|Exposure at Germ Lab
Reignites a Public Health Debate
By SCOTT SHANE
Published: January 24, 2005
http://www.nytimes.com/2005/01/24/national/24lab.html?th (must register to view original article)
Last year, while working on a vaccine to protect against bioterrorist attacks, three laboratory workers at Boston University were exposed to the bacteria that cause a rare disease called tularemia, or rabbit fever.
The workers recovered, though two of them had to be hospitalized. But the prognosis is less certain for the university's ambitious plan to build a high-security biodefense laboratory, part of a national boom in germ defense research touched off by the Sept. 11 attacks and the anthrax letters of 2001.
The tularemia episode, acknowledged by university officials only after inquiries last week from the news media, has outraged opponents of the proposed $178 million laboratory and reignited a national debate over whether the rapid expansion in work with dangerous pathogens is adequately regulated and scientifically justified.
The Boston case follows other mishaps in germ research, including the accidental shipment of virulent live anthrax from Maryland to California last March, and an investigation that revealed multiple spills of anthrax bacteria in the Army's biodefense laboratory. Such incidents have led some scientists to ask whether the growing number of germ laboratories - financed from the $14.5 billion in federal money spent on civilian biodefense since 2001 - may pose a menace to public health comparable to the still uncertain threat from bioterrorism.
Dr. David Ozonoff, a professor of environmental health at the Boston University School of Public Health who originally supported the new laboratory but now opposes it, argues that biodefense spending has shifted money away from "bread-and-butter public health concerns." Given the diversion of resources and the potential for germs to leak or be diverted, he said, "I believe the lab will make us less safe."
Dr. Mark S. Klempner, associate provost for research at Boston University's medical school, says the proposed laboratory, to be designated a National Biocontainment Laboratory along with one to be built in Galveston, Tex., will pose no public hazard. To be designated Biosafety Level 4 - the highest level of security - it will develop drugs and vaccines to protect not only against bioterror agents but also such natural emerging diseases as SARS and West Nile virus, he said.
"The nation needs this lab," Dr. Klempner said.
Such disparate views among scientists reflect deep uncertainty about the scale and imminence of the bioterror threat. Some experts believe an attack that could kill tens of thousands of people is plausible today. Others argue that the known terrorist groups have little sophistication about biological weapons. Instead, these critics say, the biodefense expansion has been fueled by a scramble for federal money.
Currently there are four Biosafety Level 4 laboratories nationwide, with six more planned; 50 laboratories operate at Biosafety Level 3, sufficient to work with anthrax, and 19 more are planned at universities and government institutions, according to the Sunshine Project, a Texas group that is tracking the growth.
In the only major bioterrorist attack in American history - the anthrax-laced letters mailed to news media figures and two senators in fall 2001, killing five people - F.B.I. investigators have focused chiefly on the theory that the anthrax originated not with outside terrorists but within an American biodefense program.
By the same token, the critics say, the tularemia that sickened the workers in Boston would not have existed if not for bioterror research. Dr. Richard H. Ebright, a molecular biologist at Rutgers University, said the disease "has zero public-health importance." Only about 130 cases a year are reported in the United States.
The flood of biodefense financing has drawn hundreds of inexperienced researchers into work with hazardous organisms, Dr. Ebright said. The Boston accident, he added, "shows gross, basic incompetence and raises real questions about the competence of that institution to run a biosafety Level 4 lab."
Boston University officials concede that the tularemia vaccine researchers did not follow proper safety procedures and have removed the principal investigator, Dr. Peter A. Rice, from his post as chief of infectious diseases. Dr. Rice was to have had a role training workers for the proposed high-security laboratory.
University officials say the tularemia vaccine researchers thought they were working with a harmless "vaccine strain" of the Francisella tularensis bacterium. But for reasons unexplained, the sample was mixed with a virulent strain.
When two laboratory workers developed flulike symptoms in May, no one tied the illnesses to the research, said Dr. Thomas J. Moore, acting provost of the university's medical campus. Only after a third worker was hospitalized for several days in September did Dr. Rice first pursue the possibility of tularemia.
Dr. Moore said the tularemia diagnosis was confirmed on Oct. 29 but not reported to state health authorities until Nov. 9, a delay he said he could not explain. But he defended the decision not to tell the public.
"I feel comfortable about the decision not to make a public announcement because there wasn't a public risk, since tularemia can't be passed from person to person," Dr. Moore said.
Opponents of the proposed laboratory see things differently. Douglas H. Wilkins, a Boston lawyer who filed a lawsuit on Jan. 12 challenging the laboratory plan on behalf of 10 neighborhood residents, noted that the university's environmental impact statement claims the medical center has "not had any laboratory-acquired infections."
Tomas Aguilar of Alternatives for Community and Environment, a group opposed to the laboratory, said: "Three infections in a five-month period - and this is all going on when Boston University is saying how safe this dangerous laboratory is going to be. A lot of people are saying, 'It's even worse than we thought.' "
Similar safety questions have been raised by two other incidents. In 2002, the discovery of lethal anthrax outside a high-security laboratory at the military's premier biodefense laboratory, the Army Medical Research Institute of Infectious Diseases at Fort Detrick in Maryland, led to sampling throughout the institute. Investigators found three different strains of anthrax bacteria outside the sealed-off laboratories, indicating at least that many leaks, according to an Army report.
Then, last spring, Southern Research Institute, a contractor in Frederick, Md., shipped anthrax bacteria to an Oakland, Calif., hospital after immersing it in hot water to kill the germs. When mice injected with the supposedly harmless bacteria for a vaccine experiment quickly died, researchers realized the bacteria were still lethal.
Those incidents produced no human illnesses. But Dr. Ebright said some current research poses a much higher risk, notably the work by several groups that are trying to reconstruct the 1918 influenza virus, which killed more than 20 million people.
"This work is being done in the absence of any real oversight," he said.
One scientist who supports the increase in biodefense spending, Dr. Tara O'Toole, does not dismiss the safety issues. In fact, she said, the biodefense expansion has focused attention on long-neglected biosafety rules. But she believes the danger of bioterrorism is so great that the billions of dollars being spent on protections may not be enough.
"I think bioterrorism is the biggest national security threat of the 21st century," said Dr. O'Toole, director of the Center for Biosecurity of the University of Pittsburgh Medical Center. "So I want a robust biodefense research and development program."
Dr. O'Toole recently helped organize a bioterror exercise, called Atlantic Storm, in which terrorists attack with smallpox in the United States and four foreign countries, killing more than 87,000 people. Such a potential toll puts the risk of laboratory accidents in a different perspective.
But is that situation realistic, when nothing remotely approaching such an attack has ever occurred?
"After 9/11, I don't think anyone would say that just because an attack hasn't happened, it can't happen," Dr. O'Toole said. "I keep trying to talk myself out of this. But it just keeps getting scarier and scarier."