April 26, 2012 — The Senate Homeland Security Committee met today with health officials in biotechnology and infectious diseases to discuss dual use research of concern (DURC) and the ongoing issues related to conducting and publishing such research.
Senator Joe Lieberman (I-CT), chaired the meeting and appeared to be reassured about the security issues.
Testifying before the committee were:
Anthony Fauci, MD, National Institutes of Health (NIH), director of the National Institute of Allergy and Infectious Diseases (NIAID);
Daniel Gerstein, PhD, Homeland Security (DHS) deputy undersecretary for science and technology;
Thomas Inglesby, MD, CEO and director of the Center for Biosecurity at University of Pittsburgh Medical Center; and
Paul Keim, PhD, acting chair, National Science Advisory Board for Biosecurity (NSABB).
Senator Lieberman began the meeting by summarizing the events of the past 5 to 6 months. He said he hoped the witnesses would address concerns expressed earlier by Michael T. Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP). On April 12, he wrote a letter to Amy Patterson, MD, associate director for science policy at the NIH, in which he outlined his concerns about how the NSABB has handled this issue.
In particular, Dr. Osterholm questioned the proceedings of a March 29-30 meeting at which the board voted 12-6 in favor of full publication of research conducted by Ron Fouchier, MD, and colleagues from Erasmus Medical Center in Rotterdam, the Netherlands. At that same meeting, the NSABB voted unanimously in favor of full publication of research conducted by Yoshihiro Kawaoka, DVM, PhD, and colleagues at the University of Wisconsin in Madison. These decisions were in stark contrast to the NSABB's initial request that the researchers redact important information about the methods and results of their research before publishing in Science and Nature.
Dr. Gerstein testified first, speaking about the process of internal management of DURC within the Department of Homeland Security. He said an international approach is needed that addresses concerns about DURC while allowing for unfettered research. He said the H5N1 papers have served as a wakeup call.
Dr. Fauci clarified the difference between dual use research (DUR) and DURC, saying," Almost any time you even go near a microbe, it's considered dual use research." Dr. Fauci said NIH conducted an inventory of research at its Bethesda and Rocky Mountain centers, and 404 studies, as well as 147 manuscripts, were DUR. None of them was designated DURC.
NIH conducted another inventory of extramural grantees and contractors, and out of 381 DUR studies, 10 were DURC. Of those 10, 7 were about influenza, 1 was about anthrax, 1 was about plague, and 1 was about botulism.
Sen. Lieberman asked if much DURC research is being conducted by the Department of Defense (DOD). Dr. Fauci was hesitant to answer, but did say that NIH collaborates with the DOD. He said he imagines that they are doing "some" DURC but that the majority of it comes through NIH.
Dr. Inglesby stated that he is concerned about the H5N1 situation, but he realizes that the decision has already been made. He feels this research is unlikely to improve surveillance, and that even if we could detect H5N1 early, the response, which includes the culling of infected flocks, would still be the same.
He believes that accidental release of the virus could result in catastrophe. He says he has 3 recommendations about what should happen next:
Extend the research moratorium and limit research to the smallest possible number of laboratories. He noted that Canada and the United Kingdom conduct this research only in biosafety level 4 laboratories.
Identify "red lines" that should not be crossed.
The US should continue working on pandemic preparedness, including the development of a universal vaccine, new antivirals, and better surveillance and culling of flocks.
Dr. Inglesby believes the new DURC policy is good, but its success will depend on how it is implemented. He said the following steps should be taken with regard to implementing this policy:
Implement the policy at the local level. The involvement of individual scientists and institutions will be critically important.
Learn from experience; the process will need to evolve.
Attend to the regulatory burden. Regulations should not be so strict that they impede the research.
Reaffirm the role of the NSABB. The NSABB deserves a lot of credit for their work. Review should happen early in the process. In the case of H5N1, the NSABB became involved too late.
A 2-Sided Coin
Dr. Keim said that DURC is a 2-sided coin. The NSABB realizes that DURC policies need to protect the public while not overburdening scientists with restrictions.
He spoke about the security briefing at the March 29-30 meeting, saying he felt comfortable with it. After that briefing, "many on the board were left with the impression that the risks of misuse did not appreciably increase with full publication, and there is a high likelihood of undesirable political consequences associated with not publishing."
He said the split vote on Dr. Fouchier's research highlights the fact that the board still believes there is great potential for misuse. The majority of the board voted for publication, but it was clear there was still great concern, he said.
Sen. Lieberman asked about the likelihood that the virus could accidentally escape from a laboratory. Dr. Inglesby said that in all previous cases of accidental escape, it was a laboratory worker who got infected, and the risk did not extend beyond the lab. Dr. Fauci said that the 2 labs involved in this research (in the United States and the Netherlands) met or exceeded biosafety and biosecurity requirements.
"We Rarely Agree on Anything"
Dr. Keim explained that Dr. Osterholm's letter was "constructive communication" and that it was "unfortunate that it was leaked." He reiterated that the NSABB is composed of strong-minded individuals who "rarely agree on anything" and that "we embrace this dissent."
He said that while it is true that the speakers are biased, he doesn't see that as a bad thing. Yes, the scientists were biased in favor of publication, but the biases were not a problem, he said. He felt the questioning of the speakers was thorough, saying Dr. Fouchier "was in front of us for 2 hours."
Dr. Keim said he is confident about the completeness of the information provided in the security briefing. "This was never set up as a 'point/counterpoint', he said.
When asked by Sen. Lieberman if they would do anything differently, Dr. Keim said the process should have been started earlier and the timeline was much too tight. In the case of Dr. Fouchier and colleagues' research, there were strong opinions on both sides.
Dr. Fauci said he disagreed with many things in Dr. Osterholm's letter, including the quality of the security briefing. He said they have responded to Dr. Osterholm's concerns point by point. He denied getting information from Dr. Osterholm about people he thought should have been at the meeting but who were not.
Dr. Fauci agreed that the NSABB is a strong board that would not let itself be influenced by bias, and he said it isn't necessary for there to be short-term benefit in order for research to be useful, noting that if it were, much research would never be conducted.
When asked by Sen. Lieberman if there are any scenarios in which DURC should not be conducted under any circumstances, Dr. Fauci answered that this is rare. He said it is important to have risk mitigation strategies for DURC research "built into the policy." Continual risk-benefit evaluation needs to take place, with each case evaluated individually. We need a global culture of responsibility, he said.
Sen. Lieberman asked if this research would lead the NIH to increase the priority they place on these kinds of efforts. Dr. Fauci answered that it will, adding that a universal vaccine is important for seasonal influenza, so scientists don't have to keep changing the vaccine, and it is important for pandemic prevention also. "We're not there yet, but there is a light at the end of the tunnel," he said. We are on the road to developing a universal vaccine, he said.
Sen. Lieberman said that overall, he is reassured after today's hearing. He asked if they felt there was anything else the Senate committee should be asking the government to do, or should be doing themselves.
Dr. Inglesby said that oversight is useful and that asking reasonable questions of government as they evolve this process is important. "The next issue is going to come up relatively soon," he said.
Dr. Keim stressed that the new policy and how it is implemented is key. He said that the NSABB is nongovernment, independent of funding agencies, and outside of the research community.
It's a complicated issue, said Dr. Gerstein. Defining red lines is tricky because once you do, it is a sure bet that someone will cross it. They're making progress, and learning, he said. He added that perhaps later, they could consult with Congress on this very critical issue.
Dr. Fauci agreed that today's hearing was important. It is important for the rest of the world to see that the US government is involved and that the US is taking this issue seriously.
Sen. Lieberman concluded the hearing by saying that perhaps they would "have one more meeting toward the end of the year."
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Cite this: H5N1 Subject of Senate Homeland Security Committee Hearing - Medscape - Apr 26, 2012.