Clear and Present Danger continued...
The government's effort to produce a new vaccine stockpile for American civilians has gotten off to a slower start. It began in 1998, shortly after a public health doctor named Peggy Hamburg arrived in Washington, fresh from doing battle with an epidemic of drug-resistant tuberculosis in New York. As commissioner of health for New York City, Hamburg had already begun preparing for the possibility of a bioterrorism attack. When she took her new post as assistant secretary for planning and evaluation at the Department of Health and Human Services, Hamburg was concerned that a similar public health effort did not appear to be underway at the federal level.
Ali Maow Maalin, the last smallpox vicim. Terence Spencer - TimePix
"When I got to Washington, I called a higher-up at HHS," Hamburg says. "I asked what kinds of special, high-alert activities are we responsible for in the threat of bioterrorism. He was stunned that the department would even need to be involved in such a situation. The department didn't view the issue as theirs."
Soon after, then-HHS Secretary Donna Shalala gave Hamburg responsibility for reviewing the agency's role in protecting the nation from bioterrorism, and coming up with a road map. Hamburg began talking to other agencies, and to security experts from the National Security Council, the CIA and the Pentagon. She found that few Washington officials had grasped that a biological attack would most resemble an infectious disease epidemic and would require a massive public health effort. Some thought of a biological attack as a version of a bombing. "Somebody in the FBI told me firemen were going to go in and defuse the pathogen," says Hamburg. Other experts in the intelligence community were mired in a kind of nuke-think, the misconception that preparing for a biological threat is no different from combating nuclear weapons.
A significant turning point came when President Bill Clinton requested that HHS seek emergency funding from Congress to combat bioterrorism. One of the first tasks Hamburg set for herself was rebuilding the civilian smallpox vaccine stockpile. Initially, she hoped to piggy back on the Pentagon's effort, and that DynPort could simply ramp up production to make an additional 40 million doses for civilian use. "It seemed like a no-brainer," she says. But representatives from HHS, the Pentagon and DynPort found themselves, at a series of meetings, stumbling over one reason after another not to collaborate.
"DynPort wanted to charge us an unbelievable amount of money if we piggybacked," Hamburg recalls. "They claimed they would have to revamp their whole production methodology to make millions of doses." A former military scientist involved in the negotiations says it was JVAP that balked, because the military did not want its effort to be delayed by joining forces with HHS. A spokesman for the Pentagon says that its vaccine "remains a viable candidate for use in the civilian stockpile" if there are problems with a civilian vaccine.
A DynPort official says the company did not want to bid on the civilian vaccine contract because HHS would not accept liability for civilians who would suffer side effects from the vaccine. For every thousand people vaccinated for smallpox, several will be hit with side effects ranging in severity from giant, spreading pustules to gangrene. In the past, one or two per million died from the vaccination.
After months of wrangling, Hamburg and HHS abandoned the effort to collaborate with the military. Last year, HHS signed a $343 million contract with a different company, OraVax, a small biotech company based in Cambridge, Mass., to produce 40 million doses of smallpox vaccine for civilian use -- an amount that medical scientists believe would be enough to stop an epidemic in the United States. OraVax, which has since merged with Acambis, is already making pilot-scale lots of vaccine. Originally, it expected to produce its first 10 million doses by 2003, with the final 30 million doses available two years later. Now, that schedule has been speeded up, and by the second half of 2002 a new stockpile of smallpox vaccine will be building up.
Sometime next year, if things go according to the current plan, the last official stocks of the smallpox virus, the contents of the frozen vials in Atlanta and Novosibirsk, will be destroyed. Half an hour at 250 degrees in a sterilizing device called an autoclave ought to do it. Similar deadlines have come and gone before. For all the dread that smallpox inspires, and the terrifying possibility of its reemergence as a terrorist weapon, scientists, anti- terrorism experts and doctors remain deeply divided over whether it would now be a colossal error to eliminate those vials.
A child with smallpox in the Congo in 1960. J. Wickett - Pan American Health Organization; World Health Organization
Peter Jahrling believes strongly that the smallpox virus must be preserved to allow scientists to test AIDS-era antiviral drugs against the virus for their potential to treat victims in the event of an outbreak. Since 1995, Jahrling has led a team of scientists from Fort Detrick to spend several months a year in the biocontainment laboratory at the CDC in Atlanta, for such testing. They now have a handful of candidate drugs that can kill the smallpox virus effectively, at least in a test tube. Jahrling also has recently succeeded in infecting cynomolgus monkeys with variola, producing a disease resembling human smallpox and providing an animal model for testing both antiviral drugs and new generations of vaccine. The need to test drugs on the actual virus has been a persuasive argument against destruction in the past. The virus was given its most recent stay of execution by the WHO in 1999 in part to give Jahrling's teams more time.
D.A. Henderson objected vehemently to that delay. "You have to stretch your imagination and your pocketbook to even think an antiviral will work," he says. He argues that developing antiviral drugs for use with smallpox victims will be expensive, time-consuming and ultimately pointless, since there is no way to actually test the drug in humans before an outbreak. In his view, the vaccine vanquished smallpox before; it will do it again.
But Jahrling argues the ring method Henderson used in the past won't work now. Back then, most of the population was already immunized, so it was possible to surround a victim with people who would not get smallpox. That is not the case now. And these days, people are much more mobile. But the most important reason to search for antiviral drugs, Jahrling says, is the emergence of AIDS.
People infected with the AIDS virus have compromised immune systems and will almost certainly resist being vaccinated for smallpox, since the vaccine is a live virus that could kill them. They also will be acutely vulnerable to the smallpox virus itself, which reproduces explosively in the body when its immune system is weakened. In past epidemics, smallpox patients whose immune systems were already debilitated by another illness became human hot zones. Far more infectious than the average smallpox patient, they sent millions upon millions of viral particles into the air with every breath.
"With a family living in a thatched hut in Africa exposed to one guy shedding smallpox virus, it may be that you can successfully intervene with vaccine four days later," says Jahrling. "But that may not be true in an air-conditioned condo with recirculating air where the exposed person also has HIV and is putting out a hundred times as much virus. We just don't know."
Such uncertainties do not sway Henderson, who wants more than anything to see the official stocks of smallpox virus destroyed. He acknowledges that other countries now have clandestine stocks of virus. But the World Trade Center and Pentagon attacks have only strengthened his belief that a ceremonial destruction of the official stocks would serve as a moral deterrent to rogue nations that might consider using variola as a weapon.
It is hard to believe that moral suasion alone can stop terrorists. Yet Henderson's wish is understandable. His greatest accomplishment, indeed, one of the great achievements of medical science, could be subverted by a few vials of a tiny organism that were spirited out of Soviet bioweapons laboratories and are now being kept alive in some unknown freezer. Henderson looks out the window of his office, at a vast, dense cityscape of Baltimore. He turns back toward the room and then says, "I thought both countries could be trusted to keep it under lock and key."
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