UN limits melamine in formula after China scandal

A U.N. commission has set a recommended limit on the amount of melamine allowed in liquid infant formula after a 2008 scandal in China in which six babies died from drinking formula and milk products containing the industrial chemical.

Two years ago, the U.N. food security body known as the Codex Alimentarius Commission set the maximum limit of melamine in powdered infant formula at 1 milligram per kilogram of formula. On Wednesday, the commission said it had adopted a limit for liquid formula at 0.15 milligrams/kilogram.

The recommendations are not binding. The commission, which is jointly run by the U.N. Food and Agriculture Organization and the World Health Organization, is made up of 184 government representatives plus the European Commission.

Melamine is used to make dishes and kitchenware, and trace amounts can sometimes get into food from packaging. In China, melamine was being added to watered-down milk to elevate protein levels. In addition to the six deaths, some 300,000 babies became sick after consuming the tainted formula and milk.

The U.N. commission also made recommendations to limit the spread of salmonella and listeria in pre-packaged melon slices. Codex said the exposed pulp from the fruit can become a breeding ground for bacteria and that the risk was increasing since melon is increasingly being sold in easy-to-eat slices. It recommended that melon be wrapped quickly and refrigerated at 4 degrees Centigrade (39.2 Fahrenheit) or less.

And Codex issued a warning about dried figs: the fruit can host carcinogenic aflaxotoxins, which are produced by mold, if not stored properly. The commission agreed to limit the amount of aflaxotoxins in dried figs at 10 micrograms/kilogram.

The commission, which wraps up its meeting Saturday, is expected to make recommendations on a big issue in livestock circles: the use of growth-promoting veterinary drugs. The commission plans to set maximum residue limits for these drugs, though its members are deeply divided on the issue.

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Prostate drug limits love life

Q. I am at my wits’ end. I’ve been taking Prempro for hot flashes. Now my doctor wants me to stop because of cancer concerns. Whenever I quit, though, the hot flashes return worse than ever.

My friends swear by bioidentical hormones, but my doctor says that they have not been proven any safer than Prempro. She wants me to try Effexor XR, but I am not ready to take an antidepressant for hot flashes. Help!

A. Your doctor may be reacting

to a study reported at the American Association for Cancer Research this spring. The Nurses’ Health Study acquired data from 60,000 women over several decades. Those who took postmenopausal estrogen were at greater risk of breast cancer. Progesterone increased the risk even more.

Bioidentical hormones have not been tested so thoroughly, so your doctor is erring on the side of caution. For more information on dealing with hot flashes and vaginal dryness, plus the pros and cons of hormones, we are sending you our Guide to Menopause. In it we discuss nondrug approaches such as Pycnogenol and black cohosh. Anyone who would like a copy, please send $3 in check or money order with a long (No. 10), stamped (65 cents), self-addressed envelope to: Graedons’ People’s Pharmacy, No. W-50, P.O. Box 52027, Durham, NC 27717-2027. It also can be downloaded for $2 from our website: www.peoplespharmacy.com.

Although antidepressants like fluoxetine (Sarafem), venlafaxine (Effexor) and paroxetine (Paxil) may ease hot flashes, stopping such drugs suddenly can cause unpleasant withdrawal symptoms, including dizziness, headache and hot flashes.

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Regulators seeks voluntary antibiotic limits in livestock

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FDA wants limits on antibiotics given to animals

The Food and Drug Administration called on drug companies Wednesday to help limit the use of antibiotics given to farm animals, a decades-old practice that scientists say has contributed to a surge in dangerous, drug-resistant bacteria.

Antibiotics are mixed with animal feed to help livestock, pigs and chickens put on weight and stay healthy in crowded barns. Scientists have warned that this routine use leads to the growth of antibiotic-resistant germs that can be passed to humans.

The FDA has struggled for decades with how to tackle the problem because the powerful agriculture industry says the drugs are a key part of modern meat production.

Under the new FDA guidelines, the agency recommends antibiotics be used "judiciously," or only when necessary to keep animals healthy. The agency also wants to require a veterinarian to prescribe the drugs. They can currently be purchased over-the-counter by farmers.

"Now you have a veterinarian who will be consulting and providing advice to these producers, and we feel that is an important element to assure that they are in fact using these drugs appropriately," said William Flynn, a deputy director in FDA's veterinary medicine center.

The draft recommendations by the FDA are not binding, and the agency is asking for drug manufacturers' cooperation to put the limits in place. Drug companies would need to adjust the labeling of their antibiotics to remove so-called production uses of the drugs. Production uses include increased weight gain and accelerated growth, which helps farmers save money by reducing feed costs. The FDA hopes drugmakers will phase out language recommending those uses within three years.

But the voluntary approach was met with skepticism by some public health advocates, who said they do not trust the drug industry to voluntarily restrict its own products.

"This is not an issue where trust should be the measure. This is an issue where the measure is whether or not the FDA has fulfilled its authority of protecting public health," said Richard Wood, Chair of the Keep Antibiotics Working coalition, in a statement.

FDA officials said that a formal ban would have required individual hearings for each drug, which could take decades.

"The process we would have to go through is a formal hearing process, product-by-product that is extremely cumbersome," said Mike Taylor, FDA Commissioner for foods. "There's no point in going through those legalistic proceedings when companies are willing to make this shift voluntarily."

Taylor said the FDA has consulted closely with animal drugmakers, and expects them to support the measures.

The debate over antibiotics has long pitted the benefits for producing safe, low-cost meat against the risk of contributing to dangerous antibiotic-resistant bacteria that can infect humans. In its guidelines Wednesday, the FDA said the benefits for meat production do not warrant overuse of the drugs.

"FDA believes that using medically important antimicrobial drugs to increase production in food-producing animals is not a judicious use," the agency states.

The rollout from FDA comes at an unusual time in the agency's attempts to curb antibiotic use in animals. Last month a federal court judge ordered the agency to take action on its own 35-year-old rule that would have banned non-medical use of two popular antibiotics, penicillin and tetracycline, in farm animals.

The FDA issued the rule in 1977 but never enforced it, following vigorous pushback from members of Congress and lobbyists for farmers and drugmakers. Four public safety groups sued the agency to act on the regulation, winning the case handed down in the U.S. District Court of Southern New York on March 22. The agency was given 60 days to appeal the decision.

The waning effectiveness of antibiotics has been a global health concern for several decades, attracting the attention of the World Health Organization, the Institute of Medicine and other health groups. As bacteria have grown more resistant, new and more deadly forms of malaria, staph and other infections that were once easily treatable have emerged across the globe.

Experts say overuse of antibiotics in both animals and humans has contributed to the problem. Both medical societies and government agencies have launched educational programs designed to educate physicians on appropriate prescribing of antibiotics.

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Personal Gene Mapping Has Limits, Study Says

HealthDay – 21 mins ago MONDAY, April 2 (HealthDay News) -- Many people have pinned their hopes on human genome scans as the cornerstone of the rapidly emerging field of personalized medicine, able to predict the future health of individuals.

But there may be limits to what information whole genome sequencing can provide, according to new research slated for presentation Monday at the American Association for Cancer Research annual meeting in Chicago. The study will be simultaneously published online in Science Translational Medicine.

"In most cases, genome sequencing is not going to tell people what disease they're going to get or die from. It can be valuable in telling what diseases they have an excess risk for," said study co-author Dr. Bert Vogelstein, director of the Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins University in Baltimore.

"Genome sequencing is not going to be the dominant component of patient care," he added. "It will not be a substitute for preventive medicine strategies incorporating routine check-ups, exercise, physical status, lifestyle."

The costs of whole genome sequencing are plummeting, making the test more accessible to more people, yet the ability of the test to provide useful information to patients has not been studied quantitatively, Vogelstein said.

The authors used data on identical twins in registries in Sweden, Denmark, Finland and Norway, as well as a U.S. registry of World War II military veteran twins, to look at genetic risk for 24 common diseases including diabetes, Alzheimer's and breast cancer.

The researchers calculated that genetic sequencing would reveal a predisposition to at least one disease in 90 percent of the twins studied.

But that's only predisposition, not whether you actually fall ill or not. The actual risk of getting one of these conditions would be no different from that of the general population, the authors noted.

The analysis also concluded that most individuals would receive negative test results for 23 of the 24 diseases but, again, this hypothetical information would not necessarily predict the future. Even with a negative test result, the risk for developing most of the diseases for which one tested negative would still be 50 percent to 80 percent of that in the general population.

To put the results in context: 2 percent of women who undergo whole genome tests will likely get a positive result for ovarian cancer risk, explained Vogelstein, who is also an investigator at the Howard Hughes Medical Institute, in Chevy Chase, Md.

That puts their overall risk of developing a tumor in their lifetime at 10 percent.

And the 98 percent of women who get a negative result don't necessarily get a "get-out-of-jail-free pass" as they still harbor the same risk as the general population, Vogelstein said.

If it comes down to a choice between spending money on a genome test and spending it on health measures such as regular check-ups and joining a gym, it might be wise to go with the latter, he said.

"If I spend it on a gym membership, that will definitely decrease my risk for ovarian cancer," Vogelstein said.

On the other hand, a genetic test might seem prudent for someone with a family history of a specific disease.

Commenting on the study, Dr. Marc Williams, vice president of clinical genetics for the American College of Medical Genetics and Genomics in Salt Lake City, said: "There's certainly some promise in this type of testing but we're still trying to sort out what are the best situations in which to apply this type of whole genome technology."

Williams pointed out that "if we broadly apply it without thinking about the clinical context -- why we are doing the test, what we hope to learn -- then we could get into a lot of trouble in terms of coming up with a lot of information we don't know what to do with."

In the end, though, said study author Vogelstein, it comes down to an individual decision.

More information

The Human Genome Project has more on genetic sequencing.

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Supreme court limits damages in HIV-infected pilot's case

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