Last fall, in a startling move, the U.S. government announced that a handful of U.S.-funded studies on risky pathogens were so dangerous that researchers should halt the work until experts could review them. After weeks of quiet, that review now appears to be moving forward. The National Institutes of Health (NIH) has chosen a private firm to conduct a formal risk assessment to help experts decide whether the halted studies, which generally focus on flu viruses, should ever be allowed to resume.
But two prominent scientists have written the National Science Advisory Board for Biosecurity (NSABB), a federal advisory board that is helping guide the analysis, to complain that it is being rushed through in secret and that the board lacks the needed range of expertise.
The controversy goes back to the fall of 2011, when two labs announced that they had modified the deadly H5n1 avian influenza virus to make it spread more readily in mammals. Many researchers worried about the risks of a pandemic if the new virus escaped the lab, and flu scientists doing so-called gain-of-function (GOF) experiments agreed to a 1-year pause in these studies. But the studies then restarted, despite ongoing concerns from many scientists that the risks were unacceptable.
Then last year, several accidents with dangerous pathogens at U.S. federal labs prompted the White House to step into the debate. On 17 October, federal officials halted new funding for 18 NIH-supported projects involving GOF studies that make influenza, MERS or SARS more pathogenic or likely to spread among mammals. (NIH later exempted five projects developing an animal model for MERS, and some studies on low-risk influenza strains have since been deemed not fall under this definition.)
Federal officials said the moratorium would stand while federal officials, NSABB, and the National Research Council (NRC) conducted a 1-year review of the risks and benefits of such studies. That discussion began with an NRC meeting in December where both sides aired some of the issues.
Now NIH is poised to award a contract for a risk-benefit analysis. Sources say it will go to Gryphon Scientific in Takoma Park, Maryland, a firm that has done infectious disease modeling and high-containment lab risk assessments for other agencies.
But NIH’s 1-year plan for the overall review “seems rushed” and the timetable to complete the risk-benefit study is “unrealistic,” wrote two scientists on 24 February in a letter to NSABB Chair Samuel Stanley, president of Stony Brook University in New York. “This is not the rigorous, comprehensive, in-depth risk-benefit assessment for which many groups have called,” write Nobel Prize winner Richard Roberts, chief scientific officer of New England Biolabs in Ipswich, Massachusetts, and microbiologist David Relman Stanford University in Palo Alto, California. Both are members of the Cambridge Working Group, an informal organization that last July called for such a risk-benefit analysis of GOF studies on pathogens with pandemic potential.
Among other things, the letter also calls for more transparency. “The impression is that the public is being deliberately kept in the dark, only to be presented with a fait accompli when the studies have been completed,” it says. And it urges NSABB to gather input from the international community and from vaccinemakers (proponents claim the H5N1 GOF studies inform vaccine design) and to include risk assessment experts on NSABB itself. “Given the gravity of the risks associated with this research, it is imperative that the process be of the highest caliber, with the most expert input possible, and not perceived as an unseemly rush to an outcome favorable to one side or the other,” the letter says.
The NIH Office of Science Policy said in a statement that NSABB does expect to gather public input on the risk review. It will meet this spring to recommend “a framework for guiding the risk and benefit assessments.” The public will have a chance to comment then, NIH says. As for the timetable, the plan is to complete the risk-benefit analysis by late 2015 and to keep the overall review “time-limited,” NIH says.
Meanwhile, the staff that run NSABB is undergoing a change. Amy Patterson, who oversaw biosecurity and biosafety in the NIH Office of the Director, is moving to a new position at the National Heart, Lung, and Blood Institute (NHLBI). And Mary Groesch, executive director of NSABB, told the board in an e-mail yesterday that she is moving to NHLBI to join Patterson. Groesch took flak from some scientists last July when she abruptly told many long-serving members of NSABB that they were being replaced.
*Clarification, 11:45am, 2/27/2015: The staff changes involving NSABB are not a "shake-up," as originally characterized in this story, says Lawrence Tabak, Principal Deputy Director at NIH. “This is something that had been in the works for a long time... this is a wonderful opportunity for Amy," he says. Amy Patterson’s new position at NHLBI is Director of Scientific Research Programs, Policy, and Strategic Initiatives and Chief Scientific Advisor. Patterson has been on detail as a senior adviser to the NHLBI director for the past 6 months.