Preventing release of lethal science

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When researchers used federal funding to genetically mutate the lethal H5N1 bird flu virus to make it capable of respiratory transmission between ferrets, the U.S. government was caught flat-footed on how to proceed with this potentially dangerous research. This week, a Senate panel is investigating biological security in the wake of the H5N1 research, with good reason.

Initially, the National Science Advisory Board for Biosecurity (NSABB) recommended against publication of the research. The board initially believed that any benefits from publishing the research were outweighed by the risks that the information could be used as a recipe for terrorists seeking to create biological weapons. But when the National Institutes of Health asked the board to reconvene three weeks later, the NSABB recommended in favor of publication.

Then in a leaked letter, Michael T. Osterholm, a member of NSABB and director of the Center for Infectious Disease Research and Policy at the University of Minnesota, wrote that the decision to reverse its position on the H5N1 studies was based on a biased presentation of the evidence and was “a lot less about a robust science and policy-based risk-benefit analysis and more about how to get us out of this difficult situation.”

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The controversy surrounding the H5N1 study and the criticisms in Mr. Osterholm’s letter confirm my suspicions that the U.S. government is woefully unprepared for dealing with dual use research of concern – research that, while conducted for a legitimate scientific purpose, could be dangerous if misused. In the present case, the government presumably did not address the risks of misuse until after the research was submitted for publication. Furthermore, once the NSABB recommended against publication, the government had no mechanism for sharing the research on a limited basis with those researchers with a legitimate need to analyze the results.

On March 1, I wrote to Office of Science and Technology Policy Director John P. Holdren and raised concerns about the U.S. government’s policies on potentially dangerous research. A few weeks later, the administration announced a new policy that asked federal agencies to review research they conduct or fund that involves specific pathogens that “pose the greatest risk of deliberate misuse with most significant potential for mass casualties.”

In his response to my letter, Mr. Holdren cited the new policy as the government’s mechanism to identify future research of concern and argued that, until now, the government has “not needed to have a system in place” for restricting dissemination of dual use research because this is the first time the NSABB recommended restricting publication.

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While this issue has been brought to the public’s attention by the H5N1 study, the U.S. government should not have been caught by surprise. The NSABB was created in 2004 and charged with the specific responsibility of reviewing this type of research and offering guidance to all federal agencies that conduct biological research.

If properly implemented, the administration’s new, albeit belated, policy for life science review could help identify sensitive research, but it does nothing to address the government’s inability to control its dissemination if necessary. By asking the NSABB to reconvene and steering the board toward reconsidering its recommendation, the administration has simply kicked that can down the road.
The stakes couldn’t be higher. Of the 598 confirmed cases of bird flu, 352 were fatal. The vast majority of these cases were contracted by individuals who worked in close proximity to birds. If the genetically mutated and more easily transmissible virus was released in nature, the effect could be devastating. Mr. Osterholm noted in his letter that one of the researchers who conducted the H5N1 study has found an additional mutation that allows for virus transmission between mammals. The NSABB will likely consider this research as well, so the administration has not, in fact, kicked the can very far.

The risk to national security is both immediate and real. Secretary of State Hillary Rodham Clinton issued a warning at the United Nations Biological Weapons Convention Review in December that the threat of biological weapons could no longer be ignored and that “al Qaeda in the Arabian Peninsula made a call to arms for – and I quote – ‘brothers with degrees in microbiology or chemistry to develop a weapon of mass destruction.’ “

I am investigating further the actions of NSABB and will watch closely to see how the administration implements the new policy. The challenge of how to deal with the publication and dissemination of potentially dangerous research is not going away, and it is long past time for the administration to prepare the U.S. government to handle potentially dangerous research.

Rep. F. James Sensenbrenner Jr. (R-Wis.) is vice chairman of the House Committee on Science, Space and Technology.

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