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THIRD WORLD NETWORK BIOSAFETY
INFORMATION SERVICE We bring to you two articles which raise several issues related to laboratory biosafety, bioterrorism and contained use. The New York Times article highlights a number of incidences where biodefence work on vaccines or germs resulted in mishaps which put into question the ability and capacity of labs in handling such experiments safely. The prospect of escape of dangerous viruses or bacteria is real, with the health of lab workers and the public put at risk. Meanwhile, the WHO is considering creating a genetically engineered version of the smallpox virus to counter any threat of a bioterrorist attack. Opponents warn that tinkering with the genetic makeup of the variola virus - which causes smallpox - might accidentally produce a more lethal form of the disease. Genetic engineering may cause unintended effects, for example, a few years ago Australian scientists inadvertently created a highly virulent strain of a mousepox virus (related to the smallpox virus) just by inserting an apparently harmless gene. With best wishes, REF: Doc.TWN/Biosafety/2005/D
Exposure at Germ Lab Reignites
a Public Health Debate 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 contracted flulike illnesses in May, no one tied the symptoms 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 Massachusetts 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." "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," said Tomas Aguilar, of Alternatives for Community and Environment, a group opposed to the laboratory. "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 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."
Outcry over creation of GM
smallpox virus Senior scientific advisers to the World Health Organisation (WHO) have recommended the creation of a genetically modified version of the smallpox virus to counter any threat of a bioterrorist attack. Permitting researchers to engineer the genes of one of the most dangerous infections known to man would make it easier to develop new drugs against smallpox, the scientists said. But the man who led the successful global vaccination campaign to eradicate smallpox from the wild said he opposed the move on the grounds that the scientific benefits were not worth the risks to public health. Professor Donald Henderson, of the Centre for Biosecurity at the University of Pittsburgh, said he feared that tinkering with the genetic makeup of the variola virus - which causes smallpox - might accidentally produce a more lethal form of the disease. "What I worry about is that there is rather too much done in this area and the minute you start fooling around with it in various ways, I think there is a danger," Professor Henderson said. "I'd be happier if we were not doing it and the simple reason is I just don't think it serves a purpose I can support. The less we do with the smallpox virus and the less we do in the way of manipulation at this point I think the better off we are." Laboratory stocks of smallpox are stored at only two locations - one in America and one in Russia - but there are fears that samples of the virus may have fallen into the hands of terrorists. Scientists advising the WHO believe that creating a GM form of the virus would accelerate research into developing new antivirals. The WHO is due to consider the recommendations of its scientific committee at the world health assembly in May. Four years ago, scientists in Australia genetically modified a mousepox virus and inadvertently created a highly virulent strain that could not be stopped by vaccination. But the WHO insisted the latest proposal to engineer the human smallpox virus was inherently safer. Professor Geoffrey Smith of Imperial College London, who chairs the WHO committee for variola virus research, said American scientists simply wanted to insert a jellyfish gene, which produced a glow under fluorescent light, in order to see the virus better under the microscope. "The reason why the proposal was made and the reason why the committee was prepared to consider it was that it is clear that there is a need to develop drugs against the virus," Professor Smith said. "The quickest way to screen a large database of compounds is to have an automated way and if you have a virus that expresses the green fluorescent protein you can do the drug screening in a much more rapid and automated way." It is understood there are seven recommendations in the proposal, including permission to allow relatively large fragments of the virus - up to 20 per cent of its entire genome - to be shipped from the two secure laboratories to other research institutes in the world. Another recommendation allows Russian and US laboratories to snip small fragments of the virus and insert them into other members of the same pox-virus family. Smallpox is one of the biggest killers in the history of infectious diseases. At least 300 million people died of it in the 20th century alone. It was eradicated in 1977.
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