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tv   [untitled]    April 27, 2012 2:30am-3:00am EDT

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to the best of your ability, you're providing assurances that information is not going to be released in the two studies, that would significantly increase the risk of modified h h5n1. >> in the case of the paper, it was a split vote. there were strong feelings on both sides. each of us had to weigh the evidence. i mean, there were great uncertainties in this type of research. a very small, relatively small number of ferrets were used this these experiments, so understanding the biological property of these viruses is not 100% certain.
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you won't find a more helpful group to do this. came to a split vote on the fauci paper. >> dr. fauc krrkfauci, do you w respo respond? >> sure. with regard to the letter, i'm sure you have a copy of the letter, there were several issues that were brought up in there. i agree with many of the things that dr. keim said. this is a strong board. a really good board. we've worked with them for a long time, so if they did, i believe as paul has done in the
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past, if you have an issue with something, you bring it up. the letter was sent to the executive secretary at the nih, dr. patterson. we responded on a point by point basis to everything in that letter. so we'd be more than happy to make that response available to you so that you could see the point by point discussion. again, there were important ibs about looking forward. there were several things in there that i must say quite frankly, mr. chairman, that i disagree with. one about the security briefing. as you know. i have a great deal of trust in the director of the national intelligence to tell us what we need to know. so that's just one example. the idea is as you mentioned, the idea about the picking of people who would be on. we did not get any indication of people he wanted to see.
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i can just say that i think the general principles brought up by dr. keim, i totally agree with. i just have to say for the record, i disagree with many of the things in his letter. >> no, i appreciate it and i thank you for it. do you have reaction that the moratorium should be extended and if so, for how long? >> i totally agree about an extension. the real critical issue is for how long. this is a voluntary moratorium and i think that's something the public need to. i had discussions with the scientists and encouraged them and they to their credit and to the discussion that dr. keim had, that was something they
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agreed upon. exa exactly when to call it off, i think we need to see how we can have and we're very actively involveds in bush pushing forward the imp menation of the dirk policy. that's going to have an important impact on when we can feel comfortable that we can then go on. so as long as people understand the mechanisms of how would dress dirk. several of the labs involved understand that now. i definitely agree with that. i just want to make one point of minor disagreement, if you want to call it that. with my esteemed colleague. if we only look at the short-term benefit of research, we wouldn't do a lot of research at the nih. you very often have a situation where it's incremental and you build up into something that
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really becomes important. so i understand the point that's being made, if you look at wh p the immediate benefit is going to have now, sure you can say there isn't a lot of surveillance capabilities, high sequences et cetera, but the incremental accumulation of knowledge is one of the fundamental principles that the nih research agenda is built on. i think there's a little bit of a disagreement on that. i don't think you have to have a benefit not to be importantly to do and to polish. >> want to respond? >> i completely agree. i agree that fundamental research, understanding biological principles is critical and critical part of the science mission. i think this is just one very specific and rare example where i think the bar for when to proceed with this line of research should be beyond a deep er -- the basic test and
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benefits in the next year, but in this case, there's been a lot proponents of the research, haven't seen a compelling case. >> if anybody else wants to answer, in some sense, it's a question at the margins. when considering future research that would be seen as research of concern, can you imagine instances in which you would include research not be taken under any circumstances? >> i do. i think it would be -- for scientist to say we can do anything we want to do regardless. just for the curiosity of it. for understanding it. so i do think there are some
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experiments that better not be done. i think that would be a very rare situation. mr. chairman, you can fantasize about ridiculous and dangerous experiments, those we don't even bother with, but in the realm of trying to keep up with something that is a clear and present danger of it happening in nature itself, that's the critical thing we're dealing with. and yet all of us at the table know that this is a delicate issue. if you're doing something in the experimental fashion that you might be pushing the envelope of doing something that would give you information, it really isn't addressing danger, i think that's very ill advised to go there. but when you have a situation where nature itself is is already doing some of the things that you're trying to stay ahead of, that's when you really have to seriously consider it. short answer to your question.
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the principles of the new government wide policy we put out on march 29th actually put that into the consideration. so when you look at the number of experiments you can do, after these seven, there are seven classic experiments, if they come up, you have to decide do you have a risk mitigation for that particular experiment. one of the risk mitigations very well may be don't do the experiment. really falls very nicely into the answer to your question. it is built into the new government wide policy. that that is in fact an option. >> so, i presume this is not an area where you can draw a clear red line, right? what you described is the -- about the policy, particularly
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with regard to risk mitigation and in a case, the decision makers might decide that in the interest of risk mitigation, the research simply should not be conducted. >> you take each individual case and if it turns out that clearly, the risk and our ability to mitigate the risk is such that it's just not worth doing. >> -- from homeland security point of view, why don't you talk to us a little bit about this and whether you think there ought to be clearer red lines here or whether this is an area of scientific inquiry where it's simply impossible to state a red line unless you see it in a particular proposal for a research project of concern. >> well, i agree exactly with dr. fauci said. i believe there are some
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experiments that should not be done. that is a intent of the compliance review group. looking at the nsabb, seven experiments and the type pathogens we typically work with in the analysis and characterizations that we do. so we look at these very hard and make sure we're doing them in the safest possible ways, in the appropriate facilities. as the end of the day, we recognize that national security and assess what sort of frets they pose. city, we're doing in the highest containment, we do most of our internal work in our facilitief. and then the plum island facility, so we're very keen on that. >> okay, we've talked so far about the u.s. government
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response to this challenge but obviously, scientific research is global and in this case, one team in wisconsin, one in the netherlands, so help me understand and the committee understand for the record, let's just -- scientific bodies, moving to adopt a standard such as the march 29th policy. are there national standards being adopted in the individual countries throughout the world? what's happening? because we're talking about a fear in one sense of a global pandemic, so if something wrong happens in a laboratory halfway around the world, it could still affect the lives of people here
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in the u.s. >> let me take a shot at that, mr. chairman. it's very interesting because this gets into what we call the culture of responsibility. back in the '70s when the revolution in dna technology took place globally, but fundamentally here in the united states, scientists got together and tried to develop you know, it's -- it's strikingly spectaculsimilar to the challenges we're facing now, and came up with what we have now. the dna advisory committee, rack as it's called. although that pertains when you talk specifically about government funded research here in the united states, what's happened is that the fundamental principles, the codes of conduct, the culture of responsibility that was engendered by the discussions back in the '70s regarding the dna technology without any capability of enforcinging it
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globally. essentially permeated the global approach to recombinant dna technology. so although we didn't have any enforcement capability, it became something widely shared throughout the world. now, other countries including the netherlands are addressing in a serious way how they are going to approach this. but it's, so we hope and we envision is that as a result of this, there will be a culture responsibility that even though we don't have the carrot in the stick of funding, these principles will be implemented throughout the world. we're all hoping for that and i have confidence that it will. >> good. >> dr. gerstei, i know people in
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the department are developing relationships with people in comparable departments around the world. is there discussion of this particular concern in those international meetings? >> there is. we have a number of bilaterals. we have 12 nations and we have had these discussions. the nations feel very similar to us. but there is not all good news as far as this is concerned and i would take you back to the biological weapons convention. some interesting things come out when you look at that. there's a london based verification research center and in one analysis they did a couple of years ago, they discovered that very few nations of the 87 they surveyed even had laws or definitions of what a select agent is. and they didn't have laws against developing, stockpiling or storing biological material
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and the news doesn't get any better when you talk about control measures. it highlights the fact that we may be working very hard in this country and may put in place the proper provisions, but it's important we do the international outreach especially into some countries that may not have the same sense of the life science issue and the dirk issue that we do. >> yes. >> good news side of the story. i think the h5n1 debate has been somewhat useful internationally because people are paying attention to this. one good consequence has been enlightenment or awakening in places in the world that weren't paying any attention to this. a science meeting two weeks ago when this came up, there was concern that private foundations wouldn't follow the lead of the u.s. government in your policy. a representative from one of the most important sign foundations stood up and said let me make very clear, if the u.s. is going
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to follow this policy, we absolutely intend to follow it ourselves and i imagine that others well. a third element of good news, an article published in "nature" magazine. said that the u.s. is taken an important leadership position on this poll spi and that other nations should follow suit. there are indications that this will move in that direction. >> let me go to a different aspect of the policy which interested me, is that it required members to report to the security staff in the next several months of the -- mitigation measures. the concern i want to express that given national security staff is probably larger than most people think, but it's still relatively small for the
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range and responsibleties it's given. particularly for those that work on biosecurity and terrorism issues. i wonder if you have a sense of how the information's going to be used and whether any of you expect that your agencies will be asked to support the oversight charged with carrying out here. i'll start with you. >> i would just like to take you back to deliberations today. we have used those deliberations to better understand what has gone on with the papers. we have been briefed on the science. we've been briefed on the policies, the issues that have
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surfaced. and i think what's come out of the 29 march white house-led effort is a good first start. what we expect is that this will continue. that this is not an end point so to speak, but the beginning of a process that we will continue to look and try to ensure that our policies with regard to dirk are as good as they can be. to ensure national security, homeland security and that scientific work goes on unfettered. so in that record, we're hopeful. it's a reporting requirement. all departments and agencies are submitting to that. and we have not come up with the next steps so to speak, in trying to finalize the policy. this has generated the incredible discussions across the agency where departments are getting together and discussing how they're handling it. we received several phone calls
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to see how we were deal iing wi our university grants program and the language that we have inserted that provides us at least a stopgap measure should it be necessary to ensure that publication of certain materials would not proceed. so this has actually been a very positive outcome across the government. >> good. dr. keim, do you anticipate that the nsabb may be asked to help the white house? >> we do whatever the administration asks us to do and nothing they don't. >> good standard. i thank you for that. you want to comment on that? >> if you look carefully at the dirk policy, really the part about within 60 day to give an inventory. within 90 days, determine how you're going to do a risk mitigation. that was really the first cut at making sure we know what's going
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on. ultimately, we are going to try and make sure that when you get down to the local level of the biosafety communities, this is where the monitoring done will be essentially automatic by well trained people. >> let me ask this question in your testimony now. the parts you discussed nih efforts to develop the influenza vaccine and the ongoing efforts to develop vaccines focused on h5n1. whether the findings will lead nih and other organizations that fund vaccine research to increase the priority that you're placing on these kinds of research efforts. >> the answer is a resounding yes. the situation, there are a couple of ways of getting around this problem. one i think dr. inglesby
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mentioned in his testimony. kill the chickens that have h5n1 and make sure we get rid of the reservoir, that's difficult to do because you have countries not interested for economic and other reasons. the other thing is to have available countermeasures that actually work and work really very well. and the idea of getting a universal influenza vaccine is not only going to be very important for seasonal influenza, so we don't have to keep chasing each year and getting the right combination and matching it with what is circulating out there, but also, it is a major, major countermeasure against the emergence of a pandemic, so we are putting a considerable amount of effort and we've had some encouraging scientific advances over the past year and a half to two years on understanding much better the type of immune response that you need to induce in an individual to cover virtually all strains.
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we're not there yet, but this is something we see as the light at the end of the tunnel. it's risky to predict when you have a vaccine, but unlike a few years ago, that we are on the road to developing a universal flu vaccine. >> that's tremendously encouraging. do you want to xhoecomment? >> i would say that's it's encouraging, exciting. if we had it, it would change everything we talked about today in the realm of influenza, so i would strongly support the efforts going on in the industry on that. >> i have a final question, which is the kind of question i must say for the benefit of staff that my friend and colleague from delaware, senator carper, would normally sask if e
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were here, which is incidentally, i learned a lot from the testimony today and overall, i'm reassured by the government policies that have been put into effect in the decision making process. even at the far end that we've set up a process considers and values risk mitigation and citizens in some cases, it may be that there will be a decision that research shouldn't proceed because it's impossible to adequately mitigate the risk. the question senator carper would ask, i believe, if he were here, if you were a member of the committee, i want you to assume you have to knowledge you have. is there anything more than we with our primary concern about homeland security ought to be either asking the government to do or doing ourselves. either by way of encouraging
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regulation or in the extreme, some kind of legislation. dr. inglesby, why don't you start first? >> i don't see at this point any proposal that would substantially improve the situation. i think it's very useful to have oversight like this on the development of the new policy because i think there are a lot of things along the way that are going to be challenging. for example, understanding the criteria for risk assessment and how we manage those risks is going to be very important. i think the composition responsibleties of the nsabb will be very important, so asking reasonable questions of government is very important. and i think in particular, paying attention to the very specific case of the trans misty research. i think the next issue is is going to come up soon unless
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there's a change in course. i think it will l come up again, so you have to pay attention to that. >> dr. keim. >> i guess i would reiterate what tom just said. the new policy is going to be very key. one thing that i think was an important role is we are an independent body. we're non government. i think it's very important you have extennernal eyes as a part this new policy. there are inherent conflicts of interest between the funding agencies and investigators and what was a unique rule that we played in this was we were outside the small influenza research community and we were independent of the funding agencies and were able to look at this in a way that was unique and i think that's an important part to what needs to happen. >> i agree. >> thank you, senator. i'll go back to the original remarks i made that i think it's
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a very complex issue. requires balancing outcomes. we don't want to do something haas going to have a dill tearrius effect on the science. on the other hand, we have an important mission in homeland security that we must ensure is well served. we have to avoid red lines. the best point is to very thinking, very judgemental type bodies that has played extraordinarily important role in getting us through these two papers and understanding what was going on with those papers. so it really does coupme down ta matter of judgment. on the direct question, do we need regulations, executive has a lot of to work through
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policies as we talked about. the 29 march policy is is a first step. we are making great headway. continuing those deliberations. we are learning from each other. we think at dhs, we've got a lot of good policies that we've got implemented. we're sharing those to the maximum possible. >> we'll do that. >> i don't see any immediate issue that would be appropriate at this point, what would i do, i think what you just did today was a really important thing. very beneficial to this process we're going through particularly with the new policy we're going through and implement it right. the fact that an important question like this with yourself
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as chair are actually interested in the subject, looking at us and we know that you'll come back some time to just give you follow up and how we're progressing on the implementation of this policy. you've done something and that's invaluable to us. not only here in the united states, but globally, people are aware that the united states senate is interested in this problem and that adds a degree of seriousness to it, which we appreciate. >> i appreciate you saying that and that clearly is our intention. we will keep in touch. you know, we want the benefits of scientific inquiry. we need them. we also need to mitigate risk and i think policy we have now is clearly aimed at doing exactly that. so we'll follow it to see how it's going. make we'll come back again and do one more hearing toward the end of the year, but i thank you very much for the work you did on your prepared testimony which
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will be entered into the record for the hearing and for the testimony this morning. we're going to leave the record of the hearing own for 15 days for any additional questions or statements. with that, i thank you very much and the hearing is adjourned.

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