Senate committee seeks answers in H5N1 study debate

Apr 26, 2012 (CIDRAP News) – Spurred by events surrounding two controversial H5N1 transmission studies, a US Senate committee today questioned federal officials whose agencies have a stake in dual-use research of concern (DURC) about the procedures they use to spot possible bioterror threats.

Today's Senate committee hearing marked the first time officials have testified before Congress on the issue, and follows concerns raised in recent letters to federal officials by Rep. Jim Sensenbrenner, R-Wisc., who has questioned the Obama administration's safeguards on DURC and has inquired about allegations of bias that arose following an expert group's recommendation that helps clear the way for publication of the two papers.

The Senate Committee on Homeland Security and Governmental Affairs is the Senate's chief oversight committee and is led by Sen. Joseph Lieberman, Ind-Conn., the only member who questioned the witnesses during today's hearing, which was aired live on CSPAN and on the Senate committee's Web site. Federal officials who testified today included Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), and Daniel Gerstein, PhD, deputy under secretary for science and technology at the Department of Homeland Security (DHS).

The two H5N1 studies that helped prompt today's hearing involve a team led by Ron Fouchier, PhD, of Erasmus University in the Netherlands, and a team led by Yoshihiro Kawaoka, DVM, PhD, of the University of Wisconsin, Madison.

Witnesses also included Paul Keim, PhD, acting chair of the National Science Advisory Board for Biosecurity (NSABB), the independent expert group that advises the NIH in dual-use research issues, and Thomas Inglesby, MD, chief executive officer for the Center for Biosecurity at the University of Pittsburgh Medical Center. Keim is also director of pathogen genomics in the Translational Genomics Research Institute at Northern Arizona University.

At the start of the hearing, Lieberman said he hoped the witnesses could shed light on recent charges from NSABB member Michael T. Osterholm, PhD, MPH, that the NIH shaped the agenda for the group's meeting  in late March to induce the board to reverse its earlier recommendation to withhold details of the H5N1 studies from publication. Osterholm aired his concerns in a letter to the NIH that was leaked to ScienceInsider. Osterholm is director of the Center for Infectious Disease Research and Policy (CIDRAP), the publisher of CIDRAP News.

Fauci told the committee that H5N1 is one of the NIH's research priorities, because flu viruses are known to undergo extensive genetic changes and can jump species. "The goal is to anticipate what the virus is continually trying to do on its own." He noted that a public misperception arising during the H5N1 debates was that the aerosolized virus was lethal to the ferrets used in the study. "That was not the case," he said.

The NIH's goal is ensure that research is conducted and communicated in a transparent manner and that the risks and benefits of research are thoroughly considered, Fauci said, adding that in this case, "The risk-benefit balance clearly tips toward benefit."

Gerstein said the DHS faces DURC issues with some of its research projects, such as work on foot-and-mouth disease (FMD). He stated that project managers at early stages are trained to watch for possible DURC issues. He said not all security concerns can be entirely addressed by US policies but that a new life-sciences DURC policy unveiled Mar 29 reflects much of the agency's work and that the DHS is already well equipped to implement the changes.

Lieberman asked Gerstein and Fauci how many of the agencys' research projects fall into the DURC category. Gerstein said that of 225 research projects, between 5 and 10 fall into the highest tier of concern. Fauci said that according to a recent NIH inventory, none of the 404 intramural research projects have DURC concerns, and 10 of 381 extramural projects raise DURC concerns. Of the 10, seven involve influenza, he noted.

Keim shared some details about NSABB deliberations that led the group to reverse its earlier recommendation that only redacted versions of the two H5N1 papers be published. He said many on the board, after hearing a classified security presentation, were left with the impression that there wasn't an increased risk if the full versions of the papers were published. However, he noted that the split (12-6) vote on the Fouchier paper shows that the board is still troubled by some of the issues.

He stated that the group was also aware there would be "undesirable consequences" if the papers weren't published in full. When pressed about what the consequences were, Keim said one was international collaborations to control and understand flu, such as the fragile influenza virus–sharing agreement that- was approved by the World Health Assembly in 2011 after 3 years of difficult deliberations.

Lieberman asked Keim why the NSABB's decision on full publication was unanimous for Kawaoka's study but not Fouchier's. He said because Kawaoka's work involved a hybrid virus, the advisory group viewed the platform as less risky and less virulent.

When Lieberman asked him about Osterholm's criticisms, Keim said the group embraced the dissent, which was constructive during the discussions. However, he said the leaked letter makes it harder to have proactive discussions on the topic.

Keim said he agreed with Osterholm that the witness list was biased toward scientists who have an interest in getting their work published, but he said that factor wasn't problematic and that the NSABB handled the issue well.

Fauci said the NIH has responded to Osterholm's concerns on a point-by-point basis in a letter that he offered to share with the Senate committee. He told the committee that he disagreed with many of Osterholm's charges, especially his assertion that the security briefing was weak.

Inglesby said that now that the NSABB has made its final recommendation and the Department of Health and Human Services (HHS) has accepted it, it's time to look forward. He had three recommendations on how to manage future H5N1 work that raises dual-use concerns, including extending the research moratorium on engineered transmissible viruses, defining "uncrossable" lines that would signal when work shouldn't be done or continued, and increasing the nation's pandemic preparedness efforts.

Several of the witnesses expressed the opinion that there is more work to do on dual-use research concerns at the global level. "We're all hoping for an international culture of responsibility," Fauci said.

Gerstein added that few countries have "select agent" (dangerous pathogen) regulations and export controls, and health officials need to do more outreach on the importance of these topics as security issues.

Fauci said he didn't see any immediate legislative issues that need to be addressed in the wake of the debate on the H5N1 studies but added that the committee's airing of the issue was useful.

See also:

Apr 26 Senate committee hearing written testimony page

Apr 23 CIDRAP News Scan "Congressman questions NSABB decision reversal process"

Apr 13 CIDRAP News story "NSABB member says officials stacked deck for board's H5N1 decision"

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