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Renegade Flu Virus

Monday, April 18, 2005; Page A16

MORE THAN three weeks have passed since a Canadian laboratory discovered that it unknowingly possessed a sample of a dangerous strain of flu virus, one that caused an epidemic in 1957. The lab informed the World Health Organization and the Centers for Disease Control and Prevention, which subsequently discovered that the Canadian lab was one of 6,000 labs around the world that had received the same strain of virus. Ironically, the virus had been sent out as part of a "quality assurance" testing exercise organized by the College of American Pathologists and other organizations. To maintain their accreditation, diagnostic labs have to periodically prove that they can identify particular viruses. Normally, the viruses used in these routine procedures are relatively benign, but in this case, Meridian Bioscience Inc., whose lab contracted to produce the testing panels, broke with accepted practice and sent out a virus against which very few people would have immunity if it escaped.

That explanation is fine, as far as it goes. Less acceptable is the fact that after three weeks no one at CDC is yet able to explain whether Meridian put this particular strain of virus in its testing samples knowingly or by accident. Meridian does not respond to questions. CDC spokesmen say the agency is "working on" coming up with an explanation, but they point out that it has no mandate to monitor lab safety. It appears that this strange accident falls through the cracks of regulation. The virus in question is not classified as a "select agent," the misuse of which would be a criminal offense, although it may eventually be reclassified that way. The lab is certified under rules set out by the Clinical Laboratory Improvement Amendments, which are ultimately under the thumb of the Department of Health and Human Services. But if Meridian was not doing anything illegal, it isn't clear what kind of action authorities will be able to take.

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Clearly, the time has come to update the rules that govern the exchange of viruses and other biological material. The world of biological science is very decentralized and growing more so all the time. As a result, as one scientist put it, the average person "might be appalled by how and how many things circulate," in cars, on planes, in refrigerated containers or in FedEx packages. This isn't necessarily a bad thing: More labs, and more science, mean more rapid cures and diagnoses. And most of the time, these transfers are completely safe. Even this odd incident has not led to anyone contracting the flu. But if the relatively free exchange of such materials is to continue, safety standards need to be updated more regularly, and everyone needs to be much clearer about what those standards are. Whatever CDC's investigation discovers, HHS's inspector general should conduct a separate review, looking not just at what happened in the Meridian lab but also examining how the current system can be changed so that it doesn't happen again.

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