June 27, 2004
The federal government has responded to the threat of bioterrorism with a spending blitz that has already surpassed the annual cost of the Manhattan Project to build the first atom bomb. But as illustrated by a recent mishap in which a Frederick lab inadvertently shipped lethal anthrax across the country, the biodefense push might be creating new hazards even as it seeks to make the country safer.
The flood of new money - $14.5 billion spent since 2001 - has drawn scores of new researchers and facilities into the field, creating more possibilities for the release of anthrax and other "select agents," the legal term for pathogens with bioterrorist potential.
Known incidents have been few, but scientists say the proliferation of places and people involved in germ experiments in the United States - 11,119 workers in 317 labs approved to date - inevitably boosts the chance of accidental leaks or deliberate diversion of germs.
In addition, the Bioterrorism Act of 2002 requires that the location of labs handling lethal pathogens be kept secret, giving citizens no way to find out what research is being conducted in their neighborhoods.
Martin E. Hugh-Jones, a veteran anthrax researcher at Louisiana State University, says he has been "amazed" by the influx of people into his field.
Before 2001, with only a dozen U.S. research groups studying anthrax, "we all knew each other by first name," Hugh-Jones says. Today, when he reviews anthrax research proposals, "I see a lot of names I've never heard of. ... On a probabilistic basis, there's more of a risk of accidents or attacks," he says.
While advances have been made toward new ways to detect anthrax, Hugh-Jones says that overall, "I think we've spent an awful lot of money, and I'm not sure we're much better off."
Richard H. Ebright, a Rutgers University biochemist and critic of the expansion, said the lure of funding has drawn neophytes into the field. "With the expansion of the biodefense effort - especially to institutions and individuals without experience with lethal biological agents - accidents are more likely," he says.
"I think people will find it surprising that 11,000 people are cleared to work with the most dangerous agents, which have little importance for public health outside the bioterrorism field," Ebright says.
Passed in the aftermath of the anthrax letters that killed five people in 2001, the Bioterrorism Act imposed tough new regulations on germ research. Safety experts say that while researchers complain about paperwork, the rules have unquestionably raised awareness of the threat and added accountability to a field with lax recordkeeping.
Stefan Wagener, president of the American Biological Safety Association, says the law prompted some labs to destroy little-used stocks of germs, sometimes forgotten in freezers, that might have posed a hazard.
"I would say the impact has been positive," says Wagener, a microbiologist who oversees the Canadian government's highest-security biodefense lab, in Winnipeg, Manitoba. "But has the law made the United States safer from an insider's bioterrorist attack?
"That's harder to answer."
It is also an important question, because the FBI has focused its investigation of the still-unsolved anthrax attacks largely on U.S. biodefense facilities rather than foreign terrorist groups. The letters contained a strain of anthrax used mainly in a few U.S. and foreign labs supplied by the Army's biodefense center at Fort Detrick.
Since registration began last year, the federal Centers for Disease Control and Prevention have inspected and fully certified 235 facilities nationwide and given provisional approval to 82 more to work with anthrax and other select agents. The 11,119 people who work in them have been cleared by the FBI, which checked them against criminal and terrorist databases.
Not all applicants have passed muster. The CDC has denied three labs' applications and "suspended" nine others, indicating that a provisional approval was revoked, said Ted Jones, acting director of the Select Agent Program.
The FBI's Monte D. McKee, who oversees the checks on lab workers, will say only that "less than 1 percent" of lab workers have been turned down, usually because of a criminal record. The check does not involve confirming the worker's academic or work credentials, or interviewing associates, he says.
Because there was no previous count of labs or researchers, it's impossible to measure the growth precisely. But most observers say that while red tape has driven some scientists out of the field, new research money has attracted a greater number.
The National Institutes of Health's database of research grants shows that the number of projects involving anthrax soared from 28 in 2000 to 253 last year. NIH projects mentioning "bioterrorism" and related words climbed from 25 in 2000 to 665 last year.
"The number of institutions working actively with select agents has skyrocketed," says Edward Hammond, who tracks biodefense research for the Sunshine Project, a Texas-based watchdog group. "In terms of accidental release, I think we're unquestionably less safe than we were before 2001."
The federal spending increase has been so rapid that even the government seems to be having trouble keeping track. In April, when President Bush issued a sweeping directive to step up the nation's defenses against bioterrorism, the White House said the government had spent $10 billion on biodefense since 2001. The Department of Health and Human Services counted $12.9 billion the same day.
But Ari Schuler, an analyst at the Baltimore-based Center for Biosecurity of the University of Pittsburgh Medical Center, did a more complete search and documented $14.5 billion in federal spending on civilian biodefense since 2001. For the 2005 fiscal year that starts Oct. 1, President Bush has requested a record $7.6 billion, more than 18 times the budget in 2001.
For the years 2002 to 2005, average annual biodefense spending comes out to $5.4 billion a year - more than the annual spending in 2004 dollars on the Manhattan Project, the World War II quest for an atomic bomb, or the Reagan-era Strategic Defense Initiative, a missile defense program.
Some of the money has gone into buying a stockpile of antibiotics and improving communications between local, state and federal health authorities. But much has gone to hands-on research on dangerous germs.
Some of the new work is being done at Southern Research Institute in Frederick, which accidentally shipped the potentially lethal anthrax to research collaborators in Oakland, Calif.
Thomas G. Voss, a microbiologist who oversees SRI's homeland defense work, said that before late 2001 the Frederick lab had handled only mild vaccine strains of anthrax.
Since then, he said, virulent strains have been used for research on vaccines, antibiotics and detection methods.
In March, SRI shipped vials of a liquid anthrax mixture by Federal Express in a sealed container to Children's Hospital Oakland Research Institute in California for a vaccine study. The anthrax was of a virulent strain, but SRI workers had tried to kill the bacteria before shipping it by immersing the vials in hot water, Voss said.
Only early this month, after two groups of mice inoculated with the supposedly "inactivated" anthrax sickened and died, did the Oakland researchers suspect something was awry. Tests showed the anthrax bacteria were alive.
At least seven people working on the Oakland project were given antibiotics as a precaution, officials said. None has developed symptoms of anthrax.
SRI officials did not return phone calls last week. In an earlier interview, Voss said the company would review its procedures for killing anthrax. But he said, "The take-home message is, this is biology, which can be unpredictable."
CDC spokesman Von Roebuck said the agency is monitoring SRI's self-review. But he said that while the incident suggests that "there's a tradeoff" in safety with growing numbers of labs conducting biodefense work, the registration and background checks "certainly raise the safety level."
The Bioterrorism Act requires labs to report the theft, loss or release of pathogens. The CDC was unable to provide the number of such incidents, but Jones said there have been "not very many."
Jones said the law's confidentiality requirements prohibit him from saying whether SRI is registered to handle select agents. "I'm not confirming or denying that this [SRI] is a registered entity," he said.
The confidentiality rules, designed to prevent terrorists from learning the location of germ stocks, also keeps the public in the dark, says Hammond, of the Sunshine Project.
"There is legitimate information to withhold - such as the combination to the lock on a lab's freezer," Hammond says. "But the mere fact of which institutions are using select agents, which agents they're using and what they're doing with them should be made public."
Copyright (c) 2004, The Baltimore Sun
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