Grudgingly, Virologists Agree to Redact Details in Sensitive Flu Papers

20 December 2011 2:38 pm

Two groups of scientists who carried out highly controversial studies with the avian influenza virus H5N1 have reluctantly agreed to strike certain details from manuscripts describing their work after having been asked to do so by a U.S. biosecurity council. The as-yet unpublished papers, which are under review at Nature and Science, will be changed to minimize the risks that they could be misused by would-be bioterrorists.

But the stricken details may still be made available to influenza scientists who have a legitimate interest in knowing them under a new system the journals and U.S. government officials have been actively debating for some time.

The two papers have both been reviewed at length by the U.S. National Science Advisory Board for Biosecurity (NSSAB), and both have been the subject of intense global media attention the past 2 months. They have also triggered debates among scientists, security experts, and officials within various branches of the U.S. government.

The studies show how certain mutations in H5N1's genome can make the virus more easily transmissible among ferrets, flu scientists' preferred animal model—and thus, also more dangerous to humans. An H5N1 strain that transmits well between people could trigger an influenza pandemic with potentially millions of casualties, scientists fear.

This morning, the U.S. Department of Health and Human Services (HHS) issued a statement saying that NSABB has recommended to the authors and the journals that the manuscripts "not include the methodological and other details that could enable replication of the experiments by those who would seek to do harm."

The team that wrote the H5N1 paper under review at Science has grudgingly agreed to do so, says one of its members, virologist Albert Osterhaus of Erasmus MC in Rotterdam, the Netherlands. The group received the recommendations in writing on 1 December and sent Science a revised paper more than a week ago—although they completely disagree with NSABB's verdict. "This is unprecedented," says Osterhaus, who believes public health is best served by making the information widely available. Science has sent the revised version back to NSABB for another round of review, Osterhaus says.

Virologist Yoshihiro Kawaoka of the University of Wisconsin, Madison, the lead author of the paper under review at Nature, has also agreed to go along—says Terry Devitt, a spokesperson for the university—reluctantly, because he, too, feels the full results should be published. Devitt says Kawaoka is working with editors at Nature to produce a new manuscript. NSABB's recommendations to Kawaoka were quite general and did not say specifically what to redact, says Devitt, making it hard to decide what goes out. "We are doing our best to be as responsible as we can be," he says.

In this morning's statement, HHS also said that the government recognizes that the details from the studies may be important in the surveillance for pandemic strains and for the development of drugs and vaccines. That's why the U.S. government is setting up a system that will allow bona fide researchers to access the redacted information, the statement says—but it offered no details on what that system would look like, who would be in charge, how scientists would qualify for access, or how they would use it.

Science Editor-in-Chief Bruce Alberts suggested in a statement today that Science will go along with the redactions only after the U.S. government comes up with a "written, transparent plan" for access to the sensitive details. "Science editors will be evaluating how best to proceed," Alberts wrote, adding that "[o]ur response will be heavily dependent upon the further steps taken by the U.S. government."

Ginger Pinholster, a spokesperson for Science, says that Alberts has discussed the proposed system with officials at NSABB, the National Institutes of Health, the Office of Science and Technology Policy, and others for several weeks, and that he is "very optimistic" that a plan can be agreed on "in a couple of weeks." At that point, Science will publish the Rotterdam team's paper, she says.

Nature, too, is involved in discussions on how to make redacted data accessible, the journal's editor, Philip Campbell, said in a statement issued today. Campbell, too, called NSABB's recommendations "unprecedented."

NSABB also recommended that both manuscripts be revised to explain the potential public health benefits of the studies and the safety and security measures at the labs. Osterhaus says the Rotterdam team has done so in a separate editorial, in which it also explains its "genuflection" to NSABB's demands. Publication of the editorial is "a condition from our side" for publishing the paper in Science, says Osterhaus. "We have a responsibility to explain to the scientific community why we yielded to the NSABB." He hopes the arguments will win over critics, and that the full results can be published eventually.

Redacting the papers is a better solution than publishing the entire manuscripts, says Thomas Inglesby, director of Center for Biosecurity at the University of Pittsburgh Medical Center in Pennsylvania and an outspoken critic of the H5N1 work. In an editorial for the journal Biosecurity and Bioterrorism, published online last week with smallpox eradication veteran Donald Henderson, Inglesby wrote that the Science study, which is by lead author Ron Fouchier of Erasmus MC, should not have been conducted in the first place. Now that it has been done, "the information will ultimately probably get out one way or another," says Inglesby. "But hopefully by that time we'll have better countermeasures," such as vaccines. "If this information gets out later, that's better."

H5N1 is primarily a bird virus; humans can become infected but they rarely pass the illness on. The Science paper, some details of which Fouchier presented at a September meeting in Malta, shows how a combination of genetic mutations to the H5N1 genome make the virus easily transmissible between ferrets. That very likely means that the virus will transmit between humans as well, Fouchier told ScienceInsider last month, adding that the lab strain is "probably one of the most dangerous viruses you can make."

Kawaoka's study differs from Fouchier's in several respects, says Devitt, who adds that he cannot discuss details because the study has not been published.

Osterhaus is surprised that the issue appears to have raised far more debate than the 2005 publication in Science about the resurrection of the H1N1 virus that caused the 1918 flu pandemic. "I don't know why this is getting so much more attention," he says. "We could have had the fundamental debate back then."

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