Archive for the ‘General Information’ Category

Salmonella Scare Prompts Wide Product Recall

Monday, June 7th, 2010

A wide array of food products are being recalled after traces of salmonella were discovered in a common ingredient, officials at the U.S. Food and Drug Administration announced late Thursday.

Salmonella Tennessee has been found in a widely used brand of hydrolyzed vegetable protein, a common flavor enhancer that is added to processed foods, the FDA said.

Products such as dips, salad dressings, pre-packaged meals, snacks and soup mixes from a variety of makers are included in the recall. A full list of the items involved in the recall can be found at Foodsafety.gov.

“At this time, there are no known illnesses associated with this contamination,” FDA Commissioner Dr. Margaret Hamburg said during the news conference.

The FDA said the problem was identified after a customer of the manufacturer, Las Vegas-based Basic Food Flavors Inc., notified the FDA in early February that they found salmonella in one lot of the company’s hydrolyzed vegetable protein.

The FDA collected and analyzed samples at Basic Food Flavors’ plant and found Salmonella Tennessee in processing equipment. Based on this finding, Basic Food Flavors is recalling all hydrolyzed vegetable protein in powder and paste form that was produced since Sept. 17, 2009.

Dr. Jeffrey Farrar, FDA’s Associate Commissioner for Food Protection, said that although the contaminated product is in potentially thousands of food items, it poses a low risk to consumers.

The risk remains low because the ingredient makes up less than 1 percent of any foods. In addition, these foods often go through a cooking step, which kills the bacteria, Farrar noted.

“We believe the risk represented by this recall is very low to consumers,” he said. “Many of the foods that incorporated this product, at a very low level, have ‘kill steps’ in place that would eliminate salmonella.”

Only those products that do not have a “kill step” will be recalled, Farrar said.

The FDA has advised companies that the recalled product should be destroyed or reconditioned according to the agency’s protocol. For products that may already be in consumers’ kitchens, the FDA is advising that they check the recalled product list and follow “cooking instructions for all foods.”

In addition, the agency is asking anyone who had symptoms of salmonella to contact their doctor.

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy people infected with salmonella often have fever, diarrhea, nausea, vomiting and abdominal pain, according to the FDA.

Most healthy people recover from salmonella infection within four to seven days without treatment. However, in rare cases, the bacterium can get into the bloodstream causing severe illnesses, such as arterial infections, infection of the lining of the heart and arthritis, the agency noted.

SOURCES: 2010, teleconference with: Margaret Hamburg, M.D., FDA Commissioner, Jeffrey Farrar, D.V.M., Ph.D., M.P.H., FDA Associate Commissioner, Food Protection

Aspirin cuts death risk after breast cancer: U.S. study

Sunday, May 30th, 2010

Breast cancer survivors who take aspirin regularly may be less likely to die or have their cancer return, U.S. researchers reported Tuesday.

The study of more than 4,000 nurses showed that those who took aspirin — usually to prevent heart disease — had a 50 percent lower risk of dying from breast cancer and a 50 percent lower risk that the cancer would spread.

“This is the first study to find that aspirin can significantly reduce the risk of cancer spread and death for women who have been treated for early stage breast cancer, ” said Dr. Michelle Holmes of Harvard Medical School, who led the study published in the Journal of Clinical Oncology.

“If these findings are confirmed in other clinical trials, taking aspirin may become another simple, low-cost and relatively safe tool to help women with breast cancer live longer, healthier lives,” Holmes added in a statement.

Holmes and her team studied 4,164 female registered nurses taking part in the Nurses’ Health Study, an ongoing analysis of a wide range of health issues.

They started in 1976, looking at who took aspirin, watching for breast cancer and all causes of death until 2006.

Over this time, 341 of the nurses died of breast cancer.

Women who took aspirin two to five days a week had a 60 percent reduced risk of their cancer spreading and a 71 percent lower risk of breast cancer death. Six to seven aspirins a week lowered the risk of spread by 43 percent and the risk of breast cancer death by 64 percent.

Most of the women were taking low-dose aspirin to prevent heart attacks and stroke.

Other drugs in the same class as aspirin also apparently lowered the risks, too. These drugs, called non-steroidal inflammatory drugs or NSAIDs, include ibuprofen and naproxen but not acetaminophen, also known as paracetamol.

But there was not enough data on these drugs to give a clear answer.

The researchers said they are not sure how aspirin and other NSAIDS may affect tumors but it could be by lowering inflammation. Other studies have shown that aspirin and ibuprofen can lower colon cancer risk, for instance.

“Aspirin has relatively benign adverse effects compared with cancer chemotherapeutic drugs and may also prevent colon cancer, cardiovascular disease, and stroke,” the researchers wrote. It affected both estrogen-positive tumors and those not fueled by the hormone.

Holmes’ team stressed that patients should not take aspirin while undergoing radiation or chemotherapy because of the risk of side effects.

And aspirin can cause stomach bleeding so it should not be taken without a doctor’s supervision.

Added Drug Aids MS Treatment

Sunday, May 23rd, 2010

Adding the drug daclizumab to standard treatment with interferon beta may reduce multiple sclerosis disease activity more than interferon beta alone, a new study reports.

Previous non-randomized studies found that daclizumab — a humanized monoclonal antibody — reduced MS disease activity.

This new phase 2 study at 51 centers in the United States, Canada, Germany, Italy and Spain included 230 patients with active relapsing MS who were taking interferon beta. They were randomly selected to also receive either high-dose daclizumab (2 milligrams/kilogram every two weeks), low-dose daclizumab (1 milligram/kilogram every four weeks) or an inactive placebo. The combined treatments continued for 24 weeks.

MRI scans of the patients’ brains were taken every four weeks between weeks 8 and 24 of the study in order to determine the number of new or enlarged gadolinium contrast-enhancing lesions, which indicate MS disease activity.

By the end of the study, the adjusted mean number of new or enlarged gadolinium contrast-enhancing lesions was 1.32 in the high-dose group (75 patients), 3.58 in the low-dose group (78 patients) and 4.75 in the placebo group (77 patients).

Levels of CD56bright natural killer cells were seven to eight times higher in patients taking daclizumab than in those taking the placebo.

“This study provides confirmatory data that daclizumab treatment causes an expansion of CD56bright natural killer cells and adds support to the theory that expansion of CD56bright natural killer cells might mediate some of the effects of daclizumab on reducing multiple sclerosis lesion activity. In addition to the results of previous trials of daclizumab in multiple sclerosis, several lines of evidence have suggested a potential immunoregulatory function for CD56bright natural killer cells: they are expanded during conditions of natural immune tolerance, for example, pregnancy,” the researchers from the Neurovirology Research Laboratory at the VA Medical Center in Salt Lake City, and the University of Utah, reported in a news release.

“This randomized controlled trial indicates that daclizumab can reduce new lesion formation in relapsing multiple sclerosis compared with interferon-beta alone,” the researchers concluded. “Multiple sclerosis treatments that have the potential to improve in risk-benefit ratios when compared with available treatments are needed; thus, additional studies to define the long-term clinical risks and benefits of daclizumab are warranted.”

Mail-Order May Help People Stick to Med Regimens

Tuesday, April 27th, 2010

Using mail-order pharmacies makes it easier for people to stick with their doctor’s prescribed medication regimens, a new study suggests.

Researchers analyzed medication refill data from 2006 and 2007 from 13,922 people with diabetes, high blood pressure or high cholesterol. Good adherence was defined as having prescribed medication on hand at least 80 percent of the time.

People who ordered their medications by mail were more likely to take them as prescribed by their doctors than were people who bought their medications at local pharmacies — 84.7 percent vs. 76.9 percent, the study found. The results were consistent for medications used to control diabetes, high blood pressure and high cholesterol.

Among the other findings:
About 24 percent of whites used mail-order more than two-thirds of the time, compared with 8 percent of Asian/Pacific Islanders, 5 percent of Hispanics, 4 percent of blacks and 8 percent of those of mixed race.
People who used mail-order pharmacies were more likely than those who used local pharmacies to have a financial incentive to fill prescriptions by mail (about 50 percent vs. 23 percent) and to live a farther from a local pharmacy (8 miles vs. nearly 7 miles).

“The field of medication adherence research typically focuses on patient factors for poor adherence, leading to a ‘blame-the-patient’ approach for non-adherence,” the lead researcher, Dr. O. Kenrik Duru, an assistant professor in the division of general internal medicine and health services research at the David Geffen School of Medicine, University of California, Los Angeles, said in a university news release.

“Our work helps to place this issue in a larger perspective,” Duru said. “Our findings indicate that mail-order pharmacies streamline the medication acquisition process, which is associated with better medication adherence.”

The study appears online in the American Journal of Managed Care.

More Evidence That Statins Cut Stroke Risk

Tuesday, April 20th, 2010

One of the largest analyses of the effect of statin drug therapy on the risk of stroke confirms the benefits of these widely used drugs.

Much of the benefit from statins such as Crestor, Lipitor and Zocor appears tied to the drugs’ lowering of blood levels of “bad” LDL cholesterol, the researchers found.

Data from clinical trials including almost 267,000 participants showed an overall 12 percent reduction in stroke incidence among those taking statins, with each 1 percent reduction in total cholesterol predicting a 0.8 percent relative risk reduction of stroke.

The report, published in the Jan. 19 issue of the Journal of the American College of Cardiology, was led by physicians at G. d’Annunzio University in Chieti, Italy.

“This is consistent with prior studies and reinforces the benefit of statin therapy in preventing stroke in selected populations of patients,” said Dr. Larry B. Goldstein, director of the Stroke Center at Duke University.

But the report contains hints that the reduction of stroke risk is not entirely explained by the cholesterol-lowering effect of statins, added Dr. Brendan M. Everett, an instructor in medicine at Harvard Medical School and attending cardiologist at Brigham and Women’s Hospital. The JUPITER study, which he helped conduct, found a benefit for people with high levels of C-reactive protein, a marker of inflammation.

“There are many possible explanations for the reduction in stroke risk observed in actively treated patients, and one of those is a reduction of inflammation with statin therapy,” Everett said. “In JUPITER, we observed a 48 percent reduction in total stroke and 51 percent reduction in ischemic stroke among patients with a normal LDL cholesterol at baseline.”

An ischemic stroke, the most common form, occurs when a blood clot blocks a brain artery.

“We took people with normal cholesterol levels and saw a reduction in stroke similar to that in trials that selected people with higher levels of cholesterol,” Everett said. “That suggests to me there’s something else going on there.”

That’s possible, Goldstein said. “In clinical trials you measure LDL cholesterol, but many other things are going on at the same time,” he said. “Still, the amount of benefit is directly related to the amount of cholesterol lowering.”

While the JUPITER researchers focused on inflammation, “they still reduced LDL cholesterol levels significantly,” Goldstein said.

There was no debate about the value of statin therapy in reducing other cardiovascular risks in people with high LDL levels. The Italian analysis found more benefits from statins than from other cholesterol-lowering regimens.

“Statins really ought to be our first choice for cholesterol reduction,” Everett said. “That is true for heart disease and true for stroke. We showed that even patients with normal cholesterol levels may benefit from statins.”

“The most gratifying thing reported by this meta-analysis is that statins among all lipid-lowering therapies appear to be the most effective,” said Dr. Robert D. Brown, chairman of neurology at the Mayo Clinic in Minnesota. “The use of statin therapy is particularly important among people who have had a stroke. They are being used more aggressively in people who have had a stroke in an attempt to prevent another.”

At least one trial has shown a significant reduction in second strokes among people taking statins, Brown noted.

SOURCES: Larry B. Goldstein, M.D., director, Duke Stroke Center, Durham, N.C.; Brendan M. Everett, M.D., instructor, medicine, Harvard Medical School, and attending cardiologist, Brigham and Women’s Hospital, Boston; Robert D. Brown, M.D., chairman, neurology, Mayo Clinic, Rochester, Minn;

1 in 4 U.S. Teen Girls Involved in Violent Behavior

Monday, April 12th, 2010

A new national survey finds that almost 27 percent of girls aged 12 to 17 were involved in serious fights or attacks on other girls within the previous year.

“These findings are alarming,” SAMHSA administrator Pamela S. Hyde said in a news release. “We need to do a better job reaching girls at risk and teaching them how to resolve problems without resorting to violence.”

Results from the 2006-2008 survey showed that just under 19 percent of the girls got into a serious fight at school or work, 14 percent were part of fights involving groups and nearly 6 percent attacked others with an intention to seriously hurt them. In total, 26.7 percent of the girls surveyed fell into at least one of those groups, the researchers noted.

The girls least likely to get involved in the violent behavior are those from families with higher incomes, those who achieved higher grades, and those who don’t use drugs or alcohol, according to the results of the survey conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA).

The findings are based on responses from 33,091 girls participating in SAMHSA’s National Survey on Drug Use and Health.

SOURCE: Substance Abuse and Mental Health Services Administration, news release,

Beating Heart Differs by Gender, Age: Study

Saturday, March 27th, 2010

The human heart twists and turns as it beats, and a German study shows how the twisting and turning differs between men and women, and young and old.

In the study, published in the Dec. 8 online edition of Circulation: Cardiovascular Imaging, researchers at University Hospital Freiburg describe the different heartbeats they saw in 29 men and 29 women, all healthy, using an advanced imaging technology called MRI tissue phase mapping. The participants ranged in age from 20 to 60-plus.

The healthy heart doesn’t just contract as it pumps blood. The base of the left ventricle, the chamber that pumps blood to the body, changes its direction of rotation up to six times for each beat.

“The left ventricle doesn’t just shorten or get narrower,” said Dr. Thomas C. Gerber, associate professor of medicine and radiology at the Mayo Clinic in Jacksonville, Fla. “It really twists like a dishrag, a very effective way of getting the blood out.”

Clear differences by age and gender emerged from the study, the report said. Among them:
The rotation speed of the apex of the heart decreases with age.
Younger women have higher up-and-down motion velocities along the long axis of the ventricle than younger men, but those differences were reversed in older men and women.
Compared to men, women demonstrated reduced twisting of the ventricle, apex rotation and muscle velocity toward the center of the left ventricle during contraction.

The study could lead to the use of such coronary imaging in diagnosing heart problems, cardiologists say.

“To understand what is abnormal, we have to understand what is normal, and that can differ by gender and age,” said Gerber. Full knowledge of those normal differences could help physicians understand “which abnormalities correspond to a particular disease phase,” he said.

“This information could change the diagnosis and assessment of heart disease from its earliest stages,” the lead author of the report, Dr. Daniela Foell, a senior consultant in cardiology at the University Hospital Freiburg, said in a news release.

But there’s a long way to go before that happens, Gerber noted.

“At this stage of the game, it is a nice proof of principle paper, but to make it clinically useful, other groups would have to use the same tools to see if they get the same results and in a much larger group of patients,” he said.

Also, the study included only a selected group of Germans, Gerber pointed out. “This was a fairly small group and to accept this as normal findings across the world would be premature,” he said.

While the study “hasn’t uncovered anything breathtakingly new,” it has provided very detailed information about the normal heartbeat and sets the stage for more detailed future studies, Gerber added.

“If we had a large data base for different ages and genders, we could establish what is normal and then we could tell for a particular patient whether a particular aspect of cardiac rotation was abnormal, and that would tell the physician that something was wrong,” Gerber said. “But there are no abnormalities we know now that are specific for a particular disease.”

Vitamin D Linked to Survival in Lymphoma Patients

Saturday, March 20th, 2010

The levels of vitamin D in patients with a type of lymphoma appear to be connected to cancer progression and the likelihood of survival, researchers have found.

“These are some of the strongest findings yet between vitamin D and cancer outcome,” said lead investigator Dr. Matthew Drake, an endocrinologist at Mayo Clinic in Rochester, Minn. “While these findings are very provocative, they are preliminary and need to be validated in other studies. However, they raise the issue of whether vitamin D supplementation might aid in treatment for this malignancy, and thus should stimulate much more research.”

The study authors looked at 374 patients who had been newly diagnosed with diffuse large B-cell lymphoma. Tests suggested that half of the patients didn’t have enough vitamin D in their systems, and those patients had a 1.5-fold greater risk of disease progression. After the researchers adjusted their figures to account for the influence of other factors, the risk of death among patients with vitamin D deficiency during the study period was doubled compared to patients with ideal levels of vitamin D.

“The exact roles that vitamin D might play in the initiation or progression of cancer is unknown, but we do know that the vitamin plays a role in regulation of cell growth and death, among other processes important in limiting cancer,” Drake said.

What to do? “It is fairly easy to maintain vitamin D levels through inexpensive daily supplements or 15 minutes in the sun three times a week in the summer, so that levels can be stored inside body fat,” Drake said.

States Slash Funding for Tobacco Prevention Programs

Saturday, March 13th, 2010

States cut funding for tobacco prevention programs by more than 15 percent in the past year, even though they’re receiving record amounts of money from tobacco taxes and from the 1998 state tobacco settlement, says a report released Wednesday.

“Fully funded tobacco prevention and cessation programs stop addiction before it starts, and improve the health of our nation’s communities. States must do better at funding programs that help reduce tobacco use and protect the health of children, 3,500 of whom try their first cigarette every day,” John R. Seffrin, chief executive officer of the American Cancer Society Cancer Action Network, said in a news release.

“Despite their current budget challenges, the states lack excuses for failing to do more. They are collecting record amounts of tobacco money, more of which should be used to fight the tobacco problem,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in the release. “And there is overwhelming evidence that tobacco prevention programs not only reduce smoking and save lives, they also save money by reducing tobacco-related health-care costs. Those states that make short-sighted decisions to cut tobacco prevention will pay a steep price in lives and dollars.”

The American Heart Association, the American Lung Association and the Robert Wood Johnson Foundation are the other groups involved in the release of the report, “A Broken Promise to Our Children: The 1998 State Tobacco Settlement 11 Years Later.”

Among the findings:
In the past year, states have cut funding for tobacco prevention by $103.4 million (15.4 percent). Including cuts approved last week, New York made the largest cut — $25.2 million (31 percent) — even though the state has a successful program that’s reduced smoking to well below the national rate. Colorado, Maryland, Pennsylvania and Washington are other states that have made large cuts to tobacco prevention programs.
In fiscal year 2010, states will collect $25.1 billion in revenue from the tobacco settlement and from tobacco taxes, but will spend just 2.3 percent ($567.5 million) of that on tobacco prevention and cessation programs. Many states are expected to hike tobacco taxes next year.
North Dakota is the only state that currently funds a tobacco prevention program at the level recommended by the U.S. Centers for Disease Control and Prevention. Only nine states fund tobacco prevention at even half the CDC-recommended level, while 31 states and the District of Columbia provide less than one-quarter of the recommended funding.
For every dollar states spend to discourage tobacco use, tobacco companies spend $20 to market their products. In total, tobacco companies spend $12.8 billion a year on marketing, according to the Federal Trade Commission.

Decreases in smoking have slowed and even stalled in the United States, according to recent surveys. For example, the adult smoking rate in 2008 was 20.6 percent, compared with 20.9 percent in 2004, the CDC reported in November. While smoking among high school students has declined from a high of 36.4 percent in 1997, 20 percent of high school students still smoke and the rate of decline has slowed in recent years.

Along with calling for states to significantly increase funding for tobacco prevention and cessation programs, the new report calls on Congress to ensure that health-care reform legislation provides adequate funding for anti-tobacco programs and makes it mandatory for Medicaid and other health insurance programs to cover medications and counseling for people trying to quit smoking.

“The inadequate funding of tobacco prevention and cessation programs is a powerful example of misplaced priorities in our nation’s health-care system,” Dr. Risa Lavizzo-Mourey, president and CEO of the Robert Wood Johnson Foundation, said in the news release. “We spend too much time on treating people after they get sick and too little on keeping them healthy in the first place. Investing more in proven tobacco prevention programs and policies, like smoke-free restaurants and workplaces, will help people lead healthier lives and reduce health-care costs.”

Tobacco use — the leading preventable cause of death in the United States — claims more than 400,000 lives and $96 billion in health-care dollars each year. Every day, another 1,000 children or teens become regular smokers and one-third of them will die prematurely as a result of their tobacco use.

Soy compounds may not prevent bone loss

Saturday, March 6th, 2010

Supplements containing soy isoflavones may do little to preserve women’s bone mass after menopause.

In a study of more than 200 women ages 46 to 65, researchers found that the soy supplement did not appear to ward off bone-density loss over 3 years. In general, women on the supplement showed the same degree of bone loss as those given a placebo — though there was some evidence that a higher dose helped protect bone density in the hip.

The findings, reported in the American Journal of Clinical Nutrition, add to a conflicting body of research on soy and postmenopausal bone health.

Some studies have suggested that soy-based foods, isolated soy protein or isoflavone-containing supplements may be beneficial, while others have found no advantage.

Isoflavones are natural chemicals found in soybeans and certain other plant foods that are structurally similar to estrogen, and may have certain estrogen-like effects in the human body. Since declining estrogen levels after menopause spur bone-density loss, isoflavone supplements could theoretically protect women’s bone mass.

The current findings, however, do not support that theory.

“I would not be able to recommend that women should take soy isoflavone tablets — extracted from soy protein — since these have not been demonstrated convincingly to be effective for prevention of bone loss,” lead researcher Dr. D. Lee Alekel, a professor of nutrition at Iowa State University in Ames, told Reuters Health in an email.

Still, she said, women should still try to eat a variety of soy-based foods — such as tofu, tempeh and soy-derived versions of cheese and yogurt — since these are “nutritionally sound” choices.

For their study, Alekel and her colleagues randomly assigned 255 postmenopausal women to one of three groups: one that took 80 milligrams (mg) of a soy isoflavone supplement each day; one that took a 120-mg dose; and one given inactive placebo pills.

All of the women also took calcium and vitamin D supplements.

Over three years, women in the isoflavone and placebo groups showed similar average declines in whole-body bone mass, as well as bone density in the spine and hip area.

Women in the higher-dose isoflavone group did, however, show less bone loss in the femoral neck — an area at the top of the thigh bone, where it meets the pelvis. But, the researchers write, because the effect was “very modest,” and limited to the femoral neck, “we cannot conclude that soy isoflavones hold potential promise in the prevention of postmenopausal osteoporosis.”

The idea that soy or soy isoflavones may protect bone mass comes, in part, from studies showing lower rates of hip fracture among women in Southeast Asia, where the traditional diet is rich in soy.

Those types of studies do not prove cause-and-effect, however. Because the current study looked only at soy isoflavone supplements, Alekel said it cannot speak to the potential effects of soy foods on women’s bone health.