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Selasa, 31 Maret 2009

Pistachio warning could signal food safety shift

TERRA BELLA, Calif. – It could take weeks before health officials know exactly which pistachio products may be tainted with salmonella, but they've already issued a sweeping warning to avoid eating the nuts or foods containing them.
The move appears to indicate a shift in how the government handles food safety issues — from waiting until contaminated foods surface one-by-one and risking that more people fall ill to jumping on the problem right away, even if the message is vague.
Officials wouldn't say if the approach was in response to any perceived mishandling of the massive peanut recall that started last year, only that they're trying to keep people from getting sick as new details surface about the California plant at the center of the pistachio scare.
"What's different here is that we are being very proactive and are putting out a broad message with the goal of trying to minimize the likelihood of consumer exposure," said Dr. David Acheson, FDA's assistant commissioner for food safety. "The only logical advice to consumers is to say 'OK consumers, put pistachios on hold while we work this out. We don't want you exposed, we don't want you getting salmonella.'"
Dr. Joshua Sharfstein, the president's new acting commissioner who started Monday, made it clear staff needed to move quickly, Acheson said.
The agency announced Monday that Setton Pistachio of Terra Bella Inc., the second-largest pistachio processor in the nation, recalled more than 2 million pounds of its roasted pistachios.
Suspect nuts were shipped as far away as Norway and Mexico, Acheson said Tuesday. One week after authorities first learned of the problem, they still had little idea what products were at risk, he said.
As federal health inspectors take swabs inside the plant to try to identify a salmonella source, a whole range of products from nut bars to ice cream and cake mixes remain in limbo on grocery shelves.
Company officials said Tuesday they suspected their roasted pistachios may have been contaminated by salmonella-tainted raw nuts they were processed with at the hulking facility.
Roasting is supposed to kill the bacteria in nuts. But problems can occur if the roasting is not done correctly or if roasted nuts are re-exposed to bacteria.
The firm sells its California-grown pistachios to giants of the food industry such as Kraft Foods Inc., as well as 36 wholesalers across the country.
"We care about our business and our customers greatly," said Lee Cohen, the production manager for Setton International Foods Inc., a sister company to Setton Pistachios. "We've never had an illness complaint before but obviously this affects the whole industry. It's not good."
California supplies 99.99 percent of the U.S. pistachio market, according to the California Pistachio Board.
"What's scary is that it's after the nuts have been processed that this stuff is getting into it, so it really makes you wonder," said Marcia Rowland, an avid pistachio eater in Apopka, Fla.
The FDA learned about the problem March 24, when Kraft notified the agency that routine product testing had detected salmonella in roasted pistachios. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day and expanded the recall to include any Planters and Back to Nature products that contain pistachios Tuesday.
Kraft spokeswoman Laurie Guzzinati said her company's auditors visited the plant early last week, and "observed employee practices where raw and roasted nuts were not adequately segregated and that could explain the sporadic contamination."
She said she didn't know specifically what they saw.
Federal inspectors last visited the plant in 2003, and the California Department of Public Health was there last year, Acheson said. Federal officials made note of several problems — an open door into one of the nut rooms, and an employee wearing street clothes that weren't adequately covered — but nothing that posed a food safety threat, he said.
Acheson said management corrected the problems that day, and said he did not have access to California inspectors' records.
Cohen said the plant had never had an illness complaint, followed industry health guidelines and had its huge metal silos and warehouse inspected regularly, but refused to provide additional details or records. Several plaques on the firm's office walls showed the firm won industry awards for food safety excellence.
No illness have been tied to contaminated pistachios. Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasn't been confirmed, Acheson said.
While consumer advocates praised the government's swift action, they said the pistachio recall illustrated that more oversight was needed.
"It is encouraging that this response was so quick, but we need to move to a system that focuses on prevention through the entire food production process," said Jeff Levi, executive director of Trust for America's Health.
Two California legislators introduced a bill Tuesday that would require periodic testing of food at food processing facilities and mandate processors to report to state authorities within 24 hours any positive test result for a dangerous contaminant.
"We shouldn't be reacting to the next crisis, we should be preventing the next crisis," said Assemblyman Mike Feuer, D-Los Angeles.
___
Associated Press writers Tracie Cone in Fresno and Samantha Young in Sacramento contributed to this report.
___
On the Net:
http://us.rd.yahoo.com/dailynews/ap/ap_on_re_us/storytext/salmonella_pistachios/31503103/SIG=10s3n7kvf/*http://www.settonfarms.com
http://www.fda.gov/

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FDA cracks down on unapproved narcotic painkillers


WASHINGTON – The government ordered 14 unapproved narcotic painkillers off the market Tuesday, prescription versions of potent morphine, hydromorphone and oxycodone. The Food and Drug Administration told nine manufacturers to quit distributing the drugs within 90 days — but insisted there are plenty of legal versions of the painkillers being sold for patients who need relief.
"There will be no shortage for consumers," said Deborah Autor, director of FDA's drug compliance office.
The move is part of the FDA's years-long attempt to weed out thousands of prescription drugs that sell despite never being formally approved by the health regulatory agency. Many entered the market decades ago, before federal law required such approval. The FDA estimates that unapproved drugs account for 2 percent of all prescriptions filled.
Tuesday, the FDA targeted unapproved versions of high-concentrate liquid morphine sulfate and unapproved immediate-release tablets containing morphine sulfate, hydromorphone and oxycodone. Most are generic.
To help consumers tell if they have an approved or unapproved version, the FDA posted both lists on its Web site: http://www.fda.gov/cder/drug/unapproved_drugs/narcoticsQA.htm.
Manufacturers receiving warning letters Tuesday are: Boehringer Ingelheim Roxane Inc. of Columbus, Ohio; Cody Laboratories Inc. of Cody, Wyo.; Glenmark Pharmaceuticals Inc. of Mahwah, N.J.; Lannett Co. Inc. of Philadelphia; Lehigh Valley Technologies Inc. of Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group of St. Louis; Physicians Total Care inc. of Tulsa; Roxane Laboratories Inc. of Columbus, Ohio; and Xanodyne Pharmaceutical Inc. of Newport, Ky.
The largest, Boehringer, didn't immediately return a call seeking comment.
Even FDA-approved versions of these painkillers pose a risk of serious side effects, but the unapproved products add an extra problem: Regulators haven't checked that those versions work as well and are as pure as their approved competitors.
Companies that don't heed the FDA's deadline could face big penalties: The government once seized $24 million worth of unapproved drugs from a company that ignored a stop-selling order, Autor noted.

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St. Louis hospital to study birth defect


ST. LOUIS – A top children's hospital wants to improve the survival rate of infants born with a birth defect that many families have never heard of until their child is diagnosed.
Dr. Brad Warner, surgeon-in-chief of St. Louis Children's Hospital, said Tuesday that he and others plan research to better understand the condition, known as CDH, or Congenital Diaphragmatic Hernia. One in 2,000 babies is diagnosed with the disease, doctors say. Half of those don't live to their first birthday.
The condition occurs when the diaphragm, which separates the chest cavity from the abdomen, does not completely form in the womb. The contents of the belly migrate to the chest, which keeps the lungs from developing properly.
Eight babies at the St. Louis hospital died last year from the condition.
Doctors at St. Louis Children's Hospital say they're part of a national database registry to collect and track information on children with the condition. They plan to recruit faculty candidates that are able to explore fetal surgery intervention and are working to collect DNA for analysis.
Treatment for the birth defect varies.
Many are stillborn. Babies who die from the birth defect usually have insufficient lung tissue to survive, or develop hypertension in the blood vessels of the lungs. Medications to lower blood pressure in the lungs lower the baby's overall blood pressure, which can be problematic.
Of those who live, some are in distress from the moment the umbilical cord is clamped; others are OK for their initial hours of life, then get worse. A third group, which is the most uncommon, initially looks good, but later exhibits signs, such as bowel sounds in the chest, that reveal the condition.
In some cases, doctors have performed surgery on pregnant women and their fetuses to try to address problems before a baby is born, but those procedures have risks. Children with CDH can grow up to be healthy adults.
Doctors say they hope to better understand predictors of good and bad outcomes for babies with the condition, as well as how to address the many complications that can arise.
____
On the Net:
Breath of Hope: http://www.breathofhopeinc.com/

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Study: Plavix plus aspirin helps prevent strokes


ORLANDO, Fla. – Taking the blood thinner Plavix along with aspirin helped prevent strokes and heart attacks in people with a common heartbeat abnormality that puts them at high risk of these problems, doctors reported Tuesday.
The treatment is for atrial fibrillation, a rhythm disorder that 2.2 million Americans have. It occurs when the upper parts of the heart quiver instead of beating properly. This allows blood to pool and form clots that can travel to the brain, causing a stroke.
The usual treatment is the blood thinner warfarin, sold as Coumadin and in generic form. But finding the right dose is tricky — too little and patients can have a stroke; too much and they can have life-threatening bleeding. Patients on the drug must go to the doctor often for blood tests to monitor their dose.
For these reasons, as many as half of patients take aspirin instead of warfarin, even though aspirin is much less effective at preventing strokes.
Dr. Stuart Connolly of McMaster University in Hamilton, Ontario, led a study testing whether adding clopidogrel, sold as Plavix by French-based Sanofi-Aventis SA, could help.
The study involved 7,554 patients in the United States and 32 other countries who were not able or chose not to take warfarin. All were treated with aspirin; half also were given Plavix.
After nearly four years of followup, the dual drug treatment lowered a combined measure — heart attacks, heart-related deaths, strokes and blood clots — by 11 percent. There were 924 of these problems in patients on aspirin alone but only 832 in those also getting Plavix.
However, the combination treatment raised the risk of serious bleeding — 251 cases versus 162 for those on aspirin alone.
Doing the math, patients still come out ahead on the combination, Connolly said. For every 1,000 patients treated for three years, it would prevent 28 strokes and six heart attacks, and lead to 20 bleeding cases. Bleeding often is treated with transfusions and is not as likely to prove fatal.
"For the first time in 20 years, there's a new treatment for atrial fibrillation," Connolly said.
Results were presented Tuesday at an American College of Cardiology conference and published online by the New England Journal of Medicine.
The study was sponsored by Sanofi, and Connolly and other authors have consulted for the company. Plavix costs about $4 a day.
"Warfarin was, and remains, first-line therapy — this does not change that," said Dr. Richard Page, cardiology chief at the University of Washington School of Medicine in Seattle and an American Heart Association spokesman.
But for those who can't tolerate it, the Plavix-aspirin combo gives a better option than aspirin alone, he said. Page has consulted for Sanofi in the past.
On Saturday, other doctors at the cardiology conference reported on another potential treatment for atrial fibrillation — an experimental heart device called the Watchman aimed at preventing clots from reaching the brain. A federal Food and Drug Administration panel meets to consider it on April 23.
___
On the Net:
Cardiology meeting: http://www.acc.org
Medical journal: http://www.nejm.org

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Stop-smoking lines flooded as tobacco tax rises

WASHINGTON – Calling your state stop-smoking hot line for help kicking the habit? Expect a wait: Smokers are flooding the lines in a panic over an increase in the tobacco tax.
Denver-based National Jewish Health received triple the usual number of calls Monday for a March day to quit lines it runs in six states: Colorado, Idaho, Iowa, Montana, New Mexico and Ohio.
The calls — 2,317 on Monday — had steadily increased all month as smokers began dealing with a big price hit in a sour economy. Not only does the per-pack federal tax climb from 39 cents to $1.01 on Wednesday, but the major cigarette makers raised prices several weeks ago in anticipation.
Quit lines around the country are feeling the surge, according to an informal survey by the Campaign for Tobacco-Free Kids that found a missed opportunity as cash-strapped states struggled to meet demand.
Michigan's quit line itself had to quit — working, that is. It ran out of money in mid-March after logging more than 65,000 callers in five days. Besides counseling and tips, Michigan's hot line offered free nicotine patches, gum or lozenges. The giveaway program in 2008 generated only about 20,000 calls in six weeks, the campaign noted.
Arkansas quit general advertising of the quit line to keep up with calls that rose from about 500 a week in January to more than 2,000 a week in mid-March, the campaign said. And Indiana and Oklahoma were receiving record-level weekly calls.
Price surges typically spur would-be quitters to take the plunge. Not all will be successful. The tobacco-free kids group estimates that about 1 million adults will quit as a result of the tax increase.
Consumers can dial 1-800-QUIT-NOW to be directed to their state hot lines.
____
Campaign for Tobacco-Free Kids: http://www.tobaccofreekids.org/index.php

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Selasa, 24 Maret 2009

German researchers testing veggie Viagra: reports


BERLIN (AFP) – German researchers are testing an impotency treatment for men made using only natural ingredients that in some cases works better than Viagra, newspapers reported Monday.
"In clinical trials, 50 men had much better sex afterwards, more fun in bed and just generally felt better about themselves," the Sueddeutsche Zeitung daily cited Olaf Schroeder from Berlin's Charite hospital as saying.
"Their libido was even higher than the control group taking Viagra," he said.
The potent cocktail includes tribulus terrestris, a herb already used in alternative medicine, a root vegetable found in the Andes called maca and grape juice extract, newspapers said.
The treatment, dubbed "Plantagrar", is due to be launched in early 2010, the Bild daily said.
But some of those tested had unwelcome side effects.
"Two of the subjects had bad diarrhoea," the Berliner Kurier quoted Schroeder as adding.

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Second-Generation Female Condom Approved


WEDNESDAY, March 11 (HealthDay News) -- The Female Health Co.'s FC2 Female Condom has been approved by the U.S. Food and Drug Administration, the company said Wednesday. The product helps protect women against pregnancy and sexually transmitted diseases.
The second-generation condom is similar in design and performance to the FC1, except that it is made of a synthetic rubber called nitrile and costs about 30 percent less, the company said. The FC1 was approved in 1993.
The FDA approval of the FC2 will allow the U.S. Agency for International Development to distribute the condoms via global HIV/AIDS programs, the Associated Press reported.
The first-generation FC1 has been distributed by United Nations agencies in 142 countries, the wire service said.
More information
To learn more about female condoms, visit the U.S. National Library of Medicine.

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Suriname starts free circumcision project

PARAMARIBO (AFP) – Suriname has launched a three-month pilot project offering free circumcisions in a bid to cut sexually transmitted diseases, Health Minister Celsius Waterberg said Friday.

Circumcision "could also minimize the risk of HIV infection", he said, adding the project would run in the capital city, Paramaribo.

Some two percent of the Suriname population is HIV-infected, about 10,000 people, and the project aims to carry out the operations on 100 men aged between four and 21 years old over the next three months.

If successful then the project will spread nationwide, Waterberg said.

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Weight loss enhances obese men's sexual well-being


NEW YORK (Reuters Health) – Obese men who undergo gastric bypass surgery will not only lose weight; their sex lives are likely to improve, too, new research shows.
"We wanted to know if obesity was biologically associated with an unsatisfying sex life, and if so, could it be reversible," Dr. Ahmad Hammoud of the University of Utah in Salt Lake City, who led the study, said in a press release accompanying the new report. "Our results show that the answer to both questions may be yes."
While obesity in men has been linked to low testosterone levels, high levels of estrogen, impaired fertility, and worse sexual quality of life, Hammoud and his colleagues note in the Journal of Clinical Endocrinology and Metabolism, there is little information on what happens to these men's sex hormones and sexual function if they lose weight.
To investigate, Hammoud and his team looked at 22 men who had undergone gastric bypass surgery and 42 obese men who didn't have the operation. At the study's outset, participants weighed 330 pounds, on average, while the average BMI for the group was 46.2, what is considered to be .
The heavier the men were, the lower their testosterone, and the more likely they were to report dissatisfaction with their sex lives-especially avoiding sexual encounters and having difficulty performing sexually.
Two years later, the men who'd had weight loss surgery had dropped an average of nearly 17 points from their BMI. Their estrogen levels had fallen significantly, while their testosterone levels had gone up. And all showed improvements on each of the four measures of sexual quality of life the researchers looked at: they were less likely to avoid sexual encounters, have difficulty with sexual performance, have little sexual desire, or report not enjoying sex.
There were no significant changes in measures of sexual quality of life or hormone levels in the group of men who didn't have the surgery.
Because other both biological and psychological factors involved in obesity can affect both sexual health and hormone levels, Hammoud and his team conclude, more research is needed to determine whether there is a causal relationship between hormone changes and sexual quality of life.
SOURCE: Journal of Clinical Endocrinology and Metabolism, April 2009.

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Insurers offer to stop charging sick people more

WASHINGTON – The health insurance industry offered Tuesday for the first time to curb its controversial practice of charging higher premiums to people with a history of medical problems. The offer from America's Health Insurance Plans and the Blue Cross and Blue Shield Association is a potentially significant shift in the debate over reforming the nation's health care system to rein in costs and cover an estimated 48 million uninsured people. It was contained in a letter to key senators.
In the letter, the two insurance industry groups said their members are willing to "phase out the practice of varying premiums based on health status in the individual market" if all Americans are required to get coverage. Although the letter left open some loopholes, it was still seen as a major development.
"The offer here is to transition away from risk rating, which is one of the things that makes life hell for real people," said health economist Len Nichols of the New America Foundation public policy center. "They have never in their history offered to give up risk rating."
"This letter demonstrates that insurance companies are open to major insurance reform, and are even willing to accept broad consumer protections," said Sen. Jeff Bingaman, D-N.M., a moderate who could help bridge differences on a health care overhaul. "It represents a major shift from where the industry was in the 1990s during the last major health care debate."
Insurers are trying to head off the creation of a government insurance plan that would compete with them, something that liberals and many Democrats are pressing for. To try to win political support, the industry has already made a number of concessions. Last year, for example, insurers offered to end the practice of denying coverage to sick people. They also said they would support a national goal of restraining cost increases.
The latest offer goes beyond that.
Insurance companies now charge very high premiums to people who are trying to purchase coverage as individuals and have a history of medical problems, such as diabetes or skin cancer. Even if such a person is offered coverage, that individual is often unable to afford the high premiums. About 7 percent of Americans buy their coverage as individuals, while more than 60 percent have job-based insurance.
"When you have everyone in the system, and you can bring (financial) assistance to working families, then you can move away from health status rating," said Karen Ignagni, president of America's Health Insurance Plans, the leading trade group.
The companies left themselves several outs, however. The letter said they would still charge different premiums based on such factors as age, place of residence, family size and benefits package.
"If the goal is to make health care affordable, this concession does not go far enough," said Richard Kirsch, campaign manager for Health Care for America Now. "It still allows insurers to charge much more if you are old." His group, backed by unions and liberals, is trying to build support for sweeping health care changes.
Importantly, insurers did not extend to small businesses their offer to stop charging the sick higher premiums. Small employers who offer coverage can see their premiums zoom up from one year to the next, even if just one worker or family member gets seriously ill.
Ignagni said the industry is working on separate proposals for that problem.
"We are in the process of talking with small-business folks across the country," she said. "We are well on the way to proposing a series of strategies that could be implemented for them."
___
On the Net:
America's Health Insurance Plans: http://us.rd.yahoo.com/dailynews/ap/ap_on_he_me/storytext/insurers_sick_people/31419391/SIG=10l8ksrl2/*http://www.ahip.org
Blue Cross and Blue Shield Association: http://www.bcbs.com/

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WHO issues pessimistic global tuberculosis report

RIO DE JANEIRO – The number of people infected with both tuberculosis and HIV is twice what researchers previously thought, top health officials said Tuesday. The World Health Organization's annual report on TB, presented in Rio, indicates that there were 1.37 million cases of people with both TB and HIV in 2007, the latest year for which statistics are available. About 700,000 people were infected with both in 2006, according to a report released by WHO last year.
Researchers attribute the numbers mostly to more widespread testing and reporting. They say direct information on the HIV status among TB patients is now available from 64 nations — up from just 13 nations in recent years. More reporting is also coming from Africa, where 79 percent of the dual-infection cases were reported.
In 2007, 1.3 million people died from TB, while another 465,000 people who had both TB and HIV died. About 1.5 million people died in 2006 from TB, according to WHO's report last year. It was not clear how many of those who died also were infected with HIV.
WHO researchers said the new data means HIV-positive people are about 20 times more likely than HIV-negative people to develop TB in countries where HIV is at epidemic levels, and between 26 and 37 times more likely to develop TB where HIV prevalence is lower.
In a message to mark World TB Day, U.N. Secretary-General Ban Ki-moon said the epidemic is continuing to decline "but the rate of decline is far too slow, and TB still takes a life every 20 seconds."
"Millions of people are benefiting from treatment through coordinated national efforts, but millions more are still missing out," he said in the message released at U.N. headquarters in New York. "Unless we accelerate action, the numbers of those falling ill will continue to grow."
The WHO's annual report had other pessimistic points: an expected $1.6 billion gap in funding needed to fight the disease this year and an increase in the number of cases of drug-resistant TB.
"We have a situation with very little progress, particularly in Africa and Eastern and Central Europe," said Tido von Schoen-Angerer, the executive director of Doctors Without Borders, who was attending the TB conference. "There is no room anywhere in this report for congratulations."
The survey estimates that 9.27 million people around the globe had TB in 2007 — slightly up from 9.24 million in 2006.
That amounts to a per capita rate of 139 per 100,000 people globally, the report states. That pace, a drop of less than 1 percent a year, has continued for the past several years, said Mario Raviglione, director of the WHO's Stop TB program.
He said it would take millennia to wipe out the disease at that rate.
Multiple-drug-resistant cases of TB also rose in 2007 to 500,000. Such cases are more difficult to treat and have a higher rate of deaths.
Aggravating the fight against TB is the global financial crisis.
Michel Kazatchkine, executive director of the U.N.-backed Global Fund to Fight AIDS, Tuberculosis and Malaria, said funding for programs to fight TB will fall $1.6 billion short in 2009, a gap he estimates will reach at least $4 billion in 2010.
"The crisis is severely affecting developing nations," he said. "But countries should realize health costs are an investment for development and not just a strain on budgets."
Asia registered the most TB cases in 2007, with 55 percent, while Africa had 31 percent. Among nations, India had the most cases with 2 million, China had 1.3 million and Indonesia 530,000.
___
Associated Press Writer Edith Lederer contributed to this story from the United Nations in New York.

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Senin, 23 Maret 2009

Alzheimer's cost triple that of other elderly


CHICAGO – The health care costs of Alzheimer's disease patients are more than triple those of other older people, and that doesn't even include the billions of hours of unpaid care from family members, a new report suggests.
Compared with people aged 65 and older without Alzheimer's, those with the mind-destroying disease are much more often hospitalized and treated in skilled-nursing centers. Their medical costs also often include nursing home care and Medicare-covered home health visits.
That all adds up to at least $33,007 in annual costs per patient, compared with $10,603 for an older person without Alzheimer's, according to a report issued Tuesday by the Alzheimer's Association.
The numbers are based on 2004 data and include average per-person Medicare, Medicaid and private insurance costs.
Costs likely have grown since then as the U.S population has aged and the number of Alzheimer's diagnoses has risen, said Angela Geiger, the Alzheimer's Association chief strategy officer.
According to the group's report, nearly 10 million caregivers — mostly family members — provided 8.5 billion hours of unpaid care for Alzheimer's patients last year.
"All of these statistics paint a really grim picture of what's going to happen ... unless we invest in solutions" to delay or prevent the disease, Geiger said.
This week a Senate committee will hear from an independent coalition of experts that has been working on a strategy for dealing with the growing Alzheimer's population.
An estimated 5.3 million Americans have the disease; by next year nearly half a million new cases will be diagnosed, according to the Alzheimer's Association.
As the disease progresses, people lose the ability to care for themselves and need help with eating, bathing, dressing and other daily activities. Eventually, they may need help with breathing and swallowing.
From 2000 to 2006, while deaths from heart disease, stroke, breast and prostate cancer declined, Alzheimer's deaths rose 47 percent.
Geiger said those trends reflect improved treatments for other diseases, while there are no treatments that can slow or prevent Alzheimer's.
___
On the Net:
Alzheimer's Association: http://www.alz.org

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Study: Lots of red meat increases mortality risk


CHICAGO – The largest study of its kind finds that older Americans who eat large amounts of red meat and processed meats face a greater risk of death from heart disease and cancer. The federal study of more than half a million men and women bolsters prior evidence of the health risks of diets laden with red meat like hamburger and processed meats like hot dogs, bacon and cold cuts.
Calling the increased risk modest, lead author Rashmi Sinha of the National Cancer Institute said the findings support the advice of several health groups to limit red and processed meat intake to decrease cancer risk.
The findings appear in Monday's Archives of Internal Medicine.
Over 10 years, eating the equivalent of a quarter-pound hamburger daily gave men in the study a 22 percent higher risk of dying of cancer and a 27 percent higher risk of dying of heart disease. That's compared to those who ate the least red meat, just 5 ounces per week.
Women who ate large amounts of red meat had a 20 percent higher risk of dying of cancer and a 50 percent higher risk of dying of heart disease than women who ate less.
For processed meats, the increased risks for large quantities were slightly lower overall than for red meat. The researchers compared deaths in the people with the highest intakes to deaths in people with the lowest to calculate the increased risk.
People whose diets contained more white meat like chicken and fish had lower risks of death.
The researchers surveyed more than 545,000 people, ages 50 to 71 years old, on their eating habits, then followed them for 10 years. There were more than 70,000 deaths during that time.
Study subjects were recruited from AARP members, a group that's healthier than other similarly aged Americans. That means the findings may not apply to all groups, Sinha said. The study relied on people's memory of what they ate, which can be faulty.
In the analysis, the researchers took into account other risk factors such as smoking, family history of cancer and high body mass index.
In an accompanying editorial, Barry Popkin, director of the Interdisciplinary Obesity Center at the University of North Carolina at Chapel Hill, wrote that reducing meat intake would have benefits beyond improved health.
Livestock increase greenhouse gas emissions, contributing to global warming, he wrote, and nations should reevaluate farm subsidies that distort prices and encourage meat-based diets.
"We've promoted a diet that has added excessively to global warming," Popkin said in an interview.
Successfully shifting away from red meat can be as easy as increasing fruits and vegetables in the diet, said Elisabetta Politi of the Duke Diet and Fitness Center in Durham, N.C.
"I'm not saying everybody should turn into vegetarians," Politi said. "Meat should be a supporting actor on the plate, not the main character."
The National Pork Board and National Cattlemen's Beef Association questioned the findings.
Dietitian Ceci Snyder said in a statement for the pork board that the study "attempts to indict all red meat consumption by looking at extremes in meat consumption, as opposed to what most Americans eat."
Lean meat as part of a balanced diet can prevent chronic disease, along with exercise and avoiding smoking, said Shalene McNeill, dietitian for the beef group.
___
On the Net:
Archives: http://www.archinternmed.com

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Alcohol flush signals cancer risk for East Asians


WASHINGTON – Turn a bit red when you drink a mere half bottle of beer? If you're of East Asian descent, consider that a warning: You may be at higher risk of alcohol-caused esophageal cancer. Researchers reported the link Monday in hopes of increasing awareness that the inherited flushing trait — found in about a third of people from Japan, China and Korea — offers valuable health information.
Alcohol is a known risk factor for a variety of cancers, including esophageal, and heavier drinking is considered riskier than light drinking.
Lots of people turn slightly red if they imbibe too much. At issue here is facial flushing from a small amount of alcohol. It's due to a deficiency in an enzyme that helps metabolize alcohol, called ALDH2.
People with a severe deficiency of the enzyme usually don't drink because it makes them feel too bad; in addition to flushing they feel nausea and a rapid heartbeat.
But people with a partial deficiency — they inherited one bad copy of the enzyme-producing gene instead of two — may put up with the flushing. A series of studies by Dr. Akira Yokoyama of Japan's Kurihama Alcohol Center found that those people are six to 10 times more likely to develop esophageal cancer than people who drink a comparable amount but aren't enzyme-deficient.
"Somehow the message just hadn't gotten out," said Dr. Philip J. Brooks, who researches alcohol and cancer at the U.S. National Institutes of Health.
So he paired with Yokoyama and others to review the link for PLoS Medicine, a journal published by the Public Library of Science.
Without enough of that enzyme, alcohol breaks down into a DNA-damaging chemical similar to formaldehyde but it doesn't go the next step and turn into yet another chemical that's non-toxic, said Brooks. Don't drink, and the flushers aren't at increased risk.
Esophageal cancer is fairly rare, but it's also hard to treat. Worldwide, anywhere from 12 percent to a third of people who develop it survive five years.
Up to 8 percent of the world's population has the enzyme deficiency, meaning if even a small number of the at-risk avoided alcohol, esophageal cancer deaths could drop substantially, the review concluded.
In the U.S., most esophageal cancer is a type called adenocarcinoma that is linked to chronic, severe heartburn. The flushing-linked type is squamous cell carcinoma, less common here than abroad.


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Hunting tailored care for advanced prostate cancer


WASHINGTON – Prostate cancer has been left behind in the race for personalized medicine but that may be changing: Doctors are starting to attempt gene-guided treatment for men with advanced disease.
It's an approach already offered in treating breast and certain other cancers. The new prostate work is a small initial step at catching up. And it targets the men in most dire need — those whose prostate cancer has spread to the bones or other parts of the body, and hormone treatment to slow its march has quit working.
These are the men who ultimately wind up dying of prostate cancer, some 28,000 a year.
"Prostate cancer has learned some tricks," says Dr. Phillip Febbo of Duke University Medical Center, who is unraveling how to decode those tricks to better direct therapy — by looking directly at the tumor's genetic signature.
The research is very preliminary but if a gene-guided method ultimately works it could ease what the American Cancer Society's Dr. Durado Brooks calls today's "shotgun approach" to advanced prostate cancer. Patients slog their way through a handful of medications in no particular order, changing course only after the cancer quits responding.
"This gives us a more scientifically reasoned, evidence-based approach to treating these men — hopefully. That's the theory," Brooks cautions.
Starting next month, Duke will recruit men for a study that will help determine their treatment.
Tumors carry a pattern of gene and protein activity that signal whether a cancer is more or less aggressive and whether it is susceptible to various treatments. Those signatures already have led to breast cancer tests that predict which tumors are more likely to return, helping patients decide whether to try or skip chemotherapy, for example. Everyone with advanced colon cancer is supposed to get a genetic test before trying one of two leading treatments, to see if their tumor will respond.
Yet even though prostate cancer hits as many men as breast cancer hits women, finding genetic signatures in prostate tumors has been a struggle. Men tend to get prostate biopsies early on, before the cancer has spread. Very few get one after their cancer worsens, when the tumor has evolved, leaving few advanced tumor samples for scientists to examine which genetic activity is most crucial, Febbo explains.
But that's slowly changing, and the result is a race to find genetic signatures that might predict a therapy's usefulness.
First up, the "androgen receptor." It's the male counterpart to the estrogen receptor that determines how strongly estrogen fuels breast cancer growth.
Hormone therapy to block testosterone production is a key prostate cancer treatment. But some cancers keep growing despite low testosterone levels, and researchers in the last few years have found that how tumor cells use their androgen receptor plays a major role. The cancer might make copies of its androgen receptor so a cell now has 10 instead of two, Febbo says, the better to suck in remaining testosterone. Or the receptors may become more sensitive, able to react to the tiniest bit of testosterone instead of usual levels. Prostate tumors sometimes even start making their own testosterone.
Febbo's team genetically profiled more than 100 samples of prostate cancer. A genetic signature separates which men with hormone-resistant advanced cancer still have a very active androgen receptor and which don't — something else, perhaps a gene named Src, is fueling their cancer, he reported this month in the Journal of Clinical Oncology.
Next month, Duke and other hospitals that are part of the Defense Department's Prostate Cancer Consortium will begin recruiting 60 such patients and custom-profile their cancer to decide treatment. Those with highly active androgen receptors will get nilutamide, a receptor blocker. Those whose androgen receptors aren't the problem will receive an experimental treatment, the leukemia drug dasatanib that's known to target prostate-related factors.
Also under way: Testing whether there's a genetic signature that says which men will respond best to a different drug, docetaxel. It's proven to increase survival in hormone-resistant advanced prostate cancer but only in a fraction of patients.
Separately, doctors are closely watching studies of an experimental drug named abiraterone that's supposed to target mutated androgen receptors.
It's way too soon to predict if any of these approaches will pan out. But the genetics rationale appeals to Tim Atkeson, a Denver lawyer whose prostate cancer already had spread to his bones when he was diagnosed at the unusually young age of 49.
Atkeson read up on studies presented at leading cancer meetings and, while systematically working through treatments for the hormone-resistant, he contacted Febbo about volunteering for the gene-guided study. At the very least, he hopes to spur science in case his sons or brothers ever face the same disease.
"I keep my fingers crossed that perhaps I'll be one of the lucky ones," says Atkeson, now 51.
___
EDITOR's NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

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Marine moves fingers after rare hand transplant


PITTSBURGH – Surgeons have transplanted a hand onto a Marine who was hurt in a training accident, and he has some movement in his fingers, according to the hospital where the operation occurred.
The surgery was performed at the University of Pittsburgh Medical Center by a team headed by Dr. W.P. Andrew Lee on March 14-15. The man still must undergo bone marrow infusion to reduce the need for traditional anti-rejection drugs. The drugs have side effects that include diabetes and high blood pressure.
The hospital is not releasing the 24-year-old's identity or details of how he lost his right hand, but hopes to hold a news conference next week.
"For a hand, it takes quite some time to get full movement," said spokeswoman Amy Dugas Rose. "He has some movement, which is a good sign."
The Marine will undergo intense daily physical therapy for three months to gain movement, she said.
The surgery is the first of its kind at the Pittsburgh hospital network, and only the sixth in U.S. history. The other five have occurred at Jewish Hospital Heart and Lung Center of Louisville, Ky.
The first U.S. hand transplant was performed in January 1999 on Matthew David Scott, of New Jersey, who lost his hand in December 1985 in an M-80 blast.
The first hand transplant was done in Ecuador in 1964, but the patient's body rejected the hand after two weeks.
Worldwide, there have been about 32 other patients, and 40 hands transplanted.
UPMC has two people on its hand transplant waiting list, Rose said. One is a man waiting for a double hand transplant.
Finding donors — from cadavers — is challenging, Rose said. Besides matching tissue and blood type, the gender, size and skin tone also must match.
Surgery can last eight to 10 hours as doctors attach two major arteries, veins and repair multiple tendons and nerves.

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Minggu, 22 Maret 2009

AP IMPACT: Mentally ill a threat in nursing homes

CHICAGO – Ivory Jackson had Alzheimer's, but that wasn't what killed him. At 77, he was smashed in the face with a clock radio as he lay in his nursing home bed.
Jackson's roommate — a mentally ill man nearly 30 years younger — was arrested and charged with the killing. Police found him sitting next to the nurse's station, blood on his hands, clothes and shoes. Inside their room, the ceiling was spattered with blood.
"Why didn't they do what they needed to do to protect my dad?" wondered Jackson's stepson, Russell Smith.
Over the past several years, nursing homes have become dumping grounds for young and middle-age people with mental illness, according to Associated Press interviews and an analysis of data from all 50 states. And that has proved a prescription for violence, as Jackson's case and others across the country illustrate.
Younger, stronger residents with schizophrenia, depression or bipolar disorder are living beside frail senior citizens, and sometimes taking their rage out on them.
"Sadly, we're seeing the tragic results of the failure of federal and state governments to provide appropriate treatment and housing for those with mental illnesses and to provide a safe environment for the frail elderly," said Janet Wells, director of public policy for the National Citizens' Coalition for Nursing Home Reform.
Numbers obtained through the Freedom of Information Act and prepared exclusively for the AP by the Centers for Medicare and Medicaid Services show nearly 125,000 young and middle-aged adults with serious mental illness lived in U.S. nursing homes last year.
That was a 41 percent increase from 2002, when nursing homes housed nearly 89,000 mentally ill people ages 22 to 64. Most states saw increases, with Utah, Nevada, Missouri, Alabama and Texas showing the steepest climbs.
Younger mentally ill people now make up more than 9 percent of the nation's nearly 1.4 million nursing home residents, up from 6 percent in 2002.
Several forces are behind the trend, among them: the closing of state mental institutions and a shortage of hospital psychiatric beds. Also, nursing homes have beds to fill because today's elderly are healthier than the generation before them and are more independent and more likely to stay in their homes.
No government agency keeps count of killings or serious assaults committed by the mentally ill against the elderly in nursing homes. But a number of tragic cases have occurred:
• In 2003, a 23-year-old woman in Connecticut was charged with starting a fire that killed 16 fellow patients at her Hartford nursing home. A court guardian said Leslie Andino suffered from multiple sclerosis, dementia and depression. She was found incompetent to stand trial and committed to a mental institution.
• In 2006, 77-year-old Norbert Konwin died at a South Toledo, Ohio, nursing home 10 days after authorities said his 62-year-old roommate beat him with a bathroom towel bar. Sharon John Hawkins was found incompetent to stand trial.
• In January, a 21-year-old man diagnosed with bipolar disorder with aggression was charged with raping a 69-year-old fellow patient at their nursing home in Elgin, near Chicago. A state review found that Christopher Shelton was admitted to the nursing home despite a history of violence and was left unsupervised even after he told staff he was sexually frustrated.
Jackson's roommate was 50 and had a history of aggression and "altered mental status," according to the state nursing home inspector's report. Solomon Owasanoye wandered the streets before he came to All Faith Pavilion, a Chicago nursing home, and he yelled, screamed and kicked doors after he got there.
On May 30, 2008, he allegedly picked up a clock radio, apparently while Jackson slept, and beat him into a coma. Exactly what set him off is unclear. Jackson died of his injuries less than a month later. Owasanoye pleaded not guilty to first-degree murder, and after a psychiatric review was ruled unfit to stand trial. He now lives in a state mental hospital.
All Faith Pavilion co-owner Brian Levinson said his staff is trained to deal with aggressive behavior, and he disputed state findings that Owasanoye had a history of aggression. The for-profit nursing home was fined $32,500 for failing to prevent the assault.
Under federal law, nursing homes are barred from admitting a mentally ill patient unless the state has determined that the person needs the high level of care a nursing home can provide. States are responsible for doing the screening. Also, federal law guarantees nursing home residents the right to be free from physical abuse.
Families have sued in hopes of forcing states to change their practices and pressuring nursing homes to prevent assaults. Advocates say many mentally ill people in nursing homes could live in apartments if they got help taking their medication and managing their lives.
The problem has its roots in the 1960s, when deplorable conditions, improved drug treatments and civil rights lawsuits led officials to close many state mental hospitals. As a result, some states have come to rely largely on nursing homes to care for mentally ill people of all ages.
Also, mixing the mentally ill with the elderly makes economic sense for states. As long as a nursing home's mentally ill population stays under 50 percent, the federal government will help pay for the residents' care under Medicaid. Otherwise, the home is classified a mental institution, and the government won't pay.
In Missouri, more than 4,400 younger mentally ill people are living in nursing homes, in part because of a state program that helps the elderly stay in their own homes longer.
Nursing homes "are looking at 60 to 70 percent occupancy, and the statistics tell us they've got to be in the 90s to operate successfully," said Carol Scott, the state long-term care ombudsman for 20 years. "They're going to take anybody they can."
Gaps in staff training leave the homes inept at handling the delusions and aggression of the mentally ill, said Becky Kurtz, the state long-term care ombudsman in Georgia, where nearly 3,300 younger mentally ill people live in nursing homes.
"Often they'll say, 'I hate it there. I'm angry. I don't want to be there.' Sometimes the behavioral issues are the result of being ticked off you're in a nursing home," Kurtz said.
Pat Willis of the Center for Prevention of Abuse said she has seen elderly residents terrified by younger, mentally ill residents who scream and yell, day and night. "The senior residents are afraid," Willis said. "They would prefer to sit in their rooms now and keep the doors shut."
Nursing home operators say protections against frivolous transfer or discharge keep the homes from throwing out some mentally ill residents.
"Many times, the nursing home's only option becomes dialing 911," said Lauren Shaham, a spokeswoman for the American Association of Homes and Services for the Aging.

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Drug industry advocates join chorus to split FDA

WASHINGTON – As momentum builds to rework the nation's food-safety system after a salmonella outbreak linked to peanuts, the drug industry is hoping for a happy side effect: faster approvals for new medicines.
Drug industry advocates are quietly allying with some of their longtime critics pushing to split the Food and Drug Administration into two agencies, one for food safety and one for medical products.
President Barack Obama bolstered hopes for a breakup last Saturday when he named two public health specialists to the agency's top positions and appointed an advisory group to reassess the nation's decades-old food safety laws.
Drug executives see a chance to speed up drug approvals that have lagged amid a drought of new products, provided their regulator is no longer distracted by high-profile food-safety breakdowns.
"Every CEO that I know in health care is in favor of this, but none that value their share prices will go on the record for fear of retribution from the FDA," said Steve Brozak, president of WBB Securities, an investment brokerage focused on drug and biotech companies.
While FDA's food and drug staffs are separate, Brozak and others believe the public lashings over food outbreaks have made senior officials even more risk-averse on drug approvals. Even before the recent food safety problems, FDA was under pressure from Congress for failing to catch problems with drugs like Merck's Vioxx, which was pulled from the market in 2004.
"The history of FDA is that the commissioner focuses on medical products and only turns to food safety when a crisis comes up," said Professor Michael Taylor, a former FDA and U.S. Department of Agriculture official now at George Washington University.
This year, the agency will spend just 73 cents on food safety for every dollar spent on drugs, according to the Institute of Medicine.
Recent outbreaks connected with spinach, lettuce, peppers and tainted milk from China have created a drumbeat for change.
Margaret Hamburg, a former New York City Health Commissioner, has been tapped to address these issues as Obama's pick for FDA commissioner. Her deputy will be Joshua Sharfstein, a pediatrician and critic of the safety of children's cold medicines.
One former FDA official said Obama's appointment of two safety experts suggests he favors splitting the agency.
"Peggy Hamburg is a safety and security expert, and it seems pretty clear she would become administrator of the food agency," said Peter Pitts of the Center for Medicine in the Public Interest, an industry-funded advocacy group. "Josh Sharfstein would then slide over" to head the drug agency.
The FDA's associate commissioner for food, Dr. David Acheson, would only say, "The agency welcomes all discussions about ways to make our food supply even safer."
The drug industry's lobbying group has not taken a position on a new drug agency. But the group's president says the status quo is unacceptable.
"One of our premier scientific agencies that's responsible for all of our health and safety is still living in the 19th century in many ways, and we shouldn't tolerate that," said Billy Tauzin, head of the Pharmaceutical Research and Manufacturers of America and a former congressman from Louisiana.
The distraction created by food crises is wreaking havoc on the drug industry and its investors, making it harder to predict which drugs the agency will approve, Brozak and others say.
"That makes for a completely untenable position for people trying to make decisions in the health care capital markets," said Brozak, who ran for Congress as a Democrat in 2004.
Last year the FDA missed review deadlines on more than 12 drugs, or more than 20 percent of those received, analysts estimate. The agency's internal goal is to miss no more than 10 percent. FDA officials have blamed one-time problems, including an influx of new staffers.
Experts say there's no reason the agency that assures the safety of complex, $3,000-a-month biotech drugs is also tasked with regulating $3 jars of peanut butter.
The Government Accountability Office endorsed a single food agency in 1999, and lawmakers have been trying unsuccessfully to realize it ever since.
Splitting FDA would likely mean reshuffling committees that oversee food and drug regulation, which could diminish clout and contributions for some lawmakers.
"Once you get an idea like this on Capitol Hill, it creates winners and losers in power and dollars, and when that happens, it usually results in a stalemate," said Patrick Ronan, a former FDA staffer and founder of GreenLeaf Health consultants.
Sen. Dick Durbin, D-Ill., and Rep. Rosa DeLauro, D-Conn., have narrowed their proposals in order to gain support.
DeLauro previously aimed to consolidate food responsibilities, including the USDA's, into one agency, which proved to be politically tricky. Her current bill would carve a separate agency out of FDA with additional powers, including ordering recalls, which are now voluntary, and increasing food inspections.
The Congresswoman said she welcomes Obama's formation of a food safety task force, but showed no sign of backing away from her proposal. The task force must not be "merely a cosmetic bureaucratic endeavor," she said in a statement.
"The working group must produce definitive recommendations that result in the modernization of our food safety regulatory structure."
Durbin's bill similarly would expand FDA powers and would add $775 million to its budget to bolster food safety. Currently, the FDA's $1.9 billion federal budget is supplemented by more than $300 million in application fees paid by drugmakers to fund speedy reviews.

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Brain injury victims can seem OK, symptoms delayed

At first, Natasha Richardson said she felt fine after she took a spill on a Canadian ski slope. But that's not unusual for people who suffer traumatic head injuries like the one that killed the actress.
Doctors say sometimes patients with brain injuries have what's called a "lucid interval" where they act fine for an hour or more as the brain slowly, silently swells or bleeds. Later, back at her hotel, Richardson fell ill, complained of a headache, and was taken to a hospital. She died Wednesday in New York.
An autopsy Thursday showed that the 45-year-old actress hit her head, which caused bleeding between the skull and the brain's covering, resulting in what's called an epidural hematoma. It's a type of injury often caused by a skull fracture.
Because of that lucid interval, doctors always tell patients who seem OK after a brain injury to have someone keep a close eye on them, in case symptoms emerge.
Symptoms — headache; loss of consciousness; vomiting; problems seeing, speaking or moving; confusion; drainage of a clear fluid from the nose or mouth — appear after enough pressure builds in the skull. By then it's an emergency.
"Once you have more swelling, it causes more trauma which causes more swelling," said Dr. Edward Aulisi, neurosurgery chief at Washington Hospital Center in the nation's capital. "It's a vicious cycle because everything's inside a closed space."
Pressure can force the brain downward to press on the brain stem that controls breathing and other vital functions, causing coma or death. Frequently, surgeons cut off a portion of the skull to give the brain room to swell. Or they drain the blood and remove clots that formed.
"This is a very treatable condition if you're aware of what the problem is and the patient is quickly transferred to a hospital," said Dr. Keith Siller of New York University Langone Medical Center. "But there is very little time to correct this."
Details of Richardson's treatment have not been disclosed.
A CT scan can detect bleeding, bruising or the beginning of swelling after an injury. The challenge is for patients to know whether to seek one.
"If there's any question in your mind whatsoever, you get a head CT," Aulisi advised. "It's the best 20 seconds you ever spent in your life."

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Attempting to zap Parkinson's through spinal cord

WASHINGTON – Implanting a pacemaker-like device deep in the brain helps some Parkinson's disease patients move better, but could less risky zapping of the spinal cord work instead? It did in mice and rats nearly immobilized with Parkinson's-like symptoms: Scientists at Duke University Medical Center turned on the electricity and videotaped the rodents immediately scurrying around almost like normal.
The research, reported in Friday's edition of the journal Science, is just a first step. More animal testing is needed to tell if the approach could be tried in people. Implants in marmosets, a type of primate, are to begin soon.
But sufferers of chronic pain already can have spinal cord stimulators implanted that send electrical currents to block the "I'm hurting" messages sent to and from the brain. For Parkinson's, the idea is similar.
The 1.5 million Americans with Parkinson's gradually lose brain cells that produce dopamine, a chemical key to the circuitry that controls muscle movement. The result: Haywire brain signaling that leads to increasingly severe tremors and periodically stiff or frozen limbs. Medication helps early in the disease. More severely affected patients may try "deep brain stimulation," where wires are implanted inside the brain to deliver tiny electrical zaps that disable overactive nerve cells and improve motor control.
Exploring a less invasive approach, the Duke team attached tiny wires to the spinal cords of mice and rats whose brains produced so little dopamine that they had the slow, stiff motions of advanced Parkinson's disease.
When the electricity was turned on, the animals became 26 times more active and movement visibly improved in seconds, Duke neuroscientist Dr. Miguel Nicolelis and colleagues wrote.
Why would it work?
Proper movement requires orderly nerve cell firing to different muscles at different moments in time, like members of an orchestra must play in proper sequence for a symphony.
There's increasing if circumstantial evidence that rhythmic waves of brain activity, called oscillations, play a role in Parkinson's movement problems — and that interrupting those abnormal waves allows the more normal, symphony-like brain cell firing to resume, said Dr. Walter Koroshetz, deputy director of the National Institute of Neurological Disorders and Stroke, which helped fund the work.
The spinal cord stimulation appears to have sent a signal up to the brain that interrupted those oscillations.
Koroshetz cautioned that much work remains, including testing whether the stimulator's effect might last long enough to be useful.
But, "it's something that has definitely got some scientific traction to it," he said. "It's a really good idea."

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Private inspections of food companies seen as weak

WASHINGTON – The mortgage meltdown exposed the weakness of self-regulation in financial markets. Now the salmonella outbreak is doing the same for the food industry.
A House subcommittee Thursday released new documents that showed how private inspectors contracted by Peanut Corp. of America failed to find long-standing sanitary problems at company facilities. Peanut Corp. is at the center of a nationwide outbreak that has sickened nearly 700 people and is blamed for at least nine deaths.
Lawmakers said the food industry's private inspection system failed to catch filthy conditions because the company itself hired the inspectors.
"There is an obvious and inherent conflict of interest when an auditor works for the same supplier it is evaluating," said Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce investigations subcommittee. He termed it a "cozy relationship."
Last summer, Peanut Corp.'s private inspector, a company called AIB, awarded the peanut processor a certificate in 2008 for "superior" quality at its Plainview, Texas, plant. This year, salmonella was discovered there.
The outbreak was initially traced to a Peanut Corp. facility in Blakely, Ga. Later, contamination was found at the Texas plant. Peanut Corp. is under criminal investigation for allegedly shipping products it knew to be tainted.
Owner Stewart Parnell has refused to answer questions from lawmakers, citing constitutional protections against self-incrimination. On Thursday, Parnell told The Associated Press he couldn't comment on the allegations and referred questions to his attorney, who was not immediately available.
Federal law does not require food companies to pay for their own inspections of suppliers. Nor are industry labs and inspectors required to tell the government about any problems they find.
At least one food company that used its own inspectors, Nestle USA, ultimately decided not to do business with Peanut Corp. Nestle USA had no recalls. But a Nestle affiliate in Puerto Rico recalled some ice cream products, and Nestle HealthCare Nutrition — another affiliate — recalled a nutritional bar.
The committee released a 2002 Nestle USA inspection report of Peanut Corp.'s Blakely plant. "They found that the place was filthy," said Rep. Henry Waxman, D-Calif.
A second audit by Nestle USA of Peanut Corp.'s Texas facility in 2006 also found major pest control and other problems. The audit said that would disqualify the plant from supplying chopped peanut pieces to sprinkle atop Drumstick ice-cream cones.
Auditors found at least 50 mouse carcasses in and around the plant and also a dead pigeon "lying on the ground near the peanut-receiving door."
The audit also said the plant had no pathogen-monitoring plan and noted that one needed to be developed for the plant to be in compliance with audit standards.
Companies that bought ingredients from Peanut Corp. said they had no way of defending themselves against a supplier they accuse of deliberately breaking the rules and covering up.
"I think we did everything we could do," Kellogg Co. chief executive David Mackay told the committee.
"The issue was that (Peanut Corp.) acted in a dishonest and unethical way," he added.
Lawmakers and the Obama administration say the problem goes beyond a rogue company, and major reforms are needed. Legislation has been introduced in Congress to take food safety oversight away from the Food and Drug Administration and give it to a new agency with stronger legal powers and more funding.
Peanut Corp. produced not only peanut butter, but peanut paste, an ingredient found in foods from granola bars and dog biscuits to ice cream and cake. More than 3,490 products have been recalled, including some millions of Kellogg's Austin and Keebler peanut butter sandwich crackers.
___
On the Net:
FDA salmonella page: http://tinyurl.com/8srctw

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Selasa, 03 Maret 2009

Call for autopsy to unravel tragedy of stillbirth


WASHINGTON – Adding to the devastation of her daughter Clare being stillborn is the fact that Erin Fogarty Owen doesn't know why: What went wrong in a pregnancy that seemed textbook? And that unknown means Owen is facing her new pregnancy with as much fear as joy, repeating what she calls sanity sonograms for reassurance that this baby's still fine.
More than 25,000 U.S. babies a year are stillborn, and in more than a third of the cases doctors can't find an explanation. New guidelines for obstetricians aim to help change that with a too often taboo recommendation: Gently urge more parents to accept an autopsy to help unravel this mystery killer, so that maybe doctors can start preventing it.
Even an autopsy doesn't always give an answer. It didn't explain why Clare Owen died.
The hope is that if more are performed — and done better, to the same set of standards — scientists might finally have enough tests to compare and uncover risk factors that doctors today know nothing about.
"We need some answers," says Owen, of Arlington, Va. "It all starts at the bedside of the grieving parent who's just been told her baby is dead."
The new guidelines from the American College of Obstetricians and Gynecologists come as bereaved parents and child advocates are pushing to break the silence that surrounds those deaths.
"People don't want to frighten their patients near the end of pregnancy," says Dr. Ruth Fretts of Harvard Vanguard Medical Associates and the Harvard Medical School, who led the new guidelines. "So basically the issue about late stillbirth is generally not brought up. We've been afraid to talk about it."
Among Fretts' top questions: Should older and other higher-risk mothers be induced before their due dates? And some doctors order women to count their babies' kicks in late pregnancy while others don't. Should they, and what tests are needed to tell if dwindling movement means trouble or a false alarm?
"My dream of being a mother will soon be here," Owen signed off her online journal at 2:39 a.m. on March 7, 2008, while feeling early contractions.
"My God, how do I tell you the news?" is the next entry, on March 24.
She'd woken her husband, Rob, shortly after her optimistic signoff and headed for the hospital — where they almost immediately learned Clare had no heartbeat.
"My beautiful, kicking, active, hiccuping little girl was dead," she wrote, returning to her journal as catharsis.
Most at risk are black women — they have roughly twice the rate of stillbirths as other U.S. women — and mothers age 35 and older, even if they seem just as healthy as younger women. Obesity, diabetes and high blood pressure also increase the risk.
Birth defects, problems with the placenta and too little fetal growth account for many stillbirths. But there's been no progress in a decade in explaining the rest, babies like Clare Owen who appear normal despite intense testing and whose mother's only risk factor was age, 37.
Few stillbirths occur during labor in developed countries. Usually a woman has labor induced after her baby has died.
Early into hours of labor, Owen vividly remembers a comforting nurse rubbing her arm while asking her to consider an autopsy to find out what happened. Owen didn't hesitate; she needed to know.
Fretts estimates a third of mothers never get asked about an autopsy, and there's no good count of how many are done. It's a delicate issue for families who may know the procedure only from grisly TV crime shows. The guidelines stress explaining that such testing can be crucial to calculating future pregnancy risk and needed care, and is conducted with respect. Families who reject a full autopsy should be offered alternatives, such as full-body X-rays and biopsies, the guidelines say.
An autopsy isn't immediate. The Owens spent seven hours with Clare to say goodbye. Complicating the choice, insurance doesn't always pay — Owen's did — and the tab can reach $1,500.
Moreover, Fretts says most death certificates are filled out before a stillbirth assessment is completed, meaning scientists culling them for new clues never see key information.
"That isn't good enough," says Owen, frustrated that Clare's autopsy merely ruled out known stillbirth causes. The main clue was that Clare weighed almost 11 pounds, startling for slim parents. "We need to get together and come up with better answers."
To help, Sen. Frank Lautenberg, D-N.J., is writing legislation that aims to increase stillbirth research and public awareness. Also, the March of Dimes is designing a Web-based tool to one day guide women in asking relatives about miscarriages, stillbirths and other family conditions, helping doctors better determine their risk and alter prenatal care accordingly.
For now, Owen is hanging onto sympathetic care from a high-risk OB practice that allows repeated reassurance sonograms during her new pregnancy — and figuring out how to handle well-meaning "is this your first" queries from strangers.
"Do I, you know, bring this person down by saying, 'Oh no, we have one in heaven and we hope that we get to keep this one?' I can't deny Clare's existence, but it's also very uncomfortable," she says.
___
EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
___
On the Net:
American College of Obstetricians and Gynecologists: http://www.acog.org
Stillbirth-related groups: http://www.firstcandle.org and http://www.stillbirthalliance.org

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Fewer kids have high lead levels than 20 years ago

CHICAGO – In a stunning improvement in children's health, far fewer kids have high lead levels than 20 years ago, new government research reports — a testament to aggressive efforts to get lead out of paint, water and soil.

Lead can interfere with the developing nervous system and cause permanent problems with learning, memory and behavior. Children in poor neighborhoods have generally been more at risk because they tend to live in older housing and in industrial areas.

Federal researchers found that just 1.4 percent of young children had elevated lead levels in their blood in 2004, the latest data available. That compares with almost 9 percent in 1988.

"It has been a remarkable decline," said study co-author Mary Jean Brown of the Centers for Disease Control and Prevention. "It's a public health success story."

The 84 percent drop extends a trend that began in the 1970s when efforts began to remove lead from gasoline. The researchers credited continuing steps to reduce children's exposure to lead in old house paint, soil, water and other sources.

The study was being released Monday in the March edition of the journal Pediatrics. It is based on nearly 5,000 children, ages 1 to 5, who were part of a periodic government health survey.

The government considers levels of at least 10 micrograms of lead per deciliter of blood to be elevated, although research has shown that levels less than that can still cause problems including attention and reading difficulties. There is no known "safe" level, the study authors noted.

Caroline Cox, research director of the Center for Environmental Health, a California-based advocacy group, noted that lead poisoning "is entirely preventable."

"There's no reason even one child in the United States should be poisoned by lead," Cox said. "It's great there aren't as many now as there were, but there are still too many."

By 2004, racial disparities among children with blood-lead levels higher than 10 micrograms had mostly disappeared: About equal numbers of white, black and Mexican-American children had levels in that range.

However, disparities at lower levels remained. For example, almost 18 percent of white children had levels of less than 1 microgram per deciliter, versus 11 percent of Mexican-Americans and 4 percent of blacks.

Children from lower-income families also had higher lead levels than those from wealthier families.

Dr. Bruce Lanphear, a lead specialist at Cincinnati Children's Hospital Medical Center who wasn't involved in the government study, said lead levels have probably continued to decline since 2004. But the findings show "we need to still continue to be aggressive" with prevention efforts, he said.

Lead-based paint in old housing, which can contaminate house dust and soil, is the main source. Children also can be exposed to lead in water, mostly from old plumbing pipes, as well as toys and certain folk medicines.

The CDC recommends that pregnant women and young children avoid housing built before 1978 that is undergoing renovation. Other recommendations include regularly washing children's hands and toys; frequent washing of floors and window sills, where paint dust can collect; and avoiding hot tap water for drinking, cooking and making baby formula. Hot tap water generally contains higher lead levels from plumbing than cold water.

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On the Net:

Pediatrics: http://www.pediatrics.org/

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

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Finding genes that make teeth grow all in a row

WASHINGTON – Ever wonder why sharks get several rows of teeth and people only get one? Some geneticists did, and their discovery could spur work to help adults one day grow new teeth when their own wear out.
A single gene appears to be in charge, preventing additional tooth formation in species destined for a limited set. When the scientists bred mice that lacked that gene, the rodents developed extra teeth next to their first molars — backups like sharks and other non-mammals grow, University of Rochester scientists reported Thursday.
If wondering about shark teeth seems rather wonky, consider: Tooth loss from gum disease is a major problem, here and abroad, and dentures or dental implants are far from perfect treatments. If scientists knew exactly what triggers a new tooth to grow in the first place, it's possible they could switch that early-in-life process on again during adulthood to regenerate teeth.
"It's exciting. We've got a clue what to do," said Dr. Songtao Shi of the University of Southern California School of Dentistry, who said the Rochester discovery will help his own research into how to grow a new tooth from scratch.
Also intriguing: All the mice born without this gene, called Osr2, had cleft palates severe enough to kill. So better understanding of this gene might play a role in efforts to prevent that birth defect, the Rochester team reported in the journal Science.
Teeth may not be visible until long after birth, but they start to form early in embryo development. Teeth ultimately erupt from a thickened band of tissue along the jaw line called the dental lamina, a band that forms in a top layer of the gum called the epithelium. Scientists have long thought the signals for tooth formation must lie in that tissue layer as well.
Not so, the Rochester team found: All the action takes place instead in a deeper cell layer called the mesenchyme.
Think of the Osr2 gene as a control switch, a kind of gene that turns on and off the downstream actions of other genes and proteins. In that mesenchymal tissue, the Osr2 gene works in concert with two other genes to make sure budding teeth form in the right spot, said lead researcher Dr. Rulang Jiang, a geneticist at Rochester's Center for Oral Biology.
"It's almost a self-generating propagation of the signal" that leads to one tooth after another forming all in a row, he explained.
Knocking that molecular pathway out of whack causes either missing or extra teeth to result, Jiang showed in a series of mouse experiments.

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Study: Old drugs might give TB a 1-2 punch

WASHINGTON – Scientists might have found a way to deal drug-resistant tuberculosis a one-two punch using two old, safe antibiotics — and studies in ill patients could begin later this year.
TB is one of the world's oldest killers, and the lung disease still claims the lives of more than 1.5 million people globally every year. The bacteria that cause TB are fast becoming impervious to many treatments, drug resistance that is seen worldwide but is a particular problem in parts of Asia and Africa. While typically the TB doesn't respond to two top treatments, an emerging threat is so-called extensively drug-resistant disease, or XDR-TB, that is virtually untreatable by remaining options.
So researchers are frantically hunting new approaches, including taking a fresh look at some old drugs.
TB bacteria contain a certain enzyme that renders the penicillin family of antibiotics drugs useless.
"It chews them up and spits them out and they never get to see their target," explained biochemist John Blanchard of the Albert Einstein School of Medicine.
But there are different antibiotics that can block that enzyme, called beta-lactamase. One, named clavulanate, has long been sold as part of the two-drug Augmentin combination that's widely used for various children's infections.
So Blanchard's team tested whether administering clavulanate might make TB vulnerable to other antibiotics — and found a combination that in laboratory tests blocked the growth of 13 different drug-resistant TB strains.
The combo: Clavulanate to drop TB's shield, plus a long-sold injected antibiotic — meropenem, part of that penicillin-style family — that then attacks the bacteria.
The findings are reported Thursday in the journal Science.
What happens in a lab doesn't necessarily work in people. Still, the findings were so compelling that two teams of U.S. researchers — from the National Institutes of Health and New York's Montefiore Medical Center — already are planning small patient studies in South Korea and South Africa. They hope to begin those studies later this year.
"It's very clever," said Dr. Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases. When one drug knocks out the TB microbe's defense, "that leaves the original drug with the capability of doing what it's supposed to be doing."


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