Goal 2: Discussion Questions and Answers

Biodefense Summit Transcript

​Panel Moderator: Mike Shannon, Director at the Office Manage​ment Assessment, National Institutes of Health

​>> MICHAEL SHANNON: Well, as I mentioned, it's an eclectic blend of awareness and areas to consider and all of you know that more than most. We don't have the luxury of being unaware. And so I'm grateful that we have such a panel with such a diverse background, whether it's from training through ASPR or the veterinary sciences, recognizing the dual use and dual priority nature of what we are dealing with, wanting to promote innovation and health safety but also preventing misuse of those items. So we'll take questions now and I'd ask you, just since we are the panel I think just before lunch can we keep the conversation going and we will dialogue back and forth but do we have questions from the floor or from the off-line or online?

>> FEMALE SPEAKER: We will get started with one from online. David Gillam from Arizona State University has written to ask one of the bio security challenges we see is how to responsibly communicate dual use or gain a function science without giving away too much information about the specifics of the experiment. Social scientists are calling these information hazards as the information itself has the ability to be reproduced with negative consequences. I'd like to know what the panel recommends to best communicate the science without providing the specifics for reproducibility.

>> MELISSA MORELAND: Oh boy. You want to answer, Dean?

[Laughter]

​[indiscer​nible voices off microphone]

>> DEE ZIMMERMAN: Good morning. I am Dee Zimmerman and I'm the current president of the American Biological Safety Association and I also have 27 years in high and maximum containment biosafety. And part of my job was bio security. And the question that David Gillam asks is something that we grapple with constantly. Is how do we balance that aspect of bio security without bringing forth aspects of what we might consider secure or protected information in respect of what we do. And it's not an easy question. And as much as possible I think as institutions as a whole that we need to be grounded in transparency, so that that public awareness of what we do and how we function makes public comfortable. So it is a balancing act. How do we create that aspect of bio security within our institutions, yet ensuring bio security. So it is a dual edged sword.

>> FEMALE SPEAKER: Thank you.

>> MICHAEL SHANNON: Thank you very much. We have another comment, question?

>> FEMALE SPEAKER: Before I make, ask my question I just want to comment on this same issue, and that has to do with the fact that I don't think that any research or any science in and of itself is immoral. It doesn't have morality. This is my personal opinion. But I think the way that we deal with it and the way that we train people about their role in science is very important. And the point I was previously trying to make is I think that laboratory scientists, in particular because they can give us so many wonderful things and advances also need to have special attention focused on them throughout the life science growth and education to ensure that they do not go into the nefarious side. So okay. Now my question is, because we are increasingly in the US in monoculture, not only for animals but for plants as well, the ability to deliver a bio threat agent that could wipe out the food supply and therefore undermine really the social safety net is very important. How do we better address that as well as part of this bio, this national bio security and bio defense strategy?

>> WILLIAM KARESH: If you want to start, I can add a little.

>> JAMES ROTH: Okay yes, with the rapidly expanding human population worldwide as everyone is aware, we need to increase food production, and for animal-based food, there is two major ways to do that. One is through increased backyard production. And we see that especially in developing countries, both urban and rural backyard production, which has a lot of advantages, but disadvantage in there is no bio security, very little veterinary care. And there's close contact between the animals and the people. So the zoonotic diseases transmit. The other method is [indiscernible], large concentrated animal feeding operations that are very efficient, produce very high quality product, typically have very good bio security, but if a disease gets in there, like high path avian influenza, it can spread very very rapidly and with influenza, it can mutate of course. So there's disadvantages and advantages to both methods. We really need a better bio security, rapid detection and plans for rapid response when it is detected. But it is a continuing problem.

>> WILLIAM KARESH: So I would just add... [Laughter] you know, as you were just describing, for dual use there is this balance in needs too. So the intensification of production systems whether plant or animals there are tremendous benefits there. Reduced cost, being able to feed more people, feeding more animals, those things, balanced with this risk of infectious disease or an organism moving very rapidly through those systems. So once again it is finding that balance. But also I think with globalization, I mean basically since the Columbia, since Columbus started spreading organisms, since those days of the last 300 years of the earth becoming a big mixing pot I think we also, for the strategy, you mentioned about getting back to some unbiased diagnostics. So we've gotten very good with our diagnostic capabilities, specificity, sensitivity is really better and better, but it means we miss on cross-reactivity. We are missing out on organisms. So this ability to detect things that shouldn't be there by the clinician. So Zika, like no one is looking for Zika in South America, that took a while. Before we really figured that out. Yellow fever broke out a few years ago in Uganda. They hadn't seen a case in 40 years so no one ran a test for it because the test is now so good and so specific that the clinician s didn't think of running it. So I think we also have to kind of think about these broader diagnostic capabilities and the technology side so we pick up some of these things earlier as they are moving I think would help contribute to that early detection, to protect these monoculture crops or intense programs.

>> MICHAEL SHANNON: Good questions. Thank you. We will go to the side.

>> CASSIE CONNOLLY: Thank you. Cassie Connolly. I am an Astro biologist at NASA. I spent 12 years as the NASA planetary protection officer. I'm very glad you mentioned the Colombian expansion because that's actually the textbook for planetary protection and also addresses the question I wanted to ask, which is how will new activities be addressed in terms of assessing risk and also preventing bio threats? Certainly Columbus didn't realize that they were bringing malaria to the New World and realize they were bringing a spirochete back to Europe that would result in syphilis. So, that is a new set of activities. Planetary protection is the process of preventing contamination of other planets in space exploration and also preventing harm caused by bringing extraterrestrial material back. This is something that was identified in the 1950s before we had a chance to go to space, and it's probably the first time in human history that there was this risk prevention effort set up before we had the activities even going on. However with new actors coming in to space exploration, commercial entities aren't necessarily following some of the guidelines that have been set forward and NASA and the FAA aren't experienced in bio threats, bio hazards, they are not planetary security organizations, so they don't have the expertise and really should not be the only organizations tasked with addressing these problems. And I will give you one example in that on the space station there is an experiment to grow dahlia plants. Some of them died for reason that was not recognized. Those, the material was then brought back to Texas. It was then sent to Florida, sorry, it was brought back to Russia, transported to Texas, then to Florida. And the person that I was funding when I was in that bureaucratic job did research to identify the type of fungus, which was a fairly common plant pathogen. It was only when he went to publish the paper that the Florida agriculture organizations realized that a plant pathogen had been brought from space to Russia, to the US, to Florida, and they then were quite concerned about the publication of this paper. But this failure to monitor new activities can result in significant problems. We did see that during the Colombian expansion, but space exploration is another potential location and all the planetary protection addresses extraterrestrial matter, nobody to my knowledge, and I was planetary protection officer for 20 years, is addressing concerns of Earth organisms that go out and then come back.

>> MICHAEL SHANNON: Well again, fascinating and diverse array of things to think about, but how do we approach the kind of nontraditional thinking, although that is a traditional area of consideration, but it's not something that many attend to perhaps if they are not specifically in that field. How do we address some of those?

>> WILLIAM KARESH: Well I don't know specifically for that, but I do think it was interesting that you ended up with a person that got in trouble for publishing the paper, which gets back to the earlier question from ASU. So in some ways letting scientists work on these things and publishers actually letting us know what's going on because I don't live in Washington. I know all of you follow the rules. But outside of Washington, people don't all follow the rules. And so maybe somebody publishing on what they are doing is really a better way to find out what's going on around the world than it is by not letting them publish. Just kind of throwing that out as a disruptive thought. And having a better sense of knowing what is the landscape is of the risk and threats.

>> CASSIE CONNOLLY: That's true, however the release of organisms that then become endemic is not an effective way to address that problem.

>> WILLIAM KARESH: And that gets into the lab biosafety, and containment.

>> MICHAEL SHANNON: Thank you.

>> DR. JOE FERKO: Hi, I'm Dr. Joe Ferko. I'm both a physician and also an entrepreneur and in business for 23 years in this area. My question goes to the panel. There has been a change in what I would say is common sense in the public, very different from when I grew up, had many many experiences, many of the millennial's that we are dealing with now haven't had those experiences and their common sense level is a lot different than mine and perhaps yours. So how do you increase that level of common sense, and perhaps making simple decisions such as not taking a suspected Ebola patient to the ICU where we have our negative pressure room. Through the hospital for a half hour. Secondly, is, at what level do we need to determine that the rights of the many outweigh the rights of the few? And that is a question that's been debated many many many times, but could we stop some of these incidences from occurring by limiting the rights of the few and benefiting the rights of the many? So those two questions please.

>> MICHAEL SHANNON: Very interesting bioethics question and then in defense of millennials, I think they have a great deal to offer us because some of the innovative thinking that we may be missing from our generation can certainly come from there as well is our sharing of our more pragmatic approaches to dealing with this. But how do we address this?

>> MELISSA MORELAND: Those are tough questions.

>> WILLIAM KARESH: There are certainly ethical questions, but I don't know if that second part needs to be a binomial decision. And I think , for all of what you are talking about even the common sense part maybe we need to be doing a better job just in messaging communications, which was brought up in the first panel, an important part of risk management is risk communications and maybe we are not explaining the risks we all understand in this room. But as was referred to at the beginning of the day, most people don't know about it. So part of our work is to get that, translate what we are talking about in a way that's easy for people to understand. So I don't know that it's common sense or just sense or a little exposure and education, and put things in perspective./p>

>> MICHALE SHANNON: Okay. Over here?

>> JOSEPH DUDLEY: Yes, Joseph Dudley, LIDOS Corporation provides support to the military and civilian communities on emerging diseases and bio threats. I think we need to come back to the example of the H5N2 outbreak, the African swine fever outbreak and the previous H5N1 avian flu influence outbreak in Asia. These three things demonstrate the threats of the industrial agricultural supply chain. They also demonstrate the reluctance of the public and the governments to inform of the risks of supply chain transmission. These three incidents were largely supply chain driven. They were not acknowledged as such. Prevention and response efforts were not based on a supply chain transmission activity proliferation. And I think this is responsible for, for example, an outbreak that started in close to turkey barns in southern Minnesota in the dead of winter, getting to Iowa two months later. Did not come from migratory birds moving south. From Minnesota to Iowa in the dead of winter. But this was the explanation. I think that effective prevention and response must be predicated on transparency, must be predicated on accurate assessments of the risks and the ability to intervene with large corporate entities that are being affected by outbreaks to prevent a pathogen from moving from a focus of infection to other states, other farms, other areas, other countries through unacknowledged supply chain transmission risk factors. Thank you.

>> MICHAEL SHANNON: So how do we take the definitions and apply them in a way that allows us to plan a strategy most effectively?

>> JAMES ROTH: I would just comment on that example, the H5N2 started on the West Coast for migratory waterfowl that had mingled from waterfowl from China up in the Alaska area. But then there was a recombination event to become H5N2 and it percolated in the West Coast for two or three months in small flocks. Somehow it got to the Midwest, but once it got to the Midwest it was definitely spread between large operations by human movement sharing equipment, sharing people. So it's widely acknowledged that it was spread, the big outbreak was because it was spread from human activity. The avian industry has taken that lesson to heart and have greatly increased their bio security as mandatory bio security that has to be audited but that is a huge problem. Once again send to these very large concentrated operations, 4 million laying hens in one premises, about 200,000 per building, one hen comes down with avian influenza, they are all going to die. 90% from the virus, the rest have to be destroyed. So that's a definite downside. The upside is they produce very high quality product at reasonable costs. And if we change the production system to increase the cost of production, then the 40 million people in the US in food insecure households will have a harder time and the 800 million people in the world that are food insecure will have a harder time feeding themselves. So they are not easy balances to achieve. I think all the questions we have had so far have been really hard questions.

[Laughter]

>>JAMES ROTH: Don't do the research, do the research, don't publish, publish.

[Several voices]

>> MICHAEL SHANNON: Over here, please.

>> MALE SPEAKER: Thanks. Trying to stick to point one. From what I have heard and from what I have read in the plan, the most significant gap that I'm aware of is garage biology.

>> JAMES ROTH: What was that?

>> MALE SPEAKER: Garage biology. The bio hacking. Bio hacking is here. The IC has done studies where they have asked whether or not our weaponized pathogens of the prior century could be re-created. Its child's play now. You can get all the stuff off of any of these. You can get it from eBay. You can get the tools you need. Now this is stuff that my colleagues in IC [indecipherable] worry about. We haven't been talking about it here. I really appreciated your comment about publishing because I think we need to bring it out. I don't think we need to hide it. But this discussion about the ethics and training and all that of academics, I come out of this system, I've had extensive bioethics training. I've seen how that works and that's lovely. I'm so glad it's happening and it has no relevance to what I think is our major threat right now, which is not being addressed here and personally I suggest for your consideration that we have kind of got to get out ahead of the millennial world [indiscernible] shows or we can go the various tools we have for data mining, social media across multiple languages shows where we can go. We've got to get there and it can be done, but I'm not seeing it here. And I suggest in closing, your biggest gap right now, you are kind of worrying about 20th-century problems, bless your hearts. We still haven't solved those. I get that. I mean, we still don't have a vaccine for tularemia plague, blah blah blah, but the wave of stuff that is about to hit us is so much bigger and we're not even thinking about it right now. And if we are not thinking about black swans, I guarantee we're not going to see them.

>> MICHAEL SHANNON: Anticipation of threats requires that expansion of imagination, and it's good that there is a multidisciplinary approach to any strategy. And I think we have to have an all of the above focus. I don't mean to answer for the panelists, but it seems to me that that is what I would want to see. But there is one aspect of that that I think we can flesh out in a question. In the area of, do you think that there might be a need for a due diligence or a more defined due diligence for some of the ability for people to get various agents to do some of the things he's discussing?

>> MELISSA MORELAND: So I do want to say that if you are speaking of DIY bio that ASPR has looked into that. We are engaging some, there is a group like the Baltimore underground bugs and they’re working at DYI bio and they have a lab and some of those have started to interface with us. We've started to be more receptive to our help. Some of them have even hired a biosafety officer for one year period to put in plans. And so there are people looking into DYI bio. And the ability to get things for nefarious actions, I think that is a concern for all of us. But yeah, we are trying to address those that we know are doing it. It is those that are back in the garage is doing at that, you know.

>> MALE SPEAKER: That's what I suggested is that there's ways we can try to bring those folks out. And rather than into the dark. I think your comment about publishing local source journals, creating venues for folks to discuss, we can't be afraid of that. We have to embrace it. [Indiscernible] an information and media is critical. We can't [indiscernible]

>> MICHAEL SHANNON: Thank you.

>> KITTY CARDWELL: I'm Kitty Cardwell. I'm the director of the National Institute of Microbial Forensics and Food and Ag Bio Security at Oklahoma State University. Before I was at OSU I was a national program leader at NIFA here at Washington DC and I was the one that started the NPDN and with a vet colleague [indiscernible]. We were the ones that were asked to rate the concept note, and we stood that up and so I want to just give a little bit of situational awareness right now about the plant world, that it has not been represented really so far. I want you to know that we have over 1 billion acres of field, forage, fiber, forests, and we have about I think if we've got 500 people at the diagnostic level, that's a lot. I don't, it's not even that. We have a lab, one or two labs per state in each of those has one or two people in it. The federal contribution to the NPDN is less than $1 million a year. On top of that, now, PDQ, AFIS, PPQ does an exceptionally good job of risk analysis, and they are very good and they are very focused looking outward. But once something gets in, we are thin on the ground, very thin on the ground. It's hard to say that we can detect something if it's brought in intentionally. The other point that I want to make, though, is that we are supposed to be able to stop things at the border, we are supposed to be able to stop things that are coming in through trade but it's estimated that we can only actually physically look at 2 to 6% of everything that's coming in in terms of crops, food supply, that's moving. So we are not covering it. We don't have it even close to covered. And so my one little pitch, and that is a gap that I would identify, is that we need technology to compensate for the lack of personnel, for one thing. We really have very little, we are too thin on the ground in all kinds of ways. We need technology that can identify and detect multiple things in a single go, with somebody who is not necessarily a trained technical person. And we need really quite a bit of renewed funding and emphasis. I'm good with the animal side, too. I agree that [NALM] also needs strengthening but man the plant side is the poor little sister and they are not getting any kind of recognition and its wide open. We are very vulnerable.

>> MICHAEL SHANNON: So, thoughts on increasing our confidence level in this or any other area that you think might need more attention?

>> JAMES ROTH: Well I will just say that the NAHLN lab, the National Animal Health Laboratory Network, was absolutely crucial in handling the avian influenza outbreak. Our diagnostic lab at Iowa State is the largest one in the US because we have more animals, livestock and poultry than anywhere else. And they had to ramp up very very quickly all of those poultry facilities had to test birds every day, send them to the lab by noon, by 5 o'clock the lab report about the PCR results so they could move their eggs. We produced twice as many eggs as any other state so if we couldn't move our eggs there's going to very rapidly be an even bigger shortage so the NAHLN labs are crucial, no matter what disease we are talking about. Even if it is a new disease they can ramp up very quickly with PCR technology for finding new diseases like porcine epidemic diarrhea virus so on the plant side I'm sure the same is needed.

>> MICHAEL SHANNON: Is there an online question?

>> FEMALE SPEAKER: I have two questions from the watchers online both about international partnerships and preparedness. So the first is, what steps are being taken particular by the government to persuade foreign allies to purchase bio defense drugs in the same way that BARDA purchases for the SNS, and for ASPR about corporations with your colleagues in other countries when it comes to taking up new initiatives and bio security.

>> MELISSA MORELAND: Someone want to take the first one?

>> WILLIAM KARESH: Well, I can't speak for what the government, our government is doing to encourage other governments to do that. It's a complex system with a private industry and the pharmaceutical industry and the pricing and the bidding and who gets to buy what, and production supply chains. Maybe every country doesn't have to have their own stockpiles. Maybe they could be regional approaches. I think we need some kind of creative thinking on this. But in general with the international question, you know, I think that's just, is a big subject area, and as with the plant diseases I tend to get concerned that we just kind of keep drawing back to protecting our little interest area in some part of this country. And the risk of not being big and and sharing those around the world and getting everyone engaged, and it's not just a piling. It's about knowing, you know situational awareness around the world and everybody agrees in that transparency. It is improved diagnostics everywhere in the world and we are sharing that information. It is somehow about being able sharing access to stockpiles. That's, the worst-case scenario is when we are depending on stockpiles to save our lives. I mean, we really want to be ahead of the game and do some things with biosafety and protection, share best practices. So I think it's an amazing opportunity. I encourage all of you if you haven't read the national bio defense strategy to do that. I mean, we are in a unique opportunity right now that people are asking, well this is great. If you look at what Dr. Carter and SC, what they have done to pull together that strategy, it's the most comprehensive thing I've seen in a long time and it includes plants. It includes animals. It includes bio hacking. It's all in there. And they are asking us private citizens, government employees to submit comments. I mean we have a great opportunity. I don't know how the three of us became responsible for the world

​​[laughter]

>> WILLIAM KARESH: Please, please.

>> MELISSA MORELAND: I will take part two of that.

>> WILLIAM KARESH: Write some comments and send them in. It's a great opportunity of how to implement this.

>> MELISSA MORELAND: There was a part two specific to ASPR, so I want to answer that really quick. She had asked two questions. So ASPR has partnerships. With EBSA we were on the same workshop agreement and now have people working on the standardization of that through ISO. But we are hoping that that international bio security symposium that we are holding in 2020 will bring some of our international partners together to talk about bio security. We have an international session every year at our ASPR symposium specific to bio safety and bio security needs in the international country so we are really engaging as much internationally as we can and we continue to try to reach out on both biosafety and bio security. So I hope that answers that question.

>> FEMALE SPEAKER: I wanted to comment on the online issue about the sharing of medical countermeasures, or everyone having their own strategic national stockpile. Importantly among the bio threats, many of them of course, as we know, are zoonotic in nature, with the exception of smallpox, at least the knowns, not the unknowns or the synthetic biology. And they arise in countries that are low resource. These are countries which actually have to use essential drug lists to even decide what drugs they will bring in to their countries to treat people with normal conditions, with everyday conditions. And that money runs out. So you can go to countries where people are being treated or potentially go to health stations to be treated when the money for the essential drugs runs out by the third or fourth month of the year. So to ask these countries also to create a strategic national stockpile is, I think, unrealistic. But having places like the United States and other upper resource countries which do have stockpiles to make arrangements to be able to share medical countermeasures is important, and the US has shared medical countermeasures in public health emergencies with international partners.

>> MICHAEL SHANNON: So some themes I'm hearing as we conclude are transparency, and what I'm also hearing is reciprocity and making sure that we're not vulnerable to someone withholding for economic or other reasons, or, and that they are sharing, and available accountability for how we move those things about. I want to thank you very much for the questions. Very engaging, a wide, diverse as I expected topic matter and I want to encourage you also to, do participate in the national strategy. Submit your comments to that. The expertise, we haven't established panel here, but you are all distinguished experts in your field and it's vital that the comments we receive can be incorporated because that's where the answers lie. Because that's where the imagination is. You see it every day. And also to comment on this forum if you didn't have a chance to ask a question or get your answer fully heard or your comment fully heard on the ASPR site at HHS.gov, I would encourage you to do that too. So please join me in thanking our panelists and thank you for your questions.

[Applause]

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