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The Big Bad Flu, or Just the Usual?

By Lawrence K. Altman, the New York Times

December 14, 2003



For all the public concern over the rapid spread of the new Fujian strain of influenza, health officials and doctors say there is still no way to know whether this year's flu season is particularly severe or just off to an early start. And for all the clamor for dwindling supplies of vaccine, no one knows how effective the current vaccine will be against the Fujian strain.

But the flu season has already thrown some realities about the public health system into sharp relief, these experts say. It suggests that the country needs to be far better prepared to deal with influenza — either the conventional strains that cause serious illness each year, or a horrendous strain like the one that caused the 1918-19 pandemic, which killed at least 30 million people worldwide.

Influenza is arguably the most unpredictable of viruses, and protecting the public against it is a tricky balancing act. It involves a number of factors: inadequate scientific knowledge of the virus; educated guesswork in choosing what strains of influenza to include in each year's vaccine; time-consuming, old-fashioned manufacturing techniques; and skills in communicating with a skeptical public.

Such protection also depends on a strong public health system. But years of underfinancing have weakened the system. And confidence in it was scarred by the flawed emergency swine flu immunization program in 1976, which was halted after a relatively few of the 45 million people who had been vaccinated became temporarily paralyzed from Guillain-Barré syndrome.

More recently, gaffes and miscommunication about events like the anthrax attacks of fall 2001 left Americans unsure what to think about public pronouncements, and insecure about the nation's capacity to deal with a severe epidemic of SARS or a new strain of influenza.

Communication has improved since then. Still, the government had little to say about influenza this fall, while the health and human services secretary, Tommy G. Thompson, and his top aides visited African countries torn by AIDS. Only after their return did news conferences about influenza resume.

Government health officials have repeatedly warned about the inevitability of another influenza pandemic. Yet the government has to approve final plans to counter such a disaster.

No one knows why influenza has hit the western United States in particular, or why it happened so early this season. No evidence exists to suggest that the Fujian strain is more virulent than other strains that have caused past epidemics or that this season's influenza is worse than those of the past. Although the Fujian strain also struck early in Europe , the World Health Organization said it was not aware of unusually severe influenza this season outside the United States .

Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, put it bluntly: "No way will the Fujian strain cause a pandemic."

Dr. Julie L. Gerberding, director of the Centers for Disease Control and Prevention, says the vast majority of influenza cases are an annoyance, causing only a mild respiratory illness. But Dr. Gerberding also noted that influenza is lethal for 36,000 Americans on average each year.

The deaths are among the reasons health officials have been urging Americans to take influenza vaccine. An estimated 185 million Americans are eligible for it, but manufacturers produced enough vaccine for only 83 million Americans.

Each February and March, the World Health Organization and the United States government invite experts to meet independently to choose the three influenza strains they believe are most likely to cause outbreaks the following season.

The three strains are turned into the following season's vaccine, and W.H.O. provides the seed viruses free to all vaccine manufacturers.

The Fujian strain was detected too late to be included in this season's vaccine. Officials have said that the vaccine should still afford "some protection" against the Fujian strain but do not know how much.

Because the manufacture of influenza vaccine is entirely in the private sector in the United States , market forces determine the amount produced.

One reason for the gap between supply and demand this season is the perennial lack of response to pleas from health officials for most Americans to get flu shots. That consumer response forced manufacturers to discard 12 million of the 95 million doses produced last season at a loss of millions of dollars. So manufacturers produced 83 million doses for this season.

The time when the three strains are chosen is critical to vaccine production. One reason is that it takes tens of millions of chicken eggs to produce each season's vaccine, and they must be bought months in advance. Once production is complete, additional doses cannot be made without reducing the amount that could be produced for the next influenza season, Dr. Gerberding said.

Because the process is complex and even the best influenza vaccines are about 70 to 90 percent effective, a notch below the standard childhood immunizations, health officials have long urged researchers and industry to find new ways to produce influenza vaccine. Scientists have come up with promising new methods. But major problems, including those involving technology and intellectual property rights, are unresolved.

Dr. Barry R. Bloom, dean of the Harvard School of Public Health, said that because of industry's limited capacity to make vaccine, "we would be in terrible shape" if there was a pandemic of a virulent strain. "That is unlikely to change without government intervention," he said.

Soon after the swine flu episode in 1976, the government began drafting a plan for its response to a real pandemic. Then in 1993, it created a panel to come up with the plan. Many drafts have been prepared as the science has changed, but there is no final one, said Dr. Bruce G. Gellin, the director of the government's National Vaccine Program Office.

Critics say an official plan is needed. But even a draft, Dr. Gellin said, has been useful as a blueprint for preparing against a bioterrorism attack and in dealing with SARS.

"We need to diversify our manufacturing base and develop new techniques to improve our chances of success," Dr. Gellin said. "Ideally, that would produce a vaccine that would be given once and protect against all influenza viruses."

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