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FDA reversal OKs morphine painkiller for dying

2009-04-09T19:17:00.001-07:00

NEW YORK - A liquid morphine painkiller given by family caregivers to dying patients can remain on the market, federal regulators have decided after hearing protests over their decision to remove it. The Food and Drug Administration had announced last week that it was ordering manufacturers to stop making 14 medications including the liquid morphine. All were developed so long ago they had never received FDA approval.
But on Thursday, the FDA's Dr. Douglas Throckmorton told The Associated Press the morphine liquid will remain on the market until it's replaced by an approved version or some equivalent therapy.
The reversal was welcomed by experts in hospice care and pain relief. One doctors group had told the FDA that last week's order would "cause extreme suffering for many patients who are nearing the end of life."
The order has not changed for the other painkillers, at least for now, said Throckmorton, deputy director of the agency's Center for Drug Evaluation and Research.
The agency said last week that the unapproved drugs might be unsafe, ineffective or poor quality. The order gave manufacturers 60 days to stop making those products.
The liquid morphine is highly concentrated. Other approved forms of liquid morphine are more dilute, and Throckmorton said the FDA had thought the other forms could take the place of the concentrated form.
But reaction from hospice experts and others "helped us understand" that some patients need the unapproved version, Throckmorton said.
In interviews, experts said they didn't have firm numbers on how many patients use the concentrated liquid. But Dr. Diane Meier, director of the Center to Advance Palliative Care at the Mount Sinai School of Medicine in New York, estimated that it may be at least 2 million Americans a year.
She called Thursday's decision "fabulous.... It's incredibly refreshing and makes me hopeful about our government."
The high morphine concentration is crucial, she and others said. It allows caregivers to rapidly relieve pain by placing just a few drops in the mouth of a person who has trouble swallowing, perhaps because of confusion, lethargy or other conditions.
The more dilute morphine requires much more liquid, which could make an impaired person choke or sputter, or refuse to take the medication, experts say.
Caregivers can administer the concentrated solution at home, where morphine shots often aren't a good option. Without the concentrated liquid, families could end up calling 911 to rush their loved ones to an emergency room for morphine shots, which would be expensive and against patient wishes, said Dr. Porter Storey, executive vice president of the American Academy of Hospice and Palliative Medicine.
Storey called the FDA reversal "a really important step in the right direction," showing "an amazing level of responsiveness we're not used to seeing in our government officials."
But Storey said he was still concerned about the other painkillers ordered off the market, products containing morphine, hydromorphone or oxycodone.
While approved medications with those ingredients remain on the market, Storey noted that opiate painkillers are in short supply. So rather than removing the unapproved versions all at once, exacerbating the problem, he suggested the FDA proceed more slowly.
In a letter to the FDA earlier this week, Storey's organization said the painkillers covered by last week's order "have been used safely and effectively for decades."
Throckmorton said the FDA is open to getting additional information about the other painkillers, and would discuss them with experts in hospice and palliative care.
But Storey said that in a later phone call with physicians and pharmacists, the FDA said that the order against the other painkillers would stand.

Further shortfalls in painkiller supply could spell trouble for chronic pain patients such as 62-year-old Ora Chaikin in New York City, said her physician, Dr. R. Sean Morrison at Mount Sinai.

Chaikin takes an unapproved version of the drug Dilaudid � hydromorphone � when her joint pain flares, which is typically on most days. She said she needs that medication "just to be able to walk, to be able to do daily activities (like) putting a coat on."

Although approved versions of the drug are available, the FDA order makes Morrison worry about their supply.

"It's already hard to get them," he said.

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On the Net:

FDA statement on original order: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01983.html

FDA background information: http://www.fda.gov/cder/drug/unapproved_drugs/narcoticsQA.htm

FDA web page on unapproved drugs: http://www.fda.gov/cder/drug/unapproved_drugs/default.htm

Studies of 'good' fat could help with weight loss

2009-04-08T19:18:00.001-07:00

Fight fat with fat? The newest obesity theory suggests we may one day be able to do just that. Just like good and bad cholesterol, there apparently are good and bad types of body fat. Scientists until recently believed this good fat, which spurs the body to burn calories to generate body heat, played an important role in keeping infants warm but by adulthood was mostly gone or inactive.
Now three studies � from researchers in Boston, Finland and the Netherlands � show that some good fat remains in adults, affecting metabolism and potentially offering a target to help people shed pounds.
Dr. Francesco Celi, an endocrinology and metabolism researcher at the National Institute of Diabetes and Digestive and Kidney Diseases, said the studies show this fat burns large amounts of energy.
"So it could be used as a target" for a pill that would somehow rev up the fat, he said.
Dr. Louis Aronne, former president of the Obesity Society and a weight control expert at Weill Cornell Medical Center in New York, said the findings are the most conclusive evidence so far of the role of such fat in regulating body temperature and weight.
"I don't want to use the word 'exercise-in-a-pill,' but it's doing something (that's) getting rid of calories," he said, adding that any obesity treatment developed around the fat could be a potential treatment for diabetes as well.
The studies were published in Thursday's New England Journal of Medicine.
The good fat is actually brownish, while the more predominant bad fat is white or yellow. Brown fat is stored mostly around the neck and under the collarbone. White fat tends to concentrate around the waistline, where it stores excess energy and releases chemicals that control metabolism and the use of insulin.
All three research groups documented the presence and activity of the brown fat by examining tissue samples from some patients and using high-tech imaging that indicated how much sugar, and therefore calories, the fat burned.
One group from Joslin Diabetes Center, Harvard Medical School and three hospitals in Boston looked at scans done on nearly 2,000 patients to diagnose various health problems. The other two groups scanned small numbers of patients, first at room temperature and then after a couple hours in mild cold, about 60 degrees.
Here's what the scientists learned about brown fat:
• Lean people had far more than overweight and obese people, especially among older folks.
• It burns far more calories and generates more body heat when people are in a cooler environment.
• Women were more likely to have it than men, and their deposits were larger and more active.
Finding a successful treatment for obesity would be a Holy Grail for scientists. Most obese and overweight people are unable to shed pounds and keep them off with dieting and exercise.
And despite plenty of effort, pharmaceutical companies have been unable to develop a medicine that helps people safely lose and keep off a significant amount of weight. Any drug that could do that would be a guaranteed blockbuster.
Aronne said the findings likely would renew interest in the area of brown fat among drugmakers; at least one briefly studied a treatment in lab animals several years ago.
So how could researchers use these basic findings about good fat to eventually come up with a weight-loss medication?

One possibility would be a pill to stimulate a specific protein to release more energy from the fat cells in the form of heat rather than storing it for future energy needs, Aronne and Celi said.

Finding a way to increase the amount of brown fat in a person would be another strategy. Researchers at Dana-Farber Cancer Institute in Boston have been injecting certain genes into mice to try to produce brown fat cells instead of white ones.

Celi said researchers also could try to make a pill that stimulates nerve endings inside brown fat to make it burn more calories.

Or overweight people could simply try turning down the thermostat to see if it makes them burn more energy and lose weight � a strategy that Celi and researchers are testing in a small study that could produce results by the end of the year.

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On the Net:

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

Obesity Society: http://www.obesity.org

Skin cancer now top cancer among young women in UK

2009-04-07T19:25:00.001-07:00

LONDON - Melanoma, the deadliest kind of skin cancer, is now the most common cancer in young British women, the country's leading cancer organization said Wednesday. Skin cancer has overtaken cervical cancer as the top cancer striking women in their 20s, according to the latest data from Cancer Research United Kingdom.
The trend is particularly worrying since younger people are not generally those most susceptible to melanoma. Rates of skin cancer are typically highest in people over age 75.
But experts worry that increasing numbers of younger people being diagnosed with skin cancer could be the start of a dangerous trend. Women in their 20s make up a small percentage of all patients diagnosed with melanoma in Britain, but nearly a third of all cases occur in people younger than 50.
Based on current numbers, Cancer Research UK predicts that melanoma will become the fourth most common cancer for men and women of all ages by 2024, and that cases will jump from about 9,000 cases a year to more than 15,500.
Cancer experts attribute the rising number of skin cancer cases largely to the surge in people using tanning salons. "Spending time on sunbeds is just as dangerous as staying out too long in the sun," said Caroline Cerny of Cancer Research UK. The organization is starting a SunSmart campaign to warn Britons of the dangers of being too bronzed.
"The intensity of UV rays in some sunbeds can be more than 10 times stronger than the midday sun," Cerny said.
In the United States, several states require parental approval before minors can use tanning salons. Wisconsin bans people 16 and under from using tanning beds, and others ban children under 14. At least 29 states have regulations governing minors' use of tanning salons.
In the U.K., Scottish politicians passed legislation banning those under 18 from using tanning beds, though it hasn't yet been implemented. There are no plans for legislation in the rest of the U.K.
The World Health Organization has previously recommended that tanning beds be regulated because of their potential to damage DNA in the skin.
Experts said most deadly skin cancers could be avoided if people took the proper precautions when in the sun and avoided tanning beds.
One the Net:
http://www.cancerresearchuk.org
http://www.sunsmart.org.uk

Study finds 1 in 5 obese among 4-year-olds

2009-04-06T19:08:00.001-07:00

CHICAGO - A striking new study says almost 1 in 5 American 4-year-olds is obese, and the rate is alarmingly higher among American Indian children, with nearly a third of them obese. Researchers were surprised to see differences by race at so early an age.
Overall, more than half a million 4-year-olds are obese, the study suggests. Obesity is more common in Hispanic and black youngsters, too, but the disparity is most startling in American Indians, whose rate is almost double that of whites.
The lead author said that rate is worrisome among children so young, even in a population at higher risk for obesity because of other health problems and economic disadvantages.
"The magnitude of these differences was larger than we expected, and it is surprising to see differences by racial groups present so early in childhood," said Sarah Anderson, an Ohio State University public health researcher. She conducted the research with Temple University's Dr. Robert Whitaker.
Dr. Glenn Flores, a pediatrics and public health professor at University of Texas Southwestern Medical School in Dallas, said the research is an important contribution to studies documenting racial and ethnic disparities in children's weight.
"The cumulative evidence is alarming because within just a few decades, America will become a 'minority majority' nation," he said. Without interventions, the next generation "will be at very high risk" for heart disease, high blood pressure, cancers, joint diseases and other problems connected with obesity, said Flores, who was not involved in the new research.
The study is an analysis of nationally representative height and weight data on 8,550 preschoolers born in 2001. Children were measured in their homes and were part of a study conducted by the government's National Center for Education Statistics. The results appear in Monday's Archives of Pediatrics & Adolescent Medicine.
Almost 13 percent of Asian children were obese, along with 16 percent of whites, almost 21 percent of blacks, 22 percent of Hispanics, and 31 percent of American Indians.
Children were considered obese if their body-mass index, a height-weight ratio, was in the 95th percentile or higher based on government BMI growth charts. For 4-year-olds, that would be a BMI of about 18.
For example, a girl who is 4 1/2 years old, 40 inches tall and 42 pounds would have a BMI of about 18, weighing 4 pounds more than the government's upper limit for that age, height and gender.
Some previous studies of young children did not distinguish between kids who were merely overweight versus obese, or they examined fewer racial groups.
The current study looked only at obesity and a specific age group. Anderson called it the first analysis of national obesity rates in preschool kids in the five ethnic or racial groups.
The researchers did not examine reasons for the disparities, but others offered several theories.
Flores cited higher rates of diabetes in American Indians, and also Hispanics, which scientists believe may be due to genetic differences.
Also, other factors that can increase obesity risks tend to be more common among minorities, including poverty, less educated parents, and diets high in fat and calories, Flores said.
Jessica Burger, a member of the Little River Ottawa tribe and health director of a tribal clinic in Manistee, Mich., said many children at her clinic are overweight or obese, including preschoolers.
Burger, a nurse, said one culprit is gestational diabetes, which occurs during a mother's pregnancy. That increases children's chances of becoming overweight and is almost twice as common in American Indian women, compared with whites.
She also blamed the federal commodity program for low-income people that many American Indian families receive. The offerings include lots of pastas, rice and other high-carbohydrate foods that contribute to what Burger said is often called a "commod bod."

"When that's the predominant dietary base in a household without access to fresh fruits and vegetables, that really creates a better chance of a person becoming obese," she said.

Also, Burger noted that exercise is not a priority in many American Indian families struggling to make ends meet, with parents feeling stressed just to provide basic necessities.

To address the problem, her clinic has created activities for young Indian children, including summer camps and a winter break "outdoor day" that had kids braving 8-degree temperatures to play games including "snowsnake." That's a traditional American Indian contest in which players throw long, carved wooden "snakes" along a snow or ice trail to see whose lands the farthest.

The hope is that giving kids used to modern sedentary ways a taste of a more active traditional American Indian lifestyle will help them adopt healthier habits, she said.

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On the Net:

Archives: http://www.archpediatrics.com

Association of American Indian Physicians: http://tinyurl.com/c8raox

(This version CORRECTS the group's name to National Center for Education Statistics, not Educational Statistics.)

Doctor in hepatitis B case has license suspended

2009-04-03T18:24:00.001-07:00

NEWARK, N.J. - State regulators on Friday temporarily suspended the medical license of a doctor who health officials suspect is linked to a hepatitis B outbreak.
Nearly 3,000 of Dr. Parvez Dara's patients have been warned to get tested after five cancer patients tested positive for the disease, which is transmitted through exposure to infected blood and can cause serious liver damage.
On Friday, the state presented evidence about the conditions at the oncologist's Toms River office. Investigators said they found blood on the floor of a room where chemotherapy was administered, blood in a bin where blood vials were stored, open medication vials and unsterile saline and gauze.
Inspectors also cited problems with cross-contamination of pens, refrigerators and countertops; use of contaminated gloves; and misuse of antiseptics, among other health code violations.
"This was not a one-time episode," Deputy Attorney General Siobhen Krier told regulators. "This is a case of egregious, bad medical judgment displayed over a long period of time."
A special committee of the state Board of Medical Examiners issued the suspension, effective immediately, on an emergency basis. The full board will consider whether to continue the suspension on Wednesday.
During the hearing Friday, Krier said Dara had a history of health code violations dating to 2002 and posed "a clear and imminent danger to the public."
Since 2002, Dara has paid nearly $56,000 in fines for infection control health code violations, court records show.
Dara said he only used sterile supplies and equipment and took steps correct the violations. He questioned whether the patients may have contracted the disease some other way, such as from a hospital or from surgery, and suggested some may have been latent carriers � meaning they had the virus but it was dormant � until they began receiving chemotherapy, which can suppress the body's immune system.
"It's not that rare," Dara said.
In making its decision, the committee said Dara showed "a significant and gross deficiency in judgment" and that that could not be remedied by changing office practices.
"Dr. Dara's own testimony has not persuaded the committee that he has an appreciation for the gravity of multiple breaches of basic infection control practices," the committee said in its order to suspend Dara's license.
Dara did express sympathy for his patients: "This is hurting them so much more than it's hurting me."
A March 28 letter was sent to his patients warning them of the risk and suggesting they be tested for the liver diseases hepatitis B and hepatitis C and for HIV, the virus that causes AIDS.
Dara, originally from Pakistan, has been practicing at his Toms River office for 23 years. He estimated that he sees between 45 and 60 patients a day, with about a dozen receiving chemotherapy each day.
His attorney, Robert Conroy, argued to the board that there was no direct evidence the hepatitis cases were linked to Dara's office. He characterized the state's investigation as sloppy and said the fact that the outbreak investigation is ongoing should have precluded regulators from drawing any conclusions.
"There's no proof," he said. "This is a rush to judgment ... before they get test results back."
Conroy said Dara plans to immediately appeal the decision.

NJ warns nearly 3,000 to get tested for hep B

2009-04-02T18:18:00.001-07:00

TRENTON, N.J. - New Jersey officials have advised nearly 3,000 people who share a doctor to get tested after five cancer patients who visited the physician were found to have hepatitis B.
Two cases of hepatitis B were confirmed in late February as connected with the office of Dr. Parvez Dara, an oncologist with offices in Toms River and Manchester, near the Jersey Shore, Marilyn Riley, spokeswoman for the state Health Department, said Thursday.
Health officials recently learned of three more cases, all in Toms River, in which the patients were also under Dara's care.
"These were older adults who didn't have other risk factors, so that is what raised a red flag," Riley said.
Ocean County decided to send a letter to all Dara's patients dating to 2002. The March 28 letter warns them of the risk and suggests they be tested for the liver diseases hepatitis B and hepatitis C and for HIV, the virus that causes AIDS.
Linda Bradford of Bayville said she's worried about her husband's health after hearing news of the outbreak.
"The first thing I did was call my husband," Bradford told WCBS-TV. "I was terrified. Oh my God, what's going on here?"
Hepatitis B is transmitted through exposure to infected blood, often by sexual contact or infected needles. Dara's office treats patients with blood disorders and cancer, some of whom receive chemotherapy there.
"The evidence that's available suggests the infections could be linked to the method the clinical staff used to administer injectable medications," such as chemotherapy, Riley said. "There's no evidence to suggest the medications were a problem."
Dara faces suspension of his medical license in connection with the outbreak and for other alleged health code violations. A hearing is scheduled for Friday before the state Board of Medical Examiners.
Until then, he is performing only patient consultations, not procedures, said his lawyer, Robert Conroy. Neither of Dara's offices were open Thursday.
According to a report by the state epidemiology division, Dara has infection control violations dating to 2002, including violations of standards of the federal Occupational Safety and Health Administration.
Conroy said that there is no proof the patients got the disease from Dara's office and that other factors aren't being considered. All five patients were also seen at Community Medical Center in Toms River, he said.
Health officials said they ruled the hospital out as a possible source of the infection.
Hepatitis B is transmitted through exposure to infected blood, often by sexual contact or infected needles.
Conroy said three patients were found to have dormant hepatitis infections that might have been noticed only after they started cancer treatments, which can suppress the body's immune system.
Because the patients live in the same area, he said, there could be another possible source.
"Absent any evidence, it is just as likely that those patients were infected (at) ... a common eatery," he wrote in a letter to the Medical Examiners Board.

Meanwhile, Conroy said Dara has received only support from his patients.

"The doctor has never felt more appreciated by his patients than he does right now," he said.

Ocean County Health Department spokesman Edward Rumen said no new cases have been reported since the alert was issued.

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Associated Press writer Bruce Shipkowski in Toms River contributed to this report.

1 in 5 Medicare patients readmitted within month

2009-04-01T18:09:00.001-07:00

NEW YORK - One in five Medicare patients end up back in the hospital within a month of discharge, a large study found, and that practice costs billions of dollars a year. The findings suggest patients aren't told enough about how to take care of themselves and stay healthy before they go home, the researchers said. A few simple things � like making a doctor's appointment for departing patients � can help, they said.
The study found that a surprising half of the non-surgery patients who returned within a month hadn't even seen a doctor between hospital stays.
"Hospitals put more effort into the admission process than they do into the discharge process," said Dr. Eric Coleman, one of the study's authors from the University of Colorado in Denver.
Coleman, who runs a program to improve "hand-offs" between health care systems, said patients often have a honeymoon notion about how things will be once they're home. Then when they become confused about how to take their medicine or run into other problems, they head back to the hospital because they don't know where to turn, he said.
The issue of hospital readmissions and their cost has come under scrutiny in recent years. And it's getting attention now because President Barack Obama's budget calls for reducing spending on Medicare readmissions to pay for health care reform.
For their study, reported in Thursday's New England Journal of Medicine, the researchers looked at Medicare records from late 2003 through 2004. They found that about 20 percent of 11.9 million patients were readmitted to the hospital within a month of discharge; about a third were back in the hospital within three months.
About half of the patients hospitalized for ailments didn't see a doctor before they landed back in the hospital within a month.
Patients with heart failure and pneumonia had the most readmissions overall; among surgical procedures, heart stents and major hip and knee surgery had the highest returns.
About 10 percent of all readmissions were probably planned, such as putting in a stent, the researchers said. They estimated that the cost of unplanned return visits in 2004 was $17.4 billion.
"It's a big hunk of money and it's a big hunk of misery," said another study author, Dr. Stephen Jencks, an independent consultant who worked for the Centers for Medicare and Medicaid Services.
Besides making follow-up doctor appointments, Jencks said hospitals should give patients a list of all their medications, explain what to do at home and where to call if they run into problems. He said the hospitals should also call the patient within two days and make sure that the patient's doctor knows they were in the hospital.
He said the goal is to keep patients from getting really sick again, not to keep them out of the hospital if they do.
The differences in readmission rates among states suggests that improvements can be made, he said. Iowa had the lowest rate with 13 percent, while Washington, D.C., had the highest at 23 percent.
Dr. Brian Jack at Boston Medical Center tells the story of a patient who didn't understand that the blood pressure medicine that the hospital told her to take was the same as the one she had at home � just with different names. She took both and returned to the hospital with kidney failure. Jack and his colleagues tested a new checklist that nurses used when they sent patients home. The patients who used the checklist had 30 percent fewer visits to the emergency room or return hospital stays over the next month, compared to patients who didn't use it, they found.
"There are not too many things that improve health and save money," said Jack, who was not involved in the new research.
In 2007, a panel that advises Congress on Medicare suggested ways to cut hospital readmissions. One recommendation was to change how Medicare pays hospitals and to cut payments to those with high rates � an approach included in Obama's budget proposal.
Currently, hospitals get the same payment for each hospital stay and critics say there's no incentive to reduce readmissions.
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On the Net:

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

Care Transitions: http://www.caretransitions.org/

Project Red: http://www.bu.edu/fammed/projectred

Unrequired test nipped tainted pistachios in bud

2009-04-01T15:08:00.001-07:00

TERRA BELLA, Calif. - The reason it didn't take dozens of illnesses for federal regulators to learn about salmonella-tainted pistachios has nothing to do with federal regulations.
Routine but unrequired testing by a manufacturer for Kraft Foods Inc. first detected the contamination almost two weeks ago, when workers at a plant in Illinois decided to check roasted nuts going into huge vats of trail mix. Private auditors hired by Kraft later found problems they think caused the contamination at a supplier's processing facility in central California.
If Kraft had not chosen to prioritize testing, 2 million pounds of pistachios that touched off government warnings and a nationwide salmonella scare this week probably would still be on the market. Neither the Food and Drug Administration nor state laws require food manufacturers to test the safety of their products.
"We're relying on companies to find the contaminated foods on their own, and since there's no national standards for this, some companies don't bother to test at all," said Rep. Diana DeGette, D-Colo., a critic of the nation's food safety system. "What if these nuts had been distributed by a company that doesn't test? We wouldn't have found out until people got sick."
DeGette and numerous other lawmakers are calling for the FDA to develop testing regulations for every segment of the food industry, and want companies to be required to release test results.
Federal health officials warned people this week to avoid eating all pistachios and products containing them while they determine which products may be contaminated. The nuts Kraft manufacturer Georgia Nut Co. tested on March 20 came from Setton Pistachio of Terra Bella Inc., the second-largest pistachio processor in the nation, which has recalled more than 2 million pounds of its roasted pistachios.
The investigation of tainted pistachios contrasts sharply with that in this year's salmonella outbreak involving peanuts, the subject of a criminal investigation and thousands of recalls. The contamination was not traced to peanuts until hundreds of people around the country got sick. The company involved, Peanut Corp. of America, had tested its products, but inspection records show that in some cases it shipped peanuts it knew were probably tainted.
Private industry reported the pistachio problem immediately, rather than waiting for public health officials to intervene. And as of Wednesday, authorities had not confirmed any illnesses.
"You can call it a fluke, you can call it good luck, or you can call it good judgment on the part of Kraft," said Dr. David Acheson, FDA's assistant commissioner for food safety. "They're not required to tell us, they did and we're moving on it."
Acheson said the FDA does not mandate testing so companies are free to decide whether to take that step before distributing food products to stores.
Officials with the Grocery Manufacturers Association, an industry group that represents major food manufacturers, say Kraft has one of the most aggressive food safety systems in the business.
But they say getting the government to require testing of all foods is not the answer, since different foods are at risk of becoming contaminated at very different steps in the manufacturing process.
"You don't want to do testing just for the sake of doing testing," said the association's chief science officer, Robert Brackett. "That tends to be this one-size-fits all situation where it may work really well for some products and not for others. What we really focus on is for companies to build the safety into their programs in the first place."

Pistachio warning could signal food safety shift

2009-03-31T18:08:00.000-07:00

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.

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Associated Press writers Tracie Cone in Fresno and Samantha Young in Sacramento contributed to this report.

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On the Net:

http://www.settonfarms.com

http://www.fda.gov

Once-a-day heart combo pill shows promise in study

2009-03-30T17:32:00.001-07:00

ORLANDO, Fla. - It's been a dream for a decade: a single daily pill combining aspirin, cholesterol medicine and blood pressure drugs � everything people need to prevent heart attacks and strokes in a cheap, generic form. Skeptics said five medicines rolled into a single pill would mean five times more side effects. Some people would get drugs they don't need, while others would get too little. One-size-fits-all would turn out to fit very few, they warned. Now the first big test of the "polypill" has proved them wrong.
The experimental combo pill was as effective as nearly all of its components taken alone, with no greater side effects, a major study found. Taking it could cut a person's risk of heart disease and stroke roughly in half, the study concludes.
The approach needs far more testing � as well as approval from the Food and Drug Administration, something that could take years � but it could make heart disease prevention much more common and more effective, doctors say.
"Widely applied, this could have profound implications," said Dr. Robert Harrington, an American College of Cardiology spokesman and chief of Duke University's heart research institute. "President Obama is trying to offer the greatest care to the greatest number. This very much fits in with that."
The polypill also has big psychological advantages, said Dr. James Stein of the University of Wisconsin-Madison.
"If you take any medicines, you know that every pill you see in your hand makes you feel five years older. Patients really object to pill burden" and respond by skipping doses, he said.
No price for the polypill has been disclosed, but its generic components cost only a total of $17 a month now and doctors expect the combo would sell for far less.
The study was led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. John's Medical College in Bangalore, India. The findings were presented Monday at the cardiology college's conference in Florida and published online by the British medical journal Lancet.
The study tested the Polycap, an experimental combo formulated by Cadila Pharmaceuticals of Ahmedabad, India. It contains low doses of three blood pressure medicines (atenolol, ramipril and the "water pill" thiazide), plus the generic version of the cholesterol-lowering statin drug Zocor, and a baby aspirin (100 milligrams).
Doctors have talked about such a possibility for years. As the patents on many heart medicines expired and the drugs became available as cheap generics, a few companies started trying to develop all-in-one pills.
Formulating a single pill of five drugs that work in five different ways is a complex task � more complex than simply mixing the medicines. Pills have coatings and other ingredients that control the rate at which the medicine is released into the bloodstream. The polypill must be designed so that the five drugs work as intended.
The Polycap is the furthest along, and this is the largest study of one so far.
The study involved about 2,000 people at 50 centers across India, average age 54, with at least one risk factor for heart disease � high blood pressure, high cholesterol, obesity, diabetes or smoking.
Four hundred were given the polypill. The rest were placed in eight groups of 200 and given individual components of the pill or various combinations. Treatment lasted 12 weeks.
Compared to groups given no blood pressure medicines, those who got the polypill lowered their systolic blood pressure (the top number) by more than 7 units and their diastolic (the bottom number) by about 6 � comparable to levels for people who were given the three drugs without aspirin and the cholesterol drug.
These drops were modest, probably because doses were low and most participants had only moderately high blood pressure to start with, Yusuf said.
LDL, or bad cholesterol, dropped 23 percent on the polypill versus 28 percent in those taking the statin drug separately. Triglycerides dropped 10 percent on the combo pill versus 20 percent with individual statin use. Neither pill affected levels of HDL, or good cholesterol.
Anti-clotting effects seemed the same with the polypill as with aspirin alone.

Side effect rates were the same for the polypill as for the five medicines individually.

"That was a big surprise. I would have expected five times the number of people to have side effects," because of the possibility the drugs would interact and magnify any problems, said Dr. Christopher Cannon, a cardiologist at Harvard-affiliated Brigham and Women's Hospital in Boston who had no role in the study.

Collectively, the results show the polypill could cut the risk of heart disease by 62 percent and the risk of stroke by 48 percent, based on what previous studies show from lowering risk factors by these amounts, the study concludes.

Polycap's maker sponsored the study, and Yusuf has been a paid speaker for several makers of heart drugs.

A bigger study is now needed to see whether the polypill actually does cut heart attacks and strokes, he wrote in a commentary in the medical journal.

"It's a first step. I would caution against jumping to the conclusion this is the magic solution to our prevention problems," said Dr. Raymond Gibbons of the Mayo Clinic, a former American Heart Association president.

Studies show that healthy diets and exercise give better protection than pills, and too many people already think "that because they're on a statin, they can go to McDonald's," Gibbons said.

A big issue is who should get the polypill. The study tested it in people with risk factors that would already qualify them for treatment.

"Should high-risk people who do not yet have heart disease take it? My guess is, that's where the field will go to rapidly," Yusuf said.

Conversely, people with established heart disease may need more medicines than the modest amounts in this all-in-one pill.

"It won't be for everybody," Cannon said. Some people would be overtreated by getting medicines for conditions they don't yet have, such as high cholesterol. Others may be undertreated by too-low doses in the combo pill. Several polypills of different strengths may be needed, he said.

"We have to be cautious about assuming that one size fits all," Stein said. "Treating risk factors is a lot like cooking � the ingredients count."

A polypill also would need FDA approval, even though all of its components have long been sold separately. And establishing the proper doses could become a regulatory nightmare, Cannon warned.

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On the Net:

Cardiology meeting: http://www.acc.org

Medical journal: http://www.lancet.com

Study: Cholesterol drug lowers blood clot risk

2009-03-29T17:29:00.001-07:00

ORLANDO, Fla. - Statin drugs, taken by millions of Americans to lower cholesterol and prevent heart disease, also can cut the risk of developing dangerous blood clots that can lodge in the legs or lungs, a major study suggests.
The results provide a new reason for many people with normal cholesterol to consider taking these medicines, sold as Crestor, Lipitor, Zocor and in generic form, doctors say.
In the study, Crestor cut nearly in half the risk of blood clots in people with low cholesterol but high scores on a test for inflammation, which plays a role in many diseases. This same big study last fall showed that Crestor dramatically lowered rates of heart attacks, death and stroke in these people, who are not usually given statins now.
"It might make some people who are on the fence decide to go on statins," although blood-clot prevention is not the drugs' main purpose, said Dr. Mark Hlatky, a Stanford University cardiologist who had no role in the study.
Results were reported Sunday at the American College of Cardiology conference and published online by the New England Journal of Medicine.
The study was led by statistician Robert Glynn and Dr. Paul Ridker of Harvard-affiliated Brigham and Women's Hospital in Boston. Ridker is a co-inventor on a patent of the test for high-sensitivity C-reactive protein, or CRP. It is a measure of inflammation, which can mean clogged arteries or less serious problems, such as an infection or injury.
It costs about $80 to have the blood test done. The government does not recommend it be given routinely, but federal officials are reconsidering that.
For the study, researchers in the U.S. and two dozen other countries randomly assigned 17,802 people with high CRP and low levels of LDL, or bad cholesterol (below 130), to take dummy pills or Crestor, a statin made by British-based AstraZeneca PLC.
With an average of two years of follow-up, 34 of those on Crestor and 60 of the others developed venous thromboembolism � a blood clot in the leg that can travel to the lungs. Several hundred thousand Americans develop such clots each year, leading to about 100,000 deaths.
However, this is uncommon compared to the larger number who suffer heart attacks. Many doctors have been uncomfortable with expanding statin use to people with normal cholesterol because so many would have to be treated to prevent a single additional case.
"I don't know that it changes the big picture very much" to say that a statin can prevent blood clots, Hlatky said. "Where do you draw the line? Are we giving it to 10-year-old kids that are fat?"
AstraZeneca paid for the study, and Ridker and other authors have consulted for the company and other statin makers. Many doctors believe that other statins would give similar benefits, though Crestor is the strongest such drug. It also has the highest rate of a rare but serious muscle problem, and the consumer group Public Citizen has campaigned against it, saying there are safer alternatives.
Crestor costs $3.45 a day versus less than a dollar for generic drugs. Its sales have been rising even though two statins � Zocor and Pravachol � are now available in generic form.
Researchers do not know whether the benefits seen in the study were due to reducing CRP or cholesterol, since Crestor did both. Another new analysis reported Sunday and published in the British journal the Lancet found that the patients who did the best in the study were those who saw both numbers drop.
Many doctors remain reluctant to expand CRP testing or use of statins. A survey by the New England journal found them evenly divided on the questions. Others questioned why so few people in the study were getting other treatments to prevent heart problems.
"If more of them were on aspirin, you would have less benefit from the statin," said Dr. Thomas Pearson of the University of Rochester School of Medicine and Dentistry.
Dr. James Stein of the University of Wisconsin-Madison said that doctors examining treatment guidelines should pay close attention to the new results.
He said the CRP test had helped him convince patients that they need to be on a statin drug.

"There are very few times you can say to a patient, 'this medicine is going to keep you alive.' We should try not to pick apart studies that save lives," Stein said.

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On the Net:

Heart meeting: http://www.acc.org

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

Stroke-blocking device shows promise, doctors say

2009-03-28T17:34:00.001-07:00

ORLANDO, Fla. - A novel device to treat a common heart problem that can lead to stroke showed promise in testing, but not without risk, new research shows.
The experimental device, called the Watchman, is the first to try to permanently fix atrial fibrillation, a heartbeat problem afflicting more than 2 million Americans. A federal Food and Drug Administration panel will consider it next month.
In the study, the Watchman was at least as good at preventing strokes as warfarin, sold as Coumadin and other brands. The drugs pose hazards of their own, so doctors and their patients are anxious for a better option.
But the procedure to implant the Watchman led to strokes in some patients, study results showed. Complications and side effects were twice as common with the device as with warfarin.
Despite those drawbacks, doctors who saw the results Saturday at the American College of Cardiology Conference were impressed.
"Wow. At first blush, this is very encouraging," and could help as many as two-thirds of those who have the heartbeat problem, said Dr. Richard Page, cardiology chief at the University of Washington in Seattle and an American Heart Association spokesman.
Atrial fibrillation occurs when the upper chambers of the heart quiver instead of beating properly. That lets blood pool in a pouch-like appendage. Clots can form and travel to the brain, causing a stroke.
The usual treatment is the anti-clotting drug warfarin, but getting the right dose is tricky � too little means a risk of stroke, and too much can cause fatal bleeding. The right amount varies by 10 times from one person to another, and even certain foods can throw it off. Patients must go to the doctor often for blood tests to monitor the dose.
The Watchman device is a fabric-covered metal cage that plugs the pouch. Doctors pass a hollow tube through a leg vein into the heart's right atrium, puncture the wall separating it from the left atrium, and implant the device through the tube.
Dr. David Holmes Jr. of the Mayo Clinic in Rochester, Minn., led a study of it in 707 patients in the United States and Europe.
After an average of 16 months of followup, there were 15 strokes and 17 deaths (from all causes) in the 463 who got the device and 11 strokes and 15 deaths in the 244 treated with warfarin, Holmes said.
The balance tipped in favor of the device. Just over 3 percent of Watchman patients suffered the main problems doctors were measuring in the trial (a composite of strokes, heart-related deaths and certain blood clots) versus 5 percent of those treated with warfarin.
About 90 percent of device patients were able to go off warfarin.
However, complications were twice as common � 8 percent in the device group and 4 percent on warfarin. Five strokes were triggered by implanting the device, and about 5 percent of device patients developed serious fluid buildup around the heart. Doctors were unable to implant the Watchman in 41 people assigned to get it.
These problems declined as the study went on, Holmes said.
Any new technology has "a learning curve" that improves with experience, said Dr. Ralph Brindis, a heart specialist at the California-based Kaiser Permanente health plan and spokesman for the college of cardiology.
The device's maker, Atritech Inc. of Plymouth, Minn., paid for the study, and Mayo may potentially receive future royalties from the device. Medicare paid $9,500 for the procedure, including $6,000 for the device itself, a company spokeswoman said. Hospitals typically charge two to three times the Medicare rate, she said.
Dr. Tristram Bahnson of Duke University said that if the device is approved, "patients and their physicians will have to decide whether assuming some increased risk up front is preferred to ongoing therapy with Coumadin, where there's a small risk of complications and the risk is cumulative."

For Kenneth Giunchedi, that was an easy choice. Giunchedi, 75, of suburban Chicago, had the device implanted last March by Dr. Bradley Knight of the University of Chicago Medical Center as part of the study. He had been on Coumadin for about two years.

Taking the drug was "a horrible experience for me," he said. "I was never easy to regulate � I was always in trouble. They were constantly adjusting the dosage and I would go in for a blood draw sometimes as often as three times a week. I would have done anything to get off of the Coumadin."

Experimental vaccine used in Ebola exposure case

2009-03-27T17:38:00.001-07:00

BERLIN - It was a nightmare scenario: A scientist accidentally pricked her finger with a needle used to inject the deadly Ebola virus into lab mice. Within hours, members of a tightly bound, yet far-flung community of virologists, biologists and others were tensely gathered in a trans-Atlantic telephone conference trying to map out a way to save her life.
Less than 24 hours later, an experimental vaccine � never before tried on humans � was on its way to Germany from a lab in Canada.
And within 48 hours of the March 12 accident, the at-risk scientist, a 45-year-old woman whose identity has not been revealed, was injected with the vaccine.
So far, so good. If the woman is still healthy by Thursday, she can consider herself safe.
Ebola hemorrhagic fever, seen mostly only in Africa, is one of the world's most feared diseases. It begins with flu-like symptoms, followed by bloody diarrhea and vomiting. Days later, some victims begin bleeding through the nose, mouth and eyes. Depending on the strain of virus, it can kill up to 90 percent of victims.
There is no cure. The virus is spread through direct contact with the blood or secretions of an infected person.
Dr. Stephan Guenther, head of the Bernhard Nocht Institute for Tropical Medicine in Hamburg, where the researcher was working, said tests so far show the scientist is healthy and free of the virus.
The peak period for an outbreak during the 21-day Ebola incubation period passed this week, he said.
"We are now on the downside," Guenther told The Associated Press, noting that with each passing day the chance of infection taking root diminishes.
It's not entirely clear the researcher was actually infected with the virus. At the time of the accident, she was wearing three layers of protective gloves, and though the needle stuck her, the plunger of the syringe was not pushed so it's not certain the virus entered her bloodstream.
That means scientists may never know if the vaccine worked or she was just lucky.
There are two other known accidents involving researchers who came into direct contact with a similar strain of Ebola. A Russian researcher died, and a British scientist became ill but survived.
After the needle stick, Guenther knew he had to act swiftly.
He rushed an e-mail to fellow scientists in the Ebola research community. One was Dr. Heinz Feldmann, chief of the virology laboratory at the Rocky Mountain Laboratories, a U.S. National Institutes of Health research facility in Hamilton, Mont.
"We considered this as serious as (the Russian) case, in terms of the exposure," Feldmann told the AP in a telephone interview last weekend.
Feldmann was part of an international group of experts from the U.S. Centers for Disease Control and Prevention, the U.S. Army Medical Research Institute of Infectious Diseases, the Canadian Public Health Agency, Boston University and the University of Texas Medical Branch.
Feldmann, Guenther and several other experts took part in the teleconference debating the options. These included a live vaccine never before tried on humans, another treatment designed to interfere with the virus' ability to multiply, or an anticoagulant that Army research found had saved the lives of monkeys exposed to Ebola.
The option that emerged as the strongest was the vaccine, which had been developed by Feldmann and collaborating researchers at several institutions. Much of the key work was done about nine years ago at a microbiology research lab run by the Canadian government in Winnipeg, Manitoba, where Feldmann worked at the time.

Although the vaccine is based on a different kind of virus, researchers used genetic engineering to make the virus look like Ebola, triggering an immune system response.

In a 2008 study, Feldmann and other researchers showed that when given 20 minutes after a lethal dose of Ebola virus, four of eight monkeys survived. There were no side effects, Feldmann said.

"The group came very swiftly to agreement that this vaccine would be the best ... because it had showed an effectiveness when used after exposure," Guenther said.

In the end, the scientist whose life was at risk made the decision herself. She took the vaccine about 48 hours after the accident. Within 12 hours, she had a headache, muscle pain and a fever, but recovered quickly.

"Those are normal reactions to live attenuated vaccines," Feldmann said.

While future study of the woman's immune response may help to clarify whether the vaccine saved her life or she was never infected with Ebola in the first place, it will most likely remain open to interpretation.

Either way, Feldmann said scientists cannot draw conclusions about the experimental vaccine's safety or effectiveness.

There's a long history of researchers testing vaccines on themselves or people close to them. Edward Jenner, the English physician who first invented a smallpox vaccine, included his own son among the children he first gave the immunization. And Jonas Salk, an inventor of polio vaccine, reportedly gave the vaccine to himself and his entire family before making it public.

This case is somewhat different. Using the experimental vaccine, "was to save her life, that was the priority," Feldmann said. It might have been five years or more before it was tried on humans because of additional animal studies and production issues, he added.

Guenther expressed hope the case would attract funding for more research in the field of such vaccines.

"Of course, we can't just go to Africa, now that we have seen such a vaccine went well when used on a human," Guenther said.

"Perhaps this will be like a little push, where one says, yes, it's possible. Everything that we are doing on an experimental level can actually be put into practice."

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AP Medical Writer Mike Stobbe reported from Atlanta and Melissa Eddy contributed from Berlin.

Doctors say kidney stones in kids are on the rise

2009-03-26T17:20:00.001-07:00

CHICAGO - Doctors are puzzling over what seems to be an increase in the number of children with kidney stones, a condition some blame on kids' love of cheeseburgers, fries and other salty foods.
Kidney stones are usually an adult malady, one that is notorious for causing excruciating pain � pain worse than childbirth. But while the number of affected children isn't huge, kids with kidney stones have been turning up in rising numbers at hospitals around the country.
At Children's Hospital of Philadelphia, the number of children treated for kidney stones since 2005 has climbed from about 10 a year to five patients a week now, said Dr. Pasquale Casale.
Johns Hopkins Children Center in Baltimore, a referral center for children with stones, used to treat one or two youngsters a year 15 or so years ago. Now it gets calls about new cases every week, said kidney specialist Dr. Alicia Neu.
In a 2007 study in the Journal of Urology, doctors at North Shore-Long Island Jewish Medical Center reported a nearly fivefold increase in children brought in with kidney stones between 1994 and 2005. In 2005, 61 youngsters were treated there for stones.
Dr. David Hatch at Loyola University Medical Center in Maywood, Ill., near Chicago, also has seen an increase. His youngest patient was a cranky 8-month-old girl whose mother found a pea-size kidney stone in her diaper.
Kids' stones have been the talk of recent pediatric kidney specialists' conferences, said Dr. Uri Alon, director of the bone and mineral disorders clinic at Children's Mercy Hospital in Kansas City.
So far, the only evidence is anecdotal. But Alon is involved in research trying to determine if the increase is real and not just the result of greater awareness and better ways of detecting stones. Alon also is studying whether improved nutrition can prevent kids' kidney stones.
Eating too much salt can result in excess calcium in the urine. In children, most stones are calcium-based, and Alon said their eating habits, plus drinking too little water, puts them at risk. Plenty of water is generally recommended to help prevent kidney stones.
Matty Billemeyer is just 8 years old but already has had four bouts with stones, the first in 2007, the last a year ago in April. He was first stricken in his first-grade class; the school nurse, his parents and even the emergency room doctors all thought it was his appendix.
"It felt really painful and intense," the Doylestown, Pa., boy recalled. "I was really scared because it was hurting a lot."
Darryl Billemeyer said it was frightening seeing his son writhing and screaming in pain. The boy was transferred from a local hospital to Children's Hospital of Philadelphia, where ultrasound tests showed kidney stones.
"We really didn't know what to make of it," Billemeyer said. "I definitely thought they were more of an adult thing."
The first time, Matty needed surgery; the other times the stones passed during urination.
Now he takes diuretic pills to increase urination, brings a water bottle to school everyday, and has given up favorite foods, including sausages, pickles and packaged ramen noodles � all high in salt.
His parents are both busy teachers, and with four other sons, family meals used to include quick processed foods like canned spaghetti or chicken nuggets. Until Matty's diagnosis, salt "wasn't something we really thought about," Billemeyer said.
The main problem associated with kidney stones is extreme pain. It is caused by stones blocking urine flow, which, if untreated, could lead to kidney damage.
The preferred treatment is observation � giving kids pain medicine but nothing else to see if the stones will pass on their own. Stones can be as small as a sugar granule or as large as a pearl. Bigger ones have been reported but are rare; most are less than 1/4 inch in diameter, which can usually pass on their own. But even small ones can mean incredible pain.

When that doesn't happen, the patient is anesthetized and doctors may thread a slender scope through the urinary tract to break up and remove the stone. Other treatment may involve noninvasive shock-wave therapy that uses sound waves to break up the stone, or minimally invasive surgery.

Dr. Barry Duel, a pediatric urologist at Cedars-Sinai Medical Center in Los Angeles, said kidney stones can be a sign of underlying metabolic problems that result in too much calcium in the urine. But he said in most cases children have no underlying disorder and are otherwise healthy.

Still, because some metabolic problems can slow growth if untreated or lead to repeated bouts with kidney stones, the American Academy of Pediatrics recommends metabolic testing for all children with kidney stones.

Hatch, the Loyola urologist, said the best prevention is plenty of water, so that the minerals in urine stay dissolved.

How much water depends on a child's size, but for an average-size 10-year-old it would be about four cups a day, on top of whatever else they are drinking. That is far more than most kids drink.

"What I like to tell kids is that they should drink enough water to keep their pee almost clear," Hatch said.

For children who have had one kidney stone, doctors sometimes recommend fresh-squeezed lemonade or other citrus juice, which can help keep the urine from forming stones.

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On the Net:

National Institutes of Health:http://www.nlm.nih.gov/medlineplus/kidneystones.html

Study: Male circumcision helps prevent 2 STDs

2009-03-25T17:23:00.001-07:00

LOS ANGELES - Circumcision not only protects against HIV in heterosexual men, but it also helps prevent two other sexually transmitted infections, a large new study found. Circumcised males reduced their risk of infection with HPV, or human papillomavirus, by 35 percent and herpes by 28 percent. However, researchers found circumcision had no effect on the transmission of syphilis.
Landmark studies from three African countries including Uganda previously found circumcision lowered men's chance of catching the AIDS virus by up to 60 percent. The new study stems from the Uganda research and looked at protection against three other STDs. The findings are reported in Thursday's New England Journal of Medicine
"Evidence now strongly suggests that circumcision offers an important prevention opportunity and should be widely available," Drs. Matthew Golden and Judith Wasserheit of the University of Washington wrote in an accompanying editorial.
Worldwide, only about 30 percent of men are circumcised. The figure is higher in the United States, where about 79 percent of men are circumcised, according to surveys by the National Center for Health Statistics.
An international team of researchers who conducted the study said circumcision, the surgical removal of the foreskin from the penis, should be an accepted method to reduce sexually transmitted infections among heterosexuals.
"It must be emphasized that protection was only partial, and it is critical to promote the practice of safe sex," they wrote.
HPV can cause cervical cancer and genital warts. Herpes greatly increases the chances of infection with HIV.
The American Academy of Pediatrics previously said there was not enough evidence to recommend routine circumcision of infants. The doctor's group is reviewing its position based on recent studies. About 2,800 herpes cases in newborns occur in the U.S. every year transmitted from mothers to infants that can lead to disability or death.
The latest research involved 3,393 HIV-negative heterosexual adolescent boys and men from Uganda who were part of the original HIV study. About half were randomly selected to undergo circumcision right away while the rest had the procedure 2 years later. All had physical exams and were offered voluntary HIV counseling and condoms.
After two years, herpes infection was detected in 114 circumcised men compared with 153 uncircumcised men. HPV was detected in 42 circumcised men compared with 80 uncircumcised men. There was no significant difference between the two groups on rate of syphilis infections. The researchers considered condom use, number of sex partners and other factors to calculate the risk reductions.
Why circumcision may reduce the risk of infection is not entirely known. But researchers think cells in the foreskin of the penis may be susceptible to HPV and the herpes virus.
The study was funded by the National Institutes of Health and the Bill and Melissa Gates Foundation. It was conducted by the Rakai Health Sciences Program and Makerere University in Uganda, Johns Hopkins Bloomberg School of Public Health and a division of the National Institutes of Health.
The results were similar to two recent studies from South Africa that found circumcision reduced HPV and herpes by up to a third.
Researchers plan to study whether circumcision reduces the spread of HPV to female sex partners.
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On the Net:
New England Journal: http://www.nejm.org
Male circumcision clearinghouse: http://www.malecircumcision.org

Insurers offer to stop charging sick people more

2009-03-24T16:53:00.001-07:00

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."
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On the Net:
America's Health Insurance Plans: http://www.ahip.org
Blue Cross and Blue Shield Association: http://www.bcbs.com/

Study: Lots of red meat increases mortality risk

2009-03-23T16:46:00.001-07:00

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

AP IMPACT: Mentally ill a threat in nursing homes

2009-03-22T16:41:00.001-07:00

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.

Brain injury victims can seem OK, symptoms delayed

2009-03-19T16:06:00.001-07:00

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."

US births break record; 40 pct out-of-wedlock

2009-03-18T16:10:00.001-07:00

ATLANTA - Remember the baby boom? No, not the one after World War II. More babies were born in the United States in 2007 than any other year in the nation's history � and a wedding band made increasingly little difference in the matter. The 4,317,119 births, reported by federal researchers Wednesday, topped a record first set in 1957 at the height of the baby boom.
Behind the number is both good and bad news. While it shows the U.S. population is more than replacing itself, a healthy trend, the teen birth rate was up for a second year in a row.
The birth rate rose slightly for women of all ages, and births to unwed mothers reached an all-time high of about 40 percent, continuing a trend that started years ago. More than three-quarters of these women were 20 or older.
For a variety of reasons, it's become more acceptable for women to have babies without a husband, said Duke University's S. Philip Morgan, a leading fertility researcher.
Even happy couples may be living together without getting married, experts say. And more women � especially those in their 30s and 40s � are choosing to have children despite their single status.
The new numbers suggest the second year of a baby boomlet, with U.S. fertility rates higher in every racial group, the highest among Hispanic women. On average, a U.S. woman has 2.1 babies in her lifetime. That's the "magic number" required for a population to replace itself.
Countries with much lower rates � such as Japan and Italy � face future labor shortages and eroding tax bases as they fail to reproduce enough to take care of their aging elders.
While the number of births in the U.S. reached nearly 4.3 million in 2006, mainly due to a larger population, especially a growing number of Hispanics, it's not clear the boomlet will last. Some experts think birth rates are already declining because of the economic recession that began in late 2007.
"I expect they'll go back down. The lowest birth rates recorded in the United States occurred during the Great Depression � and that was before modern contraception," said Dr. Carol Hogue, an Emory University professor of maternal and child health.
The 2007 statistical snapshot reflected a relatively good economy coupled with cultural trends that promoted childbirth, she and others noted.
Meanwhile, U.S. abortions dropped to their lowest levels in decades, according to other reports. Some have attributed the abortion decline to better use of contraceptives, but other experts have wondered if the rise in births might indicate a failure in proper use of contraceptives. Some earlier studies have shown declining availability of abortions.
Cultural attitudes may be a more likely explanation. Morgan noted the pregnancy of Bristol Palin, the unmarried teen daughter of former GOP vice presidential candidate Sarah Palin. The young woman had a baby boy in December, and plans for a wedding with the father, Levi Johnston, were scrapped.
"She's the poster child for what you do when you get pregnant now," Morgan said.
Teen women tend to follow what their older sisters do, so perhaps it's not surprising that teen births are going up just like births to older women, said Sarah Brown, the chief executive for the National Campaign to Prevent Teen and Unplanned Pregnancy.
Indeed, it's harder to understand why teen births had been declining for about 15 years before the recent uptick, she said. It may have been due to a concentrated effort to reduce teen births in the 1990s that has waned in recent years, she said.
The statistics are based on a review of most 2007 birth certificates by the National Center for Health Statistics, part of the Centers for Disease Control and Prevention. The numbers also showed:
_Cesarean section deliveries continue to rise, now accounting for almost a third of all births. Health officials say that rate is much higher than is medically necessary. About 34 percent of births to black women were by C-section, more than any other racial group. But geographically, the percentages were highest in Puerto Rico, at 49 percent, and New Jersey, at 38 percent.
_The pre-term birth rate, for infants delivered at less than 37 weeks of pregnancy, declined slightly. It had been generally increasing since the early 1980s. Experts said they aren't sure why it went down.

_Among the states, Utah continued to have the highest birth rate and Vermont the lowest.

CDC officials noted that despite the record number of births, this increase is different from occurred in the 1950s, when a much smaller population of women were having nearly four children each, on average. That baby boom quickly transformed society, affecting everything from school construction to consumer culture.

Today, U.S. women are averaging 2.1 children each. That's the highest level since the early 1970s, but is a relatively small increase from the rate it had hovered at for more than 10 years and is hardly transforming.

"It's the tiniest of baby booms," said Morgan in agreement. "This is not an earthquake; it's a slight tremor."

___

On the Net:

The CDC report, including some state-by-state figures: http://www.cdc.gov/nchs

Study: 'Smart drug' Provigil may be habit-forming

2009-03-17T16:16:00.001-07:00

CHICAGO - A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students.
"It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects."
The study, appearing in Wednesday's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said.
Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and its sales approached $1 billion last year. The company is developing a spin-off called Nuvigil.
Modafinil's reputation as a brain enhancer stems from an Air Force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying.
Several scientists recently wrote in the journal Nature that healthy people should have the right to boost their brains with pills like Provigil. One author of that commentary, brain scientist Martha Farah of the University of Pennsylvania, said the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry."
"But even now, after all the years that it has been on the market, we are still learning things about it that are relevant to its safety," Farah said.
The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters.
Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise.
The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence.
Volkow said modafinil acts slowly when swallowed and is difficult to inject, making it less likely to be abused. Its high price, about $10 per pill compared to Ritalin at $2 per pill, also makes it less attractive to people seeking a high. That may change when generics become available in 2012, Volkow said.
Jeffry Vaught, chief science officer for Cephalon, said the company has seen no evidence the drug is highly abused.
"If abuse is a problem with modafinil, it's minimal at best," Vaught said. "We're not seeing it used at rave scenes."
Prescribing information for the drug warns of severe rashes and other side effects such as headache, nausea and anxiety. Cephalon doesn't support the drug's use as a cognitive enhancer.
"There's no substitute for sleep," Vaught said.
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On the Net:
JAMA: http://jama.ama-assn.org

(This version CORRECTS that Provigil's sales "approached" $1 billion.))

Possible therapy takes bite out of peanut allergy

2009-03-15T16:19:00.001-07:00

WASHINGTON - Scientists have the first evidence that life-threatening peanut allergies may be cured one day.
A few kids now are allergy-free thanks to a scary treatment � tiny amounts of the very food that endangered them.
Don't try this at home. Doctors monitored the youngsters closely in case they needed rescue, and there's no way to dice a peanut as small as the treatment doses required.
But over several years, the children's bodies learned to tolerate peanuts. Immune-system tests show no sign of remaining allergy in five youngsters, and others can withstand amounts that once would have left them wheezing or worse, scientists reported Sunday.
Are the five cured? Doctors at Duke University Medical Center and Arkansas Children's Hospital must track them years longer to be sure.
"We're optimistic that they have lost their peanut allergy," said the lead researcher, Dr. Wesley Burks, Duke's allergy chief. "We've not seen this before medically. We'll have to see what happens to them."
More rigorous research is under way to confirm the pilot study, released Sunday at a meeting of the American Academy of Allergy, Asthma and Immunology. If it pans out, the approach could mark a major advance for an allergy that afflicts 1.8 million people in the United States.
For parents of these little allergy pioneers, that means no more fear that something as simple as sharing a friend's cookie at school could mean a race to the emergency room.
"It's such a burden lifted off your shoulder to realize you don't have to worry about your child eating a peanut and ending up really sick," said Rhonda Cassada of Hillsborough, N.C. Her 7-year-old son, Ryan, has been labeled allergy-free for two years and counting.
It's a big change for a child who couldn't tolerate one-sixth of a peanut when he entered the study at age 2 1/2. By 5, Ryan could eat a whopping 15 peanuts at a time with no sign of a reaction.
Not that Ryan grew to like peanuts. "They smell bad," he said matter-of-factly.
Millions of people have food allergies and peanut allergy is considered the most dangerous, with life-threatening reactions possible from trace amounts. It accounts for most of the 30,000 emergency-room visits and up to 200 deaths attributed to food allergies each year. Although some children outgrow peanut allergy, that's rare among the severely affected.
There's no way to avoid a reaction other than avoiding peanuts. Those allergy shots that help people allergic to pollen and other environmental triggers reduce or eliminate symptoms � by getting used to small amounts of the allergen � are too risky for food allergies.
Enter oral immunotherapy.
Twenty-nine severely allergic children spent a day in the hospital swallowing minuscule but slowly increasing doses of a specially prepared peanut flour, until they had a reaction. The child went home with a daily dose just under that reactive amount, usually equivalent to one-thousandth of a peanut.
After eight months to 10 months of gradual dose increases, most can eat the peanut-flour equivalent of 15 peanuts daily, said Burks, who two years ago began reporting these signs of desensitization as long as children took their daily medicine.
Sunday's report goes the next big step.
Nine children who had taken daily therapy for 2 1/2 years were given a series of peanut challenges. Four in the initial study report � and a fifth who finished testing last week � could stop treatment and avoid peanuts for an entire month and still have no reaction the next time they ate 15 whole peanuts. Immune-system changes suggest they're truly allergy-free, Burks said.

Scientists call that tolerance � meaning their immune systems didn't forget and go bad again � and it's a first for food allergy treatment, said Dr. Marshall Plaut of the National Institutes of Health.

"Anything that would enable kids to eat peanuts would be a major advance," Plaut said, cautioning that more study is needed. "This paper, if it's correct, takes it to the next level. ... That is potentially very exciting."

Arkansas Children's Hospital has begun a study randomly assigning youngsters to eat either peanut flour or a dummy flour. It's not over, but after the first year, the treated group ate the equivalent of 15 peanuts with no symptoms while the placebo group suffered symptoms to the equivalent of a single peanut, Burks said.

The treatment remains experimental, Burks stressed, although he hopes it will be ready for prime time in a few years.

He isn't taking chances with the first five allergy-free kids. They're under orders to eat the equivalent of a tablespoon of peanut butter a day to keep their bodies used to the allergen.

Ryan Cassada says his mom sometimes "hides them in things so she can force me to eat it." Peanut butter cookies are OK, he says, just not straight peanut butter.

The battle is a small price, his mother said. "As much as I can get into him is fine with me. It's huge knowing he won't have a reaction."

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On the Net:

American Academy of Allergy, Asthma and Immunology: http://www.aaaai.org/

Obama: Food safety system a health 'hazard'

2009-03-14T16:17:00.001-07:00

WASHINGTON - The nation's food safety system is a "hazard to public health" and overdue for an overhaul, President Barack Obama said Saturday as he filled the top job at the Food and Drug Administration.
Obama used his weekly radio and video address to announce the nomination of former New York City Health Commissioner Margaret Hamburg as agency commissioner and the selection of Baltimore's health commissioner, Joshua Sharfstein as her deputy. Consumer groups applauded the picks.
The president also is creating a special advisory group to coordinate food safety laws and recommend how to update them. Many of these laws have not changed since they were written early in the last century, he said.
Obama said too many agencies are responsible for food safety, making it difficult to share information and stop problems from falling through the cracks.
The FDA does not have enough money or workers to conduct annual inspections at more than a fraction of the 150,000 food processing plants and warehouses in the country, Obama said.
"That is a hazard to public health. It is unacceptable. And it will change under the leadership of Dr. Margaret Hamburg," he pledged.
Hamburg, 53, is a bioterrorism expert. She was an assistant health secretary under President Bill Clinton and helped lay the groundwork for the government's bioterrorism and flu pandemic preparations.
As New York City's top health official in the early 1990s, she created a program that cut high rates of drug-resistant tuberculosis. She is the daughter of two doctors. Her mother was the first black woman to earn a medical degree from Yale University, and she credits her father for instilling in her a passion for public health.
Sharfstein, 39, is a pediatrician who has challenged the FDA on the safety of over-the-counter cold medicines for children. He also served as a health policy aide to Rep. Henry Waxman, D-Calif., who plays a leading role in overseeing the pharmaceutical industry.
Both are doctors and outsiders to the troubled agency and will face the challenge of trying to turn it around.
Those with a stake in the FDA's work, from health and consumer groups to the food and drug industries, said Obama made good choices.
The Trust for America's Health said Hamburg is a proven manager who turned around the ailing health department in New York City.
"She restored both morale among workers and the agency's credibility among citizens," said Lowell Weicker Jr., a former Connecticut senator and president of the trust's board. "And she has shown she can reach across party lines, having worked for both Democratic and Republican mayors in New York City."
Gail Cassell, an Eli Lilly & Co. vice president who once served on a government advisory board with Hamburg, said Hamburg "is a big believer" in backing up policy with the best scientific evidence and data.
"She is very balanced and thoughtful about the actions that she takes and certainly has had the experience of running a very complex organization," Cassell said.
Ellen Bloom of Consumers Union said Sharfstein's experience is "just what the doctor ordered for FDA," and Carol Tucker Foreman of Consumer Federation of America said, "Their resumes are extremely impressive."
The main food industry group said Obama seems committed to overhauling the agency.
"The president's appointment of these two prominent public health professionals is a clear signal that this administration has placed a priority on bolstering FDA's food safety role," said Pamela Bailey, president and chief executive of the Grocery Manufacturers Association.

Hamburg's appointment requires Senate confirmation; Sharfstein's does not.

Obama said while he doesn't believe government has the answer to every problem, there are certain things that only government can do such as "ensuring that the foods we eat and the medicines we take are safe and don't cause us harm."

"Protecting the safety of our food and drugs is one of the most fundamental responsibilities government has," he said.

Obama cited a string of breakdowns in assuring food safety in recent years, from contaminated spinach in 2006 to salmonella in peppers and possibly tomatoes last year. This year, a massive salmonella outbreak in peanut products has sickened more than 600 people, is suspected of causing nine deaths and led to one of the largest product recalls in U.S. history.

These cases are a "painful reminder of how tragic the consequences can be when food producers act irresponsibly and government is unable to do its job," Obama said, noting that contaminated food outbreaks have more than tripled to nearly 350 a year from 100 incidents annually in the early 1990s.

Separately, Obama announced a ban on the slaughter of "downer" cows, which are too sick or weak to stand on their own, to keep them out of the food supply. These animals pose a higher risk of having mad cow disease, E. coli and other infections.

Obama said he takes food safety seriously, not just as a president but also as the parent of two young daughters.

"No parent should have to worry that their child is going to get sick from their lunch," he said.

Also awaiting the next FDA chief is a renewed effort in Congress to require government regulation of cigarettes and other tobacco products, to reduce the harm from smoking.

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Associated Press writers Ricardo Alonso-Zaldivar, Mary Clare Jalonick and Lauran Neergaard contributed to this report.

___

On the Net:

Obama address: http://www.whitehouse.gov

Food and Drug Administration: http://www.fda.gov

Safety net health centers struggle to meet demand

2009-03-12T15:43:00.001-07:00

STONE MOUNTAIN, Ga. - The health care safety net is straining. Just look at Jeffrey Taylor's parking lot. Taylor oversees a community health center for the poor in this suburb a dozen miles east of downtown Atlanta. The center, a modest one-story brick building on a hillside, has never been busier. People who recently lost their jobs and health insurance fill the waiting rooms, and their cars jam into the clinic's 50-space parking lot � with much of the overflow ending up at the nightclub next door.
"We need to expand this lot," said Taylor, who runs Oakhurst Medical Centers Inc., which operates two clinics.
Oakhurst is among 1,200 community health centers, 1,100 public hospitals and nearly 3,000 local health departments that are primary strands in the nation's health care safety net. Most say they have become significantly busier in the last seven months, as the economy has worsened.
These last-resort centers coping with waves of new customers are looking forward to a jolt of new money from the $787 billion federal stimulus package signed into law last month.
Safety net providers struggle as a rule, but times are unusually tough. Most community health centers and public hospitals are temporarily maintaining their razor-thin operating margins, but say they can't keep it up for long. Many health departments � which play a leading role in preventive care and are heavily dependent on waning state revenues � are doing worse, eliminating thousands of jobs and shedding services.
"We've never seen it this bad," said Dr. Georges Benjamin, executive director of the American Public Health Association.
The stimulus package includes $87 billion for government health insurance for children and the poor, and another $3.5 billion to bolster public health services and safety net care. Federal officials are still deciding specifically how and where to spend that money, causing hand-wringing at these facilities.
A survey released last month indicates most ER doctors are seeing more unemployed patients who have lost health benefits. About 88 percent of the 1,200 doctors who answered a survey from the American College of Emergency Physicians said they had patients who had been turned away elsewhere because they couldn't pay. (Federal law bars ERs from turning away patients with emergency needs for lack of money.)
Perhaps the most common theme involves the recently unemployed who have chronic health problems, like heart disease, that require prescription drugs. When their work coverage runs out, they turn to safety net providers to keep the medications going, said Dr. Michael Brooks of West End Medical Centers Inc., an Atlanta-based community health center organization.
But in some cases, patients have simply put off care � like Sharon Moore. Uninsured and recently unemployed, the soft-spoken 59-year-old was suffering worsening headaches but saw a doctor visit as too costly.
A friend, also uninsured, told Moore about Southside Medical Center, which runs a bustling clinic in a poor area a few blocks from the Atlanta Braves baseball stadium. Moore made her first visit late last year and learned the cause of her headaches was severe high blood pressure.
She was given water pills that lowered her blood pressure, eased her pain and potentially averted a heart attack or stroke. She pays $30 per doctor visit, a sliding-fee scale based on income. The pills cost just $9 for a three-month supply. "It's a blessing," Moore said.
Comprehensive statistics about the U.S. health safety net are hard to come by, and details vary by community. But it's clear that many of the medically needy go to hospital emergency rooms.
Hospital officials say the recession has hit them hard. Hospital funds lost money in the stock market like everyone else. Charitable donations are drying up. It's harder to borrow from banks or through tax-exempt bonds. Medicaid funding, which depends on state tax revenues, is precarious. And more affluent patients � whose business offsets the unreimbursed care of the uninsured � are cutting back on elective procedures and other care.
Most safety-net hospitals seem to be managing at the moment, but some are showing signs of strain. This week Atlanta's Grady Health System, which runs one of the largest public hospitals in the country, announced it cut 150 jobs because of the economy.
Many more public hospitals probably will end the year in the red, said Larry Gage, president of the National Association of Public Hospitals and Health Systems. "For some, the situation is even more dire, with projected losses potentially reaching tens of millions of dollars next year," he added.
Federally funded community health centers, first created in the 1960s, have long been a mainstay of the safety net. Annual funding almost doubled in the last decade, to about $2 billion. In many towns, hospitals and health departments have abdicated patients to these clinics.
"We've held our own for the past several years," said Craig Kennedy, an official with the National Association of Community Health Centers. "But we're facing the worst difficulties we've seen in quite some time."

Health departments are another piece of the safety net. Most aim at disease prevention, like vaccine clinics, restaurant inspections and tuberculosis-monitoring to make sure patients take their medicine. About 10 percent offer full-service clinics, partly because that brings in some income, whether it's cash or Medicaid reimbursement.

But many are looking at cutting services, or restricting what they pay for.

Northern California's Santa Cruz Health Department likely will cut as many as 30 of its 150 jobs this year. The department � which manages state and local funds for indigent care � also stopped paying for such things as joint replacements and cataract surgery.

"They're all wrenching decisions," said Dr. Poki Namkung, the department's director. "It's not the level of services people would expect to have in a civilized country."

Last year, health departments cut 11,000 jobs and this year expect to shed another 10,000, according to a report this week by Trust for America's Health, a research group.

Some health departments have been getting out of the patient care business. In Georgia, the suburban DeKalb County Board of Health treated patients for a dozen years at two clinics. That ended in September, in part because the state's Medicaid HMO system quit paying for care at health departments.

The department is now referring its previous patients to nearby community health centers. That's how Kordie Green ended up at Jeffrey Taylor's Stone Mountain clinic one morning this week.

It's hard to find a doctor, especially an attentive one, when you don't have good health coverage, said Green, 52, an uninsured child care worker who needs a continuing prescription for a thyroid condition.

"You want someone to take the time to see you and take the time to explain what's going on with you," she said.

___

On the Net:

National Association of Coummunity Health Centers: http://www.nachc.com/

American Public Health Association: http://www.apha.org/

Chain results in 10 kidney swaps among strangers

2009-03-11T15:49:00.001-07:00

When Matthew Jones decided to donate a kidney to a stranger, the Michigan father of five had no idea he'd be starting a lifesaving, "pay it forward" chain. His kidney donation to a Phoenix woman in 2007 set off a long-running organ swap that resulted in 10 sick people getting new kidneys over a year. It hasn't ended yet.
This chain of living donors and others like it could help increase the number of kidney transplants, lead to better matches that will increase survival and even reduce spending on costly, long-term dialysis, says the Ohio doctor behind the effort.
"My dream would be that we eliminate the waiting list because we could turn every altruistic donor into 100 transplants," said Dr. Michael Rees, a transplant surgeon at University of Toledo Medical Center.
Rees founded the Alliance for Paired Donation, which orchestrated the now 10-person transplant chain first begun by Jones and reported in Thursday's New England Journal of Medicine.
A half-dozen other transplant groups have started similar programs, and the organization the federal government pays to oversee all U.S. organ transplants is developing its own national system.
Such efforts are needed, with the national waiting list for kidneys growing quickly due to the epidemic of overweight Americans with diabetes and high blood pressure, which damage kidneys.
Transplants from living donors accounted for more than a third of the 16,514 kidney transplants last year. Meanwhile, more than 78,000 Americans were waiting for a kidney and more than 4,000 died waiting in 2008.
Elizabeth Sleeman of the United Network for Organ Sharing, which runs the federal transplant system, cites estimates that paired donor chains could lead to 1,000 to 2,000 more kidney transplants a year.
"I think it definitely has that potential" to reduce the waiting list, she said.
Later this year UNOS plans to do a test run of matches among two-donor pairs � two kidney patients, each with an incompatible donor who matches the other patient. She hopes by late 2010 to be doing both donor pairs and chains nationally.
The program Rees started now includes more than 70 of the 244 U.S. centers with kidney transplant programs. Here's how his 10-person donor chain worked:
Jones, who lives in Petoskey, Mich., heard a news report about a man giving a kidney to a stranger and thought he'd like to do that, too. He worked with a transplant center in Buffalo, N.Y., but no match worked out.
He ultimately was referred to Rees, who was trying to devise a sophisticated living-donor pairing system. Rees' father, a computer programmer, had developed donor matching software.
It paired the 30-year-old Jones with Barb Bunnell, a 53-year-old Arizona woman whose husband wanted to donate a kidney but was incompatible.
Ignoring pleas from relatives to think of his children and drop the idea, Jones flew to Arizona for medical tests, taking his wife Meghan with him. Her staunch opposition vanished once she met Bunnell.
Just after the July 18, 2007 surgery, Jones recalls feeling "like a truck had run over me." But he was well enough to go to a Diamondbacks baseball game five days later. The cost of the surgery and Jones' travel were paid by Bunnell's insurance.
Bunnell's grateful husband, Ron, then became what Rees believes is the world's first "bridge" donor, meaning his kidney donation was made later. Usually, paired transplants are done at the same time, with relatives agreeing to donate a kidney to a compatible stranger in exchange for a kidney for their loved one. That way donors can't back out.
Such reneging hasn't happened in his chains, Rees said.

Ron Bunnell was on a plane a week later to give his kidney to a 32-year-old Toledo woman, Angie Heckman. She's a waitress at a bar owned by her mother, Laurie Sarvo. Sarvo then gave a kidney to a woman in Columbus, Ohio, whose daughter then became the fourth donor in the chain.

On it ran, through patient-donor pairs including two more married couples, siblings, a daughter and father, and two friends. The last operation was done last March, with a 60-year-old woman in Toledo getting a kidney from a Baltimore donor. That recipient's daughter wants to donate a kidney, but a match hasn't worked out yet.

"There's a very good possibility that when I'm dead and gone, this chain will still be going on," Jones said.

___

On the Net: http://www.nejm.org

Alliance for Paired Donation: http://www.paireddonation.org

Donate Life America (site to register as a future organ donor): http://www.donatelife.net

United Network for Organ Sharing: http://www.unos.org

More evidence that depression is hard on the heart

2009-03-10T15:48:00.001-07:00

WASHINGTON - Severe depression may silently break a seemingly healthy woman's heart. Doctors have long known that depression is common after a heart attack or stroke, and worsens those people's outcomes. Monday, Columbia University researchers reported new evidence that depression can lead to heart disease in the first place.
The scientists tracked 63,000 women from the long-running Nurses' Health Study between 1992 and 2004. None had signs of heart disease when the study began, but nearly 8 percent had evidence of serious depression.
The depressed women were more than twice as likely to experience sudden cardiac death � death typically caused by an irregular heartbeat, concluded the 12-year study, published Monday in the Journal of the American College of Cardiology. They also had a smaller increased risk of death from other forms of heart disease.
The big surprise: Sudden cardiac death seemed more closely linked with antidepressant use than with the depression symptoms the women reported.
That might simply mean that women who used antidepressants were, appropriately, the most seriously depressed, cautioned lead researcher Dr. William Whang. But he said the finding merited more research.
Studies of the newer antidepressants most often used today so far haven't signaled a risk of irregular heartbeat, and some even have suggested protection, noted Dr. Redford Williams of Duke University, a specialist in how psychosocial factors affect health.
The drug question aside, Williams said the work adds to growing evidence that depression is an independent risk factor for heart disease � on top of the classic risks of high blood pressure, diabetes, high cholesterol and smoking.
The predominantly white Nurses' Health Study may underestimate it, Williams said. "If anything, the impact in African-American women is probably greater," he said, adding that it's time for the next step: A study testing whether properly treating depression lowers the risk.
Why might depression have that effect? The study found that the more severe the women's reported depression symptoms, the more likely she was to have traditional heart risk factors. Also, stresses like depression have been linked to such physical effects as a higher resting heart rate.
Perhaps a more straightforward reason: Depression can make people do a worse job taking care of themselves. Indeed, the American Heart Association last year recommended that everyone who already has heart disease be regularly screened for depression � because depressed patients may skip their medications, sit indoors instead of exercising, and eat particularly poorly.

Blacks, Hispanics have steeper end-of-life costs

2009-03-09T15:55:00.001-07:00

CHICAGO - Striking new research shows dying blacks and Hispanics have much steeper treatment costs than whites, sobering evidence that racial health-care differences continue right up until death.
It's not that minorities are being charged more than whites. It's that they tend to get more costly, intensive treatments including feeding tubes and other invasive medical procedures near death. That's in sharp contrast with what often happens throughout their lives, when minorities are less likely than whites to get aggressive medical care.
The results raise a troubling question about whether medical resources for nonwhite patients are "misallocated over a lifetime," with minorities receiving more treatment at the end, when there is little chance of improving or extending life, the study authors said.
The study appears in Monday's Archives of Internal Medicine. It involved nearly 160,000 Medicare patients and records on their treatment in the last six months of life. It is the most comprehensive on the topic and confirms results suggested in smaller studies on disparities in end-of-life care, said co-author Dr. Ezekiel Emanuel, a researcher in the bioethics department at the National Institutes of Health.
Medicare costs in those final months averaged $20,166 for whites. Among blacks, they were $26,704, about 30 percent higher; and among Hispanics, $31,702 or almost 60 percent higher. Those individual cost differences can add up to billions of dollars on a national scale, Emanuel said.
Reasons why minorities receive more costly end-of-life care are unclear; the study had no data to explain that. But Emanuel and other doctors offered several theories.
"Some of it may be preference. Some of it may be fear-based," Emanuel said.
Distrust of doctors and suspicions about getting less attentive treatment than whites likely is another factor, the study authors said.
Also, because of cultural or spiritual beliefs, some minorities are more likely to hold out hope for a miraculous recovery, or to oppose letting doctors play God and hasten death by abandoning treatment, said Dr. Elbert Huang, a Chinese-American physician with the University of Chicago Medical Center.
Letting doctors withdraw aggressive end-of-life treatment is mostly a western European approach, Huang said.
In a smaller, earlier study of healthy elderly patients in Rochester, N.Y., Dr. William Bayer said he found blacks were more likely than whites to say they would favor aggressive treatment even after brain death.
Blacks in that study tended to believe that "if God wants to take our lives, he will decide when and where that will happen," said Bayer, of the University of Rochester Medical Center.
Dr. Otis Brawley, a black physician in Atlanta and chief medical officer for the American Cancer Society, said the new findings "make sense."
"They play into all of my prejudices and they play into all of my personal experiences," Brawley said.
He said other reasons contribute to the phenomenon.
Because low-income minority patients often get less preventive medical care, they're less likely than whites to have long-term relationships with doctors, Brawley said. So physicians who treat them late in life may be strangers unwilling to "pull the plug" without knowing their wishes.
Also, Brawley said, black patients often have splintered families, and estranged relatives are in charge of making end-of-life decisions.
"They feel guilt about saying, 'let this patient die,'" he said.

"The breakdown of the family in certain cultures contributes somewhat to this phenomenon," he said. "I've seen it so many times."

___

On the Net:

Archives: http://www.archinternmed.com

Consensus bid could be derailed by health overhaul

2009-03-07T15:06:00.001-08:00

WASHINGTON - The search for agreement on health care may be short lived.
The flashpoint is a proposal that would give Americans the option of buying medical coverage through a government plan. President Barack Obama and many Democrats have endorsed it, as one part of a broader health overhaul. On Saturday, Republicans laid down a challenge.
"I'm concerned that if the government steps in, it will eventually push out the private health care plans millions of Americans enjoy today," Rep. Roy Blunt, R-Mo., said in the Republican weekly radio address.
Blunt, who will play a leading role in the debate, warned: "This could cause your employer to simply stop offering coverage, hoping the government will pick up the slack."
The proposal he referred to would, for the first time, offer government-sponsored coverage to middle-class families, as an alternative to private health plans. By some estimates, it could reduce premiums by 20 percent or more � making it much more affordable to cover the estimated 48 million people who don't have health coverage.
It could also be a deal breaker for broad, bipartisan agreement on health care.
Insurers fear competition from a government plan could drive them out of business, and Republicans worry it would lead to a government takeover of health care. Liberals, meanwhile, are equally adamant that Americans deserve the choice of government-sponsored health care.
"The purpose of health care reform is to make sure all Americans have health care, not to promote the insurance industry," said Rep. Jan Schakowsky, D-Ill., who serves on a House panel that will help write the legislation.
The new government coverage could be similar to what seniors have in Medicare, which is run directly from Washington. Or it might be designed like the federal employee health plan, available to members of Congress, and delivered through private insurers.
Asked at the White House health care summit this week about the brewing controversy, the president promised to address the qualms felt by some. But he did not abandon the notion of a government plan.
"I'm not going to respond definitively," Obama said, answering a question from Sen. Charles Grassley, R-Iowa. "The thinking on the public option has been that it gives consumers more choices and it helps ... keep the private sector honest, because there's some competition out there.
"I recognize, though, the fear that if a public option is run through Washington, and there are incentives to try to tamp down costs ... that private insurance plans might end up feeling overwhelmed."
Obama says he is committed to preserving a health care system in which government, employers and individuals share responsibility. Many Americans may not realize the government already picks up nearly half the nation's $2.4 trillion health care bill, through programs including Medicare and Medicaid.
A public plan for the middle class could give a final nudge that puts the system firmly in government hands.
Obama's campaign proposal � a foundation for Democrats in Congress � called for setting up a national insurance marketplace through which individuals and small businesses could buy coverage. People could pick private insurance or opt for a government plan that would resemble coverage for federal employees.
A recent analysis by the Commonwealth Fund, a nonprofit group that sponsors health care research, is giving supporters of a public plan some ammunition.
The study estimated costs and coverage under a hypothetical health reform plan similar to what Obama proposed in the campaign. It found that a public plan like Medicare could reduce projected health care costs by about $2 trillion over an 11-year period. Premiums in the public plan would be at least 20 percent lower, partly because of reduced administrative costs. Within a decade or so, some 105 million people would be in the public plan, compared with about 107 million with private insurance.
Commonwealth Fund President Karen Davis said the administration has been very interested in the study. "Some of their top economists are on the phone, poring over it," she said in an interview.

Democrats say they will fight to ensure a public plan stays in the final bill.

___

On the Net:

http://www.whitehouse.gov

Government-run plan could trip up health overhaul

2009-03-06T15:10:00.001-08:00

WASHINGTON - Giving Americans the option of buying medical coverage through the government � an idea put forth by President Barack Obama � is a potential deal breaker for some Republicans and insurance companies whose support would ease the way for a health care overhaul.
The proposal, which Obama advocated in his presidential campaign, would for the first time offer government-sponsored coverage to middle class families, as an alternative to private health plans. By some estimates, it could reduce premiums by 20 percent or more � making it much more affordable to cover the estimated 48 million people who don't have health coverage.
But insurers fear competition from a government plan could drive them out of business, and Republicans worry it would lead to a government takeover of health care. Liberals, meanwhile, are equally adamant that Americans deserve the choice of government-sponsored health care.
Such a plan could be similar to what seniors have in Medicare, which is government run. Or it might be designed like the federal employee health plan, available to members of Congress, and delivered through private insurers.
Whatever he decides, Obama could find himself trapped between liberals in his own party and conservatives he's trying to woo in support of a health care overhaul.
Asked about the issue at the White House health care summit this week, the president said he would address the qualms. And while saying he wanted to consider all ideas, he did not abandon the notion of a government plan.
"I'm not going to respond definitively," Obama said, answering a question from Sen. Charles Grassley, R-Iowa. "The thinking on the public option has been that it gives consumers more choices and it helps ... keep the private sector honest, because there's some competition out there.
"I recognize, though, the fear that if a public option is run through Washington, and there are incentives to try to tamp down costs ... that private insurance plans might end up feeling overwhelmed."
Obama says he is committed to preserving a health care system in which government, employers and individuals share responsibility. Many Americans may not realize the government already picks up nearly half the nation's $2.4 trillion health care bill, through programs including Medicare and Medicaid.
A public plan for the middle class could give a final nudge that puts the system squarely in government hands.
Obama's campaign proposal � a foundation for Democrats in Congress � called for setting up a national insurance marketplace through which individuals and small businesses could buy coverage. People could pick private insurance or opt for a public plan that would resemble coverage for federal employees.
Sen. Mike Enzi, R-Wyo., meanwhile, said he is wary that a public plan could make insurance reforms "a sham." His views carry weight because he is the Senate health committee's top Republican.
"It's important that the private market be involved, and not to set up the whole thing so it's a sham to compete with the government, so the government eventually can be the only supplier," Enzi said in a recent interview. "We are not going to do an expansion of Medicare. To use that as the model and try to make everybody compete with it would severely limit the market."
A recent analysis by the Commonwealth Fund, a nonprofit group that sponsors health care research, is giving supporters of a public plan some ammunition.
The study estimated costs and coverage under a hypothetical health reform plan similar to what Obama proposed in the campaign. It found that a public plan like Medicare could reduce projected health care costs by about $2 trillion over an 11-year period. Premiums in the public plan would be at least 20 percent lower, partly because of reduced administrative costs. Within a decade or so, some 105 million people would be in the public plan, compared with about 107 million with private insurance.
Commonwealth Fund President Karen Davis said the administration has been very interested in the study. "Some of their top economists are on the phone, poring over it," she said in an interview.
But Robert Zirkelbach, a spokesman for the industry group America's Health Insurance Plans, said Medicare and Medicaid pay hospitals and doctors below their actual costs. "It would be very difficult to create a level playing field," he said.
Democrats say they will fight to ensure a public plan stays in the final bill.

"We're not trying to figure out what represents the interests of private insurers, we're trying to come up with a plan that makes sure all Americans have health care," said Rep. Jan Schakowsky, D-Ill., who serves on a House panel that will help write the bill.

___

On the Net:

http://www.whitehouse.gov

Obama welcomes allies, skeptics to health summit

2009-03-05T15:45:00.001-08:00

WASHINGTON - President Barack Obama pumped health care allies and skeptics alike for ways to overhaul the nation's costly and frustrating system Thursday and heard only applause and agreement when he told them there's "a clear consensus that the need for health care reform is here and now."
However, he conceded at a White House summit that opinions vary widely on exactly what to do and said that winning quick approval for historic and stunningly expensive legislation won't be easy.
Still, the unanimity on the urgency to act underscored how the political environment has become more favorable to revamping the thorny system since President Bill Clinton's attempt failed in the 1990s under intense resistance from drug makers, insurance companies and others. All those interest groups were on hand Thursday, and Obama intended his daylong Washington session and a series of meetings to follow around the country to signal that his push for universal health care coverage will be more open and inclusive than Clinton's.
"Every voice has to be heard. Every idea must be considered ... The status quo is the one option that is not on the table," Obama said during the White House forum on what he calls the greatest threat to the U.S. economy � rising health care costs. Mindful of the demise of the Clinton plan, Obama warned, "Those who seek to block any reform at all, any reform at any cost, will not prevail this time around."
The U.S. system is the world's costliest; the country spends some $2.4 trillion a year on health care. It leaves an estimated 48 million people uninsured, and many others lack adequate insurance.
Firm in his insistence on action, Obama was relaxed as he fielded questions from lawmakers and the heads of crucial interest groups. At one point he sneezed twice, and then as the audience laughed said, "This is a health care forum, so I thought I'd model what happens when you don't get enough sleep."
In an emotional moment, Sen. Edward Kennedy of Massachusetts addressed the group, his first Washington appearance in weeks as he battles brain cancer. He received a long ovation and declared, "I'm looking forward to being a foot soldier in this undertaking, and this time we will not fail."
Although Obama wants coverage for all, the president suggested a willingness to compromise. That, too, was a break from Clinton's posture in the 1990s when he promised to veto any health care measure that didn't give him what he sought.
This time, Obama said, "Each of us must accept that none of us will get everything we want, and no proposal for reform will be perfect."
Republicans as well as Democrats agreed. Speaker after speaker at the end of a day of smaller White House sessions said action was needed.
Sen. Charles Grassley of Iowa, top Republican on the Senate Finance Committee, said that panel should be working on a version by June. He said the timetable might seem "a little ambitious, but if you aren't ambitious on a major problem like this that the country decides needs to be done, it'll never get done."
Signaling arguments to come, however, he told Obama that there is concern that giving many people the option of a government insurance plan � something Obama has proposed � would reduce competition
Republican Rep. Roy Blunt of Missouri said the same at one session: "That's clearly going to be a big area of contention."
But no one told Obama he or his group would stand in the way of significant action.
Making his case, the president said health care overhaul is both a moral and economic imperative because of the system's huge stress on the nation's financial books. He blamed Washington politics and industry lobbying for past failures, while pledging to put the public's interest ahead of both this time.
Obama is setting a rigorous timeline to enact "comprehensive health care reform" by year's end, though he didn't precisely define what that would entail. His advisers say while he hopes for a bipartisan measure, he won't be deterred by ideological fights or interest group opposition.
Unlike Clinton, Obama isn't offering a specific plan, but rather is outlining general principles to guide the Democratic-controlled Congress as it writes the measure: increased coverage, improved services and better control of costs. The House and Senate will be left to do the heavy lifting.
Although he proposed a plan during the campaign, Obama said that he's open to any solution � from an entirely private system to more government involvement � as long as it meets his general priorities. "I just want to figure out what works," he said.

Still, there is a fault line between Democrats and Republicans over the role of government in the health care system � and that could complicate Obama's push to ensure health care for everyone.

Signaling likely areas of contention ahead, Senate Republican leader Mitch McConnell of Kentucky told Obama in a letter that his party was ready to work with the administration on health care but he also warned that the GOP would bristle at changes that lead to a government-run system and coverage expansions that don't come with curbs on costs.

In office just six weeks, Obama already has made one big move on health care. He proposed a budget that has a $634 billion "down payment" for expanded coverage over a 10-year period. The government will spend trillions on health care over the same period.

In hindsight, both supporters and opponents agree that Clinton made a series of missteps and miscalculations that doomed his plan from the outset.

With first lady Hillary Rodham Clinton leading the charge, the White House wrote the measure with little input from lawmakers or interest groups. Stakeholders on all sides complained they were shut out of the process.

Obama, even before he took office, used his campaign apparatus to encourage people to hold open meetings across the country to discuss the matter. The White House says more than 30,000 people attended more than 3,000 meetings in 50 states and Washington, D.C.

___

Associated Press Writer Erica Werner contributed to this story.

Obama: Every voice must be heard on health reform

2009-03-05T15:15:00.001-08:00

WASHINGTON - President Barack Obama pumped health care allies and skeptics alike for ways to overhaul the nation's costly and frustrating system Thursday and heard only applause and agreement when he told them there's "a clear consensus that the need for health care reform is here and now."
However, he conceded at a White House summit that opinions vary widely on exactly what to do and said that winning quick approval for historic and stunningly expensive legislation won't be easy.
Still, the unanimity on the urgency to act underscored how the political environment has become more favorable to revamping the thorny system since President Bill Clinton's attempt failed in the 1990s under intense resistance from drugmakers, insurance companies and others. All those interest groups were on hand Thursday, and Obama intended his daylong Washington session and a series of meetings to follow around the country to signal that his push for universal health care coverage will be more open and inclusive than Clinton's.
"Every voice has to be heard. Every idea must be considered ... The status quo is the one option that is not on the table," Obama said during the White House forum on what he calls the greatest threat to the U.S. economy � rising health care costs. Mindful of the demise of the Clinton plan, Obama warned, "Those who seek to block any reform at all, any reform at any cost, will not prevail this time around."
The U.S. system is the world's costliest; the country spends some $2.4 trillion a year on health care. It leaves an estimated 48 million people uninsured, and many others lack adequate insurance.
Firm in his insistence on action, Obama was relaxed as he fielded questions from lawmakers and the heads of crucial interest groups. At one point he sneezed twice, and then as the audience laughed said, "This is a health care forum, so I thought I'd model what happens when you don't get enough sleep."
In an emotional moment, Sen. Edward Kennedy of Massachusetts addressed the group, his first Washington appearance in weeks as he battles brain cancer. He received a long ovation and declared, "I'm looking forward to being a foot soldier in this undertaking, and this time we will not fail."
Although Obama wants coverage for all, the president suggested a willingness to compromise. That, too, was a break from Clinton's posture in the 1990s when he promised to veto any health care measure that didn't give him what he sought.
This time, Obama said, "Each of us must accept that none of us will get everything we want, and no proposal for reform will be perfect."
Republicans as well as Democrats agreed. Speaker after speaker at the end of a day of smaller White House sessions said action was needed.
Sen. Charles Grassley of Iowa, top Republican on the Senate Finance Committee, said that panel should be working on a version by June. He said the timetable might seem "a little ambitious, but if you aren't ambitious on a major problem like this that the country decides needs to be done, it'll never get done."
Signaling arguments to come, however, he told Obama that there is concern that giving many people the option of a government insurance plan � something Obama has proposed � would reduce competition
Republican Rep. Roy Blunt of Missouri said the same at one session: "That's clearly going to be a big area of contention."
But no one told Obama he or his group would stand in the way of significant action.
Making his case, the president said health care overhaul is both a moral and economic imperative because of the system's huge stress on the nation's financial books. He blamed Washington politics and industry lobbying for past failures, while pledging to put the public's interest ahead of both this time.
Obama is setting a rigorous timeline to enact "comprehensive health care reform" by year's end, though he didn't precisely define what that would entail. His advisers say while he hopes for a bipartisan measure, he won't be deterred by ideological fights or interest group opposition.
Unlike Clinton, Obama isn't offering a specific plan, but rather is outlining general principles to guide the Democratic-controlled Congress as it writes the measure: increased coverage, improved services and better control of costs. The House and Senate will be left to do the heavy lifting.
Although he proposed a plan during the campaign, Obama said that he's open to any solution � from an entirely private system to more government involvement � as long as it meets his general priorities. "I just want to figure out what works," he said.

On Capitol Hill, Rep. Steny Hoyer, the No. 2 House Democrat, and Senate Finance Committee Chairman Max Baucus, D-Mont., said Thursday they want their respective chambers to pass bills this summer so lawmakers can spend the rest of the year working out a compromise and get a final bill to Obama's desk by year's end.

Still, the political reality of reshaping the complex medical system is certain to intervene as the broad discussion about the need for reform gives way to the details. Those may well conflict with the priorities of a host of stakeholders, including patients, doctors, labor unions, drug companies, businesses and employers, insurers and lawmakers up for re-election next year.

There is also a fault line between Democrats and Republicans over the role of government in the health care system � and that could complicate Obama's push to ensure health care for everyone.

Broadly, Obama is seeking to use his popularity as a new president and the public's high level of frustration with medical costs to generate momentum for universal coverage.

In hindsight, both supporters and opponents agree that Clinton made a series of missteps and miscalculations that doomed his plan from the outset.

Now, Obama is making a point to consult openly with people.

Even before he took office, he used his campaign apparatus to encourage people to hold open meetings across the country to discuss the matter. The White House says more than 30,000 people attended more than 3,000 meetings in 50 states and Washington, D.C.

On Thursday, more than 120 people from all sectors � and with a wide range of viewpoints � were taking part in the program. They included longtime health reform heavyweights, and some people who helped kill Clinton's overhaul in the 1990s. One by one, they stood and praised Obama's willingness to cast a wide net for advice and include them in the process.

Later on, Obama is planning to hold a series of health care events around the country, including in rural areas, to solicit ideas and drum up support for his vision.

___

On the Net:

White House: http://www.whitehouse.gov/agenda/health_care/

Is my chemo working? Scans may give faster answer

2009-03-04T15:21:00.001-08:00

NEW YORK - When Mike Stevens learned his lungs were riddled with cancer, it took only a week to start chemotherapy � but six weeks to find out if it was doing any good. "You're going through all this suffering and stuff and you want to know, am I going to survive? Is this stuff working?" said Stevens, 48, of La Jolla, Calif. "Your whole life is in sort of a limbo."
Doctors typically must wait weeks or months to see if a treatment is shrinking tumors or at least halting their growth. But researchers are exploring a new use for medical imaging that could shorten the stay in purgatory, possibly revealing within a few days whether chemo is working.
That speed could save both lives and money. It would allow doctors to switch more quickly from an ineffective drug to a different one, and save health care dollars by waving doctors off expensive but futile treatments.
The same approach may also prove useful for monitoring radiation therapy.
This experimental imaging relies on a familiar hospital workhorse: PET scans, typically used for things like detecting cancer or revealing the effects of a heart attack. Unlike CT scans or MRIs, PET scans can show a tumor's internal activity, not just its size.
When used to assess the effects of cancer treatment, it can reveal inside information about what the therapy is doing to a tumor even when there's no outward sign.
To do a PET scan, doctors inject a patient with a radioactive substance that shows up on the scan in places where certain processes are happening � like hungry cancer cells gobbling up a lot of blood sugar. Think of it as looking around your neighborhood late at night for light in bedroom windows to see who is still awake.
Many cancer patients get PET scans now to assess their disease before treatment, or to spot recurrences later on. But except for lymphoma, PET scans aren't routinely used to get a quicker answer on how cancers are responding to therapy.
The new research tests both standard PET scans and a newer approach that involves injecting a different tracer substance.
The standard scan, which looks for blood sugar usage, has gotten good results in tests with a variety of tumors including breast, prostate, colorectal and esophageal cancers, said Dr. Steven Larson of the Memorial Sloan-Kettering Cancer Center in New York.
"I think it's going to be extremely valuable for most tumors where there are effective treatments," he said. Some experiments have revealed chemo's effects within 10 days to two weeks.
As a practical matter, the goal of researchers is to convince federal regulators to cover the procedure under Medicare and Medicaid, which would open the door to routine use. That might take two or three years, he said.
Farther out on the research horizon is a PET scan that uses injections of a different radioactive material and has revealed chemotherapy's impact even faster. Larson figures it will be especially useful for assessing newer drugs that aim to stop a patient's cancer from growing rather than killing the tumor.
This scan is called FLT PET, after radioactive fluorothymidine. These scans show whether cancer cells are dividing. Uncontrolled division is a hallmark of active cancer, and stopping that division should be an early effect of successful chemotherapy.
"Our hope ... is you might be able to give a single dose of a chemotherapy agent and within a day or two figure out whether the tumor is going to respond," says Dr. Michael Graham of the University of Iowa.
If the tumor doesn't respond, doctors would "go on to Plan B," he said. "This is really ... giving us the ability to tailor the therapy to the disease."
Research into FLT PET is still in the early stages. Graham said there are maybe a dozen published human studies so far, most involving too few patients to draw a firm conclusion.
One report that impressed him involved 28 patients in Korea who were treated for advanced lung cancer � just like Stevens, who had to wait six weeks to learn whether it was working. The researchers reported that just one week after treatment began, they could tell with 93 percent certainty which patients would eventually respond to the drug and which would not.

In a much smaller study at the University of Wisconsin in Madison, seven patients with acute myeloid leukemia were scanned at various times during a week of aggressive chemotherapy. Normally, doctors wait a month after chemo is stopped to see if it worked. But the FLT PET scans offered an answer as soon as a day after treatment started.

"It's always hard to get too excited about a study that just involves seven people," said Dr. Mark Juckett, one of the authors. But "in these few patients, it looked like we could predict those who were going to respond well to chemotherapy and those who weren't."

Other preliminary studies suggest the new PET technology might be useful in gauging treatment for breast and brain cancers as well as lymphoma.

Graham figures there's a good chance FLT PET scans will become routine for assessing therapy in the next 10 years.

"It's a terrible waste of money to spend thousands and thousands of dollars on these patients when it doesn't do any good," he said.

Graham, president-elect of the Society of Nuclear Medicine, has been involved in discussions between the society and drug companies about incorporating FLT PET in their studies of experimental cancer drugs.

The hope is that, over time, FLT PET would prove reliable for giving a faster answer on whether an experimental treatment is working. That would save companies a lot of money, because they could spot ineffective drugs more quickly and not waste further research on them. And the drug company research would produce data to help persuade federal regulators to approve FLT PET for use in tracking therapy.

Dr. Samuel C. Blackman of pharmaceutical giant Merck & Co. said he couldn't comment on the specifics of talks with the nuclear medicine group, but he said, "We're definitely enthusiastic about FLT PET" for cancer drug research.

Mike Stevens, the lung cancer patient, has seen his disease held generally stable by continuing chemotherapy since 2005. And along with the scientists, he also likes the idea of an earlier end to the limbo of not knowing whether a new treatment is working.

"It's like having a rope tied around you and you're leaning over a canyon at about a 45-degree angle, and you don't know if someone is going to pull you back in, or let go of it," he said. "If you get that encouragement earlier on that you're doing well ... you've got something to fight for."

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On the Net:

Information on PET scans: http://www.radiologyinfo.org/en/info.cfm?PGpet

Call for autopsy to unravel tragedy of stillbirth

2009-03-02T15:29:00.001-08:00

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.

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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

AP Source: Obama to rescind Bush abortion rule

2009-03-01T15:34:00.001-08:00

WASHINGTON - The Obama administration is moving to rescind a federal rule that reinforced protections for medical providers who refuse to perform abortions or other procedures on moral grounds, an official said Friday.
A Health and Human Services official said the administration will publish notice of its intentions early next week, and open a 30-day comment period for advocates, medical groups and the public. The official spoke on condition of anonymity because the official notice has not been completed.
The Bush administration instituted the rule in its last days, and it was quickly challenged in federal court by several states and medical organizations. As a candidate, President Barack Obama criticized the regulation and campaign aides promised that if elected, he would review it.
Abortion opponents hailed the Bush regulation, saying it clarified federal policies and raised awareness about the rights of medical providers to follow their consciences. But abortion rights advocates said it could reduce access to other services � allowing a drug store clerk to refuse to sell birth control pills, for example.
Federal law has long forbidden discrimination against health care professionals who refuse to perform abortions or provide referrals for them. The Bush administration's rule requires institutions that get federal funding to certify their compliance with laws protecting conscience rights. It was intended to block the flow of federal funds to hospitals and other institutions that ignore the rights of religious and moral objectors.
The Obama administration supports the underlying federal laws that protect conscience rights, said the HHS official.
But the administration was concerned that the Bush regulation could also be used to refuse birth control, family planning services and counseling for vaccines and transfusions.
"The administration supports a tightly written conscience clause," said the HHS official. "While we are concerned about the Bush rule, we also understand there might be a need to clarify existing laws."
The administration will review comments from the public before making a final decision. Options range from simply repealing the regulation to writing a new one with a narrower scope.
The administration's move was first reported by The Los Angeles Times.
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On the Net: Health and Human Services Department: http://www.hhs.gov

Finding genes that make teeth grow all in a row

2009-02-26T14:54:00.001-08:00

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.

Low-carb? Low-fat? Study finds calories count more

2009-02-25T14:56:00.001-08:00

LOS ANGELES - Low-fat, low-carb or high-protein? The kind of diet doesn't matter, scientists say. All that really counts is cutting calories and sticking with it, according to a federal study that followed people for two years. However, participants had trouble staying with a single approach that long and the weight loss was modest for most.
As the world grapples with rising obesity, millions have turned to popular diets like Atkins, Zone and Ornish that tout the benefits of one nutrient over another.
Some previous studies have found that low carbohydrate diets like Atkins work better than a traditional low-fat diet. But the new research found that the key to losing weight boiled down to a basic rule � calories in, calories out.
"The hidden secret is it doesn't matter if you focus on low-fat or low-carb," said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, which funded the research.
Limiting the calories you consume and burning off more calories with exercise is key, she said.
The study, which appears in Thursday's New England Journal of Medicine, was led by Harvard School of Public Health and Pennington Biomedical Research Center in Louisiana.
Researchers randomly assigned 811 overweight adults to one of four diets, each of which contained different levels of fat, protein and carbohydrates.
Though the diets were twists on commercial plans, the study did not directly compare popular diets. The four diets contained healthy fats, were high in whole grains, fruits and vegetables and were low in cholesterol.
Nearly two-thirds of the participants were women. Each dieter was encouraged to slash 750 calories a day from their diet, exercise 90 minutes a week, keep an online food diary and meet regularly with diet counselors to chart their progress.
There was no winner among the different diets; reduction in weight and waist size were similar in all groups.
People lost 13 pounds on average at six months, but all groups saw their weight creep back up after a year. At two years, the average weight loss was about 9 pounds while waistlines shrank an average of 2 inches. Only 15 percent of dieters achieved a weight-loss reduction of 10 percent or more of their starting weight.
Dieters who got regular counseling saw better results. Those who attended most meetings shed more pounds than those who did not � 22 pounds compared with the average 9 pound loss.
Lead researcher Dr. Frank Sacks of Harvard said a restricted calorie diet gives people greater food choices, making the diet less monotonous.
"They just need to focus on how much they're eating," he said.
Sacks said the trick is finding a healthy diet that is tasty and that people will stick with over time.
Before Debbie Mayer, 52, enrolled in the study, she was a "stress eater" who would snack all day and had no sense of portion control. Mayer used to run marathons in her 30s, but health problems prevented her from doing much exercise in recent years.
Mayer tinkered with different diets � Weight Watchers, Atkins, South Beach � with little success.
"I've been battling my weight all my life. I just needed more structure," said Mayer, of Brockton, Mass., who works with the elderly.

Mayer was assigned to a low-fat, high-protein diet with 1,400 calories a day. She started measuring her food and went back to the gym. The 5-foot Mayer started at 179 pounds and dropped 50 pounds to 129 pounds by the end of the study. She now weighs 132 and wants to shed a few more pounds.

Another study volunteer, Rudy Termini, a 69-year-old retiree from Cambridge, Mass., credits keeping a food diary for his 22-pound success. Termini said before participating in the study he would wolf down 2,500 calories a day. But sticking to an 1,800-calorie high-fat, average protein diet meant no longer eating an entire T-bone steak for dinner. Instead, he now eats only a 4-ounce steak.

"I was just oblivious to how many calories I was having," said the 5-foot-11-inch Termini, who dropped from 195 to 173 pounds. "I really used to just eat everything and anything in sight."

Dr. David Katz of the Yale Prevention Research Center and author of several weight control books, said the results should not be viewed as an endorsement of fad diets that promote one nutrient over another.

The study compared high quality, heart healthy diets and "not the gimmicky popular versions," said Katz, who had no role in the study. Some popular low-carb diets tend to be low in fiber and have a relatively high intake of saturated fat, he said.

Other experts were bothered that the dieters couldn't keep the weight off even with close monitoring and a support system.

"Even these highly motivated, intelligent participants who were coached by expert professionals could not achieve the weight losses needed to reverse the obesity epidemic," Martijn Katan of Amsterdam's Free University wrote in an accompanying editorial.

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On the Net:

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

How heart handles anger predicts irregular beat

2009-02-23T14:46:00.000-08:00

WASHINGTON - How the heart handles anger seems to predict who's at risk for a life-threatening irregular heartbeat. Negative emotions like hostility and depression have long been considered risks for developing heart disease, and deaths from cardiac arrest rise after disasters such as earthquakes.
But research released Monday goes a step farther, uncovering a telltale pattern in the EKGs of certain heart patients when they merely recall a maddening event � an anger spike that foretold bad news.
In already vulnerable people, "anger causes electrical changes in the heart," said Dr. Rachel Lampert, a Yale University cardiologist who led the work. When that happens even in the doctor's office, "that means they're more likely to have arrhythmias when they go out in real life."
At issue is cardiac arrest, when the heart's electrical system goes haywire and heartbeat abruptly stops. Survival requires a fast electrical shock from a device called a defibrillator.
To track anger's effect, Lampert gave EKGs to 62 patients who had defibrillators implanted in their chests because of preexisting heart disease. When they recounted something that had made them angry, some patients experienced beat-to-beat EKG alterations that were similar to irregular heartbeat-predicting alterations that doctors can spot during treadmill testing.
In other words, the emotional stress was producing a red flag like physical stress can. But it did so without causing the jump in heart rate that exercise does, suggesting anger's Adrenalin rush may act directly on heart cells.
The result: People whose EKGs showed a big anger spike were 10 times more likely to have their defibrillators fire a lifesaving shock in the next three years than similarly ill patients whose hearts didn't react to anger, Lampert reported in the Journal of the American College of Cardiology.
Next she's studying whether anger-reducing techniques might help those high-risk patients avoid irregular heartbeats.
Don't race out for an EKG. Nobody knows if anger has a similar electrical effect in people whose hearts aren't already diseased.
But that question should be studied, said Dr. Nieca Goldberg, a spokeswoman for the American Heart Association who wasn't involved with the research.
There's a clear connection between the heart and the head, that chronic negative emotions are somehow heart-damaging. "But we haven't been able to explain why that happens," said Goldberg, a cardiologist at New York University School of Medicine. "This is a step in the right direction."
The question of the still-healthy aside, this is a small study and researchers must test the anger spike's predictive ability in many more heart patients to be sure of its value.
But if it pans out, the finding could affect a huge population: About 100,000 defibrillators are implanted each year in people at risk of irregular heartbeats because of damage from a survived heart attack, genetic disorders and other conditions. Scientists are searching for ways to tell which patients most need the implants, and the anger spike may offer help.

AP IMPACT: Most fertility clinics break the rules

2009-02-20T14:30:00.001-08:00

NEW YORK - The California fertility doctor who implanted the octuplet mom with lots of embryos was no lone wolf: Fewer than 20 percent of U.S. clinics follow professional guidelines on how many embryos should be used for younger women.
"Clearly, most programs are not adhering to the guidelines," said Dr. Bradley Van Voorhis, director of the fertility clinic at the University of Iowa.
The furor over Nadya Suleman and her octuplets has brought scrutiny to U.S. fertility clinics and how well they observe the guidelines, which are purely voluntary. The controversy had led to talk of passing laws to regulate clinics, something that has already been done in Western Europe.
"There are enough clinics that quite openly flout professional guidelines that we really do need to start thinking about public policy in this area," said Marcy Darnovsky of the Oakland, Calif.-based Center for Genetics and Society, a public interest group. "I think it's way overdue."
The 20 percent figure is contained in reports filed by clinics with the Centers for Disease Control and Prevention.
Fertility doctors say there are many reasons clinics skirt the guidelines: pressure from patients who want to use more embryos to improve their chances of getting pregnant; financial concerns from those who are paying for their treatment out of their own pockets; and the competition among clinics to post good success rates.
And the only penalty for violating the guidelines is expulsion from some of the industry's professional organizations, though that can affect whether insurance companies will cover a clinic's treatments.
"You have patients who are desperate and you have doctors who are driven by success rates. It's not a good combination," said Pamela Madsen, founder and former head of the American Fertility Association.
When the guidelines were issued in 1996 by the American Society of Reproductive Medicine, the intent was to cut down the number of multiple births, particularly triplets and higher, that can result when many embryos are implanted and more than one takes. Big multiple births can lead to disastrous, life-threatening complications, lifelong disabilities such as cerebral palsy, and crushing medical costs.
The guidelines suggest how many embryos doctors should use, with the number varying by age and other factors. They also allow for some flexibility for more if previous attempts have failed or the embryo quality is poor.
"These decisions are complex and need to be individualized, which is why we strongly believe that guidelines are better than hard rules," said Dr. David Adamson, a former president of the reproductive medicine society.
The group credits the guidelines with reducing triplets and higher multiple pregnancies from 7 percent of attempts to 2 percent in 2006. Nearly two-thirds of the procedures involved four or more embryos in 1996; that has fallen to 16 percent.
But for women under 35, government records show that just 83 of 426 clinics followed the guidance calling for one and no more than two embryos. The average for fresh embryos (as opposed to frozen) implanted in women in that age group ranged from a 1.4 to 4.8. The vast majority of the clinics averaged between two and three embryos.
Dr. Mousa Shamonki, director of the IVF program at the University of California, Los Angeles, said his patients frequently ask for more embryos to boost their chances of getting pregnant. He tells patients that it's not OK to end up with triplets or even twins.
"The only thing that happens when you add additional embryos is you're increasing the multiple pregnancy rate," he said. "You're rarely increasing the overall pregnancy rate significantly."
The UCLA program had one of the highest transfer rates in 2006 for younger women. That rate � 3.5 embryos per cycle � matched that of the West Coast IVF Clinic in Beverly Hills, Calif., where Suleman was treated. Shamonki said changes he implemented after he took over drove down UCLA's rate to 2.1 embryos the next year.
Fertility specialists have attacked Suleman's doctor, Michael Kamrava, for using so many embryos. Suleman, 33, has said she had six embryos implanted; two presumably split. She said she refused selective abortion to reduce the number, which is a common option in such cases. Kamrava has declined requests for interviews.
The reproductive medicine society and the Medical Board of California are looking into the case.

Europe has brought down transfer rates and multiple births through laws and voluntary agreements. England and Sweden have laws barring more than two embryo transfers for younger women.

In Sweden, "we have a slogan: One at a time," said Dr. Karl Nygren, former head of an IVF monitoring committee for the European Society of Human Reproduction and Embryology.

Seventy percent of in vitro fertilization procedures in Sweden involved only a single embryo in 2005, according to Nygren. For Europe, the average was 20 percent. By contrast, only 11 percent in the U.S. involved one embryo in 2006.

A key difference, though, is that health programs in Europe cover the cost, so that if one attempt fails, women can try again without having to worry about the expense.

In the U.S., most patients have to foot the bill for IVF, which costs about $12,400 per attempt. Only 14 states make insurers cover some infertility treatments.

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On the Net:

CDC fertility clinic reports: http://www.cdc.gov/ART/

Food poisoning strikes 1 in 4 Americans each year

2009-02-19T14:19:00.001-08:00

ATLANTA - Next time you have a case of diarrhea that lasts a day or more, chances are better than 1 in 3 that it was food poisoning. As many as a quarter of Americans suffer a foodborne illness each year � though only a fraction of those cases get linked to high-profile outbreaks like the recent salmonella-peanut scare, according to the U.S. Centers for Disease Control and Prevention.
"Outbreaks are dramatic instances," says Dr. Robert Tauxe, a CDC expert on the subject. But they highlight a health threat that many people exaggerate and misunderstand, according to some experts.
Scientists have counted more than 250 food-related types of illness � from viruses to bacteria to parasites. Most common are Norwalk-like viruses � famous for sickening cruise-ship passengers. They account for about two-thirds of known food-poisoning cases, according to the CDC.
Two types of bacteria, campylobacter and salmonella, are the next most common. Campylobacter is blamed for about 14 percent of food poisonings, salmonella for roughly 10 percent.
The exact toll of these and other bugs is not really known.
Ten years ago, a team of CDC scientists put together the best enduring estimate of how many Americans get food poisoning each year: 76 million illnesses, which resulted in 325,000 hospitalizations and 5,000 deaths.
No more recent figures are available. But the current numbers must be close to 87 million cases, 371,000 hospitalizations and 5,700 deaths, according to an Associated Press calculation that used the CDC formula and current population estimates.
The statistics seem even more alarming in the context of a parade of high-profile food-poisoning outbreaks in recent years: salmonella poisoning linked to hot peppers and tomatoes from Mexico that sickened more 1,400 last year; an E. coli outbreak from bagged spinach in 2006; and even deadly cases of hepatitis A from green onions in 2003.
The recent peanut-related salmonella outbreak has caused more than 640 confirmed illnesses in 44 states and been linked to nine deaths. It was traced to a Virginia-based company, Peanut Corp. of America, which makes minor-label peanut butter, peanut paste and other products.
Those numbers just scratch the surface: A case is confirmed only after a lab test is sent to the CDC. Many sick people just soldier on without even seeing a doctor.
Health officials assume that for every salmonella case, there are three dozen unreported cases. By that calculation, the latest peanut-related outbreak actually has sickened closer to 20,000 people.
But the problem could be a lot worse.
The number of confirmed food poisonings has basically held steady in recent years. It may seem worse because more advanced testing allows investigators to better link cases and identify outbreaks, CDC officials said.
Also, despite sometimes dramatic problems in food production and inspections, the U.S. food supply is still considered one of the safest in the world, several experts said.
Food poisoning affects an estimated 25 percent of Americans every year. That compares with roughly 30 percent of people in industrialized countries, according to the World Health Organization. The toll, of course, is much higher in developing countries, where diarrheal diseases are a major cause of death for children.
But not all of our food comes from within our borders, as demonstrated by last summer's vegetable-caused outbreak.
"I usually say it is one of the safest in the world," said Tauxe, when asked about the U.S. food supply. "But increasingly, our food supply is the world."
Patients suffering gastric distress sometimes assume food poisoning, partly because of all the outbreak news and partly because it's human nature, some doctors said.

"I think a lot of people in general say, 'I have symptoms. I must have eaten something that's caused this,'" said Dr. Andi Shane, a pediatric infectious disease specialist at Atlanta's Emory University.

Patients may not consider an infection came from some other means, like handling a contaminated tissue, she said.

Some may also find the latest outbreak unsettling because it involved a prepackaged food like peanut butter, said Dr. Akiko Kimura, an epidemiologist with the California Department of Public Health.

"It's ready-to-eat, and so there wasn't anything the consumer could do," she said.

Food disease investigators say their experience has made them careful to wash their hands, review restaurant inspection reports and think carefully about the foods they eat.

"I am fond of many foods, but I draw the line at eating raw meat and raw poultry, raw oysters and raw unpasteurized eggs," said the CDC's Tauxe.

"I run the cutting boards through our dishwasher," he added.

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On the Net:

CDC's frequently asked questions on foodborne illness: http://tinyurl.com/2fpjx

Gene test helps set accurate blood thinner dose

2009-02-18T14:25:00.001-08:00

ATLANTA - People taking warfarin, a leading blood thinner to prevent clots that cause heart attacks and strokes, soon may have a better way to get the tricky dose right. A new formula that includes gene testing proved much better at setting the ideal dose than what doctors do now: Give a standard amount and adjust it by trial and error. The formula was tested in a large international study, which found the usual approach gets it wrong about half the time.
About 4 million Americans take warfarin, also known as Coumadin, the top-used blood thinner worldwide. It could be used even more, but doctors have worried about the all-too-common risks to patients if they get the dose wrong. Too little means a risk of stroke and too much can mean fatal bleeding.
The new study is one of the first to show genetic testing can be used to prevent dosing problems, experts said.
A new experiment will soon test the gene study's results in a more rigorous way. Most patients will likely have to wait at least a few years before genetic testing becomes a common factor in warfarin dosing, some experts said.
Patients are generally started on 5 milligrams a day, but that's just a starting guess. The proper amount for one patient may be 10 times as much as what's best for another. Improper dosing leads to problems for thousands of patients each year and can even result in death, according to some estimates.
"You need to be just right," said Donna Arnett, a researcher of genetic testing and cardiovascular health at the University of Alabama at Birmingham, who wasn't involved in the study.
Variations in two genes can indicate how effective the drug will be, but such a test is not yet widely used.
In the new study, researchers in nine countries collected data on about 5,700 patients who � after some trial-and-error � were already on stable doses of the blood thinner. The scientists developed a dosing formula based on the gene test and other factors, including age and weight.
The formula using the gene test proved accurate in setting the dose in about 1 out of 3 warfarin users � more accurate than a method based solely on age, weight and other characteristics.
The study didn't report on serious side effects or consider how tobacco and alcohol use might figure into blood thinner dosing.
The research was funded by the National Institutes of Health and several international medical organizations. Key researchers have received consulting fees and grants from pharmaceutical companies, and companies involved in genetic testing.
Federal officials want to follow up the report by launching a large, three-year study of more than 1,200 patients beginning in April.
"People will go to their doctors and ask" about genetic tests, predicted Jeremy Berg, director of the National Institute of General Medical Sciences, one of the just-published study's funders.
But until the larger study is done, "it's unlikely that very many places will offer this," he said.
A few clinics are already using these gene tests and others to estimate warfarin dosing, but some researchers have concluded it's not cost-effective for most patients.
Dr. Janet Woodcock, who heads the Food and Drug Administration's drug evaluation center, noted that many patients have, for a long time, complained to doctors that the standard warfarin treatment didn't work for them. Now science is showing how right they were.
"The patients are beginning to be vindicated," Woodcock said.
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On the Net:

New England Journal: http://nejm.org

Appeals court upholds NYC's calories-on-menus rule

2009-02-17T14:26:00.001-08:00

NEW YORK - A federal appeals court has upheld New York City's regulation requiring some chain restaurants to post calories on menus and menu boards.
A 2nd U.S. Circuit Court of Appeals panel on Tuesday rejected an appeal filed by a New York trade group representing 7,000 restaurants. It said the rule the city began enforcing last July is a reasonable attempt to curb obesity.
The panel rejected the New York State Restaurant Association's arguments that federal law gives restaurants discretion on whether to present nutritional information.
The new rule applies to restaurants that are part of chains with at least 15 outlets across the country.
The city and restaurant association didn't immediately comment on the ruling.

Push is on to tailor cancer care to tumor's genes

2009-02-16T14:31:00.001-08:00

WASHINGTON - The days of one-size-fits-all cancer treatment are numbered: A rush of new research is pointing the way to tailor chemotherapy and other care to what's written in your tumor's genes.
Everyone with advanced colon cancer now is supposed to get a genetic test before taking two of the leading treatments. It's a major change adopted by oncologists last month after studies found that those pricey drugs, Erbitux and Vectibix, won't work in 40 percent of patients.
Scientists are furiously testing similar genetically tailored care in breast and lung cancer. It's a flurry of work that reflects a huge problem: Most medications today benefit at best about half of patients but it usually takes trial-and-error to tell.
That means a lot of people suffer side effects for nothing, and it's incredibly costly. When the American Society of Clinical Oncology recommended giving colon cancer patients that $300 test for a gene called KRAS, it estimated the move could save a stunning $600 million a year � by keeping drugs that cost up to $10,000 a month away from patients who won't benefit.
Here's the critical consumer issue: As tantalizing as this personalized medicine is, gene testing is like the Wild West. Laboratories often introduce new tests at the first clues they might work, not waiting for final proof. Few tests so far have won the backing of major medical groups like ASCO, the cancer specialists, making research studies a best bet for many patients.
"A bad test is as dangerous to a patient as a bad drug," notes Dr. Richard Schilsky, ASCO president and a University of Chicago oncologist. "The tricky part is to figure out which of those (genetic differences) are clinically important and which are just variations that exist."
This is not about testing if people carry so-called cancer genes that make them prone to illness. Instead it's about finding a tumor's genetic signature � a pattern of gene and protein activity that signals if the cancer will grow fast or slowly, be more or less likely to recur, and whether it would be susceptible to treatment.
"We're getting into science fiction sort of, if now medicine is being able to analyze things at the genome level," breast cancer patient Claire Weinberg of Oxford, N.C., says in wonder.
A community hospital initially dismissed Weinberg's breast lump but she fortunately sought a second opinion at Duke University Medical Center � where, cancer confirmed, she enrolled in a study of gene-directed chemotherapy.
"I felt it could only benefit me for them to know even more about me," she says.
The ultimate goal: "What's the right recipe for those patients?" explains Dr. Matthew Ellis of Washington University in St. Louis, co-inventor of a different breast cancer genetic approach.
Under study:
_A less precise test already can tell certain breast cancer patients if they're at high or low risk of relapsing, helping the chemo-or-not decision. But which chemo? Duke's Dr. Kelly Marcom is genetically profiling breast biopsy tissue from nearly 300 newly diagnosed patients headed for pre-surgery chemo. Some are randomly assigned to one of two standard chemotherapy cockails; the rest get the cocktail that matches their tumor profile.
It's too early to tell if the gene-directed approach helps more tumors shrink.
But, "I can have no regrets," says Weinberg, who learned after surgery that she'd been in the gene-tailored group and her tumor shrank enough to save her breast. She's also getting post-surgery chemo in case any rogue cells remain.
_Instead of custom profiling, an experimental test unveiled last week examines 50 breast cancer genes to determine which of four disease subtypes the woman has.
If it pans out � and much larger studies are planned � the Breast Bioclassifier could change breast cancer's very names. When studied on stored samples of old tumors, researchers found some women safely skipped chemo � their subtype responded better to post-surgery tamoxifen, or hormone therapy. A more aggressive type was sensitive to most chemo choices but not hormone treatment, the team reported in the Journal of Clinical Oncology.
And still another group didn't respond well to either care, a group that desperately needs new options, said Ellis, who co-developed the test with doctors at the University of Utah and University of North Carolina, Chapel Hill.

_Next up, lung cancer. Hospitals nationwide are recruiting 1,200 lung cancer patients to study who carries extra copies of the tumor-spurring gene EGFR. They'll get either of two top treatments, Tarceva or Alimta, to see which is best for which genetic condition.

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

Amid nurse shortage, hospitals focus on retention

2009-02-15T14:35:00.001-08:00

MIAMI - Newly minted nurse Katie O'Bryan was determined to stay at her first job at least a year, even if she did leave the hospital every day wanting to quit.
She lasted nine months. The stress of trying to keep her patients from getting much worse as they waited, sometimes for 12 hours, in an overwhelmed Dallas emergency room was just too much. The breaking point came after paramedics brought in a child who'd had seizures. She was told he was stable and to check him in a few minutes, but O'Bryan decided not to wait. She found he had stopped breathing and was turning blue.
"If I hadn't gone right away, he probably would have died," O'Bryan said. "I couldn't do it anymore."
Many novice nurses like O'Bryan are thrown into hospitals with little direct supervision, quickly forced to juggle multiple patients and make critical decisions for the first time in their careers. About 1 in 5 newly licensed nurses quits within a year, according to one national study.
That turnover rate is a major contributor to the nation's growing shortage of nurses. But there are expanding efforts to give new nursing grads better support. Many hospitals are trying to create safety nets with residency training programs.
"It really was, 'Throw them out there and let them learn,'" said University of Portland nursing professor Diane Vines. The university now helps run a yearlong program for new nurses.
"This time around, we're a little more humane in our treatment of first-year grads, knowing they might not stay if we don't do better," she said.
The national nursing shortage could reach 500,000 by 2025, as many nurses retire and the demand for nurses balloons with the aging of baby boomers, according to Peter Buerhaus of Vanderbilt University Medical Center. The nursing professor is author of a book about the future of the nursing work force.
Nursing schools have been unable to churn out graduates fast enough to keep up with the demand, which is why hospitals are trying harder to retain them.
Medical school grads get on-the-job training during formal residencies ranging from three to seven years. Many newly licensed nurses do not have a similar protected period as they build their skills and get used to a demanding environment.
Some hospitals have set up their own programs to help new nurses make the transition. Often, they assign novices to more experienced nurses, whom they shadow for a few weeks or months while they learn the ropes. That's what O'Bryan's hospital did, but for her, it wasn't enough.
So more hospitals are investing in longer, more thorough residencies. These can cost roughly $5,000 per resident. But the cost of recruiting and training a replacement for a nurse who washed out is about $50,000, personnel experts estimate.
One national program is the Versant RN Residency, which was developed at Childrens Hospital Los Angeles and since 2004 has spread to 70 other hospitals nationwide. One of those, Baptist Health South Florida in the Miami area, reports cutting its turnover rate from 22 percent to 10 percent in the 18 months since it started its program.
The Versant plan pairs new nurses with more experienced nurses and they share patients. At first, the veterans do the bulk of the work as the rookies watch; by the end of the 18-week training program, those roles are reversed.
The new nurses must complete a 60-item checklist. They must learn how to put in an IV line and urinary catheter; interpret different heart rhythms and know how to treat them; monitor patients on suicide watch and do hourly checkups on very critically ill patients; know how to do a head-to-toe physical assessment on a patient, as well as how to inform families about the condition of their loved one.
For Yaima Milian, who's currently in the program at Baptist, this is markedly different from the preparation she got at her first hospital in New Jersey. She left after a six-week orientation because she didn't feel ready to work solo.
While Milian was paired with a more experienced nurse at the New Jersey hospital, they didn't see patients together; they split the workload. Her first week on the job, Milian was charged with caring for several patients with complicated issues � those on ventilators and with chest tubes � and she felt thoroughly unprepared.
"It just didn't feel right, it felt very unsafe," Milian said.

Besides the residency's professional guidance, which includes classroom instruction, new nurses also get personal support from mentors � people they can call after a bad day or to get career advice. The new nurses also gather with their peers for regular debriefing, or "venting" sessions.

"Here you have this group that is pretty much experiencing the same things you're experiencing," Milian said, "and it makes you feel better."

To be sure, not all the nurses who leave do so because of a rocky transition. But for nurses who do leave because of stress, these programs seem to help.

The American Association of Colleges of Nursing and the University HealthSystem Consortium teamed up in 2002 to create a residency primarily for hospitals affiliated with universities. Fifty-two sites now participate in that yearlong program and the average turnover rate for new nurses was about 6 percent in 2007.

"We believe all new graduates should be given this kind of support system," said Polly Bednash, the nursing association's executive director. "We are facing downstream a horrendous nursing shortage as a large number of nurses retire from the field... So you need to keep the people you get and keep them supported."

The federal government has jumped on the bandwagon. Since 2003, it has awarded $17 million in grants for 75 hospitals to start first-year training programs.

The National Council of State Boards of Nursing is considering a standardized transition program. It cited a study showing a link between residencies and fewer medical errors, but also pointed to the inconsistency among current efforts.

That's something O'Bryan, the Dallas nurse, knows about. Her hospital � which she declined to identify because she didn't want to be seen as complaining about a former employer � had a three-month program, in which she attended weekly classes and was assigned a nurse to shadow. After that period was over, though, O'Bryan was abruptly alone, even as she continued to face new situations that she wasn't sure how to handle.

"When things are going good and I'm not overwhelmed and I'm able to help people, I love it," she said, recalling the gratification of seeing a bedridden patient finally manage to take a few steps.

"There are always those moments," she said, "but they're interrupted pretty quickly."

The 27-year-old is currently looking for a new job. She's not sure it will be in nursing.

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American Association of Colleges of Nursing: http://www.aacn.nche.edu/

Moms offer sober reality check on multiple births

2009-02-13T14:42:00.001-08:00

CHICAGO - Nadya Suleman's daunting future of raising octuplets into adulthood may best be understood by the exhausted but proud parents of other multiples and the researchers who study them.
And if there's anyone who could give Suleman some frank advice, it's a mom with five toddlers.
"There's a lot of hype for the first few months and everybody is interested in how you're doing, but the newness wears off after the first year," said Jenny Ferrill, 31, of Danville, Ill. She and her husband, Pete, 35, are raising 2-year-old quintuplets. Four of the five children have lifelong medical problems and the Ferrills are falling behind paying bills.
She and other parents of multiples say they would advise the California mother of 14 that donations that seem plentiful now will taper off after the first year. Somehow free formula and diapers never morph into free shoes or forgiven medical bills. Requests for TV interviews dwindle. Offers to baby-sit, if they ever existed, vanish.
Next can come financial stress, emotional strain and marital struggles � although Suleman is single.
One German study of 54 families of multiples found that most were severely fatigued with worry about money problems, their children's disabilities and chronic diseases. Nearly all the families relied on outsiders for help and financial support. Some felt guilty they had brought a burden on their families through fertility treatment.
A U.S. study of nearly 250 mothers found that for each additional multiple birth child � from twins to triplets, for example, or triplets to quadruplets � the odds of having trouble meeting basic material needs more than tripled. The odds of lower quality of life and increased social stigma more than doubled with each added child. And the risk of depression in the mothers also rose with each additional child.
"Parents really underestimate the enormity of the burden of providing care for multiple birth children, and this increases with the number of children," said study co-author Dr. Janet E. Hall, a professor of medicine at Harvard Medical School.
In focus groups conducted by the researchers, mothers who'd had fertility treatments described moral judgments from friends, and even strangers, telling them they had interfered with Mother Nature or God's will.
These studies, among only a few on the topic, have led some experts to call for mental health screening or counseling for parents seeking treatment for infertility.
But fertility clinics don't routinely counsel parents about the emotional and financial strains of multiple births, said Barbara Collura, executive director of Resolve, an infertility support group.
Suleman suffered intense depression after a 1999 injury during a riot at a state mental hospital where she worked, according to California documents. The 2001 birth of her first child "helped my spirits," Suleman said in a psychological evaluation detailed in the documents.
In an interview on NBC's "Dateline," she said she always dreamed of having "a huge family" to make up for "certain connections and attachments with another person that I really lacked, I believe, growing up."
Ferrill, the Illinois mother of quintuplets, said she's seen several Suleman TV interviews and is concerned about whether the California woman can get over her admitted desire to have children to make up for the isolation she felt as a child.
"That's a really heavy burden to put on children," Ferrill said. "It's your responsibility to give love to the children, not to have them give that to you, you know what I mean?"
The Ferrills received no counseling after fertility treatment � in their case, a type of artificial insemination and fertility drugs � resulted in more embryos than they expected.
"We went to a doctor specializing in selective reduction (reducing the number of embryos in a pregnancy), and he was one of the most cold-hearted men I have ever met," Jenny Ferrill said.
The couple decided to forge ahead with all the embryos, and while they don't regret their decision, Jenny Ferrill said it's important that couples get counseling on "not just the medical risks, but how your life changes."

The Ferrills have three boys and two girls. One of the girls had heart surgery as an infant and is healthy now. A boy has a chronic inflammatory throat condition that can make it difficult to swallow. Another boy needs physical therapy for abnormally low muscle tone. The other two children are highly sensitive to bright light.

Collura, of the Resolve support group, predicted the California octuplets may jar the industry to do more. Her nonprofit group will continue to educate families that a successful fertility treatment leads to a single baby, not twins, triplets or other multiples.

"We want a healthy outcome and that's a singleton birth," she said. The group began several years ago using stronger language emphasizing single babies. It's published a 10-page article outlining the medical, financial and emotional risks of multiple births.

There were only 68 births of five or more children in the United States in 2005, according to the National Center for Health Statistics. Most are not the result of in vitro fertilization, Collura said, but other types of fertility treatment.

Keith and Becki Dilley of Decatur, Ind., have sextuplets who will turn 16 in May. All six � four boys and two girls � are starting driver's education next week.

"They're going to have jobs," said Becki Dilley, 42. "That's when they can have their driver's license. They know they have to get good grades so they can get a lower rate on their (car) insurance."

The Dilleys wrote a book titled "Special Delivery" about their sextuplets, the first surviving set in North America, which brought in only enough money to buy some appliances. Becki Dilley and her husband both now work full time.

Their schedule is dizzying. The children, all high school sophomores, are involved collectively in choir, jazz band, football and soccer. They all are on the honor roll.

The Dilleys had some couples counseling early on. "In the exhaustion of focusing on the kids, you can forget to focus on each other," Becki Dilley said.

Her advice for Suleman? "Try to make time for yourself. Take it one day at a time," she said. "Put down the camera every once in a while. Your kids don't care if there's not a picture of them dressed up as a reindeer."

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On the Net:

Resolve, http://www.resolve.org/site/PageServer

Ferrill family, http://www.ferrillfive.com/

When toddlers point a lot, more words will follow

2009-02-12T14:44:00.001-08:00

WASHINGTON - Don't just talk to your toddler � gesture, too. Pointing, waving bye-bye and other natural gestures seem to boost a budding vocabulary. Scientists found those tots who could convey more meaning with gestures at age 14 months went on to have a richer vocabulary as they prepared to start kindergarten. And intriguingly, whether a family is poor or middle class plays a role, the researchers report Friday.
Anyone who's ever watched a tot perform the arms-raised "pick me up now" demand knows that youngsters figure out how to communicate well before they can talk. Gesturing also seems to be an important precursor to forming sentences, as children start combining one word plus a gesture for a second word.
University of Chicago researchers wondered if gesturing also played a role in a serious problem: Children from low-income families start school with smaller vocabularies than their better-off classmates. It's a gap that tends to persist as the students age. In fact, kindergarten vocabulary is a predicter of how well youngsters ultimately fare in school.
One big key to a child's vocabulary is how their parents talked to them from babyhood on. Previous research has shown that higher-income, better-educated parents tend to talk and read more to small children, and to use more varied vocabulary and complex syntax.
Do those parents also gesture more as they talk with and teach their children?
To see, university psychology researchers Susan Goldin-Meadow and Meredith Rowe visited the homes of 50 Chicago-area families of varying socioeconomic status who had 14-month-olds. They videotaped for 90 minutes to count both parents' and children's words and gestures. Quantity aside, they also counted whether children made gestures with specific meanings.
This is not baby sign-language; parents weren't formally training their tots. Instead, they used everyday gestures to point something out or illustrate a concept. A child points to a dog and mom says, "Yes, that's a dog." Or dad flaps his arms to mimic flying. Or pointing illustrates less concrete concepts like "up" or "down" or "big."
The researchers found an income gap with gesturing even in toddlerhood, when children speak few words.
Higher-income parents did gesture more and, more importantly, their children on average produced 25 meanings in gesture during that 90-minute session, compared with an average of 13 among poorer children, they reported in the journal Science.
Then the researchers returned to test vocabulary comprehension at age 4 1/2. The poorer children scored worse, by about 24 points. Researchers blamed mostly socioeconomic status and parents' speech, but said gesturing contributed, too.
It's not just that richer parents gesture more, stressed Peggy McCardle of the National Institute of Child Health and Human Development, which funded the work.
"It's that there's a greater variety of types of gesture that would signal different types of meaning," McCardle said. "It sure looks like the kids are learning that and it's given them kind of a leg-up."
The study doesn't prove gesturing leads to better word-learning, but it's a strong hint. Now scientists wonder if encouraging low-income parents to gesture more could translate to toddlers who do, too, and in turn improve school readiness.
"It wouldn't hurt to encourage parents to talk more and gesture more," Rowe said.

Study: Paying smokers to quit boosts success rate

2009-02-11T14:44:00.001-08:00

Dangling enough dollars in front of smokers who want to quit helps many more succeed, an experiment with hundreds of General Electric Co. workers indicates. Among those paid up to $750 to quit and stay off cigarettes, 15 percent were still tobacco-free about a year later. That may not sound like much, but it's three times the success rate of a comparison group that got no such bonuses.
GE was so impressed it plans to offer an incentive program nationwide next year, aiming to save some of the company's estimated $50 million annually in extra health and other costs for smoking employees.
"This kind of reward system provides them with direct, positive feedback in the present," not just delayed, intangible health benefits, said Dr. Kevin Volpp, the lead researcher of the study.
Volpp, who oversees the health incentives center at the University of Pennsylvania, called the study the largest ever of employer incentives to stop smoking. Several past studies failed to find higher quit rates linked to financial bonuses, but he said those included too few people or the financial incentives were too tiny, some as low as $10.
The $750 was "a good incentive," said Dan Anzalone, a study participant who quit smoking cold turkey three years ago next month � after a 35-year habit.
"I was getting rewarded for something that I should be doing anyway," said Anzalone, 54. "You'd be surprised at what that little incentive does."
A logistics specialist at a GE plant in Schenectady, N.Y., Anzalone tried quitting with antidepressants about seven years ago but couldn't. He tried quitting on New Year's Day most years, but generally only lasted a couple days.
So he signed up for Penn's federally funded study, unaware that he would be paid. Half the 878 participants, at about 85 U.S. GE sites, were put in the financial rewards group; the other half were just encouraged to join quit-smoking programs and use the company's health coverage for doctor visits and anti-smoking drugs.
Results of the study, which began in 2005, were reported in Thursday's New England Journal of Medicine.
The incentive group got increasingly higher payments the longer they stayed off tobacco, up to a total of $750 after 12 months.
Anzalone said the incentive program was all he needed: He didn't go to smoking cessation classes or use nicotine patches or gum, or medicines.
"Every week got easier and easier," he said. "Now it's been three years and I don't even think about it."
The study showed that after nine to 12 months, about 15 percent of those being paid had stayed off cigarettes, compared to just 5 percent of the unpaid group. In addition, four times as many people getting cash completed a smoking cessation program.
Volpp said similar numbers of people in the two groups used aids such as nicotine patches and the drug Zyban, which reduces irritability and depression.
Dr. Norman Edelman, chief medical officer of the American Lung Association, said paying people for healthy behavior remains controversial. But he said the study was well done because it was "more real-world" than the tests drug companies run to get anti-smoking products approved. Study volunteers decided what classes to attend and which products to use, rather than having tightly controlled conditions and constant calls from nurses checking on them, he noted.
Edelman said the 15 percent quit rate is pretty good and that employers should consider trying such a program, although it's not clear it would succeed in settings outside workplaces.
GE's chief medical officer, Dr. Robert Galvin, said Wednesday that starting next January, the company will offer a quitting incentive program covering its 152,000 U.S. employees, at more than 250 sites. GE expects to recoup the costs of the smoking cessation program in three to five years.
"We know that incentives work," Galvin said. "We're very excited about it."

Not all those in the study saw the bonuses as crucial. Guy Ardizzone, 49, an engineer at a GE factory in Madisonville, Ky., smoked for "probably 30 years," then quit nearly three years ago. He said other factors were more important than the $750: completing a 12-week smoking cessation course, using Commit lozenges and his own motivation.

"I was ready to quit," said Ardizzone, who has five young grandchildren. "I want to enjoy them."

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On the Net:

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

American Lung Association's Freedom From Smoking program: http://tinyurl.com/dej47r

University of Pennsylvania's center for health incentives: http://www.med.upenn.edu/ldichi

Sobering results for cost-cutting Medicare project

2009-02-10T14:50:00.001-08:00

CHICAGO - An ambitious effort to cut costs and keep aging, sick Medicare patients out of the hospital mostly didn't work, a government-contracted study found. The disappointing results show how tough it is to manage older patients with chronic diseases, who often take multiple prescriptions, see many different doctors and sometimes get conflicting medical advice.
The study showed just how hard it is to change the habits of older patients and their sometimes inflexible doctors. And it points up the challenges the Obama administration will face in trying to reform health care for an aging nation.
Most of the patients had serious, but common, age-related illnesses including diabetes, heart disease and lung disease. Programs were set up at 15 centers around the country. Only two cut the number of times these patients were hospitalized, and those are still in operation. None saved Medicare any money.
The authors of the study called the results "underwhelming." An editorial in the Journal of the American Medical Association, where the study appears Wednesday, used the term "sobering."
"The only way you can really do it is by changing patients' behavior and by changing physicians' behavior, and both things are really hard to do," said study author Randall Brown, a researcher at Mathematica Policy Research Inc., in Princeton, N.J., which was hired to evaluate the programs.
Often, these patients need to stop smoking, or lose weight, exercise more, eat healthier foods � a challenge even for generally healthy people. Those changes are especially tough for sick, older patients who often are set in their ways.
"The same thing with physicians," Brown said. "A lot of them feel like they know how to take care of patients, so why do they need a nurse calling up and asking them why the patient isn't on some certain medication?"
Many patients in the study had more than one chronic disease, a common Medicare scenario. In 2002 alone, half of Medicare patients had been treated for five or more ailments, and they accounted for 75 percent of Medicare spending, the study authors noted.
Seeking ways to reduce those costs and improve care, the Centers for Medicare & Medicaid Services selected 15 proposals for test-site programs in 2002. The sites developed their own programs, enrolling a total of 18,309 fee-for-service Medicare patients through 2006.
About half got the patients got the usual care. The others got more intensive, coordinated care. That often involved nurses who acted as go-betweens, helping doctors give patients clear, appropriate advice; counseling patients on changing bad habits and recognizing worrisome symptoms. The nurses were available on a regular basis by phone or in person to answer patients' questions.
Jim Reid, a 74-year-old retired Pennsylvania welder, was among study patients who got coordinated care.
When he enrolled in 2002 in a test program run by Health Quality Partners, a nonprofit group in Doylestown, Pa., he was obese, had high blood pressure, high cholesterol and pre-diabetes.
But Reid was a rare success story.
He actually took the advice offered in group sessions run by nurses. He learned how to read food labels and avoid salty, calorie-laden foods. He also started exercising, walking with a pedometer and building up to a few miles daily.
Now, he breakfasts on oatmeal or vegetable omelets instead of coffee and doughnuts He's lost almost 60 pounds. His blood pressure and cholesterol have greatly improved and his pre-diabetes is gone.
Sticking with the program "is hard," he acknowledged. "As you get older, you don't want to do it." But he said it has "put an extra 10 years in my life."
Reid credits his success to the personal attention of a nurse coordinator.
"I have to have somebody to own up to," he said.

That close, in-person contact with nurses was also a feature of the project's other more successful, still-operating program, at Mercy Medical Center-North Iowa in Mason City, Iowa.

In both programs, each patient had face-to-face contact an average of about once a month with a nurse. That was far more frequent personal contact than in other programs. Both reduced hospitalizations � 17 percent yearly compared with usual-care patients at Mercy, and by about 20 percent in the Pennsylvania program, but only among its sicker patients. That program worked with Doylestown Hospital and recruited patients from area physicians' offices.

Targeting sicker patients and providing frequent in-person contact show the approach has some benefits and that success with future reform efforts "is possible, but it's not easy," Brown said.

Peter Ashkenaz, a spokesman for the Centers for Medicare & Medicaid Services, said the agency is evaluating the Iowa and Pennsylvania programs to see if their positive results persist.

He said there are other approaches being tested, some that offer incentives to doctors who meet quality benchmarks, or who use electronic health records to improve quality.

But so far, Ashkenaz said, "as the study shows, we have not yet found broad success."

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On the Net:

JAMA: http://jama.ama-assn.org

Centers for Medicare & Medicaid Services: http://www.cms.hhs.gov

Huge study boosts disappointment on multivitamins

2009-02-09T14:52:00.001-08:00

CHICAGO - The largest study ever of multivitamin use in older women found the pills did nothing to prevent common cancers or heart disease. The eight-year study in 161,808 postmenopausal women echoes recent disappointing vitamin studies in men.
Millions of Americans spend billions of dollars on vitamins to boost their health. Research has focused on cancer and heart disease in particular because of evidence that diets full of vitamin-rich foods may protect against those illnesses. But that evidence doesn't necessarily mean pills are a good substitute.
The study's lead author, researcher Marian Neuhouser of the Fred Hutchinson Cancer Research Center in Seattle, offered this advice: "Get nutrients from food. Whole foods are better than dietary supplements," Neuhouser said.
The study appears in Monday's Archives of Internal Medicine.
Co-author Dr. JoAnn Manson said despite the disappointing results, the research doesn't mean multivitamins are useless.
For one thing, the data are observational, not the most rigorous kind of scientific research. And also, it's not clear if taking vitamins might help prevent cancers that take many years to develop, said Manson, chief of preventive medicine at Harvard's Brigham & Women's Hospital.
She said multivitamins may still be useful "as a form of insurance" for people with poor eating habits.
The study involved an analysis of data on women in their 50s and up who participated in long-running government studies on postmenopausal women. Almost 42 percent of the women said they used multivitamins regularly.
After about eight years, roughly equal numbers of vitamin users and nonusers developed common cancers, heart attacks and other cardiovascular problems. Overall, there were 9,619 cases of cancer, including cancers of the breast, lung, ovary, colon and stomach; and 8,751 cardiovascular ailments including heart attacks and strokes. In addition, 9,865 women died, also at similar rates in multivitamin users and nonusers.
Alice Lichtenstein, a Tufts University nutrition professor who was not involved in the research, said the study is important because it involved so many women.
"All the evidence keeps pointing in the same direction," Lichtenstein said.
Eric Jacobs, an American Cancer Society epidemiologist, said while his group doesn't advise vitamins to prevent cancer, it does recommend maintaining a healthy weight and eating at least five servings of fruits and vegetables daily while limiting red meat. Similar habits are also thought to help reduce heart disease risks.
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On the Net:
Archives: http://www.archinternmed.com
American Cancer Society: http://www.cancer.org

1st US case of Marburg fever confirmed in Colo.

2009-02-08T14:55:00.001-08:00

WHEAT RIDGE, Colo. - The first U.S. case of Marburg hemorrhagic fever has been confirmed in Colorado, and authorities say the patient � who contracted the rare illness while traveling in Uganda � has since recovered.
The disease, caused by a virus indigenous to Africa, spreads through contact with infected animals or the bodily fluids of infected humans. Centers for Disease Control and Prevention spokesman Dave Daigle said no previous cases have been reported in the United States.
The patient had traveled to Uganda, visited a python cave in Maramagambo Forest in Queen Elizabeth Park and encountered fruit bats, which can carry the Marburg virus. The Ugandan government closed the cave after a tourist from the Netherlands died from Marburg in July.
The patient was treated at Lutheran Medical Center in January 2008 and sought follow-up care in July, after learning of the tourist's death. The patient recovered and his or her identity wasn't disclosed.
Pierre Rollin, acting chief of the Special Pathogens Branch of the CDC, said specialized tests of the initial sample taken in January 2008 confirmed the illness in the Colorado patient in December.
CDC officials said identifying the virus and how a patient contracted it can be difficult. It often depends on the quality of the sample being tested and the timing; samples taken early in the patient's illness makes identification easier, Rollin said.
Marburg hemorrhagic fever is extremely rare. The CDC's Web site counts fewer than 500 confirmed cases since the virus was first recognized in 1967. More than 80 percent of the known cases are fatal.
It has an incubation period of 5 to 10 days. The first symptoms are fever, chills and headaches, but symptoms worsen significantly after the fifth day of illness.
Lutheran hospital spokeswoman Kim Kobel said none of the staff and physicians who cared for the patient has developed symptoms.
Rollin said the CDC is testing hospital staff to see if any illnesses were undetected at the time.
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Information from: Rocky Mountain News, http://www.rockymountainnews.com/

FDA: Plant knew peanuts laced with salmonella

2009-02-07T15:02:00.001-08:00

WASHINGTON - As far back as 2007, salmonella-laced products were shipped by a Georgia peanut company that knew the peanuts probably were tainted and sometimes after tests confirmed that contamination, inspection records show.
Federal law forbids producing or shipping foods under conditions that could make it harmful to consumers' health.
Food and Drug Administration officials earlier had said Peanut Corp. of America waited for a second test to clear peanut butter and peanuts that initially were positive for salmonella. But the agency amended its report Friday, saying that the Blakely, Ga., plant actually shipped some products before receiving the second test and sold others after confirming salmonella.
In 2007, the company shipped chopped peanuts on July 18 and 24 after salmonella was confirmed by private lab tests, the FDA report said. Peanut Corp. sold products "on or after the positive salmonella results were obtained."
In other cases, the company didn't wait for a second round of salmonella tests.
"In some instances, peanut products were shipped by (the company) prior to having assurance that the products were negative for salmonella," said Michael Rogers, head of field investigations for the FDA.
Rogers said the FDA made the discovery after a more detailed analysis of records submitted by the company.
The salmonella outbreak has been blamed for at least eight deaths and 575 illnesses in 43 states. The Justice Department has opened a criminal investigation. More than 1,550 products have been recalled.
Wary consumers are shunning all brands of peanut butter, even those not caught up in the massive recall, driving sales down by nearly 25 percent, The New York Times reported Saturday.
A Peanut Corp. lawyer said the company is investigating what happened at the plant and had no comment on the latest FDA findings.
"We have not made a determination yet on liability," said attorney Amy Rotenberg. "We are neither denying or admitting liability at this point. We are still investigating."
Peanut Corp. previously said it "categorically denies any allegations" that it sought lab results that would put its products in a favorable light.
Problems at the plant are not new. FDA inspectors found in 2001 that products potentially were exposed to insecticides, one of several violations uncovered during the last visit federal officials made before the current food-poisoning scare, according to a report obtained by The Associated Press.
Also on Friday, Agriculture Secretary Tom Vilsack said he supports merging the nation's food-safety system into one agency. His department shares duties now with the FDA.
The USDA abruptly suspended all business with the company this week. It shipped some of the company's potentially contaminated peanut butter and peanuts to eight states, including school lunch programs in California, Minnesota and Idaho in 2007. None of the states reported illnesses as a result of people eating the products, agency officials said.
Some of the problems FDA discovered at the plant in 2001 are similar to those found last month, when federal inspectors returned to the plant after nearly eight years.
The 2001 inspection found dead insects near peanuts and holes in the plant big enough for rodents to enter. Those inspectors also discovered that workers at the plant used an insecticide fogger in food-processing areas and didn't wash the exposed equipment. They also found dirty duct tape wrapped on broken equipment.
Inspectors did not find evidence of insecticides in peanuts at the plant during the 2001 visit. Company officials told them the fogger was last used two weeks earlier, according to the inspection report.

The USDA was one of Peanut Corp.'s two biggest clients at the time. USDA officials also regularly visited the plant, including in recent years. But those agency workers were not trained to perform food safety inspections, USDA spokesman Jerry Redding said.

The USDA visits to the plant were made by "contract auditors" who are "number crunchers," Redding said, who know nothing about peanuts. They only visited to review records, he said.

Plant owner Stewart Parnell told FDA inspectors in 2001 that USDA officials knew about the insecticide fogger and approved use of the duct tape on broken equipment, the FDA inspection report says. The insecticide fogger discovered by inspectors noted on its labels that any exposed equipment should be thoroughly washed after use. Plant workers covered some areas and told inspectors that no peanuts were in any equipment when the foggers were used at night.

The plant manager told inspectors that workers didn't clean the exposed areas and didn't realize the insecticide couldn't be used around food.

Parnell promised that he would correct the problems because he "wanted to assure us that he wanted his firm to be in compliance," FDA inspectors wrote. Parnell told inspectors that the insecticide's "labeling had been changed and they had not been aware of the change," according to the FDA report.

He and the plant manager said the company was assured by the insecticide supplier that the chemical was safe for use in food areas.

FDA officials said Friday the company was allowed in 2001 to fix the problems on its own because the inspection showed no evidence that finished products were being contaminated.

___

Associated Press writer Mary Clare Jalonick contributed to this report.

FDA: Plant knowingly sold salmonella-laced food

2009-02-06T15:46:00.001-08:00

WASHINGTON - A Georgia peanut plant knowingly shipped salmonella-laced products as far back as 2007, at times sending out tainted products after tests confirmed contamination, according to inspection records released Friday.
Food and Drug Administration officials earlier had said Peanut Corp. of America waited for a second test to clear peanut butter and peanuts that initially were positive for salmonella. But the agency amended its report Friday, noting that the Blakely, Ga., plant actually shipped some products before receiving the second test and sold others after confirming salmonella.
Federal law forbids producing or shipping foods under conditions that could make it harmful to consumers' health.
In 2007 the company shipped chopped peanuts on July 18 and 24 after salmonella was confirmed by private lab tests. Peanut Corp. sold products "on or after the positive salmonella results were obtained," the FDA report states.
In other cases, the company didn't wait for a second round of salmonella tests.
"In some instances, peanut products were shipped by (the company) prior to having assurance that the products were negative for salmonella," said Michael Rogers, head of field investigations for the FDA.
Rogers said the FDA made the discovery after a more detailed analysis of records submitted by the company.
The salmonella outbreak has been blamed for at least eight deaths and 575 illnesses in 43 states. The Justice Department has opened a criminal investigation. More than 1,550 products have been recalled.
A Peanut Corp. lawyer said the company is investigating what happened at the plant and had no comment on the latest FDA findings.
"We have not made a determination yet on liability," said attorney Amy Rotenberg. "We are neither denying or admitting liability at this point. We are still investigating."
Peanut Corp. previously said it "categorically denies any allegations" that it sought lab results that would put its products in a favorable light.
Problems at the plant are not new. FDA inspectors found in 2001 that products potentially were exposed to insecticides, one of several violations uncovered during the last visit federal officials made before the current food-poisoning scare, according to a report obtained by The Associated Press.
Also on Friday, Agriculture Secretary Tom Vilsack said he supports merging the nation's food-safety system into one agency. His department shares duties now with the FDA.
The USDA abruptly suspended all business with the company this week. It shipped some of the company's potentially contaminated peanut butter and peanuts to eight states, including school lunch programs in California, Minnesota and Idaho in 2007. None of the states reported illnesses as a result of people eating the products, agency officials said.
Some of the problems FDA discovered at the plant in 2001 are similar to those found last month, when federal inspectors returned to the plant after nearly eight years. The 2001 inspection found dead insects near peanuts and holes in the plant big enough for rodents to enter.
The inspectors also discovered that workers at the plant used an insecticide fogger in food processing areas and didn't wash the exposed equipment. They also found dirty duct tape wrapped on broken equipment.
FDA inspectors did not find evidence of insecticides in peanuts at the plant during that visit. Company officials told them the fogger was last used two weeks earlier, according to the inspection report.
The USDA was one of Peanut Corp.'s two biggest clients at the time. USDA officials also regularly visited the plant, including in recent years. But those agency workers were not trained to perform food safety inspections, USDA spokesman Jerry Redding said.

The USDA visits to the plant were made by "contract auditors" who are "number crunchers," Redding said, who know nothing about peanuts. They only visited to review records, he said.

Plant owner Stewart Parnell told FDA inspectors in 2001 that USDA officials knew about the insecticide fogger and approved use of the duct tape on broken equipment, the FDA inspection report says.

The insecticide fogger discovered by inspectors noted on its labels that any exposed equipment should be thoroughly washed after use. Plant workers covered some areas, and told inspectors that no peanuts were in any equipment when the foggers were used at night.

The plant manager told inspectors that workers didn't clean the exposed areas and didn't realize the insecticide couldn't be used around food.

Parnell promised that he would correct the problems because he "wanted to assure us that he wanted his firm to be in compliance," FDA inspectors wrote.

Parnell told inspectors that the insecticide's "labeling had been changed and they had not been aware of the change," according to the FDA report.

Parnell and the plant manager said the company was assured by the insecticide supplier that the chemical was safe for use in food areas.

FDA officials said Friday the company was allowed in 2001 to fix the problems on its own because the inspection showed no evidence that finished products were being contaminated.

___

Associated Press writer Mary Clare Jalonick contributed to this report.

FDA: Ga. plant knowingly shipped tainted products

2009-02-06T15:07:00.001-08:00

WASHINGTON - Federal health officials say the Georgia peanut plant at the center of the salmonella outbreak knowingly shipped tainted products. Previously, the Food and Drug Administration had said Peanut Corp. of America retested products after getting an initial positive result for salmonella. The agency said the company shipped the goods after follow-up tests came back negative.
But Friday, the FDA said the company sent out peanut butter, chopped peanuts and peanut meal that had tested positive even before it got back any negative findings.
Peanut Corp. denies any wrongdoing. The government has opened a criminal investigation.

Few get surgery for grim pancreatic cancer

2009-02-05T15:07:00.001-08:00

WASHINGTON - Supreme Court Justice Ruth Bader Ginsburg got a shot at survival that unfortunately few people with pancreatic cancer do: not just care from a celebrated specialist but the chance to have surgery at all. As few as 10 of every 100 patients have their pancreatic tumor cut out. The majority have the most aggressive form of pancreatic cancer, called adenocarcinoma, and usually it's too far gone to operate.
This is one of the most formidable cancers. The American Cancer Society estimates that nearly 38,000 people last year were diagnosed with it, and no more than 5 percent overall survive five years.
But look at those whose cancer is caught early enough for surgery, followed by chemotherapy, and that five-year survival grows, reaching anywhere from 20 percent to 24 percent.
And very occasionally � 10 percent to 15 percent of the time � patients have a far less aggressive form of pancreatic cancer called an islet-cell tumor. Those sometimes are curable.
Ginsburg's surgeon, well-known specialist Dr. Murray Brennan of New York's Memorial Sloan-Kettering Cancer Center, offered no clue Thursday about what type of cancer the justice has or her prognosis. A court statement characterized it only as apparently early stage.
This is key: Ginsburg, who survived colon cancer a decade ago, reported no symptoms � but doctors spotted the very small new tumor by accident when she had a CT scan as part of a regular checkup.
Because the small tumor also was in the center of the pancreas, she almost certainly had a slightly easier surgery than most patients, removing what's called the body and tail of the pancreas plus her spleen, said Dr. Aaron Sasson, a pancreatic cancer surgeon at the University of Nebraska Medical Center. Most patients require the more arduous Whipple procedure that removes a trickier side of the pancreas, part of the small intestine, the gallbladder and bile duct, and sometimes part of the stomach.
Why is cancer in such a tiny organ so grim? Not only is it typically aggressive, there's no early detection test. Vague indigestion may be the only early sign. By the time such classic symptoms as yellowing skin, itching, weight loss and abdominal pain appear, the cancer has spread.
Scientists know far less about what causes pancreatic cancer than about most other solid tumors. But smoking and a family history of the disease are considered the top risk factors; high-fat diets, diabetes and a chronically inflamed pancreas may be risks, too.
Once the cancer has spread, chemotherapy helps minimize symptoms and slow its march.
Surgery patients with adenocarcinoma also need chemotherapy, typically the drug gemcitabine, to attack remaining cancer cells, said Dr. John Marshall, a medical oncologist at Georgetown University Hospital who specializes in pancreatic cancer. Their prognosis depends largely on whether the tumor had reached lymph nodes.
But the success rates are frustrating: "Twenty percent is still a crummy number," Marshall said.
So most patients are encouraged to consider enrolling in research studies looking for better treatments. One such study is being closely watched: Testing whether an immune therapy can block the cancer's return when the tumor contained a specific genetic mutation.

In colon cancer drug study, more wasn't better

2009-02-04T15:02:00.001-08:00

NEW YORK - Doctors thought that combining two newer drugs that more precisely attack cancer would help people with advanced colon cancer. Instead, it made the cancer worse and made the patients more miserable, a study found. The surprising findings underscore the importance of doing rigorous studies before rushing to mix these pricey, new-generation drugs, the Dutch researchers and other experts said.
The doctors tried combining Erbitux and Avastin because lab tests and an earlier small study had shown promising results.
"This will stand out as a warning," said Dr. Cornelis Punt, the study's leader. "You have to do the randomized studies to see what really happens."
For the study, Eli Lilly & Co.'s Erbitux was added to standard treatment, which includes Genentech Inc.'s Avastin. Since both are "targeted" drugs and attack tumors in different ways, the thinking was that the combo would do a better job of keeping the cancer from growing.
But the results show "more is not always better," said Dr. Robert Mayer, of Dana-Farber Cancer Institute in Boston. He wrote an editorial published with the study in Thursday's New England Journal of Medicine.
What makes the results even more compelling, Mayer said, is that another similar study reached the same conclusion. That study, released in December, tested another targeted drug that works the same way as Erbitux.
"This is the first time we've seen harm by combining targeted therapies and it tells us we need to be cautious," said Dr. Jordan Berlin, a gastrointestinal cancer specialist at Vanderbilt-Ingram Cancer Center in Nashville, Tenn.
Berlin, who had no role in the research, stressed that the drugs do help patients, just not when given together.
Colorectal cancer is the nation's second leading cancer killer. The disease was expected to kill almost 50,000 Americans last year although death rates are dropping because of screening and better treatment.
The research was done at hospitals throughout the Netherlands and led by Punt at Radboud University Nijmegen Medical Center. The 755 study patients had colon cancer that had spread. They all received Avastin, also known as bevacizumab, and two chemotherapy drugs. Half of them also got Erbitux, also called cetuximab. They were followed for nearly two years.
The group that got Erbitux saw their cancer get worse sooner, the researchers found. On average, their cancer progressed after 9.4 months compared to 10.7 months for those who didn't get Erbitux. The Erbitux group also had lower quality-of-life scores.
The overall survival in both groups was about the same.
Punt said they are now trying to figure out why the combo didn't work; it could be an interaction between these two specific drugs, Erbitux and Avastin.
After the study began in 2006, it was shown that Erbitux didn't help colon cancer patients who had a specific gene mutation. The Dutch researchers said their study confirmed that � the worst results were in those with the mutation who got Erbitux.
Vanderbilt's Berlin said the results also show doctors need to be careful when using drugs "off-label." Drugs are approved for specific uses but doctors can prescribe them for other purposes. Medicare has recently expanded its coverage for such use of some cancer drugs, which can cost thousands a month.
Off-label use "needs to be cautious and this proves it," said Berlin.
The study was supported by a network of Dutch researchers which receives grants from a cancer foundation and drug companies. The two targeted drugs were provided by the companies that market them in Europe. Several of the researchers have consulted for cancer drug companies, as has the editorial writer and Berlin.
___

On the Net:

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

Group opposes NYC health official for CDC job

2009-02-03T15:02:00.001-08:00

NEW YORK - On paper, New York City's health commissioner looks like the kind of doctor an AIDS activist would love.
In his seven years on the job, Dr. Thomas Frieden has championed efforts to boost the number of New Yorkers getting HIV tests, promoted needle exchange programs, distributed millions of free condoms and earned praise for letting science � not politics � drive his agenda.
Yet on Tuesday, a group of AIDS activists gathered at City Hall to denounce Frieden as a poor candidate to lead the country's top public health agency, the U.S. Centers of Disease Control and Prevention.
Charles King, president of the nonprofit group Housing Works, said a Frieden appointment to the CDC would be a "devastating blow to combating HIV/AIDS in the U.S."
Regina Quattrochi, chief executive of Bailey House, an organization that serves homeless people with HIV, accused Frieden of being too autocratic and inflexible for the post.
"I think the people of this country have had enough of that type of leadership," she said.
Their chief complaint involved a cornerstone of Frieden's HIV policy: his campaign to alter medical-privacy laws passed in the 1980s that created a special process for obtaining patient consent for an HIV test.
In New York, as in many other states, a health care provider must get a patient's written consent and provide a brief counseling session before giving them a test for the AIDS virus.
The process was originally created at the insistence of AIDS activists, at a time when a positive HIV test was tantamount to a death sentence. In those early days of the epidemic, there was no treatment for the disease, and people who tested positive could face so much discrimination that activists said people should have the right to turn a test down.
Since then, the stigma has diminished, but some AIDS support groups have continued to favor the consent procedures, especially the counseling requirement.
Frieden and many other public health experts don't like those additional steps, saying they unnecessarily complicate a test that should be as easy to get as a cholesterol check.
The CDC recommended in 2006 that states drop such requirements and encourage routine HIV testing routine for all Americans ages 13 to 64.
Other AIDS activists familiar with Frieden's record expressed dismay over the criticism, saying he had an exemplary record.
"I've seen commissioners come and go, and he's certainly been one of the best," said Debra Fraser-Howze, former president of the National Black Leadership Commission on AIDS.
Frieden is one of several health officials of national prominence who have been mentioned as good choices for the job of CDC director. Others include Dr. Helene Gayle, a former CDC administrator now with CARE International; Dr. Margaret Hamburg, a former Health and Human Services official now with the Global Health and Security Initiative; and Dr. James Marks, a former CDC administrator now at the Robert Wood Johnson Foundation.
Dennis deLeon, president of the Latino Commission on AIDS, said Frieden would make an excellent choice if selected.
"I've been doing this work since 1994, and he's the first health commissioner to really go after the HIV orthodoxy with an eye toward bringing solutions," deLeon said.
DeLeon said he also supported Frieden's stance on HIV testing because it gets more people into treatment.

Health Department clinics in New York City gave 70,000 HIV tests last year, compared to 30,000 in 2002.

___

Associated Press Writer Mike Stobbe contributed to this report from Atlanta.

Dope-smoking among teens down in many countries

2009-02-02T15:07:00.001-08:00

CHICAGO - Kids on both sides of the Atlantic are smoking less pot and going out less often with friends at night, a study of 15-year-olds in 30 countries found. The double declines occurred in the United States, Canada and mostly European countries from 2002 to 2006. The trends are likely related, since other research has found that kids who spend many evenings out are more likely to smoke dope than homebodies.
Since few parents approve of marijuana use, teens are most likely to use the drug secretly away from home, said lead author Emmanuel Kuntsche of the Swiss Institute for the Prevention of Alcohol and Drug Problems.
Reasons for the declines are unclear. But the researchers said drug prevention efforts and technology may have contributed.
Instant messaging, e-mail and cell phones "may have partly replaced face-to-face contacts, leading to fewer social contacts in the evenings," Kuntsche said.
The study appears in February's Archives of Pediatrics and Adolescent Medicine, released Monday.
The researchers analyzed data on 93,297 15-year-olds from periodic health surveys in dozens of countries conducted in collaboration with the World Health Organization.
Survey questionnaires were distributed to entire classrooms at various schools, asking various health-related questions including about marijuana use and evenings out with friends in the past year. Responses to 2006 surveys were compared with those in 2002.
Users were kids who'd tried marijuana at least once in the past year.
Marijuana use increased only in Estonia, Lithuania and Malta, and among Russian girls.
While rates varied widely among countries, prevalence was highest both years in Canada, where 30 percent of boys and almost 28 percent of girls used marijuana in 2006. That was down 13 percent among boys and almost 10 percent among girls.
The United States ranked third in 2006, with 24 percent of boys and girls each reporting marijuana use. That was down almost 12 percent among boys and 2 percent among girls, echoing previous reports of declining pot use among U.S. teens.
Switzerland ranked second in prevalence among boys, and Wales was second among girls. Greece, Macedonia and Sweden were at the bottom of the list � with fewer than 5 percent of boys and girls reporting marijuana use in 2006.
Average number of evenings out also decreased in most countries. In the United States, nights out fell slightly to about twice a week in 2006 for boys and girls.
An Archives editorial said that while evenings out may increase chances for marijuana use, parents shouldn't discourage socializing since teens need time away from home to gain independence. Instead, the editorial advises, parents should help steer kids to activities that don't encourage drug use.
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On the Net:
Archives: http://www.archpediatrics.com

Inspection reports from peanut plant varied widely

2009-02-01T15:13:00.001-08:00

BLAKELY, Ga. - A Georgia health inspector who toured the peanut butter plant now at the center of a national salmonella outbreak noted only two minor violations in October. Less than three months later, federal inspectors found roaches, mold, a leaking roof and other sanitation problems.
Food safety experts say the lapse is a major concern and shows state inspectors are spread thin and might need more training on how to spot unsanitary conditions.
"It's surprising to me that that many major deficiencies were observed at one time, and none of these were picked up previously," said Michael Doyle, head of the food safety center at the University of Georgia.
In October, state inspector Donna Adams noted only two violations in her report on the Peanut Corp. of America plant: tote containers with butter residue and "black buildup" and "mildew and possibly some static dust on ceiling of butter storage room."
No samples of the finished product were taken for salmonella testing during the October inspection, despite a push by the state to check for the bacteria after a salmonella outbreak was traced to another Georgia peanut butter plant in 2007.
The October report showing only minor violations seems to conflict with conditions observed by at least one former employee, though others said they saw no problems.
Jonathan Prather, who said he worked in the plant's peanut butter room until he and most of the plant's other employees were recently laid off, said he sometimes saw old and soggy peanuts being used and other unsanitary conditions. When he raised concerns about the plant's cleanliness, Prather said he was ignored by managers.
"The only thing they said is, 'We'll handle this, we'll handle the problem,'" he said. "But I don't see that they did because if they had, none of this would have happened."
Another former employee, Jimmy Boozer, said he worked at the plant for six years and never noticed any unsanitary conditions. Co-worker Lewis Smith, who had been working at the plant for about two years, said the plant appeared generally clean. One problem Smith noticed was a roof that leaked for months and continued to leak even after plant managers said it had been repaired.
A leaky roof would likely cause some concern for inspectors: After the 2007 salmonella outbreak was linked to a Georgia peanut butter plant operated by ConAgra Foods Inc., company officials said jars were contaminated when moisture from a roof leak and a malfunctioning sprinkler system mixed with dormant salmonella bacteria in the plant.
Adams, who inspected the plant twice last year, did not come to the door to speak to a reporter who visited her home in southwestern Georgia. A man who identified himself as her husband referred all questions to the state.
Georgia agricultural officials did not immediately return repeated phone calls Friday. Earlier in the week, Agricultural Commissioner Tommy Irvin defended his inspectors, saying they did the best they could with limited manpower and funding.
Irvin said the department has about 60 inspectors responsible for examining 15,000 sites � or 250 food sources per inspector � ranging from ice machines to sprawling factories. Some territories are left uncovered, forcing the state to shift employees from one area to another.
Peanut Corp. did not respond to several requests asking for details of plant operations. The company issued a general statement late Friday that emphasized its top concern continues to be ensuring public safety.
"For Peanut Corporation to engage in any discussion of the facts at this point is premature," the statement said.
The Food and Drug Administration said Friday it had asked the Justice Department to launch a criminal investigation into Peanut Corp., which authorities say shipped products that initially tested positive for salmonella after retesting and getting a negative result.
At least 529 people have been sickened as a result of the outbreak, and at least eight may have died because of it. More than 430 products have been recalled.
The 29-year-old Prather painted a grim picture of the facility, describing managers more concerned with the company's bottom line than with properly cleaning the plant and equipment.

He said both soggy peanuts and peanuts in packages marked with dates showing they were five or six years old were dumped into the production line. The American Peanut Council, an industry trade association, says peanuts need to be kept dry to prevent mold and other risks.

Prather also said a dry roaster at the plant was halted only one day a month for cleaning. Doyle, the food safety expert, said peanut roasters should be cleaned and sanitized at least once a week.

"What they needed to do and what they didn't do is clean up right," said Prather, who noted the plant was sometimes shut down for cleaning on the weekends but said that wasn't enough.

Doyle, who has been asked by the American Peanut Council to help review the industry's practices, said the state would likely have to provide inspectors with "more in-depth training in terms of the really critical areas."

And he said it's a problem that likely spans far beyond Georgia.

"It's something the federal government is going to have to take a lead role on, to develop criteria for different producers," Doyle said. "I think this peanut plant is just an example of the weakness in our system."

___

Greg Bluestein reported from Atlanta.

America abortion debate reaches into African slums

2009-01-31T15:16:00.001-08:00

NAIROBI, Kenya - Nairobi's sprawling Kibera slum is far from America but not from America's battle over abortion.
Aid workers and experts say President Barack Obama's decision to allow aid money to flow again to international groups that offer abortion counseling will help restart programs desperately needed in Africa, the continent hardest hit by a so-called "gag rule."
Dr. Walter Odhiambo, the country director for Marie Stopes Kenya, said his family planning organization had been limping along on European aid because of the U.S. rule Obama overturned on Jan. 23 in one of his first presidential acts. Now, Odhiambo said, he would be applying for U.S. funds he hoped to use to expand counseling and other services, particularly in rural Kenya.
"Family planning was not given the prominence it needs," Odhiambo said.
The policy banned U.S. government money from going to international family planning groups that either offer abortions or provide information, counseling or referrals about abortion. Its critics call it the "global gag rule," because it prohibits funding for groups that lobby to legalize abortion or promote it as a family planning method. That can affect a range of services provided by private groups on a continent where governments can meet few of their citizens' health needs.
"The biggest impact has been in sub-Saharan Africa," said Wendy Turnbull, a researcher for Washington-based Population Action International, which lobbies on family planning issues and applauded Obama's move.
Turnbull applauded the Bush administration for spending millions to fight AIDS and other health threats in Africa, but said the gag rule undermined that effort.
For instance, she said, groups that could have helped distribute the condoms the U.S. was supplying to fight AIDS were denied funding because of their stance on abortion.
"When you are making rules, it's not right to just look at the immediate effects," said Nkandu Luo, a Zambian former minister of health who currently heads her country's independent Society for Women and AIDS. "It's important to look at the long-term implications."
A study by the Washington-based Center for Reproductive Rights said the policy hit hardest in Africa, the fastest growing and poorest continent. Latin Americans and Asians were more likely to accept the ban and keep funding, either because they embraced its intent or relied more on U.S. money, the study concluded.
Clinics serving over 1.5 million women closed in Kenya, homeland of Obama's father, said Marie Stopes Kenya and Family Health Options Kenya. Contraceptive availability in Zambia was reduced. AIDS programs run by family planning groups in Ethiopia were affected.
Even without the U.S. policy, abortions would be controversial here. They are illegal in almost all African countries, many of which have conservative Christian or Muslim populations � one of the reasons women interviewed about their abortions declined to give their full names.
But the laws have simply pushed abortions into back rooms instead of ending the practice.
Marie Stopes Kenya, which does not offer abortions, closed two slum clinics after losing its USAID funding because of its association with Marie Stopes International, one of the world's largest family planning organizations.
Odhiambo, the country director for Marie Stopes Kenya, said it was likely that women who would have used his group's contraceptive services became pregnant instead and joined the 300,000 Kenyan women that Marie Stopes says seek dangerous, illegal abortions each year.
Two years ago, Joyce and her cousin Carolyne went to a Kibera slum clinic for a contraceptive injection. Because supplies were low, the doctor shared one between the two. Joyce, then a shy 18-year-old high school student, became pregnant. Her boyfriend deserted her and she had an illegal abortion.
"The fetus came out but she did not stop bleeding," recalled 29-year-old Carolyne. By the light of a small kerosene lamp, the two women used every sheet and towel in Carolyne's small house to try to stop the blood. Joyce spent the night twisting in pain on the floor, crying out for God to forgive her and screaming for her mother.
At dawn the two women went to a government hospital and had to plead with doctors to treat Joyce without informing police of the abortion.

Dr. Louis Machogo, the pharmacist for another Kenyan family planning group, said politicians may not understand the dilemmas that their policies forced on poor families.

"We are struggling with poverty, health issues, even hunger," he said. "We should let families decide for themselves how many children to have."

The U.S. ban was established by Republican President Ronald Reagan in 1984, ended by Democrat Bill Clinton in 1993 and reinstated by Republican George W. Bush in 2001.

"We now have a challenge, as the representatives of women's groups, (to) make sure that even if we have another president from the Republican party, we don't go back to this rule," said Luo, the ex-minister. "We shouldn't just sit back and celebrate. We need to go out and campaign and get the Republicans to realize the impact of these decisions."

___

Associated Press Writer Donna Bryson in Johannesburg, South Africa contributed to this report.

Make that 14: Octuplet mom already had 6 kids

2009-01-30T15:15:00.001-08:00

WHITTIER, Calif. - How in the world does a woman with six children get a fertility doctor to help her have more � eight more? An ethical debate erupted Friday after it was learned that the Southern California woman who gave birth to octuplets this week had six children already.
Large multiple births "are presented on TV shows as a 'Brady Bunch' moment. They're not," fumed Arthur Caplan, bioethics chairman at the University of Pennsylvania. He noted the serious and sometimes lethal complications and crushing medical costs that often come with high-multiple births.
But Dr. Jeffrey Steinberg, who has fertility clinics in Los Angeles, Las Vegas and New York, countered: "Who am I to say that six is the limit? There are people who like to have big families."
Kaiser Permanente announced the mega-delivery Monday, with delighted doctors saying they had initially expected seven babies and were surprised when the cesarean section yielded an eighth.
Multiple births this big are considered impossible without fertility treatment, but the doctors who delivered the babies would not say whether the 33-year-old woman had used fertility drugs or had embryos implanted in her womb.
However, the children's grandmother, Angela Suleman, was quoted as telling the Los Angeles Times that her daughter had embryos implanted last year, and never intended to give birth to eight, but "they all happened to take." Suleman said her daughter rejected an offer from doctors to abort some of the embryos.
More common among younger women is the use of fertility drugs that stimulate egg production; doctors are supposed to monitor budding eggs and stop the drugs if too many develop.
Some medical experts were disturbed to hear that the woman was offered fertility treatment, and troubled by the possibility that she was implanted with so many embryos.
Dr. David Adamson, former president of the American Society of Reproductive Medicine, said he was bracing for some backlash against his specialty.
In 30 years of practice, "I have never provided fertility treatment to a woman with six children," or ever heard of a similar case, said Adamson, director of Fertility Physicians of Northern California.
Women seeking fertility treatment are routinely asked to give a detailed history of prior pregnancies and births, and "it's a very realistic question to ask about someone who has six children: How does this fit into the concept of requiring fertility treatment?" Adamson said.
The woman's fertility doctor has not been identified. The hospital has not released the mother's name, citing her desire for privacy. There was no immediate information on whether she is married or who the father of the babies is. Her six other children range in age from 2 to 7.
Records show that she held a psychiatric technician's license from 1997 to 2002. It was unclear whether she is now employed.
It was only the second time in U.S. history that eight babies survived more than a few hours after birth. The six boys and two girls were said to be in remarkably good condition but were expected to remain in the hospital for several more weeks.
The mother of the octuplets lives with her parents in a modest, single-story home on a quiet cul-de-sac in Whittier, a Los Angeles suburb of about 85,000. Children's bicycles, a pink car and a wagon were scattered in the yard and driveway.
On Thursday night, the children's grandfather came to the door and angrily told reporters to leave the property.
Court records show Angela Suleman filed for bankruptcy last March, but after she failed to make required payments and appear at a creditors' meeting, the case was dismissed. She reported liabilities of $981,371, mostly money owed on two houses she owns in Whittier.
The births were a hot topic of conversation on the Internet, with many people incredulous that a woman with six children would try to have more � and that a doctor would help her do so. Some criticized the doctor and suggested that the mother would be overwhelmed trying to raise her brood and would end up relying on public support.

Jessica Zepeda, who identified herself as a friend of the mother, said the woman and family would have enough money to raise 14 children. "She is not on welfare," Zepeda said. "She is an awesome mom, and will be able to take care of her babies."

Several doctors said it is not their role to dictate family size.

"I am not a policeman for reproduction in the United States. My role is to educate patients," said Dr. James Grifo, professor of obstetrics and gynecology at the New York University School of Medicine.

But Caplan said not enough attention is paid to the well-being of the children in high-multiple births. Such babies are often premature and underdeveloped, and are almost always found to have some health problem.

Caplan said everyone has a stake in mega-multiple births because they cause insurance premiums to rise when hospitals cannot get reimbursed for the huge costs such babies incur, and because those with disabilities typically require social services.

"To say all you need is cash and the will to have more kids should not be a sufficient standard to access services," he said. "It is insufficient for adoption. It isn't sufficient to be a foster parent. Why would it be sufficient to run down to the fertility clinic to get embryos transplanted or super-ovulated?"

A few years ago, Caplan and others did a survey of U.S. fertility clinics. They found few had policies for deciding whether to help a woman get pregnant. Most clinics said they had patients meet with financial coordinators, but only 18 percent had them see a social worker or psychologist.

With in vitro fertilization, doctors frequently implant more than one embryo to improve the odds that one will take. Mothers-to-be who are found to be pregnant with several babies are given the option of aborting some of them to increase the chances the others will survive.

The U.S. fertility industry has guidelines on how many embryos doctors can implant, with the number varying by age and other factors. The guidelines call for no more than one or two for a generally healthy woman under 35, and no more than three to five, depending on the embryos' maturity, for women over 40.

If eight embryos were implanted at once, that is "well beyond our guidelines," Dr. R. Dale McClure, president of the reproductive medicine society, said in a statement.

Clinics that clearly violate guidelines can be kicked out of another group, the Society for Assisted Reproductive Technology, which in turn affects whether insurance covers their services. But the guidelines do not have the force of law.

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Thomas Watkins reported from Whittier, while Medical Writer Lauran Neergaard reported from Washington. AP writers Alicia Chang and Jacob Adelman in Los Angeles and Medical Writer Maria Cheng in London contributed to this story.

Peanut plant problem forces fresh recall

2009-01-29T15:11:00.001-08:00

WASHINGTON - Worried about salmonella, the Army said Thursday it's removing some peanut butter items from warehouses in Europe, the latest in an ever-growing list of recalled peanut products linked to a national salmonella outbreak.
Already more than 430 kinds of cakes, cookies and other goods in the civilian world have been pulled off store shelves in what the Food and Drug Administration is calling one of the largest product recalls in memory. The Army's recall does not affect Meals-Ready-to-Eat, but another kind of military grub called Unitized Group Rations-A, which provide a complete 50-person meal.
More than 500 people have gotten sick in the U.S. outbreak, and at least eight may have died as a result of salmonella infection.
At the center of the investigation is a Georgia peanut processing plant where federal inspectors reported finding roaches, mold, a leaking roof and other sanitary problems.
Managers at the Blakely, Ga., plant owned by Peanut Corp. of America continued shipping peanut products even after they were found to contain salmonella, the FDA said. The company shipped the food items after retesting them and getting negative results.
Peanut Corp. expanded its recall Wednesday to all peanut goods produced at the plant since Jan. 1, 2007. The company makes just 1 percent of the peanut products sold in the United States, but those products are ingredients in hundreds of other foods, from ice cream, to Asian-style sauces, to dog biscuits. Major national brands of peanut butter are not affected.
A senior lawmaker in Congress and Georgia's agriculture commissioner called for a criminal probe of the company, but the FDA said that would be premature while its own food safety investigation continues.
The company says it is fully cooperating with the government and has stopped all production at the plant. Peanut Corp. said in a statement it "categorically denies any allegations that the company sought favorable results from any lab in order to ship its products."
Stewart Parnell, the firm's president, said that the recall was expanded out of an abundance of caution.
"We have been devastated by this, and we have been working around the clock with the FDA to ensure any potentially unsafe products are removed from the market immediately," Parnell said.
Most of the older products in the expanded recall have probably been eaten already. Officials said they see no signs of any earlier outbreaks from those goods.
The recall covers peanut butter, peanut paste, peanut meal and granulated products, as well as all peanuts � dry and oil roasted � shipped from the factory. FDA officials could not quantify the amount of products being recalled.
Officials recommend that consumers check the FDA web site, which lists all the products being recalled, and toss out any that are named.
Salmonella had been found previously at least 12 times in products made at the plant, but production lines were never cleaned after internal tests indicated contamination, FDA inspectors said in a report. Products that initially tested positive were retested. When the company got a negative reading, it shipped the products out.
That happened as recently as September. A month later, health officials started picking up signals of the salmonella outbreak.
Michael Rogers, a senior FDA investigator, said it's possible for salmonella to hide in small pockets of a large batch of peanut butter. That means the same batch can yield both positive and negative results, he said. The products should have been discarded after they first tested positive.
Separately, senior congressional and state officials on Wednesday called for a federal probe of possible criminal violations at the plant.
The company's actions "can only be described as reprehensible and criminal," said Rep. Rosa DeLauro, D-Conn., who oversees FDA funding. "This behavior represents the worst of our current food safety regulatory system."

In Georgia, the state's top agriculture official joined DeLauro in asking the Justice Department to determine whether the case warrants criminal prosecution.

"They tried to hide it so they could sell it," said Georgia Agriculture Commissioner Tommy Irvin. "Now they've caused a mammoth problem that could destroy their company � and it could destroy the peanut industry."

___

On the Net:

FDA's recall page: http://tinyurl.com/8srctw

Study: Kidney donors do fine, no long-term issues

2009-01-28T14:54:00.001-08:00

NEW YORK - Donating a kidney doesn't appear to have any long-term health consequences for the donor, a reassuring study shows. Researchers at the University of Minnesota found those who gave up one of their two kidneys lived a normal life span and were as healthy as people in the general population. The donation also didn't raise the risk of having kidney failure later.
Kidney donation has generally been considered safe, although with surgery, there are always risks. The new research of nearly 3,700 donors dating back more than four decades is the largest and longest study to look at long-term outcomes, said the researchers. They reported their findings in Thursday's New England Journal of Medicine.
"It is a confirmation that living donation is a safe thing," said Dr. Matthew Cooper, a transplant surgeon at the University of Maryland, who was not involved in the research.
Kidneys filter waste and excess fluid from the blood. If your kidneys fail, the options are dialysis or a transplant. More than 78,000 people are on the national waiting list to receive a kidney from a deceased donor. The need for kidneys has soared with the rise in diabetes and obesity and the wait can last for years.
Living donation has increased as more people became willing to donate and newer surgery techniques shortened recovery time. In 2007, more than a third of the 16,629 kidneys transplanted in the U.S. came from living donors, according to the United Network for Organ Sharing.
Dr. Hassan Ibrahim, the study's leader, and his colleagues wanted to find out what happened to the 3,698 people who had donated a kidney at the university since 1963. They tried to contact everyone and used government records to find out who had died. A group of 255 donors was randomly selected to have kidney and other tests. Results were compared with health outcomes for the general population.
Overall, 268 of the donors died, which the researchers said was comparable to survival in the general population. Eleven donors developed kidney failure decades later and needed dialysis or a transplant. The researchers said the rate of kidney failure in the donors was lower than that reported in the general population.
Most of the donors tested had good kidney function and reported an excellent quality of life, the study found.
The good outcomes likely reflect the strict criteria used to pick the donors, the researchers said. The donors had to be healthy with no kidney problems, and be free of high blood pressure and diabetes � two main causes of kidney disease.
Ibrahim said he hopes the results will increase donations and encourage transplant centers to continue to carefully select donors and not relax their requirements.
"We think these donors do extremely well because they were screened very well," said Ibrahim.
While there are no regulations for selecting living donors, the transplant network offers guidelines, said Cooper, who heads a UNOS committee on living donors. He said any kidney donor who later needs a transplant is given priority on the waiting list.
"There is a recognition of the sacrifice that these people have made," Cooper said.
Drs. Jane Tan and Glenn Chertow, of Stanford University School of Medicine, who wrote an accompanying editorial in the journal, noted that the study donors were mostly white and were likely younger than donors today. The results may not apply to older, nonwhite donors, they said.
The value of the study is its large size and duration, Tan said.
"We always have to be careful when it comes to potential harm to another individual," she said. "This study is very reassuring."
The University of Minnesota is part of a similar, ongoing study with other transplant centers that will have a larger and more diverse donor group, Ibrahim said.
One of the study donors said she didn't worry about potential problems when she gave a kidney to her oldest brother in 1983.

"I really didn't think too much past that," said Susan Kivi, 52, of Roseville, Minn. "He just deserved another chance to live a normal life."

Her recovery from surgery was a little harder than she expected, said Kivi. But she hasn't had any health problems related to giving up a kidney since then. Her brother died about four years later.

"It was worth it. He got a few good years," she said.

___

On the Net:

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

UNOS: http://www.unos.org

Doctors say newborn octuplets appear healthy

2009-01-27T14:59:00.000-08:00

BELLFLOWER, Calif. - Newborn octuplets in Southern California are a feisty bunch that appear healthy even at nine weeks premature, a doctor said Tuesday.
Three babies are being given oxygen but appeared to be doing well, said Dr. Mandhir Gupta, a neonatologist at Kaiser Permanente Bellflower Medical Center. Two of the newborns were initially on ventilators but no longer need them.
At least four could be ready for their first oral feeding later Tuesday.
"All babies were delivered vigorous, crying, kicking. Everyone was very excited," said Dr. Karen E. Maples, chief of service for obstetrics and gynecology and the physician who personally delivered Baby No. 8.
The mother, who has not been identified, gave birth Monday to the six boys and two girls weighing between 1 pound, 8 ounces, and 3 pounds, 4 ounces. She was resting comfortably Tuesday and was elated at welcoming eight children to her family, Gupta said.
The eighth baby surprised the parents and doctors who had prepared to deliver seven children.
"It is quite easy to miss a baby when you're anticipating seven," said Dr. Harold Henry, chief of maternal and fetal medicine and one of 46 doctors, nurses and assistants who delivered the children by Caesarean section.
Two of the newborns � the second live octuplets born in U.S. history � were initially put on ventilators but were later removed.
The mother checked into the hospital in her 23rd week of pregnancy. Hospital officials would not say whether she had used fertility drugs, which make multiple births more likely.
The babies � dubbed with the letters A-through-H � will probably remain in the hospital for at least two months and the mother could be released in a week.
The world's first live octuplets were born in March 1967 in Mexico City, but all died within 14 hours, according to Encyclopedia Britannica.
The United States' first live octuplets were born in Houston in 1998, three months premature. The tiniest died a week after the birth. The surviving siblings turned 10 in December.
___
Associated Press writers Raquel Maria Dillon and Alicia Chang in Los Angeles contributed to this report.
(This version CORRECTS which doctor described babies kicking and crying.)

How to help when smoking, alcohol complicate PTSD

2009-01-26T15:01:00.001-08:00

WASHINGTON - Reaching for a cigarette to cope with a flashback is all too common among sufferers of post-traumatic stress disorder. The nicotine hit may feel good but scientists say its brain action probably makes their PTSD worse in the long run.
Here's the rub: At least half of PTSD sufferers smoke, and others wind up dependent on alcohol, anti-anxiety pills, sometimes even illegal drugs. Yet too few clinics treat both PTSD and addictions at the same time, despite evidence they should.
Now studies are recruiting PTSD patients � from New England drug-treatment centers to veterans clinics in North Carolina and Washington � to determine what combination care works.
"It's kind of a clinical myth that you can only do one at a time or should only do one at a time," says Duke University PTSD specialist Dr. Jean Beckham, a psychologist at the Durham, N.C., Veterans Affairs Medical Center. "Everybody's afraid to have their patients quit smoking because they're afraid they're going to get worse. There's not a lot of empirical data about that."
And her research on how to break the nicotine-and-PTSD cycle raises a provocative question for a tobacco-prone military: Are people at higher risk of developing PTSD if they smoke before they experience the violent event or episode?
Post-traumatic stress disorder � which can include flashbacks, debilitating anxiety, irritability and insomnia � is thought to affect nearly 8 million Americans at any given time. Anyone can develop it after a terrifying experience, from a mugging to a hurricane, a car crash to child abuse. But PTSD is getting renewed attention because so many veterans returning from combat in Iraq and Afghanistan seem vulnerable. A study last year by the RAND Corp. research organization estimated nearly 20 percent of them, or 300,000 people, have symptoms of PTSD or major depression.
What's less discussed is that patients often don't realize they might have PTSD and try to relieve symptoms by self-medicating with alcohol, tobacco and other substance use � worsening habits that existed before the trauma or starting anew.
Addiction itself is a mental health disorder that causes changes in some of the same brain areas disrupted by mood and anxiety disorders like PTSD, says a new report on the co-illnesses from the National Institute on Drug Abuse. That argues for simultaneous treatment. Indeed, up to 60 percent of people in addiction treatment are estimated to have PTSD � although they seldom acknowledge symptoms � and they're three times more likely than other patients to drop out.
A handful of studies suggest combo care helps. One example: VA researchers in Connecticut gave the alcoholism drugs naltrexone and disulfiram to PTSD patients, and watched not only their drinking ease but their PTSD symptoms improve, too.
Then there's nicotine. It temporarily enhances attention when it hits the brain � one reason that members of military tell the VA's Beckham they smoke. Although PTSD patients say a cigarette helps their mood when they're having symptoms, the extra attention may be reinforcing bad memories.
"If you think about your traumatic event and you smoke your cigarette, you can think about it even better," explains the VA's Beckham.
Yet the NIDA report found combination care rare, partly because of our specialty-driven health system.
Another big reason: "The majority of people with PTSD don't seek treatment," Dr. Mark McGovern of Dartmouth Medical School told a NIDA meeting this month that brought together military and civilian experts to jump-start research.
"People try to swallow it or take care of it on their own and it just kind of gets out of control," agrees Bryan Adams, 24, who is working with the Iraq and Afghanistan Veterans of America to raise PTSD awareness.
Adams, now a business major at Rutgers University, was awarded a Purple Heart after being shot when his Army patrol was ambushed in Iraq in 2004. Back home he handled restlessness and irritability with increasing alcohol use. Only when he got into college did a checkup lead to a PTSD diagnosis and therapy. He quit excessive drinking as the PTSD improved, despite no formal alcohol treatment.
The new studies may prompt more merging of care:
_In Durham, Beckham is giving PTSD-suffering smokers either a nicotine patch or a dummy patch to wear for three weeks before they quit smoking. The theory: Steady nicotine release will blunt a cigarette's usually reinforcing hit to the brain, possibly helping both withdrawal symptoms and the intensity of PTSD symptoms.
_In some New Hampshire and Vermont substance-abuse clinics, McGovern is randomly assigning patients to standard addiction-only care or cognitive behavioral therapy traditionally used for PTSD. A pilot study found the cognitive behavioral therapy improved both PTSD symptoms and substance use.

_In Seattle, researchers at the VA Puget Sound Health Care System have PTSD therapists conducting smoking cessation therapy in the same visit. In a pilot study, those patients were five times more likely to quit cigarettes than PTSD patients sent to separate smoking programs.

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

High-tech sensors help seniors live independently

2009-01-24T14:46:00.001-08:00

COLUMBIA, Mo. - After back-to-back hospital visits for congestive heart failure, Eva Olweean figured her health was back to normal. But the nurses at her retirement home knew better: Motion sensors in the 86-year-old's bed detected too many restless nights.
Tiny sensors hover unobtrusively over the toilet, shower and doorways to detect Olweean's movements inside her apartment. Pneumatic tubes tucked in the mattress and beneath her easy chair measure weight shifts. Caregivers and researchers at the University of Missouri-Columbia study the data, noting changes in behavior that could signal medical problems.
Recognizing the coming "silver tsunami" of graying baby boomers, tech companies are racing to help aging Americans spend more time living independently instead of in nursing homes. For the first time earlier this month, the International Consumer Electronics Show in Las Vegas featured a special section devoted to high-tech senior living.
Among the advances at the show were motion sensors, the kind that allowed Olweean's nurses to figure out what was keeping her up at night. She was experiencing excessive bloating, a common symptom of congestive heart failure. So Olweean's cardiologist prescribed diuretics and made other adjustments to her medication that helped the woman again sleep soundly.
"We try to identify when those small problems occur, so we can fix them before they become big problems," said Marjorie Skubic, an electrical and computer engineering professor who works with Sinclair School of Nursing researchers on the aging-in-place project.
At Oatfield Estates in the Portland suburb of Milwaukie, Ore., resident movements in the private retirement home are tracked by what employees call "bed bugs." Those are embedded motion sensors that detect when someone's behavior could trigger a medical alert.
Sensors like those, "smart carpets" and other tracking devices will be the norm in both private homes and group settings within the next decade, said Jason Hess, chief executive officer of Elite Care, the Portland company that owns Oatfield Estates. He said that will especially be true as insurers start embracing the cost-saving devices.
"You will see a lot more places implementing these," he said. "It comes down to cost, and out-of-the-box thinking."
At the Las Vegas show, on display were talking pill boxes that remind seniors to take their medicine at regular intervals, and which can notify out-of-town caregivers if that doesn't happen. There were robotic companion pets that mimic the real thing for lonely seniors in need of a psychological boost.
"We're talking about an important paradigm shift in how we think about aging," said Majd Alwan, director of the Washington-based Center for Aging Services Technologies. Alwan led a panel discussion on smart-home technology at the Las Vegas event.
Delaying institutionalization by a year or more, is a significant financial savings, he added. "Let alone the benefits in quality of life for the senior and for the caregiver."
Alwan previously led the eldercare technology unit of the University of Virginia's Medical Automation Research Center, which developed the passive sensor technology used in Missouri.
Unlike medical warning badges worn by seniors, the motion sensors' success doesn't depend on the cooperation of patients. Elderly people can be prone to forget the badges when dressing, or who might resist the devices as too obtrusive, said University of Missouri nursing professor Marilyn Rantz.
"Our intent with this project was to incorporate (it) into their daily lives � and make it invisible to their daily lives," she said.
Olweean, a retired factory worker, said she barely notices the sensors.
"I don't even know they're here half the time," she said.
Fifteen of the 35 residents at her apartment complex take part in the motion sensor research project. The complex is named Tiger Place after the University of Missouri mascot and is owned by the university, though managed by a private company.
Researchers there are also fine-tuning a more advanced monitoring system using virtual-reality silhouette images to allow observation of posture, gait and other movements. The silhouettes are considered a preferred alternative to more invasive video cameras.

Rantz, Alwan and other experts acknowledge that rapid technological advances in elder care must be balanced with privacy protections. That dilemma concerns Fredda Vladeck, executive director of the United Hospital Fund's Aging in Place Initiative.

"Technology does have a role to play," she said. "It's a tool, not the answer."

___

On the Net:

Center for Aging Services Technologies: http://www.agingtech.org/index.aspx

MU Interdisciplinary Center on Aging, Tiger Place: http://www.aging.missouri.edu/programs/tigerplace.php

US approves 1st stem cell study for spinal injury

2009-01-23T14:43:00.001-08:00

NEW YORK - A U.S. biotech company says it plans to start this summer the world's first study of a treatment based on human embryonic stem cells � a long-awaited project aimed at spinal cord injury.
The company gained federal permission this week to inject eight to 10 patients with cells derived from embryonic cells, said Dr. Thomas Okarma, president and CEO of Geron Corp. of Menlo Park, Calif.
The patients will be paraplegics, who can use their arms but can't walk. They will receive a single injection within two weeks of their injury.
The study is aimed at testing the safety of the procedure, but doctors will also look for signs of improvement like return of sensation or movement in the legs, Okarma said.
Whatever its outcome, the study will mark a new chapter in the contentious history of embryonic stem cell research in the United States � a field where debate spilled out of the laboratory long ago and into national politics.
While some overseas doctors claim to use human embryonic stem cells in their clinics, stem cell experts said they knew of no previous human studies that use such cells.
"It's a milestone and it's a breakthrough for the field" because Geron passed the safety hurdles for getting federal clearance to launch the study, said Ed Baetge, chief scientific officer of Novocell Inc. His company hopes to begin a similar human study for treating diabetes in a few years.
In addition, said spinal cord injury researcher Dr. Wise Young of Rutgers University, "a lot of hope of the spinal cord injury community is riding on this trial."
Embryonic stem cells can develop into any cell of the body, and scientists have long hoped to harness them for creating replacement tissues to treat a variety of diseases. But research has been controversial because embryos must be destroyed to obtain them.
President Barack Obama has promised to relax the Bush administration's restrictions on federal financing for such research. But Obama's ascent to the White House had nothing to do with the U.S. Food and Drug Administration's granting permission for the new study, Okarma said in a telephone interview Thursday.
In fact, the company says, the project involves stem cells that were eligible for federal funding under Bush, although no federal money was used to develop the experimental treatment or to pay for the human study.
Other human cells, called adult stem cells, have been tested before in people to treat heart problems, for example.
In the Geron study, the injections will be made in the spine at the site of damage. The work will be done in four to seven medical centers around the country, Okarma said.
Animal studies suggest that once injected, the cells will mature and repair what is essentially a lack of insulation around damaged nerves, and also pump out substances that nerves need to function and grow.
Apart from assessing safety, investigators will hope to see some signs of improvement in the patient, Okarma said. The idea is "not to make somebody ... get up and dance the next day," he said, but rather to provide some level of ability that can be improved by physical therapy.
Each patient will receive a low dose of anti-rejection drugs for about two months, because after that time the medications shouldn't be needed, Okarma said. The study will follow each patient for at least a year.
Okarma said he can't estimate how much such a therapy would cost if it proves effective, but that "this is not going to be a $500,000 price tag. It will be remarkably affordable ... in the context of the value it provides."
Evan Snyder, a stem cell researcher at the Burnham Institute for Medical Research in La Jolla, Calif., said scientists in the field will focus chiefly on the study's results about safety.

"The one hope that everybody has is that nothing bad happens," he said.

Geron Corp. has spent at least $100 million on human embryonic stem cell research. Founded in 1992, it does not have any therapies on the market.

However, the company is considered the world's leading embryonic stem cell developer thanks to its claims on several key stem cell technologies. Geron helped finance researchers at the University of Wisconsin who first isolated human embryonic stem cells in 1998. The company has retained exclusive rights on several of those cell types.

___

On the Net:

Geron Corp.: http://www.geron.com/

CDC study: Kentucky has highest smoking death rate

2009-01-22T14:47:00.001-08:00

ATLANTA - Kentucky and West Virginia � where people traditionally smoke the most � have the highest death rates from smoking, a new federal study has found.
Rounding out the 10 states with the highest average annual smoking death rates were Nevada, Mississippi, Oklahoma, Tennessee, Arkansas, Alabama, Indiana and Missouri.
The lowest death rates were in Utah and Hawaii, according to the U.S. Centers for Disease Control and Prevention study.
The smoking death rate in Kentucky was about 371 deaths out of every 100,000 adults age 35 and older.
That was nearly one-and-a-half times higher than the national median of 263 per 100,000. And it was nearly three times the rate for Utah, which was 138 per 100,000.
The smoking death rates were calculated using death certificate data from the years 2000 through 2004, focusing on lung cancer and 18 other diseases caused by cigarette smoking.
The rates track pretty closely with the adult smoking rates in each state. Kentucky and West Virginia had the highest smoking rates in 2004 as well.
But obesity and other problems that trigger heart disease are also factors. Smoking, added to those problems, "is like gasoline on the fire," said Terry Pechacek, a CDC senior scientist for tobacco-related issues.
For every state, the annual number of smoking deaths was higher among males than females. However, rates declined in men in 49 states since the late 1990s, but declined in women in only 32 states.
The report is published this week in the CDC's Morbidity and Mortality Weekly Report.
___
On the Net:
The CDC publication: http://www.cdc.gov/mmwr

Study: Cleaner air adds 5 months to US life span

2009-01-21T14:26:00.000-08:00

LOS ANGELES - Cleaner air over the past two decades has added nearly five months to average life expectancy in the United States, according to a federally funded study. Researchers said it is the first study to show that reducing air pollution translates into longer lives.
Between 1978 and 2001, Americans' average life span increased almost three years to 77, and as much as 4.8 months of that can be attributed to cleaner air, researchers from Brigham Young University and Harvard School of Public Health reported in Thursday's New England Journal of Medicine.
Some experts not connected with the study called the gain dramatic.
"It shows that our efforts as a country to control air pollution have been well worth the expense," said Dr. Joel Kaufman, a University of Washington expert on environmental health.
Scientists have long known that the grit in polluted air, or particulates, can lodge deep in the lungs and raise the risk of lung disease, heart attacks and strokes. The grit � made of dust, soot and various chemicals � comes from factories, power plants and diesel-powered vehicles.
In 1970, Congress passed a revised Clean Air Act that gave the Environmental Protection Agency the power to set and enforce national standards to protect people from particulate matter, carbon monoxide and other pollutants.
The law is widely credited with improving the nation's air quality through such things as catalytic converters on cars and scrubbers at new factories.
For the study, scientists used government data to track particulate pollution levels over two decades in 51 U.S. cities. They compared these changes to life expectancies calculated from death records and census data. They adjusted the results to take into account other things that might affect life expectancy, such as smoking habits, income, education and migration.
On average, particulate matter levels fell from 21 micrograms per cubic meter of air to 14 micrograms per cubic meter in the cities studied. At the same time, Americans lived an average 2.72 years longer.
"We saw that communities that had larger reductions in air pollution on average had larger increases in life expectancies," said the study's lead author, C. Arden Pope III, a Brigham Young epidemiologist.
Pittsburgh and Buffalo, N.Y., which made the most progress cleaning up their air, saw life spans increase by about 10 months. Los Angeles, Indianapolis and St. Louis were among the cities that saw gains in life expectancy of around five months.
The study was partly funded by the Centers for Disease Control and Prevention and EPA.
"This finding provides direct confirmation of the population health benefits of mitigating air pollution," Daniel Krewski, who does pollution research at the University of Ottawa in Canada, wrote in an accompanying editorial.
Last year, government researchers reported that U.S. life expectancy has surpassed 78 years for the first time. They attributed the increase to falling mortality rates for nine of the 15 leading causes of death, including heart disease, cancer, accidents and diabetes.
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On the Net:
New England Journal: http://www.nejm.org

General Mills and Kroger pull peanut butter items

2009-01-20T14:16:00.001-08:00

MILWAUKEE - General Mills Inc. and grocers Kroger Co. and Safeway Inc. have joined the growing list of food companies and retailers pulling items made with peanut butter amid a salmonella outbreak.
The Food and Drug Administration has traced the outbreak to a Georgia plant owned by Peanut Corp. of America, which makes peanut butter and peanut paste and sells it to institutions and food companies. The outbreak may have contributed to the deaths of six people and sickened more than 470 others in 43 states.
The government has advised consumers to avoid eating cookies, cakes, ice cream and other foods containing peanut butter until health officials learn more about the contamination. Peanut butter sold in jars to consumers is not included, officials said.
The FDA has created a searchable list of recalled products and brands on the agency's Web site.
The Centers for Disease Control and Prevention said the bacteria behind the outbreak is common and not an unusually dangerous strain but that the elderly or those with weakened immune systems are more at risk. At least five of the six people who died were elderly. All had salmonella when they died, though their exact causes of death haven't been determined.
The salmonella outbreak is the second in two years involving peanut butter. Salmonella is the nation's leading cause of food poisoning; common symptoms include diarrhea, fever and abdominal cramps.
Peanut Corp. expanded its own recall Sunday to all peanut butter and peanut paste produced since July 1 at its plant in Blakely, Ga. The recalled products were distributed to institutions, food service industries and private label food companies in 24 states.
"We deeply regret that this product recall has expanded, and our first priority is to protect the health of our customers," said Stewart Parnell, president of Peanut Corp.
Late Monday, Safeway said some of the products it makes, including Ready Pack Eating Right Kids Apples with Peanut Butter and Orchard Valley Harvest's Organic Bark Peanut Butter Cookies and Cream, may use peanut butter involved in the recall and asked customers to throw them out or return them to the store for a full refund.
Kellogg Co. recalled 16 cracker and cookie products last week. The company said Monday that federal authorities have confirmed that salmonella was found in a single package of its peanut butter crackers: Austin Quality Foods Toasty Crackers with Peanut Butter, which had previously been recalled.
Other recently recalled items that contain peanut butter:
• Grocer Meijer, which operates 181 stores in Michigan, Indiana, Illinois, Ohio and Kentucky: Meijer brand Cheese and Peanut Butter and Toasty Peanut Butter crackers, Peanut Butter and Jelly and Peanut Butter Cup ice cream.
• Kroger, the nation's largest traditional grocery chain: Private Selection Peanut Butter Passion Ice Cream sold in stores named City Market, Fred Meyer, Fry's, King Scoopers, QFC and Smith's in 11 states, primarily in the West. The company said the ice cream was not sold in its namesake Kroger stores or any other retailers it operates.
• General Mills: two flavors of snack bars, LARABAR Peanut Butter Cookie and JamFrakas Peanut Butter Blisscrisp.
• Clif Bar & Co.: Some Clif branded bars, including some under Luna and Clif Mojo labels.
• Abbott Nutrition: ZonePerfect Chocolate Peanut Butter bars, ZonePerfect Peanut Toffee bars and NutriPals Peanut Butter Chocolate nutrition bars. The items are sold in the U.S., Mexico, New Zealand and Singapore.
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On the Net:

FDA: http://www.fda.gov

Peanut Corp.: http://www.peanutcorp.com

Study: Women less able to suppress hunger than men

2009-01-19T15:23:00.001-08:00

WASHINGTON - Faced with their favorite foods, women are less able than men to suppress their hunger, a discovery that may help explain the higher obesity rate for females, a new study suggests. Researchers trying to understand the brain's mechanisms for controlling food intake were surprised at the difference between the sexes in brain response.
Gene-Jack Wang of Brookhaven National Laboratory and colleagues were trying to figure out why some people overeat and gain weight while others don't.
They performed brain scans on 13 women and 10 men, who had fasted overnight, to determine how their brains responded to the sight of their favorite foods. They report their findings in Tuesday's edition of Proceedings of the National Academy of Sciences.
"There is something going on in the female," Wang said in a telephone interview, "the signal is so much different."
In the study, participants were quizzed about their favorite foods, which ranged from pizza to cinnamon buns and burgers to chocolate cake, and then were asked to fast overnight.
The next day they underwent brain scans while being presented with their favorite foods. In addition, they used a technique called cognitive inhibition, which they had been taught, to suppress thoughts of hunger and eating.
While both men and women said the inhibition technique decreased their hunger, the brain scans showed that men's brain activity actually decreased, while the part of women's brains that responds to food remained active.
"Even though the women said they were less hungry when trying to inhibit their response to the food, their brains were still firing away in the regions that control the drive to eat," Wang said.
Nora Volkow, director of the National Institute on Drug Addiction and a co-author of the paper, said the gender difference was a surprise and may be because of different nutritional needs for men and women, although she stressed that idea is speculative.
Because the traditional role of the female is to provide nutrition to children, the female brain may be hard-wired to eat when foods are available, she said. The next step is to see if female hormones are reacting directly with those specific parts of the brain.
"In our society we are being constantly being bombarded by food stimulus," she said in a telephone interview, so understanding the brain's response can help in developing ways to resist that stimulus.
Eric Stice, an expert on eating disorders at the Oregon Research Institute, called the findings provocative.
"I think it is very possible that the differences in hunger suppression may contribute to gender differences in eating disorders and that they are likely linked to gender differences in estrogen and related hormones," said Stice, who was not part of Wang's research team.
According to the Centers for Disease Control and Prevention, 35.3 percent of American women and 33.3 percent of men were considered obese in 2006.
Rosalyn Weller, a professor of psychology at the University of Alabama-Birmingham, said she was surprised by the results and "thought the dissociation between subjective reports of hunger and brain activation in women but not men was very interesting."
The results suggest that training in reducing food desires or in reacting to food cues could be effective treatments to combat obesity, said Weller, who was not part of the research team.
Weller was a co-author of a recent paper in the journal NeuroImage that studied women's brains when participants were shown pictures of food. They found that obese women had a much stronger reaction than normal-weight women in brain regions related to reward.
Wang noted that behavioral studies have shown that women have a higher tendency than men to overeat when presented with tasty food or under emotional distress.

This may result from differences in sex hormones, he said, and further research is planned to see if that is the case.

Alice H. Lichtenstein, an expert in eating behavior at Tufts University, called Wang's research "very interesting ... I hope to see more like it."

But, she added, a lot of different factors figure in what and when we eat.

"As we learn more about the different factors that go into making that decision we'll be better at helping people regulate" their eating, said Lichtenstein, who was not part of the research team.

Obesity has been increasing and Wang also suggested that another part of the reason is changes in society.

While food choices were seasonal and more limited for our ancestors, choices today are wider and the food is so tempting, he said.

"You go to the buffet, you see the food, you want it," Wang went on. "Some people go to the buffet, they don't eat so much, some do. There is something different in the people."

The study was funded by the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and by the General Clinical Research Center of Stony Brook University.

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On the Net:

PNAS: http://www.pnas.org

Study: Women less able to suppress hunger

2009-01-19T14:20:00.001-08:00