The Nature of Microbial Research Intertwined with the Future of Biosecurity

Apr 25, 2023

Clear and Present Podcast: Episode 7

About This Episode

Dr. Giordano and Dr DiEuliius dive into the recently released Senatorial report that points to causative factors for the global Covid pandemic. Giordano and DiEuliius discuss the nature of research involved in studying various forms of microbial disorders and their possibility of human infection. These two experts consider what the report says for the current needs of biosecurity, and in the case of covid both retrospectively in terms of what happened and prospectively of what we have learned.


James Giordano, PhD, MPhil., serves as the Executive Director of the Institute for Biodefense Research; a neuroscientist and ethicist with over four decades experience in the field, his areas of expertise include the development, oversight, governance and control of biological, chemical, and cyber/informational weapons; scientific and technological approaches to human performance optimization; and international ethico-legal and social issues of biosecurity and biodefense.


Transcript

Dr. James Giordano:

Welcome to another episode of Clear and Present, and what is clear and what is present today is that the United States Senate has released its report that points to causative factors for the global COVID pandemic. Of interest is the nature of research that has been involved in studying various forms of microbial disorders and their possibility of human infection, but also what that scientific and technological progress portends for needs for current biosecurity.

In this particular case, looking both retrospectively in terms of what happened and prospectively in what have we learned, with us today is a familiar voice to the Clear and Present podcast and one of our Senior Fellows at the Institute for Biodefense Research, Dr. Diane DiEuliis, who is now a distinguished Senior. Fellow at the National Defense University in their directorate of weapons of mass destruction. Diane, welcome back.

Dr. Diane DiEuliis:

Thanks, Jim. It’s great to be here this morning. We have a lot to talk about.

Dr. James Giordano:

Indeed. Why don’t we just jump right into the focus scope and content of the Senatorial report, because I think that provides much of the tractionable fabric for what we want to talk about today. Over to you.

Dr. Diane DiEuliis:

Sure, I’d be happy to say a few words about that. First and foremost, this report is particularly comprehensive. As you know, there’s been ongoing dialogue about whether or not SARS-CoV-2 emerged from a zoonotic or jumped from animals to humans or whether it was a result of a laboratory acquired infection or, in other words, a lab leak. We’ve heard a lot of discussion of that over the past, probably more than a year or so, and most of that discussion is centered around looking at the SARS-CoV-2 sequence itself and looking at that sequence and trying to figure out how it emerged.

The paper covers quite a bit of that and sort of recaptures the essence of the different arguments. In this case, that the SARS-CoV-2 is particularly humanized. It isn’t something that is necessarily adapted to animals and they have not yet found an animal reservoir which would’ve been needed for it to jump to humans, but it is particularly adapted to humans, so that remains an enigma on the technical side. But what I think is really fascinating about this report is that it highlights, in the second part, a huge amount of information of what was going on at the Wuhan Institute of Virology where the so-called gain of function experiments were going on with regard to SARS-CoV-2, which as we know became the COVID-19 pandemic.

What was going on there? There’s been a number of things they were able to observe in the latter half of 2019 that was happening in and around the institute. First and foremost, there was an influenza-like illness that was observed of individuals living in the Wuhan area, and this started sooner than we learned about SARS-CoV-2. It started probably back around October or November of 2019.

At the same time, there was a very big visit of Chinese diplomatic and governmental officials to the Wuhan Institute to specifically talk about biosecurity and biosafety and how they had a plan to immediately revamp biosafety and biosecurity protocols, and they made these announcements at the Wuhan Institute of Virology. A lot was happening there in regards to the possibility that there could have been a laboratory acquired infection. This is just some of what the report covers, but I think a lot of it is they recognize, “Hey, these are observations. This is circumstantial.”

As a friend of mine put it to me, if it didn’t emerge from the Wuhan Institute of Virology, it was not for lack of trying, a little bit tongue in cheek. But the report fully highlights a slew of biosafety and biosecurity breaches, lack of adherence to protocols that would make it dangerous to be studying this kind of gain of function research at the WIV. Jim, let me stop there and see what you think about all of that.

Dr. James Giordano:

It’s interesting. I mean, there are two things that I think need to really get into the public view or the public awareness. Number one, is there a need for gain of function research? How important is that? I think, arguably, one could say as humanity tends to intrude and disrupt on natural ecologies, both by virtue of urban and suburban sprawl and spread, climate disruption, a variety of different human environmental and cultural factors. I mean, clearly, there’s sort of an obligation to protect human populations to understand how various manipulations to natural genomes and phenotypes could affect humans. In other words, it’s the precautionary step, what could happen?

But my thought is, if you’re going to go down that road, you need to be protected not only going down the road, but in what you find along the road and what you do along the road. In other words, you don’t want the stance of what would be preparation to then turn into potential risk or, as we saw here, pandemic problem. The scenario itself is one of gain of function research and its potential validity and value, and then what needs to be done to retain that value as a broad-based global public health good.

Now, interesting. I want to refer back to something that we wrote well over a year ago. We had a paper that appeared in the journal called mSphere, and that was published back in February 2022. Can you tell our listeners about that paper?

Dr. Diane DiEuliis:

Yeah. Jim, I’m so glad you brought that up because I think we may have not realized it at the time, but that paper was quite prescient to what we’re looking at right now in light of this Senate report that’s just come out. When we wrote that report together, we discussed the idea that although we didn’t know if COVID-19 came about because of a lab leak, we looked at and examined the different issues that would come into play if it were indeed a lab leak.

We played pretend a little bit and looked at some of the biosecurity issues and our conclusion, as you know, was that we really need to think harder about and upgrade our biosecurity policies and protocols. First and foremost, this idea of gain of function research and the funding for this, really, we should think about this as a subset of dual use research of concern or DURC. A Really important aspect in attempting to do that for all the reasons you just highlighted, that we could see an increase in emerging infectious diseases from zoonotic jumps and encroachment into natural habitats, et cetera, all the things you listed, if there is going to be higher risk of these things, we need to actually do risk assessments of gain of function research.

It’s just as risky to do gain of function in the laboratory, and we’re seeing more and more of these laboratories springing up around the world because people realize, “Hey, we need to be prepared for biological events that could be very damaging to populations, and so we want to have laboratories to study this.” In fact, most people would say that the Wuhan Institute of Virology was created by the Chinese just for the very reason that they had experienced the original SARS outbreak a decade earlier, and this was their attempt to prevent that from happening again.

This question of gain of function really requires doing risk assessments, weighing the risk against the benefits, and determining how to mitigate those risks in the laboratory. And then mitigation of those risks in the laboratory brings us to how do we do that? What is the biosafety and biosecurity protocols that need to be in place to ensure, once we’ve determined what the risks are, how are we going to mitigate those risks and enable the research to go forward?

Dr. James Giordano:

Let’s back up, because you made a really important point that I want to reinforce for our listeners. I want to reinforce for our listeners, who’s ever listening, wherever they are on the globe. One of the issues with talking about dual use research of concern is the connotation of what dual use means. Of course, the connotation there is that there’s something that can be used for what may be considered to be a benevolent and a biomedical end, treating people who may be sick, can also then be used to make people sick. In other words, what might be considered a bellicose uptake and/or utility of whatever you’re finding in the lab? Well, the truth of the issue is that what it really speaks to is the duality of this type of research because the subject of the research, these types of microbial infestations and infections, whether they be viruses or bacteria or, one of the most contemporary concerns, fungi and parasites is certainly concerning. It’s concerning to public health locally, regionally, and globally.

But the dual aspect of that entails the intent to not only do the research because the intent of the research is to be preservative of human health, but to do that research in ways that are sustaining and preservative of human health, which then speaks back to the biosecurity issue. The conundrum that occurs is that, yeah, anything that occurs in the laboratory that creates an entity, whether through standard gain of function techniques and technologies or through some of the application of those that are most new on the palette, and you and I have spoken about this, some of the gene editing techniques and certainly aspects of synthetic biology, then afford the ability to create precision pathogens or certainly profound pathogens that have broad populational effects such as we see with SARS-CoV-2, with COVID-19.

The question is how do we engage that level of biosecurity by intent, by design? I mean, if the intent is to do research that’s going to be protective of the human species, whether it’s local or whether it’s global, there’s also the obligation of any and all research for non harm. I mean, you may not be able to achieve the good ends because it is research, it’s investigative but, at very very least, there’s the obligation and incumbent responsibility for non harm. That’s where the biosecurity piece comes in. Can you speak to that a bit?

Dr. Diane DiEuliis:

Exactly, Jim. As always, you are spot on in describing this scenario. When you and I were writing this paper that we spoke of from about a year ago, we talked about some of these issues. And so, for example, we have sets of protocols here in the United States that are pretty stringent for biosafety and biosecurity. There are regulations about using particular pathogens in the way that you describe. For example, if you just want to study a pathogen and how it behaves in the laboratory, there are different levels of biosafety from BSL-1, that we call it, all the way up to BSL-4, for the most dangerous pathogens.

Now, imagine the fact that you’re doing gain of function on a pathogen and you may take a pathogen that is normally easy to study at BSL-1 levels, the most sort of least dangerous kind of organisms, or not dangerous at all organisms, and you could tinker with that and inadvertently create something that now belongs at a higher level of containment and protection in terms of biosafety and biosecurity.

We have rules about these things and the issues that you describe are spot on. When doing these kinds of experimentation, there has long been concern that, inadvertently, things could happen in the laboratory that could lead to inadvertent harm. One of the things we talked about in that paper was also something called the National Science Advisory Board for Biosecurity. A year ago, we had sort of bemoaned the fact that we hadn’t heard from this advisory board in a while and it is their job to look at these kinds of biosecurity considerations very specifically. We had asked that perhaps they should be reconvened and take a look at the issues arising out of Wuhan and look at the gain of function and DURC question in a much broader context, and that is actually exactly what they have done, I’m glad to say.

And so, as these deliberations go on, they are talking about how to update the current biosecurity gain of function policies that we have, what should be included in it considering all the novel and emerging biotechnology capabilities that we have now that we didn’t have when these policies were originally designed and they are hoping to revisit those and update those. Now, my concern with that… And so, Jim, of course, this is great. It’s great that you and I were in the front end of this conversation and we can see some really good things coming out of the NSABB now as a result of that.

One of my concerns is that, great, we are having this conversation here in the United States, we’re beginning to get engagement and we’re beginning to understand where biosecurity policy may need to go in the future. But really, we can’t dictate biosecurity policy for the rest of the world. The WIV is an example of something that, although the United States provided some funding for some of this research, the policies that we would’ve wanted to see adhered to here in the United States were not necessarily adhered to in China. I would maybe toss that back to you and say, what do you think that we could do in this international forum?

Dr. James Giordano:

Well, it’s a great question. I mean, a couple of things. I mean, the thought here is that if we have an investment footprint, we should also be able to determine how you stand on your feet, right?

Dr. Diane DiEuliis:

Right.

Dr. James Giordano:

If the work was even in part funded by United States interests, then preservation of those interests with regard to the United States’ stance on dual use research of concern, biological toxins, chemical toxins, et cetera, things that are worrisome for public health should at least be addressed and there should be some consensus on minimum standards. This minimum standard may also involve a particular level of surveillance inclusive of sentinel features in the communities, which is monitoring the area in and around any laboratory that does gain of function, and that would then be multinational transparency. What you’re really seeing there is it’s not just the United States versus or the United States’ interests in, let’s say in this particular case, China, but rather opening that up so that the United States’ investments also allow a broader perspective that is therefore accessible by the United States’ allies. We’re talking here, bioeconomic allies, not necessarily in a military sense.

I mean, the other thing there is the nature of surveillance. It’s necessary to do that. If you recall, Joseph DeFranco and you and I had addressed this in a paper that was a little more specific to the key areas of neuroscience and neurotechnologies, but is certainly more broadly applicable than even here. But the other question becomes, well, all right, if these things happen, and let’s make the assumption perhaps rightly so that this was indeed an accident and the accident was due at least in part to some laxity in those safeguards and principles and protocols of biological safety and security, then what is the result of that?

In other words, if there is attribution, even attribution of accident, well then, what is the level of, if you will, retribution or at very, very least recuperate responsibility that should be born by the site and/or locale, nation, in which the accident occurs, particularly if the results of that accident have multinational consequences, which of course COVID did.

The question then becomes in the failure to be able to engage those responsibilities, admit to those responsibilities, admit to certain lack of transparencies, which may be cultural. I mean, there is a mien principle that’s highly operative in much of Chinese culture and society, a principle of pride. I think there’s also the definitive risk that said, “Well, okay, did this really happen this way?”

But the other question then becomes, in making those types of attributions, whether or not this then represents something larger?

Dr. Diane DiEuliis:

Right.

Dr. James Giordano:

Is that then attainable as something as a crime against humanity if, and only if, certain protocols that were in placed by consensus agreement were not followed? In other words, is this now a crime of negligence? Not necessarily malfeasance, intentionally doing wrong, but negligence which is still a crime. I think that the implications based upon intentionality as well as obligation for responsibility of effect are huge. As you say, this is going to require considerable discourse and I think it’s going to be dialectical. I mean, I think it’s going to be one position against another with various counterpoints that then need to be synthesized. What are your thoughts?

Dr. Diane DiEuliis:

Wow. Jim, you really opened a whole Pandora’s box there of issues. I agree with you, these are very thorny problems to try and sort out. One of the things that I would note in just getting back to at the beginning of talking about this report that’s come out, and I mentioned that there was the first half of the report spends some time and attention in looking at the SARS-CoV-2 sequence itself and what could be learned from that as to whether it was zoonotic or a lab leak, and there is a set of laboratories around the world where outbreaks are examined from a public health perspective, and they can do sequencing and they can do epidemiological tracking and surveillance in that regard. Again, these are set up by various different countries. Some are sponsored by the WHO and so forth.

We talked about how the importance of doing forensics, for example, in trying to figure out exactly how emerging infectious diseases were emerging, we need to make sure they weren’t purposely done or something like that, something nefarious. I would suggest that, as you very well noted, there needs to be some kind of set of norms and international standards to which there can be some adherence. Because, without that, all of those things that you brought up are exactly right. We are sitting in a level of question marks in terms of if something like this happens, what should be the ramifications? What is the level of attribution?

If we had a way to perhaps leverage beyond these laboratories, these public health kind of laboratories that do sort of traditional bio-surveillance and epidemiology, and go beyond that and really start to talk about these ethical norms in terms of doing risk assessments for gain of function research, in terms of monitoring and surveillance for things that maybe just go beyond the sequence itself and go to building some coalitions internationally so when something like this maybe happens, if there is a lab leak or something that a country is concerned about, they have a forum they can go to and not be shamed into a much worse problem and actually gain some help from the international community in the best way to mitigate the problem before it becomes a global pandemic. Those are just some thoughts I had off the top of my head, but you may have additional ones.

Dr. James Giordano:

I agree. I certainly agreed. I mean, I think that, once again, you’ve brought up something that’s very, very important, which is that although the nature and conduct of this work is scientific and, obviously, has now become political in the truest sense, in other words, multiple populations, multiple polists, have been affected in their governments have been profoundly affected on a variety of levels from the medical and public health all the way to the economic and certainly beyond. I mean, the ramifications within actual politics are huge.

But I think that having a common body that is sentinel and very much responsive to both cooperation on certain levels and competition on certain levels, what is sometimes referred to as a coopetition model is important. In other words, the reality check is that there is going to be that level of competition, but there needs to be cooperation and key factors that allow that competition to occur in those ways that are safe, even in those situations where there may be some possibility of what we formally referred to and others have as heroic rescue.

In other words, you discover something in the laboratory that could be profoundly damaging. And then, does that become proprietary information for you to be able to develop some possible treatment or intervention or vaccine, so to speak, as we saw with COVID? And then, what are the economic issues that go along with that? As you know, with COVID, there are a number of economic issues that came into play with regard to availability, provision and cost of vaccine, and then what that also does with regard to relative balances and asymmetries of capability and power between developed nations, competing developed nations, cooperative developed nations, and developing and non developed nations.

I think when you speak to the ethical piece, you’re absolutely right. I mean, ethics is all about balance. Balance of what can be done and what should be done or what should not be done. Balance of goods and non goods, relative goods, what’s good for me may not be good for you. Certain balance of what is considered to be right and what is considered to be wrong under whose conditions of rationality. But, more than that, what it really deals with, as you said, is risk assessment, the risks of doing certain things, in other words, risks and harms of commission, and the risks and harms of not doing certain things, risks and harms of omission. I think those things need to be explicit.

And then, any transgression of those consensus and defined upon protocols and parameters would need to be seen and appreciated as being malfeasant. In other words, understanding that these are the boundaries, but you crossed them anyway. I think that makes attribution and possible retribution inclusive of remunerative retribution a far easier process by consensus. Diane, closing thoughts.

Dr. Diane DiEuliis:

Right. Well, we touched on a lot of topics today, Jim, and I think all of them are going to continue to be hot button topics in the biosecurity community moving forward. Certainly, this report that came out yesterday has pushed the ball a little bit farther forward on the side of the lab leak emergence for COVID-19. I think there’s going to be a lot more discussions.

For my part of it, what I am glad about is that the things that you and I were talking about a year ago will possibly have more urgency now. All the kinds of things, the needs for the biosecurity community that we talked about, not only in our paper of a year ago, but just this morning, rehashing them again on this podcast, I’m hoping that this breathes new life into all of those things, doing risk assessments, engaging in the gain of function and DURC conversation more fully, and also trying to engage in that conversation internationally as well. Jim, I’d like to hear your final thoughts.

Dr. James Giordano:

I mean, I think this is a necessary and important work in progress, and it’s going to take work if, in fact, what we look to do is not just sort of go forward, but go forward in a way that is actual progress. In other words, beneficial progress to any and all share and stakeholders that are involved, and that’s complicated. Diane-

Dr. Diane DiEuliis:

I couldn’t agree more. I couldn’t agree more.

Dr. James Giordano:

If our listeners want to get in touch with you, your email.

Dr. Diane DiEuliis:

Sure. I’m Diane.DiEuliis.siv@ndu.edu. If you just Google National Defense University, you’ll find me there.

Dr. James Giordano:

Outstanding. Diane, as always, it’s a pleasure. It’s an honor. Thanks so much.

Dr. Diane DiEuliis:

Great working with you, Jim, and nice talking to you this morning.

Dr. James Giordano:

Thanks.

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