Prions key in Alzheimer's disease

Proteins which cause mad cow disease may also protect against Alzheimer's disease, UK researchers say.

Prions naturally present in the brain appear to prevent the build up of a key protein associated with the condition.

In laboratory tests, beta amyloid, the building block of Alzheimer's "plaques", did not accumulate if high levels of the prions were present.

The findings could lead to new treatments, the Proceedings of the National Academy of Sciences reported.

In variant Creutzfeldt-Jakob disease (vCJD), the human version of mad cow disease, the normal version of the prion protein present in brain cells is corrupted by infectious prions causing it to change shape, resulting in brain damage and death.

But little is known about purpose of the normal prion proteins.

Due to the similarities between Alzheimer's and diseases such as variant CJD, researchers at the University of Leeds, looked for a link.

Plaque formation

They found that in cells in the laboratory, high levels of the prions reduced the build-up of beta-amyloid protein, which is found in the brains of people with Alzheimer's disease.

In comparison, when the level of the prions was low or absent, beta amyloid formation was found to go back up again, suggesting they have a preventive effect on the development of the condition.

The researchers also looked at mice who had been genetically engineered to lack the prion proteins and again found that the harmful beta-amyloid proteins were able to form.

Study leader Professor Nigel Hooper said they now needed to look at whether ageing had an affect on the ability of the prion proteins to protect against Alzheimer's.

"Until now, the normal function of prion proteins has remained unclear, but our findings clearly identify a role for normal prion proteins in regulating the production of beta-amyloid and in doing so preventing formation of Alzheimer's plaques.

"Whether this function is lost as a result of the normal ageing process, or if some people are more susceptible to it than others we don't know yet."

He said although they needed to learn more, theoretically if a treatment could be designed to mimic the effect of the prions it could halt the progression of the disease.

Professor Clive Ballard, director of research at the Alzheimer's Society said this was the first time a link had been made between prions and Alzheimer's.

"These are early findings, which suggest prion proteins may have a regulatory effect on the development of beta amyloid."

He added: "This provides the foundations for a novel approach to finding new therapeutic targets in Alzheimer's disease."

China Vows Food-Safety Changes

GUANGZHOU, China, June 29 — A day after regulators in the United States placed a partial ban on imports of certain types of seafood from China, the Chinese government promised Friday to cooperate in tackling its food safety problems but urged a quick resolution.

In tones that were at times defiant, China pressed the United States to act promptly and fairly and cautioned that Chinese seafood products should not be “automatically held and rejected indiscriminately.”

In a statement issued late Friday, China’s top quality watchdog, the General Administration of Quality Supervision, Inspection and Quarantine, acknowledged that there were safety problems with Chinese seafood exports but also said that it had found similar problems in food imported from the United States.

“Just like the U.S. imported food in China, there are quality problems with aquatic products that are exported to the U.S. by some Chinese enterprises,” the government said in a statement posted on one of its Web sites. “China has cooperated and handled these problems properly.”

The statement came after the Food and Drug Administration in the United States said Thursday that it would effectively block the sale of five types of farmed fish, including shrimp and catfish, unless independent testing proved that the goods were free of contamination.

China’s sharp response to the restrictions in the United States sets the stage for what could be a high-stakes trade dispute over seafood, one of the fastest-growing segments of the global food market.

F.D.A. officials declined to comment on China’s response.

China is already the world’s biggest producer and exporter of seafood, and a growing portion of that is sent to the United States, which imports more than 80 percent of its seafood.

But China also has leverage because it is one of the largest importers of American grain, and its food market is increasingly enticing to big American corporations. Indeed, United States authorities are pressing China to lift a ban on American beef.

“If I were the Chinese I would not start a trade war over this,” said Dermot Hayes, a professor of agricultural economics at Iowa State University. “They have a huge trade surplus with us, so it’d be like picking a fight with a rich grandmother. This is a problem that can easily be solved by scientists.”

China has an increasingly poor track record of exporting tainted seafood products to the United States. Time and again over the last few years, Chinese seafood has tested positive for carcinogens and excessive antibiotic residues.

Chinese goods make up about 22 percent of United States seafood imports. But they accounted for about 63 percent of the shipments that were refused by the F.D.A. last year for having animal drug residues.

And early this year, the F.D.A. said it saw a spike in rejections of Chinese seafood products, particularly catfish, shrimp, eel, basa (which is related to catfish) and dace (which is like carp). Those five farm-fished products are facing new F.D.A. restrictions.

Growing concerns about tainted seafood have come after a string of recalls involving Chinese products as varied as pet food, toothpaste, toys and tires.

The recalls have alarmed members of Congress and American consumers and created an ugly side show to already tense trade relations between China and the United States.

China has insisted that its food is largely safe. But regulators here have also vowed to overhaul the country’s food safety regulations and to step up inspections of exports. But American regulators have grown impatient.

To combat the safety problems involving imported Chinese seafood, the F.D.A. said Thursday that it planned to hold all shipments of the restricted seafood products unless they are proven to be safe. Until now, the F.D.A. has only done spot checks on those and other products, testing only a tiny fraction of food imports from China.

In its statement Friday, China said it was willing to cooperate with United States regulators and even proposed its own system of testing and certifying the quality of certain food exports.

Chinese regulators also said that they were “highly concerned” about food safety matters and were working to fix the problem involving tainted seafood exports.

But in striking back at American regulators, China insisted that food products made in the United States also had quality and safety problems. For instance, earlier this week, China rejected batches of orange pulp and apricots from the United Sates, contending that they contained mold, excessive amounts of bacteria and other contaminants.

Andrew Kaelin, managing director of AIS Aqua Foods, a seafood importer, said he thought that Chinese regulations were generally effective but were simply not enough to control the huge number of aquaculture producers. Consequently, he said, it was up to importers and processors to make sure the shipments were clean.

“We test all our shipments before they leave,” he said, explaining that his company ships primarily Chinese scallops, calamari and tilapia to the United States. He said that Chinese regulators stopped a shipment of his that contained shrimp on Friday until he could provide the testing paperwork.

Stacey Viera, a spokeswoman for the National Fisheries Institute, which represents the American seafood industry, said that she expected the restricted Chinese seafood would continue to be sold in the United States. She said, however, that there might be a delay while importers set up testing procedures for the seafood, which may create a temporary problem for restaurants and stores.

Replacing a genome boosts race to develop designer bugs: study

CHICAGO (AFP) - Researchers have transformed one bacterial species into another by swapping their genomes, a move that will accelerate the race to develop custom-built synthetic bugs, a pioneer on genetics has said.

Craig Venter, who had a hand in mapping the human genome, said a team of his researchers had transplanted the entire genetic code of one bacterial organism into another closely related species.

The experiment marks the most ambitious attempt yet to re-engineer a living cell with a view to one day developing microorganisms that could be used for biofuels, cleaning up toxic waste, sequestering carbon or other applications.

It "is a landmark in biological engineering taking us from moving one gene or a set of genes to the ability to move an intact genome," said Barbara Jasny, deputy editor of the journal Science, which first reported the experiment in this week's issue.

For decades, molecular biologists have genetically modified microbes and other kinds of cells by adding short DNA sequences, whole genes and even large pieces of chromosomes in their quest to fashion synthetic bugs that can make anti-malaria drugs or novel biofuels.

But this is the first time that researchers have transplanted an entire genome into a living organism and shown that the cell can express the foreign DNA.

"This is equivalent to changing a Macintosh computer to a PC by inserting a new piece of software," Venter said.

It's a "landmark in biological engineering," said Barbara Jasny, deputy editor of the journal Science, which first reported the experiment in this week's issue.

The experiment shows for the first time that it is possible to insert an intact genome into a host organism and have that organism express the foreign DNA. The next step is to create a synthetic genome and transplant that into a host organism.

"It's a key enabling step," said Venter. "Synthetic biology still remains to be proven, but now we are much closer to knowing it's absolutely theoretically possible."

In this experiment, the scientists at the J. Craig Venter Institute in Rockville, Maryland, used naturally-occurring DNA from a living organism, but they believe the transplantation techniques could be used on artificial, or man-made genomes, once they are developed.

To that end, they are seeking patents on the methods they used in this study.

The researchers took the genome of a simple, one-celled organism called Mycoplasma mycoides and transplanted it into a close relative, M. capricolum.

Both of these bacteria, which are innocuous goat pathogens, lack an outer membrane, facilitating genome transfer.

Before transplantation, the researchers modified the DNA of the donor bacteria, adding two genes that would provide proof if the transfer had worked. One gene conferred antibiotic resistance, the other caused bacteria expressing it to turn blue.

The enhanced Mycoplasma mycoides genome was added to a test-tube of M. capricolum, and the contents of the tube were exposed to an antibiotic.

Within four days blue colonies appeared, indicating that the host organisms had taken up the foreign DNA.

When the team analyzed the blue bacteria for DNA sequences specific to either mycoplasma, it found no evidence of the host bacteria's genetic material.

Many questions still remain. The researchers acknowledged that they were not sure how the one genome displaced the other.

"We don't know for certain how the donor genome takes over," Hamilton Smith, a lead author on the paper, told a teleconference.

The process is also "extremely inefficient" with a success rate of one in 150,000, said John Glass, a lead author on the paper.

Still, Venter said this proof of concept is likely to speed research in this emerging discipline, yielding new developments in months, instead of years as was previously the case.

F.D.A. Curbs Sale of 5 Seafoods Farmed in China

In the latest move against Chinese imports, the Food and Drug Administration yesterday effectively blocked the sale of five types of farm-raised seafood from China because of repeated instances of contamination from unapproved animal drugs and food additives.

The F.D.A. said it decided to take the action after years of warnings and even a visit to Chinese fish ponds that resulted in no signs of improvement. But Dr. David Acheson, the F.D.A.’s assistant commissioner for food protection, stressed that the seafood posed no immediate health threat, though long-term consumption could result in health problems.

“There’s been a continued pattern of violation with no signs of abatement,” Dr. Acheson said.

The seafood announcement comes after a string of reports in recent months about Chinese imports that have failed to meet American health and safety standards: pet food ingredients, toothpaste, toy trains and tires.

The seafood move, however, may have the broadest impact on China, the world’s biggest producer of farm-raised fish. The country is also the biggest foreign supplier of seafood to the United States, accounting for 22 percent of the total imports.

The seafood named in the F.D.A.’s “import alert” are shrimp; catfish; eel; basa, which are similar to catfish; and dace, similar to carp. Some of the contaminants cited have been found to cause cancer in laboratory animals, while others may increase antibiotic resistance. Under the import alert, the seafood can be sold in the United States only if importers provide independent testing that shows the seafood does not contain the contaminants.

Officials at the Chinese Embassy in Washington did not respond to messages seeking comment.

The announcement fueled concerns about both the integrity of Chinese products and the effectiveness of the American system for identifying contaminated food.

“The list continues to grow of Chinese imports that are dangerous to American consumers,” said Senator Richard J. Durbin, Democrat of Illinois. “There reaches a point where I think it’s clear, if China wants to live in the 21st century, then they have to produce to those standards.”

After the F.D.A. announcement, Mr. Durbin and Representative Rosa L. DeLauro, Democrat of Connecticut, called on federal officials to establish a food safety agreement with China.

Ms. DeLauro, a frequent critic of the F.D.A.’s oversight of food safety, also questioned why the agency waited so long to act.

The banned substances, primarily antifungals and antibacterials, have been used by some Chinese farmers to prevent disease among their seafood. Because they are often crowded into ponds, farmed fish and shrimp can become sick as the quality of the water becomes polluted by waste and feed.

“You may have 10 to 20 times the density of fish as in a natural environment,” said Robert P. Romaire, professor of aquaculture at Louisiana State University.

American regulators allow the use of a limited number of antibiotics. But Mr. Romaire said some of the Chinese farmers used antibiotics indiscriminately.

None of the antibiotics and food additives found in the Chinese seafood — nitrofuran, malachite green, gentian violet and fluoroquinolones — are on the approved list of regulators. Long-term exposure to nitrofuran, malachite green and gentian violet, which are also illegal in China, has been shown to cause cancer in laboratory animals.

Fluoroquinolones are allowed in Chinese aquaculture. Nevertheless, they are not permitted in fish in the United States because their use may increase antibiotic resistance for people.

The problems with contaminated Chinese seafood imports date back at least six years. Before this week, the F.D.A. had issued other, more narrow warnings about contaminated Chinese seafood beginning in 2001.

In the fall of 2006, F.D.A. officials went to China to inspect aquaculture operations and found “the residue control program ineffective.” The agency increased its inspections of Chinese seafood, starting last October, and, officials said, found that 15 percent of the samples were contaminated.

China’s seafood shipments to the United States were valued at $1.9 billion in 2006, a 193 percent increase over 2001, according to the Department of Agriculture. The biggest American imports from China are shrimp, tilapia, scallops, cod and pollock, federal statistics show, although only shrimp was affected by yesterday’s announcement.

Several Southern states, which have their own catfish and shrimp-farming operations, have already blocked the sale of some Chinese seafood. Their rules say that the seafood can be sold only if it passes testing that proves it has no contaminants.

The state of Alabama announced its ban after testing found 14 of 20 samples contained fluoroquinolones. Mississippi officials found that 18 of 26 samples of Chinese catfish were contaminated with fluoroquinolones.

“We are saying all Chinese seafood that comes in here has to be tested prior to sale,” said Bob Odom, Louisiana’s agriculture and forestry commissioner. “The simple reason for that is we found a lot of it that is contaminated.”

The F.D.A. maintains a database of imported products that are prevented from entering the United States because they do not comply with American standards. In May, for instance, the agency turned away 165 shipments from China, 49 of them seafood.

Monkfish was rejected for being filthy and unfit to be eaten, the records show. Frozen catfish nuggets were turned away because they contained animal drugs. Tilapia fillets were contaminated with salmonella.

The problems were even worse in April, when 257 shipments from China were rejected, including 68 of seafood. Frozen eel contained pesticides, frozen channel catfish had salmonella and frozen yellowfin steaks were filthy, the records show.

In a report on the F.D.A.’s oversight released in May, Food and Water Watch, a Washington-based nonprofit group, found that more than 60 percent of the seafood that was rejected at the border by the F.D.A. came from China.

The group’s report also found that the percentage of seafood shipments that were pulled out for laboratory analysis declined in recent years, from 0.88 percent in 2003 to 0.59 percent in 2006. Over all, about 2 percent of seafood imported from 2003 to 2006 received either a sensory examination for color and smell or a more detailed laboratory analysis.

Of the seafood that was refused at the border, filth was the top listed reason and salmonella was second, with shrimp accounting for about half of those cases, the report found.

Of the shipments rejected for animal drug residues in 2006, 63 percent were from China, the report found. Vietnam ranked second in rejections for animal drug residue, 11 percent.

F.D.A. officials said yesterday, however, that the agency inspected a higher percentage of Chinese seafood imports — 5 percent — because of continuing concerns about farm-raised fish from that country.

F.D.A. Issues Alert on Chinese Seafood

The Food and Drug Administration today issued an alert challenging imports of five major types of farm-raised seafood from China, including shrimp and catfish, because testing found recurrent contamination from carcinogens and antibiotics.

The alert means that the fish will be allowed for sale in the United States only if testing proves that it is free of those substances.

While the federal agency stopped short of an outright ban, the alert is nonetheless hugely significant because China is a major source of imported seafood in the United States, accounting for 21 percent of total imports.

The United States imports 81 percent of the seafood that is consumed here.

“There’s been a continued pattern of violation with no signs of abatement,” said David Acheson, the F.D.A.’s assistant commissioner for food safety. He insisted that there was no imminent danger to human health, but that prolonged consumption could cause health problems.

The other varieties affected by the ban are eel, basa, which is related to catfish, and dace, which is related to carp.

The seafood alert is the latest and perhaps broadest indictment yet against Chinese products, which have come under increasing scrutiny in recent months after pet food, toothpaste, toy trains and tires have been found to be contaminated or defective in some way.

China is the world’s leading producer of farm-raised fish. Its shipments to the United States were valued at $1.9 billion in 2006, a 193 percent increase from 2001, according to the Department of Agriculture. The biggest American imports from China are shrimp, tilapia, scallops, cod and pollock, federal statistics show.

The move by the F.D.A. comes after several Southern states have already blocked the sale of Chinese seafood contaminants. Now, Chinese catfish can be sold only if it passes testing that proves it has no contaminants.

The state of Alabama announced its ban after testing found 14 of 20 samples contained fluoroquinolones, a type of antibiotic banned by the F.D.A. Mississippi officials found that 18 of 26 samples of Chinese catfish were contaminated with fluoroquinolones.

“We are saying all Chinese seafood that comes in here has to be tested prior to sale,” said Bob Odom, Louisiana’s agriculture and forestry commissioner. “The simple reason for that is we found a lot of it that is contaminated.”

The problems with Chinese seafood are evident in a database of products that the FDA stops at the border. In May, for instance, the F.D.A. turned away 165 shipments from China, 49 of which were seafood.

Monkfish was rejected for being filthy. Frozen catfish nuggets were turned away because they contained veterinary drugs. Tilapia fillets were contaminated with salmonella.

The problems were even worse in April, when 257 shipments from China were rejected, including 68 of seafood. Frozen eel contained pesticides, frozen channel catfish had salmonella and frozen yellowfin steaks were filthy, the records show.

In a report on the F.D.A.’s oversight released in May, Food and Water Watch, a Washington-based nonprofit organization, found that more than 60 percent of the seafood that was rejected at the border by the F.D.A. came from China.

The report also found that the percentage of seafood shipments that were pulled out for laboratory analysis declined in recent years, from .88 percent in 2003 to .59 percent in 2006, the report found. Over all, about 2 percent of seafood import shipments between 2003 and 2006 received either a sensory examination for color and smell or a more detailed laboratory analysis.

Of the seafood that was refused at the border, filth was the top reason and salmonella was second, with shrimp accounting for about half of those, the report found.

Of the shipments rejected for veterinary drug residues in 2006, 63 percent were from China, the report found. Vietnam had the second most rejections for veterinary drug residue, 11 percent.

The Government Accountability Office has also criticized the F.D.A.’s oversight of seafood imports. In a 2004 report, the G.A.O. determined that the seafood inspection program had improved from 2001, when the agency concluded that the seafood inspection program did not sufficiently protect consumers.

But the G.A.O. also found that the F.D.A. still had considerable room for improvement.

Food-Safety Crackdown in China

SHANGHAI — After weeks of insisting that food here is largely safe, regulators in China said Tuesday that they had recently closed 180 food plants and that inspectors had uncovered more than 23,000 food safety violations.

The nationwide crackdown, which the government said began last December, also found that many small food makers were using industrial chemicals, banned dyes and other illegal ingredients in things like candy and seafood.

The announcement came as part of an overhaul of food safety regulations after a series of international food scares involving Chinese exports.

The country’s exports of contaminated ingredients for animal feed earlier this year led to one of the largest pet food recalls in American history.

Tainted animal feed ingredients also leached into American meat and fish supplies, and problems with contaminated fish and other food have been reported in other parts of Asia and in Europe.

China has strongly denied that its food exports are hazardous and has seemingly retaliated against criticisms in recent weeks by seizing American and European imports.

This week, China said it had impounded two shipments, of orange pulp and apricots, from the United States because they contained “excessive amounts of bacteria and mold.”

Earlier this year, regulators blocked imports of Evian water from France, saying bacteria levels in the water exceeded national standards.

Still, the government has moved aggressively in recent months to enforce food safety regulations and to weed out fake or contaminated food products.

Tuesday’s announcement, which appeared on the Web site of the country’s top food-quality watchdog, the General Administration of Quality Supervision, Inspection and Quarantine, has intensified concerns about rampant fraud in the food industry here.

Regulators said an investigation involving 33,000 law enforcement officials found illegal food-production and meat-processing operations, fake soy sauce and the use of banned food additives.

“These are not isolated cases,” Han Yi, director of the administration’s quality control and inspection department, told the state-run media. China Daily, the nation’s English-language newspaper, said industrial chemicals not intended for use in foods had been found in products as diverse as candy, pickles and seafood. Among the substances were dyes, mineral oils, paraffin, formaldehyde and malachite green, a chemical primarily used as a dye but also used as a topical antiseptic or treatment for parasites and infections in fish.

Regulators said they also learned that the potentially toxic chemicals sodium hydroxide and hydrochloric acid were being used to process shark fin and ox tendon.

These industrial chemicals are often corrosive, and are used in drain cleaners, detergent, fertilizer and surfboard wax, among other products.

Such discoveries have become common in China. In 2005, officials in south China found a company repackaging food waste and shipping it to 10 other regions. And just last week, officials said a company in Anhui Province, not far from Shanghai, was selling a two-year-old rice dumpling mix as fresh, according to the state-controlled media.

Experts here say that the country’s food regulations are not being enforced and that small-business men are willing to go to extraordinary lengths to increase profit.

Corruption and bribery are also part of the food and drug industry here.

The former head of the food and drug watchdog agency was recently sentenced to death for accepting bribes and approving the licensing of substandard drugs. And now, a Ministry of Agriculture official is on trial in Beijing for accepting bribes in exchange for endorsing food products.

But not all the problems stem from corruption or malfeasance. A. T. Kearney, an international management consulting firm, issued a report this week saying that one cause of food safety problems in China was inadequate logistics systems and a lack of cold storage.

The firm said China needed to invest about $100 billion over the next 10 years to upgrade its logistics and refrigeration abilities and to put new standards into effect.

In China, the study said, there are only about 30,000 refrigerated trucks for transporting food; the United States has about 280,000.

“In the entire supply chain there’s no common standard or world-class standard,” said Zhang Bing, who helped prepare the study. “There are a lot of things contributing to the food safety problem. There are companies putting chemicals into food. But there’s also a lot of spoilage.”

Wider Sale Is Seen for Toothpaste Tainted in China

After federal health officials discovered last month that tainted Chinese toothpaste had entered the United States, they warned that it would most likely be found in discount stores.

In fact, the toothpaste has been distributed much more widely. Roughly 900,000 tubes containing a poison used in some antifreeze products have turned up in hospitals for the mentally ill, prisons, juvenile detention centers and even some hospitals serving the general population.

The toothpaste was handed out in dozens of state institutions, mostly in Georgia but also in North Carolina, according to state officials. Hospitals in South Carolina and Florida also reported receiving Chinese-made toothpaste, and a major national pharmaceutical distributor said it was recalling tainted Chinese toothpaste.

The Food and Drug Administration has advised consumers to discard all Chinese-made toothpaste, regardless of the brand.

State officials in Georgia and North Carolina said all the tainted tubes were being replaced with brands made outside China. The officials said there had been no reports of illnesses caused by the toothpaste.

Officials of the Food and Drug Administration said toothpaste with even small amounts of the bad ingredient, diethylene glycol, a syrupy poison, had a “low but meaningful risk of toxicity and injury” for children and people with kidney or liver disease.

“This stuff does not belong in toothpaste, period,” a spokesman for the drug agency, Doug Arbesfeld, said. “No Chinese toothpaste has come into the country since the end of May.”

Since the Panamanian government found Chinese toothpaste with diethylene glycol in May, countries from Latin America to West Africa to Japan have seized the toothpaste.

Panama last year inadvertently mixed the poison made in China into 260,000 bottles of cold medicine, killing at least 100 people, prosecutors there said.

Diethylene glycol is often used in Chinese toothpaste in place of its more expensive chemical cousin glycerin. Chinese regulators have said that toothpaste with small amounts of diethylene glycol is not harmful and that international concern is unjustified.

After the drug agency expressed concern about tainted toothpaste, the Georgia Department of Administrative Services checked to see whether Chinese toothpaste was being used by the state. The department found it in 83 prisons, 4 mental health centers and 4 juvenile detention centers, said Rick Beal, contracts manager for the department.

Mr. Beal said officials confiscated 5,877 remaining cases, each with 144 tubes, of the Springfresh brand. Tests showed the toothpaste had a diethylene glycol concentration of about 5 percent, he said.

The state bought the toothpaste for about 9 cents a tube in 2002. Mr. Beal said he did not know how many tubes had been used.

There are no reports of harm resulting from the toothpaste, bought from a distributor, American Amenities in Seattle.

“We do not know who their manufacturer from China was,” Mr. Beal said.

A lawyer for American Amenities, Jesse Lyon, said it had recalled all suspect shipments of the product and had decided to stop importing Chinese toothpaste. Mr. Lyon said he believed that American Amenities had about 30 institutional customers, with Georgia being the largest.

A spokesman for the North Carolina Department of Corrections, George Dudley, said his agency estimated that it bought 22,000 tubes of Pacific brand Chinese toothpaste with a small amount of diethylene glycol from Pacific Care Products in San Francisco.

Pacific Care did not respond to a request for comment, but an executive wrote to North Carolina officials that the toothpaste came from Amercare Products, also in Seattle. A spokeswoman for Amercare declined to comment.

Chinese toothpaste containing “trace amounts” of diethylene glycol has also been recalled from healthcare institutions by McKesson, a major pharmaceutical distributor and health services company, said a spokesman, James Larkin.

Mr. Larkin said although this particular brand, McKesson EverFRESH, was not on the drug agency’s list of contaminated toothpaste, McKesson asked a laboratory to test it. When small amounts of diethylene glycol turned up, the company recalled the product, he said.

“We went back through our records, and every customer that ever bought the product was contacted,” Mr. Larkin said.

He added that on short notice he could not determine how many customers had bought the product.

One institution that did was Florida Hospital Waterman, a 200-bed institution in Tavares, Fla.

“We pulled that product,” Bonnie Zimmerman of the hospital said.

Ms. Zimmerman said that the toothpaste that replaced it also came from China and it had “trace amounts” of diethylene glycol. It, too, was removed, she said.

In South Carolina, four hospitals in the Greenville Hospital System also removed Chinese toothpaste, even though its distributor said it did not have diethylene glycol, said John Mateka, executive director of materials management for the group.

New stem cell could aid research

UK scientists say the discovery of a new type of stem cell should aid research into cures for disease.

The journal Nature features two studies in which scientists extracted rodent embryonic stem cells which closely resembled their human counterparts.

Previously extracted animal stem cells behaved very differently.

Substituting rodent for human embryonic stem cells could speed up research, as they would be easier to obtain, and less controversial to use.

Making spare parts

The "epiblast stem cells", as they have been named, were taken from the rat or mouse embryo at a slightly later stage of its development than previous rodent embryonic stem cells.

Professor Roger Pederson, who led a team of scientists at Cambridge University, said they constituted "the missing link between mouse and human embryonic stem cells".

"On a molecular level, epiblast stem cells are more similar to human embryonic stem cells than to mouse embryonic stem cells."

Independently, scientists at Oxford University, made the same findings, a coincidence which both teams said bolstered each other's research.

Many scientists believe stem cells from embryos - rather than adults - are the most useful as they have the potential to become virtually any type of cell in the human body.

This means they offer great potential for "regenerative medicine", in which doctors hope they might be able to replace tissue that is damaged by disease.

Parkinson's and Alzheimer's are among the neurological diseases which are thought most likely to benefit from stem cell therapies, but they are also said to offer hope for conditions as diverse as heart disease, arthritis, diabetes, and burns.

But there are both practical and ethical issues surrounding the use of human embryos for stem cell research.

Scientists currently have to rely on obtaining surplus embryos from IVF clinics for their work, while some of those with religious convictions are unhappy at experimenting on and then destroying human life - even if it does pave the way to potentially life-saving treatment.

So what?

Despite the high hopes, so far there have been no major breakthroughs which suggest treatments are imminent.

The two studies do not in themselves offer cures for anything, but independent experts say they could dramatically speed up research if the findings really do stand up.

"In the future it should be much more straightforward to translate results obtained in lab rodents using these epiblast cells into procedures for stem cell therapies in humans," said Professor Harry Moore of the Centre for Stem Cell Biology in Sheffield.

"We would certainly want to use these new epiblast lines to test out the potential of therapies we are developing with human embryonic stem cells."

Professor Pederson himself said he thought the first clinical applications of stem cells were about five years away.

"Those would be very early studies that involve a human individual. I think we can envisage larger scale clinical trials occurring within a decade, certainly."

Artificial skin 'cuts scarring'

A prototype artificial skin used to heal wounds has been developed by British researchers.

Writing in the journal Regenerative Medicine, UK-based company Intercytex said it had produced promising results in early trials.

It said the skin seemed to incorporate itself much better with real tissue than any other skin substitutes tried in the past.

The researchers hope it might provide an alternative to skin grafts.

Currently the best way of treating serious burns and large wounds is to take skin from part of a patient's body and graft it on to the damaged area.

But this is not ideal, and there have been attempts to create a form of artificial skin.

However, some doctors say that the failure of these to fully integrate with the wound have rendered these efforts of limited value.

Intercytex believes its latest version weaves into wounds much better. The skin is created from a matrix made up of fibrin, a protein found in healing wounds.

To this is added human fibroblasts - cells used by the body to synthesise new tissue.

In a process that effectively replicates the way the body makes new skin, the cells produce and release another protein, collagen, which makes the matrix more stable.

It is in this form that the "skin" is implanted into a wound.

The researchers say that because the matrix is in a stable form, it is more able to withstand changes that take place during the healing process.

The fact that the collagen is synthesised directly by the cells themselves also more closely mirrors the natural healing process.

Quick healing

In tests researchers cut an oval section of skin from the arms of six healthy volunteers and replaced it with their lab-grown skin.

After 28 days the artificial skin had remained stable and the wounds had healed with relatively little scarring.

Dr Paul Kemp, Intercytex's chief scientist, said: "I was very surprised at how quickly the wounds healed.

"If this continues in larger trials then it could revolutionise the way in which wounds and burns are treated in the future."

Dr Kemp has been working with Ken Dunn, a consultant surgeon at the burns unit at Wythenshawe Hospital in Manchester.

Mr Dunn said: "This particular product behaves like the patients' own skin.

"It seems to excite much less reaction than the other materials we are using at the moment.

"If this is borne out in larger clinical trials then we would be very interested in using it with our patient group."

Others, however, have warned it is easy to heal a small, surgically-created wound in health volunteers, and that the true test will come when the technique is tried on real patients with real burns.

New Cancer Drugs Prove Their Worth

MONDAY, June 25 (HealthDay News) -- New cancer drugs often save lives, but are they cost-effective?

Two new analyses of two new breast cancer drugs found that they are indeed worth what you pay for them.

The aromatase inhibitor Aromasin (exemestane) and the monoclonal antibody Herceptin (trastuzumab) have already been proven in clinical trials to improve survival.

As new breast cancer drugs exit the pipeline and enter the market, the U.S. health-care system, including the insurance companies or governments paying for therapy, want to know if the drugs are economically, as well as clinically, viable. And new drugs are almost always more expensive compared to the usual standards.

"This is always important to do when you have a drug or a procedure or intervention that is expensive compared to standard care," said Nicole Mittmann, senior author of the Aromasin study, and a scientist with Sunnybrook Health Sciences Centre and assistant professor of pharmacology at the University of Toronto. "The clinical data still drives the decision to use the medication, and this is another piece of the puzzle in the decision-making process."

Dr. Jay Brooks, chairman of hematology/oncology with Ochsner Health System in Baton Rouge La said, "The clinical research trials we've done in the last 50 years have been spectacular, and we know how good or how not good our treatments are, and because of the excellent clinical research that's been done, we can then ask ourselves can we afford these treatments.

"These two studies involving Herceptin and Aromasin clearly show that doing these two maneuvers are very, very cost effective in certain subgroups of women with breast cancer. When insurance companies come to you and ask why are you doing this, you have excellent studies to back them up," he added.

A large clinical study had already shown that women with hormone-receptor-positive breast cancer who switched from tamoxifen to Aromasin after two to three years lived longer than women who took tamoxifen continuously for five years.

But aromatase inhibitors are more expensive than tamoxifen, which has been around for years. And aromatase inhibitors do have some side effects, including musculoskeletal problems such as osteoporosis and fractures.

"Tamoxifen is pretty cheap. Aromasin is newer and more expensive," Mittmann said. "Is the added cost worth the added benefit?"

Cost-effectiveness is measured in number of life years gained and is also adjusted for the quality of life gained, expressed as quality-adjusted life year (QALY).

In Canada and elsewhere, the commonly accepted threshold for a QALY is $50,000 (Canadian dollars).

In this case, the authors found that using tamoxifen and Aromasin sequentially for five years (after 2.5 years of surgery and other standard therapies) improved disease-free survival at an additional cost of $2,889 (Canadian) per patient. This translates into an incremental cost-effectiveness ratio of $24,185/QALY gained, well below the $50,000 bar.

"If this is $24,000, it seems to make sense that this is good value for money," Mittmann said.

According to Mittmann, the model would be applicable to the U.S. market.

The authors of the second study estimated that women would gain three years of life, on average, by adding Herceptin to therapy.

Over a woman's lifetime, the cost-effectiveness ratio would be $26,417/QALY (U.S.), again, below the commonly accepted threshold.

The Aromasin study was funded by an unrestricted grant from Pfizer Inc., which makes the drug. The Herceptin study was funded partly by Genentech, which makes Herceptin.

Study Says Chatty Doctors Forget Patients

A new patient comes into a doctor’s office weighing 204 pounds. He’s six feet tall. The following conversation ensues:

Doctor: Is that up a little bit for you, weightwise?

Patient: It might be up a few pounds. I used to jog and I just haven’t ...

Doctor: See, ’cause I’m weighing more like 172, 173 and I’m six foot. And I’m still running. I’m doing the 5 and 10 and 15 K’s. The half marathons and ...

Patient: So, I’m 30 pounds heavier than you?

Doctor: Right now, yeah.

That, a group of researchers say, is part of an actual conversation they recorded in the course of a study that showed that many doctors waste patients’ time and lose their focus in office visits by interjecting irrelevant information about themselves.

Their paper, published yesterday in The Archives of Internal Medicine, involved 100 primary-care doctors in the Rochester area. As part of a study on patient care and outcomes, the doctors agreed to allow two people trained to act as patients come to their offices sometime over the course of a year. The test patients would surreptitiously make an audio recording of the encounter. The investigators analyzed recordings of 113 of those office visits, excluding situations when the doctors figured out that the patient was fake.

To their surprise, the researchers discovered that doctors talked about themselves in a third of the audio recordings and that there was no evidence that any of the doctors’ disclosures about themselves helped patients or established rapport.

Nor, in the vast majority of cases, did the doctors circle back to the personal conversation or try to build upon it.

“I think all of us on the team thought self-disclosure is a potentially positive aspect to building a doctor-patient relationship and that we ourselves were quite good at it,” said Susan H. McDaniel, a psychologist who is associate chairwoman of the department of family medicine at the University of Rochester and lead author of the study.

“We were quite shocked,” Dr. McDaniel added. “We realized that maybe not 100 percent of the time, but most of the time self-disclosure had more to do with us than with the patients.”

Dr. Howard B. Beckman, medical director of the Rochester Individual Practice Association and an internist and geriatrician who was an author of the study, analyzed conversations before and after the doctors started talking about themselves.

“I’d been saying for many years that disclosure was a form of patient support,” Dr. Beckman said. “If someone says, ‘I have a problem,’ and you say, ‘I understand because I have it, too,’ that would be comforting.” But, he added, “in truth that never happens.”

Patients were not comforted, he said, and conversations got off track. Four out of five times when a doctor interjected personal information, the doctor never returned to the topic under discussion before the interruption.

“We found that the longer the disclosures went on, the less functional they were,” Dr. Beckman said. “Then the patient ends up having to take care of the doctor and then the question is who should be paying whom.”

The researchers studied the conversations looking for any hint that patients were helped when the doctors talked about themselves.

“We looked for any statement of comfort, any statement of appreciation, any deepening of the conversation,” Dr. Beckman said.

They found none.

Dr. Jeffrey Borkan, who is a professor and chairman of the department of family medicine at Brown University, said it was easy to see why doctors thought it was helpful to talk about themselves. Doctors are told that they must make a connection with patients. But, Dr. Borkan said, “the instruction is often imprecise — how do you make a connection?” Many think the way to do it is by talking about themselves.

“What’s shocking about this article is how often they moved from the patient’s concerns to their own,” Dr. Borkan said.

But Dr. Richard Frankel, a professor of medicine and geriatrics at Indiana University, hopes that doctors do not conclude that the best course is to clam up completely about themselves.

Patients, for example, may ask a female physician who is pregnant when she is due or whether she is having a boy or a girl. “It would not be appropriate not to say anything,” Dr. Frankel said.

The Rochester researchers, though, say their results opened their eyes to their own transgressions and made them change their ways.

They also made them see that they, too, had been the victims of doctors’ time-wasting disclosures.

Dr. McDaniel said, “I went to my doctor recently, and I realized after I left, when I was in the parking lot, that I had only asked one of my two questions because my doctor was telling me about his trip to Italy.”

But not all doctors informed of the results saw themselves in the data.

Dr. John K. Min, an internist at the Kernodle Clinic in Burlington, N.C., said he had always been circumspect when he talked to patients.

Then, however, he recalled a patient who came to see him five years ago for a physical exam. Dr. Min is avid about building furniture and the patient was skilled at furniture building. The patient spent 40 minutes with Dr. Min. When he left, Dr. Min looked at his notes.

“I realized that I didn’t even examine him,” Dr. Min said. The man, he added, was gracious when Dr. Min called to apologize.

“He said, ‘We’ll just wait for next time,’ ” Dr. Min recalled.

HIV infection theory challenged

A longstanding theory of how HIV slowly depletes the body's capacity to fight infection is wrong, scientists say.

HIV attacks human immune cells, called T helper cells. Loss of these cells is gradual, often taking many years.

It was thought infected cells produced more HIV particles and that this caused the body to activate more T cells which in turn were infected and died.

Imperial College London modelling suggests that, if that was true, cells would die out in months not years.

The Imperial findings have been published in journal PLoS Medicine.

The imperial team used a mathematical model of the processes by which T cells are produced and eliminated.

Using this they showed that the current theory of an uncontrolled cycle of T cell activation, infection, HIV production and cell destruction - dubbed the "runaway" hypothesis - was flawed.

They concluded that it could not explain the very slow pace of depletion that occurs in HIV infection.

They showed that if the theory was correct, then T helper cell numbers would fall to very low levels over a number of months, not years.

Lack of certainty

Researcher Professor Jaroslav Stark said: "Scientists have never had a full understanding of the processes by which T helper cells are depleted in HIV, and therefore they've been unable to fully explain why HIV destroys the body's supply of these cells at such a slow rate.

"Our new interdisciplinary research has thrown serious doubt on one popular theory of how HIV affects these cells, and means that further studies are required to understand the mechanism behind HIV's distinctive slow process of cellular destruction."

The Imperial team thinks one possible explanation could be that the virus slowly adapts itself over the course of the infection.

But they stress that further analysis is needed to verify this alternative theory.

Professor Stark said: "If the specific process by which HIV depletes this kind of white blood cell can be identified, it could pave the way for potential new approaches to treatment."

Roger Pebody, a treatment advisor at HIV charity Terrence Higgins Trust, said: "HIV is an incredibly complex virus and research is ongoing to try and establish exactly how it works.

"We need more studies in this area before we can draw any clear conclusions."

HIV infection theory challenged

A longstanding theory of how HIV slowly depletes the body's capacity to fight infection is wrong, scientists say.

HIV attacks human immune cells, called T helper cells. Loss of these cells is gradual, often taking many years.

It was thought infected cells produced more HIV particles and that this caused the body to activate more T cells which in turn were infected and died.

Imperial College London modelling suggests that, if that was true, cells would die out in months not years.

The Imperial findings have been published in journal PLoS Medicine.

The imperial team used a mathematical model of the processes by which T cells are produced and eliminated.

Using this they showed that the current theory of an uncontrolled cycle of T cell activation, infection, HIV production and cell destruction - dubbed the "runaway" hypothesis - was flawed.

They concluded that it could not explain the very slow pace of depletion that occurs in HIV infection.

They showed that if the theory was correct, then T helper cell numbers would fall to very low levels over a number of months, not years.

Lack of certainty

Researcher Professor Jaroslav Stark said: "Scientists have never had a full understanding of the processes by which T helper cells are depleted in HIV, and therefore they've been unable to fully explain why HIV destroys the body's supply of these cells at such a slow rate.

"Our new interdisciplinary research has thrown serious doubt on one popular theory of how HIV affects these cells, and means that further studies are required to understand the mechanism behind HIV's distinctive slow process of cellular destruction."

The Imperial team thinks one possible explanation could be that the virus slowly adapts itself over the course of the infection.

But they stress that further analysis is needed to verify this alternative theory.

Professor Stark said: "If the specific process by which HIV depletes this kind of white blood cell can be identified, it could pave the way for potential new approaches to treatment."

Roger Pebody, a treatment advisor at HIV charity Terrence Higgins Trust, said: "HIV is an incredibly complex virus and research is ongoing to try and establish exactly how it works.

"We need more studies in this area before we can draw any clear conclusions."

Girls Who Like Dad Favor Partners Who Look Like Him

SUNDAY, June 17 (HealthDay News) -- Women who had a good childhood relationship with their father are more likely to choose partners who resemble their father, new research suggests.

The study, published in the July issue of the journal Evolution and Human Behavior by British and Polish psychologists, also found that women who had a negative/less positive childhood relationship with their father weren't attracted to men who looked like their father.

The researchers had 49 Polish women (eldest daughters) look at pictures of 15 faces and choose the one they found most attractive. Their selections were compared to their fathers' faces. The women were also asked to rate their childhood relationship with their father.

The findings offer new insight into how people select partners and the effect that parents have on the process, the researchers said. Until recently, it was believed that this parental influence was a passive process. But this study adds to growing evidence that it's actually an active process.

The results of this study "show for certain that the quality of a daughter's relationship with her father has an impact on whom she finds attractive. It shows our human brains don't simply build prototypes of the ideal face based on those we see around us, rather they build them based on those to whom we have a strongly positive relationship. We can now say that daughters who have very positive childhood relationships with their fathers choose men with similar facial characteristics to their fathers," study author Dr. Lynda Boothroyd of Durham University said in a prepared statement.

More information

There's more on the mental health of children and adults at The National Institute of Mental Health.

Experts Call for More Research and More Vigilance Against TB

ATLANTA, June 14 — In the wake of a worldwide scare caused by an American who traveled abroad with a highly dangerous strain of tuberculosis, the country’s top experts on the disease called Thursday for a vast increase in federal research dollars. They also asked for expanded authority to restrict travel by infected persons and a heightened explicitness in counseling patients on the risks of infecting others.

“I think we’ve been too mealy-mouthed in our communication of risk to patients,” said Dr. Kenneth G. Castro, director of the division of tuberculosis elimination at the federal Centers for Disease Control and Prevention. Dr. Castro spoke at a three-day annual conference of tuberculosis physicians and nurses from across the country. The Thursday session was devoted to the emerging global challenge posed by multidrug-resistant tuberculosis, known as MDR, the most lethal form of which is defined as extensively drug-resistant tuberculosis, known as XDR.

The XDR form infected Andrew Speaker, a 31-year-old Atlanta lawyer who traveled to his European wedding in May after learning that he had MDR, and then flew to Montreal by commercial jet after receiving a diagnosis of XDR. He drove from Canada to New York City, where he was kept in isolation at Bellevue Hospital before flying to Atlanta on a C.D.C. plane.

Public health officials in Georgia had advised Mr. Speaker in May not to travel but said they did not have the authority to prohibit him. Mr. Speaker has said that county officials told him they preferred he not travel, but that they never forbade it and did not seem concerned about his ability to infect others.

Doctors for Mr. Speaker, who is in medical isolation in Denver, said Thursday that they would operate soon to remove infected lung tissue.

The incidence of tuberculosis in the United States has been falling for 15 years. But the specialists here are alarmed by the emergence of drug-resistant strains. Forty-eight cases of extensively drug-resistant tuberculosis have been reported in this country since 1993, with 12 fatalities, according to the disease centers.

Tuberculosis experts at the Thursday meeting said they were perversely grateful that Mr. Speaker had revived the public’s focus on the disease. They called for an increase in federal financing for domestic tuberculosis programs, to $300 million a year from $137 million, while raising spending on global programs to $450 million from $90 million.

There is an urgent demand for new drug development, the experts said. And because the disease could spread quickly from abroad, there is a particular need for more laboratories overseas.

Officials at the disease centers said they had met with Homeland Security officials to discuss updating laws permitting the forcible quarantine of people with communicable diseases. Current statutes, intended to keep communicable diseases from reaching America, are “silent on exportation,” said Dr. Martin S. Cetron, the director of global migration and quarantine at the centers.

F.D.A. Panel Rejects Drug for Obesity

A drug once viewed as a possible magic bullet against obesity was rejected yesterday by a federal advisory panel because of worries that it causes neurological and psychiatric problems and increases the risk of suicide.

Although the drug, rimonabant, is already marketed in 37 countries, it is now unlikely that the Food and Drug Administration will approve its sale in the United States without additional safety data.

The advisory panel voted unanimously, 14 to 0, against recommending the drug, saying there was inadequate evidence of its safety. The F.D.A. is not required to follow the advice of such panels, but it typically does.

The panel’s vote was a blow to Sanofi-Aventis, the French company that makes the drug, which is sold in many countries under the brand name Acomplia. As the advisory committee finished voting, the company’s stock, which trades in this country as American depositary receipts, closed at $43.07, down $1.31 or 2.95 percent. It fell another $1.02 in after-hours trading.

Sanofi had expressed hope that the drug would be a $3 billion seller, with much of that market in the United States, a country with a growing obesity problem.

In a statement issued after the panel’s vote, the company said it would continue to work with the F.D.A. to address the panel’s concerns, which included worries about a high dropout rate in clinical studies of the drug, evidence of a doubling of psychiatric events and questions about whether the drug induced seizures.

Dr. Jules Hirsch, an advisory committee member who is a research physician at Rockefeller University, summed up the sentiments of the other panelists. “I couldn’t in any way suggest that it be approved at the present time for use.”

The drug, which the company had planned to call Zimulti in the United States, works on the brain’s endocannabinoid system. The system was discovered through research into marijuana, which works on brain receptors to give users the “munchies.”

By suppressing those receptors, Zimulti curbs hunger. Clinical studies revealed that patients taking it lost about 5 percent of their weight.

But the same brain system also modulates depression, phobias, anxiety and post-traumatic stress disorder. Testimony before the panel yesterday in Silver Spring, Md., suggested that tampering with the endocannabinoid system also increased such psychiatric symptoms, including suicidal thoughts.

“The potential market for this drug and the continued uncertainty about its risks, both known and unknown, lead to our concern about the use of this drug in the general population,” an F.D.A. staff medical reviewer, Dr. Amy G. Egan, told the panel.

The committee’s vote that there was not enough safety data to approve the drug came after Dr. Egan’s presentation, which indicated that the drug doubled a patient’s risk of problems like anxiety, depression, aggression and psychosis.

The committee also heard about data showing an increase in suicidal thinking among users of the drug, including four patients who did commit suicide while taking it: three during clinical studies and one in Europe after the drug was approved last year.

In a presentation to the panel, representatives of Sanofi recommended a special screening of prospective patients to measure their risk for psychiatric symptoms.

The company also argued that the drug should be evaluated in light of a growing need for drugs to treat obesity, citing benefits in glucose, HDL cholesterol, tryglycerides and inflammatory markers in patients taking the drug.

Currently only two drugs are approved to assist patients with weight loss. One of them, Meridia, by Abbott Laboratories, has been linked to high blood pressure. The other, Xenical by Roche, causes diarrhea and gas.

Yesterday’s vote came on the same day that Xenical became available without a doctor’s prescription under the brand name Alli. The drug is being marketed by GlaxoSmithKline, which purchased over-the-counter rights to the drug from Roche and won F.D.A. approval this year to sell the product directly to consumers.

Dr. Hirsch of Rockefeller University said Zimulti’s effects on weight were similar to those of other drugs already marketed — a 5 percent loss followed by a regain of weight.

“The problem I see with this whole thing is that the number of people who are going to lose weight is very small,” Dr. Hirsch said. “You’re telling a 220-pound woman that she has a one in four chance of getting down to 200 pounds if she sticks with the program. That’s not going to make anyone very happy.”

Sanofi-Aventis had first petitioned the F.D.A. in 2005 to approve the drug, counting on it to help replace the sales lost through the patent expiration this year of its sleep medication Ambien as well as the anticipated 2011 patent expiration of another big seller, Plavix, an anticlotting agent.

In a statement yesterday after the panel’s vote, the company said it would work with the F.D.A. to address concerns about the drug.

Kellogg to Phase Out Some Food Ads to Children

Froot Loops’ days on Saturday morning television may be numbered.

The Kellogg Company said yesterday that it would phase out advertising its products to children under age 12 unless the foods meet specific nutrition guidelines for calories, sugar, fat and sodium.

Kellogg also announced that it would stop using licensed characters or branded toys to promote foods unless the products meet the nutrition guidelines.

The voluntary changes, which will be put in place over the next year and a half, will apply to about half of the products that Kellogg currently markets to children worldwide, including Froot Loops and Apple Jacks cereals and Pop-Tarts.

Frosted Flakes, for example and Rice Krispies with Real Strawberries will still make the nutritional cut, though regular Rice Krispies will not (too much salt).

The president and chief executive of Kellogg, David Mackay, said that the products that did not meet the guidelines would either be reformulated so that they did, or no longer be advertised to children.

“It is a big change,” Mr. Mackay said. “Where we can make the changes without negatively impacting the taste of the product, we will.”

If the product cannot be reformulated, Mr. Mackey said, the company will either market it to an older audience or stop advertising it.

The policy changes come 16 months after Kellogg and Viacom, the parent company of Nickelodeon, were threatened with a lawsuit over their advertising to children by two advocacy groups, the Center for Science in the Public Interest and the Campaign for a Commercial-Free Childhood, and two Massachusetts parents.

Because of the changes by Kellogg, the groups said that they would not proceed with the lawsuit against the company. Viacom had not negotiated with the groups and was not part of today’s announcement; the groups said that they had not determined if they would proceed with legal action against the broadcaster.

“Kellogg’s position has really evolved over those months from pretty much ‘no way’ to acceptance of some nutrient criteria,” said Michael F. Jacobson, executive director of the Center for Science in the Public Interest. He said he hoped the Kellogg announcement would lead its competitors to adopt even tougher standards for food advertising to children.

Susan Linn, the co-founder of the Campaign for a Commercial-Free Childhood, said that Kellogg’s decision to stop using licensed characters on sugary food was particularly significant. “Until now the industry has absolutely dug in their heels,” Ms. Linn said.

In the last several years, health officials have repeatedly warned that the steady stream of food ads aimed at children is contributing to the number of overweight or obese children, which has soared over the last several decades.

Some countries have banned advertising of nutritionally questionable food to children altogether, and some members of Congress have suggested that federal regulation may be needed in the United States, too. The food industry has promised to bolster its own self-regulation.

Last November, for instance, 10 of the largest food and beverage companies, including McDonald’s, General Mills and Kellogg, vowed that at least half of their advertising directed at children under 12 would promote healthier foods or encourage active lifestyles.

The companies also agreed not to advertise in elementary schools and to reduce the use of licensed characters to promote food. Those companies are expected to complete individual plans for how they will address the guidelines in the next 60 days or so.

But like Kellogg, a few companies have already unveiled tougher standards for advertising to children. Last October, for instance, Walt Disney said that it would allow its characters to be used in food advertising only if the products complied with nutritional standards.

And in 2005, Kraft Foods announced that it would stop advertising products to children under 12 that did not meet specific nutrition guidelines.

Under Kellogg’s new guidelines, food advertised on television, radio, Web sites and in print that have an audience that is 50 percent or more of children under 12 will have to meet the new nutrition standards. Kellogg already had a policy of not aiming advertising at children younger than 6, so the new guidelines apply to children 6 through 11.

Kellogg officials said that about 27 percent of its advertising budget in the United States aims at that age group. They declined to give the dollar value of that budget.

Under the new standards, one serving of food must have no more than 200 calories, no trans fat, no more than 2 grams of saturated fat, no more than 230 milligrams of sodium (except for Eggo frozen waffles) and no more than 12 grams of sugar.

Cocoa Krispies cereal would not qualify because one serving has 14 grams of sugar. But Kellogg could still advertise Frosted Flakes to children because it has 11 grams of sugar. Shrek cereal does not meet the criteria because it has 15 grams of sugar a serving and uses a licensed character.

In a related initiative, Kellogg said it would introduce Nutrition at a Glance labels on the top right corner of cereal boxes this year.

Already introduced in Europe and Australia, the new labels will take information from the Nutrition Facts panel on the side of the boxes, which are mandated by the federal government, and highlight important parts on the front of the box.

The new labels will show consumers the percentage of calories, total fat and sodium in a single serving, based on a 2,000-calorie daily diet, and will also display grams of sugar and nutrients like fiber and calcium.

In Health Care, Cost Isn’t Proof of High Quality

Stark evidence that high medical payments do not necessarily buy high-quality patient care is presented in a hospital study set for release today.

In a Pennsylvania government survey of the state’s 60 hospitals that perform heart bypass surgery, the best-paid hospital received nearly $100,000, on average, for the operation while the least-paid got less than $20,000. At both, patients had comparable lengths of stay and death rates.

And among the 20 hospitals serving metropolitan Philadelphia, two of the highest paid actually had higher-than-expected death rates, the survey found.

Hospitals say there are numerous reasons for some of the high payments, including the fact that a single very expensive case can push up the averages.

Still, the Pennsylvania findings support a growing national consensus that as consumers, insurers and employers pay more for care, they are not necessarily getting better care. Expensive medicine may, in fact, be poor medicine.

“For most consumers, the fact that there is no connection between quality and cost is one of the dirty secrets of medicine,” said Peter V. Lee, the chief executive of the Pacific Business Group on Health, a California group of employers that provide health care coverage for workers.

Some Pennsylvania employers said the state’s findings, based on data from 2005, might put more pressure on insurance carriers and hospitals to start demonstrating the value of care. “It now provides us a tool to have a serious dialogue with our carriers,” said Mark Dever, a benefits consultant for Duquesne Light, a regional utility in Pittsburgh.

“We have to question,” he said. “There’s a big difference in price — why?”

The report by the Pennsylvania Health Care Cost Containment Council, a state agency, provides a rare public glimpse of detailed information about hospital payments and patient outcomes. And the seemingly random nature of the payments is striking.

Although federal Medicare payments are largely fixed, they varied somewhat among the Pennsylvania hospitals surveyed. The far greater disparity involved commercial insurers, which must negotiate their rates hospital by hospital.

And the survey found that good care can go unrewarded. One Philadelphia area hospital, Main Line Health’s Lankenau center, which performs a large number of bypass surgeries and has a high success rate, according to the survey, was paid an average of $33,549 by private insurers. That was less than half the nearly $80,000 in average payments received by the other hospitals, with poorer track records.

“It doesn’t make sense,” said Marc P. Volavka, the executive director of the Pennsylvania Health Care Cost Containment Council. “Certain payers are paying an awful lot for poor quality.”

He points to some of the experiments to change how hospitals are paid, like Geisinger Health System in central Pennsylvania, which is trying to demonstrate its commitment to high-quality care by offering a 30-day warranty on its cardiac surgery.

“The current reimbursement paradigm is fundamentally broken,” said Dr. Ronald Paulus, an executive with Geisinger, who says there is no current financial incentive for a hospital to provide the kind of care that leads to better outcomes and lower payments.

Pennsylvania is the first state to make such information, normally closely guarded by the hospitals and the insurers, available to everyone — including patients who may never see their hospital bills or be aware of how their hospitals compare with others in the state.

The council collected the payment data from the insurers and calculated averages of the payments to each hospital. So each hospital’s average includes small numbers of extraordinarily high-cost cases, where patients may have developed complications and had lengthy hospital stays.

As a result, a hospital with a relatively low number of surgeries but a high number of costly cases, could wind up with a high average payment. In the Philadelphia area, for example, Lower Bucks Hospital says its average of nearly $100,000 paid by commercial insurers for a bypass patient was skewed by a single very expensive case. Without that case, its average would be closer to $40,000, the hospital said.

But fully explaining the discrepancies in payments and quality of care is difficult.

In Philadelphia, heart patients have a choice among several academic medical centers. Two, Albert Einstein and Hahnemann University, were paid nearly $80,000, on average, for treating a bypass patient. The hospitals at the University of Pennsylvania and Thomas Jefferson University, whose patients did as well or better, were paid much less.

Both Albert Einstein and Hahnemann disputed the survey’s findings, saying payments they receive are lower than the state is reporting.

Hahnemann says its calculations show the average to be significantly lower — $23, 420 — rather than the $78,312 reported in the survey.

The council conceded that the pool of Hahnemann patients it used for its calculations was different from the patients the hospital might count. The council defended its conclusions, saying it used the same methodology for all the hospitals surveyed.

As for the quality measures, Hahnemann says its higher-than-expected mortality rates might reflect the hospital’s own poor record-keeping, which it says did not give the state an accurate picture of how sick some of its patients were before their surgeries. As eye-opening as the Pennsylvania report may be to the public, insurers have already been aware that their payment practices do not necessarily encourage hospitals to provide better care. Medicare, for example, pays essentially a flat fee, which varies depending on location and type of hospital, for the same surgery, regardless of outcome. Complications tend to simply mean additional payments. And many insurers follow the government’s lead.

And so hospitals are rewarded for providing more care, not better care.

“The Medicare program pays for services,” said Leslie Norwalk, the acting administrator for the federal program, who says hospitals are reimbursed even if the care they are providing is a result of a mistake or avoidable hospital infection.

Independence Blue Cross, which is Philadelphia’s largest private insurer, says the difficulty lies in finding the right measures to use to pay for quality care.

“Philosophically, you’re not going to get an argument from us,” said Dr. Richard Snyder, a senior executive at Independence. “We believe we should pay more for high quality than poor quality.”

He says hospitals that are poor performers do risk being excluded from its network, as happened in one case with a hospital — which he would not identify — that was not allowed to deliver cardiac care to the plan’s members for a year until the hospital improved its performance.

Fears over child epilepsy drugs

Urgent safety studies are needed for newer anti-epilepsy drugs that are being increasingly prescribed for children, say UK researchers.

The British Journal of Clinical Pharmacology report says prescriptions have risen five-fold in 13 years.

Yet the drugs' long-term safety has not been established, say the researchers.
Many medicines are not fully tested on children before licensing, meaning consultants have no official guidance on doses to refer to when prescribing.

Instead they often have to estimate a safe and effective dose based on the age and the size of the child.

Lead author Professor Ian Wong, from the Centre for Paediatric Pharmacy Research in London, studied antiepileptic drugs given to nearly 8,000 children over a 13-year period.
The centre is a collaborative project run by the School of Pharmacy at the University of London, the UCL Institute of Child Health and Great Ormond Street Hospital.
Professor Wong and his colleagues found three drugs in particular - lamotrigine, topiramate and levetiracetam - had seen a "massive" rise in prescribing.
Professor Wong said this was concerning.
"The uptake of these drugs has been rapid, yet their long-term safety has not been established and further research must now be seen as a priority."

Side-effects
He said that while newer drugs were less likely to react with other prescribed drugs, it was possible that restrictions in their use might have to be introduced as any side-effects in children became more apparent.
He said multi-organ failure, renal failure, blood disorders and skin reactions had been reported in patients using lamotrigine.

Dr Jeffrey Aronson, a reader in clinical pharmacology at Oxford University, said many drugs were not tested on children because of the difficulties that including children in clinical trials posed.
"This means that clinicians often have to rely on their experience and scale down adult drugs for paediatric use, which is widely regarded as most unsatisfactory," he said.
Dr Colin Ferrie, a consultant paediatric neurologist at Leeds General Infirmary, said that not only were new trials important, but pharmaceutical companies should be encouraged to carry out "clinically relevant" trials prior to the original granting of a licence.
"Obviously it's an area of concern, and when you are prescribing a drug 'off licence' to a child, it's important to let the family know exactly the implications of this.
"However, it is often possible to find data, either from journal abstracts or the drug company, which can help you calculate a safe and effective dose of a drug."

New Drug Fails to Improve Odds for Heart Failure Patients

TUESDAY, May 1 (HealthDay News) -- A new drug is no more effective at improving the survival rates of people with decompensated heart failure than a widely used medication is, a new international study has found.

Decompensated heart failure is one form of the general condition in which the heart progressively loses the ability to pump blood. It is characterized by a set of symptoms including shortness of breath and intolerance to exercise.

There were hopes that the new drug, levosimendan, would improve survival, because it uses a unique mechanism that makes heart muscle cells more sensitive to the calcium that causes them to contract. However, the study of 1,347 persons with acute decompensated heart failure, done at 75 centers in nine countries between March 2003 and December 2004, found essentially the same death rate for participants who got levosimendan as those who received an established medication, dobutamine, said a report in the May 2 issue of the Journal of the American Medical Association.

The trial leaves cardiologists without a totally satisfactory treatment for decompensated heart failure, said Dr. Robert Hobbs, a Cleveland cardiologist specializing in treatment of the condition. Some 5 million Americans have one form or another of heart failure, and about 1 million of them are hospitalized for it each year.

"The original therapy, which is still basic, is diuretics," Hobbs explained. "They make the body lose water, so people feel better. In the 1980s, ACE inhibitors came along to make people feel better and live longer, and they were added for long-term benefit. The third group of drugs to be used were beta blockers."

Dobutamine is a positive inotropic agent that has been found to improve symptoms, but it has also been associated with an increased risk of death and cardiovascular problems. In the latest trial, participants with decompensated heart failure received levosimendan or dobutamine intravenously.

"The common practice has been to give dobutamine in the belief that the heart is like a battery that has lost its charge," Hobbs said. "By giving dobutamine, you would recharge it. That didn't actually happen [in previous studies]. It appeared to be associated with complications, longer hospital stays and more mortality."

In another previous study, careful analysis indicated that levosimendan was associated with a lower risk of death than dobutamine. "It did have the different mechanism of action, and it was felt that might translate into improved safety," Hobbs said. But it proved to be no better in the new trial.

In the 180 days after drug infusion, the death rate was 26 percent among patients who got levosimendan and 28 percent in those getting dobutamine. There was no statistical difference between other endpoints, such as incidence of breathing difficulties and days spent out of the hospital.

Participants who got levosimendan were less likely to experience cardiac failure but more likely to experience the abnormal heartbeat called atrial fibrillation, low blood levels of potassium, and headache.

"The bottom line on all of this is that it is hard to show benefit for what we do for acute decompensated heart failure," Hobbs said.

More information

All aspects of heart failure are explored by the American Heart Association .

Egyptian girl dies of bird flu

CAIRO (AFP) - A 10-year-old Egyptian girl has died of bird flu, the health ministry announced on Saturday, bringing to 15 the number of Egyptians who have succumbed to the deadly H5N1 strain of the virus.

The girl, from the southern province of Qena, was found to be "very critical" and hospitalised "too late," health ministry spokesman Abdel Rahman Shahin told AFP.

Although the girl had been ill for more than 10 days, she had only been treated with Tamiflu for the past two days, he added.

John Jabbour, a World Health Official in Cairo, had earlier in the week told AFP the girl had been in contact with poultry.

The highly pathogenic virus has killed 15 people out of the 35 cases reported to date in Egypt. The disease was first diagnosed in the country in February 2006.

Egypt's geographical location on major bird migration routes and the widespread practice of keeping domestic fowl near living quarters have led to it being the hardest-hit country outside of Asia.

Women and children have borne the brunt of the virus due to their role in taking care of domestic fowl.

The government says it is conducting a vigorous campaign to combat the spread of the virus through vaccinations and raising awareness, but cases continue to appear.

Yoga tested as back pain therapy

The potential for yoga to be used to treat low back pain is being investigated by researchers.

Millions of UK people suffer from chronic low back pain, and existing treatments have only a limited effect.

A team of academics, yoga teachers and practitioners have joined forces to find out if a 12-week course of yoga can make a difference.

The Arthritis Research Campaign-backed project will assess moves from the two most popular types of yoga.

These are lyengar yoga and hatha yoga, favoured by the British Wheel of Yoga.

More than 260 people between the ages of 18 and 65 who have had back pain in the past 18 months will be recruited for the trial.

Recent, small studies in the US have shown that yoga can be helpful for back pain sufferers.

But David Torgerson, director of the University of York Clinical trials Unit, and Jennifer Klaber Moffett, deputy director of the Institute of Rehabilitation at the University of Hull, believe a bigger study is needed to unequivocally establish the benefits.

'Considerable impact'

Professor Torgerson said: "Yoga offers a combination of physical exercise with mental focus that may make it a suitable therapy for the treatment of low back pain.

"If the trial shows yoga to be effective then this low-cost treatment will have a considerable impact in the quality of life of patients with back pain."

Yoga develops flexibility and muscular endurance by allowing the muscles to be stretched and strengthened.

Patients will be recruited from GP surgeries from September and the 12-week classes, to be held in north and central London, York, Manchester and Cornwall, will begin in November.

The classes will be run by 10 experienced yoga teachers who have all received specialist training.

No difficult poses

Half the participants will take part in yoga classes, and the other half will receive the usual care.

They will be assessed at the end of the classes, then six months and a year later to see if there are any longer-term benefits.

The yoga classes will be carefully structured for people who are complete novices and will not involve any difficult poses.

They will be graduated over the 12-week period, starting off gently and becoming more demanding, with a combination of stretches, bends, lying sitting, standing and relaxing poses.

Patients will also be encouraged to practise daily at home.

Anna Semlyen, a yoga teacher who is helping to run the classes, said: "Regular yoga increases the benefits, and we would hope that at the end of the 12 weeks people would carry on."

House Votes to Expand Stem Cell Research

WASHINGTON, June 7 — The House gave final Congressional approval on Thursday to legislation aimed at easing restrictions on federal financing of embryonic stem cell research, but Democratic leaders in both chambers conceded they were short of the votes needed to override a veto threatened by President Bush.

On a vote of 247 to 176, the House overwhelmingly passed the bill, with more than three dozen Republicans joining a Democratic-led effort to authorize federal support for research using stem cells from spare embryos that fertility clinics would otherwise discard. The Senate approved the legislation in April.

“Science is a gift of God to all of us and science has taken us to a place that is biblical in its power to cure,” said Speaker Nancy Pelosi, Democrat of California, arguing for the bill’s passage. “And that is the embryonic stem cell research.”

But minutes after the vote, Mr. Bush renewed his pledge to veto the proposal, which he called “a recycled old bill.” It would reprise the first veto of his presidency, which occurred last year when he rejected a similar bill passed by the Republican-controlled Congress.

“Recent scientific developments have reinforced my conviction that stem cell science can progress in ethical ways,” Mr. Bush said in a statement from Germany, where he was attending the Group of 8 meeting. “Researchers have been investigating innovative techniques that could allow doctors and scientists to produce stem cells just as versatile as those derived from human embryos, but without harming life.”

The House bill received support from 210 Democrats and 37 Republicans, 35 votes short of what would be needed to override a presidential veto; 16 Democrats joined 160 Republicans in opposing the legislation.

Several Republicans voting against the bill seized upon scientific findings reported Wednesday, in which biologists said they could use cells from ordinary, adult cells of the body, instead of stem cells. Critics of the bill also said taxpayer dollars should not be used for research on cells derived from discarded human embryos, particularly in the wake of such advances.

“How many more advancements in noncontroversial, ethical, adult stem cell research will it take before Congress decides to catch up with science?” said Representative Joseph R. Pitts, Republican of Pennsylvania, holding up a front-page newspaper account of the scientific discovery. “These have all of the potential and none of the controversy.”

Such techniques, if proven successful, could sidestep heated debates about the research. The technique described on Wednesday works only in mice and is unsuitable for humans. Scientists hope it will prove adaptable to human cells, but cannot say when that may happen.

“None of this work lessens the imperative to loosen federal and state restrictions that currently slow progress in this area,” said Dr. Sean J. Morrison, director of the Center for Stem Cell Biology at the University of Michigan.

While lawmakers who support more federal financing of embryonic stem cell research also hailed the research development, they said such advances should not stop Congress from expanding research that could lead to treatments for a litany of diseases, including Alzheimer’s and juvenile diabetes.

“We welcome these advances as we welcome all advances in ethical life-saving research,” said Representative Diana L. DeGette, a Colorado Democrat and a sponsor of the bill. “However, this new scientific research should not be used as an excuse to say that it is a substitute for embryonic stem cell research.”

Many scientists agree, saying they need to generate new lines of embryonic cells from discarded human blastocysts, or very early embryos. They also want to develop embryonic stem cells by nuclear transfer, the replacement of an egg nucleus with one from an adult cell. A major benefit of nuclear transfer would be to walk a patient’s cell back to an embryonic state so disease processes could be better understood.

“I would find it immoral to delay the research to see if egg nuclear transfer or this method gets to our goals first,” said Dr. Irving L. Weissman, a Stanford University researcher, referring to the new technique.

Democrats urged the president to change his mind and sign the legislation. Their campaign to override the expected veto began only hours after the bill was passed, with Ms. Pelosi and Senator Harry Reid of Nevada, the majority leader, staging a ceremony to send the legislation to Mr. Bush. They invited a few dozen children and adults — many of them in wheelchairs — who say they could benefit from stem cell research.

Any effort to override a veto would begin in the Senate, where the bill passed April 11 on a 63-45 vote. Even counting the three Senate Democrats who were not present for the vote, passage was one vote shy of the two-thirds majority needed to override a veto.

“I would hope that people around the president will have him understand how important this is,” Mr. Reid said. “We’re depending on the president to do the right thing.”

Representative John A. Boehner of Ohio, the Republican leader, said Democrats were trying to turn the debate into a political opportunity because they knew the president intended to veto it. After winning the majority in both houses last fall, Democrats made expanding federally financed stem cell research a priority in the new Congress.

“This is politics. This is not about expanding research,” Mr. Boehner said. “They understand clearly that the president has vetoed this bill in the past and will veto it again.”

Since 2001, when Mr. Bush issued an order prohibiting the use of federal money for research on new stem cells derived from embryos, medical research and domestic politics have been intertwined. His order limited federal financing to the handful of lines of embryonic stem cells already in existence, but researchers complained that most of those cells were damaged or inadequate.

The new legislation essentially would overturn Mr. Bush’s order. Polls suggest a wide majority of Americans support embryonic stem cell research, but many social conservatives in Congress find the use of discarded embryos unacceptable. “I believe that life begins at conception and destroying embryonic human life for the purpose of research is morally wrong,” said Representative Mike Pence, Republican of Indiana.

Others vigorously disagreed.

“Being pro-life is about more than caring for the unborn,” said Representative Christopher Murphy, Democrat of Connecticut. “It’s about caring for the living as well.”