[Senate Hearing 117-555]
[From the U.S. Government Publishing Office]
S. Hrg. 117-555
REVISITING GAIN OF FUNCTION RESEARCH:
WHAT THE PANDEMIC TAUGHT US AND WHERE
DO WE GO FROM HERE
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HEARING
BEFORE THE
SUBCOMMITTEE ON
EMERGING THREATS AND SPENDING OVERSIGHT
OF THE
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
SECOND SESSION
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AUGUST 3, 2022
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Available via the World Wide Web: http://govinfo.gov
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
__________
U.S. GOVERNMENT PUBLISHING OFFICE
48-703 WASHINGTON : 2023
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COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
GARY C. PETERS, Michigan, Chairman
THOMAS R. CARPER, Delaware ROB PORTMAN, Ohio
MAGGIE HASSAN, New Hampshire RON JOHNSON, Wisconsin
KYRSTEN SINEMA, Arizona RAND PAUL, Kentucky
JACKY ROSEN, Nevada JAMES LANKFORD, Oklahoma
ALEX PADILLA, California MITT ROMNEY, Utah
JON OSSOFF, Georgia RICK SCOTT, Florida
JOSH HAWLEY, Missouri
David M. Weinberg, Staff Director
Zachary I. Schram, Chief Counsel
Pamela Thiessen, Minority Staff Director
Andrew Dockham, Minority Chief Counsel and Deputy Staff Director
Laura W. Kilbride, Chief Clerk
Thomas J. Spino, Hearing Clerk
SUBCOMMITTEE ON EMERGING THREATS AND SPENDING OVERSIGHT
MAGGIE HASSAN, New Hampshire, Chairman
KYRSTEN SINEMA, Arizona RAND PAUL, Kentucky
JACKY ROSEN, Nevada MITT ROMNEY, Utah
JON OSSOFF, Georgia RICK SCOTT, Florida
JOSH HAWLEY, Missouri
Jason Yanussi, Staff Director
Peter Su, Professional Staff Member
Adam Salmon, Minority Staff Director
Kate Kielceski, Chief Clerk
C O N T E N T S
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Opening statements:
Page
Senator Paul................................................. 1
Senator Scott................................................ 11
Senator Johnson.............................................. 14
Senator Marshall............................................. 16
Senator Hawley............................................... 19
Prepared statements:
Senator Paul................................................. 35
Senator Peters............................................... 37
WITNESSES
Wednesday, August 3, 2022
Richard H. Ebright, Ph.D., Laboratory Director, Waksman Institute
of Microbiology, Rutgers University............................ 3
Steven Quay, MD, Ph.D., Chief Executive Officer, Atossa
Therapeutics, Inc.............................................. 6
Kevin M. Esvelt, Ph.D., Assistant Professor of Media Arts and
Sciences, MIT Media Lab........................................ 9
Alphabetical List of Witnesses
Ebright, Richard H., Ph.D.:
Testimony.................................................... 3
Prepared statement........................................... 38
Esvelkt, Kevin M., Ph.D.:
Testimony.................................................... 9
Prepared statement........................................... 73
Quay, Steven, MD, Ph.D.:
Testimony.................................................... 6
Prepared statement........................................... 66
APPENDIX
Senator Peters documents submitted for the Record................ 92
Senator Marshall documents submitted for the Record.............. 1443
REVISITING GAIN OF FUNCTION RESEARCH: WHAT THE PANDEMIC TAUGHT US AND
WHERE DO WE GO FROM HERE
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WEDNESDAY, AUGUST 3, 2022
U.S. Senate,
Subcommittee on Emerging Threats and
Spending Oversight,
of the Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:30 p.m., via
Webex and in room 342, Dirksen Senate Office Building, Hon.
Rand Paul, presiding.
Present: Senators Ossoff, Paul, Scott, Hawley, and Johnson.
Also present: Senator Marshall.
OPENING STATEMENT OF SENATOR PAUL\1\
Senator Paul. I call this meeting of the Senate Homeland
Security and Governmental Affairs Subcommittee on Emerging
Threats and Spending Oversight (ETSO) to order. I want to thank
Senator Hassan for allowing this hearing to occur.
Welcome to each of our panelists. Thank you for joining us.
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\1\ The prepared statement of Senator Paul appears in the Appendix
on page 35.
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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. We are grateful for their work and we are grateful
to each of you for taking the time to appear with us this
afternoon.
Gain-of-function (GOF) 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.
Today we will discuss what gain-of-function research
entails, how gain-of-function research is defined, and whether
the definition of gain-of-function research is applied
consistently by the Department of Health and Human Services
(HHS) Potential Pandemic Pathogens (P3CO) Review Committee.
This is a committee that was set up to study potential pandemic
pathogens.
We will discuss the responsibility for how we determine the
risks and benefits. We will also discuss how this committee
operates, how this committee approves or denies projects from
receiving Federal funding based on whether the pathogen is
considered to be a credible source of potential future human
pandemic, and if the potential risks, as compared to the
potential benefits to society, are justified. In other words, a
project is not gain-of-function if the review committee is
unsure if a recombinant virus will create a future pandemic.
There is a question of whether or not there is a reasonable
expectation that it might be or whether or not it has been in
the past, or what viruses should be and should not be
experimented upon. This broad criterion gives one sole
committee, which is comprised of an unknown group of
bureaucrats--I believe the names are not released of who is on
the committee so there is not necessarily any oversight of the
oversight--the power to spend millions of taxpayer dollars on a
single, preemptive guess, with potentially devastating
consequences.
Today we will also consider whether gain-of-function
research was performed at the Wuhan Institute of Virology
(WIV). First, no one, not myself or anyone I am aware of,
argues that a recombinant super-virus that has been published
in scientific journals is Coronavirus Disease 2019 (COVID-19)
or a close relative. If--and I underline ``if''--COVID-19
leaked from the Wuhan lab, it would be a laboratory-created
virus that the Wuhan scientists have not yet, and are unlikely
ever to reveal.
I maintain that the techniques that the National Institutes
of Health (NIH) funded in Wuhan to create enhanced pathogens
may have or could have been used to create COVID-19. The
American people deserve to know how this pandemic started and
to know if the NIH funded research that may have caused this
pandemic.
Gain-of-function research has the potential to unleash a
global pandemic that threatens the lives of millions. Yet this
is the first time the issue has been discussed in a
congressional committee.
I am sure each Member of this Committee, as well as the
full Senate, can agree that we need stronger government
oversight of how our tax dollars are being used to finance
experimenting with possibly fatal diseases.
Again, I thank each of our distinguished witnesses for
being here today and I thank Chair Hassan for working with me
to convene this meeting.
Before we begin I would like to note that I have invited
Senators who are not on the Subcommittee to also attend today.
Therefore, I ask unanimous consent (UC) to allow Senator
Marshall and Senator Johnson to fully participate in the
hearing, provided that any Members of the Subcommittee be given
deference in the order of recognition. Without objection.
Next I would like to remind witnesses that any written
testimony they have, anything that they have submitted, will be
included in the record, and to please keep your opening remarks
to around 7 minutes.
With that I am going to introduce the witnesses, and we
will hear their remarks after the introduction, which is
slightly different than we do sometimes, and then I will
introduce the next witnesses.
The first witness will be with via WebEx. It is Dr. Richard
Ebright. 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.
Dr. 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 at Rutgers University. He is
a Fellow of the Infectious Disease Society of America, the
American Academy of Microbiology, 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, has provided testimony to the
House Committee on Energy and Commerce on the 2014 anthrax
incident, and 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. Ebright.
TESTIMONY OF RICHARD H. EBRIGHT, PH.D.,\1\ LABORATORY DIRECTOR,
WAKSMAN INSTITUTE OF MICROBIOLOGY, RUTGERS UNIVERSITY
Mr. Ebright. Thank you. Chair Hassan and Members of the
Committee, thank you for inviting me to discuss gain-of-
function research and its oversight. I am Board of Governors
Professor of Chemistry and Chemical Biology at Rutgers, the
State University of New Jersey, and Laboratory Director at the
Waksman Institute of Microbiology. In my oral statement I will
discuss the definition of gain-of-function research of concern,
risks and benefits of the research, U.S. oversight of the
research, and steps to strengthen U.S. oversight of the
research.
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\1\ The prepared statement of Dr. Ebright appears in the Appendix
on page 38.
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What is gain-of-function research of concern? 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 one-tenth of 1
percent of biomedical research and less than 1 percent of
virology. However, because gain-of-function research of concern
can cause pandemics, this small part is highly consequential
and requires effective oversight.
What are the risks? Gain-of-function research of concern
poses high, potentially existential, risks. Gain-of-function
research of concern poses material risks by creating new
potential pandemic pathogens. If a 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.
What are the benefits? 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.
What should oversight entail? Because gain-of-function
research of concern poses high, potentially existential risks
and provides limited benefits, the risk-benefit ratio for the
research almost always is unfavorable and in many cases is
extremely unfavorable. Therefore, it is imperative that gain-
of-function research of concern be subject to national or
international level oversight to ensure before the research is
started that risk-benefit ratios are acceptable and risks are
mitigated.
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 the decision from the risk-benefit
assessment must be mandated, monitored, and enforced.
I turn now to U.S. oversight of gain-of-function research
of concern.
Before 2014, there was no national-level U.S. 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, severe acute
respiratory syndrome (SARS), or Middle East respiratory
syndrome (MERS) viruses. The policy was referred to as the
Pause.
Under the Pause, 18 projects were paused. However, at least
7 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, covered projects must be
identified and flagged by the funding agency, the NIH, and
covered 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 by the policy is equivalent, in all respects,
to the reasonable person standard employed in U.S.
administrative law and U.S. civil law.
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 4\1/2\ years since the policy was announced, only three
projects have been reviewed. Most covered 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
covered 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.
Current U.S. oversight of gain-of-function research of
concern thus has serious shortcomings. Moving forward, any
effective system of U.S. oversight of gain-of-function research
of concern must address these shortcomings. My recommendations
are as follows:
First, responsibility for U.S. 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, U.S. oversight of gain-of-function research of
concern should cover all U.S. and U.S.-funded research,
irrespective of funding source, classification status, and
research location.
Third, U.S. oversight of gain-of-function research of
concern should be codified in regulations with force of law and
should be mandated, monitored, and enforced.
Fourth, U.S. oversight of gain-of-function research of
concern should be transparent and accountable.
Thank you for your attention, and I would be pleased to
address questions.
Senator Paul. Thank you, Dr. Ebright.
Next we will have Dr. Steven Quay. Dr. Steven 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 the goal of
preventing the two 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 Massachusetts Institute of Technology (MIT), and
served on the faculty of Stanford University's 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 Food and Drug
Administration (FDA)-approved pharmaceuticals, and is the
holder of 87 patents and over 130 pending U.S. and foreign
patent applications.
He is also an author. Notably, during the pandemic, Dr.
Quay published his No. 1 Amazon best seller, Stay Safe: A
Physician's Guide to Survive Coronavirus.
Finally, Dr. Quay recently presented testimony to lawmakers
as part of an expert forum convened by the House Select
Committee on Coronavirus, titled ``Led by Science: The COVID-19
Origin Story.''
Dr. Quay.
TESTIMONY OF STEVEN QUAY, MD, PH.D.,\1\ CHIEF EXECUTIVE
OFFICER, ATOSSA THERAPEUTICS, INC.
Dr. Quay. I am honored to participate with my esteemed
colleagues, Doctors Ebright and Esvelt, in this forum entitled
``Revisiting Gain-of-Function Research: What the Pandemic
Taught Us and Where Do We Go From Here.''
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\1\ The prepared statement of Dr. Quay appears in the Appendix on
page 66.
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I offer six statements in opening. One, 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, I can spend an entire hearing painstakingly
going through the scientific evidence for this conclusion, but
that is not the purpose of today's meeting.
I am happy to discuss the evidence contained in my written
remarks during questioning. I am also willing to publicly
debate any virologist on this question, at any time or place.
Only one infectious disease doctor was willing to debate this
question with me last year in a formal debate format, and he
lost.
I am also willing to testify under oath, if requested.
No. 2, all evidence is consistent with an accidental and
not a deliberate release.
No. 3, SARS2 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, United States and WIV
scientists proposed inserting ``human-specific furin cleavage
sites in a bat virus backbone.'' Two years later, SARS2
appeared on the WIV's doorstep. SAR2 is a bat-derived virus
with a human-specific furin cleavage site.
One region of SARS2, called open reading frames (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 degree theses
available only in Chinese.
COVID exhibits 40 percent asymptomatic transmission,
unheard of for a new respiratory virus. Patients infected with
an acquired deletion of ORF8 have a milder infection. Could the
reduced efficacy of vaccines and natural immunity be an
engineered feature? It appears likely.
Six, in December 2019, the Wuhan Institute of Virology was
conducted synthetic biology research on the Nipah virus, which
is 60 percent lethal in low-containment, biosafety level 2
(BSL-2), 3 facilities. The Nipah virus was in an infectious
clone format. Nipah is a BSL-4 level pathogen and a Centers for
Disease Control and Prevention (CDC)-designated bioterrorism
agent. This is the most dangerous gain-of-function research I
have ever encountered. We should assume this research continues
to this day at the WIV.
I will close with five recommendations for future gain-of-
function research.
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 SARS2 places
the first human infection in the fall of 2019, long before the
December market cases. All infections in the market in human
were what is called Lineage B, and not the most ancestral
lineage, Lineage A. I, like many other scientists, believe the
market cases were a superspreader event, on this first chart
here.
The earliest cluster of hospitalized patients with both the
Lineage A and B virus was at the People's Liberation Army (PLA)
Hospital in Wuhan. This hospital is about six kilometers from
the WIV, and on Line 2 of the Wuhan subway system, as shown in
this chart. All early cases are in hospitals adjacent to Line
2, and the probably that this was a chance occurrence is 1 in
68,000.
The Line 2 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 suggests that the pandemic could not have occurred
without the international spreading impact of Line 2.
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 helped in either the COVID pandemic or other smaller
epidemics.
We now know that an Messenger Ribonucleic acid (mRNA)
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.
It is also important to point out that gain-of-function
research is a tiny sliver of all research funded by NIH.
Specifically, there were over 36,000 Research Project (RO1)
grants funded by NIH in 2020, the latest year with statistics.
Of these, the self-described gain-of-function on potential
pathogens research grants numbered only 21 in the latest
funding year. Even expanding this by tenfold with a less
stringent definition of gain-of-function would mean we are
talking about less than 1 percent of all NIH research funding.
I cannot imagine a scenario where but for this tiny research
effort a new pandemic occurs.
What reforms should be considered in order to assure that
such research is conducted in a safe and transparent manner?
While I found no actual benefit of gain-of-function research, I
believe efforts to ban it, given the vested interests of
literally the entire virology community, is a hill too steep to
climb. A proposal that I believe is achievable is the placement
of all select agent research within the existing institutional
review board structure used for human clinical trials. I
believe 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 and a
court-ordered search warrant allow the work of any lab in the
world to be scrutinized remotely.
My fourth recommendation is simple: do not put dangerous
infectious disease laboratories near subways, like Line 2,
where every major city in the world is accessible with the
incubation period of an infection.
Finally, I am including what I call gain-of-opportunity
research, going into caves where humans are seldom found,
taking a bat fecal sample containing thousands of viruses,
bringing those viruses back to a laboratory, and culturing the
specimens where a virus might be controlled in a diverse
natural environment, is now able to grow unrestricted in pure
culture, provides an immense increased potential risk, a gain
of opportunity for the virus.
This is the goal of the Global Virome Project, a Gates
Foundation-funded, Eco-Health Alliance-associated effort. Their
stated goal: collect the estimated 500,000 unknown viruses that
are capable of infecting humans and bringing them back to a
laboratory near you. What could go wrong?
Could I have the last slide here.
What happens if we have these hearings and nothing happens?
In December 2019, 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
U.S. CDC defines as a bioterrorism agent. Nipah virus is one of
the deadliest on the planet, with a greater than 60 percent
lethality.
Why were they conducting this experiment? I do not know.
But laboratory-acquired infection with this virus, if it became
airborne, would make COVID-19 look like a walk in the park.
The work of this Committee is critical to protecting the
American people as well as the people of all countries from
future pandemics, manmade or natural. If we now fail to act
with the knowledge we have, history will judge us poorly.
Thank you for the opportunity to speak.
Senator Paul. Thank you, Dr. Quay. Our final witness is Dr.
Kevin Esvelt. He 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 (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
Clustered Regularly Interspaced Short Palindromic Repeats
(CRISPR) gene drives could be used to alter the traits of wild
populations in an evolutionary 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
biorisks.
Dr. Esvelt.
TESTIMONY OF KEVIN M. ESVELT, PH.D.,\1\ ASSISTANT PROFESSOR OF
MEDIA ARTS AND SCIENCES, MIT MEDIA LAB
Mr. Esvelt. Chair Hassan, Ranking Member Paul, Senators,
thank you for the kind invitation. I have to say that I have no
special insights regarding the origins of COVID. In fact, I
kind of doubt that there is sufficient evidence to be
conclusive in one way or the other. But our models suggest that
knowing where it came from would not actually help us defend
against future pandemics.
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\1\ The prepared statement of Mr. Esvelt appears in the Appendix on
page 73.
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I agreed to speak to a bipartisan hearing today because
this is the Emerging Threats Subcommittee, and I am
increasingly concerned by our continuing failure to recognize
an increasingly dire technological threat.
Leo Szilard who invented the nuclear chain reaction and
launched the modern nonproliferation movement, is a scientific
hero of mine, and he wrote, ``The most important step in
getting a job done is the recognition of the problem.''
The problem is not our inability to agree on what does or
does not constitute gain-of-function research or even whether
the putative benefits of this research outweigh the risks of
accidents. Rather, the problem is that we are so used to
thinking of pandemics as a health and safety issue that we have
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 SARS2 was first
posted online, scientists did not have to wait for physical
samples of the virus to become available to begin studying it
and working on countermeasures. That is because we could order
synthetic deoxyribonucleic acid (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.
Thankfully, we still do not know of any particularly
concerning examples, that is, agents that would likely cause a
pandemic if they were to be released, even at multiple sites.
If we did know, then the modern-day equivalent of a terrorist,
like Seiichi Endo, who is a graduate-trained virologist and
doomsday cultist, who sought samples of Ebola and used chemical
weapons to commit mass murder, might have well assembled them
and released them in airports by now.
But 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. That is why
both United States Agency for International Development (USAID)
and NIH have funded research attempting to find or create novel
pandemic-capable viruses in labs all over the world.
Now we disagree on whether some of those experiments might
fall into an arbitrarily defined category called gain-of-
function research. We biologists disagree over what a species
is. Did you know that a tiger and a lion can interbreed? But
what nobody disputes is that 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 struggle to imagine anyone evil
enough to deliberately cause one. They never considered that
these advances in technology, which are continuing, plus a list
of pandemic-capable viruses, would allow a single skilled
terrorist to unleash more pandemics at once than would
naturally occur in a century. No one warned them, perhaps
because, as has been previously noted, they lack independent
security oversight of their work.
Now it is always possible that we could save more lives by
helping to prevent natural pandemics than we would lose due to
deliberate acts of terrorism. But according to our numerical
cost-benefit model, it is not even close, even for the best-
case scenario. The reason is there are so many viruses in
nature, most of which will never encounter a human. The lowest
published estimate suggest that for every pandemic virus that
does spill over in a century there are 100 that will never
encounter a human.
That means if you identify one at random, even if we could
perfectly prevent it from spilling over and causing a pandemic,
that one virus, then we have a 1-in-100 chance of actually
preventing a pandemic. But if there is just a 1 percent chance
of deliberate misuse per year, then in that same time period we
can expect to cause a pandemic. In other words, pandemic virus
identification, whether it is created in the lab or whether it
is just identified in the wild, is expected to kill 100 times
as many people as it would save.
For 75 years, the United States successfully kept nuclear
weapons out of the hands of terrorists. In the wake of a
pandemic that has killed more people than could any
thermonuclear explosion, it is time to start doing the same for
pandemic viruses.
For starters, Congress could study the issue and release a
finding on whether pandemic virus identification endangers
national security. It is 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.
Perhaps most important, Congress could legislate
catastrophe liability, that is, liability for human-caused
events that result in more than 1 million American casualties,
as SARS2 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.
Now I am optimistic about this issue because we just need
to buy time. If we can keep pandemic-capable viruses out of the
hands of terrorists for a decade then we can deploy new,
general-purpose defensive technologies. These range from
ubiquitous sequencing that can detect any emerging threat, to
perfect protective equipment for our essential workers, to low-
wavelength germicidal lights, and these together could protect
us from all pandemics, whether natural, accidental, or
deliberate.
Pandemic proliferation is a solvable national security
problem, but only if we recognize it as one. Thank you.
Senator Paul. Thank you, Dr. Esvelt. We will start with
Senator Scott from Florida.
OPENING STATEMENT OF SENATOR SCOTT
Senator Scott. All right. Thank you, Chair.
Dr. Esvelt, in your testimony you talk about USAID funding
gain-of-function experiments through Discovery & Exploration of
Emerging Pathogens--Viral Zoonoses (DEEP VZN), the program
which specifically conducts experiments geared toward pandemics
and virology and Strategies to Prevent (STOP) SPILLOVER, which
as you know, research is spillover between animals and humans.
Can you talk about what these programs specifically are and why
they may be dangerous?
Mr. Esvelt. DEEP VZN and STOP SPILLOVER are extensions of
USAID's long-running PREDICT program, the goal of which was to
predict pandemics, that is, to identify viruses in the wild
that had a good chance of spilling over and causing a pandemic
in humans. This is part of the laudable One Health program
which seeks to identify essentially hotspots where viruses are
likely to spill over into humans and cause a pandemic. The idea
is if we find these hotspots, educate the community, teach them
what to do in the event of an outbreak, then we might be able
to stop it before it reaches our shores. That makes sense.
But again, they do not seem to have thought of the security
issues associated with publishing a list of pandemic-capable
viruses, by threat order. Now we cannot necessarily know
whether a given pandemic would take off until it is spreading
in humans, but there is a narrow set of laboratory experiments
that can tell us, does it look like a human endemic virus, in
certain traits? These are a tiny subset of all experiments that
really are not very useful for anything else. They do not help
with therapeutic development.
Part of PREDICT was to take samples of these viruses, bring
them back to the lab, run these kinds of experiments, sequence
the genomes, share them. They did not find anything
particularly scary, but they found some candidates that looked
fairly nasty, including at the Wuhan Institute of Virology. It
is hard to know what USAID did and did not approve, but they
are listed as an acknowledgement, as is NIH, on a paper that
recombined those dangerous-looking but definitely not pandemic-
capable viruses, and then performed experiments to see, did
they look like they could plausibly cause prescription drugs.
Senator Scott. Do you think these programs are dangerous?
Mr. Esvelt. I think any program attempting to identify an
agent that would be widely accessible and could be deliberately
released to kill millions of people is pretty much the
definition of dangerous, yes.
Senator Scott. Do you think that USAID, whose main job is
to provide humanitarian aid globally, has the oversight for
programs and experiments like STOP SPILLOVER and DEEP VZN,
which are not humanitarian in nature?
Mr. Esvelt. I think there is a very strong humanitarian
case for preventing pandemics. I think that the absence of
security oversight means that USAID was probably just not aware
of the security consequences of their work, and it remains to
be seen whether they will decide that it is inadvisable to
maintain a ranked-order list of those most threatening viruses.
Senator Scott. Do you think they have the oversight ability
to handle this job?
Mr. Esvelt. It is unclear exactly who they are seeking
advice from. My understanding is that they are seeking advice
from folks with greater security expertise, and the real
question is what actions are going to come of that.
Senator Scott. Would these programs go through a P3CO
review?
Mr. Esvelt. My understanding is that federally funded
research does go through P3CO review. However, it is unclear
whether the basic find-the-pathogens program, would go through
such review because until you find it and at least run some
characterization to determine whether or not it looks like a
pandemic virus it would not necessary be regulated. As
previously mentioned, due to the transparency issues with that
committee it is very much unclear what their remit is and is
not.
Senator Scott. Do you know who is on the panel for P3CO?
Mr. Esvelt. I do not.
Senator Scott. Is it not public?
Mr. Esvelt. My understanding is it is not public.
Senator Scott. Why would it not be public?
Mr. Esvelt. That is an excellent question.
Senator Scott. Do any of the witnesses know why it would
not be public?
Mr. Esvelt. No.
Dr. Quay. No. I know it is not public and I do not know why
it is not public.
Senator Scott. That is part of our Federal Government,
right?
Dr. Quay. Correct.
Senator Scott. Do they think Americans are not smart enough
to understand it?
Dr. Quay. You will have to ask the people at the NIH.
Senator Scott. Do you know how they made the decision not
to make the names public?
Dr. Quay. No.
Senator Scott. OK. For each of you, do you think that the
P3CO review is comprehensive enough on NIH grants or do you
think gain-of-function grants have been approved without a P3CO
review?
Senator Paul. Let us go to Dr. Ebright. I do not want to
leave him out. Then we will go to each of you. Dr. Ebright,
would you like to respond to that?
Mr. Ebright. Yes. As I mentioned in my summary statement,
there have been only three P3CO reviews in the 4\1/2\ years
that the P3CO Framework has been in effect. The majority of
gain-of-function research of concern enhanced potential
pandemic pathogen research supported by NIH has not undergone
P3CO review. It has not undergone P3CO review for the simple
reason that the NIH has not identified and flagged the
proposals as subject to P3CO review and has not forwarded the
proposals for P3CO review.
Senator Paul. Let me ask the other two to respond as well.
Dr. Quay. Yes. I think, just echoing Dr. Ebright, it has
been a failure, I think, at this this point in time, and so we
need to find an alternative, which is perhaps to take it out of
the NIH, make the oversight outside of the agency that is
funding.
Mr. Esvelt. One major problem is that gain-of-function is a
terrible term. It applies to most of biotechnology in the raw.
You can try to add qualifiers as you want. But it also
inherently does not catch efforts to identify perfectly natural
but nevertheless highly lethal pandemic-capable viruses. It
really does not matter where the thing comes from. What matters
is do you know that there is a good chance that it causes a
pandemic.
Again, maybe you do not think we can ever be confident more
than, say, 50 percent for a given virus, but if you get a list
of eight viruses that you are 50 percent confident, it is
possible to make all eight, let them go, and you have pretty
good odds there.
I am concerned by efforts to continue to focus on gain-of-
function because it is so ill-defined, and it seems more
productive to narrow in on the classes of experiments that can
substantially increase our confidence that a virus is pandemic
capable, wherever it comes from. I certainly echo the calls for
external security oversight.
Senator Scott. Do you think there is appropriate oversight
of existing research after it has been approved, to ensure
continuous compliance?
Mr. Ebright. I would say that there is not. 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 accept the decision, and it is free to determine
whether to monitor or not to monitor the progress of the work.
This is a major shortcoming.
Senator Scott. Thank you.
Senator Paul. I want to interject on the definition,
whether gain-of-function is good definition or not. That began
with the NIH. They gave us the definition and we started with
that. I do think Dr. Esvelt is making some good points that we
ought to be concerned with viruses that are not created but
that actually come from nature that could cause pandemics. I
think part of this discussion is to try to figure out where we
get to.
Senator Johnson.
OPENING STATEMENT OF SENATOR JOHNSON
Senator Johnson. Thank you, Mr. Chairman. How long have we
had gain-of-function capability? Is that with the CRISPR
technology? Mr. Esvelt.
Mr. Esvelt. I should probably defer to Dr. Ebright on that.
Senator Johnson. Dr. Ebright, how long have we even had
this capability?
Mr. Ebright. The discussions have been underway since 2002
and 2003. The first examples involved reconstruction of
previously eradicated or extinct pathogens. Those presented a
prototype for understanding experiments that would create new
health threats and the need to address them. Again, we are
talking a two-decade-long discussion.
Senator Johnson. The technology emerged or they started
discussing it and then developed the technology--which came
first?
Mr. Ebright. The discussions occurred as the technology
emerged. 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.
Senator Johnson. Talk about the ease and the cost because I
have heard it is very accessible now and it is very cheap, and
a knowledgeable individual can basically do this in their
garage.
Mr. Ebright. That is an exaggeration. But as Dr. Esvelt has
pointed out, given the genome sequence of a virus it is
typically possible to reconstruct infectious particles of the
virus and to do so for costs well under $10,000 in one-person
month or two-person months. For an equipped laboratory, the
kind of laboratory that would be present in any State program,
and that is present in many research laboratories at academic
institutions, this is eminently possible.
Senator Johnson. Reconstructing a virus is one thing, but
my understanding of what, at least, the theory might be with
severe acute respiratory syndrome coronavirus (SARS-CoV-2) is
there is gene splicing that occurred here and some very unusual
markers in this furin cleavage site and it would be beyond my
comprehension exactly what that means. But talk to me a little
bit about the whole gene-splicing aspect of this.
Mr. Esvelt. There are two ways to edit a virus. Nowadays
the easiest way is usually to assemble it from scratch using
synthetic DNA. But if it large then in some cases it is better
to create the altered piece that you wish to insert into the
virus and then use a tool such as CRISPR to do the insertion
into the backbone.
With respect to the cost, the first virus with a chemically
synthesized genome from synthetic DNA was made in 2002. Since
then, the cost of gene synthesis has fallen by roughly 1,000-
fold. Today the cost of ordering the components of an
infectious influenza virus, for example, the synthetic DNA
costs less than $1,000, and that does not require any further
editing. That requires following the reverse genetics protocol,
transfecting it into the cells to get the infectious virus.
I estimate that there are around 30,000 people who can do
that, who have doctorates, and you can say 125 virology Ph.D.s
per year are in the United States. That is roughly one-third in
the world. There are probably four times as many people who
have degrees in other disciplines, such as mine, who can do it.
Assume a 20-year career, and that is 30,000 people, add a few
technicians.
Senator Johnson. Was there a specific incidence or
something that concerned people that caused the Pause?
Dr. Quay. Yes. There were experiments in influenza in the
Netherlands and Wisconsin that took a virus that was 90 percent
lethal but not airborne and created it and made it airborne
through passage in the laboratory.
Senator Johnson. That occurred when?
Dr. Quay. In 2013, 2012.
Senator Johnson. That caught the attention of who? I mean,
who was alarmed by that and instituted the Pause? I know it had
to have occurred under President Obama, but which member of our
health agencies?
Dr. Quay. I think Dr. Ebright would be the best to answer
that.
Senator Johnson. Dr. Ebright.
Mr. Ebright. 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 U.S. 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. The Pause was
driven, ultimately, from the White House, from the Obama Office
of Science, Technology, and Policy.
Senator Johnson. Listening to your testimony I am assuming
all three of you would agree with this statement that this
research--and I would say even the mining of dangerous
potential pathogens, crawl in a bat cave and try and pull these
things out and bring them to a lab--there is surely no benefit
that overrides the risk. We should not be doing this at all.
Dr. Quay. Yes. I call it gain-of-function and gain-of-
opportunity, where you bring a virus back. As I said, my
analysis is that it has not contributed to the response to this
pandemic.
Senator Johnson. We should not do it. I mean, we can talk
about controls but the bottom line, we should not have controls
so we should not even do it. Is that your position as well?
Mr. Esvelt. For balancing the potential benefits of
prevention against the risk of accidents it can go either way,
depending on the numbers you use for those. You can reasonably
come out with either answer. When you add the misuse case, that
is what absolutely blows it out of the water.
Senator Johnson. Dr. Ebright.
Mr. Ebright. 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 will not arise
without intervention but is addressing a health threat that is
in place currently.
For that reason and for reasons like that, I believe
enhancing the oversight of the research is more a more
effective and more prudent strategy than simply banning it.
Senator Johnson. I would say improved oversight but would
you also agree dramatically limit it?
Mr. Ebright. Absolutely.
Senator Johnson. OK. Thank you, Mr. Chairman.
Senator Paul. Senator Marshall.
OPENING STATEMENT OF SENATOR MARSHALL
Senator Marshall. Thank you, Mr. Chairman, and I hope
America is listening today. To our witnesses let me say
welcome, and I regret that none of you were able to get into
the Kansas State University biochemistry program, but I
certainly appreciate your credentials that are all here today.
I think it is important to not only identify the true
problem but also talk about where we have been, and you all can
help us fill in some of the pieces here when we talk about
gain-of-function research.
It was late in 2011, when the National Science Advisory
Board on Biosecurity (NSABB), which is the NIH's advisory
board, stopped two scientists from publishing an influenza
gain-of-function study that I believe Dr. Ebright was referring
to. They stopped it because they were afraid it could afraid
bioterrorists. This is 2011. Over a decade ago, scientists had
figured out how to make H5N1, which is highly pathogenic avian
influenza, more contagious.
In 2012, those 2 scientists and 39 others implemented a
voluntary gain-of-function research pause on influenza
experiments. In early 2012, Dr. Fauci encouraged all influenza
scientists to pause gain-of-function, and said, and I am
quoting Dr. Fauci, 2012, ``It is essential we respect the
concern of the public, domestically or globally, and not ask
them to take the word of the influenza scientists.'' It is
interesting to me that Dr. Fauci was focused on the messaging
but he still wanted to continue the gain-of-function research.
Again, in 2012, Dr. Fauci also said, almost prophetically,
that he worried about unregulated laboratories, perhaps outside
the United States, doing work sloppily and leading to an
inadvertent pandemic. He went on to say the accidental release
is what the world is really worried about.
I go forward to 2014 now, after biosecurity accidents in
United States research labs, which our witnesses have talked
about, the Obama White House implemented the second gain-of-
function moratorium on influenza plus MERS and SARS because of
the potential risk of lab accidents and inherent gain-of-
function danger. But gain-of-function still continued at the
University of North Carolina, research later that we shared
with Dr. Shi, the Bat Lady.
Nevertheless, clearly the U.S. Government and Dr. Fauci
knew that the viral gain-of-function research was very
concerning. Almost counterintuitively, while Dr. Fauci
encouraged United States scientists to pause their GOF studies,
Dr. Fauci offshored the paused research to China, not once but
twice. In 2012, Dr. Fauci gave a new grant to Peter Daszak's
EcoHealth Alliance for influenza research in China, and then
again in 2014, Dr. Fauci gave another grant to Daszak for SARS
research in China. Daszak partnered with who? The Wuhan
Institute of Virology.
In late 2017, NIH announced a lift on the gain-of-function
moratorium, what became known as the P3CO Framework, that we
referred to, apparently without consultation from a Senate-
confirmed State Department head or national security
leadership. Also significant, there was no Office of Science
and Technology Policy (OSTP) director in place and only an
acting HHS Secretary at the helm.
What was the result of this? NIH essentially lifts the
moratorium on their own by slipping it in-between
administrations and self-policing. Today we cannot see the
research record for Dr. Fauci's offshore projects because the
Chinese Communist Party supposedly has EcoHealth's records, and
NIH resists sharing theirs.
I will get to my question now. 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?
Mr. Ebright. Yes. Lapses in U.S. oversight of gain-of-
function research of concern may have caused the current
pandemic, and could cause future pandemics. The U.S. 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 overlapped
the pause that was in effect in 2014 to 2017, and met the
criteria to be paused, but was not paused.
The research also overlapped the subsequent policy, the
P3CO Framework, that has been in effect from 2018 to the
present, and met the criteria for Federal risk benefit review
under the P3CO Framework, but did not undergo Federal risk
benefit review under the P3CO Framework.
Senator Marshall. Thank you so much. I have to stop and
point out, too, that USAID, who is knee-deep in this type of
research, is part of the State Department, where they can get
the security advice that they should have asked for before they
cleared this with P3CO.
Certainly I believe that this virus came from Wuhan, China,
and that it is a product of gain-of-function research. This is
a bipartisan national security issue, like several of our
witnesses have testified, that this viral gain-of-function
could become, and has become a weapon of mass destruction, that
this model--this is a 3-D model of what the COVID virus looks
like, and this is the gain-of-function. This is the protein
spike, the two units that allows this key to fit into the door
perfectly and the cleavage site and all that. This became a
nuclear hand grenade, is what happened.
Dr. Quay then Dr. Esvelt, considering the extreme risk of
this research and the incredulous obstruction by the NIH,
USAID, EcoHealth, and China, should Congress immediately pause
this dangerous research?
Dr. Quay. I think that is an appropriate step for Congress
to take.
Senator Marshall. OK. Dr. Esvelt.
Mr. Esvelt. I think it would be somewhat dangerous to
attempt to pause gain-of-function research when it is 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.
Senator Marshall. Are there any countries that you would
say we should not be doing this type of research with?
Mr. Esvelt. 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, because it is expected to kill 100 times as
many people as it might save, even if we could perfectly
prevent an identified natural virus from spilling over.
Senator Marshall. Thank you, Mr. Chairman. I have some more
questions if we have time for later, but I yield the floor
back. Thank you.
Senator Paul. Senator Hawley.
OPENING STATEMENT OF SENATOR HAWLEY
Senator Hawley. Thank you, Mr. Chairman. Thanks to the
witnesses for being here.
Dr. Quay, if I could start with you. You said in your
written testimony that the genome of COVID has some of the
hallmarks of gain-of-function research, and in particular three
genomic regions you say have the signature of synthetic
biology. One region has features of the two types of forbidden
gain-of-function research that are associated with bioweapons
development. You said in your opening remarks that you believe
COVID-19 was the product of gain-of-function research and was
from a lab leak from the Wuhan Institute of Virology.
My question, I guess, is, do you think China engaged in a
coverup to prevent the world from knowing the true origins of
this virus and a lab leak?
Dr. Quay. I think there is abundant evidence that they have
not shared all the information they had at the time. They
continue to not share information. I could give you a laundry
list of 20 things that they have done, starting with a website
with 21,000 viruses. On September 12th at 2 a.m., someone was
in the Wuhan Institute of Virology. That had been available to
virologists for a decade. It was taken offline. It has not been
returned. We have asked to see it, and no one, that I know of,
has ever seen it. It goes on from there.
Senator Hawley. Are you concerned with the continuation and
expansion of Chinese gain-of-function research?
Dr. Quay. I think I testified here that in December 2019,
they were doing synthetic biology on a cloning vector of the
Nipah virus, which is 60 percent lethal. We just experienced a
1 percent lethal virus. My estimates would be that that could
set us back a millennium. The black plague was a 20 percent
lethal event and it was 250 years for civilization to return.
Senator Hawley. Let me ask you this. How safe were the
testing conditions at Wuhan, to your knowledge?
Dr. Quay. I think that a lot of the Western virologists
actually use the findings of that as a way to get around saying
it was OK at the beginning. All of the work that I have
described is being done at what is called BSL-2, 3 level, which
is commonly spoken of as a dentist's laboratory level of
biosafety. Maybe a little higher than that, but that is not a
bad euphemism.
Senator Hawley. You said, I think, in your testimony, that
this is the most dangerous research that you have ever
encountered. What makes this particular research so dangerous?
Dr. Quay. If you doing experiments with a pathogen that is
60 percent lethal but is not airborne, and you make it airborne
in the laboratory and someone walks out with it--Nipah has a
21-day incubation period. It is perfect for wide spread without
being detected. We cannot afford 10 percent lethality.
Senator Hawley. Yes. 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? I mean, what is the
value, the real value of gain-of-function research?
Mr. Ebright. 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. Eliminate any one of those incentives and it will
not be.
Senator Hawley. Thinking about China for a second, what is
China's interest in gain-of-function research?
Mr. Ebright. They have witnessed the United States leading
the way with gain-of-function research. Most gain-of-function
research of concern performed to date has been performed either
in the United States, with U.S. funding, or overseas with U.S.
funding. China has wished to be part of that and has
participated in gain-of-function research of concern in China
with U.S. funding and has also supported gain-of-function
research of concern in China entirely through Chinese programs.
Senator Hawley. Let me ask you this. Gain-of-function
research and bioweapons, what is the connection there? I mean,
what role does gain-of-function research play?
Mr. Ebright. As I mentioned, there are no civilian
practical applications. There are immense bioweapons practical
applications. As you have heard from Dr. Esvelt, the potential
pandemic pathogens that can emerge from such studies are
potential weapons of mass destruction--inexpensive, accessible,
easily distributed weapons of mass destruction.
Senator Hawley. Let me ask you about some of the things
that you have commented on with regard to what NIH and Dr.
Fauci have said, and frankly, the lies they have been caught in
regarding the coronavirus. I want to highlight two of them.
In response to a congressional inquiry from October 2021,
just last year, the NIH attempted to walk back assertions by
NIH Director Collins and Fauci that NIH had not funded gain-of-
function research in Wuhan. You commented at the time, saying,
and I am going to quote you now, ``NIH, specifically Collins,
Fauci, and Daszak lied to Congress, lied to the press, and lied
to the public, knowingly, willfully, brazenly. On May 11th, Dr.
Fauci said the NIH and National Institute of Allergy and
Infectious Disease (NIAID) categorically has not funded gain-
of-function research to be conducted in the Wuhan Institute of
Virology.'' You commented on that, saying the documents make it
clear that assertions by the NIH Director, Francis Collins, and
Fauci, that the NIH did not support gain-of-function research
are untruthful.
Expand on that if you would. What are the implications of
Dr. Fauci's continued blatant dishonesty regarding NIH's
funding of gain-of-function research in Wuhan?
Mr. Ebright. I stand by my statement. The statements made
on repeated occasions to the public, to the press, and to
policymakers by the NAIAD Director, Dr. Fauci, have been
untruthful. I do not understand why those statements are being
made because they are demonstrably false.
Senator Hawley. In my few remaining seconds here, let me
ask you about an effort to shut down any kind of questioning of
the origins of COVID. On February 19, 2020, a group of
virologists and others published that famous letter, infamous
letter, in The Lancet, which said, among other things, ``We
stand together to strongly condemn conspiracy theories
suggesting COVID-19 does not have a natural origin.''
Of course, we later found out that The Lancet letter had
been organized by Peter Daszak, president of EcoHealth
Alliance, who we have discussed today operated a lab in Wuhan,
with a $600,000, 5-year annual grant of taxpayer dollars from
Fauci's NAIAD to study bat coronaviruses.
That letter conveniently concluded by stating, ``We declare
no competing interests.'' Many people designate this letter as
the first effort to quash any kind of debate about the origins
of COVID-19. Do you think that labeling the lab leak theory as
a conspiracy theory so early on have the effect of slowing down
investigations into the origins of the virus?
Mr. Ebright. It certainly had that effect, but The Lancet
letter that you described was only one of two efforts to impose
the false narrative that science shows SARS-CoV-2 entered
humans through natural spillover, and that that is the
consensus view of scientists. One of the efforts was The Lancet
letter you discussed. The other effort was coordinated and
orchestrated through the National Institutes of Health, through
the NAIAD Director, Dr. Fauci, and the NIH Director, Dr.
Collins, and resulted in the publication of an opinion article
entitled ``Proximal Origins of SARS-CoV-2,'' making the case,
again, that SARS-CoV-2 could not have been a product of a
research-related spillover.''
Senator Hawley. Thank you very much. Thank you, Mr.
Chairman.
Senator Paul. Thank you. Had there not been a pandemic I
think there would still be a need for this hearing. This
discussion, Dr. Ebright got this started back as early as 2003,
2004. Others have commented on the danger of being able to
manipulate influenza viruses to be used as either weapons or by
accidental release.
But I think given that there was this pandemic, that a
million Americans died, I lost friends, good friends, to the
pandemic--I think we should be curious. I am perplexed by the
lack of curiosity to know are there any precautions we can
take, is there any kind of government oversight that we could
do to try to prevent this from happening.
Now some will say, we cannot prove it came from a lab. That
is, in all possibility, true, that we cannot prove it. But
there are arguments to be made and examination of facts to give
us an idea of whether it might have come from a lab. Even if we
did not, I think that this could have come from a person in a
lab handling a virus, if it was a virus out of nature, and we
have discussed that as well.
I do think that we have to get to the truth of the matter
of whether or not dangerous research was going on that should
have been reviewable. We had a pause of gain-of-function
research, but then we had research occurring during the pause
that should have gone to this committee, this P3CO committee,
and did not get to the committee.
I think Dr. Ebright described it well. He says that in
Wuhan, in the 2016 to 2018 period, they were constructing novel
chimeric SARS-related coronaviruses that combined the spike
gene of bat SARS coronavirus with the rest of the genetic
information of a SARS1-related virus, one that was already
known to have lethality, and they found that it could
efficiently infect human airway cells and exhibited up to a
10,000-fold increase in viral growth.
But when we have asked before, is this gain-of-function, we
get sort of arguments and protestations that this is not gain-
of-function as if this is no big deal and the experts looked at
this. As we look farther into this we find that the experts
never looked at this, that it is sort of a select-in kind of
program to this committee. It does not go looking for dangerous
research. It looks at it if you come to them and say, ``Hey, I
think I have gain-of-function research. Do you all want to look
at my research?'' And so there is this opting-in aspect to
this.
But I think it is important that we get to the truth. Was
there research going on in Wuhan that was dangerous? Was it
funded by the NIH, and should it have gone through this
committee process?
By the definition that they have given us, gain-of-
function--I think I agree with Dr. Esvelt--can be better
defined, and particularly if we are going to have oversight on
this we are going to have to figure out what our oversight is
going to be. By all means moving forward we need to ask and
include the scientists to get a precise definition of what we
are talking about if we want to have more oversight.
We have to look back before we look forward, not so much to
assign blame but to figure out is it really necessary. Do we
need to have hearings on this? Should we have follow-up
hearings? Should we have legislation? If a million people died
and there is a chance this came from a lab, I think without
question we should. Both sides of the aisle should be looking
at this.
My question, and I think it is pretty clear but I would
like to go through everybody, even though Dr. Ebright has said
this was gain-of-function, to each of the three witnesses, was
the research, where you take the backbone of a SARS1 virus that
has known lethality, and you mix it together with an unknown
bat virus, S protein genes to create a new virus, was this
gain-of-function according to the NIH definition and should it
have been reviewed and discussed by this committee that was
supposed to prevent dangerous research from going on?
We will start with Dr. Ebright.
Mr. Ebright. As you mentioned, the 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 4-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 review.
Senator Paul. Dr. Quay.
Dr. Quay. The Wuhan Institute of Virology is unique in the
entire world. Before 2019, 65 percent of all publications on
coronaviruses came from that single institution. They are
unique for two reasons. For almost a decade, they were going
into bat caves throughout China and actually into Africa as
well, 20 visits a year, and bringing these samples back to the
laboratory.
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 were doing experiments, published experiments
between 2015 and 2019.
I believe it is 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.
Senator Paul. Dr. Esvelt.
Mr. Esvelt. On the list of experiments you would need to
perform in order to learn whether a novel virus could
potentially cause a pandemic you would need to test growth in
human primary cells, such as human airway epithelial cells, and
you would need to test transmission in a suitable animal model.
The question is, if they were not intending to determine
whether a novel recombinant event between these coronaviruses
could lead to something that might kill millions of people then
why were they doing it? If there was no chance that it would
come up with a result that looked like it was more dangerous,
what is the point? What is the scientific hypothesis?
Again, whatever you call it, what they were trying to do
was identify a biological agent that has a good chance of being
able to kill millions of people if released. They shared the
description of what they did and they shared the genome
sequence, because they thought that this would make us safer,
because they think that knowing which viruses in nature might
cause pandemics makes us safer.
They did not consider the security risks, and it is worth
noting that both USAID and NIH funded those particular
coronavirus chimeric studies. 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. But again, I would call that gain-of-function.
Another reasonable scientist would say, no, that is not gain-
of-function, because the term is so ill-defined.
Senator Paul. Even beyond the term, though, would it be
qualified as dangerous research that actually should have gone
before this committee, the P3CO committee, and been reviewed?
Mr. Esvelt. Here is where you come back to the problem of
thinking this is a health and safety issue rather than a
national security issue. The question is why are we trying to
identify readily accessible agents that could plausibly be used
to kill millions, and will, as soon as identified, fall into
the hands of all of our adversaries as well as, perhaps,
individual terrorists who would want to use them?
The fundamental principle behind even wanting to do these
experiments in the first place is, I think, a fundamental
threat to not just national security but international
security. It is hard to see why you would ever want to do this,
when you think about the misuse potential. I have not seen
anyone else publish a numerical model of that.
Senator Paul. People have said, well, the closest relative
that we have found is only 96 percent identical to COVID-19.
This could not have come from the lab. They have also
mistakenly accused those who say it came from the lab saying,
oh, it came from this particular variant. I think what people
who are saying that this could have come from a lab are saying
is that there could also be possibly other viruses that are
closer that were manipulated or that the one that is 96 percent
analogous to COVID-19 could have gone through serial cell
culture and become COVID-19.
I would like to ask the three of you whether or not the
variant that is 96 percent analogous to COVID-19, could it,
through serial passage, be transformed to COVID-19? Is it
possible? Is it so far away that you cannot do it
experimentally? Could you do it through gene splicing? Could it
be done? Or is it something that argues that this could not
have come from the lab?
We will start with Dr. Ebright.
Mr. Ebright. The closest relatives are more on the order of
97 percent identical to SARS-CoV-2 genome than 96 percent.
Viruses with that level of genetic difference cannot rapidly,
in the time scale of weeks or months, move from their State
into being a proximal progenitor of SARS-CoV-2. However, in the
laboratory those viruses can be combined, at will.
They can be combined, in particular, using a method that
would be described as constructing a consensus genome virus. In
a constructed consensus genome virus, one takes the sequences
of several related viruses, identifies the most commonly
observed nucleotides at each position in these sequences, and
then synthesizes the nucleic acid corresponding to the average,
if you will, the consensus genome for the group of viruses.
This has been done successfully in coronaviruses. This has
been done and published a decade ago in coronaviruses. That
kind of research could have been done using viruses that are on
the order of 96 to 97 percent identical in their genome
sequences to SARS-CoV-2 and with two or three or more such
virus genome sequences, one could develop a consensus.
That is just 1 of a series of potential routes by which one
of the known viruses with 96 to 97 percent identity could,
through a laboratory, in a relatively short time, be
transformed into a progenitor of SARS-CoV-2.
Senator Paul. Dr. Quay.
Dr. Quay. The three sets of viruses that are closest to
SARS2 are one from southern China, RTG-13, and a series of
BANAL from northern Laos. As indicated there are probably 1,200
letters different in the whole 30,000-letter alphabet. In
nature, that takes approximately 40 years, so the most common
ancestor is about 40 years ago. But most of that can be done in
a couple days in a laboratory.
However, I do not believe we currently have the starting
material, the backbone on which SARS2 was found. I think it is
one of the other 21,000 viruses in the database that was taken
down at 2 a.m., September 12, 2019.
Senator Paul. A great deal of information was destroyed by
the Chinese.
Dr. Quay. It was taken offline and not available. I do not
know if it was destroyed.
Senator Paul. Dr. Esvelt.
Dr. Esvelt. If a Ph.D. student proposed to take a 30,000-
base-paired viral genome and attempt to passage it in the
laboratory to acquire 1,000 or so mutations, I would say that
is not a Ph.D. project. Go do something else. I concur with Dr.
Ebright that the only way that you could get something so
divergent would be to computationally design it and synthesize
it, which could certainly have been done, from what dataset,
and again, why? Why would you do such a thing unless you want
to know what the ancestral virus was like and whether the
ancestral virus was dangerous. There are basic science reasons
why you might want to know where they all came from, but at the
end of the day the reason why this research is of interest to
us is the risk of pandemics.
Again, why would you run the tests to determine whether
something was pandemic capable? They certainly ran those on all
of the other coronaviruses that they found and thought might be
dangerous. On the other hand, they never published anything
like that, right, and presumably they would have. They
published their data on the other stuff.
This is why I do not think we have enough information to
know, but it was definitely not passaged in a lab from
something that was maybe 7 percent----
Senator Paul. I agree, and one of the things that tips us
off that they may have been trying was in 2018, they asked for
money from Defense Advanced Research Projects Agency (DARPA),
and in that money they wanted to insert the furin cleavage
site, which makes it highly infectious in humans. If they had
the idea of that and they are asking for money, they must have
thought, wow, we can do this and this is going to be a great
experiment. Even our government, finally, at that point,
decided not to fund that.
But what they are asking for, and this is why I think there
was a ``holy cow'' moment when all of a sudden these scientists
see the sequence of COVID-19, they say, ``Oh, my goodness.
Didn't they ask us, in 2018, to put that furin cleavage site
in?'' Lo and behold, it is there.
What I am going to ask, and I am going to finish with this
and then we will have another round if some people would like
to ask some other questions, is, Dr. Quay, could you sort of
lay out, in as simple a fashion as possible, two or three items
about the virus that makes you think it came from--and I do not
think anybody knows, with 100 percent, whether this came from a
lab or whether it came from animals, but if there is some
compelling evidence that suggests it could have come from the
lab. Even if it was a 10 percent chance it came from a lab it
is another reason for us to be concerned about having oversight
on this kind of research.
Can you give me two or three things that this virus has
that makes you think it is from a lab versus some of the
evidence for MERS and SARS that it came from animals?
Dr. Quay. Yes. There are three regions--the receptor
binding domain, the furin cleavage site, and this protein 8
from a gene called ORF8. With respect to the receptor binding
domain, if you look at what happened with SARS1, we have the
virus sequenced when it first was in civet cats in the markets.
It jumped into a few humans. We have the virus sequenced then.
It started infecting more. Then we have the virus sequenced
when human-to-human passage could occur and an epidemic
occurred. 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 it had only 15 percent of the mutations
it needed to support an epidemic.
OK. Let us look 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, 4,000 possible changes. There were only 17 mutations
that could make it a better virus. Its receptor binding
optimization was 99.5 percent, and, in fact, one of the 17
ended up being the Delta variant. That kind of optimization,
juxtaposed by the fact that there were no patients in Wuhan,
36,000 blood-backed specimens tested for antibodies, not a
single patient was infected.
Let us go back to SARS1. Twenty percent of all people in
the markets were infected while the virus was practicing to set
up an epidemic, 1 percent of the general population. We would
have expected 360 in the general population in Wuhan, and we
had zero.
Furin cleavage site has obviously never occurred in this
related virus, the sarbecoviruses, that split from their
cousins, the MERS viruses, around the time of William crossing
the Channel, 1060. That was when sarbecoviruses came. There has
never been a furin cleavage site, and the genetic sequence of
it uses a code that has never been used, the CGG-CGG dimers, it
is called, which has never been used before.
Finally, ORF8, this protein that goes into the bloodstream
and suppresses interferon response so you are asymptomatic, and
suppresses major histocompatibility complex (MHC) antigen
presentation, so you cannot 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 percent homology in SARS1. Between
SARS1 and SARS2 there is a protein there but it is only 5
percent homologous.
But this master's thesis, the first one optimized its
function in suppressing interferon, symptoms of fever and
chills, and suppressed its antigen presentation. The second one
was making synthetic biology tools so you could move it around
inside genomes.
Senator Paul. To reiterate, there have been no animals
found that have COVID-19. When they did find that animals had
the first SARS and MERS, they found it out within months. When
they tested the animals in question, 90 percent of the animals
had the SARS virus. We have not found any animals yet with
COVID-19. Most viruses that come from animals first are not
very infectious at first and they infect a few humans. You do
not 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 do not know
they had it.
When they tested the background of people who were working
with the animals that had COVID they found 20 percent of them
hand antibodies to having had SARS.
Dr. Quay. SARS1, yes. Correct.
Senator Paul. But then if we test the people in the
marketplace we are not finding that. If we look at the people
in the Wuhan marketplace we are not finding significant numbers
that were positive, and finding almost nobody positive from the
previous year that had been ill.
Dr. Quay. No. It is zero out of 36,000.
Senator Paul. Thank you.
Why do we not do a second round, and we will go in the same
order. Senator Johnson.
Senator Johnson. Dr. Quay, how did we find out about the
Nipah virus?
Dr. Quay. In December 2019, five patients at a Wuhan
hospital had their specimens sent--a bronchial lavage, where
they stick into the throat and get a specimen--to the Wuhan
Institute of Virology for sequencing. The process is to amplify
it with a polymerase chain reaction (PCR) process. You make a
lot of copies of what is in the specimen and you usually,
inadvertently, make copies of what is going on in the
laboratory.
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. Nineteen
of the things we found were in publications from the laboratory
over the previous 2 years. This clearly was a signal of what
was going on in the lab around there.
The one thing they did not publish on was the cloning
vectors of the Nipah virus. It is in the patient specimens
because it was in the laboratory at the time, not in the
patients, and they have never published on that at this point
in time.
Senator Johnson. How do we know it is 60 percent lethal?
Dr. Quay. The Nipah has had epidemics, sporadic epidemics
in the belt around Africa and India, Bangladesh, and it is
between 60 and 80 percent lethal in the pockets where it comes
out. It is 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.
Senator Johnson. OK. This is a virus that occurs in nature
but you detected it in this database.
Dr. Quay. I detected cloning vectors of it. They are
manipulating it, which is not allowed by biological treaties.
Senator Johnson. That is a pretty scary scenario right
there, that the Wuhan lab that might have been the originator
of the coronavirus is fooling around with something far more
deadly.
Dr. Quay. Yes.
Senator Johnson. Obviously mum is the word.
Dr. Ebright, I am a little confused. You talked about, if
we were doing gain-of-function on the current coronavirus that
would be OK. That is not the indication I am getting from Dr.
Esvelt here. The thing that really concerns me is--and I am not
saying that you are saying this is the justification. You are
just saying the reality situation is we have research centers,
we have scientists that are doing this gain-of-function
research, I mean very dangerous gain-of-function research, for
two completely unnecessary reasons, because it is fundable and
it is publishable. You have a little greed involved and you
have hubris. Is that what you are saying?
Mr. Ebright. The research is performed because it is fast,
easy, fundable, and publishable. In the academic research
ecosystem those are determinants of what research gets pursued.
Senator Johnson. I view that as a very corrupt research
ecosystem. If that is what is driving research, and very
dangerous research, it is so that you can get a funding grant
just to do something for grins and then he can publish it and
get the academic kudos for it. I am sorry. I just find that
sick.
Mr. Ebright. I would not use the term corrupt. I would not
see any real difference between this than the activity of a
hedge fund or the activity of a bank or a broker. The key point
is that because of these incentives, self-regulation from
within the community is insufficient. The scientific research
community will follow the incentives. It will never effectively
self-regulate on these issues.
For this reason, we have regulations with force of law for
vertebrate animals research and for human subjects research. We
need regulations with force of law for gain-of-function
research of concern.
Senator Johnson. I think the difference, if it is a bank or
hedge fund, they are doing things for an economic incentive, to
produce something to fund a manufacturing site or fund some
kind of business. I am not hearing the benefit of this
research. I am seeing the risk. I am seeing the danger. I am
not seeing the benefit, other than what you are saying, for the
researcher itself to get money, to do something that is
dangerous, and have the academic kudos for being published.
I do not know. Maybe you do not like the word ``corrupt.''
It is completely useless. It has no benefit to society. It just
has risk. It just has danger.
Dr. Esvelt, do you disagree with that assessment?
Mr. Esvelt. I think that all institutions follow their
incentives, and I think that set of incentives--fast, easy,
fundable, and publishable--insofar as fundable and publishable
are ways of curing heart disease and cancer and forestalling
aging, those are all certainly fundable and publishable,
perhaps not as fundable as we would like. Certainly research
into defenses against the next pandemic is right now somewhat
fundable. I wish it could be more fundable. It is publishable,
right? It depends on----
Senator Johnson. What you are talking about fundable and
publishable have a beneficial reason. What I am hearing from
the three of you witnesses, there is just not a benefit to
this.
Mr. Esvelt. One clarification. You mentioned on endemic
human viruses like SARS2, why do this. 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 is why
researchers do things like deep mutational scanning of 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 to maybe 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. 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 a more pathogenic mutation could be inserted. That becomes
a problem and there is no justification for doing that because
nature is not going to come up with it.
Senator Johnson. OK. Thank you, Mr. Chairman.
Senator Paul. Senator Marshall.
Senator Marshall. Thank you, Mr. Chairman, and thank you
again to our witnesses for hanging in there with us.
I want to start by going back to a comment that Dr. Esvelt
made, that USAID paid for gain-of-function research in China.
Most people do not realize that because USAID will not give us
the records, and we have been trying for over a year to get
those records, which is why we are holding up one of their
nominees as well. Thank you for pointing that out, Dr. Esvelt.
I am going to go to Dr. Ebright next and talk a little bit
more about EcoHealth Alliance, about their record of
noncompliance. They could not provide research records to NIH
when NIH requested them. They did not have an adequate
agreement with Wuhan Institute of Virology. They do not use
appropriate rate of pay for researchers. There continues to be
noncompliance with financial conflicts of interest policies.
Dr. Ebright, based upon EcoHealth Alliance's record of
noncompliance, should they continue to be eligible to receive
Federal funds?
Mr. Ebright. Their most important aspect of noncompliance
was that they were informed by the NIH, in terms and conditions
in the notice of award for their grant, that in the event they
encounter viral growth in their engineered coronaviruses that
exceeded the growth of the parent coronaviruses by more than a
factor of 10, they must immediately inform NIH and immediately
stop the research. They did not do this.
That is not merely a financial violation. That is a serious
hazard violation and a violation that may be connected to the
origins of the current pandemic.
With that being said, it is inexplicable that they were
awarded subsequent Federal awards and that they remain eligible
to receive Federal awards.
Senator Marshall. I need to submit for the record--thank
you for the answer--a couple of articles. The first, I quoted
Dr. Fauci. This is an article from Science, July 2012. A
handsome, young Dr. Fauci. I want to submit that for the
record.\1\
---------------------------------------------------------------------------
\1\ The document submitted by Senator Marshall appears in the
Appendix on page 1443.
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My next two questions I want to submit something from The
Wall Street Journal, a couple of articles as well regarding
genome sequences.\2\
---------------------------------------------------------------------------
\2\ The document submitted by Senator Marshall appears in the
Appendix on page 1446.
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Senator Paul. Without objection.
Senator Marshall. We will go to Dr. Quay next. You may be
familiar with the genomic sequences in NIH's database--I think
you spoke about them--that Chinese scientists asked to be
removed and how they were, from early COVID Wuhan patients. Do
you believe there could have been more data in NIH's database
submitted by Chinese scientists that could hold a key to the
COVID-19 origins?
Dr. Quay. Yes. This was a really nice piece of work by
Jesse Bloom at the University of Washington, who found not in
the NIH database but on some Amazon web servers the actual
sequences of viruses from very early patients that had been put
on GenBank and then removed before they were published and made
available.
The remarkable thing is, again, going to another piece of
good research, the virus that first came out, the first Wuhan
virus, is three mutations away from what we now know is
probably the first virus, but that is a computational method.
It is kind of complicated. But anyway, there is a prediction.
There are three mutations that have never been seen in humans
before the first virus that we have in humans. The specimens
Jesse found had some of those.
We know that the Chinese have viral sequences that are
ancestral to what we have, and the more of those we get, the
more we will get to the bottom of this.
I will point out that these sequences were from September
and October 2019, 2 months before any person in the market was
sick. Again, the timing of the market spillover does not
coincide with the genetics of the virus.
Senator Marshall. Dr. Esvelt, anything to add to that?
Mr. Esvelt. No, other than Jesse is certainly one of the
foremost experts in this field, and if you want probably some
of the best answers that science can give then I would
recommend that you request his input.
Senator Marshall. Thank you. My last question. For 20
years, NIH sponsored EcoHealth's partnership with scientists
from the Wuhan Institute of Virology. The Chinese scientists
have bragged that their virus sample database is the largest in
the world.
They took that database offline in September 2019. NIH
asked EcoHealth for research records. EcoHealth told them that
the records are in the custody of the Chinese government. Is it
possible that the database taken offline by the Chinese
government was data collected by EcoHealth and belongs to
American taxpayers? Dr. Quay.
Dr. Quay. Since the work has been funded, in part, by U.S.
taxpayers, then by definition access to that would be
important. I also think that we do not have to rely on the
Wuhan Institute of Virology for releasing that. I believe
within U.S. jurisdiction there will be copies of that database.
It is too valuable not to have in your own possession if you
are doing research on it.
Senator Marshall. Do you think there is any way we can
still get any of that data that is missing? I feel like,
somewhere we are going to find the grandfather of COVID, or the
cousin or something here in these data banks.
Why did they take them down? What is the advantage of them
taking them down? Do you think we can ever find what we are
missing?
Dr. Quay. It was taken down at 2 a.m. on September 12,
2019, which is--I guess everyone works hard but that is a
little suspicious to be doing it at that point in time.
I believe it contains closer precursors, and my hypothesis
is it contains the one that is 50 mutations or 100 mutations,
not 1,200 away, and it was too obviously a smoking gun.
But again, if you are collaborating on that and you are
spending 10 years building a database inside the Wuhan
Institute of Virology, you are going to mirror that database in
your own facilities, which means that it has to be at EcoHealth
Alliance somewhere.
Senator Marshall. Thank you. Dr. Esvelt, anything to add?
Mr. Esvelt. Just note that I agree with Dr. Ebright's
assessment from earlier, to the extent that China is doing this
research, because it is scientifically sexy and glamorous and
is fast, easy, publishable, et cetera. Chinese scientists have
the same incentives as Western scientists in this regard.
In fact, it is very clear that this research is not in
China's strategic interest. China has no more interest than we
do in handing out the blueprints to agents that can kill
millions of people, including their people. This is not in the
interest of any established, powerful nation. The question is,
can we show leadership and persuade them of that?
Because as long as we are doing it, we are making it--we
are contributing to the fact that this is seen as glamourous
research. It gets published in our top-tier journals. Many
Chinese scientists get bonuses for publishing in our top-tier
journals. We are driving these incentives because we persist in
seeing this, again, as a health and safety issue rather than a
national security issue.
I think it is in our power to change it, and I think this
is one issue where our interests are actually aligned with
those of China, and indeed, every other established nation.
These are asymmetric tools of mass death.
Senator Marshall. OK. Dr. Ebright, anything we did not ask
you that we should have?
Mr. Ebright. That I do not know, but I just wanted to agree
completely with the last remark by Dr. Esvelt.
Senator Marshall. Thank you, and I yield back.
Senator Paul. I want to thank everybody for being part of
this hearing. I do not see this as the end. I see this as the
beginning of trying to understand what caused the pandemic and
trying to come up with solutions.
Each of your statements, which is longer than your
testimony, will be available, for anybody who is interested.
I want to point out one thing from Dr. Ebright's testimony,
for those who say, well, lab leaks should be discounted. They
do not 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 in Taipei
in 2003, and two separate laboratory accidents in Beijing in
2004.''
For people who say that it is a conspiracy theory that this
could have come from the lab, they are discounting our history.
The history has had these lab leaks. Whether or not we will
ever know, with 100 percent certainty, whether this came from
the lab, we have had lab leaks, and we have to realize the
potential danger of these pathogens.
We did not get a great deal of time into the answer. We got
a little bit into the answer, but each of the scientists we
asked today were asked to let us know how we could better
supervise or oversee this kind of research.
The interesting thing to me is I think they all worked
independently but they came up with basically very similar
solutions, an independent body outside of the funding
organizations or those receiving the funding, to make the
recommendations, something akin to an independent agency like a
nuclear regulatory agency.
In fact, I have already been using the analogy when people
ask me and say, ``What is this like?'' It is essentially we do
not let anybody sell centrifuges to Russia or centrifuges to
Iran. There are rules on the export of things. I think Dr.
Esvelt, in particular, has talked about the security aspect of
this.
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 is not oversight of
gain-of-function but maybe it includes things that some people
consider to be gain-of-function. Maybe it is more general,
pandemic viruses. There are a lot of ways we can discuss it.
But the bottom line is I do not 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.
My hope is that your suggestions, that you have taken the
time to put in writing, you have taken the time out of your
busy careers to come here, that these suggestions will become
legislation. If we can get a bipartisan bill to come forward,
what I would like is that our people who help us write the
legislation can communicate with the three scientists here. We
are willing to hear from a dozen more scientists, anybody who
wants to. I want scientists to be involved in this.
But I do think that ultimately the people making the
judgment should not be from one small field of science. Some
have said, ``Well, none of the three scientists there are
virologists.'' I do not have a problem with virologists being
part of this, but I do have a problem with them all being
virologists, the same way I have a problem with behavioral
science being approved for funding by all behavioral
scientists. I think that there need to be people who understand
science on this, but I think there also needs to be people on
the committee, as Dr. Esvelt as mentioned, that understand
bioterrorism and biosecurity.
I think it should be a mixture. This is something we can
talk to the scientific community about. I do not think an
absolute ban is what we want. What we want is better oversight
of this. But we cannot have something where three projects have
been looked at in the last 7 years. That means they are not
looking.
The fact that they did not look at what went on in Wuhan,
and then some of the folks I asked in committee about this were
saying, ``Oh, our scientists looked at it and approved it,''
even that is not really true. They did not look at the
research. They just ignored the research. It did not go before
the committee. They have not been honest.
If we want trust in public health, trust in government,
trust in science, trust in research, trust in the NIH, and
trust in the grants that we give our universities, billions of
dollars, we need to have transparency and honesty. We cannot
have a committee where the people are cloaked in secret. I
mean, what is this? This is completely insane.
I think we have made some progress. I want 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 evenly-keeled
where all the voices are heard, that we do not rashly create
any legislation that would hamper science, but we create
something that would have oversight and might save lives.
I truly think that a million people died in our country,
six million people died, and I think it was from a lab leak. I
think it is something that we need to have precautions against.
I think it was accidental, by the way. But I think if we do not
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?
Right now we are doing nothing and have changed no
behavior. We have had this pandemic and we have changed not one
bit of behavior. I think it is about time that we do get
together, that we are all curious, and that we do not make this
about Republicans and Democrats but make this about how we, as
a people, come together to try to make this world a better
place.
Thank you all for appearing.
[Whereupon, at 4:13 p.m., the Subcommittee was adjourned.]
A P P E N D I X
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