Preparing for pandemic.
Nothing has the potential to save more lives in a global flu pandemic than the ability to quickly produce an effective vaccine.
President Bush has appropriately made vaccine development the cornerstone of his $7.1 billion plan to prepare the nation for a possible bird flu emergency, earmarking $2.2 billion to stockpile vaccines and anti-viral drugs and $2.8 billion for vaccine research.
But even with fast-track support in Congress, no one should underestimate the complexity of correcting structural problems in U.S. vaccine manufacturing capacity.
In a speech Tuesday at the National Institutes of Health in Bethesda, Md., Bush outlined a three-pronged strategy that will take about five years to fully implement. He called for developing and stockpiling enough vaccines and anti-viral drugs by 2010 to inoculate every American, improving worldwide monitoring to detect outbreaks and involving all levels of government in actively preparing to stop the spread of the virus.
The biggest question mark in Bush's strategy involves how quickly vaccine producers could gear up in the face of a bird flu outbreak. Right now, manufacturing flu vaccine is a cumbersome, labor-intensive process that involves growing viruses in millions of fertilized chicken eggs.
Normally, it would take about 10 weeks to modify an existing vaccine to a new strain of virus and distribute it to vaccine manufacturers. It would then take four to six months to produce large quantities of vaccine. By that time, a worldwide flu pandemic could infect millions.
Though some humans have contracted the H5N1 strain of avian flu after being in close contact with infected birds, the virus has not yet mutated to a form that is readily passed from person to person. That means there isn't a specific variant of H5N1 on which to base a vaccine.
Part of Bush's plan calls for accelerating research into ways to grow the flu vaccine virus in cell cultures rather than in chicken eggs. Cell cultures have the potential to allow greater quantities of vaccine to be produced more quickly.
Even with the promise of technological advances, the United States still lacks adequate vaccine production capacity, and there is wide disagreement about how to remedy the situation. Thirty years ago, 25 companies manufactured vaccines for the U.S. market. Last year, only two companies produced the majority of the flu vaccine supply.
The Bush administration and the drug manufacturers insist that runaway jury verdicts in product liability lawsuits have driven companies out of the high-risk business of manufacturing vaccines. The president proposes changing the nation's legal framework to limit vaccine makers' exposure to lawsuits.
But it's not as though the federal government has ignored the product liability issue. Congress created the National Vaccine Injury Compensation Program 19 years ago. It requires people who claim they were injured by a vaccine to first seek compensation from a special government fund that is supported by an excise tax. Legislation adding flu vaccine to the program passed in 2004. Admittedly, the program is imperfect, and lawyers have found ways to exploit its loopholes.
While it's true that flu vaccine manufacturing is risky, the biggest reason why U.S. companies have lost interest is that it's unprofitable. Demand is unpredictable, and unsold doses have to be discarded at the end of each flu season.
Flu vaccine is taken at most once a year. A dose generally sells for $10 to $15. In contrast, a year's supply of Lipitor to lower cholesterol is $1,600 and a 12-month supply of 50-milligram Viagra is $3,500.
It's important to address market issues that inhibit incentives to produce vaccines. Suggestions that the federal government guarantee manufacturers an annual minimum vaccine purchase and expand the number of people receiving mandatory vaccinations have already been included in proposed legislation.
Bush has taken an important and timely step toward preparing for a flu pandemic. But having a plan in place for a predictable disaster is meaningless without follow-through on the state and local levels, and that's where the nation will be looking to the president for leadership.