursing homes, and nearly one-quarter of people admitted to one after hospitalization wind up back in the hospital within a month, Dr. Joseph Ouslander of Florida Atlantic University in Boca Raton and Dr. Robert Berenson of the Urban Institute in Washington, D.C., wrote in an editorial in the journal. Nursing homes may fear legal liability if they don't hospitalize a very sick patient, they wrote.

However, people with advanced dementia have a terminal condition.

"These are people who are unable to recognize their relatives, they're bed-bound and they're now usually having problems with swallowing. This is a population where the burdens of hospitalization often outweigh the possible benefits," Teno said. "These patients actually do better when they stay in a nursing home," where caregivers and surroundings are familiar, she said.

For families and nursing homes, "it may be difficult to recognize that in fact, this person is in the dying process," said Dr. Michael Malone, medical director of senior services for Aurora Health Care, a network of 15 hospitals in eastern Wisconsin. His 87-year-old father, Wendell Malone, died in January of advanced dementia in a nursing home that managed his care without frequent hospitalizations.

"It provided dignity, it provided comfort for the family," and let him stay in a place and with caregivers he knew, Malone said.

Beth Kallmyer, who runs programs for caregivers for the Alzheimer's Association, said the most important thing is to have a plan in place, with legal documents like "do not hospitalize" directives, before a nursing home has to make a decision about whether to hospitalize someone or instead focus on comfort care and not try to prolong life.

"When the time comes, the family will be able to say `This is what dad wanted,'" Kallmyer said.

She and other experts offered these tips:

_Involve patients in planning their care while they're still able to do so, and make sure wishes like "do not resuscitate" or "do not call 911" are spelled out in legal documents.

_Develop good relationships with nursing home staff and attending physicians so they understand the family's goals of care.

_Consider hospice care when seniors with advanced dementia are admitted.

_Revisit and review the plan whenever there is a change in a loved one's status. Someone may not be end-stage when they enter a nursing home but that can change.

_Seek advice. The Alzheimer's Association has a 24-hour toll-free number, 1-800-272-3900, with counselors to help families.

___

Online:

Medical journal: http://www.nejm.org

State reports: http://www.LTCFocUS.org

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP



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Tuesday, September 27, 2011

Lawmakers: CDC to have student concussion protocol (AP)

NUTLEY, N.J. � As awareness continues to grow about sports-related concussions among student athletes, two New Jersey lawmakers say it's time for schools to start following nationwide protocols governing such injuries.

U.S. Sen. Robert Menendez and Rep. Bill Pascrell announced Tuesday that the Centers for Disease Control and Prevention agreed to study and develop national guidelines for managing sports-related concussions for student athletes.

Menendez and Pascrell, both New Jersey Democrats, had sponsored legislation, which passed the House but stalled in the Senate, that would have made such protocols mandatory. Several states, including New Jersey, have laws requiring a physician's approval for a student to return to sports, but Pascrell said there needs to be nationwide guidance for schools and youth sports programs to follow.

"The science may be changing, but that's no excuse for not establishing a protocol," Pascrell said, referring to differing scientific findings on concussions. "We're close to that for our soldiers, we need to be even closer for our children."

Stressing that "every concussion is brain damage," Pascrell said 41 percent of student athletes who suffer concussions return to playing too soon, sometimes with serious or even fatal consequences.

The CDC will convene a panel of experts to define the scope of the protocol, review existing literature, review the current state of science on concussions and have protocols ready for distribution by fall of 2014, according to Pascrell.

"Sports are a great way for kids and teens to stay healthy and this project will help us continue the important work in traumatic brain injuries in sports and other activities," said Dr. Linda C. Degutis of CDC's National Center for Injury Prevention and Control. "CDC's new initiative on pediatric guidelines will work to improve diagnosis and management of brain injuries in younger children and teens who are injured on or off the playing field."

About a dozen states, including New Jersey, have rules related to concussions and brain injuries among student athletes, according to the National Conference of State Legislatures. Other states are considering similar measures.

Concussions are caused by a blow that forces the head to move violently. They can affect memory, judgment, reflexes, speech, balance and muscle coordination and the symptoms become worse if not properly treated. Young people, particularly girls, are more susceptible to long-term repercussions than adults.

Pascrell started pushing for legislation after the October 2008 death of Montclair High school football player Ryne Dougherty. Dougherty reportedly sat out three weeks after suffering a concussion but was cleared to return to playing after taking a test. He collapsed after making a tackle his first game back, and died after suffering a brain hemorrhage.

For years, the CDC has been working on the issue of sports-related concussions, and developed materials for coaches on steps to take if they think a student athlete suffered a concussion. Those steps include removing the athlete from the game or practice, and then having them evaluated by a health care professional with experience in concussions. The advice also suggests not returning the athlete to play until the health professional says it's OK, and telling the student's parents what happened.

But Tuesday's announcement represents something broader. The CDC is putting together an expert panel to discuss possible pediatric guidelines for doctors on how to best diagnose and treat concussions that occur not only on the sports field but also from car accidents, falls and other causes. That might include a look at the type of assessments currently used, although exactly what the panel will examine hasn't been decided.

The announcement was held at Nutley High School in New Jersey, where athletes say the school has adopted a strict policy in recent years on monitoring concussions.

Seventeen-year-old Andre Hamlin has been playing football since he was in the third grade. Now a senior on the football team, he said he's noticed a major change in recent years, with coaches making awareness and testing for concussions mandatory.

Hamlin said all student athletes take a computerized "impact test" of word problems and other questions that test brain function and must be cleared by a doctor before starting any sport.

He said awareness of concussions is now common and that coaches tell players how to avoid concussions by keeping their heads up during football plays.

"It's something that's present throughout the season, our coach emphasizes it," Hamlin said. "If you see a player put their head down incorrectly it kind of gets your skin crawling, `cause that's how you can get a concussion. We tell the younger kids: put your head up, and stay safe out there."

___

AP Medical Writer Mike Stobbe in Atlanta contributed to this report.

___

Follow Samantha Henry at http://www.twitter.com/SamanthaHenry.



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Monday, September 26, 2011

Study: Dads less likely to die of heart problems (AP)

Fatherhood may be a kick in the old testosterone, but it may also help keep a man alive. New research suggests that dads are a little less likely to die of heart-related problems than childless men are.

The study � by the AARP, the government and several universities � is the largest ever on male fertility and mortality, involving nearly 138,000 men. Although a study like this can't prove that fatherhood and mortality are related, there are plenty of reasons to think they might be, several heart disease experts said.

Marriage, having lots of friends and even having a dog can lower the chance of heart problems and cardiac-related deaths, previous research suggests. Similarly, kids might help take care of you or give you a reason to take better care of yourself.

Also, it takes reasonably good genes to father a child. An inability to do so might mean a genetic weakness that can spell heart trouble down the road.

"There is emerging evidence that male infertility is a window into a man's later health," said Dr. Michael Eisenberg, a Stanford University urologist and fertility specialist who led the study. "Maybe it's telling us that something else is involved in their inability to have kids."

The study was published online Monday by the journal Human Reproduction.

Last week, a study by other researchers of 600 men in the Philippines found that testosterone, the main male hormone, drops after a man becomes a dad. Men who started out with higher levels of it were more likely to become fathers, suggesting that low levels might reflect an underlying health issue that prevents reproduction, Eisenberg said.

In general, higher levels of testosterone are better, but too much or too little can cause HDL, or "good cholesterol," to fall � a key heart disease risk factor, said Dr. Robert Eckel, past president of the American Heart Association and professor of medicine at the University of Colorado, Denver.

"This is a hot topic," Eckel said. "I like this study because I have five children," he joked, but he said many factors such as job stress affect heart risks and the decision to have children.

Researchers admit they couldn't measure factors like stress, but they said they did their best to account for the ones they could. They started with more than 500,000 AARP members age 50 and over who filled out periodic surveys starting in the 1990s for a long-running research project sponsored by the National Cancer Institute.

For this study, researchers excluded men who had never been married so they could focus on those most likely to have the intent and opportunity to father a child. Men with cancer or heart disease also were excluded to compare just men who were healthy when the study began.

Of the remaining 137,903 men, 92 percent were fathers and half had three or more children. After an average of 10 years of follow-up, about 10 percent had died. Researchers calculated death rates according to the number of children, and adjusted for differences in smoking, weight, age, household income and other factors.

They saw no difference in death rates between childless men and fathers. However, dads were 17 percent less likely to have died of cardiovascular causes than childless men were.

Now for all the caveats.

Researchers don't know how many men were childless by choice and not because of a fertility problem.

They don't know what fertility problems the men's partners may have had that could have left them childless.

They didn't have cholesterol or blood pressure information on the men � key heart risk factors.

Less than 5 percent of participants were blacks or other minorities, so the results may not apply to them.

All those questions aside, however, some prominent heart experts were reassured by the study's large size and the steps researchers took to adjust for heart disease risk factors.

"I think there's something there," and social science supports the idea that children can lower heart risks, said Dr. Eric Topol, a cardiologist and genetics expert at Scripps Health in La Jolla, Calif. "Whether it's with a pet, a spouse or social interaction ... all those things are associated with better outcomes."

Dr. Daniel Rader, director of preventive cardiology at the University of Pennsylvania, said: "It's biologically plausible that there's a connection," but the reduced risk attributed to having children "is pretty modest."

Men often ask him what they can do to keep from dying of a heart attack, he said.

"I'm not really prepared to, on the basis of this, tell them to start having a few kids," Rader said.

___

Online:

Medical journal: http://humrep.oxfordjournals.org/content/early/recent

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP



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Decade after anthrax attacks, worry over stockpile (AP)

WASHINGTON � Anthrax vaccine � check. Antibiotics � check. A botulism treatment � check. Smallpox vaccine � check.

Ten years after the anthrax attacks brought home the reality of bioterrorism, the nation has a stockpile of some basic tools to fight back against a few of the threats that worry defense experts the most.

These defenses are not just gathering dust awaiting the next attack. In August, a Minneapolis hospital dipped into the stockpile to treat a critically ill patient � a tourist who, somewhere on his Midwest vacation, had the extraordinary bad luck to breathe anthrax spores that naturally linger in the dirt in parts of the country. The man, who survived, received a kind of medication not available in October 2001 when anthrax spores sent through the mail killed five people and sickened 17.

But there's wide concern that the nation's arsenal hasn't grown fast enough. A decade later, there are no treatments for a number of bugs on the worry list, and little to offer for other threats like a radiation emergency. Even a long-promised next-generation anthrax vaccine, that would be easier to produce, hasn't arrived yet. Nor is there information on how to treat children.

"Where are the countermeasures?" advisers to the Department of Health and Human Services asked in a critical report last year.

There are some: There's enough smallpox vaccine for everyone, plus some of a specially formulated version safe for cancer patients and others with weak immune systems. There's an improved version of the decades-old anthrax vaccine used in 2001. There are a few treatments for the toxins produced by anthrax and botulism, and a smallpox treatment is due soon.

But federal health officials are working to jumpstart production of more countermeasures and they say that more than 80 candidates are in advanced development. Over the past year, the goal has evolved into a push for more multiuse therapies, products that work not just for biodefense but for everyday health problems, too.

That's a major shift that should entice more big drug companies to the field, says Dr. Robin Robinson, who heads the federal Biomedical Advanced Research and Development Authority, or BARDA. It funds late-stage research of promising countermeasures.

Consider: BARDA just agreed to help pay for drug giant GlaxoSmithKline's testing of a novel antibiotic that might fight bioterrorism germs like plague � as well as certain hospital-spread bacteria that cause such problems as pneumonia in the already seriously ill.

So-called broad-spectrum antibiotics that can kill more than one kind of bacteria aren't unusual � this one just targets some hard-to-treat types in a new way.

The next step: Scientists are beginning to create the first broad-spectrum antivirals, medicines that would treat more than one kind of virus. Rather than having an anti-flu drug and a separate anti-AIDS drug, the goal is to have a single injection that could treat those viruses plus the gruesome Ebola virus and a few more for good measure.

It's early work, still years away, cautions Dr. Michael Kurilla, biodefense research chief at the National Institute of Allergy and Infectious Diseases. But one of the antivirals is a direct result of biodefense research to understand how viruses infect � specifically, the Nipah virus that was the model for the even-scarier fictional bug in the new movie "Contagion."

And these multipurpose antivirals are a huge goal because if they pan out, the next time a brand-new virus emerges � like the respiratory SARS bug in 2003 � treatments might not have to be started from scratch.

"We feel very excited and confident that what we're working on ... can change the whole paradigm of how we approach infectious diseases," Kurilla says.

The U.S. has invested $67 billion in biosecurity since 2001, according to research by the Center for Biosecurity at the University of Pittsburgh Medical Center.

Most of that wasn't solely for biodefense but went to broader health programs that are as crucial for dealing with natural crises � like the 2009 swine flu global epidemic � as for dealing with manmade ones, says center director Dr. Thomas Inglesby. These include scientific research, beefing up struggling public health departments to better detect and treat emerging outbreaks, and training hospitals in disaster preparedness.

Inglesby worries that the economic crisis imperils those gains � public health funding already has been cut � and will further slow the countermeasure hunt. A program named BioShield that buys countermeasures for the stockpile expires in 2013 unless Congress reauthorizes it. It's time, he says, for the government to spell out its countermeasure priorities and how to reach them.

Meanwhile, what if another anthrax attack happened? No more scrambling to buy antibiotics: 60 million 60-day treatment courses are stockpiled, Robinson says, and the plan is for the post office to get the first doses to people's homes.

Sometimes antibiotics aren't enough. In a severe infection, the germs can produce dangerous toxins that spread in the bloodstream. So also in the stockpile are two experimental toxin-clearing treatments, to be used if the immune system alone can't battle the toxin.

In August, Minnesota's sick tourist became the 19th person in the world ever treated with one of them � immune globulin culled from the blood of anthrax-vaccinated soldiers, says Dr. Mark Sprenkle of Hennepin County Medical Center. It's hard to know how much the drug contributed to the man's recovery, Sprenkle says, but his patient's toxin levels did drop more quickly after he began using it.

___

EDITOR'S NOTE � Lauran Neergaard covers health and medical issues for The Associated Press.



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Do hospitals' freebies undermine breast-feeding? (AP)

CHICAGO � Jessica Ewald brought more than a new baby boy home when she gave birth earlier this year. Like many new moms, she got a hospital goody bag, with supplies including free infant formula and formula coupons.

"We gave it away the moment we came home because I said I'm not having that in our house," Ewald said.

Ewald, 32, of Oakbrook Terrace, Ill., is the daughter of a breast-feeding activist who fought to get those goody bags out of hospitals. Ewald was taught early on that "breast is best," and even though as a teen she rolled her eyes when her mom asked pregnant women about nursing, Ewald knew she'd choose breast over bottle when her own time came.

Borrowing a line from a blogger, Ewald says hospitals sending newborns home with formula "is like giving somebody divorce papers at their wedding." It can really undermine a woman's determination to breast-feed, she said.

The head of the federal Centers for Disease Control and Prevention shares her concern.

"Hospitals need to greatly improve practices to support mothers who want to breast-feed," Dr. Thomas Frieden said last month in releasing a CDC report card on breast-feeding. It showed that less than 5 percent of U.S. infants are born in "baby-friendly" hospitals that fully support breast-feeding, and that 1 in 4 infants receive formula within hours of birth.

Routinely offering new moms free formula is among practices the CDC would like to end. In some cases, hospitals agree to give out those freebies in exchange for getting free supplies for special-needs infants, Frieden said.

Exactly how many U.S. hospitals hand out formula is unclear. The American Hospital Association and the International Formula Council, a trade group for formula makers, do not keep statistics and formula companies contacted for this story declined to comment.

A nationwide study of more than 3,000 U.S. hospitals and maternity centers published last year in the Journal of Human Lactation found that 91 percent sent new moms home with free formula in 2006-07. A smaller 2010 study of 1,239 hospitals suggests that the practice has decreased, although most � 72 percent � still offered formula. That study is being released Monday in October's Pediatrics.

"I don't think hospitals are the right place to market anything and I don't think hospitals should be marketing a product that is nutritionally inferior to breast milk," said study author Anne Merewood, an associate pediatrics professor at Boston University medical school and editor of the Journal of Human Lactation.

"People do think if a doctor gives something it must be good for you," Merewood said.

Some women and activists, though, say the move to end formula freebies is part of a breast-feeding movement that has gone too far, overstating the benefits and guilt-tripping new moms who have difficulty nursing or just choose not to. And even some breast-feeding moms don't have a problem with the free formula.

"I think it's fine to offer freebies to any mom, especially those who are undecided or have already made up their mind not to breast-feed. We are always free to refuse," said the Rev. Camille Lebron Powell, an associate Presbyterian pastor in Little Rock, Ark.

Breast milk contains antibodies that strengthen babies' immune systems and help them fight infections. Research has shown that breast-fed babies have reduced chances of becoming obese or developing diabetes in childhood, and sudden infant death syndrome is less common in breast-fed infants.

The American Academy of Pediatrics and other medical groups recommend that infants receive only breast milk for their first six months. The new CDC report shows that only 15 percent of new mothers achieve that goal, and only 44 percent of new moms breast-feed at all for six months.

Lebron Powell doesn't dispute the benefits and chose to breast-feed her children, aged 9 months and 4 years old. But she says those who choose to use formula shouldn't be demonized.

"Breast-feeding is free. It's good for the baby and it's good for the mom. But it's hard and if you work and the employer doesn't support your pumping needs, you are in trouble," she said.

Hospitals have been offering formula freebies for decades, but they have a new incentive to abandon the practice.

The Joint Commission hospital accrediting group last year added "exclusive breast milk feeding" during newborns' hospital stays as a measure that hospitals can be evaluated on. While formula giveaways won't be evaluated, the commission mentions monitoring that practice when it educates hospitals on how to improve their performance, said Celeste Milton, an associate project director at the commission.

The goal is to discourage hospitals from giving infants formula when it's not medically necessary, said commission spokeswoman Elizabeth Zhani.

Central DuPage Hospital in Winfield, Ill., the suburban Chicago hospital where Ewald had her baby last March, boasts that 93 percent of its new mothers are breast-feeding when they're sent home. It also supplies lactation consultants to new moms � a service Ewald said she appreciated. But Ewald said she got a mixed message about breast-feeding, because nurses there wanted to give her baby formula to help him gain weight, and because of those free samples in her goody bag.

Hospital spokeswoman Amy Jo Steinbruecker said the gift bags contain "literature and samples of common items newborns may need, including a small sample of formula," and are meant to support healthy parenting and baby care.

But she said the hospital is examining the formula freebies as it seeks to be designated "baby-friendly."

The World Health Organization and the United Nations Children's Fund established that designation to encourage breast-feeding, with 10 criteria hospitals must meet. These include allowing new moms and infants to remain together throughout the hospital stay and not giving newborns any pacifiers or formula.

Jennifer Smoter, a spokeswoman for Abbott Nutrition, makers of Similac formula, declined to disclose how many hospitals Abbott provides with formula samples and would not comment on the practice. Representatives of Mead Johnson, makers of Enfamil formula, did not respond to several email and telephone requests for comment.

Haley Stevens, a scientific affairs specialist for the International Formula Council trade group, said not offering new moms formula samples "is really irresponsible."

New moms should have formula available, along with information on how to use it so they don't water it down or make other mistakes that could endanger their babies' health, Stevens said.

"We agree breast-feeding is the best, when you can do it," she said. "There's no question. But if one size doesn't fit all, it's good to have a backup."

___

Online:

CDC breast-feeding report: http://www.cdc.gov/breastfeeding/data/reportcard.htm

American Academy of Pediatrics: http://www.aap.org

___

AP Medical Writer Lindsey Tanner can be reached at www.twitter.com/LindseyTanner



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Saturday, September 24, 2011

Japan finds radiation in rice, more tests planned (AP)

TOKYO � Japan is ordering more tests on rice growing near a crippled nuclear plant after finding elevated levels of radiation, government officials said Saturday.

A sample of unharvested rice contained 500 becquerels of cesium per kilogram, they said. Radioactive cesium was spewed from the Fukushima Dai-ichi nuclear power plant after it was damaged by a massive earthquake and tsunami on March 11.

Under Japanese regulations, rice with up to 500 becquerels of cesium per kilogram is considered safe for consumption.

Officials have tested rice from more than 400 spots in Fukushima prefecture. The highest level of cesium previously found was 136 becquerels per kilogram, prefectural official Kazuhiko Kanno said.

News of the elevated radiation level in rice from Nihonmatsu city, 55 kilometers (35 miles) west of the nuclear plant, set off alarm in the Japanese media.

The government has been testing vegetables and fish for radiation since the disaster, in which backup generators and cooling systems failed at the plant and the cores of three reactors melted.

Some nations have stopped importing some food products from Japan. Japanese consumers are nervous about radiation, but campaigns to buy from Fukushima have drawn support around the nation.



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Friday, September 23, 2011

AP IMPACT: Hospital drug shortages deadly, costly (AP)

TRENTON, N.J. � A drug for dangerously high blood pressure, normally priced at $25.90 per dose, offered to hospitals for $1,200. Fifteen deaths in 15 months blamed on shortages of life-saving medications.

A growing crisis in the availability of drugs for chemotherapy, infections and other serious ailments is endangering patients and forcing hospitals to buy from secondary suppliers at huge markups because they can't get the medications any other way.

An Associated Press review of industry reports and interviews with nearly two dozen experts found the shortages � mainly of injected generic drugs that ordinarily are cheap � have delayed surgeries and cancer treatments, left patients in unnecessary pain and caused hospitals to give less effective treatments. That's resulted in complications and longer hospital stays.

Just over half of the 549 U.S. hospitals responding to a survey this summer by the Institute for Safe Medication Practices, a patient safety group, said they had purchased one or more prescription drugs from so-called "gray market vendors" � companies other than their normal wholesalers.

Most also said they've had to do so more often of late, and 7 percent reported side effects or other problems with those drugs.

Hospital pharmacists "are really looking at this as a crisis. They are scrambling to find drugs," said Joseph Hill of the American Society of Health-System Pharmacists.

At a hearing Friday before the health subcommittee of the House Energy and Commerce Committee, hospital officials and other experts testified that the worsening shortages are preventing them from giving many patients the best care and are driving up costs.

"Considering the nation's budget crisis and our skyrocketing health care bill, these markups are nothing more than profiteering at the expense of patients and providers who are struggling to afford vital medicines," said Mike Alkire, chief operating officer of Premier Healthcare Alliance, a group that helps U.S. hospitals and other health providers improve their patient care and finances.

The shortages could cost hospitals at least $415 million a year, he said, citing data from health care providers across the nation. So far, hospitals have been absorbing the extra costs, but they'll soon have to start passing them on to insurers and patients, according to the American Hospital Association.

The scarcity of mainstay cancer drugs is not only hurting patients but is halting or disrupting clinical studies of potential new treatments, said Dr. Robert S. DiPaola, director of the Cancer Institute of New Jersey.

"The drug shortages of today can have a ripple effect on the availability of new drugs and treatment combinations tomorrow," he told the committee.

On Monday, the Food and Drug Administration is holding a meeting with medical and consumer groups, researchers and industry representatives to discuss the shortages and strategies to fight them.

The FDA says the primary cause of the shortages is production shutdowns because of manufacturing problems, such as contamination and metal particles that get into medicine.

Other reasons include theft of prescription drugs from warehouses or during shipment, as well as the "gray market" vendors who buy scarce drugs from small regional wholesalers, pharmacies or other sources and then sell them to hospitals at many times the normal price. These sellers may not be licensed, authorized distributors.

In addition, many companies have stopped making generic injected drugs because the profit margins are slim. Producing them is far more expensive than stamping out pills, and it takes about three weeks to produce a batch. Making things worse, companies don't have to notify customers or the FDA that they've stopped making a medicine. That means neither FDA nor competitors can fill the gap in time.

Only a half-dozen companies make the vast majority of injected generics. Even if other companies wanted to begin making a drug in short supply, they're discouraged by the lengthy, expensive process of setting up new manufacturing lines and getting FDA approval.

Hospitals that buy scarce medicines from the "gray market" are taking a gamble.

The drugs may be stolen and hospitals can't always tell whether a medicine was properly refrigerated � as required for many injectable drugs � or whether it's past the expiration date, said Michael R. Cohen, a pharmacist and president of the institute. The active ingredient might have degraded and the drug might not work well or could even harm the patient, he said.

Cohen attributes at least 15 recent deaths to drug shortages, either because the right drug wasn't available or because of dosing errors or other problems in administering or preparing alternative medications. But many deaths and injuries go unreported, he said.

In the worst known case, Alabama's public health department this spring reported nine deaths and 10 patients harmed due to bacterial contamination of a hand-mixed batch of liquid nutrition given via feeding tubes because the sterile pre-mixed liquid wasn't available.

So far this year, 210 drugs have been added to the list of those in short supply, one less than the total for all of last year, according to the University of Utah Drug Information Service, which tracks the shortages. That's triple the roughly 70 a year from 2003 to 2006, when shortages began to climb steadily.

"The shortages aren't resolving. They're piling up on top of existing ones," said Erin Fox, a pharmacist who manages the service. She said at least 55 drugs from shortages before this year are still unavailable or scarce.

The average price markup on drugs sold by secondary distributors was 650 percent, according to an Aug. 16 report by the Premier Healthcare Alliance. The figure is based on an analysis of 636 unsolicited sales offers that were faxed and emailed to hospitals from secondary distributors in April and May.

Virtually every offer was for at least double the normal price, the survey found. The drugs with the highest markups were for critically ill patients needing anesthesia or other medicines for surgery or for emergency care, cancer, infectious diseases and pain management.

In an extreme case, one vendor was offering a generic beta blocker for dangerously high blood pressure, normally priced at $25.90 per dose, for $1,200.

The FDA says it must uphold quality standards but also works hard to prevent shortages.

"When FDA detects a contaminant, whether it be shards of glass or metal particles or an infectious agent, we have to take action to protect the public," said Dr. Peter Lurie, a senior adviser in the FDA commissioner's office.

When such problems force a company to shut down production, the FDA urges other manufacturers to boost their output and expedites any approvals needed, said Valerie Jensen, associate director of the agency's drug shortage program. When raw materials used to make drugs are in short supply, the FDA tries to find new sources.

The agency averted 38 shortages last year, Jensen added. Another 99 have been prevented so far this year, Howard K. Koh, assistant secretary for health in the Department of Health and Human Services, told the committee.

Legislation pending in the House and Senate would increase penalties for drug thefts from warehouses and tractor-trailers. Another proposal, which has bipartisan support, would require drug manufacturers anticipating a shortage to immediately notify the FDA.

The pitches hospitals get from secondary distributors generally say they have small batches of specific drugs that are hard or impossible to find. "Are you enjoying this crazy `roller coaster ride' of pharmaceutical shortages? ... I utilize over 60 vendors to locate and procure needed pharmaceuticals to assist when you have shortage needs," one reads.

Several distributors who sent hospitals solicitations for scarce drugs didn't return calls from the AP. One representative said he wasn't authorized to discuss the issue.

Another company, Novis Pharmaceuticals, defended the higher prices, saying secondary distributors have to charge far more because they don't get the big rebates manufacturers give primary distributors. They also have high costs to locate and transport batches of scarce drugs, although the company, which mainly distributes blood plasma, would not disclose its profit margin.

It's illegal for companies to collude to create a medicine shortage and raise prices, and there's no evidence of that. There's no federal law against price-gouging on prescription drugs, according to the FDA, but it does urge pharmacists to report cases to its Office of Criminal Investigation. An agency spokeswoman said she could not discuss whether any cases are being investigated.

The top three wholesalers say they try to alleviate problems by working with drug manufacturers, updating hospitals on shortages and rationing scarce supplies by giving their regular hospital customers a portion of their normal order. McKesson Corp. and Cardinal Health Inc. say they halt sales to any smaller distributors found to be diverting drugs or otherwise breaking rules. AmerisourceBergen Corp. does background checks on customers.

The hospital association and other groups urge hospitals not to buy from unaccredited vendors, to insist on documentation of the drug's source if they must, and to report price gouging to state authorities. But only three states � Kentucky, Maine and Texas � have price-gouging laws that specifically cover medicines.

"Something has to be done here," said pharmacist Michael O'Neal, head of drug procurement for Vanderbilt University Medical Center in Nashville, which has had to purchase medicines from secondary suppliers about 70 times over the past two years.

"This is unethical," he said. "We're talking about people's lives."

___

Summary of state price-gouging laws: http://www.ncsl.org/default.aspx?tabid14434

Institute for Safe Medication Practices consumer site: http://www.consumermedsafety.org/



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AP IMPACT: Hospitals face drug price-gouging (AP)

TRENTON, N.J. � A severe shortage of drugs for chemotherapy, infections and other serious ailments is endangering patients and forcing hospitals to buy life-saving medications from secondary suppliers at huge markups because they can't get them any other way.

An Associated Press review of industry reports and interviews with nearly two dozen experts found at least 15 deaths in the past 15 months blamed on the shortages, either because the right drug wasn't available or because of dosing errors or other problems in administering or preparing alternative medications.

The shortages, mainly involving widely-used generic injected drugs that ordinarily are cheap, have been delaying surgeries and cancer treatments, leaving patients in unnecessary pain and forcing hospitals to give less effective treatments. That's resulted in complications and longer hospital stays.

Just over half of the 549 U.S. hospitals responding to a survey this summer by the Institute for Safe Medication Practices, a patient safety group, said they had purchased one or more prescription drugs from so-called "gray market vendors"_ companies other than their normal wholesalers. Most also said they've had to do so more often of late, and 7 percent reported side effects or other problems.

Hospital pharmacists "are really looking at this as a crisis. They are scrambling to find drugs," said Joseph Hill of the American Society of Health-System Pharmacists.

A hearing on the issue was set for Friday before the health subcommittee of the House Energy and Commerce Committee. The Food and Drug Administration is holding a meeting Monday with medical and consumer groups, researchers and industry representatives to discuss the shortages and strategies to fight them.

The FDA says the primary cause of the shortages is production shutdowns because of manufacturing problems, such as contamination and metal particles that get into medicine.

Other reasons:

� Companies abandoning the injected generic drug market because the profit margins are slim. Producing these sterile medicines is far more complicated and expensive than stamping out pills, and it can take about three weeks to produce a batch. Making things worse, companies don't have to notify customers or the FDA that they've stopped making a medicine. That means neither FDA nor competitors can try to fill the gap.

� Only a half-dozen companies make the vast majority of injected generics. Even if other companies wanted to begin making a generic drug in short supply, they're discouraged by the lengthy, expensive process of setting up new manufacturing lines and getting FDA approval.

� Theft of prescription drugs from warehouses or during shipment.

� Secondary, "gray market" vendors who buy scarce drugs from small regional wholesalers, pharmacies or other sources and then market them to hospitals, often at many times the normal price. These sellers may not be licensed, authorized distributors.

Hospitals that buy scarce medicines from the "gray market" are taking a gamble.

The drugs may be stolen and hospitals can't always tell whether a medicine was properly refrigerated � as required for many injectable drugs � or whether it's past the expiration date, said Michael R. Cohen, a pharmacist and president of the institute. Either way, the active ingredient might have degraded and the drug might not work well or could harm the patient, he said.

Cohen attributes at least 15 recent deaths to drug shortages based on reports by medical personnel, but says many deaths and injuries go unreported.

In the worst known case, Alabama's public health department this spring reported nine deaths and 10 patients harmed due to bacterial contamination of a hand-mixed batch of liquid nutrition given via feeding tubes because the sterile pre-mixed liquid wasn't available.

So far this year, 210 drugs have been added to the list of drugs in short supply, one less than the total for all of last year, according to the University of Utah Drug Information Service, which tracks the shortages. That's triple the roughly 70 a year from 2003 to 2006, when shortages began to climb steadily.

"The shortages aren't resolving. They're piling up on top of existing ones," said Erin Fox, a pharmacist who manages the service. She said at least 55 drugs from shortages before this year are still unavailable or scarce.

The average price markup on drugs sold by secondary distributors was 650 percent, according to an Aug. 16 report by the Premier Healthcare Alliance, a group that helps U.S. hospitals and other health providers improve their patient care and finances. The report is based on an analysis of 636 unsolicited sales offers that were faxed and emailed to hospitals from secondary distributors in April and May.

Virtually every offer was for at least double the normal price, the survey found. The drugs with the highest markups were for critically ill patients needing anesthesia or other medicines for surgery or for emergency care, cancer, infectious diseases and pain management.

In an extreme case, one vendor was offering a generic drug for dangerously high blood pressure, normally priced at $25.90 per dose, for $1,200.

So far, hospitals have been absorbing the extra costs, but they'll soon have to start passing them on to insurers and patients, according to the American Hospital Association.

Hospitals sometimes have to cave in to save patients, according to Cohen and several hospital pharmacy directors.

The FDA says it must uphold quality standards but also works hard to prevent shortages.

"When FDA detects a contaminant, whether it be shards of glass or metal particles or an infectious agent, we have to take action to protect the public," said Dr. Peter Lurie, a senior adviser in the FDA commissioner's office.

When the agency orders a production shutdown, it urges other manufacturers to boost their output and expedites any approvals needed, said Valerie Jensen, associate director of FDA's drug shortage program. When raw materials used to make drugs are in short supply, the FDA tries to find new sources.

The agency averted 38 shortages last year, Jensen added.

Legislation pending in the House and Senate would increase penalties for drug thefts from warehouses and tractor-trailers. Another proposal, which has bipartisan support, would require drug manufacturers anticipating a shortage to immediately notify the FDA.

Sen. Amy Klobuchar, D.-Minn., the primary sponsor of the Senate version of the notification bill, said other solutions being considered include better tracking of medicine shipments, mandatory accreditation of distributors, stockpiling of key drugs and allowing routine imports of prescription drugs from countries such as Canada.

Distributors that supply about 90 percent of prescription drugs to hospitals buy direct from drug manufacturers and deliver only to customers with appropriate licenses, said John Parker, a spokesman for the Healthcare Distribution Management Association. He said HDMA members don't participate in the "gray market" but would not comment further.

The pitches hospitals get from the secondary distributors generally say they have small batches of specific drugs that are hard or impossible to find. "Are you enjoying this crazy `roller coaster ride' of pharmaceutical shortages? ... I utilize over 60 vendors to locate and procure needed pharmaceuticals to assist when you have shortage needs," one reads.

Several distributors who sent hospitals solicitations for scarce drugs didn't return calls from the AP. One representative said he wasn't authorized to discuss the issue.

One company, Novis Pharmaceuticals, defended the higher prices, saying secondary distributors have to charge far more because they don't get the big rebates manufacturers give primary distributors. They also have high costs to locate and transport batches of scarce drugs, although the company, which mainly distributes blood plasma, would not disclose its profit margin.

It's illegal for companies to create a monopoly or collude to create a medicine shortage and raise prices, and there's no evidence of that. There's no federal law against price-gouging on prescription drugs, according to the FDA, but it does urge pharmacists to report cases to its Office of Criminal Investigation. An agency spokeswoman said she could not discuss whether any cases are being investigated.

The top three wholesalers say they try to alleviate problems by working with drug manufacturers, updating hospitals on shortages and rationing scarce supplies by giving their regular hospital customers a portion of their normal order. McKesson Corp. and Cardinal Health Inc. say they halt sales to any smaller distributors found to be diverting drugs or otherwise breaking rules. AmerisourceBergen Corp. does background checks on customers.

The hospital association and other groups urge hospitals not to buy from unaccredited vendors, to insist on documentation of the drug's source if they must, and to report price gouging to state authorities. But only three states � Kentucky, Maine and Texas � have price-gouging laws that specifically cover medicines.

"Something has to be done here," said pharmacist Michael O'Neal, head of drug procurement for Vanderbilt University Medical Center in Nashville, which has had to purchase medicines from secondary suppliers about 70 times the past two years.

"This is unethical," he said. "We're talking about people's lives."

____

Summary of state price-gouging laws: http://www.ncsl.org/default.aspx?tabid14434

Institute for Safe Medication Practices consumer site: http://www.consumermedsafety.org/



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Widely used hospital drugs are in short supply (AP)

Drugs used frequently to treat hospital patients, many of them critically ill, increasingly are difficult or impossible to find. Shortages causing the most disruption in care include:

_Sodium phosphate injection � electrolyte (controls heart, nerve, muscle function)

_Magnesium sulfate injection � electrolyte (controls heart, nerve, muscle function)

_Levofloxacin injection � antibiotic

_Foscarnet injection � antiviral drug

_Paclitaxel injection � chemotherapy

_Doxil injection � chemotherapy

_Prochlorperazine injection � for nausea

_Ondansetron injection � for nausea

___

Source: University of Utah Drug Information Service



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Thursday, September 22, 2011

Scores got sick, 1 died trying to kill bedbugs (AP)

ATLANTA � Worried about bedbugs? Maybe you should be more concerned about the insecticides used to get rid of them.

A government study counted one death and 80 illnesses linked to bedbug insecticides over three years. Many were do-it-yourselfers who misused the chemicals or used the wrong product. And most of the cases were in New York City.

The study released Thursday by the Centers for Disease Control and Prevention is the first to look at the issue.

The CDC was able to only get data from seven states, including New York, where bedbugs have become a highly publicized problem and where health officials have also been extra vigilant about unusual chemical poisonings.

Investigators said they didn't know what to expect, but were relieved to see a relatively small number of cases.

"At this point, it's not a major public health problem," said Dr. Geoff Calvert, a CDC investigator who co-authored the study.

Bedbugs are wingless, reddish-brown insects that bite people and animals to draw blood for their meals. Though their bites can cause itching, they have not been known to spread disease.

"There's nothing inherently dangerous about bedbugs," said Dr. Susi Vassallo, an emergency medicine doctor who works at New York City's Bellevue Hospital Center and occasionally deals with patients talking about bedbugs.

Vassallo, who is also a toxicologist, said most of the insecticides used against bedbugs are not a health risk but should still be applied by a trained exterminator.

The CDC looked at reports from California, Florida, Michigan, North Carolina, New York, Texas and Washington, the only states that tracked such illnesses. The study counted 111 cases in the years 2003 through 2010. Most occurred in the last few years, when bedbug reports rose across the country. More than half were in New York City.

Most were people with headaches or dizziness, breathing problems or nausea and vomiting.

The one death in 2010 was a 65-year-old woman from Rocky Mount, N.C., who had a history of heart trouble and other ailments. She and her husband used nine cans of insecticide fogger one day, then the same amount two days later, without opening doors and windows to air out their home afterward. She also covered her body and hair with another bedbug product, and covered her hair with a plastic cap.

CDC officials said it's not clear that the insecticides were a definite cause of illness in each of the cases, and it's possible some were coincidental.

About 90 percent of the cases were linked to pyrethroids or pyrethrins, common insecticides sometimes used against bedbugs. But in some cases, an incorrect and more dangerous product was used. That happened in Ohio last year, when an uncertified exterminator used malathion � which should never be used indoors � to rid an apartment of bedbugs. A couple and their 6-year-old child got sick.

The report was released through a CDC publication, Morbidity and Mortality Weekly Report.

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Online:

CDC report: http://www.cdc.gov/mmwr



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Wednesday, September 21, 2011

Study: Dialysis 3 times weekly might not be enough (AP)

LOS ANGELES � A major study challenges the way diabetics and others with failing kidneys have been treated for half a century, finding that three-times-a-week dialysis to cleanse the blood of toxins may not be enough.

Deaths, heart attacks and hospitalizations were much higher on the day after the two-day interval between treatments each week than at other times, the federally funded study found.

The president of the National Kidney Foundation said she was "very troubled" by the results published in Thursday's New England Journal of Medicine.

"We could be doing a better job for our dialysis patients" and that might mean doing it more often, said Dr. Lynda Szczech, a Duke University kidney specialist who had no role in the study.

Kidneys rid the body of waste and fluids. Most of the 400,000 Americans with failing kidneys stay alive by getting their blood purified by a machine three days a week at dialysis clinics � usually on Mondays, Wednesdays and Fridays or on Tuesdays, Thursdays and Saturdays. In both cases, there's a two-day break between the last session of the week and the next one.

The three-day dialysis schedule has been around since the mid-1960s and gives patients a weekend break from the grueling hours of being hooked up to a machine.

However, doctors have suspected that the two-day hiatus between treatments was risky, and smaller studies have found more heart-related deaths on the day after the gap.

"All the fluids and toxins are built up to the highest extent on Monday morning right before dialysis," said Dr. Anthony Bleyer of Wake Forest Baptist Medical Center in North Carolina, who has done similar studies.

The latest research, funded by the National Institutes of Health, is the largest yet. It was done by Dr. Robert Foley of the University of Minnesota and colleagues. All reported receiving fees from dialysis clinics and suppliers.

The team analyzed medical records of 32,000 people who had in-center dialysis three times a week from 2005 through 2008. The average age was 62 and a quarter had been on dialysis for a year or less. After about two years of follow-up, 41 percent had died, including 17 percent from heart-related causes.

Monday was the riskiest day for people on a Monday-Wednesday-Friday schedule. For those on a Tuesday-Thursday-Saturday schedule, the riskiest day was Tuesday.

Researchers found a 22 percent higher risk of death on the day after a long break compared with other days of the week. Put another way: For every 100 people on dialysis for a year, 22 would die on the day after the long interval versus 18 on other days.

Hospital admissions for stroke and heart-related problems more than doubled on the day after a long break than on other days � 44 versus 20 for every 100 people treated.

Fixing this problem, however, could be daunting for patients, busy dialysis centers and insurers and it would require a rethinking of how dialysis is currently delivered.

Medicare covers the cost of dialysis, regardless of age, spending about $77,000 annually per person. It covers thrice-weekly treatment, but people can get a fourth session if needed.

Dr. Paul Eggers of the National Institute of Diabetes and Digestive and Kidney Diseases said adjusting how dialysis is done "would require some fairly convincing evidence. I'm not sure this one study would be sufficient to change" standard practice.

Kidney expert Dr. Eli Friedman of SUNY Downstate Medical Center in New York, said he's in favor of every-other-day dialysis or even daily dialysis. But it would mean "a multibillion dollar change," said Friedman, who launched the country's first federally funded dialysis center.

A clinic operator said increasing treatments would require additional staff. And patients also would have to be willing to come in more often.

"They don't even like coming in three times a week. It's completely understandable. It's not fun," said Dr. Allen Nissenson, chief medical officer at DaVita, which runs more than 1,600 clinics around the country.

There has been recent interest in more frequent dialysis after studies hinted that it made people feel healthier.

This year, Medicare started giving clinics a financial incentive to teach patients to do dialysis at home, allowing them to cleanse their blood more often. But this option is not for everyone. It requires intense training and patients need a helper at home.

Unless rules change, Wake Forest's Bleyer said people can take simple steps to reduce their risk by not drinking too much fluid between long dialysis breaks and eating a healthy diet.

"Patients must be a little more careful on the weekend than on other days of the week," he said.

Carol Thomas, who has been on dialysis since 2007, watches her water intake especially on weekends and avoids dairy, beans and nuts, which are high in certain nutrients that can cause complications.

Thomas, of Sacramento, Calif., said home dialysis is not an option because she doesn't have someone to help her. Would she make the trip for dialysis more often if given the choice?

"It's an inconvenience, but probably if it meant lengthening my life," the 69-year-old said.

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Online:

New England Journal: http://www.nejm.org

Kidney disease information: http://kidney.niddk.nih.gov

National Kidney Foundation: http://www.kidney.org

American Association of Kidney Patients: http://www.aakp.org

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Alicia Chang can be followed at: http://twitter.com/SciWriAlicia



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Million young adults get health coverage under law (AP)

WASHINGTON � At least one part of President Barack Obama's health care overhaul has proven popular. With the economy sputtering, the number of young adults covered by health insurance grew by about a million as families flocked to take advantage of a new benefit in the law.

Two surveys released Wednesday � one by the government, another by Gallup � found significantly fewer young adults going without coverage even as the overall number of uninsured remained high.

The government's National Center for Health Statistics found that the number of uninsured people ages 19-25 dropped from 10 million last year to 9.1 million in the first three months of this year, a sharp decline over such a brief period.

New data from an ongoing Gallup survey found that the share of adults 18-25 without coverage dropped from 28 percent last fall to 24.2 percent by this summer. That drop translates to roughly 1 million or more young adults gaining coverage.

The new health care law allows young adults to remain on their parents' health plans until they turn 26. Previously, families faced a hodgepodge of policies. Some health plans covered only adult children while they were full-time students. Others applied an age cutoff.

Elizabeth Wilson, an aspiring opera singer who lives near Indianapolis, said her mother's plan dropped her in the midst of a medical crisis because she had turned 23. At the time, Wilson was in the hospital under treatment for an inflammation of the pancreas. Because of the overhaul, she has been able to get back on the policy.

"It means I don't have to spend every penny I make to get health care," said Wilson, now 24. "I can use some of it to further my studies � or buy food."

The two surveys were welcome news for the administration, which is trying to fight off attempts to repeal the law � which some GOP lawmakers and candidates call "Obamacare" � or to overturn it in court.

"It's very disappointing to hear some people in Congress talk about repealing the law and taking away this security," said Health and Human Services Secretary Kathleen Sebelius.

Repealing Obama's law, which Congress approved in March 2010, would end the requirement that health plans cover young adults up to age 26. But some GOP lawmakers say they would include such a mandate in replacement legislation to follow.

While the bleak economy has made it hard for young people to get jobs, fewer are being forced to go without medical care, defying an overall trend of rising numbers of working-age Americans who lack coverage.

"While we did not see a drop-off in any other age group, we did see a drop in this age group," said Frank Newport, Gallup's polling director.

Gallup found that the share of 26- to 64-year-olds uninsured rose from 18.1 percent in the fall of last year to 19.9 percent this summer.

Public opinion remains divided about Obama's overhaul, but coverage for young adults has proven to be a popular and relatively low-cost benefit in these days of prolonged school-to-work transitions. The provision technically took effect last fall but wasn't implemented by most workplace health plans until Jan. 1.

"The big change started in the last quarter of 2010 and continued further in the first two quarters of this year," said Newport. "Bingo, it started going down," he said of the percentage of uninsured young adults.

Those young Americans are still more likely to be uninsured than any other age group.

Some are making the switch from school to work. Others are in low-wage jobs that don't usually offer coverage. And some in this group � sometimes termed the "invincibles"_ pass up workplace health insurance because they don't think they'll use it and would rather get a little extra in their paychecks.

The latest surveys are in line with other findings. Mercer, the benefits consulting firm, found a 2 percentage-point increase in workplace health plan enrollment as a result of extending coverage to young adults.

It's a less expensive group to cover than middle-aged or older adults, and many companies have spread the extra premiums among their workers. Delloite LLP, another major benefits consultant, projects additional costs for covering young adults in the range of 1-2 percent.

Other early coverage expansions in the health care law have not worked as well, including a special program for people with health problems turned away by insurers.

The law's main push to cover the uninsured isn't scheduled until 2014. At that time, more than 30 million people are expected to get coverage through a combination of expanding Medicaid and providing tax credits to make private insurance more affordable. And insurers will no longer be able to turn away people in poor health.

Gallup continuously surveys nearly 1,000 people a day. Its analysis includes 89,857 respondents interviewed between April 1 and June 30. The margin of error for the full sample is plus or minus 1 percentage point; it is higher for subgroups.

The government's National Health Interview Survey is one of the primary sources of information on the U.S. public, relying on detailed household interviews. The latest results are drawn from interviews with more than 20,000 people from January through March. Wednesday's report also found an uptick in public coverage for young adults, but officials said that increase was not statistically significant.

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Associated Press writer Mike Stobbe in Atlanta contributed to this report.

Online:

Gallup survey: http://tinyurl.com/3dy4nrk

HHS report: http://tinyurl.com/3mvc7wg



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