10/23/2001

http://www.usatoday.com/news/comment/2001-10-23-ncguest2.htm
Anthrax vaccine isn't cure-all

Anthrax vaccine isn't cure-all

By Ivan Oransky and Jeanne Lenzer

With more than three-dozen cases of confirmed anthrax exposure putting the United States into a panic, and antibiotics flying off the shelves, it's time to ask: What happened to the anthrax vaccine?

Some is available, but not to the general public. And it hasn't been produced since 1998 because of quality-control concerns at the manufacturing facility.

Last week, the only U.S. maker of an anthrax vaccine, Michigan-based BioPort Corp., asked the Food and Drug Administration for approval to resume distributing the shots. But big questions remain about the vaccine's effectiveness.

In 1997, the Pentagon ordered that all troops be immunized using BioPort's vaccine. But only some 500,000 of the 2.4 million active and reserve troops have received the shots, partly because BioPort's facility is closed and partly because some troops have been reluctant to get the shots.

One concern is the fear that the vaccine could be a cause of the elusive Gulf War Syndrome, although the Pentagon argues that vaccinated troops have no more problems than non-vaccinated troops. But even if side effects are imaginary, does the vaccine actually work?

The Pentagon says it does. It quotes a study's findings that the vaccine was 88% effective in monkeys after 100 weeks. In other studies, 62 of 65 vaccinated monkeys survived lethal challenges of inhaled anthrax while none of 18 unvaccinated monkeys survived. The Defense Department also points to a study, some 40 years old, of at-risk wool-mill workers that it says showed the vaccine is 93% effective.

But Dr. Meryl Nass, who has written extensively about the anthrax vaccine and testified about it in congressional hearings, isn't convinced. "You won't see me getting in line for the vaccine," she says.

At best, some protection

A report last year by the House's Government Reform Committee supported Nass' concerns. The committee concluded: "At best, the vaccine provides some measure of protection to most who receive it. Just how much protection is acquired, by whom, for how long and against what level of challenge are questions (the Defense Department) answers with an excess of faith but a paucity of science."

The committee also found that multiple animal studies using different strains of anthrax produced widely differing results: "Without a proven model in animals that is known to correlate to protection in humans, animal data remain only suggestive."

Some doctors, including ones from the National Naval Medical Center and the U.S. Army Medical Research Institute of Infectious Diseases, also have challenged the Pentagon claim that the vaccine is 93% effective in humans.

In a 1998 Archives of Internal Medicine article, doctors noted that both the skin form and the more deadly inhaled form of anthrax were included in the study cited by the Defense Department. However, the authors noted, the 93% effectiveness claim may apply only to the skin form of anthrax, because the number of inhaled-anthrax cases was too low to assess protection against that form of the disease.

Trapped in a sole-source relationship

Despite these doubts, the government likely will reopen BioPort's plant, into which it has poured more than $126 million. As the House report noted, the Defense Department is "captive to old technology and a single, untested company" because BioPort's plant is the nation's sole producer of anthrax vaccine.

The FDA would be remiss if it cut corners and reopened the BioPort facility prematurely in response to public uncertainty and concerns about anthrax. Instead, the government needs to take a measured look at all potential treatments or preventive measures for anthrax. A faulty vaccine would be worse than none at all, especially if it lulls Americans into a false sense of complacency.

Ivan Oransky, a medical doctor, is editor of Praxis Post, a Web magazine of medicine and culture. Jeanne Lenzer is a freelance writer in New York.