Sunday, Sep 7, 2008
A federal panel debates making the controversial drug, now restricted to the military, available more widely.
Nov 2, 2001 | The lonesome death of Kathy Nguyen, the Bronx hospital worker who succumbed to anthrax on Wednesday, has raised the pressure another notch on public health officials, who must decide soon whether mail handlers, cops, nurses and even the public at large should receive a controversial vaccine against anthrax.
Until this week, all confirmed anthrax cases had been traced to mailrooms or a handful of letters directed to celebrities or news media. The approach to managing the disease was to blanket potentially exposed individuals with antibiotics, while disinfecting their workplaces.
Authorities haven't ruled out a post office link to Nguyen, a 61-year-old Vietnamese immigrant who lived in the Bronx and worked in a Manhattan hospital. But her case, as well the mysterious, cutaneous-anthrax infection of a New Jersey woman, have raised fears that lethal doses of free-floating anthrax spores could threaten more Americans than previously thought possible, though the threat of mass infection still remains small.
"If, in fact, the postal paradigm is changing, it's a whole new ballgame," said Dr. Anthony S. Fauci, the NIH's top infectious disease specialist. "Not only will it change where we look for anthrax, but also the kind of recommendations we'll be making for the public health."
Fauci, in a speech before hundreds of doctors at the National Institutes of Health on Wednesday, wouldn't speculate about whether the recommendations would likely include vaccination for a large swath of the public.
"You examine carefully what's going on, you collect the data and make a rational decision about the next step," he said. For the moment, it isn't a good idea for the public to get treatment of any kind.
"Twenty-one billion pieces of mail have been delivered since Oct. 2, and there is maybe one case of anthrax outside the context of the Postal Service," he said. "Most infectious disease specialists would agree at this point that the risk of hurting yourself with antibiotics is greater than the risk of getting anthrax from a letter delivered to your house."
But several hundred scientists studying the anthrax attack in CDC laboratories have reportedly started receiving the vaccine. Tens of thousands of postal workers and others potentially exposed to anthrax spores have received antibiotics, but no vaccine.
Currently, a bioterrorism subcommittee of the Advisory Committee for Immunization Practices, at the Centers for Disease Control, is discussing which populations should get the vaccine. The advisory committee should be making its recommendations soon, said panel member Lucy Thompkins, a Stanford microbiologist.
Dr. Charles Helms, an Iowa infectious disease specialist who chairs the subcommittee, says the committee began deliberations last week and is meeting by conference call. "Our decision and when we'll finish are still a bit up in the air," Helms said.
Certainly if anthrax attacks continue -- or the individuals behind the tainted letters decide to conduct an experiment, say, in the subway -- there would be a rising clamor for mass vaccination. But there are several enormous problems with vaccinating the public: Very little of the vaccine exists, and those who've taken the complex, six-injection vaccination course that was designed in the 1950s have complained of side effects, some of them severe.
The most obvious problem right now is the scarcity of the vaccine. The Pentagon is believed to have 24,000 doses, in reserve for use by threatened troops, and as many as 5 million doses more are said to have been stored by BioPort, the Lansing, Mich., manufacturer. But the Food and Drug Administration shut down BioPort's plant three years ago and put an embargo on the 5 million vaccines it has produced, because of worries about possible contamination.
BioPort has been repeatedly cited for FDA violations, including complaints about sterility, equipment maintenance as well as scientific procedure. BioPort's troubles have become a mini-scandal in the halls of Congress, where Reps. Walter Jones, R-N.C., and Christopher Shays, R-Conn., have repeatedly questioned the company's capacity to produce the crucial vaccine, and some have argued that the contract should have been taken from the politically well-connected firm. One of BioPort's owners is Adm. William Crowe, who served as chairman of the Joints Chiefs of Staff during the Reagan administration, but later was one of the few military leaders to back Bill Clinton.
"The most fundamental problem has to do with the quality of the process of vaccine manufacture," a congressional aide who asked not to be named told Salon last month. "They cannot show they can produce the same vaccine of the same potency and consistency twice in a row."
But Health and Human Services Secretary Tommy Thompson said Tuesday that BioPort could release its 5 million stored doses, and start producing 80,000 more a week, as early as Nov. 22. By then, Thompson said, the FDA will have had time to review the company's latest application to reopen the factory. The FDA hasn't committed itself to reopening the plant, said spokeswoman Leonore Gelb. In any case the Pentagon, which owns the doses that have been manufactured to date, would have to release it for wider use.
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