focus on life sciences - Chemical & Engineering News - American ...

GOVERNMENT & POLICYbell.” Anyone seeking the information,for any purpose, could readily find it, hepointed out.And while research journals and federalagencies are under no obligation to followNSABB’s recommendations, the advisoryboard and its decisions do carry weight inthe scientific community. The board wascreated in light of a recommendation inthe 2004 National Research Council report,“Biotechnology Research in an Age ofTerrorism.”NSABB members came to the tableto discuss the H5N1 papers withdiffering opinions, recalled memberArturo Casadevall, a professor ofmicrobiology at Albert Einstein Collegeof Medicine. Initially, he said,he was opposed to the recommendationfor publishing only redactedversions of the research papers.But “the process is deliberative andpeople can change their minds,” hesaid. “I changed mine.”But other NYAS panel membersare alarmed by the NSABB recommendation,which they see as aneffort to shut down productive linesof research and censor experimentalresults.“WE NEED TO specifically address the situationof H5N1,” said Peter Palese, chair ofthe department of microbiology at MountSinai School of Medicine. The Fouchier andKawaoka research groups, he said, “are passagingan H5N1 virus in ferrets. This is perfectlylegitimate,” and many other groupshave done similar work, he noted, referringto the experimental method in which viraladaptation is achieved by repeated passagein cells or in naive animal hosts. He said theexperiments are necessary because theyhelp researchers identify the very mutationsthey should be monitoring in wildstrains of the virus that could signal onsetof a human pandemic.Palese went on to question the casefatality rate of H5N1 infection in humans,which is estimated to be in the range of50 to 80%. He explained that this rate iscalculated only from documented cases ofhuman H5N1 infection as defined by WorldCYNTHIA GOLDSMITH/CDCHealth Organization (WHO) guidelines.The overwhelming majority of infections,including those that do not result in deathor that create asymptomatic H5N1 carriers,are not likely to be reported to WHO, hesaid. These undocumented infections occurin poor, rural areas where medical care,including access to advanced laboratory diagnostics,is not likely. Because the numberof nonlethal cases is being underreported,Palese said, “the case fatality rate is muchlower than what WHO is putting out.”The questioning of thecase fatality rate by Paleseled to a testy exchangewith NSABB memberOsterhelm, who accusedPalese of putting forwardfalse information. “Thestudy you continue to cite is the worstone of all,” Osterhelm said, referring to aJanuary Proceedings of the National Academyof Sciences article cowritten by Palese andMount Sinai School of Medicine colleagueTaia T. Wang, titled “H5N1 influenzaViruses: Facts, Not Fear” (DOI: 10.1073/pnas.1121297109 ).Casadevall chimed in on the exchangeand said, “The [fatality] numbers areunbelievable no matter any way you lookat it. When these things [the experimentalviruses] get out and combine with existingstrains, the situation becomes completelyunpredictable.”Palese continued to draw fire when heDUAL USE A colorizedTEM image showsH5N1 (gold) avian fluvirus growing amongkidney cells (green).questioned the use of ferrets in the experiments.“People are equating transmissionin ferrets with ease of transmission inhumans,” he said. The animals are indeeda model, he continued, but the implicationsfor human disease are unknowableat this time. “In fact, the ferret is much toosensitive” to make good predictions abouthuman infection, Palese said. “An animalmodel is just that—a model.”“But then what would be a good model,sir?” fellow panelist Laurie Garret, a seniorfellow at the Council on ForeignRelations and a former journalistwho has written extensively onemerging diseases, shouted acrossthe table.A visibly shaken and angry Paleseresponded: “These are not conclusiveexperiments, they are notcompelling, and we are using them toshut down a lot of science.”Other panelists also raised questionsabout how to advance importantbut risky research. Jasny tried to get ata root question: “What is it that causesvirus to jump from species to species—to become more virulent?” Getting theanswer to this and other importantquestions in virology requires dualuseresearch, she said. “Any kind ofresearch can have risk associated withit—it doesn’t mean we ignore the risk.How do we move ahead?”Panel member Alan S. Rudolph,director of the joint science and technologyoffice for the government’sChemical & Biological Technologies Directorate,noted concerns about including internationalperspectives on the research—some of which did occur outside the U.S.“The problem extends well beyondour borders,” Rudolph said. He notedthat quite a lot of activity on the H5N1experiments is starting to happen abroad,including a closed-door meeting at WHOheadquarters in Geneva scheduled for Feb.16 and 17. No agenda has been posted, butthe invitation-only conference is likely totouch on data sharing and other issues,including the possibility of distributingthe mutated experimental viruses to otherresearchers.“Any kind of research can haverisk associated with it—it doesn’tmean we ignore the risk.”WWW.CEN-ONLINE.ORG 12 MARCH 2012GARRETT N OTED that international viewson how to handle this research may be verydifferent than the consensus in the U.S.She said it is important to note that, whenpeople discuss what is ultimately a healthcare issue, the U.S. is often criticized in the