[Senate Hearing 118-376]
[From the U.S. Government Publishing Office]
S. Hrg. 118-376
RISKY RESEARCH: OVERSIGHT OF U.S. TAXPAYER FUNDED HIGH RISK VIRUS
RESEARCH
=======================================================================
HEARING
before the
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
----------
JULY 11, 2024
----------
Available via the World Wide Web: http://www.govinfo.gov
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
RISKY RESEARCH:
OVERSIGHT OF U.S. TAXPAYER FUNDED HIGH-RISK
VIRUS RESEARCH
S. Hrg. 118-376
RISKY RESEARCH: OVERSIGHT OF U.S. TAXPAYER FUNDED HIGH RISK VIRUS
RESEARCH
=======================================================================
HEARING
before the
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
__________
JULY 11, 2024
__________
Available via the World Wide Web: http://www.govinfo.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
56-403 WASHINGTON : 2025
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
GARY C. PETERS, Michigan, Chairman
THOMAS R. CARPER, Delaware RAND PAUL, Kentucky
MAGGIE HASSAN, New Hampshire RON JOHNSON, Wisconsin
KYRSTEN SINEMA, Arizona JAMES LANKFORD, Oklahoma
JACKY ROSEN, Nevada MITT ROMNEY, Utah
JON OSSOFF, Georgia RICK SCOTT, Florida
RICHARD BLUMENTHAL, Connecticut JOSH HAWLEY, Missouri
LAPHONZA BUTLER, California ROGER MARSHALL, Kansas
David M. Weinberg, Staff Director
Christopher J. Mulkins, Director of Homeland Security
Sapana R. Vora, Senior Professional Staff Member
Emily C. McHarg, Research Assistant
Rashida K. Polk, Fellow
William E. Henderson III, Minority Staff Director
Christina N. Salazar, Minority Chief Counsel
Megan M. Krynen, Minority Professional Staff Member
Laura W. Kilbride, Chief Clerk
Ashley A. Gonzalez, Hearing Clerk
C O N T E N T S
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Opening statements:
Page
Senator Peters............................................... 1
Senator Paul................................................. 2
Senator Johnson.............................................. 17
Senator Marshall............................................. 20
Senator Hawley............................................... 22
Senator Rosen................................................ 25
Prepared statements:
Senator Peters............................................... 39
WITNESS
THURSDAY, JULY 11, 2024
Gerald W. Parker, DVM, Ph.D., Associate Dean for Global One
Health, College of Veterinary Medicine Director, Biosecurity
and Pandemic Preparedness Policy Program Scowcroft Institute of
International Affairs, Texas A&M University.................... 5
Carrie D. Wolinetz, Ph.D., Senior Principal and Chair Health &
Bioscience Innovation Practice, Lewis-Burke Associates, LLC.... 6
Robert R. Redfield, M.D., Former Director (2018-2021) Centers for
Disease Control and Prevention, U.S. Department of Health, and
Human Services................................................. 9
Kevin M. Esvelt, Ph.D., Associate Professor MIT Media Lab,
Massachusetts Institute of Technology.......................... 11
Alphabetical List of Witnesses
Esvelt, Kevin M. Ph.D.:
Testimony.................................................... 11
Prepared statement........................................... 85
Parker, Gerald W. DVM, Ph.D.:
Testimony.................................................... 5
Prepared statement........................................... 41
Redfield, Robert R. M.D.:
Testimony.................................................... 9
Prepared statement........................................... 79
Wolinetz, Carrie D. Ph.D.:
Testimony.................................................... 6
Prepared statement........................................... 62
APPENDIX
Drug Adverse Event Comparison Chart.............................. 89
OSTP DURC Policy 2012............................................ 90
USG DURC Policy 2014............................................. 94
USG DURC Policy 2024............................................. 113
USG DURC Policy 2024 Implementation Guide........................ 144
National Biodefense Strategy and Implementation Plan............. 229
Policy Guidance for Development of Review Mechanisms............. 282
ODNI Updated Assessment on COVID-19 Origins...................... 288
ODNI Report-Potential Links...................................... 306
DHS S&T Master Question List..................................... 316
DOD Biodefense Posture Review.................................... 337
HHS Report-Framework Guiding Funding Decisions................... 393
NSABB-Proposed Framework......................................... 400
GAO Report--High Containment Laboratories........................ 433
GAO Report--Public Health Preparedness........................... 507
CRS Report Gain of Function...................................... 549
Council on Foreign Relations Working Paper....................... 552
CSET Report...................................................... 584
Health Security Article.......................................... 629
NAS Report GoF Research Second Symposium......................... 633
NAS Report Royal Society Sackler Forum........................... 774
ScienceInsider Article........................................... 814
DURC and GoF Meeting Email....................................... 817
DURC Meeting Document............................................ 819
Stakeholder Support Document..................................... 821
Scientific Community Support Document............................ 824
Redacted Emails.................................................. 826
Responses to post-hearing questions for the Record:
Dr. Parker................................................... 916
Dr. Wolinetz................................................. 928
Dr. Redfield................................................. 932
Dr. Esvelt................................................... 934
RISKY RESEARCH:
OVERSIGHT OF U.S. TAXPAYER FUNDED HIGH-RISK VIRUS RESEARCH
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THURSDAY, JULY 11, 2024
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 10:30 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Garry Peters,
Chair of the Committee, presiding.
Present: Senators Peters [presiding], Hassan, Rosen,
Blumenthal, Ossoff, Paul, Johnson, Lankford, Hawley, and
Marshall.
OPENING STATEMENT OF SENATOR PETERS\1\
Chairman Peters. The Committee will now come to order.
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\1\ The prepared statement of Senator Peters appears in the
Appendix on page 39.
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Last month, this Committee held a hearing on the origins of
Coronavirus Disease pandemic (COVID-19). This came as part of a
bipartisan security and life science research investigation
that I am conducting with Ranking Member Paul. In that
discussion, our expert witnesses raised the need for robust
oversight of a wide ranging or a wide range of high-risk life
sciences research, both here in the United States and abroad,
and this is the focus of today's hearing.
Life science research can be critical to protecting public
health and our national security. It helps us develop vaccines,
improve our diagnostic tests, and sharpen our understanding of
potential biological threats.
If we are to face the health and security challenges of the
21st century, we will absolutely need to draw on high risk
research. At the same time, this research can be incredibly
dangerous. It puts scientists in contact with harmful
pathogens, and they sometimes do not get the necessary training
on how to handle them properly.
If equipment fails or researchers make an innocent mistake,
it can carry serious health risk for the broader public. The
dangers are not just about physical materials, this work often
includes sensitive information, which can have devastating
consequences if it falls into the wrong hands. In short, we
have to strike a delicate balance between fostering scientific
progress and minimizing potential harms.
Today's hearing will examine how well we are striking that
very important balance, and if our policies provide enough
transparency to Congress and to the American public. The debate
on how to properly regulate Life sciences research is not new,
nor is it easy to resolve. Scientists and policymakers will
have to wrestle with these questions for decades.
The debate goes back at least as far as the 1970s when
scientists discovered that Deoxyribonucleic acid (DNA) from
different organisms could be combined together in a lab to
create a pathogen not found in nature. When they realized the
potential ramifications of this discovery, they agreed to pause
such research until the risk and benefits could be thoroughly
assessed.
Since then, experts have wrestled with other ethical issues
in life science research; from cloning to stem cell research to
modifying viruses. These questions are more important than
ever.
We are living in a remarkable age of technological change
and scientific progress. Laboratories are springing up all over
the world. Research areas are expanding, and money is pouring
into this work from governments as well as private funders.
We have a responsibility to harness the energy and
ingenuity of this moment. It will allow us to identify new
vaccines, new treatments, and better tests for novel pathogens.
New technologies will help us do research faster and safer by
modernizing lab experiments and getting more information from
smaller quantities of pathogens.
To be clear, this is an era of new research and there will
be risk, and we have to protect the American public against
those risks, but we also have to be smart and strategic as we
do it. Setting reactionary limits on Federal research could
have harmful consequences.
Other countries could make crucial discoveries while our
researchers are slowed down by red tape. Private donors could
keep funding research without proper guardrails in place. We
need to make sure that we maintain control of high-risk
research, to ensure that it's effective, innovative, and most
importantly, safe.
Science is an inherently human endeavor. The question of
what is too risky ultimately comes down to human judgment.
There is no simple answer, but today's hearing and our panel of
expert witnesses represent one important step in that work.
They will help us understand what transparency and oversight
policies exist today for high-risk science research, and what
Congress should do to improve these measures and keep the
American people safe.
I thank them for being here today, and I look forward to a
robust discussion on this very important topic. Now I would
like to recognize Ranking Member Paul for his opening remarks.
OPENING STATEMENT OF SENATOR PAUL
Senator Paul. Since 2020 American families, communities,
and businesses have borne the devastating consequences of the
COVID-19 pandemic. Lives were unnecessarily lost; civil
liberties were unilaterally stripped away by government
bureaucrats. Taxpayers will carry the burden of the trillions
of dollars borrowed and spent by the government for decades and
generations to come.
From the outset of the COVID-19 pandemic, Dr. Fauci and
others within our government, orchestrated a concerted effort
to stifle any debate over the virus's origins. They coordinated
the now debunked proximal origins paper, despite acknowledging
privately that the virus looked engineered. The purpose of this
vast cover-up, it now seems, was to conceal the dangerous
biological research National Institutes of Health (NIH) and
other government agencies were funding both abroad and here at
home.
Over the last four years, compelling evidence has emerged
supporting the lab origin of the pandemic and unraveling a web
of deception, the vast COVID cover-up. We learned that the NIH
funneled Federal dollars, through EcoHealth Alliance, to
support gain-of-function (GOF) research at the Wuhan Institute
of Virology (WIV), research that may have caused the pandemic.
We learned that multiple Federal agencies sent taxpayer
funds to China's Academy of Military Medical Sciences
supporting People's Liberation Army (PLA) research. Most
recently, the Department of Defense Inspector General (DOD IG),
found that the DOD is unable to fully account for the money
that it has sent to labs in China, because the DOD does not
track funding it sends abroad for pathogen research.
What has been done since the uncovering that our government
was funding dangerous virus research overseas with little or no
oversight? The answer is stark and chilling, virtually nothing.
Some prefer this inaction, finding comfort in the shadows of
bureaucracy and secrecy. They want Congress to remain passive,
to accept their reassurances, without question. We have fixed
it, the problem's done, nothing to see here.
But we cannot stand idly by, we must demand accountability,
strive for transparency, and ensure the safety of our citizens
is never again compromised by negligence or deceit.
You do not need to be convinced that the COVID-19 virus
originated from a lab leak to recognize the imminent need for
oversight mechanisms. The mere possibility that the virus could
have emerged from such risky research, should be more than
enough to prompt decisive action.
How can we trust in a system that so blatantly ignores its
own safeguards? How can we believe in leadership that permits
such dangerous research without conducting stringent oversight,
risking global health for the sake of dubious scientific
advancement? This is not merely a failure. It's a betrayal of
public trust.
We sit here today at a critical juncture, facing what many
believe is the nuclear threat of our time, gain-of function
research. Manipulating viruses to make them more lethal, poses
a danger akin to that of an atomic bomb. In this dystopian
reality we find ourselves in, it is our duty to challenge the
status quo, to shine a light on the darkest corners of
government operations, and to protect the freedoms and lives of
the people we serve. The era of complacency must end and change
must begin with us.
We must demand accountability for the grave oversights that
were revealed by the COVID-19 pandemic. The safety of our
nation and the trust of its institutions depends on it. This is
why yesterday, I introduced the Risky Research Review Act, to
codify an independent oversight of dangerous scientific
research funded by the Federal Government.
My bill would establish an independent board within the
Executive Branch, to oversee Federal funding for high-risk life
sciences research, ensuring the protection of public health,
safety, and national security. The board would be comprised of
non-government, scientific and national security experts who
would have the responsibility of reviewing and approving high
risk life sciences research proposals prior to the release of
Federal funds.
The bill would also implement mechanisms to ensure
accountability from agencies and applicants applying for
Federal funds to conduct high risk research. My bill not only
strengthens transverse transparency, but also ensures that
public health decisions are made in the best interest of the
American people, free from financial motives and prioritizing
national security.
The Risky Research Review Act is endorsed by stakeholder
groups and distinguished scientists, including the former
director of the Centers for Disease Control and Prevention
(CDC) who is here with us today, Dr. Robert Redfield. According
to Dr. Redfield, if the Risky Research Review Act had been in
place, it might have prevented the COVID-19 pandemic.
I urge the Chair and other Members of this Committee to
support the legislation which will begin to restore trust in
science, our scientific community and faith in our government
institutions. Together, we can prioritize the national security
of Americans, ensuring that we never again face such a
preventable devastation.
Chairman Peters. It's the practice of the Homeland Security
and Governmental Affairs Committee (HSGAC) to swear in
witnesses. If each of you would please stand and raise your
right hand. Do you swear that the testimony that you will give
before this Committee will be the truth, the whole truth, and
nothing but the truth, so help you, God?
Dr. Parker. I do.
Dr. Wolinetz. I do.
Dr. Redfield. I do
Dr. Esvelt. I do.
Chairman Peters. Thank you. You may be seated.
Our first witness is Dr. Gerald Parker. He is the Associate
Dean for Global One Health at the College of Veterinary
Medicine at Texas A&M University. He also serves as the
Director of the Biosecurity and Pandemic Preparedness Policy
Program at the Scowcroft Institute of International Affairs.
Dr. Parker, good to have you here with us today. You are
recognized for your opening comments.
TESTIMONY OF GERALD W. PARKER, DVM, PH.D.,\1\ ASSOCIATE DEAN
FOR GLOBAL ONE HEALTH, COLLEGE OF VETERINARY MEDICINE DIRECTOR,
BIOSECURITY AND PANDEMIC PREPAREDNESS POLICY PROGRAM SCOWCROFT
INSTITUTE OF INTERNATIONAL AFFAIRS, TEXAS A&M UNIVERSITY
Dr. Parker. Chair Peters, Ranking Member Paul, and Members
of the Committee, thank you for inviting me to testify before
you this morning. I am also honored to be in the company of my
fellow witnesses today, and I am also glad to be joined by my
wife, Denise, and several colleagues.
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\1\ The prepared statement of Dr. Parker appears in the Appendix on
page 41.
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The views and opinions I offer are my own, but are informed
by serving in career executive leadership positions in the
military and the Federal Government. I have a series of
recommendations in my written testimony. This includes an
evaluation of the strengths and weaknesses of the new policy
for oversight of Dual Use Research of Concern (DURC) and
Pathogens with Enhanced Pandemic Potential (PEPP), which I will
call the DURC-PEPP policy. I will highlight just a few of the
most important messages now.
First, I truly want to register my support for the new
DURC-PEPP policy, although its implementation will be complex.
In short, it is a step forward in the right direction. It
defines a more appropriate scope and gives thought to
implementation direction that was lacking in the Potential
Pandemic Pathogen Care and Oversight (P3CO) policy.
It clarifies some ambiguities in the policies, it replaces
and gives more detailed guidance to everyone from laboratory
Principal Investigators (PIs) to the Federal funding agencies.
It also adopts some of the common-sense recommendations from
the 2023 National Science Advisory Board for Biosecurity
(NSABB) report. That report was a product of over a year of
engagement with the public and stakeholders across the
scientific community.
That said, there are still pieces missing, which only
Congress can fix. The policy success depends heavily, on the
willing compliance of the spirit and letter of the policy.
There is no legislative mandate or resources provided for
implementation.
Furthermore, the policy does little to cover non-Federal
funded research. Congress should mandate the full
implementation of the White House DURC-PEPP policy by Federal
agencies to provision of authorities, appropriations, or
reallocation to resources, meaning financial personnel and
technical, and providing ongoing congressional oversight.
My second recommendation, is to establish a newly
independent authority to consolidate security related biosafety
functions and a single entity with a dedicated mission. This is
not a new idea, but the time has come to give it serious
consideration. A primary imperative is to prevent misuse and
serious accidents from especially dangerous research.
Scientific innovation will also be impacted unless we take
risk mitigation measures now, to prevent this small subset of
research from discrediting the entire life science research
enterprise, additional biosafety and biosecurity authorities
are needed to rebuild public confidence and reestablish our
international leadership and responsible stewardship of life
sciences.
The principles of oversight, independent from program
funding, and a clear point of accountability must be embodied
in an entity with a dedicated mission. These are widely
recognized as best practices for risk mitigation.
Strengthening oversight is not intended to stop meritorious
research that has a compelling justification with assurances
that risks will be mitigated. Prudent oversight is intended to
ensure the small subset of especially dangerous research has
especially important benefits. If so, that the research will be
performed safely and securely.
I believe an independent authority will benefit the
research community, by funding and being a home for neglected
biosafety research and elevating the field of biosafety. It can
support training and education for biosafety professionals and
PIs, helping them navigate the patchwork of security related
biosafety requirements. This will complement and strengthen the
safety and security culture needed to support the accelerating
paces of advances in biotechnology.
Again, I am encouraged by the new policy, but Congress
should consider closing its gaps and weaknesses. Bottom-up
responsibility must be linked to prudent top-down oversight
using the principles of ``trust but verify''. I think we should
all agree, dangerous research that could potentially create
pandemic capable pathogens ought to be limited and regulated.
In closing, I believe that your responsibility to take
legislative action to strengthen biosafety and biosecurity with
independent oversight is not a condemnation to the scientific
system. On the contrary, both Congress and the Executive Branch
must act in a nonpartisan manner to protect the integrity of
the system.
Thank you for the opportunity to appear before the
Committee today. I look forward to answering any questions you
have. Thank you.
Chairman Peters. Thank you, Dr. Parker. Our second witness
is Dr. Carrie Wolinetz. She is the senior principal and chair
of the Health and Bioscience Innovation Policy Practice Group
at Lewis-Burke Associates, LLC. Prior to her current role, Dr.
Wolinetz spent nearly a decade in public service.
She led the inaugural health and life sciences division in
the White House Office of Science and Technology Policy (OSTP),
and serves as the Associate Director for Science Policy at NIH.
Dr. Wolinetz, welcome. You may proceed with your opening
comments.
TESTIMONY OF CARRIE D. WOLINETZ, PH.D.,\1\ SENIOR PRINCIPAL AND
CHAIR HEALTH & BIOSCIENCE INNOVATION PRACTICE, LEWIS-BURKE
ASSOCIATES, LLC
Dr. Wolinetz. Chair Peters, Ranking Member Paul, and
Members of the Committee, it is an honor to speak with you
today on the topic of oversight of publicly funded research on
high consequence viruses.
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\1\ The prepared statement of Dr. Wolinetz appears in the Appendix
on page 62.
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My name is Dr. Carrie Wolinetz, and as mentioned, I am a
senior principal at Lewis-Burke Associates, which is a small
government relations firm, specializing in research and higher
education policy.
I have a long history of development and engagement on
biosecurity and biosafety policy and research oversight in my
previous roles inside and outside of government, including
Federal service at the NIH and the White House Office of
Science and Technology Policy.
I come before you today in a personal capacity, and do not
necessarily reflect the views of Lewis-Burke, their clients, or
other organizations with which I am affiliated. I have provided
more extensive written testimony for the record, but will
briefly summarize the salient points.
First, I want to note, as the Chair did, that the policy
conversation around mitigating the risk of research involving
high consequence pathogens is not new. For decades, the United
States has been at the forefront of global conversations about
how to create a research oversight system that reduces risk,
while maximizing benefit of life science research and we have
learned a lot about what works and what does not.
In thinking about our research oversight system, it's
important to understand the purpose and context of a policy
foundation on which we are building. Central to this is
recognizing that the landscape represents a mix of laws,
regulations, policies, and guidelines based on the interrelated
but distinct notions of biosafety and biosecurity.
Collectively, while this policy framework may be imperfect
and should continue to evolve with the science and current
threat landscape, it arguably represents the most rigorous
system of oversight of pathogen research in the world. In fact,
the United States approach informs the approach of many other
countries. In my written statement, I have expanded on the
history, strengths, and weaknesses of existing policy.
Second, over 20 years of policy debate, the central
question has not really changed: How do we appropriately
balance risk and benefit of high consequence research, where
there's inherent uncertainty on both sides of the equation? We
undertake scientific inquiry because there are questions about
the world around us for which we have no answers.
Nature's ability to surprise us feels infinite, which is
why we are always vulnerable to the next emerging health
threat. Even as we speak, H5N1 is rewriting the textbook of
what we know about avian flu viruses, despite rigorous research
investments.
The riskiest experiments with dangerous pathogens are not
taking place in the laboratory, they are happening in real
time, in the real world, with viral evolution serving as the
lead investigator. That means that when we ask scientific
questions or perform experiments, we will lack clarity about
whether or when we will realize benefit from that research or
if it will pose risk that outweigh those benefits.
Well-meaning technical experts can and experience teaches
us will, disagree on the magnitude of benefit and risk.
Moreover, there will always be some level of subjectivity as to
what constitutes an acceptable level risk relative to the
benefit and vice versa. There are no easy or perfect answers,
and we learn as we go, which is why our policies appropriately
continue to evolve.
Third, in considering policies to reduce risks of research,
we must not lose sight of the risk of limiting innovation or
creating rigid frameworks that are not agile enough to respond
to new and emerging threats. We have been having this policy
discussion for two decades because it's always been clear that
research on high consequence pathogens is critical and
necessary for developing the countermeasures needed to protect
human, animal, and plant health.
Simply put, if we make it too hard for scientists to
conduct and communicate the findings of experiments that expand
our knowledge of pathogens, we will be less prepared for the
next emerging biological threat.
It's very easy to become focused on the risk of doing the
research, and lose sight of the risk of not doing the research.
Additionally, in an increasingly competitive global
environment, we must consider how best to reduce safety and
security vulnerabilities in a way that does not stifle American
innovation or competitiveness.
But there is more that can be done to strengthen the
current system of oversight. The new OSTP policy for oversight
of dual use research is an important step forward. The details
of implementation will be important and resources are critical
for training the broader swath of the scientific community who
will be affected by the policy.
There's more Congress can do to bolster the global approach
to biosafety and biosecurity, which is currently primarily
based on norms, guidelines, and professional practices,
including encouraging adoption of performance-based
international standards like International Organisation of
Standards (ISO) 35001, and developing a non-punitive safety
reporting system for bio incidents against the Aviation Safety
Information Analysis and Sharing (ASIAS) system used by the
aviation industry.
Finally, global health security and prevention of the next
pandemic requires rigorous and sustained support of
capabilities that allow us to rapidly respond to new and
emerging threats, by strengthening pathogen surveillance and
early warning systems, adopting a One Health approach against
zoonotic diseases, and investing in the research development
and manufacturing capacity to meet the goals of the bold a 100
day missions.
All of these should stand on the principles of
transparency, continued U.S. leadership in driving the most
effective norms and standards for research oversight, and
balancing risk reduction with the vital need for innovation and
future security. Thank you for the opportunity to present these
views and I stand ready to discuss them further.
Chairman Peters. Thank you Dr. Wolinetz, I now recognize
the Ranking Member to introduce the two remaining witnesses.
Senator Paul. Dr. Robert R. Redfield, our first witness,
served as the 18th Director of the Centers for Disease Control
and Prevention during the Trump administration. As CDC
Director, he oversaw the agency's response to the COVID-19
pandemic at its inception.
Prior to being named director, Dr. Redfield spent more than
20 years as a U.S. Army physician and medical researcher at
Walter Reed. He served as the Chief of the Department of
Retroviral Research at Walter Reed and worked in virology,
immunology, and other clinical research.
Dr. Redfield co-founded the Institute of Human Virology at
the University of Maryland School of Medicine and has over 200
publications to his name. He earned both his Bachelor of
Science (B.S.) and Doctor of Medicine from Georgetown
University.
He has testified before Congress extensively, most recently
before the House Select Subcommittee on the Coronavirus Crisis.
Dr. Redfield, welcome to the Committee. You are now recognized
for your statement.
TESTIMONY ROBERT R. REDFIELD, M.D.,\1\ FORMER DIRECTOR (2018-
2021) CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Redfield. Thank you very much Chairman Peters, Ranking
Member Paul, and the Members of the Committee. I am pleased to
testify today in strong support of this Committee's important
work and the proposed bill designated to provide much needed
enhanced oversight of U.S. taxpayer funded high risk file
research.
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\1\ The prepared statement of Dr. Redfield appears in the Appendix
on page 79.
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From 2018 to 2021, I served as the 18th Director of the
Center for Disease Control and Prevention. As CDC Director, I
oversaw the agency's response to the COVID pandemic from the
earliest days of its spread, and I served as a member of the
White House Coronavirus Task Force.
But probably more relevant, is my 45 years in medicine I
have been focused on the study of viruses. I am a virologist by
training and practice. I spent more than 20 years as a U.S.
Army physician and medical research at Walter Reed Army
Institute Research, where I served as the Chief of the
Department of Retroviral Research and worked in virology,
immunology, and clinical research at the forefront of the
acquired immunodeficiency syndrome (AIDS) epidemic and other
viral threats.
In 1996, I co-founded the Institute of Human Virology at
the University of Maryland, where I was the Director of
clinical care and research, and I also served as a tenured
professor of medicine, microbiology, immunology, the Chief of
Infectious Disease, and the Vice Chair of Medicine.
After my time at CDC, I served as a senior public health
advisor to Governor Hogan in the State of Maryland, and more
recently, I am currently serving as a senior visiting fellow
for biosecurity and public health policy for the Heritage
Foundation.
The bill proposed in today's hearing is a very important
bill. As we witnessed during the events leading up to the
COVID-19 pandemic, there was a significant disconnect between
United States funded biomedical research and our national
security interest. In my view, biosecurity is our nation's
greatest security threat, but most biomedical researchers do
not consider it at all when making their research funding
decisions. Unfortunately, I do believe COVID-19 was an example
of this fact.
During my time as CDC Director, I had the opportunity to
work closely with the National Security Council (NSC) and key
members like Matt Pottinger and Robert O'Brien. They understood
the threat of infectious disease, and I understood the profound
security implications.
This bill once operationalized, will help ensure that our
national security implications are forefront and center at any
final funding decision and approval. Sadly, this has not been
the case in the past, and currently it does not impact
biomedical research decisions.
I believe that COVID-19 was a consequence of this
disconnect. As COVID-19 spread across the world, there were two
competing hypotheses about the origin of the virus that needed
to be vigorously explored.
The first hypothesis was the probability that COVID-19
infections in humans were the result of a spillover event from
nature. This is a situation which the virus naturally mutates
and becomes transmissible from one species to another, in this
case, from bats to humans via an intermediate species.
This is what happened previously with severe acute
respiratory syndrome (SARS) and Middle East respiratory
syndrome (MERS) in the earlier Coronaviruses that emerged from
bats and spread through an intermediate animal. It's important
to note, that four years later, I do not believe there's any
meaningful evidence only opinion to support this hypothesis.
The second hypothesis is the possibility that the virus
evolved from the lab through gain-of-function research. This
type of research is when scientists seek to increase
transmissibility or pathogenicity of an organism in order to
better understand the organism and prepare to develop
countermeasures. Under this theory, the COVID-19 affected the
general population after an accidental leak from a lab in
China.
From the early days of the pandemic, it was my view that
both of these theories needed to be aggressively and thoroughly
examined. Unfortunately, this did not happen based on my
initial analysis, I believe then, and I still believe today,
that the COVID infections were the direct result of a
biomedical research experiment and subsequent lab leak.
Unfortunately, the potential National Security consequences
of conducting the research did not receive full consideration
prior to the funding decisions to conduct such high-risk
research.
Our understanding the origin of COVID remain critical for
the future of scientific research, particularly as it affects
the ongoing ethical debate of gain-of-function research.
While some believe gain-of-function research is critical to
get ahead of viruses and developing vaccines and
countermeasures, in this case, I believe it had the exact
opposite effect on unleashing a new virus in the world without
any means of stopping it, resulting in the deaths of millions
of people, and changing our nation's way of life more profound
than if we had had a nuclear event.
More importantly, COVID is not the last pandemic. I am
particularly concerned about bird flu. Currently, H5N1 is
pandemic in chicken, turkey and wildfowl and spreading to more
than 25 other mammals in the United States and most recently
dairy cattle. In my opinion, we should call for a moratorium on
gain-of-function research until we have a broader debate and
come to consensus as a community about the value of such
research.
This debate should not be limited just to the scientific
community, and it's critical that the National Security
implications carry significant weight in making future funding
decisions.
If the decision is to do gain-of-function research, it must
be determined how, where to do it in a safe, responsible, and
effective way that does not compromise our National
Biosecurity. The proposed legislation would be critical step in
trying to achieve this.
Again, I want to thank Chair Peters, Ranking Member Paul
for inviting me here today to share my perspective, and I look
forward to answering your questions.
Senator Paul. Our next witness is Dr. Kevin M. Esvelt. Dr.
Esvelt is an associate professor at the Massachusetts Institute
of Technology (MIT) Media Lab. He serves as the director of the
Sculpting Evolution Group, which invents new ways to study and
influence the evolution of ecosystems and has over 40
publications to his name.
Prior to his current role, Dr. Esvelt invented phage
assisted continuous evolution (PACE), a synthetic ecosystem for
rapidly evolving biomolecules. He also developed the cluster
regular interspaced short palindromic repeats (CRISPR) for
Genome Engineering and Regulation at the Weiss Institute. He
was the first to discover that CRISPR base gene drive systems
could spread from a handful of laboratory organisms to edit the
genomes of entire wild populations.
Dr. Esvelt earned his Bachelor of Arts (B.A.) in Chemistry
and Biology at Harvey Mudd College and his Ph.D. in
biochemistry at Harvard University. He's testified before in
Congress. Dr. Esvelt, welcome to the Committee. You are now
recognized for your opening statement.
TESTIMONY OF KEVIN M. ESVELT, PH.D.,\1\ ASSOCIATE PROFESSOR MIT
MEDIA LAB, MASSACHUSETTS INSTITUTE OF TECHNOLOGY
Dr. Esvelt. Chair Peters, Ranking Member Paul, Members of
the Committee, it's an honor to testify today.
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\1\ The prepared statement of Dr. Esvelt appears in the Appendix on
page 85.
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I speak on my own behalf and not on behalf of MIT. I
believe that the best interest of the United States, and public
trust in science require congressional action on issues of
biosafety and biosecurity. I believe that that action will
require us to take into account past and future advances in
technology
Today, thousands of skilled individuals can create
infectious viruses using commercially available synthetic DNA
that corresponds to publicly accessible viral genome sequences.
To test our nation's ability to control access to pandemic
viruses, my team at MIT, with the Federal Bureau of
Investigations (FBI) approval, ordered DNA and coding fragments
of the 1918 influenza virus from 38 DNA synthesis firms.
The genome sequence of this virus, which killed 50 million
people, was published by Federal researchers in 2005 when
synthetic DNA was a thousand times more expensive and hardly
any researchers could construct an infectious virus from
synthetic DNA. Both of those have now changed.
1918 influenza may not cause a pandemic today, but if you
consider a 10 percent chance of another COVID, that would
equate to over 100,000 American lives, and more than a $1
trillion in economic damage.
Of those 38 gene synthesis providers, 36 ship DNA enough to
make the infectious virus three times over, even though the
person placing the orders did so using a pseudonym, had no ties
to influenza research and falsely claimed to work for
organization that does not perform wet lab research at all.
Everything that we did and the companies did was entirely
legal. There are no laws regulating DNA synthesis, even though
the industry group, the International Gene Synthesis Consortium
has requested congressional regulation. They do not want to
sell harmful DNA to anyone who is not authorized, but there is
no one to tell them which researchers and experiments are
legitimate.
This is true, even though 1918 influenza is a select agent,
anyone can still legally purchase DNA sufficient to make the
virus as long as that DNA is in pieces, even though we have
gifted high school students who can stitch those pieces
together. To put it mildly, this is not how we regulate fissile
materials and blueprints for nuclear devices.
Unlike pathogens that have zero chance of causing a
pandemic, 1918 is not even the highest tier of Select Agent,
nor does working with it require biosafety level 4 (BSL-4)
conditions. This is true even after COVID has taught us that
transmissibility is of extreme importance.
Why have we not updated? Perhaps because there is no single
agency or board in charge of biosafety and biosecurity, but
perhaps also because the agencies in charge of this research
currently regulate themselves, and this is a bad idea.
I have tremendous respect for Dr. Parker's achievements as
chair of an NSABB, but at the end of the day in that role, he
reports to a department whose research he ostensibly oversees,
and they can dismiss him or ignore him as they please, and that
is not adequate trustworthy oversight.
Now, I love science. Frankly, I would rather my lab not be
subject to more paperwork and regulation that can be harmful to
progress. But public mistrust also harms science, and the way
to build trust is to earn it, which does not happen when you
insist on regulating yourself. We are overdue for a systemic
reappraisal of which pathogens, DNA and experiments are
dangerous for safety and which for security, which are not the
same thing.
I urge Congress to empower and fund an independent board to
assess which labs should have access to which agents and
sequences, to decide when the benefits of dual use research
exceed the risks, and to determine when sharing a genome
sequence or an experimental outcome would cause irreparable
harm to national security.
The board's decision should be made with total
transparency, except when national security requires otherwise.
The board should include scientists, but also machine learning
experts, security analysts, diplomats, and most importantly,
members of the general public, who needs to have a voice.
Had such an independent board existed in 2005 when
researchers first decided to publish the genome sequence of
1918 influenza virus, I would be considerably more confident
that doing so was the responsible course of action.
If such a board existed today, I would be much more
confident that future decisions about finding, predicting, or
engineering credible pandemic pathogens will benefit our nation
and the world. Thank you.
Chairman Peters. Dr. Wolinetz, in May, the White House
released a new research oversight policy that that goes into
effect next spring, as you are well aware. Would you let the
Committee know what you think this policy improves in terms of
prior versions and give us a little bit of detail on those
improvements.
Dr. Wolinetz. Thank you, Senator Peters. I strongly support
the updated policy, the DURC-PEPP policy that the White House
put out. It streamlines the process for oversight of these dual
use experiments combining what previously had been three
separate policies for Federal and institutional oversight of
Dual Use Research of Concern, as well as a policy for
departmental review of enhanced pandemic pathogens.
The new policy also expands the scope of agents that fall
under the policy and need additional levels of oversight and
review, and includes, for example, not just human health
pathogens, but pathogens relevant to animal and plant health,
which I strongly support because I think that's long been a
neglected part of our policy process.
The policy provides an opportunity to really have an
iterative conversation at multiple levels with roles for the
principal investigator, for the research institution, for the
agency, and then independently at the department level and
across governments opportunities, to weigh the risks and
benefits of that research in a way that allows you to consider
those prior to making funding decisions.
Chairman Peters. Are there any gaps in the policy?
Dr. Wolinetz. The policy still is limited to Federal
funding of research. It is one of the many tools in the toolbox
by which we can use the power of publicly funded research to
ensure that we are conducting research ethically, safely, and
in a secure manner.
However, it does not extend beyond federally funded
research, although the policy does extend beyond an individual
funding agency at the institutional level in that it has
expectations for the institution beyond just an individual
project to really apply the scope of the policy to anything
that falls within it. But again, that's only applicable to
publicly funded institutions.
Chairman Peters. Dr. Esvelt, as was stated, this new policy
applies only to Federal funding. Should independent oversight
agency also regulate research supported by non-Federal funding
as well? Do you see that as a significant gap?
Dr. Esvelt. Yes, Chair, I agree that the gap provided by
non-Federal funding is a major one. The policy does attempt to
take this into account, by requesting that entities that
receive Federal and non-Federal funding regulate the research
that is performed using non-Federal funding.
However, this does still leave out a large fraction of
entities, and I believe in order to be consistent with security
policies and other domains, we should regulate non-Federal
funded research within our borders and take international
action to discourage research in this vein, which I believe
harms our national security.
Chairman Peters. You mentioned you know, international
action. Dr. Wolinetz, should the United States do something to
deal with oversight of research that's being done outside of
the United States as well.
Dr. Wolinetz. Thank you, Chairman Peters. I worry a lot
more about research involving pathogens that takes place
outside of the United States than I do about the system within
the United States. Our biosafety biosecurity system within the
United States may not be perfect, it still involves human
beings, and so there is still the possibility of accidents.
However, I feel a lot more comfortable with it than I do
with the promulgation of high consequence pathogen research
around the world, particularly in the wake of the pandemic.
I think in fact, it's imperative for the United States to
use the levers at our disposal in order to try to raise the
norms and standards and regulations around the world for this
sort of research, whether that is through the carrots and
sticks incentive of funding research in foreign nations where
we impose our requirements for oversights and conduct on them,
or supporting the adoption of enforceable and accountable
mechanisms like the international standard I mentioned ISO
35001.
Chairman Peters. Very good. Dr. Parker, I think I am
concerned and I know Members of our Committee are concerned,
that lab safety and security standards, let alone the standards
in other countries are not adequate to ensure that risky
research can be properly contained in labs that are working on
these dangerous pathogens.
Dr. Parker, I would like you to comment on the state of
biosafety and biosecurity standards, and specifically what we
should do to ensure that we are addressing what you consider
the largest threats that we face.
Dr. Parker. Sure. Thank you, Senator Peters. I want to also
first echo the concern about the international space and we are
going to have to step up and do more in form of leadership on
the international stage, but biosafety biosecurity standards
they have evolved over the years through best practices.
One thing that I think is a gap is we do not have a
dedicated research program focused on biosafety. What is the
evidence-based that we can actually better improve our bio
safety, then making sure that that supports any biosecurity
mandates that may be coming down, so they are more evidence
based? That's in my written testimony about how we need to
better support that going forward.
We need better ways to more in real time share best
practices. That means more real time sharing of say, laboratory
incidents, near misses so that we can capture those lessons in
real time, share them with other labs and so forth.
I cannot overemphasize the importance of our high
containment research enterprise, that really is the foundation
of our preparedness planning for the emergence of the next
dangerous thing that's going to come out in nature. We have to
support that, but we have to have a strong foundation of
laboratory, biosafety, and biosecurity to do that.
Chairman Peters. Thank you doctor, Ranking Member Paul, you
are recognized for your questions.
Senator Paul. The debate that Congress and the Senate will
have to have is whether or not White House policy is enough. I
think they are well intentioned. I think they want to fix a
problem that exists.
But we have had this conversation before when in about
2010, 2011, when the avian flu was mutated to become
aerosolized and more easily spread among mammals. There was a
pause between 2014 and 2016, but throughout the pause there
were exemptions given to many research, and then there's some
research that mysteriously does not show up in any documents.
For example, the research in Wuhan that many of us believe
evidence points toward the lab leak causing the pandemic, was
never reviewed. We then set up a committee called the P3CO
committee, which was supposed to be in charge of looking at the
safety of dangerous research. They looked at exactly three
research projects. They complained and said, well, we didn't
have the ability to go out and grab research, we could only
take what was given to us.
There are limitations of the internal changes. In fact, one
of the grave mistakes that was made is that the research in
Wuhan was never even looked at by the P3CO committee. It was
never paused. Anthony Fauci will say, ``my people up and down
told me it was not gain-of-function.'' Yet there's not one
scrap of paper of any discussion ever occurring over whether it
was gain-of-function or not.
There been camps for a long time, people say, oh, is this
Republicans versus Democrats? No, but it's contentious. There
have been scientists on both sides of this from the very
beginning, really, probably all the way back to the Spanish flu
in 2005, but certainly since 2010.
People need to realize that there are people on polar
extremes, and Anthony Fauci was a polar extreme. He believed,
and he said in 2012 that even if a pandemic should occur, the
knowledge was worth it.
I guess my question to begin for Dr. Redfield was, do you
think that taking a coronavirus, the backbone of a SARS
coronavirus and swapping out s-proteins from unknown viruses,
do you think that's research that should be scrutinized for
potentially being gain-of-function or dangerous? Does it bother
you that the internal regulations that were put in place did
not seem to work to catch that Wuhan research?
Dr. Redfield. Yes, I think the problem is the program
cannot be passive. I think while I respect some of the
improvements that happened with the May decisions that the
White House has, I still think this is sort of a passive
volunteer program for compliance.
Clearly, I think there has to be a much more active
engagement. One of the things that I want to come back to that
I said earlier, and people will disagree with me, but I think
they should reflect on what I am about to say.
In 2024-2025, biosecurity is our nation's greatest national
security threat. You need to think of it, the same way we
thought about the verge of nuclear atomic, and in the late
forties, fifties, and sixties, and, Congress and our country
was very aggressive in putting some standards around how we did
nuclear research and where we did it. I think we have to have
that same vigor toward this biological gain-of-function
research right now. It has the potential to be much more
catastrophic than, let's say, an isolated nuclear event.
Senator Paul. In preparing this bill to set up an
independent board, we interviewed dozens of scientists. We
asked them their opinions on this, what has to be done
differently. Probably the number one thing people came back to
us, is that they believe the people making the judgment on the
danger of the research should not be people dispensing money or
receiving money, because it's just a conflict of interest, and
accusations have been made.
We do not know what people's motivations are, but when they
are multimillion dollar awards being given after certain
opinions change or evolve over time, then the question is
whether or not the money motivates the change. Really, so what
we did in setting the independent commission up that we hope to
pass into legislation, is that people who are no longer
receiving--they could have been working for NIH, but they are
no longer receiving benefits, they are not in the dispensing
part, to try to get a more objective look at this.
We also put people on the Committee that would have a
national security look at this as well. They can have both,
people like Dr. Redfield have had both experiences of looking
at national security and the science of this.
We do not ban anything. We do not ban gain-of-function
research. It's really important what the definition is and it
requires some guidance and then scientists. But to Dr. Esvelt,
do you think it's important that this be outside of the
traditional NIH grant funding process to get rid of conflicts
of interest, or do you think it can be done within house at
NIH?
Dr. Esvelt. Thank you, Senator. I strongly believe that to
provide trustworthy oversight, it has to be located outside the
chains of funding in either direction, exactly as you outlined.
Senator Paul. Dr. Esvelt, the history of this, if you could
sort of review again, just because some people think this
started with COVID, going back to Spanish flu and avian flu,
that there's been really a long running debate in the
scientific community about the benefits.
Some people say, well, as Anthony Fauci, the knowledge is
always worth it, the risk does not matter, the knowledge is
worth it. But then other people say, we have never developed
any vaccines from gain-of-function research, and that it has
not been nearly as productive as some would argue. Can you
comment a little bit on the history of this debate? Where the
debate's going and what your opinion is on Dr. Redfield? I am
sorry. I was directing that one back to Dr. Redfield.
Dr. Redfield. I think it's an important debate to have, and
I think you have highlighted. If I was sitting here 20 years
ago, I would probably have the view that we may want to
consider gain-of-function research as a way for us to get a
jumpstart on countermeasures because the pace of science was so
slow.
I know when I became CDC director, I was very concerned
about a bird flu pandemic. Historically, if that occurred, it
would likely take several years before we would have a vaccine
or countermeasure. Really for the first couple years, it would
just be a body count.
But I will say the pace of science today is such that, and
we saw it obviously with the COVID pandemic and the rapid
development of the COVID vaccines, is such that we can really
develop countermeasures really in weeks and months now.
I am not of the view that we get such a jumpstart with
gain-of-function research. I do think there has to be a very
aggressive debate whether there's any benefit from that
research. I think you are right, I am not aware of any advanced
therapeutic or vaccine that has come to pass because of gain-
of-function research. I am still reticent.
I do want to have a vigorous public debate about its
benefit. If it's determined that it has benefit and I want
society to be involved in that debate, not just scientists,
then how do we do it in a safe, responsible, and effective way
that protects our national security, which I do believe it has
to be highly regulated.
Chairman Peters. Thank you. Senator Johnson, recognized for
your questions.
OPENING STATEMENT OF SENATOR JOHNSON
Senator Johnson. Chair, I appreciate you holding this
hearing. But I know of your bill, Senator Paul. I am sure I am
going to co-sponsor it once I review it. But I want to take
this in a slightly different direction because I have never had
Dr. Redfield before me.
The cover-up of the funding of dangerous research is not
the only area that our Federal agencies have been covering up,
been lying to. It's not been transparent. I have sent over 60
oversight letters. The agency has been largely ignored. I will
flash this one more time.
These are the last 50 pages of the Fauci emails that I have
been trying to get unredacted for the last couple years. One of
my oversight letters, that's what I really want to focus on, is
the standard operating procedures (SOP), Dr. Redfield, that
your agency issued nine days after you left. I am assuming you
had some input in that or knowledge of it. They issued a
standard operating procedure in terms of the analysis of the
Vaccine Adverse Event Reporting System (VAERS). Are you aware
of that, that they are going to be doing proportional reporting
ratios and empirical baying analysis on VAERS?
Dr. Redfield. Senator? I am really not up to speed on that.
Senator Johnson. OK. Is there any reason why the CDC, if
they are doing those analyses, proportional reporting ratios
and empirical bay analysis, why they would not release that to
a Member of Congress, a senator, requesting to see that data
and quite honestly release it to the public? Is there any
reason to hold that information?
Dr. Redfield. I totally agree with what you are pointing
out. I am disturbed that there's not much more aggressive
release to the public of the data they have about safety of
these vaccines. I think it's not appropriate.
Senator Johnson. They are withholding it. I think I
understand why, let me put up my chart.\1\ It is true, by the
way, they were touting VAERS. Mr. Tom--in October 2020, about a
month and a half beforehand was talking about what a great
system this was going to be. Do you agree with that? I could
give you the quote.
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\1\ The chart referenced by Senator Johnson appears in the Appendix
on page 89.
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I do not want take--trust me, you were touting the VAERS
system. But once the numbers started coming in, I think by
April, we had over 2000 deaths reported worldwide in the VAERS
system, about 40 percent of those were occurring on day zero,
one or two. So, that was concerning.
I realize the limitations of VAERS, but here's the current
Veterans Administration (VA's) report compared to other drugs
by the way, the top of the one is Ivermectin. This is the one
the Food and Drug Administration (FDA) said horse paste. Come
on y'all, you are not a cow, you are not a horse. On average
over 27 years, 16 deaths per year.
Hydroxychloroquine 80 deaths per year over 36 years. The
flu vaccine in 54 years of reporting, no, 33 years of
reporting, a total of 2,500 deaths, about 75 a year. Let me
skip ahead because, we have Tylenol, we have other things as
well.
The COVID vaccines over 37,000 deaths. Today by the way, 24
percent of those deaths reported are occurring on the day of
vaccination within two days. That's about 11,000 a year. Dr.
Redfield, I appreciate the fact that you have actually admitted
that vaccine injuries are real. There are a lot more
significant, I mean, total number of adverse events reported
1.6 million. Of course, one of the problems with VAERS is it
dramatically understates the number of vaccine injuries.
A couple questions I have for you because you did agree
that we were generally led to believe that the vaccine was
going stay in our arm, correct?
Dr. Redfield. Yes. I think, again, the people oversold the
vaccine and didn't give transparent comments about the
potential side effects of danger.
Senator Johnson. Again, we were told it was going to stay
in our arm, right? Yes. OK. We were told this was messenger
ribonucleic acid (mRNA), it degraded rapidly in our body.
Right. But it was not mRNA, was it? It was modified ribonucleic
acid (RNA). It was actually produced synthetically, so it would
not degrade. We now have studies that say the mRNA is
circulating the body, at least I think two months, and we have
not done studies beyond that. Correct. I know in your own
practice you do not administer that because you realize the
spike protein is toxic to the body.
Dr. Redfield. I prefer the killed protein vaccines.
Senator Johnson. When did you first determine, or when did
you first find out about the biodistribution studies Pfizer had
done that the Japanese regulators released in February 2021,
probably of the lipid nano particles.
Dr. Redfield. Yes, probably somewhere in the spring or
summer of 2021. It was clear that the mRNA in some patients was
persisting much longer than it should.
Senator Johnson. But when did you find out about the
biodistribution of the lipid nanoparticle or when did people in
the FBI-FDA, when should they known about the fact that they
were bio distributing all over the body?
Dr. Redfield. Yes, I do not know the answer to that. I was
telling you the summer of 2021 is when I probably became more
aware that this----
Senator Johnson. Only because the Japanese regulators
released that. But again, this was part of the Pfizer studies.
They knew that the lipid nanoparticle, which is designed to be
difficult to permeate barriers. Correct. OK. That's the design
of the lipid nanoparticle. They knew it was going to bio
distribute all over the body concentrating the ovaries, the
adrenal glands, it crosses the blood brain barrier. Correct.
Dr. Redfield. Correct.
Senator Johnson. You are a doctor. What happens when you
have a lipid nanoparticle bio distributing, and let's say this
modified mRNA attaches to a heart muscle. It injects itself
into the cells, causes that heart muscle cell to produce a
spike protein. Correct. Which is toxic to the body, and then
what does the body do?
Dr. Redfield. It has a very strong pro-inflammatory
response, which is problematic. Again, I think, Senator, what
you are getting at, which I am 100 percent agreeing with you,
is I think there was not appropriate transparency from the
beginning about the potential side effects of these vaccines. I
do think there was inappropriate decisions by some to try to
under report any side effects because they argued that would
make the public less likely to get vaccinated.
I do think one of the greatest mistakes that was made, of
course, was mandating these vaccines, they should have never
been mandated. It should have been open to personal choice.
They do not prevent infection. They do have side effects.
Senator Johnson. Again, I appreciate your admitting side
effects. But you have to admit, the people at the agencies, the
Dr. Marks, the Dr. Woodcock, they are still by and large
denying this, right? They are saying, well, they are rare, and
they are mild, they are not rare, they are severe to death.
Dr. Redfield. Yes. The FDA should release all of the safety
data they have. I was very disappointed to hear that they were
planning to hold onto that until 2026. That really creates a
sense of total lack of trust in our public health agencies
toward vaccination. It's counterproductive.
Senator Johnson. Mr. Chairman, I am not getting cooperation
out of the chairman of the permit subcommittee, investigation
to issue subpoenas to get this information. You have not yet
issued a subpoena to get the final 15 pages unredacted. I would
suggest we do that.
Again, as important as the cover-up of the origin story is,
there's a lot more that's being covered up. The public has a
right to know. We pay for these agencies, we pay their
salaries, we fund these studies, and they are not giving them
to us.
I appreciate this hearing, this is important. There are
many aspects of our miserably failed response to COVID that
needs to be uncovered, not the least of which the sabotage of
early treatment, which I did not have time to get into. Thank
you.
Chairman Peters. Thank you. Senator Marshall, you are
recognized for your questions.
OPENING STATEMENT OF SENATOR MARSHALL
Senator Marshall. Thank you, Mr. Chair. Welcome again to
our witnesses. Mr. Chair. Thank you. I greatly appreciate the
direction of these series of hearings is going.
Senator Paul's Risky Research Review Act is a giant leap
for mankind. It might be the start of something that will save
tens of millions of lives, and I commend him, and we will do
everything we can to put wind beneath yourself, to get this
across the finish line.
My concern is there's not enough National Security emphasis
on this. It's stunning to me, as I go back and talk to the
folks that knew the most at the beginning of COVID were the
National Security people. They were not surprised at all.
Dr. Redfield, I want to talk about the next pandemic.
Whether it's manmade or from nature, I do not care. We all
realize the flu vaccine works 25 or 50 percent of the time. The
mRNA vaccines were going to be the cure all that they are not.
What do you think would be the, if you were going to line up a
scenario for us to practice, what would be the virus? Talk a
little bit about vaccines as opposed to therapeutics.
Dr. Redfield. I think it's very probable that we will have
another pandemic. I think it's very probable that the pandemic
pathogen will be bird flu. The current bird flu, as you know,
is now in over a hundred million chicken and turkeys in the
United States alone. It's global. It's an H5N1 virus. That
virus now has gone into 27 mammal species in the United States
including cats, mice, and bears, and surprisingly dolphins and
seals. It's quite extensive.
It does not seem to have learned how to go mammal to
mammal, when it gets into those mammals. It use to go bird to
mammal. It's been in five humans in the United States since
2019. It has been in about 888 humans across the world since
2003. It raises concern because of those 888 individuals, there
have been about 52 percent mortality, so there's a high
mortality rate.
I think it's very likely that this virus will continue to
go out and try to learn how to infect different mammals,
including humans. Eventually it will evolve so it can transmit
efficiently human to human. We know exactly what has to happen
for that to happen. There are four amino acids that need to
change. It was published in 2012, I was not an advocate that it
should be published, because I thought it would show terrorist
a recipe to how to create a catastrophic virus. But it was
published. You know Senator Marshall I am a man of faith; I
think it's kind of a miracle that no one's exploited that yet
to cause global chaos.
But I am more concerned that the virus could be created in
university labs. Labs are doing experiments that are trying to
understand how to manipulate this virus and then be subject to
accidental laboratory leak. Once respiratory viruses get
leaked, they are very hard to contain. I am very concerned
about that.
On the other side of your question, I think that the United
States is not prepared, proportional to the threat. As I said,
I think this is the greatest national security threat our
nation faces. We have a $900 billion defense department for the
threat of China, North Korea, Iran, and Russia. We do not have
really any systematic agency or network or private sector
contractors to help us with the biosecurity threat, which I
believe we should have. We need a proportional response to the
threat.
I would like to see us build within the Department of
Energy (DOE), since they're used to weapons of mass
destruction. They have a good science base for them to
basically get the mission to help build our biosecurity
response and then build a series of private sector enterprises,
like you mentioned, antiviral drug development and vaccine
diagnostics, personal protective equipment (PPE), as well as
medical equipment that you can predict will need. When COVID
happened, you remember, vice President Pence went up to
Michigan, to the Ford manufacturers, to ask them to stop making
Fords and start to making ventilators.
Senator Marshall. Dr. Redfield, if I could interrupt you. I
want you to really nail this, the vaccine versus therapeutics,
therapeutics stop transmission. Suddenly we found, heaven
forbid, the bird flu was in humans, we could go there with a
therapeutic and really stop the spread. Am I right or wrong?
Dr. Redfield. I think your point, senator is exactly right.
Too much weight is on vaccines, they are part of the response,
but it's not where the money is, the money is in antiviral drug
development. That's where the money is.
The way I keep my patients alive today that get COVID that
are over the age of 65 is the antiviral drugs. What we really
need to have for bird flu, because we do not have them right
now, is multiple antivirals that are highly efficacious against
bird flu. We do not have it. We should have it.
Senator Marshall. Talk about the supply chain, what we do
not have in this country for you to be able to develop those
antivirals. There's some chemicals and rare earth stuff that
you need that I do not have.
Dr. Redfield. Yes. There are different technologies. This
is where I think this should invest in platform technologies
that can protect us. Right now, for many drugs, you need to get
an active pharmaceutical ingredient and the sources of that is
really two; Indian and China, right.
There's an alternative platform, which I am a big advocate
of, which is to use the mRNA platform, not for vaccines now,
but for therapeutics. If I do use the mRNA for therapeutics
what I need to do is just procure four nucleotides, which I can
procure right now, and then, I can put them in the----
Senator Marshall. We are eliminating the risk of developing
the vaccine to be leaked. I mean, developing a vaccine that
often leads to leaks, it seems----
Dr. Redfield. Yes. I just think that we should have a
robust therapeutic program that builds technology that's
independent of needing to go get active pharmaceutical
ingredients from China and India. That technology exists today
using the mRNA technology, not for vaccine development, but
using it for therapeutic product development.
Senator Marshall. Dr. Esvelt, let's talk about National
Security just one more time here. In my humble mind, a viral
biosecurity issue is a bigger issue than China's military
threat to us. This is way more important than how many more
submarines we build. Those submarines are important. Why
wouldn't we apply the same type of rules and regulations to
anybody that's working with nuclear energy, nuclear physics,
nuclear bombs? I mean, this is 10 times worse as well.
Dr. Esvelt. Thank you, Senator. The answer is that even
though there are many benefits to nuclear energy, there's a lot
more benefits to biotechnology in many different disciplines.
Carving out the fraction that is dangerous and poses these
risks to national security, which is overwhelmingly due to
agents that can transmit efficiently. That is the tiniest
fraction of all biomedical research. I believe we dramatically
under regulate that and frankly, overregulate much of the rest
of it.
Senator Marshall. Thank you.
Chairman Peters. Thank you, Senator Hawley, you are
recognized for your questions.
OPENING STATEMENT OF SENATOR HAWLEY
Senator Hawley. Thank you very much, Mr. Chairman. Thanks
to all the witnesses for being here. Dr. Wolinetz, if I could
start with you. You served as the chief of staff to Francis
Collins for four years, is that right?
Dr. Wolinetz. That's correct Senator.
Senator Hawley. From 2017 to 2021, is that correct?
Dr. Wolinetz. Yes, that's correct.
Senator Hawley. Right through the heart of the pandemic.
Yes. I noticed that Dr. Collins was intensely interested in
discrediting the lab leak. I guess we will call it a
hypothesis. I think it's probably a little bit stronger than,
that now that we know something of what our intelligence
agencies have long assessed.
Last month, I had the chance to speak with Dr. Robert
Garry, who sat right where you are, who co-authored that
really, frankly, shameless propaganda piece, the proximal
origin paper, which infamously stated that the severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) is not a
laboratory construct or a purposely manipulated virus. It went
on to say it could not possibly have come from a lab.
This of course, we now know is not what multiple U.S.
intelligence agencies assessed. What interests me is that your
office was very involved in that paper, which was supposed to
be an independent piece of scientific analysis, but Dr. Collins
actually called Dr. Garry when he was supposedly working on the
paper on February 1, 2020. Is it normal for scientists who were
supposedly doing independent research to get together and talk
about how their conclusions are going to come out?
Dr. Wolinetz. Thank you for the question, Senator Hawley. I
think in general, yes, it is quite common for scientists across
biomedical research fields, while they are in the process of
doing research to discuss the outcome and other scientists. I
do not believe that is an accurate description of the
conversations that took place.
Senator Hawley. Tell us what were the nature of the
conversations?
Dr. Wolinetz. I was not present for those conversations. My
understanding based on readouts is there was a lot of interest
in the origins and current understanding of SARS-CoV-2. I think
it's important when we are talking about the term lab leak
theory to differentiate between the idea of a virus escaping
from a lab, which is a biosafety violation versus a virus that
is engineered or manipulated in the lab and then escaped.
Senator Hawley. Your boss and Dr. Fauci tried to discredit
both of those things, they said that a lab was absolutely not
involved. We know that at the time that this paper was
supposedly being written, because we now have the private
correspondence from Dr. Fauci, your boss said that it was a
very destructive conspiracy to think that there was a lab
involved.
He's on the phone with a scientist who's supposedly writing
an independent paper. By the way, Dr. Garry testified under
oath that he was coming to his conclusions while this paper was
being written. He was discovering the answers. But we now know
that your boss was on the phone with him saying this is a very
destructive conspiracy before the paper was even written.
My question is, why was your office so intent on pushing to
the public the idea that this could not possibly have been a
lab issue? Is it because of the NIH's role in funding gain-and-
function research at the lab? Is that the reason why?
Dr. Wolinetz. Senator Hawley, I would say that in the event
of any new and emerging infectious disease, if you have ever
gone through a table top exercise in biosecurity----
Senator Hawley. Answer my question, is it because that NIH
was actually helping to fund EcoHealth, was funding gain-of-
function research?
Dr. Wolinetz. No, I believe that's an inaccurate
assessment.
Senator Hawley. In fact, your boss misled Congress and
testified falsely that NIH and the EcoHealth had never
conducted gain-of-function research at Wuhan. Correct?
Dr. Wolinetz. No, that's incorrect.
Senator Hawley. He did testify that.
Dr. Wolinetz. I believe, sir, that what he testified to was
that, there was no evidence at that time that NIH was funding
research that met the scope of the P3CO policy, which I want to
differentiate from the term gain-of-function research, which is
the broader----
Senator Hawley. Of course. This is the classic, now that we
have lied, now that you and your office lied to the American
people for years, told the American people that a lab leak was
a very destructive conspiracy, that's your boss's statement,
while you were his chief of staff.
Of course, we now know that that was the conspiracy to hide
this from the American people, to censor people who went out
and said, you know what, actually maybe this is a lab leak.
Your office, Dr. Fauci and others tried to actively censor
them. There was a propaganda effort that this paper was the
center of, and now everybody says, oh, well, we just were not
sure at the time. We did not really know. You knew exactly what
you were doing. You were actively misleading the American
people the entire time.
Get this, after that paper, it's really an opinion piece,
was published, your boss then says to Dr. Fauci that he really
hoped that the paper would settle this, is there anything more
that we can do to shut down this destructive conspiracy? This
is in April 2020.
Then Dr. Fauci went to the White House podium and said that
absolutely there's no way that this could have come from a lab.
Let me come back to my original question, why was your office
so intent on shutting down any talk about this being involved
with a lab? Why? I don't understand it. Why the hysteria?
Dr. Wolinetz. Senator Hawley, I will say that my
understanding of the situation is that no one at NIH, including
Dr. Collins, Dr. Fauci, myself, ever suggested that there
wasn't the possibility that a virus had escaped from a lab.
Senator Hawley. That's ridiculous. I mean that, let me just
stop you right there. I just cannot have these lies continue to
be told over and over again. Sorry and wrong. That's false. You
people repeatedly said it could not have come from a lab. Your
boss said it was a very destructive conspiracy. Not that it was
unlikely, not that it was not the best idea, a conspiracy.
Based on that, you censored and your administration that you
worked for, actively censored scientists, journalists.
What we now know is our own intelligence agencies at the
same time, were concluding and briefing Members of Congress
that it likely was from a lab leak. I mean, it's extraordinary.
Now you have been caught red handed because you thought that
the rest of us would not find out. You thought that the public
would always be kept in the dark.
As it turns out, we now know these emails have become
public, that you were pushing this propaganda effort and yet
claiming the mantle of science. Don't you see that what you
have done has set back the respectability and integrity of
science by generations. You are acting as propagandists. Do you
regret your role in any of this?
Dr. Wolinetz. Senator Hawley, I do not think you have
characterized my role----
Senator Hawley. Do you regret your role, in any of the
misleading of the public? Do you regret your role in your
office saying that a lab leak here is a very destructive
conspiracy? Do you regret your role in helping censor millions
of Americans who were kicked off social media, who were
disciplined at work for saying that maybe a lab was involved,
which we now know the FBI thinks is the fact of the case. Do
you regret it?
Dr. Wolinetz. I do not believe I ever had the role that you
are describing.
Senator Hawley. Do you regret anything that you did during
this period? Do you regret not speaking out? Do you regret not
advising your boss to temper his comments? Do you regret not
opposing the censorship? Do you regret it? You're in a position
of tremendous influence.
Dr. Wolinetz. I do not believe censorship took place Sir.
Senator Hawley. You do not believe censorship took place?
Dr. Wolinetz. I do not.
Senator Hawley. What world are you living in? Tell that to
the scientists who basically lost their credentials, tell that
to the people who were kicked off of social media and banned
because they asked about a lab leak. You do not believe
censorship took place? The privilege is astounding.
You were the chief of staff at the NIH pushing these
conspiracies, pushing the effort to shut down Americans, and
now you have the gall to sit here and say censorship never took
place. It's unbelievable. Unbelievable I can't believe,
Senator. I cannot believe that that's your testimony. Frankly,
I cannot believe you have the gall to sit here and say that.
Thank you, Mr. Chair. Thank you.
The Chairman. Senator Rosen, you are recognized for your
questions.
Dr. Wolinetz. Senator Peters, may I have a chance to expand
on my comments for a moment?
Chairman Peters. If you can be brief, please. We have other
questions.
Dr. Wolinetz. Yes. Thank you. I think I want to make it
very clear that I certainly, and I do believe this is true of
others at NIH as well, including Dr. Collins and Dr. Fauci have
never dismissed that the potential origins of SARS-CoV-2,
leading to the COVID-19 pandemic, are known, that we just do
not have the evidence to be able to make a determination----
Senator Hawley. That's what the paper said it could not
have come from the lab. Your boss said it----
Chairman Peters. Senator, let's just finish your last
thoughts and then we will move on.
Dr. Wolinetz. I would like to go forward with my answer
please. My reading of the proximal origin paper is that it did
not say that it could not have come from a lab. It said that it
was highly implausible that it was engineered and that no
determination could be made as to the absolute origin.
Senator Hawley. And Censorship never happened,
unbelievable.
Chairman Peters. Senator Rosen, you are recognized for your
questions.
OPENING STATEMENT OF SENATOR ROSEN
Senator Rosen. Thank you, Chair Peters. Thank you to the
witnesses for being here today, I appreciate that. I am going
to talk a little bit about university research because Nevada
universities, while they are doing cutting edge biological
research, including work focused on viruses.
Our university scientists are leading the way on everything
from studying how monoclonal antibodies could be used to detect
and treat Ebola, or how to boost the body's own immune system
to kill virally infected cells and many other areas of
critical, critical medical research.
Dr. Parker, as a university researcher, you understand both
the importance of the work that's being conducted in research
labs and the challenges universities face from a security
perspective when dealing with serious viruses.
What recommendations do you have for us here in Congress on
additional technical assistance or grant funding that might be
used for university labs to do this life saving work on
breakthrough research and making sure we are doing it in the
safest way possible?
Dr. Parker. Sure. Thank you for the question. The comments
about the importance of our university research enterprise
across the United States. It absolutely is essential. The vast
majority of the research that is conducted in our universities
and the research that you talked about that may involve working
with hazardous pathogen does not cross into this lane of what I
call the DURC-PEPP, you know the new Dual Use Research Concern
and the pathogens would enhance pandemic potential.
The vast majority does not even get into that lane. But
nonetheless the new policy, though, it gives a lot of
responsibility to our principal investigators and research
institutions, and they have the primary responsibility now to
flag, identify whether their research may cross into that lane.
I am going to go now to implementation of this new DURC-
PEPP policy. They are going to have to have a lot of help. This
does actually put a lot of additional responsibilities, and
those responsibilities will come with accountability. They will
need to have a lot of help from the Federal funding agencies
and departments. They are going to have to have resources.
They are going to have to have congressional help to ensure
that those things happen. But again, I want to emphasize that
the vast majority of our university enterprise does not cross
into that, but we want to make sure they don't.
Senator Rosen. I want to build on that a little bit because
of course, with the advent of artificial intelligence (AI) and
virtual modeling, we may be able to avoid some of these safety
issues or get around them or make things safer because we use
the artificial intelligence, we are able to use the virtual
modeling.
We are able to do multiple iterations and generations of
research just by computing power. Predictive analytics are
going to continue to advance. Technology's going to play a
larger role in this research, and I think it's going to bring
new opportunities. Hopefully it will minimize not all a risk,
you still have to do other things, but possibly minimize those
risks.
Dr. Wolinetz, throughout your career, how has the
integration of technology and integrated into the lab, how has
it changed the work that you have done? What new
vulnerabilities does it open up for you? Maybe instead of
having the actual virus, but now you may have cyber-attacks.
Dr. Wolinetz. Thank you, Senator Rosen. I think you are
asking exactly the right questions that we need to be thinking
about. As science evolves, as technology evolves, it's always
important to think about how that moving landscape alters our
assessment of benefit and risk in real time, as best as we can,
noting that it's evolving technology and we do not always know
where it's going to go.
And so, that I think speaks as to the need for both
flexible policy frameworks to be able to make those risk and
benefit assessments among that moving landscape. But also, the
importance of the fundamental knowledge about viruses that
allow us to move into this space of using maybe alternative
methods like computation in a way that might be safer than
handling actual viruses.
Right now, our computational tools, they are getting
better, but they are not great at predicting phenotype of the
virus from genotype. The more we study viruses, the better
those tools will get. Then we do need to think about the
cybersecurity and information risks.
Senator Rosen. Of course, as you get more information,
artificial intelligence, just like anyone, it gets better by
the input. The more you give it, the better it's going to
learn. But I do think that you talk about balancing risk, I am
going to follow up with you as well.
I am going to go on to Dr. Parker. Again, Dr. Wolinetz, is
that scientific research always carries risk, we know that.
Risk and reward, we hope we cure things, right? Some of that
risk in the actual research is the proper safety protocol,
containment, and control of information, as we discussed with
cybersecurity.
But not pursuing critical research, it also carries a risk
that can be fatal, because that means we are not going to be
prepared for eventuality or potentiality of something
happening. We want to be able to have treatments or
understanding as we move forward against either existing
viruses or future variants.
What do you see as the best way? I will start with Dr.
Parker, and then we will go to Dr. Wolinetz. The best way to
balance being prepared for the next serious viral outbreak,
such as a drug resistant strain of tuberculosis, maybe becoming
airborne or just whatever those needs are to prevent any risk
from happening.
Dr. Parker. Sure. First we have to understand what's
happening, and that means we have to have public health
surveillance, animal health surveillance so we understand what
is in our environment, what may be coming our way. That does
not mean we go to the laboratory and create a novel virus,
though.
Senator Rosen. State is sharing between countries, between
labs, about what you are finding on the field, right?
Dr. Parker. Absolutely. We have to have international
collaboration and there's smart ways to do international
collaboration, and we need to pursue those things.
First is what's in our environment. Then second, we also
have to have the strong research and development platform,
thinking about the vaccine candidates that we need to be
preparing for, and how those would move into advanced
development and manufacturing. We do not have the capability to
do that strong advanced development and manufacturing if bird
flu, in fact were to start infecting humans tomorrow.
Senator Rosen. Think about the supply chain----
Dr. Parker. All the supply chains, everything associated
with that. But all that does not involve, necessarily does not
need us to develop, especially dangerous pandemic capable
viruses in the laboratory to do what I just said. Right.
Senator Rosen. Thank you. Would you like to finish for a
second again?
Dr. Wolinetz. Yes. I will just quickly add that there is a
lot more that we do not know about the world around us than
that we do know. It is important to consider asking those
questions. We would not do the science if we knew the answers.
There is always going to be some measure of
unpredictability in terms of being able to gauge both the
benefit and the risk of any given research project.
Particularly when you are talking about projects involving
pathogens.
However, as we know that fundamental knowledge feeds back
into our risk benefit equation in a way that makes it better as
we go. I strongly support Dr. Parker's earlier recommendation,
that if we invest in applied biosafety and biosecurity research
to really fundamentally understands what methodologies and
procedures can actually improve our safety and security, the
better off we will be in managing those risks.
Senator Rosen. Thank you very much. I yield back.
Chairman Peters. I have heard each of our witnesses use
terms gain-of-function, high risk research, but as I listened
to you, I am not sure we have a shared understanding of what
kind of research we should actually focus on. I want to drill
down a little bit into that. Dr. Wolinetz, can high risk life
science research or gain-of-function research be clearly
defined? If so, how you define it?
Dr. Wolinetz. Thank you for the question, Senator Peters. I
think good definitions are so critical to good policy,
especially when we are talking about statutory definitions,
because if you do not start from that place, there's a danger
of either under regulating and then we are not solving the
problem that we are trying to solve, or overregulating and
potentially stifling innovation.
Risk is an especially problematic term because it
immediately raises the question risk of what? Also risk
relative to what? High risk is an equally problematic term,
because in fact, it's quite common use in science. We talk
about high risk, high reward research in a very positive way.
We talk about high-risk human subjects research, like first in
human trials.
A lot of the debate has really centered around research
that poses immediate and predictable threat to human health.
Understandably, a lot of that has been around pathogens. Is
that the only area that poses potential public health risk? No,
and I think that is a conversation worth having, but it is
really important to define these areas very specifically.
Chairman Peters. Dr. Redfield, if an independent agency
were created to review and approve high risk research, what
specific risk, would you be very specific, risk should this
agency focus on?
Dr. Redfield. I think from my perspective, the risk is an
assessment of the national security implications of the
research. I think that's what I am really looking at. What are
the national security implications of this research? Not
necessarily what the biological benefit is to clinical
medicine, to improve the human condition, which is normally
what we all look at when we do biomedical research.
But I think we need to bring in people that are looking at
this, are there national security implications to this
research? That's really what I am trying to focus on.
Chairman Peters. Very good. Dr. Parker, if an independent
agency aims to reduce the most significant risk to public
health, what kind of research should it oversee?
Dr. Parker. First, I want to agree with my colleagues on
their answers to your questions. It really kind of comes down,
and I really want to emphasize, the national security
components.
In my testimony, I have kind of coined a new term called
the security related biosafety and things that may fall into
that, but I think it's kind of been defined and then new DURC-
PEPP policy. That DURC-PEPP policy really follows the 2023 and
NSABB recommendations and how that may be defined.
But even those definitions and scope have been, I think,
better defined, it still going to come down to expert judgment.
Then expert judgment has got to be non-biased, it's got to have
probing frank discussions about those potential benefits. If
there are real compelling evidence to do such work, are the
risks mitigated? Is it supported by sound ethical decisions.
Thank you.
Chairman Peters. Thank you, Sir. We have heard a lot of
debate about the risk of virus research. Some scientists argue
that the research is essential. Others are arguing nothing good
can come of it. We want to try to get to the bottom of that
debate and Dr. Wolinetz, are there benefits to this type of
high-risk research? If there are benefits, do you have some
examples that the Committee could hear?
Dr. Wolinetz. Thank you for the question. I am so glad you
asked it because I think it's really important to remind
everybody that what we are talking about here, is research
oversight. In some ways the fact that these have benefits is a
given.
We are inherently talking about dual use research here.
Things that have potential benefit and also potential risks.
Oversight is really a matter of assessing the relative benefit
versus the relative risk.
This is importance because if there is literally no
benefit, if we are not able to articulate even a potential
benefit, and we are only talking about research that could be
used for harm, that's a different category of research, that's
biological weapons. I do not think anyone is suggesting that
there is any interest or attempts to create, an offensive
biological weapon.
The right question is really are there benefits relative to
the risk involved in this sort of research? To your earlier
question about what kind of research are we talking about, how
are we defining this in general? We are talking about
experiments in when you are taking a pathogen that we already
fear might have potential pandemic opportunities and modifying
it in a way that increases the transmissibility, increases the
virulence.
One of the most common examples that is used in which there
is the potential for benefit to outweigh the risk, is sometimes
these pathogens if we want to study them in the lab, we need to
create animal models to be able to study them. That often
requires modifying the virus in such a way that allows the
animal model to be a good model of human disease.
When you start manipulating viruses, as we have noted, we
do not always have the ability to predict what those
manipulations will produce. But we need those animal models to
be able to fundamentally understand the virus and also develop
the countermeasures against the virus. That is a sort of
generic example where you might see an assessment of the
benefits outweighing the risk.
Chairman Peters. Dr. Parker, since the pandemic, the public
has certainly raised a lot of questions about this research. I
would argue that without sufficient transparency it's very hard
for the public and Congress to trust that enough due diligence
is actually being done by the agencies before these research
projects are being funded.
My question for you sir, is how could agencies or
researchers be more engaged with the public and other
stakeholders to demystify how these funding decisions are
actually being made?
Dr. Parker. Senator Peters, thanks for the question.
Transparency is just absolutely essential. We have
unfortunately entered into an era where public trust is, many
feel like has been betrayed in some of these research
endeavors. We are going to have to work on double time to try
to increase transparency into the review process.
Sometimes we are not able to get to the specifics because
of Internet Protocol (IP) and et cetera. But we have to first
and foremost get transparency and the process is going to be
effective, it's going to be something that's going to properly
weigh those benefits and risk, and there will be a good
decision that comes out of that, if any of this research does
need to proceed. We are really going to have to open it up.
Then, I look to my own experience as a previous laboratory
commander at U.S. Army Medical Research Institute of Infectious
Diseases (USAMRIID), our high containment laboratories in those
laboratory directors at the community level. I know I did a lot
of work 25 years ago in trying to work with my community and
just talk about the benefits of our research, how we were
trying to do that safely and securely to protect our own
workforce, but also protect the community.
I know there were skeptics and I probably could have done a
better job 25 years ago in that transparency. But I knew my
kids lived in the community, their friends, and our friends. We
had to make sure and talk about that we are going to do it
safely in securely.
It starts at the Federal level, but it actually is more
important at the local level where some of these high
containment labs are and working to build trust in their
communities, which hopefully will spread out beyond just those
local communities, which is absolutely essential that we work
on transparency to rebuild public trust. Thank you.
Chairman Peters. Thank you. Senator Paul, I know you have a
request. I would like to take that before making another
statement.
Senator Paul. Mr. Chair, I ask for unanimous consent (UC)
to enter into the records statements of support for my bill,\1\
Risky Research Review Act from the scientific community and
various stakeholder groups. Thank you.
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\1\ The statements submitted for the Record appears in the Appendix
on page 824.
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Chairman Peters. Without objection, so ordered
I will now turn over the gavel to Ranking Member Paul, who
will chair the end of the meeting and bring us to a close. With
that, Ranking Member Paul, you now have the gavel.
Senator Paul [presiding]. Thank you. Dr. Wolinetz, during
your tenure of working for Francis Collins, he sent an email to
Anthony Fauci, and in the email, he directed Anthony Fauci to
orchestrate a takedown of Dr. Kulldorff and Dr. Bhattacharya.
Were you aware of that email at the time?
Dr. Wolinetz. I don't specifically recall it.
Senator Paul. OK. I want to remind the panel that you all
continue to be under oath, and it is a crime to lie to
Congress. Were you directed by Francis Collin, to participate
in a takedown, malignment, disparagement of either Dr.
Kulldorff or Dr. Bhattacharya?
Dr. Wolinetz. No.
Senator Paul. Did you plant any articles or discuss with
anyone in the media, articles that disparage Dr. Kulldorff or
Dr. Bhattacharya or their positions?
Dr. Wolinetz. No.
Senator Paul. In Dr. Fauci's response to this email, he
responds by saying, don't worry, this is a paraphrase, don't
worry Dr. Collins, I'm on it, I got a story planted in Wired
and I think another lay publication, but he was actively doing
Dr. Collins's bidding. I am surprised that as the chief of
staff, you had no awareness that there was a policy of taking
down these scientists.
Dr. Parker, you have had long, distinguished career. Have
you ever directed any of your employees to take down fellow
scientists who you disagreed with?
Dr. Parker. No.
Senator Paul. Dr. Redfield, you have had a long and
distinguished career. Have you ever directed any of your
employees to take down scientists you had a disagreement with?
Dr. Redfield. No.
Senator Paul. Dr. Esvelt, same question?
Dr. Esvelt. No.
Senator Paul. Dr. Wolinetz, did you attend the gain-of-
function dual use research of concern meetings during your
tenure in government?
Dr. Wolinetz. Yes.
Senator Paul. Were you considered to be a member?
Dr. Wolinetz. A member of what specifically Senator?
Senator Paul. I don't know. Is there a group called that?
Is it a meeting? Who gets to go?
Dr. Wolinetz. I participated in many groups inside
governments in which biosecurity management of research----
Senator Paul. This is a very specific meeting though, it's
called in this email, weekly dual use research of concern, gain
of function meeting. Did you attend those routinely?
Dr. Wolinetz. I don't recall a meeting called that.
Although it's quite possible I was involved. That name doesn't
ring a bell.
Senator Paul. This would be a meeting to discuss things
that might be gain-of-function. Did you attend those meetings?
Dr. Wolinetz. Not if they were meetings at the level of an
individual NIH institute to review research. I was not at all
involved in that process.
Senator Paul. This is an email. It's from Theresa, I do not
know how you pronounce it, Hauguel. Let's see, an Irene
Lewinski, Dennis Dixon, Linda Lambert, David Spiro. Are you
familiar with those names?
Dr. Wolinetz. I believe those are all employees of National
Institute of Allergy and Infectious Diseases (NIAID).
Senator Paul. OK. You think this meeting may have occurred
within NIAID and you might not have participated in it?
Dr. Wolinetz. Yes, that's correct.
Senator Paul. OK. Are you surprised that when I ask for the
debate over what is and what is not, because there's a debate
over what is the definition of gain-of-function, that the NIH
still refuses to give me minutes of these meetings or any of
the discussion concerning what is gain-of-function and what is
not gain-of-function?
Dr. Wolinetz. I cannot speak to NIH's decision.
Senator Paul. Do you think that's an appropriate policy for
the NIH to refuse to give Members of Congress the debate over
whether something is or is not gain-of-function?
Dr. Wolinetz. My general philosophy at NIH was to always be
as cooperative with Members of Congress as humanly possible.
Senator Paul. Your boss, not so much. He was for that when
he was not busy taking down fellow scientific colleagues. Dr.
Parker, do you think it's appropriate for the NIH to refuse to
give Congress the minutes or deliberations over what is or what
is not gain-of-function, particularly concerning research that
was done in Wuhan?
Dr. Parker. Inappropriate.
Senator Paul. Dr. Redfield, do you think the NIH should
release, do you think it's inappropriate that they won't
release and should they release the information concerning the
deliberations over gain of function?
Dr. Parker. Yes, I think it's inappropriate that they do
not share that information.
Senator Paul. Dr. Esvelt, do you think it's inappropriate
that the NIH continues to refuse to reveal information
considering the deliberations over gain-of-function?
Dr. Esvelt. I think transparency is essential to public
trust in science, and I think NIH has a duty to uphold public
trust in science in so far as possible.
Senator Paul. The public needs to realize that I only know
of this meeting existing because of a Freedom of Information
Act (FOIA). The Senate, groups of Senators, the ranking member
of a committee, they will not reveal they even have the
meeting, much less the minutes of the meeting. I can get more
information from the Central Intelligence Agency (CIA) than the
NIH.
Dr. Redfield, do you think that damages science when the
scientists are acting like the CIA and not revealing
information, does it damage our trust in science?
Dr. Redfield. I think it's going to be very hard for public
trust to be regained, NIH, CDC, FDA from what we experienced in
the Covid Pandemic.
Senator Paul. Dr. Redfield, do you think, we talked a
little bit about this before, but taking the backbone of a SARS
virus and adding various S proteins from other unknown viruses
to see what you get, running that through serial passage,
should that have gone before some sort of gain-of-function
review even if it is to figure out whether it meets a
definition of dangerous research?
Dr. Redfield. Yes.
Senator Paul. One of Anthony Fauci responses has been,
well, there are two animal viruses, and we do not know that
they will infect humans, but by the time you combine them, the
test they do is they actually test them to see if they infect
human cells after they are done manipulating them.
Their goal really is to see, hey, guys, do you think we can
make it more infectious? Yet they say, and they hide behind
definitions of, well, we did not know in advance. This becomes
the problem.
I come from a scientific background. I am aware of CRISPR
technology, not enough to do it, but aware of the great
benefits of science. I am aware of creating bacteria that makes
insulin. I'm not against any of those kinds of things, but I do
want scientists like yourselves to be on some sort of committee
to overlook this.
But I get the feeling that over and over again, this has
been hidden and been in-house. There was actually and I'm
trying to remember if it's the same board that you led, Dr.
Parker, but it's the--remind me of the acronym for the board.
Dr. Parker. Board NSABB.
Senator Paul. And you are still head of it?
Dr. Parker. I am still a member of the committee, but any
of my comments today are not reflective, they're my own----
Senator Paul. OK. I won't put you on the spot on this, but
there's a story from like four, eight, ten years ago of like a
whole bunch of people being fired by Dr. Fauci because they
disagreed with his opinion on gain-of-function.
It's just another indication that we cannot have this all
within house, and it's like, oh, no big deal. There really has
to be some independent people outside of government to look at
that. That's what I emphasize over and over is that we have to
get to some sort of independent board here.
Dr. Wolinetz, you were a member of the P3CO committee,
correct?
Dr. Wolinetz. That's correct.
Senator Paul. Who were the other members?
Dr. Wolinetz. I don't recall all of them off the top of my
head. There were about a dozen. I know there were
representatives from Asper, from the Communications Bill Hall
at the Department of Health and Human Services (HHS). It's been
a while.
Senator Paul. Are you aware that they were also refusing to
give us the names? I think the names have been published by the
COVID committee. They have been refusing to give the names of
the people on the COVID committee.
Dr. Wolinetz. As a previous member of the committee, I have
no objection to the names being released----
Senator Paul. But you can see the problem, so you set up an
oversight committee, but the oversight committee never saw the
Wuhan research. Should the Wuhan research taking a SARS
backbone and putting a new S protein on it, running it through
human cells to see if it infects, then it turns out it did.
Then we say, oh, it's only a thousand times more and we will
give you more leeway to do it, et cetera, et cetera, all the
stuff that happened with EcoHealth. In retrospect, should that
have gone before the P3CO committee?
Dr. Wolinetz. Senator Paul, I think one of the things I
have learned in engaging this, particularly as a non-virologist
myself, although I'm a scientist, I do not know that much about
virology, is that it's really important to have expertise to be
able to evaluate that that benefit and risk and talk about
whether or not it meets the scopes of, of these policies.
However, I do agree that, and I am glad we are discussing
whether or not there is an opportunity to do this better, to
introduce independence earlier in the process
Senator Paul. That's a general answer, and that's fine. But
very specifically, should the research, putting a new S
protein, a random S protein from a random unknown virus on a
SARS backbone, creating an infectious chimera, and then
deciding or looking to see if it infects human cells more,
should that have gone before the P3CO committee? Yes, or no?
Dr. Wolinetz. I do not know enough about the research to be
able to make that--that was why I was not part of the Project
process.
Senator Paul. That's really disappointing. I mean, would
exclude me from considering you for any board, frankly, if you
can't admit. Because you are still in your mind thinking, oh, I
do not want to criticize Francis Collins, or I do not want to
criticize Anthony Fauci because this is your group, you know?
But in retrospect, 15 million people died.
The Department of Energy have concluded it came from the
lab. Has the FBI, so did the CIA until higher ups at the CIA
told them to change their opinion. But the group of scientists
at the CIA, according to a whistleblower, voted six to one.
Look at what we are faced with, and your people wonder
about vaccine hesitancy or hesitancy of science. If you look at
the information, for example, one of the strongest
circumstantial pieces of evidence that they may have done this
in the lab and that the furin cleavage site may have been
added, is the fact that in 2018, Dr. Shi and Dr. Baric
presented something called the DEFUSE proposal. Are you aware
of the DEFUSE proposal?
Dr. Wolinetz. I have read about it in the news, but I was
not aware of it.
Senator Paul. Contemporaneously you were not aware of it?
Dr. Wolinetz. No, I never heard that.
Senator Paul. Here's the thing. Do you know how I am aware
of it? The NIH did not tell me, the HHS did not tell me, no one
in government told me. A colonel in the Marines who worked for
Defense Advanced Research Projects Agency (DARPA) told me,
under the protection of the whistleblower statute. In our
government, we are concerned that Chinese lied to us and that
they are distrustful, which is probably true.
But in our government, you may not have liked the tone of
the other senators, but this is what we are faced with. The
DEFUSE proposal was never told to us. In the DEFUSE proposal,
it was a proposal to take a coronavirus, put a furin cleavage
site in it, and test it to see if it was more infectious in
humans.
What did COVID-19 turn out to be? A very unusual, if not
the first SARS-CoV virus, in a family of viruses to have a
furin cleavage site. It's why alarm bells went off in all of
Anthony Fauci cronies that were all saying it came from the
lab. It looks like it was an engineered until they were
convinced somehow within days to write the proximal origins
paper saying it wasn't and calling everybody crazy and a
conspiracy theorist, and calling Facebook and everybody else
and saying, take down, do not give any credence to these
people.
You see what has happened to science? Francis Collins, your
boss at one point says it's about damage to science. If anybody
mentions that this might have come from a lab, it will damage
science. Other people were saying it will damage our relations
with China. The truth was not so important, it was the business
of science, the billions of dollars changing hand. I mean, this
whole cabal has created such damage to science in this, and it
continues to this day.
They will not give me the deliberations. We are not talking
about secrets, we are not talking about informants, we are not
talking about spies. I'm talking about scientists in my own
government, will not give me the deliberations on whether or
not the research in Wuhan was.
You still to this day won't admit it, even though the
Department of Energy, FBI, and maybe as much as half of the
scientific community are convinced it came from the lab, even
some might say it's five percent chance it came from the lab.
Yet you won't admit that it's dangerous research. To this day
you will still sit there and say you are unable to judge
whether the research going on in Wuhan was dangerous.
Dr. Wolinetz. Senator Paul, I will say that the origin of
the COVID-19 pandemic is unknown. When I was in the government,
I had a high level of clearance and received the intelligence
briefings to which you are referring. My general conclusion is
that there was a lack of consensus among analysts across the
Federal Government. It was not as cut and dried as you are
making it sound.
I cannot speak to the innermost thoughts of anyone at NIH,
but I will say in my personal experience, I never knew any of
the scientists at NIH to be anything but open-minded because
they thought that the information was power in being able to
develop the diagnostics, treatments, and countermeasures, as
well as future policies to help both address the COVID-19
pandemic and respond to future pandemics.
Senator Paul. Dr Wolinetz, have you visited the Rocky
Mountain Lab?
Dr. Wolinetz. No, I have never been there.
Senator Paul. Were you aware that the proposal to do the
DEFUSE project involved laboratory work that was to be done
through the Rocky Mountain Lab?
Dr. Wolinetz. No, as I said, I was not aware of the DEFUSE
proposal.
Senator Paul. OK. Senator Marshall.
Senator Marshall. Thank you, Senator Paul. Dr. Wolinetz,
you said earlier you were part of the P3CO review team. Who
decided that EcoHealth project should not go to the P3CO team?
Dr. Wolinetz. Decisions about whether or not proposals met
the scope of the P3CO policy and were referred to HHS were done
at the cognizant funding level, so in that case, it would have
been NIAID.
Senator Marshall. Dr. Fauci would have had direct control
of whether that project, that study should have went to
EcoHealth.
Dr. Wolinetz. It was more likely done at the staff level,
but yes.
Senator Marshall. Would you agree with me that once
research goes to China with American dollars, that NIH has zero
control over the safety of that research?
Dr. Wolinetz. No, I would not agree with that. I think it
is really important to make sure that we put the proper terms
and conditions in place on any Federal award particularly to a
foreign entity and all of the processes that meet those,
whether it's the ability to inspect or require records.
Senator Marshall. If you have faith in what's on our
American dollars research in China, what is the NIH process for
tracking research in China? And recall, regarding the
transparency that Eco Health did not report its subcontract to
the public record database as well.
You sitting here, you are telling me you have faith that
the NIH is appropriately supervising, making sure that the
research done there is safe.
Dr. Wolinetz. I think that if there is any evidence, as I
believe there has been in the case of this particular lab, that
they are not following procedures, there should be corrective
action up to and including debarment for an institution, if
there's any evidence that they are not following the terms and
conditions of their----
Senator Marshall. Did the NIH have any responsibility in
ensuring they were following safety procedures, even doing the
right research in the right biosecurity level lab?
Dr. Wolinetz. Yes, absolutely. I think this is a ripe area
for the committee to think about strengthening the biosafety
system. Right now, our biosafety system, very much depends on
guidelines and professional judgments.
I think there is more we can do in terms of adopting
standards and norms that provide systems of accountability so
that we can be assured that the highest levels and practices in
biosafety are happening.
Senator Marshall. In light of Ecohealth research project
concealments, including late reports and misrepresentations,
and NIH being surprised that Boston University conducted gain-
of-function research with monkey Pox virus fairly recently, has
NIH undertaken a full review of its research to identify gain-
of-function projects. If not, why not?
Dr. Wolinetz. I cannot speak for NIH, sir. I have not
worked there for more than a year.
Senator Marshall. Were you aware of any type of improvement
for review of these research projects then before your
departure?
Dr. Wolinetz. Could you be more specific? I was not aware
of a sort of overarching review of projects.
Senator Marshall. Was this monkeypox virus before or after
you left? I do not recall.
Dr. Wolinetz. I do not recall hearing about it before I
left. I am guessing the concerns were raised after.
Senator Marshall. Are you aware of any training that the
NIH does, requires its researchers and grant recipients about
the Bio Weapons Convention Act and China's refusal to certify
that they do not operate an active bio weapons program?
Dr. Wolinetz. No, I have actually long been a proponent for
including biomanufacturing workforce training center (BWTC)
training and biosecurity and biosafety awareness training for
scientists in general. I think that we should have the
resources and tools to be able to do that
Senator Marshall. Between January 1, 2020 and the
publication of the proximal Origins articles, were you aware of
Dr. Collins having any direct communications with the authors
of that article, either through email or through phone call?
Dr. Wolinetz. Yes. I was aware those discussions were
underway. I was not directly involved in any of them.
Senator Marshall. Would you describe his conversations with
them? Was it one or two? Were there many conversations? Was it
mostly on the phone? Was it part of conference calls were
minutes kept?
Dr. Wolinetz. I do not recall the number of those meetings,
sir. I do not believe that there were minutes kept because my
impression was these were informal conversations between
scientists, not part of a formal committee process.
Senator Marshall. Is that standard government procedure
that they should be informal?
Dr. Wolinetz. Conversations between scientists about
science are frequent at research agencies across the Federal
Government. Depending on the context, are often informal
discussions. For example, program officers talk with scientists
that they work with on a pretty regular basis about the
progress for science, future science ideas, and those
conversations are informal.
Senator Marshall. From January 1, 2020 and over the first
three or four months of this pandemic, was there any type of
national security officers, people from the National Security
programs in advising Dr. Fauci and Dr. Collins
Dr. Wolinetz. As I recall, sir, in general, when there's an
outbreak of an infectious disease, the National Security
Council has the lead and runs point on the interagency process.
Senator Marshall. I understand that process, were they in
there communicating with your people or personnel?
Dr. Wolinetz. Oh, yes. Yes, certainly. I think at many
levels people across NIH were participating in those
interagency policy conversations.
Senator Paul. We are going to conclude very quickly. I just
wanted to put into evidence for the Committee hearing today.
This is an email from June 17, 2016. It's from the weekly dual
use research of concern, gain-of-function meeting, it sounds
like all within NIAID. The discussion was, Daszak/RO1/MERS/
Eric, is the description.\1\
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\1\ The information submitted by Senator Paul appears in the
Appendix on page 817.
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We were also through Freedom of Information, nothing's been
volunteered to us, but this is what we got as far as the
deliberations. It's insulting, not only to us, but really, we
represent the people of the country. And look, 15 million
people died. The NIH won't give us the information on how the
decision was made, that that was fine research to do.
This is incredibly galling. I hope this hearing is a way of
bringing at least some of us together, that there has to be
something done. I think there has been a consensus that there
ought to be an independent board. We are very open. There is
nothing set in stone.
We put forward together the ideas in the bill. Almost every
idea in the bill is from scientists. We are more than happy to
hear more scientists. I want to get a result, I want an
independent commission, I think it needs to be outside of NIH,
and I think there's a possibility. So, any scientist here, or
any scientist listening, we are very open to it.
We do not want to exclude good research. This could be as
many as 20 projects, could be a hundred projects. I do not know
how many it is a year out of the tens of thousands of projects.
But there ought to be a discussion whether or not, putting an S
protein from a coronavirus on a SARS backbone is dangerous or
not. We ought to be able to come to an agreement. I think
rational minds could.
The hearing record will remain open for 15 days until July
26th at 5 p.m. for the submission of statements and questions
for the record.
[The information referred to follows:]
The hearing is adjourned. Thank you very much.
[Whereupon, at 12:25 p.m., the hearing was adjourned.]
A P P E N D I X
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