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University of Washington Bends Biosafety
Sunshine Project
As more laboratories begin to handle genetically-recreated 1918 “Spanish” Flu [1] and similar flu strains, the chances that a lab will be the source of the next global influenza pandemic increase.
The skyrocketing biodefense budget, now exceeding that of the Manhattan Project (adjusted for inflation), is rapidly increasing research on biological weapons agents, including risky genetic engineering projects. Despite this, the Bush administration maintains that comprehensive laboratory safety and disclosure law is unnecessary, because an alleged “culture of responsibility” among institutional biosafety committees will protect Americans, and the world, from its biodefense research.
But at the University of Washington in Seattle, whose scientists are eager to handle 1918 Spanish Flu, the IBC’s judgment is unsound. It has approved experiments by summarily changing the containment level of a planned lab, using inappropriate safety benchmarks, and unilaterally lowering the safety threshold required for work with the potentially pandemic virus.
In its heyday decades ago, 1918 influenza killed ten, perhaps twenty million people worldwide. The 1918 flu was recently brought back to life by scientists from the US Departments of Defense and Agriculture and private institutions including the Mt. Sinai School of Medicine in New York. Digging through archives of medical samples and, literally, digging up the dead, the team’s work resulted in the re-emergence—in the lab—of one of the most dreaded diseases in human history.
The 1918 flu was recreated at a lab at the University of Georgia. Now, flu strains with 1918 genes are cropping up in other labs across the country. There are reasons for scientists to study why the 1918 flu was so devastating. A similarly virulent strain could reappear naturally. But that doesn’t necessarily justify recreating and widely distributing a very dangerous—and otherwise eradicated—bug.
Because influenza spreads so easily, as the “new” strain and its lab-created genetic cousins are sent to more facilities, the risk that the next major influenza pandemic will be man-made is on the rise. It wouldn’t be the first time that an influenza lab accident made the whole world ill. [2] And, of course, scientists in other countries may repeat the US experiments, resulting in even wider proliferation of very dangerous man-made bugs.
So, then, it is logically the case that responsible labs that are handling 1918 influenza are taking extraordinary precautions through their institutional biosafety committees (IBCs), which are charged with ensuring the safety of such experiments. Ideally, that is. But things got off to a bad start with the 1918 influenza. When it was recreated, neither the US Department of Agriculture nor the University of Georgia (the institutions in charge of the Georgia lab) bothered to have an IBC review the experiments. [3]
The 1918 flu was recently brought back to life. . .
Still, according to science policymakers, USDA and Georgia’s failure should be an anomaly. But the rhetoric isn’t matched by the realities of the IBC system. USDA and the University of Georgia aren’t the only problems. In fact, they aren’t even the only problem when it comes to 1918 influenza.
In Seattle, University of Washington (UW) researchers are gearing up for some of the most ambitious experiments yet undertaken with 1918 influenza. UW will work with the recreated flu and make more types by inserting the critical 1918 virulence-related genes into a similar (H1N1) but less dangerous type of flu that was isolated in Texas in 1991. UW researchers’ plans include culturing 1918 viruses, infecting animal cell lines with them, isolating samples after such ‘passages’ and, in the course of research, shuffling through the lab with various biological materials and equipment containing live 1918 flu types.
The objective is to develop and research a non-human primate (Pigtail macaque) model for 1918 influenza infection. In other words, the experiments will culminate by UW spraying lab monkeys with genetically engineered 1918/Texas flu and recording the results. The macaques might rather be home in Southeast Asia, but the hope is that using them as models for human infection with 1918 flu will provide useful information for managing flu outbreaks, either natural or deliberate.
But the University of Washington doesn’t have an appropriate facility for the studies and its IBC isn’t at all clear or vigorous in implementing necessary safety protocols.
The UW IBC’s approval of Spanish flu experiments is, however, critical for the projects to receive federal funding. So, in August 2003, the UW IBC took up the matter. The first problem it encountered was that the animal biosafety level three (ABSL-3) facility where the experiments were to take place hasn’t been built. Secondly, USDA, which was providing the 1918 influenza, had classified it as requiring BSL-3ag containment.[4] BSL-3ag is a more stringent standard than that of existing UW labs and the planned ABSL-3 lab.
BSL-3ag is just one step short of maximum containment BSL-4, the level that a cautious institution might have assigned the 1918 constructs in the first place. (Neither USDA nor Georgia, however, have a BSL-4 lab.)
. . . institutional biosafety committees (IBCs). . . are charged with ensuring the safety of such experiments. Ideally, that is.
Apparently unwilling to hold its researchers back over biosafety issues, and despite the lack of adequate facilities, the UW IBC approved 1918 flu projects. It has allowed some activities to go forward in an existing (non-animal) BSL-3 facility, despite USDA’s BSL-3ag designation of the agent. Remarkably, the UW IBC also decided, on the spot, to change the biosafety level of the new UW lab. The IBC decided that the new lab, previously not intended to be BSL-3ag, would meet the more stringent designation “in principle.”
This dubious endorsement enabled grant applications to move forward and UW researchers to proceed to acquire the 1918 flu from USDA, with the “in principle” UW BSL-3ag lab.
After “resolving” the problem of not having appropriate containment, the UW IBC then considered the operating procedures to be followed in the existing BSL-3 lab for 1918 flu experiments. Here, the “culture of responsibility” of the UW IBC again failed.
The benchmark that the UW IBC referred to for 1918 flu safety was procedures used to handle human immunodeficiency virus (HIV). But the virus that causes AIDS is relatively difficult to transmit, especially by aerosol, the main cause for concern with influenza.
Moreover, the risk to the community posed by a lab-acquired HIV infection is trivial in comparison to the threat posed to the world by a case of potentially pandemic influenza.
The UW IBC only considered one of the many opportunities for influenza aerosolization in the studies, that of a tray being dropped. In such an event, the UW IBC decided that researchers “will be trained to stop breathing... just as they are taught to do when working with HIV.” An independent microbiologist who the Sunshine Project provided with a copy of the UW IBC minutes called the UW biosafety protocols in the 1918 project “inappropriate” and “risible.”
The minutes of the UW IBC also suggest—but don’t entirely clarify—that UW researchers, already working at a lower level of containment than that assigned by USDA, may plan to place cultures infected with 1918 influenza in an unshielded centrifuge. Because their spinning energy can rapidly aerosolize liquids, centrifuges are a notorious source of laboratory infections.
UW’s irresponsible treatment of biosafety in the 1918 influenza project does not appear to bother the National Institute of Allergy and Infectious Disease (NIAID). NIAID recently funded the project. Its formal start date was July 1, 2004.[5]
For further information contact the Sunshine Project, http://www.sunshine-project.org/.
Notes
1. The 1918 influenza strain is popularly called “Spanish” influenza, based on incorrect suspicions about its origin at the time of the outbreak. In fact, to this day, there is no scientific consensus on the origin of the strain.
2. It is an unpublished but open secret among influenza researchers that a global pandemic of H1N1-type influenza that began in 1977 was, in all likelihood, the result of an accidental release from a lab in China. Public references to the origin of this outbreak occasionally surface. See, for example, ProMedMail, 1 June 2004 (http://www.promedmail.org/).
3. USDA Agricultural Research Service reply, dated 2 October 2003, to Sunshine Project FOIA of 11 August 2003 for minutes of the IBC meeting that reviewed 1918 influenza experiments. Personal communication with Daryl Rowe, Institutional Biosafety Officer, University of Georgia, September 2003.
4. How USDA and/or Georgia determined BSL-3ag containment, which is stated in the UW IBC minutes and NIH grant abstracts, is unclear. As indicated in note 3, under FOIA, USDA asserts that no IBC ever reviewed the project to recreate 1918 influenza.
5. NIH Grant 1P01AI058113-01 to the Mt. Sinai School of Medicine includes the UW component for 1918 influenza studies.
Other sources
Minutes of the University of Washington Institutional Biosafety Committee, meetings of 2 December 2002 and 22 August 2003.
Baskin CR et al. Gene Expression Control in Pigtail Macaques Infected with Influenza A/Texas/36/91: A PILOT STUDY; Innate Immune Response and Patterns of Immune Cell Migration in an Uncomplicated Influenza Infection, online poster submission for the Fifth Annual Northwest Gene Expression Conference, to be held at the University of Washington, 25-27 May 2005. URL
http://ra.microslu.washington.edu/Website/nwgec/posters/postersubmit.html
[29 dec 04]