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Health Highlights: Aug. 6, 2005

U.S. Researchers Develop Avian Flu Vaccine FDA Adopts a More Cautious Approach: Report Scientists Working on 'Cure All' Flu Vaccine Higher Levels of Arsenic Found in U.S. Rice

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

U.S. Researchers Develop Avian Flu Vaccine

U.S. health officials say they have successfully tested a vaccine in human trials that they believe can protect against the strain of avian flu that many experts fear could be the source of the next influenza pandemic, The New York Times reported Sunday.

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said that even though the vaccine has only undergone preliminary testing, it could be used on an emergency basis if a pandemic developed. Still, it will be several months before the vaccine is tested further and, if licensed, offered to the public on a large scale, the newspaper said.

"It's good news," Fauci said. "We have a vaccine."

The bad news, Fauci added, is that "we don't have all the vaccine we need to meet the possible demand. The critical issue now is, 'Can we make enough vaccine, given the well-known inability of the vaccine industry to make enough vaccine.' "

Researchers in countries including Australia, Canada, France and Japan have been racing to develop a vaccine against the A(H5N1) strain that is spreading among birds throughout Asia and Russia. Infectious-disease experts worry that if the strain mutates and combines with a human flu virus to create a new virus, it could potentially kill tens of millions of people worldwide. The last great pandemic, the Spanish flu outbreak of 1918-19, killed an estimated 50 million people around the world.

Tens of millions of birds have already died from infection with the avian flu virus as well as culling to prevent the virus' spread. About 100 people have been infected, and about 50 have died from the bird flu strain. So far there has been no sustained human-to-human transmission, the Times reported.

As of Friday night, according to the World Health Organization, the avian strain had killed 57 of the 112 people it had been known to infect in four countries. They are Cambodia (four cases), Indonesia (one case), Thailand (17 cases), and Vietnam (90 cases), according to the newspaper.

U.S. government researchers and others developed the new vaccine, which is produced by the French drug company Sanofi-Pasteur. The federal government could decide to release the vaccine under emergency conditions if an avian flu pandemic struck before the testing process was complete, the Times said.

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FDA Adopts a More Cautious Approach: Report

The U.S. Food and Drug Administration is issuing twice as many advisories about potential risks posed by drugs and five times as many black-box warnings -- its highest alert -- as it did a year ago. And approval times for new drugs is nearly twice as slow, The New York Times reported Saturday.

This new caution comes in the wake of sharp criticism from some members of Congress and consumer advocates who said the agency was doing a poor job of protecting the public from risks posed by drugs.

Much of the criticism followed the revelation last year that certain powerful painkillers called cox-2 inhibitors could increase heart attack and stroke risks. The popular medicines Vioxx and Bextra were subsequently pulled from the market, and another, Celebrex, now carries a warning that it should be prescribed at the lowest effective dose for the shortest possible time.

The FDA's new conservative approach has failed to appease federal lawmakers and upset some doctors, who say the agency's vague warnings and confusing advice mean that physicians aren't getting the information they need to avoid health problems but will get blamed for them anyway. And drug makers contend the new wave of warnings is scaring patients who could benefit from needed medicines, the Times said.

"The FDA should not be slowing things down or speeding them up depending on how the wind blows," said Sen. Charles E. Grassley, an Iowa Republican. "Instead, the agency should be a rock of stability."

Traditionally, the FDA issued warnings about drugs only if studies demonstrated a clear risk. Now, the agency is issuing public alerts even when problems are only suspected, the newspaper said.

The FDA said it has not changed the way it regulates drugs.

"Maybe we're not being overly cautious but instead trying to be responsive," Dr. Scott Gottlieb, the agency's deputy commissioner, told the Times.

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Scientists Working on 'Cure All' Flu Vaccine

A British biotech firm says it's working on an influenza vaccine that could give lifelong protection against all types of flu, avoiding the need for an annual shot.

Cambridge-based Acambis said it hopes to target a non-mutating protein found in all strains of flu. Current vaccines work by immunizing the body to two proteins that tend to mutate from year to year, which means new vaccines must be developed just to keep up with the new strains, according to BBC News.

The company cautions that its work is in the initial stages of animal testing and it may be many years before a universal vaccine is tested in people.

The new vaccine would target a non-mutating protein named M2. The inoculation would also include other technology that its developers said they couldn't disclose for commercial reasons, the BBC said.

"This technology has special importance as a potential means of protecting human populations against pandemic influenza strains," Acambis' chief scientific officer, Dr. Thomas Monath, told the network. "The need to develop a new vaccine each time a different influenza strain emerges often results in long delays before a population can be protected."

Some experts have long warned that the deadly bird flu strain that's sweeping Asian fowl could cause a human pandemic if it were to mutate into a form that could easily pass from one person to another, rendering existing human vaccines ineffective.

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Higher Levels of Arsenic Found in U.S. Rice

Rice grown in the United States has levels of arsenic up to five times higher than rice grown in Europe, India, and Bangladesh, Scottish researchers say.

Scientists at the University of Aberdeen found that U.S.-grown rice had an average of 0.26 micrograms of arsenic per gram of rice, versus Indian basmati rice that had 0.05 micrograms per gram, according to USA Today.

While these are tiny amounts, the newspaper noted, arsenic levels are monitored because long-term exposure has been associated with some cancers.

Arsenic is found naturally in soil. The researchers, reporting in the August edition of Environmental Science and Technology, said they can't explain why levels in the United States are as high as they are, USA Today said.

What makes the results even more surprising, the newspaper said, is that Bangladesh has significant arsenic contamination of its soil and irrigation water.

A U.S. rice producers group criticized the study's findings. The Aberdeen sample wasn't large enough to be scientifically valid, spokesman David Coia of the U.S. Rice Foundation told the newspaper. "There's been no incident (in which) arsenic and rice have led to any reported human health problem," he added.

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