- The Washington Times - Thursday, June 16, 2005

Three years and eight months after the anthrax attacks of October 2001, the civilian vaccine stockpile finally got its first doses of anthrax vaccine. The doses arrived a few weeks ago, a federal official revealed in congressional testimony Tuesday, shortly after industry officials and congressmen turned up the heat on the Department of Health and Human Services to show some tangible progress in building up the vaccine stockpile. The result: A stockpile that can cover about 170,000 people, which is not even enough for Des Moines, Iowa. Federal officials anticipate that the bulk of vaccine they are counting on to build the stockpile won’t start arriving until 2006 at earliest, and possibly not until 2008. The story of why the stockpile remains so small nearly four years after the attacks is an object lesson in the disappointing politics and science of biodefense.

The politics of anthrax biodefense appears to be one where Congress and the administration take turns dragging their feet and then exhorting the other to speed up. Lately it’s the administration that has been engaging in the foot-dragging, and Congress cracking the whip. Until Tuesday, the Department of Health and Human Services had refused to specify how much vaccine the stockpile contained. That’s because the stockpile contained at most a few hundred doses before the recent arrivals. Since VaxGen, the California company that won a massive $878 million anthrax-vaccine contract in November for a product now in clinical trials, won’t be able to deliver until 2006 at the earliest, this meant the country’s contingency plan in case of attack was to use the military’s stockpile of about 5 million doses of BioThrax, the only existing approved vaccine.

This got some in Congress angry. “I remain greatly concerned that the Department is not prepared to protect the American people from an anthrax attack,” Sen. Charles Grassley, Iowa Republican, wrote Secretary of Health and Human Services Michael Leavitt in April. Of course, Congress leaning on HHS for not moving quickly enough was ironic, since it took Congress 17 months to pass BioShield legislation. But the outcry appears to have worked. On May 6, HHS announced a new contract with BioPort, the Michigan-based maker of BioThrax, for 5 million doses. The company delivered the first million doses a few weeks ago, according to testimony Tuesday by HHS Assistant Secretary Stewart Simonson.

If the politics of biodefense has thus far been disappointing, the science isn’t much better. BioThrax is far from ideal: In 2001 the FDA required that its packaging warn about potential side effects, including lymphoma, lupus, seizures and death. It has been implicated in some servicemens lawsuits against the Pentagon. BioThrax remains the only working vaccine in existence, but HHS officials rightly view it as a temporary solution.

HHS is pinning much of its hopes on a compound under development by California-based VaxGen, but this entails its own problems. The product will be available at earliest by 2006, and possibly not until 2008 — assuming all goes well. VaxGen is speeding its product through clinical trials in the effort to get it out by 2006. It doesn’t help that VaxGen has some blots on its record: It was delisted by the NASDAQ for accounting problems, and the company abandoned a much-hyped AIDS vaccine amid allegations by investors that it misled them. It’s worth asking why HHS placed so many of the country’s anthrax-defense eggs in this one experimental basket. “Neither is a ‘quote-unquote’ perfect vaccine,” Monique Mansoura, an HHS bioengineer and research planner, told us in an interview yesterday, but she stands by VaxGen’s recombinant technology and seems confident that HHS made the right decision.

Perhaps the one encouraging lesson to take from all this is that despite the many problems, congressional pressure seemed to yield some movement. It’s not fair for Congress to drag its feet and then blame HHS for doing the same. But then, security, not fairness, is the yardstick for judging the country’s biodefense efforts.

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