CD258: Gain of Function Research – Transcript

CD258: Gain of Function Research – Transcript

Sep 18, 2022

Full Episode and Shownotes

Jennifer Briney  00:00

Some people are going to be annoyed by the one sidedness of this hearing, and I get it. But it was like that because only one side showed up. There is no definite conclusion about what caused the COVID-19 pandemic. Anyone who says that there is is either uninformed, misinformed, or lying. And the shownotes will prove this to you. One particularly impactful piece of evidence you will find in the show notes is a report from the World Health Organization from just a few months ago from June 2022, in which they describe the panel they’ve convened to investigate the origins of SARS-CoV-2. Now, the fact that that investigation has just been launched, is proof enough that the cause is not yet known. But in case that’s not enough for you. They say in the report that they have “reviewed key available findings to date, and notes that there are key pieces of data that are not yet available for a complete understanding of how the COVID-19 pandemic began.” And so, the only thing that we can know right now for a fact is that no theory on the pandemic’s origin has been proven.

David Ippolito  01:10

[Music] Tired of Being Lied To

Jennifer Briney  01:38

Hello, my friend, and thank you for listening to the 258th episode of Congressional Dish. I’m your host, Jennifer Briney. If this is your first time listening to this podcast, first of all, thanks for giving it a try. I do want to let you know though, that this is probably not the best episode for you to start your Congressional Dish journey on, although I don’t know, maybe it is, but just know that this format is going to be significantly different from the vast majority of Congressional Dish episodes. Most of the time, what I do here on this podcast is I attempt to understand what Congress is doing with my money and in my name. And so I read bills, I read laws, in order to understand the changes made in those laws, I’ll sometimes watch multiple hearings and give you the highlights of them within the episode. They are deep dives, most of these. But I am in the process of reading some extremely long bills. And in my free time, I listen to a lot of hearings. And there’s information in these hearings that a lot of times can just stand on its own. So this episode is an experimental format that I really enjoy. And our producers, most of them, enjoyed. So I’m going to give this episode to the public, but just know that you might want to try a different episode, a previous episode, to really get the gist of what we do here. Because this is not representative of that. This is not a super deep dive, not at all. In fact, there’s going to be a lot of questions you’re gonna have at the end of this episode that I just simply can’t answer for you. Because we don’t know the answers. So just know that. Thank you for joining the Congressional Dish community and listening to this episode. And speaking of the Congressional Dish community, before I get started with this episode, I just want to take a second to thank the Congressional Dish community because we just had a major milestone. On September 15 it was the 10 year anniversary of this podcast going to the public. And over the years, we’ve had so many people who have paid for this show, using the value-for-value business model, in which I provide episodes of value and you return the value in whatever amount feels fair to you. So many people have participated in this that we’ve been around now for a decade, with no end in sight. I just want to take a second and thank every single person who has produced Congressional Dish over the years. I understand that making money is hard and parting with it voluntarily, for a podcast that you can get away with consuming for free. I just think that you’re amazing and you are living proof that we can run this economy in a different way. So thank you so much. And you know what, thank you to everyone who just listens to the show and shares it with your friends. Thank you even to the trolls because you assholes have made me stronger. You’ve given me a thicker skin. But there’s also people that have physically helped make this podcast possible. So I also want to thank the volunteers we’ve had over the years, especially Matt, Chas, and Brian. You guys have donated your time and abilities to making the show better over the years. I just thank you so much. Thank you also to the Congressional Dish team, which Brian is still very much on but also thank you Darrell and Mike from Pro podcast solutions. Thank you to my sister who does all the accounting for us. Thank you to Clare, my amazing assistant, who I hope state stays with me forever. Thank you, Emma, who does our video, thank you to Mark, who’s the person taking care of our website, his company is Thank you, Karen. I know you’re still in there. She’s part of the pro podcast Solutions team and she’s still trolling in our Slack. And then thank you, of course, to my dad, who has been the show’s number one fan and our chief strategist since the very beginning. In addition to Dad, thank you to all my family and friends who have kept me somewhat sane over this past decade. And most of all, I want to thank my husband, Jo. Without Joe, this podcast, never would have gotten off the ground. He financed it quite literally for the first half of this decade. And he is the one who keeps me sane. You know, he’s the one who hugs me when you people make me cry and he listens to me rant about Congress. And that can’t be fun for him. Without Joe Briney, Congressional Dish would not exist. So thank you so much for helping us get to the big 10.

Jennifer Briney  06:07

And so now for our 10 year anniversary special. Like I said before, this is going to be a different format of Congressional Dish. This format is going to be one in which I am cutting all the fluff out of a Congressional hearing for you and mixing the information presented so that you can get the gist of a fascinating congressional hearing, without having to torture yourself by listening to every member of Congress babble for five minutes, and then ask questions that have already been answered. I wasn’t sure if this format would be a hit or a miss so I gave the episode, weeks ago, to the people who make the show possible: to the people who pay for it. The people who pay per episode on Patreon, they voted, and 87% of them wanted us to air this episode to you. If you’re someone who would like to have an impact on decisions like this, and would like episodes early when they’re available, this club of Congressional Dish producers is easy to get into. You just have to support the show using any payment method that works for you. Patreon is per episode but we also have Paypal and Zelle and paper checks and Venmo and cryptocurrencies. We accept it all. All of you, regardless of your payment method — although Patreon is the easiest to set up — get access to the private podcast feed with all of the extra stuff because we have jerry-rigged a feed for those of you who pay outside of Patreon. You just have to email Lauren at congressional dish dot com. And when she gets to it, she will get you all set up when she verifies your payment. But anyway, like I said, this episode was created a while ago, and the producers have spoken. Most of them liked this new format, which has very little me in it, but a lot of Congress in it. And so here you go. Because while I was traveling across the world to return to the US last month, I in my travels, listened to eight hearings, because I’m a freak like that. And a few of them were just packed with information that I had never heard before. And one such hearing, which is the hearing you’re going to hear about today, took place in the Senate Committee on Homeland Security and Governmental Affairs Subcommittee on Emerging Threats and Spending Oversight. This hearing took place on August 3, 2022 and it was titled “Revisiting Gain of Function Research: What the Pandemic Taught Us and Where Do We Go From Here.” So here’s what the hearing is about. Here’s Senator Rand Paul of Kentucky.

Senator Rand Paul  08:30

I call this meeting of the Senate Homeland Security and Government Affairs Subcommittee on Emerging Threats and Spending Oversight to order. I want to thank Senator Hassan for allowing this bipartisan hearing to occur. The purpose of this hearing by the Subcommittee on Emerging Threats and Spending Oversight is to discuss, as our name implies, the emerging threat posed by gain-of-function research. We will hear from a panel of three witnesses, all of whom are extraordinarily accomplished experts in the scientific community. Gain of function research is a controversial scientific research method involving the manipulation of pathogens to give them a new aspect or ability, such as making viruses more transmissible or dangerous to humans. Despite all we have learned about the potential risks of this particular method of research, this is the first congressional hearing on this subject since the pandemic began.

Jennifer Briney  09:24

And this hearing was extremely one sided. And you should know that upfront, because some people are going to be annoyed by the one sidedness of this hearing, and I get it. But it was like that because only one side showed up. Senator Rand Paul of Kentucky is a Republican, and he chaired the hearing. And that’s not normal in a Senate that is controlled by the Democratic Party. You heard Senator Paul thank the actual chair of this committee, who did not show up, Maggie Hassan of New Hampshire for letting him have this hearing at all. But she wasn’t the only no show, not a single member of the Democratic Party participated. And it’s not a case where they’re absent from this episode because either their questions were dismissive or dumb, or because they didn’t ask any questions. I want to make this crystal clear. Democrats literally were not there. They did not attend. And because they chose to dismiss this hearing entirely and not participate, which is not normal — I watch a lot of hearings and it is very rare to only see one side of the aisle participate. This is not a thing that happens regularly. But because they didn’t show up, they didn’t call any witnesses that could have provided the testimony and evidence that some of you will feel is lacking in this discussion. They did not ask the questions that would have challenged the witnesses that were invited to testify by the Republicans. You have to be there to do those things. And they we’re not. And so if you find yourself angry that this episode only presents one side, please aim that anger where it belongs, which is at the members of the Democratic Party who are on this committee, who chose not to show up, who I suspect are just dismissing this entire topic as some kind of right-wing conspiracy wackadoodle theory, despite what I consider very reasonable concerns that have been expressed here, especially in terms of a clearly broken system of oversight. You know, I just simply can’t make congressional testimony happen that didn’t happen and include it in a hearing summary episode. I am not a wizard. What I can do, though, and what I have done is take every source, so every podcast episode, every video, every article, every document, everything sent to me by the producers that have already heard the episode that I recorded before. This is obviously different from the one they heard. But they heard the meat of this, and they helped me make the decision about whether or not to air this. And so what I’ve done is I’ve included what they wanted you to see in this episode show notes. So while the hearing may be one sided — in fact, is one sided — the show notes are not. And they are an excellent place for you to start down this rabbit hole if you choose that adventure. And just to be clear, by airing this, I’m not saying that any of this is correct, I have no idea. But I did look into the backgrounds of these witnesses, and none of them appear to be widely dismissed whack-jobs, they do appear to be respected experts in their fields. And I know that this was the first time that I had heard any of this information. This is Congressional testimony. And so whether you trust it or not, that’s up to you. But all of us should know what our Congress is being told. And so now, with that big fat disclaimer out of the way, let’s get to the hearing. Now, the way that I’ve structured this episode is that you’re going to hear the prepared testimony of each of the three witnesses, or at least most of it. And then within that testimony, I’ve added in relevant information from the question-and-answer part of the hearing. My aim is for you to get the gist of each witness’s expertise in full and at once. And so clearly, this testimony is heavily edited. And you may notice the fades in and out between the clips that I made. But I just need you to understand that I messed with the timeline of these testimonies. And so if you want to know what was said in context, and in order, the link to the full hearing is in this episode show notes for you, too. Now, before their testimony begins, Senator Rand Paul of Kentucky is going to introduce each of these experts and provide you with their credentials, starting with Dr. Richard E. Wright. During his testimony, you’re also going to hear questions which were asked by Senator Josh Hawley of Missouri, and then Senator Roger Marshall of Kansas. And by the way, you’re also going to hear some abbreviations. And so if you don’t know, the NIH is the National Institutes of Health. HHS is Health and Human Services. And both of those are agencies in the US federal government. And so, with no further delays or disclaimers, here’s the testimony of Dr. Richard Ebright and introduced by Senator Rand Paul.

Senator Rand Paul  14:20

Dr. Richard Ebright is the Board of Governors Professor of Chemistry and Chemical Biology, and the Director of the Waksman Institute of microbiology at Rutgers University. Dr. Ebright completed his undergraduate degree from Harvard University in biology, where he earned Summa Cum Laude honors. He later received a PhD in Microbiology and Molecular Genetics, also from Harvard. Doctor Ebright’s research has led to over 175 publications, as well as over 40 issued and pending patents. He has received numerous awards for research and is currently a member of the American Academy of Arts and Sciences, as well as the Institutional Biosafety Committee and at Rutgers. He’s a Fellow of the Infectious Disease Society of America, the American Academy of Microbiology, and the American Association for Advancement of Science. He was the editor of Molecular Biology for 16 years. Dr. Ebright currently serves as the project leader of three current NIH research grants and has provided testimony to the House Committee on Energy and Commerce on the 2014 Anthrax Incident. He was a founding member of the Cambridge working group, whose cautionary statement on gain of function research involving potential pandemic pathogens remains as relevant as the day it was released in July 2014.

Dr. Richard Ebright  15:39

Gain of function research of concern is defined as research activities reasonably anticipated to increase a potential pandemic pathogen’s transmissibility, pathogenicity, ability to overcome immune response or ability to overcome a vaccine or drug. Gain of function research of concern involves the creation of new health threats, health threats that did not exist previously, and that might not come to exist by natural means for tens, hundreds or thousands of years. Gain of function research of concern is a small part of biomedical research, it constitutes less than 1/10 of 1% of biomedical research, and less than 1% of virology. However, because gain of function research of concern can cause pandemics, this small part is highly consequential and requires effective oversight. It became possible to do this effectively starting at the beginning of the millennium. The technologies have increased in sophistication, and have increased in ease and decreased in cost over time. Gain of function research of concern poses material risks by creating new potential pandemic pathogens. If the resulting new potential pandemic pathogen is released into humans, either by accident or deliberately, this can cause a pandemic. Gain of function research of concern also poses information risks by providing information on the construction and properties of new potential pandemic pathogens. Publication of the research provides instructions, step-by-step recipes, that can enable a rogue nation, organization or individual to construct a new pathogen and cause a pandemic. Gain of function research of concern provides limited benefits. Gain of function research of concern can advance scientific understanding, but gain of function research of concern has no civilian practical applications. In particular, gain of function research of concern is not needed for and does not contribute to the development of vaccines and drugs. Companies develop vaccines and drugs against pathogens that exist and circulate in humans, not against pathogens that do not yet exist and do not circulate in humans.

Senator Josh Hawley  17:47

Dr. Ebright, let me ask you about the merits of gain of function research, because I was struck by something you said in your written testimony. You said gain of function research has no civilian practical applications. From a research perspective then, why do it? What’s the real value of gain of function research?

Dr. Richard Ebright  18:06

Not a matter of value, but incentives, particularly incentives within the academic research ecosystem. Gain of function research of concern is fast and easy, much faster and much easier than vaccine or drug development. Gain of function research is publishable and gain of function research is fundable. With those four incentives in place —  fast, easy fundable and publishable — the research will be performed. 

Senator Josh Hawley  18:34

What’s China’s interest in gain of function research?

Dr. Richard Ebright  18:38

They have witnessed the United States leading the way with gain of function research. Most gain of function research of concern performed today has been performed either in the US with US funding or overseas with US funding. China has wished to be part of that and has participated in gain of function research of concern in China with US funding and has also supported gain of function research of concern in China entirely through Chinese programs. 

Dr. Richard Ebright  19:11

I believe a strong case can be made, or a case can be made, that certain components of gain of function research of concern, particularly components involving pathogens that are currently in human populations, are categorically separate and more justifiable than other components of gain of function research of concern. For example, currently SARS-CoV-2, the virus responsible for COVID, is present in millions of humans and is generating variant after variant. Gain of function research of concern on SARS-CoV-2 involving the creation of new variants and analysis of the threat posed by them, arguably can be justified because this is not creating new health threats that won’t arise without intervention, but it’s addressing a health threat that’s in place currently. For that reason and for reasons like that, I believe enhancing the oversight of the research is a more effective and more prudent strategy than simply banning it. Effective oversight includes three components. First, research proposals that include gain of function research of concern must be identified and flagged. Second, a risk benefit assessment must be performed. This entails enumerating risks and benefits, weighing risks and benefits and reaching a decision either to proceed as proposed or to proceed with additional risk mitigation, or not to proceed. Third, compliance with a decision from the risk benefit assessment must be mandated, monitored and enforced. I turned now to US oversight of gain of function research of concern. Before 2014, there was no national level us oversight of gain of function research of concern. In 2014 to 2017, the government put in place a moratorium on federal funding for “selected gain of function research,” defined as research activities reasonably anticipated to increase the transmissibility or pathogenicity of influenza, SARS, or MERS viruses. The policy was referred to as the pause. So the the proximal impetus for the pause was a series of events, laboratory accidents, at federal laboratories that have access to and storage of potential pandemic pathogens. The accidents included an anthrax incident at the CDC, another anthrax incident at a US Army facility at Dugway in Utah, and the finding of unsecured vials labeled “smallpox virus” in an FDA-NIH freezer in Maryland. Those three incidents occurring in close succession resulted in a hearing in the House Energy and Commerce Committee, and then action by the Office of Science, Technology and Policy. So the pause was driven ultimately from the White House, from the Obama Office of Science, Technology and Policy. Under the pause, 18 projects were paused. However, at least seven of the 18 projects that were paused were allowed to resume almost immediately. More important, other projects that met the definition for coverage, including a project on SARS related coronaviruses by EcoHealth Alliance and its Wuhan-based partners, were not paused due to the failure of the NIH to identify and flag all covered projects. At the end of 2017 the pause was lifted and was replaced by an HHS policy that requires risk benefit assessment, before awarding HHS funding for “research involving enhanced potential pandemic pathogens,” defined as research activities reasonably anticipated to increase the transmissibility or pathogenicity of a potential pandemic pathogen. The policy is referred to as the P3CO Framework. Under the P3CO Framework, cover projects must be identified and flagged by the funding agency, the NIH, and cover projects must be reviewed by an HHS Secretary level committee, the P3CO Committee. The P3CO Framework assesses the reasonably anticipated results of the proposed research. The reasonably anticipated standard employed in the policy is equivalent in all respects to the reasonable person standard employed in US Administrative Law and US Civil Law.

Dr. Richard Ebright  23:34

Importantly, the P3CO Framework does not mandate compliance. If the P3CO Committee makes a decision that the research may not proceed, that decision is only advisory to the funding agency. It is not mandated for the funding agency. The funding agency is free to accept or not accepted decision and is free to determine whether to monitor or not to monitor the progress of the work. This is a major shortcoming. In principle, the P3CO Framework ensures risk benefit assessment of gain of function research of concern. However, in practice, the P3CO Framework has existed primarily on paper. In the four and a half years since the policy was announced, only three projects have been reviewed. Most cover projects, including the project by EcoHealth Alliance and its Wuhan partners, were not reviewed due to a failure by the NIH to identify and flag cover projects. In addition, the P3CO Committee has been non-transparent and unaccountable. The names and agency affiliations of its members have not been disclosed, its proceedings have not been disclosed, and even its decisions have not been disclosed.

Senator Roger Marshall  24:42

Dr. Ebright, could EcoHealth research in China have led to the COVID-19 pandemic, and Dr. Fauci’s worst fears that a lab accident in a foreign lab became reality.

Dr. Richard Ebright  24:54

Yes, lapses in US oversight of gain of function research of concern may have caused the current pandemic, could cause future pandemics. The US government funded high-risk gain of function research and high-risk enhanced potential pandemic pathogens research at the Wuhan Institute of Virology in 2016 to 2019. The research overlaped the pause that was in effect in 2014-2017, and met the criteria to be paused, but was not paused. Wuhan Institute of Virology constructed novel chimeric, SARS-related coronaviruses that combined the spike gene of one Coronavirus with the genetic information of another. They showed that the resulting viruses efficiently infected human airway cells and efficiently replicated in human airway cells, and they showed that the resulting viruses exhibited up to 10,000-fold enhancement of viral growth in lungs and up to four-fold enhancement of lethality in mice engineered to display human receptors on airway cells. Based on those facts, and they are indeed facts, the research was gain of function research of concern, subject to the pause and was enhanced potential pandemic pathogen research subject to the P3CO Framework. Nevertheless, due to the failure of the NIH to forward the proposals for review, the work was not paused, and there was no P3CO l review.

Jennifer Briney  26:21

See what I mean by a broken system of oversight? No matter what happened to cause COVID-19, that’s important and something that Congress has the power to fix. It’s too bad the members of the party currently in power didn’t bother to show up to hear it. But regardless, now let’s listen to the testimony specific to the COVID-19 pandemic by listening to the next witness, Stephen Quay. This is where the episode is going to get controversial. But I want to make this much clearer before you hear this. As you can look into the shownotes to see for yourself, there is no definite conclusion about what caused the COVID-19 pandemic. Anyone who says that there is is either uninformed, misinformed, or lying. And the shownotes will prove this to you. One particularly impactful piece of evidence you will find in the show notes is a report from the World Health Organization from just a few months ago, from June 2022, in which they describe the panel they’ve convened to investigate the origins of SARS-CoV-2. Now, the fact that that investigation has just been launched is proof enough that the cause is not yet known. But in case that’s not enough for you, they say in the report that they have, “reviewed key available findings to date, and notes that there are key pieces of data that are not yet available for a complete understanding of how the COVID-19 pandemic began.” And so the only thing that we can know right now for a fact is that no theory on the pandemics origin has been proven. Steven Quay is going to testify about the evidence supporting the theory that the virus was not something that naturally mutated into SARS-CoV-2, but was instead something generated by humans in a lab, specifically the Wuhan Institute of Virology, which is located in the town that the whole world agrees was the origin point of the pandemic, Wuhan, China. And he’s going to refer to the Wuhan Institute of Virology in his testimony by its abbreviation WIV. And one thing to note, unlike the other two witnesses, Stephen Quay did not include any sources in his written testimony submitted to the committee. That said, that doesn’t mean that his sources don’t exist. I was able to find a few Wall Street Journal articles that he co authored, where he did link to his sources, but for what it’s worth, his proof presented to Congress was the most lacking of the three witnesses. And so here’s Senator Rand Paul, introducing Stephen Quay and providing his credentials, followed by Stephen Quay’s testimony, and peppered into his testimony you’re going to hear questions from Senator Rand Paul of Kentucky and Senator Roger Marshall of Kansas.

Senator Rand Paul  29:02

Dr. Stephen Quay is the founder and chairman of the Seattle-based Atossa Therapeutics. Atossa Therapeutics is a clinical stage biopharmaceutical company that develops novel therapeutics and delivery methods for breast cancer and other breast conditions, with a goal of preventing the 2 million yearly breast cancer cases worldwide. Earlier in his career, Dr. Quay received his MD and PhD from the University of Michigan, trained as a postdoctoral fellow at MIT, and served on the faculty of Stanford University School of Medicine. Dr. Quay’s published contributions to the world of medicine have been cited extensively and he is a medical entrepreneur. He has founded six startups, invented seven FDA approved pharmaceuticals and is the holder of 87 patents and over 130 pending US and foreign patent applications. He’s also an author. Notably during the pandemic, Dr. Quay published his number one Amazon bestseller “Stay Safe: A Physician’s Guide to Survive Coronavirus.”

Dr. Stephen Quay  30:02

There is no dispositive evidence the pandemic began as a spillover of a natural virus in a market. All evidence is consistent with a laboratory acquired infection. I do understand this conclusion is not widely held. All evidence is consistent with an accidental and not a deliberate release. SARS-2 has features consistent with synthetic biology gain of function research. Two features involve acceptable academic gain of function research, the receptor binding domain optimization, and the furin cleavage site. These two features have never been found in nature and related viruses that could have reasonably started the pandemic because of the closeness of these viruses to Wuhan. These two features are, on the other hand, routinely engineered into viruses. In 2018, US and WIV scientists proposed inserting, “human-specific furin cleavage sites in a bat virus backbone.” Two years later, SARS-2 appeared on the WIV’s doorstep. SARS-2 is a bat-derived virus with a human-specific furin cleavage site. The Wuhan Institute of Virology is unique in the entire world. Before 2019, 65% of all publications on coronaviruses came from that single institution. They’re unique for two reasons. For almost a decade, they were going into bat caves throughout China, and actually back into Africa as well, 20 visits a year, and bringing the samples back to the laboratory. So on the one hand, they had the largest collection of raw material backbones from nature, to then do gain of function research on. They trained in Galveston, Texas and in North Carolina and we’re doing experiments, published experiments, between 2015 and 2019. I believe it’s the confluence of those two activities, gain of opportunity, bringing things back from bat caves, and gain of function research that led to the pandemic. One region of SARS-2, called ORF8, has features of forbidden gain of function research: asymptomatic transmission and immune system evasion. The WIV was engineering a protein related to ORF8 to have these two forbidden properties before 2019, as shown in two master’s degrees theses available only in Chinese. COVID exhibits 40% asymptomatic transmission, unheard of for a new respiratory virus. Patients infected with an acquired deletion ORF8 have a milder infection. Could the reduced efficacy of vaccines and natural immunity be an engineering feature? It appears likely. Where did the pandemic begin? The competing hypotheses are a natural spillover at the Hunan seafood market in Wuhan, and a laboratory acquired infection. Two recent papers purport to claim the pandemic began at the Hunan market in December 2019. There are at least six serious problems with these papers. The most important are that in the early months, no animal has ever been found to be infected with COVID-19 anywhere, including the market, and the molecular clock of SARS-2 places the first human infection in the fall of 2019, long before the December market cases. All infections in the market in humans were what’s called lineage B and not the most ancestral lineage, lineage A. I, like many other scientists, believe the market cases were a super spreader event. The earliest cluster of hospitalized patients with both the lineage A and B virus was at the People’s Liberation Army Hospital in Wuhan. This hospital is about six kilometers from the WIV and on line two of the Wuhan subway system, as shown in this chart. All early cases are in hospitals adjacent to line two, and the probability this was a chance occurrence is one in 68,000. The line to COVID conduit, as I called it, includes the PLA hospital, the WIV, the market and the International Airport. You can literally walk down into the subway system from the WIV in China and next exit outside in London, Paris, Dubai, Los Angeles or New York, all before having any symptoms. Modeling by others suggested the pandemic could not have occurred without the international spreading impact of line two.

Senator Rand Paul  34:18

Can you give me two or three things that this virus has that make you think it’s lab versus some of the evidence for MERS and SARS that was that it came from animals?

Dr. Stephen Quay  34:29

Yeah, there are three regions: the receptor binding domain, the Furin cleavage site, and this protein eighth from the left called ORF8, with respect to the with receptor binding domain. If you look at what happened with SARS-1 we have the virus sequence when it first was in civet cats in the markets, jumped into a few humans, we have the virus sequence, then it started infecting more, and then we have the virus sequence when human to human passage could occur and an epidemic occurred. And so you can see the progression of mutations as the virus adapted from being in civet cats and then being in humans. The first jump into humans had only 50% of the mutations it needed to support an epidemic. Let’s flip to SARS-CoV-2. When you look at the virus that first entered the human population, out of all of the changes in the receptor binding domain, there are 200 amino acids, 4000 possible changes, there are only 17 mutations that can make it a better virus. Its receptor binding optimization was 99.5%. And in fact, one of the 17 ended up being the Delta variant. So that kind of optimization juxtaposed by the fact that there were no patients in Wuhan. 36,000 blood specimens tested for antibodies in 2019, not a single patient was infected. Let’s go back to SARS-1. 20% of all people in the markets were infected while the virus was practicing to set up an epidemic, 1% of the general population. So we would have expected 360 in the general population. In Wuhan we had zero. The furin cleavage site has obviously never occurred in related viruses that split from their their cousins. The MERS viruses, around the time of William [the Conquerer] crossing the [English] Channel in 1006, that was when these related viruses came. So there’s never been a furin cleavage site and the genetic sequence of it uses a code, CG dimers, which has never been used before. Finally ORF8, this protein that goes into the bloodstream and suppresses interferon response to your asymptomatic and suppresses HC antigen presentation so you can’t make good antibodies. This was the subject of two master’s theses at the Wuhan Institute of Virology. I have found no Western scientists that worked on this location in the genome before 2019. The protein is not present in MERS. It has a 5% homology in SARS-1. Between SARS-1 and SARS-2 there’s protein there but it’s only 5% homologous. But this master’s thesis the first one optimize its function in suppressing interferon symptoms of fever and chills and suppress its antigen presentation. The second one was making synthetic biology tools, so you can move it around inside genomes.

Senator Rand Paul  37:16

So to reiterate, there’s been no animals found that have COVID 19. When they did find that animals had — for the first SARS and MERS — they found it out within months, when they tested the animals in question. 90% of the animals had the SARS virus. So we haven’t found any animals yet with COVID-19. And then most viruses that come from animals first, aren’t very infectious at first and infect a few humans. So you don’t have a pandemic that does this. It smolders, and then does this. During the smoldering phase you find background antibodies that people have had it even if they don’t know they had it. So when they tested the background of people who were working with the animals that had COVID, they found 20% of them had antibodies to having had SARS.

Dr. Stephen Quay  38:08

SARS-1, yes, correct. 

Senator Rand Paul  38:09

But then if we test the people in the marketplace, we’re not finding that. If we look at the people in the Wuhan marketplace, we’re not finding significant numbers that were positive and finding almost nobody positive from the previous year that had been ill.

Dr. Stephen Quay  38:23

No, it’s zero out of 36,000. 

Dr. Stephen Quay  38:26

So a great deal of information was destroyed by the Chinese.

Dr. Stephen Quay  38:26

The three sets of viruses that are closest to SARS-2, are one from southern China RTG13, and a series of BANALs from Northern Laos. As indicated there are probably 1200 letters different in the whole 30,000 letter alphabet. In nature that takes approximately 40 years. So the the most common ancestor is about 40 years ago. But most of that can be done in a couple of days in a laboratory. However, I don’t believe we currently have the starting material, the backbone on which SARS-2 was found. I think it’s one of the other 21,000 viruses in the [NIH] database that was taken down at 2am, September 12 2019.

Dr. Stephen Quay  38:31

It was taken offline, not available. I don’t know if it was destoryed. I think I also think that, that we don’t have to rely on the Wuhan Institute of Virology for releasing that. I believe within US jurisdiction, there will be copies of that database. It’s too valuable not to have in your own possession if you’re doing research on it.

Senator Roger Marshall  39:27

Do you think there’s any way we can still get any of that data that’s missing? I feel like you know, somewhere we’re gonna find the grandfather of COVID, or the cousin or something, here in these data banks. Why did they take them down? And what would be the advantage of them taking it down? Do you think we can ever find what we’re missing?


What was taken down at 2am on September, 12 2019 — I guess everyone works hard, but that’s a little suspicious to be doing it at that point in time — I believe it contains closer precursors. My hypothesis is it contains the one that’s 50 mutations or 100 mutations, not 1200 away and it was too obviously a smoking gun. But again, if you’re collaborating on that, and you’re spending 10 years building a database inside the Wuhan Institute of Virology, you’re going to mirror that database in your own facilities, which means that it’s got to be at EcoHealth Alliance somewhere.

Jennifer Briney  40:22

And for a little bit extra information about the lab leak theory, Senator Rand Paul provided some from Dr. Ebight. He was the first guy that you heard from, but towards the end of the hearing, Senator Rand Paul read a portion of Dr. Ebright’s testimony with some history about lab leaks. And so here is that portion of the hearing.

Senator Rand Paul  40:43

I wanted to point out one thing from Dr. Ebright’s testimony, just for those who say, “well, lab leaks should be discounted, they don’t ever happen.” At one point, Dr. Ebright writes “the second, third, fourth and fifth entries of the SARS virus, this was the first one, into human populations, occurred as a laboratory accident in Singapore in 2003, a laboratory accident and Taipei in 2003, and two separate laboratory accidents in Beijing in 2004.” So for people who say that it’s a conspiracy theory that this could have come from the lab, they’re discounting our history, the history has had these lab leaks. And so whether or not we’ll ever know, for 100% certain when this came from the lab, we have had lab leaks, and we have to realize the potential danger of these pathogens.

Jennifer Briney  41:30

And so that’s what’s being told to Congress about the origin of the COVID 19 pandemic. But I don’t want us to focus too much on that because the issue here is actually much bigger than the COVID 19 pandemic, because a pandemic could happen again, and the next time might not be an accident. 

Jennifer Briney  41:51

The next testimony that you’re going to hear is from Dr. Kevin Esvelt. In his testimony, he’s going to mention USAID, which stands for the US Agency for International Development, which is a part of the United States Federal Government. Dr. Kevin Esvelt is going to testify after being introduced by Senator Rand Paul, about gain of function research and its implications on national security.

Senator Rand Paul  42:14

On our witnesses, Dr. Kevin Esvelt, is currently an assistant professor at the MIT Media Lab group, where he leads the Sculpting Evolution group. Dr. Esvelt received his BA in Chemistry and Biology from Harvey Mudd College and would later complete his PhD in Biochemistry at Harvard University as a Hertz Fellow. While working in the laboratory of David Liu at Harvard University, Dr. Esvelt invented Phage Assisted Continuous Evolution, or PACE, which is a synthetic microbial ecosystem for rapidly evolving biomolecules. Later, during his time as a Wyss Technology Fellow, Esvelt’s focus centered around the development of gene drive technology. Many of Esvelt’s contributions related to the bioethics and biosafety of such gene drivers and he is credited as the first to describe how CRISPR gene drives can be used to alter the traits of wild populations in an evolutionarily stable manner. In his recent work at the Sculpting Evolution group, Dr. Esvelt and his colleagues invented the new technology known as Daisy Drives, which would let communities aiming to prevent disease alter wild organisms in local ecosystems. Throughout his career, Dr. Esvelt has been a champion of universal safeguards, transparency, raising scientific awareness of developing early warning systems to reliably detect any catastrophic biological threat, and advising policymakers on how to best mitigate global catastrophic bio-risk.

Dr. Kevin Esvelt  43:43

The problem is that we are so used to thinking of pandemics as a health and safety issue that we’ve missed the national security implications of identifying viruses that could be deliberately unleashed to kill millions of people. Let me illustrate. When the genome of SARS-2 was first posted online, scientists didn’t have to wait for physical samples of the virus to become available to begin studying it and working on countermeasures. That’s because we could order synthetic DNA corresponding to the genome of the pathogen and assemble infectious samples, using freely available step-by-step protocols. From a biomedical perspective, that is a triumph, particularly because it only costs a few thousand dollars, and the price is plummeting. But from a security perspective, that means that thousands of researchers could gain access to a novel pandemic agent as soon as it was identified as such. If you work in public health and infectious disease, you naturally want to know what the next threat might be, so that you can better prepare defenses. That makes sense and that is why both USAID and NIH have funded research attempting to find or create novel pandemic capable viruses in labs all over the world in the hope of preventing natural pandemics. Both agencies seek to identify viruses that could kill as many people as a nuclear weapon to alert the entire world to what they find, and to publicly sharing the complete genome sequences of those viruses, so that skilled scientists everywhere will be able to make infectious samples. The tragedy is that these are health experts, well meaning health experts, who have dedicated their lives to fighting infectious disease. And they struggled to imagine anyone evil enough to deliberately cause one. So they never considered that these advances in technology, which are continuing, plus a list of endemic-capable viruses would allow a single skilled terrorist to unleash more pandemics at once than would naturally occur in a century. And no one warned them, perhaps because, as has been previously noted, they lack independent security oversight of their work. 

Dr. Kevin Esvelt  46:15

One clarification, you mentioned on endemic human viruses like SARS-2, why do this? Well, if you want to predict the next variant that is going to arise anyway, within a couple of months, one that already exists, then that’s why researchers do things like deep mutational scanning on the spike protein to look and see which ones of them might have a bit of an edge in terms of maintaining infection while evading immunity a little bit, and is likely going to be the next variant. That then lets us design the next vaccine against the variant and guess correctly. We have to do this with flu every year. Flu vaccines are terrible, usually, because we often guess wrong. So that kind of research can help improve our guess as to what is correct. But as soon as you make a change that would not occur in nature, then it becomes dangerous, because that is something that, the more pathogenic mutation could be inserted. And that becomes a problem. And there’s no justification for doing that, because nature is not going to come up with it. USAID, to my understanding, has since disavowed those chimeric recombination studies and announced that they will only focus on finding natural pandemic capable viruses, which is at least a step in the right direction.

Jennifer Briney  47:30

And I for one am happy to hear that because COVID-19 was not the worst case scenario. Now, it’s very tragic that millions of people died. But a different virus with more lethality could kill a lot more people. And unfortunately, there’s some research going on that it sounds concerning to me. And so here’s an example from Dr. Quay and in this clip, you’re going to hear a question from Senator Ron Johnson of Wisconsin.

Dr. Stephen Quay  48:01

In December 2018, we performed a remote audit forensic examination of the Wuhan Institute of Virology and found synthetic biology experiments with the Nipah Virus. As the chart shows, they had created a cloning vector with a virus the US CDC defines as bioterrorism agent. Nipah Virus is one of the deadliest on the planet, with a greater than 60% lethality. Why were they conducting this experiment? I do not know. But a laboratory acquired infection with this virus, if it became airborne, would make COVID-19 look like a walk in the park.

Senator Ron Johnson  48:32

Dr. Quay, how did we find out about the Nipah Virus?

Dr. Stephen Quay 48:35

So in December 2018, five patients at one hospital had their specimen sent — a bronchial lavage — to the Wuhan Institute of Virology for sequencing. The process is to amplify with a PCR process. You make a lot of copies of what’s in the specimen, and usually inadvertently, make copies of what’s going on in the laboratory. So the Wuhan Institute of Virology probably regrets, but they put a 55 million letter database of the background information up in the gene bank, which is the NIH’s database there. Of everything going on, we found 20 strange things in these patient specimens, honeysuckle genes, horse viruses, 19 of the things we found were in publications from the laboratory over the previous two years. So this clearly was a signal of what was going on in the lab around there. The one thing they didn’t publish on was this cloning vectors of the Nipah Virus. So it’s in the patient’s specimens because it was in the laboratory at the time not in the patients, but in they have never published on that, at this point in time.

Senator Ron Johnson  49:40

How do we know it’s 60% lethal?

Dr. Stephen Quay  49:44

The Nipah Virus has had epidemics in the belt around Africa and India, Bangladesh and it’s between 60 and 80% lethal in the pockets where it comes out. It’s not very transmissible like Ebola, so it kills 100 or 200 people and then burns out, but if they made it airborne, it would be different.

Jennifer Briney  50:02

Okay. And so what do we do about all this? Well, each of the witnesses had some suggestions. First you’re going to hear from Dr. Esvelt who is the national security guy. And Senator Roger Marshall is going to question Dr. Quay and then Dr. Esvelt. And then after Dr. Esvelt will give his recommendations, he is going to be followed by Dr. Ebight and then Dr. Quay.

Dr. Kevin Esvelt  50:25

When it comes to identifying pandemic capable viruses that could kill millions of people, and will necessarily be shared with scientists worldwide who will be able to access them, I do not think that we should be doing it. I do not think that China should be doing it. I do not think that anyone should be doing it.

Senator Roger Marshall  50:41

Should Congress immediately pause this dangerous research?

Dr. Stephen Quay  50:45

I think that’s an appropriate step for Congress to take.

Senator Roger Marshall  50:50

Dr. Esvelt?

Dr. Kevin Esvelt  50:51

I think it would be somewhat dangerous to attempt to pause gain of function research when it’s evident that that term is so malleable as to be evaded at-will and also could plausibly do damage by applying to science that is not specifically directed at potential pandemic pathogens. For starters, Congress could study the issue and release a finding on whether pandemic virus identification endangers national security. It’s just that simple. Then, if necessary reform USAID and NIH research. It could require an oversight committee of experts from security agencies to review all requests for proposals in the life sciences. It could update the federal select agent program to automatically regulate viruses at the first sign of pandemic capability. Because these are the most dangerous agents out there. It could require all DNA synthesis orders to be screened for hazards, and perhaps most important, Congress could legislate catastrophe liability. That is liability for human caused events that result in more than a million American casualties, as SARS-2 has, and require general liability insurance to cover it. That would induce the market to price in the cost of negative externalities, and cause professional insurance risk analysts to perform those cost benefit analyses.

Dr. Richard Ebright  52:15

My recommendations are as follows. First, responsibility for US oversight of gain of function research of concern should be assigned to a single independent federal agency that does not perform research and does not fund research. Second, US oversight of gain of function research of concern should cover all US and US-funded research, irrespective of funding source classification, status and research location. Third, US oversight of gain of function research of concern should be codified in regulations with force of law and should be mandated, monitored and enforced. And fourth, US oversight of gain of function research of concern should be transparent and accountable.

Dr. Stephen Quay  52:54

I’ve found found no actual benefit of gain function research, I believe efforts to ban it, given the vested interests of literally the entire virology community is a hill to steep decline. A proposal that I believe is achievable is a placement of all select agent research within the existing institutional review board structure used for human clinical trials. I believe that this effort would put guardrails around the most dangerous aspects of this research and has the added benefit of international acceptance, including in China. My second reform would be to separate government oversight from the funding agency and the model would be the Atomic Energy Commission. My third suggestion is to place Western biotechnology equipment under export controls and monitoring. There are ways to build into these systems a forensic and law enforcement capability that could, for example, with probable cause inaccordance with search warrant, allow the work of any lab in the world to be scrutinized remotely. My fourth recommendation is simple. Don’t put dangerous infectious disease laboratories near subways like Line 2, where every major city in the world is accessible within the incubation period of an infection. Has gain of function research been useful to the COVID response or any other public health infectious disease emergency? I have found no evidence that gain of function research helps in either the COVID pandemic or other smaller epidemics. We now know that an MRI vaccine can be designed within literally days of a new outbreak once the pathogen is sequenced. And large scale manufacturing can begin soon thereafter. This capability has now been fully road tested and provides, in my opinion, the best defensive capability against future microbes.

Jennifer Briney  54:29

Now obviously, that testimony was just a few weeks ago, and so almost none of that has been implemented. But I do want to point out that we have taken a small step in the right direction in a recently signed law. So right now I am reading the so called CHIPS Law, which is the law that is giving so many billions of dollars to the semiconductor industry and also to scientific research. And I did find a provision in the new law that’s going to require — in two years is when this is going to begin — but two years from now, the government is going to have to require that ethical and societal considerations are included as a part of a proposal for funding prior to making awards for research. And that also has to include input from the peer reviewers for the proposal, kind of baffling to me that we haven’t looked at the ethical and societal considerations, until now, and that we’re waiting for two years to require that. But it’s a step in the right direction that at least before this stuff is awarded, that those considerations are thought through. Unfortunately, they’re going to be thought through and written down by the people trying to get the research funded. So there is bias there, but baby steps. But clearly, there is more work to be done here. And also, clearly, the senator who is taking the lead on this issue is Senator Rand Paul of Kentucky. And so here’s what he is proposing.

Senator Rand Paul  56:03

What I would really like to come of this and I mean this sincerely, is I would like to have a bipartisan bill that comes forward for better oversight. Maybe it’s not oversight of gain of function, but maybe includes things that some people consider to be gain of function. Maybe it’s more general pandemic viruses, there’s a lot of ways we can discuss it. But the bottom line is, I don’t think the people doing the research are able to adequately and objectively regulate themselves. And I think having a million people die, there should be bipartisan curiosity in this, that we should be able to move forward. And I for one am, open to work with any Democrat in the Senate to make this a bipartisan bill. And to make it an even keeled thing where all the voices are heard that we don’t rationally create any legislation that would hamper science. But to recreate something that would have oversight that might save lives. I truly think that a million people died in our country. 6 million people died, and I think it was from a lab link. And I think it’s something that we need to have precautions against. I think it was accidental, by the way, but I think if we don’t do anything, what if this gets in the hands of somebody who actually really wants to harm America or the world, or just some psychopath? What could happen? So right now, we’re doing nothing and have changed no behavior. We’ve had this pandemic and we have changed not one bit of behavior. So I think it’s about time, we do get together and that we’re all curious, and that we don’t make this about Republicans and Democrats, we make this about how we as a people come together to try to make this world a better place.

Jennifer Briney  57:34

Sounds reasonable to me. But it’s going to be real tough to work on bipartisan legislation to strengthen oversight of dangerous research and information sharing practices if the members of the Democratic Party won’t even listen to testimony about the problems. Specifically the senators who sit on this committee who decided to skip it, are the Chair of the Committee, Maggie Hassan of New Hampshire, Krysten Sinema of Arizona, Jacky Rosen of Nevada, and John Ossoff of Georgia. If you’re from any of those states, and are unhappy about their no show, a phone call or email to them right before a midterm election could be impactful. This is not the only committee that can work on this issue. If you have feelings about what you heard in this hearing, it doesn’t hurt to share that with your members of Congress who can actually do something about these things. I’m just the messenger. And so please keep it in mind that you are wasting your time if you direct your passions at me. Congress. Contact Congress. And don’t forget to vote according to your judgement of their job performance in November.

Jennifer Briney  58:48

Before I dismiss you from Congress class for the day, I would like to let you know that I am so excited that we have a new executive producer, someone that I have been friends with for a very long time. And his name is Troy Heinritz, and he is going to be the Executive Producer on Episode 152, the Air Traffic Controller Privatisation episode. Now for those of you who are new to the Congressional dish community, the executive producers are people that contribute a significant amount that really does cover quite a bit of the production costs of an episode. But because your name is going on it and you have no idea what I’m doing next, I do allow you to put your credit on any episode that you’re particularly proud of. And so that is why Troy picked episode 152. And what he said is, “whenever I tell people to listen to congressional dish, it is because of episodes like this. All the news covers is the flashy headlines and this topic would probably never have seen the light of day if it wasn’t for your tenacity and ability to keep us informed. You do amazing work and I’m happy to be an EP and also a friend. Also October 2 in Green Bay.” And that is about him inviting me to go and see a Green Bay Packers game, which I would love to do, but it’s right in the middle of my DC trip and my social calendar is actually quite full here in DC. And one of the things that I’ve done here in DC, just FYI, I will put it in the show notes for you. I was just on CSPAN. CSPAC, kind of out of nowhere, reached out to me and asked me to be on Washington Journal. I got a full 40 minutes where the interview was all about me, and it was so much fun. I’ll give you the link to that in the show notes. It will live in the CSPAN archives forever. And so the dork that I am, I have definitely searched my name a few times in the CsPAC archives, just to see that I’m in there twice. The dumb things I get excited about. But yeah, it was a really fun interview. Got some really good questions. Thank you to John, who is also a friend of mine, but a Congressional Dish producer who got through, and I even recognized his voice when I was on the air. So that was super fun. But yeah, I’m doing some cool things and meeting cool people here in DC. I’m also going to take a tour of the Capitol after I finish the CHIPS episode. Because, fun fact, even though I’ve been doing a podcast about Congress for the last 10 years, I’ve never actually stepped foot in the place. And so the week of the government funding debacle, because government’s supposed to be funded by September 30, I should be done with the CHIPS episode by then. And so I want to go and see what happens in person. I’m actually really hoping to go to the Rules Committee, and just watch what goes down before their Continuing Resolution makes it onto the floor because there’s no way they’re finishing government funding by the end of the month, they’re going to kick the can. The only question is: how far are they going to kick their deadline this year? Is it going to be another holiday situation, or are they going to kick it into the new Congress? And then they’re also trying to decide what dingleberries are going to get attached to the temporary government funding. So this year, I want to see it in person. I’m sorry, I can’t make it to Green Bay this year. But I definitely want to go to Lambeau Field at some point. So thank you, my friend for not only being my friend and inviting me to football games and all of that good stuff, but for supporting the show for so many years. And that goes for literally everyone that has supported the show over the years. All right, so the CHIPS episode, I’m almost done reading it. In fact, once I’m done with this, I’m gonna go and finish it. I think I’m about 100 pages left and I get to have a weekend as soon as I’m done. But I’m going to have that episode for you by the end of the month. So instead of waiting for two weeks, you only have to wait for one for the next episode. And so until you hear my voice again, be happy, be safe, and I will talk to you soon and thanks again for helping me get to 10 years. It’s still blowing my mind that I’ve been doing this for so long and and so many people helped me do it. So yeah, love you. I’ll talk to you soon. Bye.

David Ippolito  1:04:45

[Music] Tired of Being Lied To

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