University of Washington research on hold due to changing biocontainment rules
By John Dudley Miller | February 13, 2006
Controversial research to understand how macaque monkeys respond when infected with parts of the 1918 flu virus has been delayed for 16 months and will not begin for at least another year until the University of Washington (UW) renovates its regional primate lab - currently equipped only for up to Biosafety Level (BSL) 2 animal experiments - to meet beefed-up federal biosecurity requirements.
"A year and a half ago, all the regulations said [that] for influenza virus you needed biosafety level 2, and that's it," David Emery, chair of UW's institutional biosafety committee, told The Scientist. "We knew we had to go higher than that," he said, so they waited. Indeed, last fall, the US government raised the level to between BSL-3 and BSL-4, the highest possible level, and that "moving target" is one of the main reasons for the long delay, Emery said.
In September, 2004 UW professor Michael Katze won a $5.1 million grant from the National Institute for Allergy and Infectious Diseases (NIAID) to study how rhesus macaques respond to infection by ordinary flu viruses containing one or more of the eight genes in the 1918 flu. This research may provide clues why the 1918 strain was so deadly to humans, Katze told The Scientist.
The 1918 flu killed between 20 million and 50 million people worldwide. American researchers announced last October that they reconstructed the virus using tissues taken from American World War I soldiers and an Alaskan victim whose body was frozen in permafrost. The experiment raised concerns that reconstructing the deadly flu could cause another pandemic.
Katze's study is part of a five-year collaboration by UW and three other American research institutions to understand its virulence. The work at the collaborating labs has not been delayed because their facilities were all BSL-3 or above, and the new rules don't require them to make any structural changes. Katze said his lab's delay is not posing problems for his collaborators because their research does not depend on his results.
Detailed plans for the lab renovation and approvals should be completed in the next two months, according to David Anderson, acting primate center director. After the National Center for Research Resources (NCRR) - which is providing $3.7 million toward the upgrade - approves it, construction should take "approximately eight months," he said.
Jack Harding, the NCRR official in charge of regional primate centers in the US, said he worries that the moving target might rise even higher. "If people suddenly decide, based on an experiment, that the containment may suddenly need to be different," he said, "then of course, it's a whole new ballgame."
UW officials admit that another cause for the renovation's delay has been their extreme caution to avoid the kind of opposition they received when they proposed in December 2004 to build a regional biocontainment center. Local groups and some UW professors assailed the university for hiding its plans from the community, and the school dropped the project last July after the criticism scared away private investors, Emery said.
After the renovation is completed, UW departments and several federal agencies must approve the finished lab and its research procedures before Katze can begin, Anderson said. Emery and Harding say these agencies have conflicting requirements that might hold up Katze's work even longer. "They're working on harmonizing their requirements," Emery said, "but it hasn't happened yet."
Despite the delay, Katze says he's made considerable progress on his grant, studying gene expression in macaques he infected with less-virulent flu strains, in mouse lung cells infected with the 1918 flu at another institution, and in human cells infected in lab dishes. "We've done a lot of stuff," he said.
John Dudley Miller
Links within this article
Washington Regional Primate Research Center
Interim CDC-NIH Recommendation for Raising the Biosafety Level for Laboratory Work Involving Noncontemporary Human Influenza Viruses
Project 6: Microarrays and Macaque Influenza Model, PandemicINFLUENZA.org
"Researchers assemble second non-human primate genome," National Institutes of Health, February 9, 2006.
I.Ganguli, "Flu genome sequenced," The Scientist, October 6, 2005.
Title of Grant: "Molecular and biological characterization of the Spanish flu," projectINFLUENZA.org.
Division of Comparative Medicine, National Center for Research Resources, National Institutes of Health
J. Ellison, "U-W's biolab proposal gets initial thumbs-up," Seattle Post-Intelligencer, June 1, 2005.
U-W Faculty Senate Chair's Statement on Proposed Biodefense Lab