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FDA reversal OKs morphine painkiller for dying

noreply@blogger.com (Unknown) — Fri, 10 Apr 2009 02:17:00 +0000

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.

___

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

noreply@blogger.com (Unknown) — Thu, 09 Apr 2009 02:18:00 +0000

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.

___

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

noreply@blogger.com (Unknown) — Wed, 08 Apr 2009 02:25:00 +0000

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

noreply@blogger.com (Unknown) — Tue, 07 Apr 2009 02:08:00 +0000

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.

___

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

noreply@blogger.com (Unknown) — Sat, 04 Apr 2009 01:24:00 +0000

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

noreply@blogger.com (Unknown) — Fri, 03 Apr 2009 01:18:00 +0000

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.

___

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

1 in 5 Medicare patients readmitted within month

noreply@blogger.com (Unknown) — Thu, 02 Apr 2009 01:09:00 +0000

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.
___

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

noreply@blogger.com (Unknown) — Wed, 01 Apr 2009 22:08:00 +0000

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

noreply@blogger.com (Unknown) — Wed, 01 Apr 2009 01:08:00 +0000

TERRA BELLA, Calif. - It could take weeks before health officials know exactly which pistachio products may be tainted with salmonella, but they've already issued a sweeping warning to avoid eating the nuts or foods containing them.
The move appears to indicate a shift in how the government handles food safety issues � from waiting until contaminated foods surface one-by-one and risking that more people fall ill to jumping on the problem right away, even if the message is vague.
Officials wouldn't say if the approach was in response to any perceived mishandling of the massive peanut recall that started last year, only that they're trying to keep people from getting sick as new details surface about the California plant at the center of the pistachio scare.
"What's different here is that we are being very proactive and are putting out a broad message with the goal of trying to minimize the likelihood of consumer exposure," said Dr. David Acheson, FDA's assistant commissioner for food safety. "The only logical advice to consumers is to say 'OK consumers, put pistachios on hold while we work this out. We don't want you exposed, we don't want you getting salmonella.'"
Dr. Joshua Sharfstein, the president's new acting commissioner who started Monday, made it clear staff needed to move quickly, Acheson said.
The agency announced Monday that Setton Pistachio of Terra Bella Inc., the second-largest pistachio processor in the nation, recalled more than 2 million pounds of its roasted pistachios.
Suspect nuts were shipped as far away as Norway and Mexico, Acheson said Tuesday. One week after authorities first learned of the problem, they still had little idea what products were at risk, he said.
As federal health inspectors take swabs inside the plant to try to identify a salmonella source, a whole range of products from nut bars to ice cream and cake mixes remain in limbo on grocery shelves.
Company officials said Tuesday they suspected their roasted pistachios may have been contaminated by salmonella-tainted raw nuts they were processed with at the hulking facility.
Roasting is supposed to kill the bacteria in nuts. But problems can occur if the roasting is not done correctly or if roasted nuts are re-exposed to bacteria.
The firm sells its California-grown pistachios to giants of the food industry such as Kraft Foods Inc., as well as 36 wholesalers across the country.
"We care about our business and our customers greatly," said Lee Cohen, the production manager for Setton International Foods Inc., a sister company to Setton Pistachios. "We've never had an illness complaint before but obviously this affects the whole industry. It's not good."
California supplies 99.99 percent of the U.S. pistachio market, according to the California Pistachio Board.
"What's scary is that it's after the nuts have been processed that this stuff is getting into it, so it really makes you wonder," said Marcia Rowland, an avid pistachio eater in Apopka, Fla.
The FDA learned about the problem March 24, when Kraft notified the agency that routine product testing had detected salmonella in roasted pistachios. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day and expanded the recall to include any Planters and Back to Nature products that contain pistachios Tuesday.
Kraft spokeswoman Laurie Guzzinati said her company's auditors visited the plant early last week, and "observed employee practices where raw and roasted nuts were not adequately segregated and that could explain the sporadic contamination."
She said she didn't know specifically what they saw.
Federal inspectors last visited the plant in 2003, and the California Department of Public Health was there last year, Acheson said. Federal officials made note of several problems � an open door into one of the nut rooms, and an employee wearing street clothes that weren't adequately covered � but nothing that posed a food safety threat, he said.

Acheson said management corrected the problems that day, and said he did not have access to California inspectors' records.

Cohen said the plant had never had an illness complaint, followed industry health guidelines and had its huge metal silos and warehouse inspected regularly, but refused to provide additional details or records. Several plaques on the firm's office walls showed the firm won industry awards for food safety excellence.

No illness have been tied to contaminated pistachios. Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasn't been confirmed, Acheson said.

While consumer advocates praised the government's swift action, they said the pistachio recall illustrated that more oversight was needed.

"It is encouraging that this response was so quick, but we need to move to a system that focuses on prevention through the entire food production process," said Jeff Levi, executive director of Trust for America's Health.

Two California legislators introduced a bill Tuesday that would require periodic testing of food at food processing facilities and mandate processors to report to state authorities within 24 hours any positive test result for a dangerous contaminant.

"We shouldn't be reacting to the next crisis, we should be preventing the next crisis," said Assemblyman Mike Feuer, D-Los Angeles.

___

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

___

On the Net:

http://www.settonfarms.com

http://www.fda.gov

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

noreply@blogger.com (Unknown) — Tue, 31 Mar 2009 00:32:00 +0000

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.

___

On the Net:

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

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

Study: Cholesterol drug lowers blood clot risk

noreply@blogger.com (Unknown) — Mon, 30 Mar 2009 00:29:00 +0000

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.

___

On the Net:

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

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

Stroke-blocking device shows promise, doctors say

noreply@blogger.com (Unknown) — Sun, 29 Mar 2009 00:34:00 +0000

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

noreply@blogger.com (Unknown) — Sat, 28 Mar 2009 00:38:00 +0000

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."

___

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

Doctors say kidney stones in kids are on the rise

noreply@blogger.com (Unknown) — Fri, 27 Mar 2009 00:20:00 +0000

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.

___

On the Net:

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

Study: Male circumcision helps prevent 2 STDs

noreply@blogger.com (Unknown) — Thu, 26 Mar 2009 00:23:00 +0000

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.
___
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

noreply@blogger.com (Unknown) — Tue, 24 Mar 2009 23:53:00 +0000

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

Study: Lots of red meat increases mortality risk

noreply@blogger.com (Unknown) — Mon, 23 Mar 2009 23:46:00 +0000

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

noreply@blogger.com (Unknown) — Sun, 22 Mar 2009 23:41:00 +0000

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

noreply@blogger.com (Unknown) — Thu, 19 Mar 2009 23:06:00 +0000

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

noreply@blogger.com (Unknown) — Wed, 18 Mar 2009 23:10:00 +0000

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

noreply@blogger.com (Unknown) — Tue, 17 Mar 2009 23:16:00 +0000

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.
___
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

noreply@blogger.com (Unknown) — Sun, 15 Mar 2009 23:19:00 +0000

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."

___

On the Net:

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

Obama: Food safety system a health 'hazard'

noreply@blogger.com (Unknown) — Sat, 14 Mar 2009 23:17:00 +0000

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.

___

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

noreply@blogger.com (Unknown) — Thu, 12 Mar 2009 22:43:00 +0000

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.

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On the Net:

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

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

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