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Health Highlights: Aug. 7, 2005

U.S. Researchers Develop Avian Flu Vaccine Smallpox Shot Stopped U.S. Monkeypox Fatalities: Study FDA Adopts a More Cautious Approach: Report Scientists Working on 'Cure All' Flu Vaccine

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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Smallpox Shot Stopped U.S. Monkeypox Fatalities: Study

The smallpox shot millions of Americans got as children apparently protected some people who got infected in the monkeypox outbreak in 2003, new research suggests.

As many as 100 million Americans have at least some residual protection from smallpox vaccines they received as children, even if it was many decades ago, said Mark K. Slifka of Oregon Health & Science University, who led a team that conducted the study.

This potentially could be a benefit in the event of a bioterror attack, Slifka told the Associated Press.

The 2003 outbreak of monkeypox, a related illness, sickened 72 people in several midwestern states, but there were no deaths. While monkeypox kills about 10 percent of its victims in Africa, the lack of U.S. fatalities had been attributed to better medical care and the possibility that the strain of the disease was weaker than that in Africa.

Using a new test, researchers found that three of the Americans infected with monkeypox who developed no symptoms of the illness and five who had some symptoms but did not become severely ill all had an earlier smallpox shot.

This shows that the outbreak was larger than was realized and, more importantly, that protection against monkeypox can continue for decades after smallpox vaccination, the team led by Slifka reported Sunday in the online edition of the journal Nature Medicine.

Routine smallpox vaccination was halted in 1972 in the United States, more than 20 years after the last case of smallpox in this country.

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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 pass from one person to another.

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