EXHIBIT
24
FRANK
PALLONE, JR., NEW JERSEY
CHAIRMAN
CATHY
McMORRIS RODGERS, WASHINGTON
RANKING
MEMBER
ONE
HUNDRED SEVENTEENTH CONGRESS
Congress
of the United States
House
of Representatives
COMMITTEE
ON ENERGY AND COMMERCE
2125
RAYBURN HOUSE OFFICE BUILDING
WASHINGTON,
DC 20515-6115
Majority
(202) 225-2927
Minority
(202) 225-3641
March
18, 2021
The
Honorable Francis Collins, M.D., Ph.D. Director
National
Institutes of Health
9000
Rockville Pike
Bethesda,
MD 20892
Dear
Dr. Collins,
We
write to request information, assistance, and needed-leadership from the
National Institutes of Health (NIH) to advance an independent, scientific
investigation into the origins of the COVID-19 pandemic.
The
COVID-19 pandemic has been the worst public health crisis in the U.S. in about
a hundred years. Over a year has passed since the deadly virus reached our
shores and yet, the origin of the virus has yet to be determined. An
independent, expert investigation of the origin of COVID-19 is of paramount
importance to public health and biosecurity. As noted by Stanford Medical
School Professor David Relman:
A
more complete understanding of the origins of COVID-19 clearly serves the
interests of every person in every country on this planet. It will limit
further recriminations and diminish the likelihood of conflict; it will lead to
more effective responses to this pandemic, as well as efforts to anticipate and
prevent the next one. It will also advance our discussions about risky science.
And it will do something else: Delineating COVID-19’s origin story will help
elucidate the nature of our very precarious coexistence within the biosphere.1
Recently,
the World Health Organization (WHO) attempted to investigate the origin of
COVID-19. The WHO said that this investigative mission would be guided by the
science, be
1 David A. Relman, Opinion: To stop the next
pandemic, we need to unravel the origins of COVID-19, PNAS (Nov. 2020),
available at https://www.pnas.org/content/117/47/29246
“open-minded,”
and “not exclude[e] any hypothesis.”2 Unfortunately, China did not provide
complete access or independence for the critical WHO mission. On February 13,
2021, National Security Advisor Jake Sullivan issued the following statement:
We
have deep concerns about the way in which the early findings of the COVID-19
investigation were communicated and questions about the process used to reach
them. It is imperative that this report be independent, with expert findings
free from intervention or alteration by the Chinese government. To better
understand this pandemic and prepare for the next one, China must make
available its data from the earliest days of the outbreak.3
Because
of rising tensions between the U.S. and China, the WHO scrapped plans for an
interim report.4 An international group of science experts, including
specialists in virology, microbiology, and zoology, asked for a new review.5
The
NIH, as a premier scientific institution, must lead in order to foster a
transparent, independent, and science-based investigation into the origin of
the COVID-19 pandemic. Such an effort must meet the WHO’s stated goals of an
open-minded investigation that does not exclude any plausible hypothesis.6 In
addition, the NIH is well-positioned to gather and provide information through
oversight of its grants and other federal awards. Thus, the NIH is in a unique
position to investigate the possibility that the pandemic stemmed from a
laboratory accident or leak, especially regarding the Wuhan Institute of
Virology (WIV).
NIH
raised concerns over a possible link between WIV and the COVID-19 outbreak
during its review of federal awards to EcoHealth Alliance, a global
environmental health nonprofit organization dedicated to protecting wildlife
and public health from the emergence of disease. Of the $13.7 million in
federal awards that NIH authorized for EcoHealth Alliance, 17
2 Smriti Mallapaty, Where did COVID come from? WHO
investigation begins but faces challenges, NATURE (Nov. 11, 2020), available at
https://www.nature.com/articles/d41586-020-03165-9
3 The White House, Statement of National Security
Advisor Jake Sullivan (Feb. 13, 2021), available at
https://www.whitehouse.gov/briefing-room/statements-releases/2021/02/13/statement-by-national-security-advisor-jake-sullivan/
4 Betsy McKay, Drew Hinshaw and Jeremy Page, WHO
Investigators to Scrap Plans for Interim Report on Probe of Covid-19 Origins,
THE WALL STREET JOURNAL (Mar. 4, 2021), available at
https://www.wsj.com/articles/who-investigators-to-scrap-interim-report-on-probe-of-covid-19-origins-11614865067?mod=latest_headlines
5 Jaime Metzl, et al, Call for a Full and
Unrestricted International Forensic Investigation into the Origins of COVID-19
(March 4, 2021), available at
https://s.wsj.net/public/resources/documents/COVID%20OPEN%20LETTER%20FINAL%20030421%20(1).pdf
The co-organizer of the letter and a WHO advisor on human genome editing, Jaime Metzl, PhD, said there is an eighty-five percent chance the pandemic started with an accidental leak from the WIV or Wuhan CDC laboratory, available at https://jamiemetzl.com/origins-of-sars-cov-2/
(“I
have no definitive way of proving this thesis but the evidence is, in my view,
extremely convincing. If forced to place odds on the confidence of my
hypothesis, I would say there’s an 85% chance the pandemic started with an
accidental leak from the Wuhan Institute of Virology or Wuhan CDC and a 15%
chance it began in some other way (in fairness, here is an article making the
case for a zoonotic jump “in the wild”). If China keeps preventing a full and
unrestricted international forensic investigation into the origins of the
pandemic, I believe it is fair to deny Beijing the benefit of the doubt.”)
6 Washington Post Editorial Board, We’re still
missing the origin story of this pandemic. China is sitting on the answers, THE
WASHINGTON POST (Feb. 5, 2021), available at
https://www.washingtonpost.com/opinions/2021/02/05/coronavirus-origins-mystery-china/?arc404=true
projects
sponsored by the National Institute of Allergy and Infectious Disease (NIAID)
have provided over $7.9 million in federal awards for research of viral
emergence from bats in Southeast Asia.7
EcoHealth
Alliance passed some of its funding to the WIV, and in 2020, NIH made efforts
to obtain information from EcoHealth Alliance about WIV related to concerns
about the origins of COVID-19. In April 2020, NIH wrote to EcoHealth Alliance
and Columbia University about an NIH-funded project entitled, “Understanding
the Risk of Bat Coronavirus Emergency:”
It
is our understanding that one of the sub-recipients of the grant funds is the
Wuhan Institute of Virology (‘WIV’). It is our understanding that WIV studies
the interaction between corona viruses and bats. The scientific community
believes that the coronavirus causing COVID-19 jumped from bats to humans
likely in Wuhan where the COVID-19 pandemic began. There are now allegations
that the current crisis was precipitated by the release from WIV of the
coronavirus responsible for COVID-19. Given these concerns, we are pursuing
suspension of WIV from participation in Federal programs. It is in the public
interest that NIH ensure that a sub-recipient has taken all appropriate
precautions to prevent the release of pathogens that it is studying. This
suspension of the sub-recipient does not affect the remainder of your grant
assuming that no grant funds are provided to WIV following receipt of this
email during the period of suspension.8
In
January 2021, the U.S. Department of State issued a fact sheet about the
activity at the WIV.9
Among
other revelations, it reported the following:
• The U.S. government has reason to
believe that several researchers inside the WIV became sick in autumn 2019,
before the first identified case of the outbreak, with symptoms consistent with
both COVID-19 and common seasonal illnesses. This raises questions about the
credibility of WIV senior researcher Shi Zhengli’s public claim that there was “zero
infection” among the WIV’s staff and students of SARS-CoV-2 or SARS-related
viruses.10
• Starting in at least 2016, WIV
researchers conducted experiments involving RaTG13, the bat coronavirus
identified by the WIV in January 2020 as the closest sample to SARS-CoV-2 (96.2
percent similar).11
There
was no indication that this research was suspended at any time prior to the
COVID-19 outbreak.
• The WIV has a published record of
conducting “gain-of-function” research to engineer chimeric viruses.12
But
the WIV has not been transparent or consistent about its record of
7 NIH RePORTER, Research Portfolio Online Reporting
Tools (queried Mar. 4, 2021), available at
https://reporter.nih.gov/search/qlYUeI9DIk2JfWUdCcWxcA/projects/charts
8 Mark Moore, NIH investigating Wuhan lab at center of coronavirus pandemic, NEW YORK POST (Apr. 28, 2020), available at https://nypost.com/2020/04/28/nih-investigating-wuhan-lab-at-center-of-coronavirus-pandemic/
9 U.S. Department of State, Fact Sheet: Activity at
the Wuhan Institute of Virology, Office of the Spokesperson (Jan. 15, 2021),
available at
https://2017-2021.state.gov/fact-sheet-activity-at-the-wuhan-institute-of-virology//index.html
10 Id.
11 Id.
12 Id.
studying
viruses similar to the COVID-19 virus, including “RaTG13,” which was sampled
from a cave in Yunnan Province in 2013 after several miners died of SARS-like
illness.13
• WHO investigators must have access to
the records of the WIV’s work on bat and other coronaviruses before the
COVID-19 outbreak. As part of a thorough inquiry, they must have a full
accounting of why the WIV altered and then removed online records of its work
with RaTG13 and other viruses.14
• Despite the WIV presenting itself as
a civilian institution, the U.S. has determined that the WIV has collaborated
on projects with China’s military.15
The
WIV has engaged in classified research, including laboratory animal
experiments, on behalf of the Chinese military since at least 2017.16
• The U.S. and other donors who funded
or collaborated on civilian research at the WIV have a right and obligation to
determine whether any of our research funding was diverted to secret Chinese
military projects at the WIV.17
Notably,
the State Department’s former lead investigator who oversaw the Task Force into
the COVID-19 virus origin stated recently that he not only believes the virus
escaped from the WIV, but that it may have been the result of research that the
Chinese military, or People’s Liberation Army, was doing on a bioweapon.18
Accordingly,
it is imperative to determine not only where SARS-CoV-2 originated, but also
how and if NIH’s funding and research to projects at the WIV could have
contributed to SARS CoV-2. To assist our requests and inquiry, please provide
the following by April 19, 2021:
1. An assessment from a classified U.S.
Defense Intelligence Agency (DIA) report included the possibility that the
origins of SARS CoV-2 could have emerged accidentally from a laboratory in
Wuhan, China due to unsafe laboratory practices.19 The DIA report cited U.S.
government and Chinese researchers who found “about 33 percent of the original
41 identified cases did not have direct exposure” to the market.20
That,
along with what is known of the WIV’s work in past few years, raised reasonable
suspicion that the
13 Id.
14 Id.
15 Id.
16 Id.
17 Id.
18 Jennifer Griffin, Former top State Dept.
investigator says COVID-19 outbreak may have resulted from bioweapons research
accident, Fox News (March 13, 2021), available at
https://www.foxnews.com/world/top-state-official-coronavirus-bioweapon-accident
19 Fred Guterl, Naveed Jamali and Tom O’Connor, The
Controversial Experiments ad Wuhan Lab Suspected of Starting the Coronavirus
Pandemic, NEWSWEEK (Apr. 27, 2020), available at
https://www.newsweek.com/controversial-wuhan-lab-experiments-that-may-have-started-coronavirus-pandemic-1500503
20 Id.
pandemic
may have been caused by a lab error, not a wet market.21
Further,
a WHO inspector on the recent mission noted that “we know not all of those
first 174 early COVID-19 cases visited the market, including the man diagnosed
in December 2019 with the earliest onset date”.22
What
information does the NIH have on the earliest COVID-19 cases?
2. According to an editorial on February
23, 2021, in The Wall Street Journal by former Secretary of State Mike Pompeo
and Miles Yu, “[China’s] army of scientists claim to have discovered almost
2,000 new viruses in a little over a decade”.23
How
many of these discovered viruses does the NIH have information on and were any
of these viruses discovered at the WIV?
3. According to The Wall Street Journal
editorial mentioned in the previous question, some have alleged that the WIV’s
virus-carrying animals were sold as pets and may even show up at local wet
markets.24
Is
the NIH aware of these allegations? If so, please provide any information the
NIH has related to these allegations.
4. Please provide all information that NIH
has about laboratory accidents and/or biosafety practices at the WIV since
January 1, 2015.
5. Please provide all information that NIH
has from NIH staff, grantees, sub-grantees, contractors, or subcontractors
about communications and events at the WIV from August 2019 to the present.
6. Please provide all information that NIH
has from NIH staff, grantees, sub-grantees, contractors, or subcontractors
about their communications with China-based NIH, Chinese National Science
Foundation, CDC, and China CDC about events at the WIV from August 2019 to the
present.
State
Department Cables
21 Id.
22 Dominic Dwyer, I was the Australian doctor on the WHO’s COVID-19 mission to China. Here’s what we found about the origins of the coronavirus, THE CONVERSATION (Feb. 21, 2021), available at https://www.theguardian.com/commentisfree/2021/feb/22/i-was-on-the-whos-covid-mission-to-china-heres-what-we-found
See also Jeremy Page and Drew Hinshaw, China Refuses to Give WHO Raw Data on
Early Covid-19 Cases, THE WALL STREET JOURNAL (Feb. 12, 2021), available at
https://www.wsj.com/articles/china-refuses-to-give-who-raw-data-on-early-covid-19-cases-11613150580#:~:text=BEIJING%E2%80%94Chinese%20authorities%20refused%20to,over%20the%20lack%20of%20detail
(“Chinese authorities refused to provide World
Health Organization investigators with raw, personalized data on early Covid-19
cases that could help them determine how and when the coronavirus first began
to spread in China, according to WHO investigators who described heated
exchanges over the lack of detail. The Chinese authorities turned down requests
to provide such data on 174 cases of Covid-19 that they have identified from
the early phase of the outbreak in the Chinese city of Wuhan in December 2019.
Investigators are part of a WHO team that this week completed a monthlong
mission in China aimed at determining the origins of the pandemic”.)
23 Id.
24 Mike Pompeo and Miles Yu, NIH Presses U.S.
Nonprofit for Information on Wuhan Virology Lab, THE WALL STREET JOURNAL (Feb.
23, 2021), available at
https://www.wsj.com/articles/chinas-reckless-labs-put-the-world-at-risk-11614102828
7. What information does NIH have about
the WIV’s responses to the 2018 U.S. Department of State cables (attached to
this letter) regarding safety concerns?
8. The April 2018 cable from the U.S.
Department of State stated that the WIV planned to invite University of Texas
Medical Branch Galveston (UTMBG) researchers to do research in Wuhan’s labs.
Please provide any information NIH received that indicates whether the WIV
invited UTMBG researchers, and whether UTMBG researchers conducted any research
in Wuhan’s labs.
a. If there was such research, please
provide information and any documents related to this research.
9. Why was it pertinent to the NIH
investigation that the “nonprofit [EcoHealth Alliance] must provide the “WIV’s
responses to the 2018 Department of State cables regarding safety concerns”?25
a. Did EcoHealth Alliance provide this
information? If so, how did NIH use the information to further its
investigation?
EcoHealth
Alliance, Columbia University Health Sciences
10. Was the 2019 NIH federal award to
EcoHealth Alliance reviewed and approved by the HHS Potential Pandemic Pathogen
Care and Oversight (P3CO) committee?26
a. If so, please provide the documentation
with the committee’s decision.
b. Please also provide the names of the
individuals who were members of the committee at the time.
11. Please provide all correspondence and
communications between NIH and EcoHealth Alliance, since January 1, 2020,
related to federal funding involving the WIV. The documentation should include,
but not be limited to, correspondence between NIH and EcoHealth Alliance dated
sometime in April 2020, on July 8, 2020, and sometime in August 2020.
12. In April 2020, NIH suspended a 2019
federal award to EcoHealth Alliance, in part, because NIH did not believe the
work aligned with “program goals and agency priorities”.27
Please
specify the work that was done by the EcoHealth Alliance that did
25 Meredith Wadman, NIH imposes ‘outrageous’
conditions on resuming coronavirus grant targeted by Trump, SCIENCEMAG (Aug.
19, 2020), available at
https://www.sciencemag.org/news/2020/08/nih-imposes-outrageous-conditions-resuming-coronavirus-grant-targeted-trump
26 National Institutes of Health, Notice Announcing
the Removal of the Funding Pause for Gain-of-Function Research Project (Dec.
19, 2017), available at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-071.html
27 Id.
not
align with the agency’s program goals and priorities, and when that work was
conducted.
a. Was an evaluation of EcoHealth Alliance’s
work and whether it aligned with the agency’s program goals and priorities
conducted by the NIH before the award was issued? If yes, please provide any
related documentation. If not, why not?
13. In April 2020 correspondence with
EcoHealth Alliance, NIH wrote that it “received reports that the Wuhan
Institute of Virology…has been conducting research at its facilities in China
that pose serious bio-safety concerns.”28
What
are the sources for those reports to NIH and what were the specific allegations
reported?
14. Why did the NIH request that EcoHealth
Alliance provide a sample of the pandemic coronavirus that the WIV used to
determine its genetic sequence for SARS CoV-2?29
a. Why is this information important to
NIH’s investigation?
b. Has NIH obtained the sample and if so,
what evaluations have been done, and for what purpose?
c. If NIH has not yet obtained the sample,
what are the planned studies and evaluations NIH will conduct with the sample
when it is obtained?
15. What is the nature of NIH’s concerns
about purported restrictions at the WIV including “diminished cell-phone
traffic in October 2019, and the evidence that there may have been roadblocks
surrounding the facility from October 14-19, 2019[,]” about the WIV lab or
virus origin?30
a. What is the basis of information to NIH
about the purported restrictions at the WIV?
b. What are the other purported
restrictions at the WIV in October 2019?
16. After terminating EcoHealth Alliance’s
2019 project entitled “Understanding the Risk of Bat Coronavirus Emergence,”
the NIH later offered to reinstate the EcoHealth Alliance funding in July 2020
if EcoHealth Alliance agreed to meet certain conditions.31
28 Betsy McKay, NIH Presses U.S. Nonprofit for
Information on Wuhan Virology Lab, THE WALL STREET JOURNAL (Aug. 19. 2020),
available at
https://www.wsj.com/articles/nih-presses-u-s-nonprofit-for-information-on-wuhan-virology-lab-11597829400
29 Meredith Wadman, NIH imposes ‘outrageous’
conditions on resuming coronavirus grant targeted by Trump, SCIENCEMAG (Aug.
19, 2020), available at
https://www.sciencemag.org/news/2020/08/nih-imposes-outrageous-conditions-resuming-coronavirus-grant-targeted-trump
30 Id.
31 Betsy McKay, NIH Presses U.S. Nonprofit for
Information on Wuhan Virology Lab, THE WALL STREET JOURNAL (Aug. 19. 2020),
available at
https://www.wsj.com/articles/nih-presses-u-s-nonprofit-for-information-on-wuhan-virology-lab-11597829400
a. Please provide all of the information
presented to NIH from EcoHealth Alliance in response to NIH’s conditions for
reinstatement.
b. What actions did NIH take based upon
the information received? How has the information been used in NIH’s
investigation?
c. One condition for the federal award
reinstatement was for EcoHealth Alliance to arrange for an outside inspection
of the WIV and its records, “with specific attention to addressing the question
of whether WIV staff had SARS-CoV-2 [in] their possession prior to December 2019.”32
Why
is it pertinent to the NIH’s investigation if staff at WIV had SARS-CoV-2 in
their possession prior to December 2019? What is the potential significance if
the staff did have the virus in their possession prior to December 2019?
d. What information does NIH have that was
used for the basis of requesting that the EcoHealth Alliance “must ‘explain the
apparent disappearance’ of a scientist who worked in the Wuhan lab,” and on
social media was rumored to be “patient zero” of the pandemic?33
i. What is the potential significance
about the whereabouts of this scientist and the photo being removed from the
website?
17. Please provide all correspondence and
communications between NIH and Columbia University related to federal funding
involving the WIV, including email correspondence in April 2020 between Dr.
Michael Lauer, Deputy Director of extramural research, and Naomi Schrag of
Columbia University.
a. In an April 2020 email, Dr. Lauer
advised Naomi Schrag of Columbia University that it would be helpful for NIH “to
know about all China-based participants in this work since the Type 1 grant
started in 2014 - who they were and how much money they received.”34
Why
did NIH request that Columbia University provide information about all of the
China-based participants?
i. What is the pertinence of the
timeframe starting in 2014 for the requested information?
ii. Did Columbia University provide the NIH
with the requested information about all of the China-based participants from
all grantees since 2014? If so, please provide the information1. If not, why
not?
Federal
Funding Records
32 Id.
33 Id.
34 Meredith Wadman and Jon Cohen, NIH’s axing of bat
coronavirus grant a ‘horrible precedent’ and might break rules, critics say,
SCIENCEMAG (Apr. 30, 2020), available at
https://www.sciencemag.org/news/2020/04/nih-s-axing-bat-coronavirus-grant-horrible-precedent-and-might-break-rules-critics-say
18. Please provide ledgers or any accounting
for dispersion of all NIH federal funding awards that EcoHealth Alliance has
sent to the WIV, including through contracts, grants, donations, cooperative
agreements, staffing, or any other support or means. In addition, please
provide the results and outcomes from the funding and support.35
19. What is the total amount of NIH federal
funding per year from 2017 through 2021 that has directly or indirectly
supported the WIV scientists or research through grant recipients, including to
EcoHealth Alliance; Wildlife Trust, Inc.; Columbia University Health Sciences;
Trustees of Columbia University; University of North Carolina Chapel Hill;
Vanderbilt University; University of Virginia; and Oregon Health and Science
University?36
20. According to a report in The Washington
Post on April 14, 2020, the WIV issued a news release in English about the
final visit from U.S. Embassy scientist diplomats in Beijing, which occurred on
March 27, 2018.37
Does
the NIH have a copy of this news release? If so, please provide a copy.
21. For NIH award recipients that have
provided support to the WIV since January 1, 2012, please provide annual
reports, trip reports related to the WIV, documentation of any survey or field
trips by the WIV, and interim data summaries from the WIV.
22. Please provide copies of all grantee
annual reports, progress reports, projects, studies, and observations since
2014 where foreign sites for all Type 1 and Type 2 awards have been documented
as involving the WIV.
23. Please provide copies of all grantee
annual reports, progress reports, projects, studies, and observations since
2014 for NIH domestic grantee awards with a foreign component involving the
WIV.
24. Please provide the name(s) of the NIH
program manager(s) or officer(s) responsible for overseeing the grants to
EcoHealth Alliance and time period(s) of responsibility.
25. Please provide the name(s) of the NIH
Scientific Review Officers responsible for reviewing and approving any NIH
financial awards to EcoHealth Alliance and any other funding recipients that
supported the WIV.
35 Betsy McKay, NIH Presses U.S. Nonprofit for
Information on Wuhan Virology Lab, THE WALL STREET JOURNAL (Aug. 19. 2020),
available at
https://www.wsj.com/articles/nih-presses-u-s-nonprofit-for-information-on-wuhan-virology-lab-11597829400
36 National Institutes of Health, Research Portfolio
online Reporting Tools, NIH RePorter available at
https://report.nih.gov/ (last accessed March 6,
2020).
37 Josh Rogin, Opinion: State Department cables
warned of safety issues at Wuhan lab studying bat coronaviruses, THE WASHINGTON
POST (Apr. 14, 2020), available at
https://www.washingtonpost.com/opinions/2020/04/14/state-department-cables-warned-safety-issues-wuhan-lab-studying-bat-coronaviruses/
26. According to an editorial in The Wall
Street Journal, the WIV housed tens of thousands of bat samples and laboratory
animals in 2019.38
Please
provide any information the NIH has on the number of bat samples and animals at
the WIV.
a. Did any NIH scientists who are fluent
in Mandarin review the Chinese scientific literature on the WIV research
related to coronaviruses that is dated before February 1, 2020?
27. Does the NIH have the unpublished
sequences of bat coronaviruses that were maintained in the WIV database before
December 30, 2019, or before the database was removed from the internet?39
Does
NIH have the full sequences of the eight viruses sampled in the Yunnan province
on an EcoHealth Alliance bat-virus sampling trip in 2015?
a. Please provide NIH’s analysis if the
sequences have been analyzed.
b. If NIH does not have the sequences, can
NIH get this information from the EcoHealth Alliance or from other NIH-funded
sources?
28. Please provide the original version of “Origin
and cross-species transmission of bat coronaviruses in China” that was
submitted to Nature by EcoHealth Alliance on October 6, 2019, published August
25, 2020, and funded in part by NIAID (award number R01AI110964).40
If
NIH does not have the October 6, 2019 report, can NIH obtain it from EcoHealth
Alliance for this response? If so, please provide the report.
29. Have NIH, EcoHealth Alliance, or other
NIH award recipient(s) been denied permission or access to results of any WIV
research, which indirectly received financial support from NIH awards? If so,
please provide the date(s), individuals involved, and circumstances of each
denial.
We
request that the NIH provide the requested documents and information in a
coordinated response from all stakeholders and the appropriate divisions within
NIH, including but not limited to subject matter experts from NIH’s Division of
Security and Emergency Response, the Office of Management Assessment, the
Center for Scientific Review, the National Institute of Allergy and Infectious
Diseases, and the Office of Extramural Research. After the requested
information has been provided, we ask that the NIH provide a briefing to the
Minority Committee staff to discuss the information that the NIH has related to
the origins of SARS-CoV-2, including any potential links to the WIV. Finally,
we request that you appoint an NIH working group representing an appropriate
diversity of scientific disciplines to collect data and
38 Mike Pompeo and Miles Yu, NIH Presses U.S.
Nonprofit for Information on Wuhan Virology Lab, THE WALL STREET JOURNAL (Feb.
23, 2021), available at
https://www.wsj.com/articles/chinas-reckless-labs-put-the-world-at-risk-11614102828
39 Washington Post Editorial Board, We’re still
missing the origin story of this pandemic. China is sitting on the answers, THE
WASHINGTON POST (Feb. 5, 2021), available at
https://www.washingtonpost.com/opinions/2021/02/05/coronavirus-origins-mystery-china/?arc404=true
40 Latinne, A., Hu, B., Olival, K.J. et al,. Origin
and cross-species transmission of bat coronaviruses in China, Nature (Aug. 25,
2020), available at https://www.nature.com/articles/s41467-020-17687-3#Ack1
information
related to COVID-19 origins (including the WIV), and that the NIH working group
coordinate and consult with foreign scientific agencies involved in similar
work.
Your
assistance with this request is greatly appreciated. If you have any questions,
please contact Alan Slobodin or Diane Cutler of the Minority Committee staff.
Sincerely,
Cathy
McMorris Rodgers
Republican
Leader
Brett
Guthrie
Republican
Leader Committee on Energy and Commerce
Subcommittee
on Health
H.
Morgan Griffith
Republican
Leader
Subcommittee
on Oversight and Investigations
Attachment
cc:
The
Honorable Frank Pallone, Chairman
The
Honorable Diana DeGette, Chair, Subcommittee on Oversight and Investigations
The
Honorable Anna Eshoo, Chair, Subcommittee on Health
2018
Cables from Embassy Beijing and Consulate General Wuhan to State Department
Headquarters in Washington, D.C.
- -
- - -
June
10, 2021
The
Honorable Francis Collins, M.D., Ph.D. Director
National
Institutes of Health
9000
Rockville Pike
Bethesda,
MD 20892
Dear
Dr. Collins:
As
the committee of jurisdiction over public health, the Energy and Commerce
Committee has authorizing responsibilities over the U.S. National Institutes of
Health (NIH). We strongly support a comprehensive investigation into the
origins of the COVID-19 pandemic, including the possibility of an accidental
laboratory leak.
The
Chinese Communist government has not yet allowed Chinese scientists to
cooperate with an investigation into COVID-19 origins, and has admitted to
destroying samples and records pertinent to such an investigation.1
Thus,
it is imperative we assemble all data and information in U.S. possession about
bat coronavirus research experiments and lab safety protocols from all sources
outside of China, particularly from EcoHealth Alliance (EHA). EHA is an NIH
grantee who has been involved in bat coronavirus research in China and has
issued grant subawards to the Wuhan Institute of Virology (WIV). It is also
essential to collect information about the WIV, the laboratory that was
conducting bat coronavirus experiments located in Wuhan, China, the epicenter
of the COVID-19 outbreak. As a federal cognizant grant-making agency that
funded bat coronavirus research at the WIV through EHA awards, NIH is in a
unique position to publicly share detailed research reports in its possession.
Importantly, NIH has full access to EHA records and EHA has refused to
cooperate with our inquiry. Therefore, it is critical for NIH to cooperate with
our objective fact-finding investigation as we continue to collect data about
U.S. funded bat coronavirus research.
1 Josh Chin, China Told labs to Destroy Coronavirus
Samples to Reduce Safety Risks, The Wall Street Journal (May 16, 2020)
available at
https://www.wsj.com/articles/china-told-labs-to-destroy-coronavirus-samples-to-reduce-biosafety-risks-11589684291/
Since
the Republican committee leaders March 18, 2021 letter to NIH, our
investigation has found a number of additional issues that raise very serious
concerns about the adequacy of NIH’s oversight of grantees. The following newly
found issues appear troubling and given the significance of these concerns, we
expect the NIH to respond fully and substantively. Minority committee staff is
continuing to work with your staff to schedule an NIH briefing. The NIH should
be prepared to address these issues at the briefing, in addition to all of the
questions from the March 18, 2021 letter that presently remain unanswered.
1. NIH’s Award of $2 million to EHA
Despite Grant Suspension
On
May 25, 2021, a spokesperson for EHA told Fox Business that its NIH funding is
frozen and NIH did not give them guidance on when funds will be unfrozen.2
EHA’s
representation about their NIH funding was not forthcoming. NIH terminated
grant RO1AI110964 to EHA entitled, “Understanding the Risk of Bat Coronavirus
Emergence” in April 2020. 3
NIH
eventually converted the grant termination to a suspension on July 8, 2020,
pending EHA’s responses to seven requests from NIH related to WIV’s actions.
NIH could unfreeze the funding if EHA cooperates with NIH’s requests, but
apparently EHA has not yet done so. Despite EHA’s obstruction of NIH requests,
NIH gave new financial awards to EHA in June 2020 and August 2020, totaling
$2,127,602.4
By
NIH authorizing new funding to EHA, an NIH-suspended grantee, the NIH undercut
its July 8, 2020 suspension and has incentivized its grantees to defy NIH
oversight with impunity.
2. NIH’s Inadequate Oversight of EHA’s
Other Support
You
testified during a May 25, 2021 Congressional hearing that NIH was, “ ... of
course not aware of other sources of funds or other activities they might have
undertaken outside of what our approved grant allowed,” when asked about NIH
grant recipient EHA, and the WIV, an EHA subaward recipient.5
Pursuant
to the NIH Grants Policy, EHA was required to report all “other support”, in-kind contributions such as laboratory space, equipment and supplies, and
facilities and other resources for all individuals designated as the Principal
Investigator (Pl) personnel.6
Per
the NIH grants policy, the grant Principal Investigator Dr. Peter Daszak and
EHA were required to report its other research funding sources and activities
to NIH.7
Without
2 Fox News, Eiden State Department quietly ended
team’s work probing COVID origin, State Department (May 25, 2021) available at
https://www.foxnews.com/politics/biden-state-department-shut-down-team-covid-origin-investigation
3 National Institutes of Health, Understanding the
Risk of Bat Coronavirus Emergence, REPORTER (last accessed
June 2, 2021) available at
https://reporter.nih.gov/search/p1odLH_UlkyZgyOhClrN2w/project-details/9320765#similar-Projects/
4 USASpending.gov, Cooperative agreement numbers
U0JAJJ 51797 and U0JAJJ 53420, EcoHealth Alliance available at
5 House Committee on Appropriations, FY 2022 Budget
Request for the National Institutes of Health, Hearings (May 25, 2021)
available at
https://appropriations.house.gov/events/hearings/fy-2022-budget-request-for-the-national-institutes-of-health
6 National Institutes of Health, Other Support,
Grants & Funding (last accessed June I, 2021) available at
https://grants.nih.gov/grants/forms/othersupport.htm
7 Id.
further
details or documentation, your testimony bolsters the notion that NIH oversight
is largely ignorant of other awards to the grantee.
3. NTH’s Inadequate Oversight of EHA s
Delinquent Financial Reports
As
the prime recipient of NIH grant R01All 10964, EHA gave a total $598,500 in
five subaward transactions to the WIV from 2015 to 2019 for the WIV to, “conduct
high-quality testing, sequencing, and analyses of field samples; maintenance of
cold-chains from field to lab; ensuring quality control of sample storage and
testing; collaborating on scientific publications and programmatic reporting.”8
EHA
also gave a total of $201,217.10 in two subaward transactions to the Wuhan
University School of Public Health (WUSPH) to “conduct targeted site-analyses,
human behavioral surveillance including qualitative and quantitative surveys;
analyses of data; collaborating on scientific publications and programmatic
reporting”, from 2016 through 2017.9
EHA
is required to report its subawards to GSA’s FFATA Subaward Reporting System
(FSRS) by the end of the month following the month when the subaward was made.10
For
example, when EHA issued a $133,000 subaward to the WIV on May 29, 2015, EHA
was required to report that subaward to FSRS by June 30, 2015.11
USASpending
is the U.S. government’s open federal spending data source and when the grant
number R0lAil 10964 data is downloaded, details reveal that EHA did not report
subawards for that grant until 2020, even though EHA made subawards starting in
2015.12
EHA
reported all seven subaward transactions for R0lAil 10964 on July 13, 2020,
five days following NIH’s July 8, 2020 letter to EHA instructing EHA to ensure
EHA reported all subaward data to FSRS.13
Before
the year 2020, only one other EHA subaward grant is reported in
USASpending.gov, in which three subaward transactions for NIH grant number
R56TW009502 are recorded in 2014.14
EHA’s
apparent non-compliance of required financial reporting raises concerns about
the adequacy of NIH oversight of NIH grants.
4. NH ‘s Possible Funding of EHA for
Duplicative Research in China
EHA
received federal funding as both a prime and sub-recipient not only from NIH,
but also from the U.S. Agency for International Development (USAID) for its bat
coronavirus research. The project descriptions and research articles are so
similar t4at a distinction between the NIH bat coronavirus research objectives
and achievements for the awards to EHA are almost interchangeable with EHA’s
USAID-funded bat coronavirus research objectives and
8 Id.
9 Id.
10 USAspending.gov, Data Sources, About (last
accessed June 1, 2021), available at
https://www.usaspending.gov/about
11 Id.
12 USASpending.gov, Advanced Search: Recipient-
EcoHealth Alliance (June 1, 2021) available at
13 Id.
14 Id. See NIH grant number R56TW009502.
achievements.
15
The
NIH grant progress reports will reveal details about the bat coronavirus
research that can be compared to the reports from USAID-funded research. In its
research funded by the USAID, EHA partnered with the WIV and with East China
Normal University.16
We
are very concerned that the NIH and USAID may have funded duplicate projects
and that EHA partnered with additional unreported entities in China for NIH-funded
research.
5. NIH’s Inadequate Reconciliation of EHA’s
Grant Subawards
As
far back as 2005, Peter Daszak of EHA has authored over 20 bat coronavirus and
other zoonic pathogen research articles with Dr. Zhengli Shi of the WIV, plus
other researchers, about experiments funded by NIH.17
Their
collaborative research has resulted in a 2005 publication entitled “Bats Are
Natural Reservoirs of SARS-Like Coronaviruses,” funded by NIH.18
In
2013, they published “Isolation and characterization of a bat SARS-like
coronavirus that uses the ACE2 receptor,” funded by NIH and USAID.19
Their
numerous publications acknowledge NIH as a research sponsor yet the only EHA
support to the WIV in USASpending.gov was reported by EHA on July 13, 2020 (see
concern number three above).20
Vanity
Fair reported that Dr. Shi “herself listed U.S. government grant support of
more than $1.2 million on her curriculum vitae: $665,000 from the NIH between
2014 and 2019; and $559,500 over the same period from USAID.”21
EHA’s
late and potentially incomplete reporting of the WIV as its sub-award recipient
raises questions about EHA’s compliance with required financial reporting and
also raises concerns about NIH’s oversight of grant awards to EHA.
6. NIH’s Inadequate Oversight of EHA s
Place of Performance Reporting
The
Federal Funding Accountability and Transparency Act of 2006 (FFATA) requires
that federal award reporting must include the primary location of where the
work will be performed, (including the city, state, congressional district, and
country).22
For
EHA’s NIH awards, China is not listed as the place of performance in
USASpending.gov and instead, EHA’s
15 USASpending.gov, Advanced Search: Recipient- EcoHealth Alliance (June 1, 2021) available at USASpending.gov/
16 USAID PREDICT-I CONSORTIUM, Reducing Pandemic
Risk, Promoting Global Health, Final Report (Dec. 2014) available at
https://ohi.sf.ucdavis.edu/sites/g/files/dgvnsk5251/files/f1les/page/predict-final-report-lo.pdf
17 NIH Reporter, Anthropogenic change & emerging
zoonic paramyxoviruses, Project Number SRO1TW005869-04 (Budget Start Date June
1, 2005) available at
https://reporter.nih.gov/search/WMYBIQPE20aG4fAZLFj0lw/project-details/6923645#details
NIH National Library of Medicine, Advanced Search
for ‘Shi, Daszak, ‘National Center for Biotechnology Information (June 2, 2021)
available at
https://pubmed.ncbi.nlm.nih.gov/?term=Daszak%2C+Shi&sort=date&sort_order=asc&size=200
18 NIH National Library of Medicine, Bats Are
Natural Reservoirs of SARS-Like Coronaviruses, PubMed (Sept.5, 2005) available
at https://pubmed.ncbi.nlm.nih.gov/16195424/
19 Ge, XY., et al., Isolation and characterization
of a bat SARS-like coronavirus that uses the ACE2 receptor, Nature 503, 535-538
(May 16, 2013) available at https://doi.org/10.1038/nature1271l
20 Id.
21 Katherine Eban, The Lab-Leak Theory- Inside the
Fight to Uncover COVID-19 Origins, Vanity Fair (June 3, 2021) available
at https://www.vanityfair.com/news/2021/06/the-lab-leak-theory-inside-the-fight-to-uncover-covid-19s-origins
22 PL 109-282, Sept. 26, 2006 available at
https://www.govinfo.gov/content/pkg/PLAW-109publ282/pdf/PLAW-I09publ282.pdf
primary
place of performance is identified as New York.23
The
NIH grant documents, and the financial and progress reports we have requested
will contain travel budgets and research details that will confirm the
location(s) where EHA actually performed its research. Published research
articles about NIH-funded experiments describe EHA’s bat coronavirus research
and surveillance activities often partnered with the WIV in China. We are very
concerned about the discrepancy in EHA’s primary place of performance as being
New York in USASpending.gov when research articles, publications, and media
interviews suggest EHA’s primary place of performance is not domestic.24
7. NIH’s Lack of Visibility into EHA’s
Grant Subawards
USASpending.gov
limits visible data to prime and subaward recipients, and does not disclose
funds that are further disbursed subaward recipients.25
EHA
is a subaward recipient of NIH grant funds from the Arizona State University
and the Trustees of Columbia University in New York City.26
As
a subaward recipient, EHA does not publicly report when it further distributes
subaward funds to other organizations such as the WIV or other recipients in
China.27
NIH
questions to EHA in the July 8, 2020 grant suspension letter suggest that NIH
lacks information and visibility on sub-grant awards that are either issued or
received by EHA.28
8. NIH’s Inadequate Oversight of EHA’s
Grant Fund Accounting
In
our April 18, 2021 letter to EHA, we raised the issue that EHA reported a
$319,570 cash award grant and a $126,792 cash award grant disbursed by wire to
China for the purpose of “[u]understanding the risk of bat coronavirus
emergence” on its IRS Form 990, calendar year 2016. 29
EHA
reported giving $321,700 for coronavirus and emerging diseases to China on its
IRS Form 990, calendar year 2015.30
EHA
IRS Form 990’s for other years do not include that purpose or identify the WIV
as an organization to which funds were paid. With EHA organized as a 501 (c)(3)
non-profit organization, its IRS Form 990’s are public documents able to be
reviewed by NIH. As a non-federal entity that expends more $750,000 or more in
federal funds in one year, EHA is required to submit a Single Audit report,
previously known as the 0MB Circular A-133 audit. The purpose of a Single Audit
report is to provide assurance to the Federal Government that a non-federal
entity has adequate internal controls in place, and is generally in
23 Id.
24 Nidhi Subbaraman, ‘Heinous!’: Coronavirus
researcher shut down for Wuhan-lab link slams new funding restrictions, Nature
(Aug. 21, 2020), available at
https://www.nature.com/articles/d41586-020-02473-4
25 USASpending.gov, Advanced Search: Recipient- EcoHea/th Alliance (June 1, 2021) available at USASpending.gov/
26 Id.
21 Id.
28 Internal Revenue Service, EHA 990 final, Schedule
F, Parts I and II (May 3, 2017) available at
https://apps.irs.gov/pub/epostcard/cor/311726494_201606_990_2017090514700974.pdf
29 U.S. Energy and Commerce Republicans, Letter to
EcoHealth Alliance, The COVID-19 Origins Investigation (Apr. 16, 2021)
available at
https://republicans-energycommerce.house.gov/the-covid-19-origins-investigation/
30 Internal Revenue Service, EHA 990 final 2015,
Schedule F, Parts I and II (May 3, 2017) available at
https://apps.irs.gov/pub/epostcard/cor/311726494_201606_990_2017090514700974.pdf
compliance
with program requirements.31
In
EHA’s Single Audit reports for years 2016 to 2020, no payments are evident for
EHA funds paid to the WIV.32
9. NIH’s Inadequate Oversight of Its
Funded Researchers in China
The
WIV named NIH and EHA on its website as WIV international partner as of and
prior to the date of our March 18, 2021 letter to NIH.33
By
March 22, 2021, the WIV had removed NIH as a partner from its website.34
The
NIH has characterized its relationship Chinese scientists as respectable
scientific partners.35
However,
within three days following our letter to NIH which inquired about NIH grants
to the WIV, the WIV quickly concealed its long-standing relationship with NIH
by deleting evidence of its NIH partnership from its website. This action does
not seem consistent with NIH’s claim that the WIV and its scientists were a
respectable scientific partner. It has been reported that some Chinese
scientists working with EHA are current or former members of the People’s
Liberation Army of China.36
It
has also been reported that the Chinese military were conducting research at
the WIV.37
We
are concerned that NIH-funded coronavirus research in China may not have
undergone proper biodefense risk analysis.
10. NIH’ s Lack of Cooperation with
Congressional Oversight Inquiry
NIH
is supposed to be a transparent institution and the grant documents we
requested should be a matter of public record.38
Contrary
to your public statement implying that we asked for “pretty sensitive
materials, not quite classified, but getting close to that”, the grant
documents we requested are releasable to the public per NIH’s own policy and
should have already been provided to us.39
As
you are aware, the NIH grant documents and progress reports we requested will
include details pertinent to our COVID-19 origins investigation, including
information about: all research participants and collaborating organizations;
location(s) of work performed; instruments, equipment and monies provided to
grant sub-recipients; financial accounting
31 U.S. Department of Health and Human Services,
Single Audit (Apr. 25, 2016) available at
https://www.hhs.gov/aboutiagencies/asfr/data-act-program-management-office/single-audit/index.html
32 Federal Audit Clearinghouse, EcoHealth Alliance,
Inc and Wildlife Preservation Trust Int. Single Audit Reports 2017-202 I
(June7, 2021) available at https://facdissem.census.gov/SearchResults.aspx
33 Internet Archive Wayback Machine, Wuhan Institute
of Virology, CAS, Partnerships (Mar. 18, 2021) available at
https://web.archive.org/web/20210318052528/http://english.whiov.cas.cn/International_Cooperation2016/Partnerships/
34 Internet Archive Wayback Machine, Wuhan Institute
of Virology, CAS, Partnerships (Mar. 22, 2021) available at
https://web.archive.org/web/20210322053537/http://english.whiov.cas.cn/International_Cooperation2016/Partnerships/
35 House Committee on Appropriations, FY 2022 Budget
Request for the National Institutes of Health, Hearings (May 25, 2021)
available at
https://appropriations.house.gov/events/hearings/fy-2022-budget-request-for-the-national-institutes-of-health
36 Alexis, Shi Zhengli: Weaponizing Coronaviruses,
with Pentagon Funding, at a Chinese Military Lab,
https://enviroshop.com/shi-zhengli-weaponizing-coronaviruses-with-pentagon-funding-at-a-chinese-military-lab/
37 Id.
38 National Institutes of Health, NIH Grants Policy
Statement, Policy and Compliance (June 1, 2021) available at
https://grants.nih.gov/policy/nihgps/index.htm
39 Id.
reports;
research techniques and accomplishments; research products such as:
technologies, patent applications, data or databases, physical collections, and
models; significant changes in use or care of human subjects, vertebrate
animals, biohazards, and/or select agents; and budgetary information and
project outcomes.40
As
the federal grant awarding agency, NIH must have the right of access to any of
EHA’s documents or other records which are pertinent to NIH federal awards.41
The
NIH grants policy states that the Freedom of Information Act (FOIA) and U.S.
Department of Health arid Human Services regulations require NIH to release
certain grant documents and records requested by members of the public,
regardless of the intended use of the information.42
Per
NIH policy, NIH will generally release funded applications and progress reports
pursuant to a FOIA request.43
NIH
considers most grant-related information in the application or post-award
phases as being public information (emphasis added).44
In
support of this inquiry and the public interest in the origins of the COVID-19
pandemic, please provide written responses to the following by June 24, 2021:
1. We again renew our request for NIH’s
immediate compliance with our oversight inquiry for production of the grant
documents and progress reports forthwith that we first requested on March 18,
2021.
2. What is NIH’s policy for awarding funds
to organizations when the organization has NIH grant funds in suspended status
and are not cooperating NIH requests? If the NIH permits new award funding
under these circumstances, please provide the policy, and explain how such
funding does not undercut NIH’s ability to oversee grantees and does not
incentivize grantees to defy NIH’s requests for information.
3. Please explain all oversight steps NIH
has taken to ensure EHA’s full compliance with federal financial subaward
reporting requirements for all NIH grants. Please explain if EHA reported to
NIH any subaward recipients other than the WIV or the WUSPH for NIH grant
R0lAII 10964. Please provide all financial records of all NIH funds given to
Dr. Zhengli Shi of the WIV.
4. For all NIH awards in which EHA was a
subrecipient, please provide a financial accounting of EHA’s subawards to the
WIV or other organizations in China.
40 Hugh Hewitt, Dr. Francis Collis On The US. Funding of the Wuhan Lab and Congressional Oversight, The Hugh Hewitt Show (June 2, 2021) available at https://hughhewitt.com/dr-francis-collins-on-the-u-s-funding-of-the-wuhan-lab-and-congressional-oversight/
National Institutes of Health, Research Performance Progress Report, Grants
& Funding (May 4, 2021) available at
https://grants.nih.gov/grants/rppr/index.htm
41 Id.
42 National Institutes of Health, NIH Grants Policy
Statement, Policy and Compliance (June 1, 2021) available at https://grants.nih.gov/policy/nihgps/index.htm
43 Id.
44 Id.
5. How does NIH ensure it does not award
unapproved duplicate grants for same or similar research already funded by
other agencies, to EHA or other NIH grant recipients? For all NIH awards to
EHA, please provide accounting information for EHA subawards to recipients in
China.
6. Please explain how NIH has reviewed EHA
annual Single Audit reports to ensure how EHA has met program and reporting
requirements.
7. How does NIH audit the financial
reports submitted to the IRS by its 501(c)(3) non-profit organization grant
award recipients to ensure NIH awards are accurately reported? How does NIH
ensure its grantees do not act as a pass-through or money laundering provider
to send U.S. research funding to China?
8. Please explain NIH’s policy for
ensuring its awardees accurately report the actual place of research
performance. For all NIH-funded research, please provide all China site
locations where EHA’s work was performed.
9. Please explain if EHA reported its
other funding or in-kind support, including awards from federal agency, to NIH.
Please explain if EHA reported any support from organizations in China.
10. Did NIH perform a biodefense risk
analysis for coronavirus research conducted at the WIV as research with
potential for dual use of research concern, pandemic pathogen or bioweapon
development, as outlined in the HHS Framework for Guiding Funding Decisions
about Proposed Research Involving Enhanced Potential Pandemic Pathogens?45
Please
describe NIH’s coordination procedures with the U.S. Intelligence Community
that are completed before NIH funds research projects in foreign countries with
existing biodefense programs.
Please
make arrangements to schedule the briefing for Committee staff by June 24,
2021.
If
you have any questions, please contact Alan Slobodin or Diane Cutler of the
Minority Committee staff. Thank you for your attention to this request.
Sincerely,
Cathy
McMorris Rodgers
Republican
Leader
Committee
on Energy and Commerce
Fred Upton
Republican Leader
Subcommittee
on Energy
45 U.S. Department of Health and Human Services,
Framework/or Guiding Funding Decisions about Proposed Research Involving
Enhanced Potential Pandemic Pathogens, Science Safety Security (Dec. 2017)
available at https://www.phe.gov/s3/dualuse/Pages/p3co.aspx
- - - - -
Bob Latta
Republican Leader
Subcommittee
on Communications and Technology
Brett Guthrie
Republican Leader
Subcommittee
on Health
David
McKinley
Republican
Leader
Subcommittee
on Environment and Climate Change
Gus Bilirakis
Republican Leader
Subcommittee
on Consumer Protection and Commerce
Steve
Scalise
Member
of Congress
H.
Morgan Griffith
Republican Leader
Subcommittee on Oversight and
Investigations
Michael
C. Burgess, M.D.
Member
of Congress
Adam
Kinzinger
Member
of Congress
Bill
Johnson
Member
of Congress
Larry
Bucshon, M.D.
Member
of Congress
Richard
Hudson
Member
of Congress
Earl
L. “Buddy” Carter
Member
of Congress
Billy
Long
Member
of Congress
Markwayne
Mullin
Member
of Congress
Tim
Walberg
Member
of Congress
Jeff
Duncan
Member
of Congress
Gary
Palmer
Member
of Congress
Neal
P. Dunn, M.D.
Member
of Congress
John
Curtis
Member
of Congress
Greg
Pence
Member
of Congress
Debbie
Lesko
Member
of Congress
Dan
Crenshaw
Member
of Congress
John
Joyce, M.D.
Member
of Congress
Kelly
Armstrong
Member
of Congress
- -
- - -
FRANK
PALLONE, JR., NEW JERSEY
CHAIRMAN
CATHY
McMORRIS RODGERS, WASHINGTON
RANKING
MEMBER
ONE
HUNDRED SEVENTEENTH CONGRESS
Congress
of the United States
House
of Representatives
COMMITTEE
ON ENERGY AND COMMERCE
2125
RAYBURN HOUSE OFFICE BUILDING
WASHINGTON,
DC 20515-6115
Majority
(202) 225-2927
Minority
(202) 225-3641
July
21, 2021
The
Honorable Francis Collins, M.D., Ph.D. Director
National
Institutes of Health
9000
Rockville Pike
Bethesda,
MD 20892
Dear
Dr. Collins,
According
to its mission statement, a goal of the National Institutes of Health (NIH) is “to
exemplify . . .the highest level of scientific integrity and public
accountability.”1
However,
under your leadership, the NIH is falling short of that goal. On March 18,
2021, we sent NIH a detailed, eleven-page request for information about origins
of the COVID-19 pandemic, which the public deserves to see. Three months later,
the NIH has refused to cooperate with that request. The NIH has not provided a
single document to us or made any document available to the public that
responds directly to the paramount question of whether NIH funding played a
role in risky research in China that could have started the pandemic.
We
specifically requested documents related to National Institute of Allergy and
Infectious Diseases (NIAID) grant R01AI110964, “Understanding the Risk of Bat
Coronavirus Emergence” to EcoHealth Alliance that in part funded the Wuhan
Institute of Virology (WIV) research into bat coronaviruses. The NIH has not
provided the documents and did not provide written responses to any of the 29
questions in the March 18th letter. Instead, the NIH only provided a one-hour
oral briefing to bipartisan committee staff with no documents to address any of
the topics covered by the 29 questions in the March 18th letter. Additionally,
no subject matter experts from the NIAID were included in the briefing, even
though we specifically requested to hear from NIAID, which is the NIH institute
responsible for issuing this grant. The only written response provided by the
NIH was a two-page May 21, 2021, letter signed by NIH Principal Deputy Director
Lawrence Tabak that did not address any of the questions in the March 18th letter,
but instead stated:
1 National Institutes of Health, Mission and Goals,
What We Do (accessed July 14, 2021) available at
https://www.nih.gov/about-nih/what-we-do/mission-goals
The
application [from EcoHealth Alliance] was subjected to rigorous peer review and
did not propose research to enhance any coronavirus to be more transmissible or
virulent. The research proposed in the grant application sought to understand
how bat coronaviruses evolve naturally in the environment to become
transmissible to the human population. This included studying viral diversity
in bat reservoirs, surveying people who work in live animal markets or other
jobs with high exposure to wildlife for evidence of bat-coronavirus infection,
and analyzing data to predict which newly discovered viruses pose the greatest
threat to human health. To support its work, EcoHealth made sub-awards to the
Wuhan Institute of Virology and other institutions based in East Asia where
coronaviruses tend to emerge and are prevalent. NIH is not currently funding
the Wuhan Institute of Virology.2
In
addition, the NIH has denied supporting “gain-of-function” research at the WIV
through this NIAID grant. For example, NIAID Director Dr. Anthony Fauci
testified, “The NIH has not ever and does not now fund gain-of-function
research in the Wuhan Institute of Virology.”3
You
also stated: “Let me be very clear, we never approved any grant that would have
supported gain of function research on dangerous coronaviruses to see if they
could be more transmissible or lethal for individuals in the human species.”4
Yet,
the NIH has declined to produce the underlying grant documents and records to
substantiate these assertions. Importantly, the NIH has not provided complete
information about exactly what the NIH did support at the WIV.
Based
on published reports over the last few months and the NIH’s June 28, 2021,
briefing with bipartisan committee staff, we have reason to believe that the
NIH may have funded humanized mice experiments at the WIV, and that such
experiments may have had the potential to start the pandemic. This recent
information seems contrary to NIH’s characterizations of the EcoHealth grant
and WIV research at issue.
Further,
recent documents obtained under the Freedom of Information Act (FOIA) reveal
that an NIAID official visited the WIV in 2017, and that NIAID had familiarity
with the WIV research on bat coronaviruses and that some of these viruses could
be transmissible to humans.
2 NIH did not identify by name the “other
institutions based in East Asia where coronaviruses tend to emerge and are
prevalent” in its letter. The only institution (singular) other than the WIV
reported by EcoHealth Alliance as a sub-grant recipient for this grant is the
Wuhan University, the same institution from which a researcher requested NIH to
remove its submissions to the NIH Sequence Read Archive (SRA) database and NIH
removed them. Dr. Jesse Bloom of the Fred Hutchinson Cancer Center recovered
some of the removed sequence data and determined that the sequences related to
the SARS CoV-2 early Chinese COVID-19 patients.
3 Lori Robertson, The Wuhan Lab and the Gain-of-Function Disagreement, FactCheck.org (July 1, 2021) available at https://www.factcheck.org/2021/05/the-wuhan-lab-and-the-gain-of-function-disagreement/
We note collaborative projects between Dr. Ralph Baric of the University of
North Carolina at Chapel Hill and the WIV, have produced research articles that
describe Gain-of-Function research experiments when the WIV was technically
funded through a USAID cooperative agreement facilitated by a consortium that
included EcoHealth Alliance.
4 Samuel Chamberlain, NIH head accuses Rand Paul of ‘misinformation’
about US ties to Wuhan lab
New York Post (May 14, 2021) available at
https://nypost.com/2021/05/14/nih-head-accuses-rand-paul-of-misinformation-about-us-ties-to-wuhan-lab/
NIAID
indirectly continued to fund the WIV research despite concerns about biosafety
practices at the WIV raised in 2018 State Department cables, which were based
in part on the NIAID visit in 2017.
First,
we note that the FY 2018 abstract for the EcoHealth Alliance NIAID “Understanding
the Risk of Bat Coronavirus Emergence” grant renewal openly discussed
experiments with humanized mice. The abstract for the project declared that aim
number three of the research project was to: “3. Test predictions of CoV
inter-species transmission. Predictive models of host range (i.e. emergence
potential) will be tested experimentally using reverse genetics, pseudovirus
and receptor binding assays, and virus infection experiments across a range of
cell cultures from different species and humanized mice.” (emphasis added).5
As
noted by science writer Nicholas Wade, in such experiments, “laboratory mice, a
cheap and ethical stand-in for human subjects, are genetically engineered to
carry the human version of a protein called ACE2 that studs the surface of
cells that line the airways.”6
Second,
a recent article in Vanity Fair reported that the WIV and its bat coronavirus
research director, Dr. Shi Zhengli, were involved with experiments in humanized
mice in recent years. The article stated that “Shi’s own comments to a science
journal, and grant information available on a Chinese government database,
suggest that in the past three years her team has tested two novel but
undisclosed bat coronaviruses on humanized mice, to gauge their infectiousness.”7
Third,
such experiments have pandemic potential. As the EcoHealth Alliance wrote in
the FY 2019 abstract for this same NIH grant, “We will use S protein sequence
data, infectious clone technology, in vitro and in vivo infection experiments
and analysis of receptor binding to test the hypothesis that % divergence
thresholds in S protein sequences predict spillover potential”.8
Mr.
Wade further explained the implications of this research:
What
this means, in non-technical language, is that Shi set out to create novel
coronaviruses with the highest possible infectivity for human cells. Her plan
was to take genes that coded for spike proteins possessing a variety of
measured affinities for human cells, ranging from high to low. She would insert
these spike genes one by one into the backbone of a number of viral genomes (“reverse
genetics” and “infectious clone technology”), creating a series of chimeric
viruses. These chimeric viruses would then be tested for their ability to
attack human cell cultures (“in vitro”) and humanized mice (“in vivo”). And
this information would help
5 Grantome NIH, Abstract for Understanding the Risk
of Bat Coronavirus Emergence, EcoHealth Alliance Inc. FY 2018 available at
https://grantome.com/grant/NIH/R01-AI110964-05
6 Nicholas Wade, The origin of COVID: Did people or
nature open Pandora’s box at Wuhan?, Bulletin of the Atomic Scientists, (May 5,
2021). available at
https://thebulletin.org/2021/05/the-origin-of-covid-did-people-or-nature-open-pandoras-box-at-wuhan/
7 Katherine Eban, The Lab Leak Theory: Inside the
Fight to Uncover COVID 19’s origins, Vanity Fair (June 3, 2021), available at
https://www.vanityfair.com/news/2021/06/the-lab-leak-theory-inside-the-fight-to-uncover-covid-19s-origins
8 Grantome NIH, Abstract for Understanding the Risk
of Bat Coronavirus Emergence, EcoHealth Alliance Inc. FY 2019 available at
https://grantome.com/grant/NIH/R01-AI110964-05
predict
the likelihood of “spillover”, the jump of a coronavirus from bats to people.
The
methodical approach was designed to find the best combination of coronavirus
backbone and spike protein for infecting human cells. The approach could have
generated SARS2-like viruses, and indeed may have created the SARS2 virus
itself with the right combination of virus backbone and spike protein.9
From
his review of WIV research, Dr. Richard Ebright, a molecular biologist and
biosafety expert at Rutgers University, stated, “It is clear that the Wuhan
Institute of Virology was systematically constructing novel chimeric
coronaviruses and was assessing their ability to infect human cells and
human-ACE2-expressing mice.”10
He
further stated, “It is also clear that, depending on the constant genomic
contexts chosen for analysis, this work could have produced SARS-CoV-2 or a
proximal progenitor of SARS-CoV-2.”11
Even
Dr. Peter Daszak, the President of EcoHealth Alliance, noted the humanized mice
and the risks of this research in a December 2019 interview.12
Around
minute 28 of the interview, Dr. Daszak stated:
And
we have now found, you know, after 6 or 7 years of doing this, over 100 new
SARS-related coronaviruses, very close to SARS. Some of them get into human
cells in the lab, some of them can cause SARS disease in humanized mice models
and are untreatable with therapeutic monoclonals and you can’t vaccinate
against them with a vaccine. So, these are a clear and present danger….13
Likewise,
Dr. Steven Quay noted the unique characteristic of efficient human-to-human
transmission of SARS-CoV-2 in his testimony before the June 29, 2021, House
Republican Forum that the SARS CoV-2 virus was “highly adapted for infection of
humans from the start, unlike prior natural zoonoses. And growth in humanized
mice would allow this lab [adaptation],”14
like
in a March 2020 published paper by Dr. Ralph Baric of University of North
Carolina and Dr. Shi of the WIV.
Fourth,
the NIH in the June 28, 2021, staff briefing acknowledged that the NIH-funded
research at the WIV involved mice. One of the two NIH briefers, Dr. Tabak
stated that the only animals that were used in this NIH-funded research at the
WIV were mice. However, to date, the
9 Wade, note 5.
10 Id.
11 Id.
12 Vincent Racaniello, TWiV 615: Peter Daszak of
EcoHealth Alliance - YouTube, This Week in Virology, (May 19, 2020), available
at https://www.youtube.com/watch?app=desktop&v=IdYDL_RK--w
13 Id.
14 Led By Science: The COVID-19 Origin Story: Forum
Before Select Subcomm. on the Coronavirus Crisis, H. Comm. on Oversight &
Reform, 117th Cong. (June 29, 2021) (statement by Dr. Steven Quay).
NIH
has not clarified to the Committee whether the mice used in the NIH-supported
research were humanized mice.
Fifth,
humanized mice have not been ruled out as an intermediate animal host.
According to the World Health Organization joint study with China, more than
80,000 animal samples were tested with no positive results for either SARS
CoV-2 antibodies or for the virus itself in an attempt to identify the
intermediate animal host to support the zoonotic origins theory.15
There
is no evidence that any of these samples included samples of humanized mice at
the WIV.
Finally,
on October 26, 2017, Dr. Ping Chen, the Director of the NIAID office in China
located in the U.S. embassy in Beijing, wrote to several NIAID officials
stating that earlier in the week she had visited the P4 lab at the WIV and that
her contact who helped arrange the visit was Dr. Zhengli Shi, “who is a Chinese
collaborator on a NIAID grant to EcoHealth for SARS like corona virus project”. 16
Unfortunately,
the rest of this email and the trip report were redacted. But, in an April 15,
2020, email sent to Gray Handley of the NIAID with the subject “FW: 2018 Cable”
with the January 2018 State Department cable attached, Dr. Chen stated: “Rick
forwarded the cable. I was listed as a drafter. About half of the content was
taken from my summary”.17
The
January 2018 State Department cable discussed the BSL-4 lab at the WIV, China
investing in infectious disease control, unclear guidelines on virus access,
the lack of trained talent impeding research, and despite limitations, WIV
researchers produce SARS discoveries. For the last topic, the cable noted the
WIV research finding “strongly suggests that SARS-like coronaviruses from bats
can be transmitted to humans to cause SARS-like disease”.18
These
redacted documents provide a reason to believe that the NIH – or at least the
NIAID – had a much higher level of engagement and familiarity with the
EcoHealth Alliance grant and WIV bat coronavirus research than just reading
press reports during April-July 2020 as NIH suggested at the June 28, 2021,
briefing with bipartisan Committee staff.19
Over
600,000 Americans have died from COVID-19 and more than 4 million people
worldwide. We need answers to some basic questions about the origin of the
virus, and yet, the NIH continues to frustrate our efforts to get answers. The
stakes are too high to operate on an
15 World Health Organization, WHO-convened Global
Study of the Origins of SARS-CoV-2 (March 30, 2021) available at
https://www.who.int/health-topics/coronavirus/origins-of-the-virus
16 Judicial Watch, Judicial Watch: New Documents
Show Wuhan Lab Asked NIH Official for Information on Disinfectants; Nine Fauci
Agency Grants for EcoHealth Bat Coronavirus Research, Press Releases (July 8,
2021) available at https://www.judicialwatch.org/press-releases/wuhan-lab-fauci-grants/
17 Id.
18 Josh Rogin, Opinion: State Department cables
warned of safety issues at Wuhan lab studying bat coronaviruses, The Washington
Post (April 14, 2020) available at
https://www.washingtonpost.com/opinions/2020/04/14/state-department-cables-warned-safety-issues-wuhan-lab-studying-bat-coronaviruses/
19 Based on the questions the NIH Office of
Extramural Research asked EcoHealth Alliance, it is unclear that NIH maintained
control, oversight or responsibility of EcoHealth Alliance as its grantee. For
example, in an April 2020 email to EcoHealth Alliance, the NIH Deputy Director
of Extramural Research, Dr. Michael Lauer, asked EcoHealth Alliance for
information about this same grant, to include, “…it would be helpful for us to
know about all China-based participants in this work since the Type 1 grant started
in 2014 - who they were and how much money they received”.
honor
system. This not only undermines NIH’s mission goals, but also Congress’ and
the public’s trust in the NIH. It is time for the NIH to share all information
and documents that it has related to NIAID grant R01AI110964 with the public
and the scientific community.
Therefore,
we request that the NIH provide all documents related to the October 2017 visit
to the WIV, all documents related to NIAID grant R01AI110964, and the
identities of the “other institutions” referenced in NIH’s May letter by July
28, 2021. In addition, we request staff briefings immediately and no later than
July 28, 2021, with the following officials from NIAID: Dr. Ping Chen and Dr.
Erik Stemmy, the program officer for NIAID grant R01AI110964.
If
you have any questions, please contact Alan Slobodin or Diane Cutler of the
Minority Committee staff.
Sincerely,
Cathy
McMorris Rodgers
Republican
Leader
Brett
Guthrie
Republican
Leader Committee on Energy and Commerce
Subcommittee
on Health
H.
Morgan Griffith
Republican
Leader
Subcommittee
on Oversight and Investigations
cc:
The Honorable Frank Pallone, Chairman
The
Honorable Anna Eshoo, Chair, Subcommittee on Health
The
Honorable Diana DeGette, Chair, Subcommittee on Oversight and Investigations
- -
- - -
FRANK
PALLONE, JR., NEW JERSEY
CHAIRMAN
CATHY
McMORRIS RODGERS, WASHINGTON
RANKING
MEMBER
ONE
HUNDRED SEVENTEENTH CONGRESS
Congress
of the United States
House
of Representatives
COMMITTEE
ONENERGY AND COMMERCE
2125
RAYBURN HOUSE OFFICE BUILDING
WASHINGTON,
DC 20515-6115
Majority
(202) 225-2927
Minority
(202) 225-3641
August
24, 2021
The
Honorable Francis Collins, M.D., Ph.D. Director
National
Institutes of Health
9000
Rockville Pike
Bethesda,
MD 20892
Dear
Dr. Collins,
We
have significant concerns that the National Institutes of Health (NIH) has not
been adequately meeting its oversight responsibilities over the National
Institute of Allergy and Infectious Diseases (NIAID) grant R01AI110964, “Understanding
the Risk of Bat Coronavirus Emergence.” The grant was awarded to the non-profit
organization, EcoHealth Alliance, that funneled NIH funds to the Wuhan
Institute of Virology (WIV) to conduct research on bat coronaviruses. In our
July 21, 2021, letter to you, we requested that the NIH provide staff briefings
with Dr. Ping Chen and Dr. Erik Stemmy, NIAID officials involved with this
grant and responsibility for oversight of the WIV. Unfortunately, the NIH has
ignored this request.
In
addition to potentially inadequately assessing the inherent risks of the WIV
research supported by NIH’s grant, we are also concerned that the NIH failed to
oversee biosafety concerns at the WIV. The WIV is a complex of laboratories
with various Biosafety Level (BSL) levels up to a BSL-4, the most secure
biosafety level laboratory. However, under the R01AI110964 grant, the WIV
researchers specifically reported performing coronavirus research in BSL-2
laboratories.1
Yet,
risky coronavirus research should have been conducted in a laboratory with
higher safety measures. The grant award R01AI110964 was subject to biosafety
requirements as acknowledged by NIH in its the July 8, 2020, grant suspension
letter to EcoHealth Alliance: “NIH grantees and subawardees must comply with
the biosafety requirements set forth in the NIH Grants Policy
1 Lei-Ping Zeng, Peter Daszak, Zheng-Li Shi, et al,
Bat Severe Acute Respiratory Syndrome-Like Coronavirus WIV1 Encodes an Extra
Accessory Protein, ORFX, Involved in Modulation of the Host Immune Response,
ASM Journal of Virology (June 24, 2016) available at
https://journals.asm.org/doi/full/10.1128/JVI.03079-15
Statement
(see NIH GPS, § 4.1.24 ‘Public Health Security’) and the Notice of Award (e.g.,
requiring that ‘Research funded under this grant must adhere to the [CDC/NIH
Biosafety in Microbiological and Biomedical Laboratories (BMBL)]).”
These
requirements are especially relevant given the history of serious lab accidents
in China.2
In
1977, the H1N1 influenza virus escaped from a lab in China that caused a
worldwide pandemic.3
Two
lab escapes of the first SARS virus in China were reported in the spring of
2004.4
Most
recently in November 2019, an outbreak of brucellosis occurred in two research
centers in Lanzhou, China, infecting over 100 students and staff members.5
Chinese
experts have also raised concerns about laboratory safety in their own country,
lamenting that “lab trash can contain man-made viruses, bacteria or microbes”
and that “some researchers discharge laboratory materials into the sewer after
experiments without a specific biological disposal mechanism.”6
We
would expect the NIH to know about this history of lab accidents, and to know
that Chinese researchers were conducting bat coronavirus work in BSL-2 labs.
For example, bat coronavirus expert Dr. Ralph Baric of the University of North
Carolina observed that “Historically, the Chinese have done a lot of their bat
coronavirus research under BSL-2 conditions. Obviously, the safety standards of
BSL-2 are different than BSL-3, and lab-acquired infections occur much more
frequently at BSL-2. There is also much less oversight at BSL-2.”7
There
is evidence that WIV conducted other coronavirus propagation research in BSL-2
facilities. We would expect that the NIH would know this as well, since the
evidence is in published literature and presumably in NIH grant progress
reports. For example, in 2016, the WIV and EcoHealth Alliance published a study
partially funded by the NIAID grant that noted the following:
The
SL-CoV WIV1 strain (GenBank accession number KF367457) and other viruses were
propagated as described previously (2). Sendai virus (SeV) strain Cantell
(kindly provided by Hanzhong Wang) was propagated in 10 -day-old embryonated
chicken eggs at 37°C for 48 h (24). All experiments using live virus was
conducted under biosafety level 2 (BSL2) conditions.8 (Emphasis added).
2 Rossana Segreto and Yuri Deigin, The genetic
structure of SARS-CoV-2 doesnot rule out a laboratory origin, Wiley Online
Library (Nov. 17, 2020) available at
https://onlinelibrary.wiley.com/doi/full/10.1002/bies.202000240
3 Id.
4 Id.
5 Id.
6 Liu Caiyu and Leng Shumei, Biosafety guideline
issued to fix chronic management loopholes at virus labs, Global Times (Feb.
16, 2020) available at https://www.globaltimes.cn/content/1179747.shtml
7 Rowan Jacobsen, We never created a supervirus
Ralph Baric explains gain-of-function research, MIT Tech Review (July 26, 2021)
available at
https://www.technologyreview.com/2021/07/26/1030043/gain-of-function-research-coronavirus-ralph-baric-vaccines/
8 Lei-Ping Zeng, et al, Bat Severe Acute Respiratory
Syndrome-Like Coronavirus WIV1 Encodes an Extra Accessory Protein, ORFA,
Involved in Modulation of the Host Immune Response, Journal of Virology, (Jul.
15, 2016) available at https://archive.ph/dQRTH#selection-1225.0-1245.93
We
would also expect that the NIH would recognize that the NIAID grant was
supporting deficient and potentially dangerous biosafety practices. We note
that Dr. Baric stated all his research studies on bat coronaviruses are
conducted in BSL-3 plus conditions, and that he would not conduct the WIV’s
experiments in BSL-2 labs. Dr. Baric said: “There’s definitely some risk
associated with these and other SARS-like bat viruses that can enter human
cells.”9
Further,
the “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) manual,
co-authored by the NIH explains:
Biosafety Level 3 is applicable to clinical,
diagnostic, teaching, research, or production facilities where work is
performed with indigenous or exotic agents that may cause serious or
potentially lethal disease through the inhalation route of exposure. [Emphasis
added] Laboratory personnel must receive specific training in handling
pathogenic and potentially lethal agents, and must be supervised by scientists
competent in handling infectious agents and associated procedures. 10
For
this reason, the Centers for Disease Control and Prevention required that live
virus samples of SARS CoV2 could only be shipped to BSL-3 labs.11
NIH
has admitted awareness of biosafety concerns at the WIV. In its July 8, 2020,
letter to EcoHealth Alliance, NIH acknowledged receiving reports of serious
biosafety concerns at the WIV:
However,
as you are aware, the NIH has received reports that the Wuhan Institute of
Virology (WIV), a subrecipient of EcoHealth Alliance under R01AI110964, has
been conducting research at its facilities in China that pose serious
bio-safety concerns and, as a result, create health and welfare threats to the
public in China and other countries, including the United States.
NIH
expressed its concerns that EcoHealth Alliance and the WIV had not satisfied
safety requirements as recipients of NIH grant funds. NIH further acknowledged
in the July 8, 2020, letter: “We have concerns that WIV has not satisfied
safety requirements under the award, and that EcoHealth Alliance has not
satisfied its obligations to monitor the activities of its subrecipient to
ensure compliance.” Specifically, former U.S. Deputy Assistant Secretary of
State, David Feith, stated that he had uncovered safety issues at the WIV: “There
was work with very dangerous viruses carried out at Biosafety Level 2, which
has been compared to the safety level roughly of a dentist’s office.”12
9 Rowan Jacobsen, We never created a supervirus
Ralph Baric explains gain-of-function research, MIT Tech Review (July 26, 2021)
available at
https://www.technologyreview.com/2021/07/26/1030043/gain-of-function-research-coronavirus-ralph-baric-vaccines/
10 Lei-Ping Zeng, Bat Severe Acute Respiratory
Syndrome-Like Coronavirus WIV1 Encodes an Extra Accessory Protein, ORFX,
Involved in Modulation of the Host Immune Response, (Jun 24, 2016) available at
https://www.cdc.gov/labs/pdf/CDC-BiosafetymicrobiologicalBiomedicalLaboratories-2009-P.pdf
11 Glenn Rockman, To accelerate innovation, the CDC should
ease limits on which labs can handle the coronavirus, STAT (Apr. 14, 2020)
available at
https://www.statnews.com/2020/04/14/allow-bsl-2-labs-handle-novel-coronavirus/
12 CBS News, GOP seeks records on possible U.S.
funding of research at Chinese lab before pandemic (July 22, 2021) available at
https://www.cbsnews.com/news/gop-pressing-for-records-on-possible-us-funding-research-chinese-lab-before-pandemic/
Though
the NIH wrote in its July 8, 2020, letter to EcoHealth Alliance that U.S. State
Department cables in 2018 raised safety concerns about the WIV, the NIH failed
to acknowledge how its own scientist stationed in Beijing, Dr. Ping Chen of
NIAID, personally visited the WIV in 2017 and co-wrote one of the 2018 U.S.
State Department warning cables. The information about NIH’s awareness of the
WIV safety concerns and its part in supplying that information to the U.S.
State Department, only became publicly known from recently released NIH emails
in response to Freedom of Information Act requests. Although a representative
from the NIAID played a critical role in the 2018 State Department cables
raising concerns about the WIV, there is no record of NIH taking any oversight
action regarding the EcoHealth Alliance grant until after April 14, 2020, when
these Department cables were publicly revealed in a Washington Post column.
There
is no apparent justification for NIH officials to permit the NIAID grant to
support BSL-3 research at the BSL-2 level. When propagating a coronavirus and
the risks of the research are unknown, work must be done in a BSL-3 lab until
it is verified and confirmed that propagating a virus does not raise a public
health concern. Only after such confirmation can the research be moved to
BSL-2. The NIH, in accordance with its own policies and BMBL, should have
required EcoHealth Alliance to ensure that all SARS CoV research by its
sub-grantee was done in a BSL-3 lab. Even if the research did not meet a
technical definition of gain-of-function research, we have concerns that NIH
failed to address the potential risks associated with virus propagation research
in a BSL-2 lab with pathogens like SARS CoV that has of Dual Use of Research
Concern (DURC) potential, a research category of which gain-of-function
research is a subset. Further, NIH’s belated oversight interest in this grant
in 2020 has been completely ineffective, and NIH has shown no interest or
capability in getting compliance from its grantee EcoHealth Alliance.
EcoHealth
Alliance’s grant remains suspended in-house with NIH, though the NIH through
the Department of Health and Human Services has failed to report publicly the
grant suspension on the www.SAM.gov database, which provides a reporting
mechanism that can alert other U.S. Government agencies of risky non-compliant
behavior of grant recipients. For over a year, EcoHealth Alliance has not
complied with the terms of the NIH award. In the June 28, 2021, virtual meeting
with Committee staff, NIH gave no indication of any interest in taking further
action against EcoHealth Alliance for award noncompliance. In fact, when asked
if they would further pursue information gathering from EcoHealth Alliance, NIH
stated that all of EcoHealth’s research had been published. In order for NIH to
be convinced they should take action to obtain NIH-funded data from EcoHealth
Alliance, NIH put the burden on the Minority committee staff to supply
documented statements from EcoHealth Alliance indicating that EcoHealth
Alliance represented that they are in possession of unpublished bat coronavirus
sequences. Despite the Minority staff supplying such statements, there is still
no indication from NIH that they will do anything on this front.
As
indicated by the NIH’s July 8, 2020, letter suspending EcoHealth Alliance’s
grant, the NIH and the grantee are not absolved from ensuring sound biosafety
practices regardless of the merits of the research. After first notifying
EcoHealth Alliance in April 2020 that it must provide information to NIH to be
in compliance with the terms of its grant for project number R01AI110964, NIAID
separately awarded a $3 million cooperative agreement in June 2020 to EcoHealth
Alliance, followed by another cooperative agreement award to EcoHealth Alliance
in September 2020 for $1.15 million.13
After
notifying EcoHealth Alliance that their funding would stop until they complied
with NIH’s requests for information, providing additional funding to EcoHealth
Alliance in $4.5 million in NIAID cooperative agreements thereby undercut NIH’s
ability to get EcoHealth Alliance to comply with NIH’s requests for information
on biosafety practices and other issues at the WIV. The new funding to
EcoHealth Alliance suggests that the NIH is not serious about oversight of NIH
grants and, more specifically, its compliance requests of EcoHealth Alliance in
its July 8, 2020, letter.
NIH’s
conduct in this case raises serious doubts about NIH’s competent stewardship of
research funds. If the NIH continues down this path, the NIH risks losing
substantial public support and risks undermining public health efforts that are
based on trust in NIH.
We
urge you to be transparent and produce all documents and information related to
the NIAID grant and to provide in writing the NIH’s complete understanding of
the NIH-supported research conducted at the WIV by September 7, 2021. Please
immediately make arrangements to schedule the staff briefings with Dr. Ping
Chen and Dr. Erik Stemmy. Finally, in light of our concerns, please respond to
the following:
1. In recent testimony before the Senate
Committee on Health, Education, Labor and Pensions, Dr. Anthony Fauci, Director
of NIAID, testified that the WIV research in question “was judged by qualified
staff up and down the chain as not being gain of function”.
a. Please provide names and positions of
the staff involved. Please provide details on the scope of the review and the
process for how the review was conducted. Please identify all documents used in
the review and submit these documents.
b. Did the staff review the biosafety
practices and BSL level of labs that were involved with the WIV research? If
so, what were their findings?
c. Did the staff know how many novel
coronaviruses were being studied at the WIV? If so, please provide the
information.
d. Were staff aware of the WIV’s standard
operating procedures for working with a novel coronavirus? If so, please
provide the information.
13 USA Spending.gov, EcoHealth Alliance, Advanced
Recipient Search (Aug. 2, 2021) available at
https://www.usaspending.gov/search/?hash=b2b11ac84d498190e8e69a33c04cdd99
e. Were staff aware of how the WIV
collected virus samples? If so, please provide the information.
f. Were staff aware of the standard
operating procedures at the WIV for propagating or culturing viruses? If so,
please provide the information.
g. Did the staff have information on the
biosafety procedures at the WIV designed to prevent potential exposure events?
If so, please provide the information.
h. Did the staff know what cell lines were
used at the WIV? If so, please provide the information.
i. Did the staff know what safety
measures were used at the WIV to prevent cross-contamination? If so, please
provide the information.
j. Did the staff have information on the
training records of the staff? If so, please provide the information.
14
2. Since EcoHealth Alliance still has its
NIAID grant suspended due to lack of cooperation with the NIH, why is NIAID
continuing to fund EcoHealth Alliance through other cooperative agreements?
3. When did the NIH first recognize
biosafety concerns at the WIV? What actions were taken?
If
you have any questions, please contact Alan Slobodin or Diane Cutler of the
Minority Committee staff.
Sincerely,
Cathy
McMorris Rodgers
Ranking
Member
Brett
Guthrie
Ranking
Member Committee on Energy and Commerce
Subcommittee
on Health
14 Sub-questions (g), and (j) were suggested by Dr.
Ralph Baric to MIT Tech Review, note 9.
H.
Morgan Griffith Ranking Member
Subcommittee
on Oversight and Investigations
cc:
The
Honorable Frank Pallone, Chairman
The
Honorable Anna Eshoo, Chair, Subcommittee on Health
The
Honorable Diana DeGette, Chair, Subcommittee on Oversight and Investigations
- -
- - -
FRANK
PALLONE, JR., NEW JERSEY
CHAIRMAN
CATHY
McMORRIS RODGERS, WASHINGTON
RANKING
MEMBER
ONE
HUNDRED SEVENTEENTH CONGRESS
Congress
of the United States
House
of Representatives
COMMITTEE
ON ENERGY AND COMMERCE
2125
RAYBURN HOUSE OFFICE BUILDING
WASHINGTON,
DC 20515-6115
Majority
(202) 225-2927
Minority
(202) 225-3641
October
27, 2021
The
Honorable Francis Collins, M.D., Ph.D.
Director
National Institutes of Health
9000
Rockville Pike
Bethesda,
MD 20892
Dr.
Collins,
We
write again asking the National Institutes of Health (NIH) to be transparent
about its relationship with EcoHealth Alliance (EcoHealth) and to provide
information and documents related to National Institute of Allergy and
Infectious Diseases (NIAID) grant project number R01AI110964, “Understanding
the Risk of Bat Coronavirus Emergence.”1
In
2014, NIH awarded this grant to EcoHealth, the non-profit organization that in
turn funneled those funds to the Wuhan Institute of Virology (WIV)2
and
to additional research organizations to support risky research in China.
Since
March 2021, we have led a comprehensive examination of how the COVID-19
pandemic started. Understanding the root cause of this pandemic will help us
prevent future pandemics. We are examining in connection with this effort
whether NIH oversight of risky research conducted by an NIH sub-grantee in
China was adequate to prevent or render it implausible that a lab accident
could have been involved in the origins of the pandemic. Based on a review of
documents and other information recently made available, we have significant
1 This is our fourth letter to NIH seeking
information related to oversight of NIAID’s grant R01AI110964. Our prior
letters dated March 18, 2021, July 21, 2021 and August 24, 2021 are available
at https://republicans-energycommerce.house.gov/the-covid-19-origins-investigation/
At this time, NIH has yet to respond in writing to
any of the questions in these letters, and only produced EcoHealth grant
documents to us after HHS had released them to The Intercept in response to a
Freedom of Information Act lawsuit.
2 This funding was in addition to USAID funding to
EcoHealth that was also funneled to the WIV during this timeframe. USA
Spending.gov, EcoHealth Alliance, Advanced Recipient Search (Aug. 2, 2021),
available at https://www.usaspending.gov/search/?hash=b2b11ac84d498190e8e69a33c04cdd99
An April 6, 2016 correction to the Nov. 20, 2015
research article acknowledged the USAID-EPT-PREDICT funding source from
EcoHealth Alliance to Zhengli Shi. Menachery, V. et al, Correction:
Corrigendum: A SARS-like cluster of circulating bat coronaviruses shows
potential for human emergence, Nature Medicine (Apr. 6, 2016), available at
https://www.nature.com/articles/nm0416-446d
concerns
about the adequacy of NIH oversight of EcoHealth and the related research
activities at the WIV and other organizations in China.
In
2016, EcoHealth proposed a research project with the WIV using humanized mice
to test several chimeric viruses to see if these experiments would show whether
these viruses could infect human cells. EcoHealth portrayed the risks of these
experiments as if they were not of concern, and the NIH accepted EcoHealth’s
assertions without a searching inquiry. However, the assessment of the risks by
both EcoHealth and the NIH do not seem to square with the understanding of the
research risks at that time. Although the engineered viruses at the WIV were
far from SARS CoV-2 on the coronavirus family tree, this research reflected a
high tolerance for risk.3
As
noted by Stanford University microbiologist David Relman, “[The WIV] were
essentially playing Russian roulette with the virus that the world’s expert had
labelled poised for human emergence. It’s the willingness to manipulate them
without due concern.”4
Further,
the one condition imposed by the NIH was the requirement that EcoHealth stop
the humanized mice experiment and notify the NIH if the result was a virus with
enhanced growth by more than ten times (or one log) compared to the parental
backbone or strains found in nature. The purpose of this policy was to
safeguard against experiments creating viruses that could replicate quickly and
had the potential to overwhelm the immune systems of humans. We believe the
EcoHealth grant documents indicated such a reportable result from the
experiment, but there is no evidence of EcoHealth taking the required actions,
or the NIH raising any questions after getting the results of the experiment
from EcoHealth. If EcoHealth and NIH could not handle compliance and oversight
of such a basic policy, it raises more concerns about the overall adequacy of
the oversight of this research, which leaves the public vulnerable to a serious
lab accident.
In
addition to how NIH examined the research proposal, the funding of EcoHealth by
NIH after the suspension of their grant raises serious concerns about NIH’s
management and oversight of grants. Following an initial grant termination in
April 2020, NIH reinstated the grant and then suspended the grant in July 2020
because of EcoHealth’s inadequate oversight of the WIV.5
When
NIH asked EcoHealth to provide information related to its subaward to the WIV,
EcoHealth refused to comply with most of the requests.6
Despite
EcoHealth’s unwillingness to cooperate, NIH paid an additional $369,819 to
EcoHealth on July 13, 2020, a mere five days after its grant was suspended. NIH’s
payment seems inconsistent with NIH’s grant policy and possibly violates other
federal laws and regulations.7
NIH
also failed to report EcoHealth’s noncompliance and grant suspension into the
www.SAM.gov database that alerts other U.S. Government agencies to risky grant
recipients. Remarkably, the NIH, U.S. Agency for International Development
(USAID), and Department of Defense (DoD) have paid EcoHealth more than $23.4
million in new and renewed assistance
3 Carolyn Korman, The Mysterious Case of the
COVID-19 Lab Leak Theory, The New Yorker (October 12, 2021), available at
https://www.newyorker.com/science/elements/the-mysterious-case-of-the-covid-19-lab-leak-theory
4 Id.
5 Mark Moore, NIH investigating Wuhan lab at center
of coronavirus pandemic, NEW YORK POST (Apr. 28, 2020), available at
https://nypost.com/2020/04/28/nih-investigating-wuhan-lab-at-center-of-coronavirus-pandemic/
6 Id. EcoHealth did report select subgrant funding
data on July 13, 2020 into a public database. NIH had raised concerns that
EcoHealth had not accounted for its funding of subgrantees.
7 USA Spending.gov, EcoHealth Alliance, Advanced
Recipient Search (Oct. 13, 2021), available at
https://www.usaspending.gov/award/ASST_NON_R01AI110964_7529
awards
since April 2020, when NIH should have reported the administrative action it
took against EcoHealth’s grant. To date, NIH has refused to address any of
these concerns.
We
outline our concerns in more detail about NIH’s oversight of the EcoHealth
grant in the discussion that follows.
Grant
Documents and Other Information Made Recently Available
On
September 7, 2021, after the Department of Health and Human Services (HHS)
produced documents related to the EcoHealth grant because of a Freedom of
Information Act (FOIA) lawsuit, HHS shared essentially the same documents with
us.8
On
September 29, 2021, Principal Deputy Director Lawrence Tabak briefed bipartisan
Committee staff about the EcoHealth grant documents. Unfortunately, HHS and NIH
did not accommodate the staff request to include subject matter experts and
witnesses with first-hand knowledge from NIAID in this briefing. HHS arranged
an in-person bipartisan Committee staff in camera review of the printed copies
of the four highly relevant letters between NIH and EcoHealth about EcoHealth’s
humanized mice research proposal. These documents raise significant concerns
about NIH’s management and oversight of the EcoHealth grant.9
HHS
Oversight Policy of Gain-of-Function Research Was Weakened in Recent Years
On
August 30, 2021, the Washington Post published an article, A Science in the
Shadows, detailing how the HHS oversight process over risky research, often
referred to as Gain-of-Function (GOF) research, was weakened in recent years
from the policy established in 2012.10
For
example, in December 2017, the review process known as the HHS Framework for
Guiding Funding Decisions about Proposed Research Involving Enhanced Potential
Pandemic Pathogens Care and Oversight (P3CO) was revised to remove any
authority by the HHS P3CO review group to block GOF research proposals.11
Instead,
HHS redefined GOF research, which has given NIH leaders the sole discretion to
approve GOF projects without referring them to the HHS PC3O review group.12
In
a significant policy change, the 2017 policy also narrowed the criteria for
review of GOF research to cover only altered pathogens “likely capable of wide
and uncontrollable spread in human populations.”13
The
review policy that started in October 2014, required experiments to
8 Sharon Lerner and Mara Hvistendahl, New Details
Emerge About Coronavirus Research at Chinese Lab, The Intercept (Sept. 6,
2021), available at
https://theintercept.com/2021/09/06/new-details-emerge-about-coronavirus-research-at-chinese-lab/
The NIH document production appears identical to
their production to The Intercept, except the documents NIH provided to us do
not include FOIA exemption numbers in the redactions and instead include Bates
numbered pages.
9 A bipartisan in camera private in-person
inspection of the physical copies of four letters dated May 18, 2016, June 8,
2016, July 7, 2016, and July 5, 2018 controlled by NIH was conducted at HHS
headquarters on Oct. 5, 2021, monitored by HHS staff.
10 David Willman and Madison Muller, A Science in
the Shadows, The Washington Post (Aug. 26, 2021), available at
https://www.washingtonpost.com/nation/interactive/2021/a-science-in-the-shadows/
11 Id.
12 Id.
13 U.S. Department of Health and Human Services,
Framework for Guiding Funding Decisions about Proposed Research Involving
Enhanced Potential Pandemic Pathogens, Dual Use Research of Concern (Dec. 19,
2017), available at https://www.phe.gov/s3/dualuse/Documents/P3CO.pdf
be reviewed if they expected to generate flu and coronaviruses that would be “transmissible among mammals” and might accidentally cause human infections.14 (Emphasis added).
A
GOF Experiment Warning by Dr. Ralph Baric and Others
In
2015, Dr. Ralph Baric of the University of North Carolina – Chapel Hill, Dr.
Zheng-Li Shi of the WIV, and others published a study in Nature, titled A
SARS-Like Cluster Of Circulating Bat Coronaviruses Shows Potential For Human
Emergence.15
Dr.
Baric and Dr. Shi have each collaborated previously with EcoHealth.
Importantly, EcoHealth, through its funding from USAID, helped support Dr. Shi
of the WIV in this particular study.16
Near
the end of this publication, the authors issued a warning about a potential
threat of certain viruses identified with the SHC014 reference number:
We
consider viruses with the SHC014 spike a potential threat owing to their
ability to replicate in primary human airway cultures, the best available model
for human disease. In addition, the observed pathogenesis in mice indicates a
capacity for SHC014-containing viruses to cause disease in mammalian models,
without RBD adaptation.17
In
the next paragraph, the authors explain the context of GOF research and how
their expectation that the viruses they created would not increase
pathogenicity turned out to be wrong after they conducted the experiments:
In
addition to offering preparation against future emerging viruses, this approach
must be considered in the context of the U.S. government–mandated pause on
gain-of-function (GOF) studies. On the basis of previous models of emergence,
the creation of chimeric viruses such as SHC014-MA15 was not expected to
increase pathogenicity. Although SHC014-MA15 is attenuated relative to its
parental mouse-adapted SARS-CoV, similar studies examining the pathogenicity of
CoVs with the wild-type Urbani spike within the MA15 backbone showed no weight
loss in mice and reduced viral replication. Thus, relative to the Urbani
spike–MA15 CoV, SHC014-MA15 shows a gain in pathogenesis.18
The
authors then explain that scientific review panels may determine that similar
studies would be too risky, so any further research may be limited going
forward:
14 The White House, Doing Diligence to Assess the
Risks and Benefits of Life Sciences Gain-of-Function Research, Blog (Oct. 17,
2014), available at
https://obamawhitehouse.archives.gov/blog/2014/10/17/doing-diligence-assess-risks-and-benefits-life-sciences-gain-function-research
15 Menachery, V. et al, A SARS-like cluster of
circulating bat coronaviruses shows potential for human emergence, Nature
Medicine (Nov.20, 2015), available at https://www.nature.com/articles/nm.3985
16 An April 6, 2016 correction to the Nov. 20, 2015
research article acknowledged the USAID-EPT-PREDICT funding source from
EcoHealth Alliance to Zhengli Shi. Menachery, V. et al, Correction:
Corrigendum: A SARS-like cluster of circulating bat coronaviruses shows
potential for human emergence, Nature Medicine (Apr. 6, 2016), available at
https://www.nature.com/articles/nm0416-446d
17 Menachery, V. et al, A SARS-like cluster of
circulating bat coronaviruses shows potential for human emergence, Nature
Medicine (Nov.20, 2015), available at
https://www.nature.com/articles/nm.3985.pdf
18 Id.
On
the basis of these findings, scientific review panels may deem similar studies
building chimeric viruses based on circulating strains too risky to pursue, as
increased pathogenicity in mammalian models cannot be excluded. Coupled with
restrictions on mouse-adapted strains and the development of monoclonal
antibodies using escape mutants, research into CoV emergence and therapeutic
efficacy may be severely limited moving forward.19
Finally,
the authors advise that the purpose of their study – to prepare potentially for
and mitigate future outbreaks – must be carefully weighed against dangers posed
by the experiments creating more dangerous pathogens. Notably, the authors
considered whether similar studies should be pursued:
Together,
these data and restrictions represent a crossroads of GOF research concerns;
the potential to prepare for and mitigate future outbreaks must be weighed
against the risk of creating more dangerous pathogens. In developing policies
moving forward, it is important to consider the value of the data generated by
these studies and whether these types of chimeric virus studies warrant further
investigation versus the inherent risks involved.20
Letters
Reveal NIH and EcoHealth Discussed GOF Research Concerns
HHS
allowed bipartisan Committee staff to see three letters from NIH to EcoHealth
(May 18, 2016, July 7, 2016, and July 5, 2018) and one letter from EcoHealth to
NIH (June 8, 2016) in an in camera review.21
To
our knowledge, NIH has not publicly disclosed these letters, although some of
the contents in these letters appear to have been used in NIH correspondence to
U.S. Senators.22
During
the 2014 GOF moratorium in the United States, EcoHealth submitted its Year Two
progress report dated May 13, 2016, to NIAID for grant R01AI110964. EcoHealth
disclosed it would conduct experiments in humanized mice using two chimeric bat
coronaviruses. 23
In
response to the experiment descriptions in EcoHealth’s research progress
report, NIH wrote to EcoHealth on May 28, 2016,24
to
advise that NIAID determined the R01AI110964 grant research project may include
GOF experiments subject to the 2014 GOF research pause.25
19 Id.
20 Id.
21 A bipartisan in camera private in-person
inspection of the physical copies of four letters dated May 18, 2016, June 8,
2016, July 7, 2016, and July 5, 2018, was conducted at HHS headquarters on Oct.
5, 2021, monitored by HHS staff. Information presented as letter excerpts are
produced from detailed staff notes because NIH refused to release copies of the
letters to the Committee.
22 See July 28, 2021, letter from NIH Director
Francis Collins to U.S. Senator Charles Grassley, available at
https://www.grassley.senate.gov/imo/media/doc/national_institutes_of_health_to_grassley_-_covid_origins_grant_oversight.pdf
23 Sharon Lerner and Mara Hvistendahl, New Details
Emerge About Coronavirus Research at Chinese Lab, The Intercept (Sept. 6,
2021), available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-of-bat-coronavirus-emergence/
24 May 18, 2016, NIH letter to EcoHealth (per notes
taken by Minority Committee staff Oct. 5, 2021 during bipartisan in camera review).
25 On Oct. 17, 2014, the White House Office of
Science and Technology Policy and the U.S. Department of Health and Human
Services instituted a pause on funding research of Gain-of-Function (GOF)
experiments involving influenza, SARS, and MERS viruses following multiple
biosafety accidents at U.S. laboratories. The White House, Doing Diligence to
Assess the Risks and Benefits of Life Sciences Gain-of-Function Research, Blog
(Oct. 17, 2014), available at
https://obamawhitehouse.archives.gov/blog/2014/10/17/doing-diligence-assess-risks-and-benefits-life-sciences-gain-function-researcH,
and available at http://www.phe.gov/s3/dualuse/Documents/gain-of-function.pdf
Under
the signature of Dr. Peter Daszak, its president, chief scientist, and grant
principal investigator, EcoHealth replied to NIH on June 8, 2016, asserting
their research was not GOF.26
These
2 chimeric bat-like CoVs were constructed on Sept. 24, 2015. They use the
backbone of a group 2b SARS-like bat CoV WIV1 and the spike proteins of two
newly discovered bat SL-CoVs (Rs7327 and RsSHC014). The construction of these
chimeric viruses aims to understand the receptor usage and infectivity of bat
SL-CoVs that may be progenitors of SARS-CoV. We have not yet tested the
pathogenicity of these viruses in animals.27
There
was no discussion of how the RsSHC014 differed from the SHC014 spike protein of
concern in the 2015 Baric et al warning. If there was no difference between
these viruses, then there was no assessment of a known risk. In addition to the
potential threat of the RsSHC014 spike, the WIV1 backbone was already known to
be potentially dangerous to humans.28
Nevertheless,
EcoHealth stated that its research would not be considered GOF because the
virus it was using had never previously infected humans:
We
believe that this work would not be considered GOF because the pause
specifically targeted experiments that related to the pathogenicity or
transmissibility of SARS-CoV, MERS CoV and any influenza virus. Our molecular
clone is WIV1, which is a group 2b SARS-like bat coronavirus that has never
been demonstrated to infect humans or cause human disease.29
EcoHealth
also argued that because the virus was ten percent different from the original
SARS-CoV, their research did not qualify being subject to the GOF moratorium.
EcoHealth continued its justification by explaining that because EcoHealth
and/or the WIV would progressively introduce spike proteins that were
progressively more distant from the original SARS-CoV, that the research was
not subject to the GOF pause. EcoHealth also explained that its theory was
supported by the 2015 publication of Dr. Ralph Baric’s study:
Moreover,
we are introducing progressively more distant S glycoproteins into WIV1 (The
RBD of Rs7327 differs from WIV1 in several amino acid residues while RsSHC014
is even more distantly related phylogenetically), so it seems progressively
less likely that any of these viruses would be more pathogenic or transmissible
than the SARS-CoV. This is further supported by the fact that
26 June 8, 2016, EcoHealth letter to NIH (per notes
taken by Minority Committee staff Oct. 5, 2021 during bipartisan in camera review).
27 Id.
28 Carolyn Korman, The Mysterious Case of the COVID-19 Lab Leak Theory, The New Yorker (October 12, 2021), available at https://www.newyorker.com/science/elements/the-mysterious-case-of-the-covid-19-lab-leak-theory
(“Shi’s lab developed its own platform for creating chimeric viruses. She
crossed another bat coronavirus from Yunnan—named WIV1—with clones of different
novel spike proteins and tested the creation in humanized mice. The viruses
quickly replicated. One made the mice emaciated, a sign of severe pathogenesis.
What made this work especially risky was that WIV1 was already known to be
potentially dangerous to humans. Baric himself had made this clear in a 2016
study titled ‘SARS-Like WIV1-CoV Poised for Human Emergence.’”) (Emphasis
added).
29 June 8, 2016, EcoHealth letter to NIH (per notes
taken by Minority Committee staff Oct. 5, 2021, during bipartisan in camera review).
Professor
Ralph Baric’s group (Menachery et al 2015, Nature Medicine 21, 1508-1513…PNAS,
113 (11): 3048-3053) took WIV1 spike and inserted it onto a SARS-CoV backbone
and showed reduced pathogenicity in mice with human ACE-2 relative to SARS-CoV
(mortality rates were much lower, therefore this is loss of function). This
strongly suggests that the chimeric bat spike/bat backbone viruses should not
have enhanced pathogenicity in animals.30
NIH
Agreed with EcoHealth’s Self-Assessment and Added Grant Conditions
In
a July 7, 2016, response letter to EcoHealth, NIH replied that NIAID agreed
with EcoHealth’s determination that its work was not subject to the GOF pause
based on its review of the original grant application, and cited two of the
justifications provided by EcoHealth as the basis for its agreement:
NIAID
is in agreement that the work proposed under Aim 3 to generate MERS-like or
SARS-like chimeric coronaviruses (CoVs) is not subject to the GOF research
funding pause. This determination is based on the following: (1) the chimeras
will contain only S glycoprotein genes from phylogenetically distant bat CoVs;
and (2) recently published work demonstrating that similar chimeric viruses
exhibited reduced pathogenicity. Therefore, it is not reasonably anticipated
that these chimeric viruses will have enhanced pathogenicity and/or
transmissibility in mammals via the respiratory route.31
As
a result, the NIAID added the following award condition, per the grant
documents:
NIAID
acknowledges that if any of the MERS-like or SARS-like chimeras generated under
this grant show evidence of enhanced virus growth greater than 1 log over the
parental backbone strain, Dr. Daszak will immediately stop all experiments w/
these viruses and provide the NIAID Program Officer and Grants Management
Specialist, and Wuhan Institute of Virology Institutional biosafety Committee,
with the relevant data and information related to these unanticipated outcomes.
(Emphasis added).32
In
a revised grant award notice for Year Three, NIAID added the following in the
special terms and conditions section:
Per
the letter dated July 7, 2016 to Mr. Aleksei Chmura at EcoHealth Alliance,
should any of the MERS-like or SARS-like chimeras generated under this grant
show evidence of enhanced virus growth greater than 1 log over the parental
backbone strain you must stop all experiments with these viruses and provide
the NIAID Program Officer and Grants Management Specialist, and Wuhan Institute
30 Id.
31 Id.
32 Id.
of
Virology Institutional Biosafety Committee with the relevant data and
information related to these unanticipated outcomes.33 (Emphasis added).
Neither
EcoHealth nor NIAID discussed alternative approaches that could have been less
risky but may have been able to achieve the same research goals.
EcoHealth’s
Progress Report for Year Four Raises Question of Cover-up
EcoHealth
submitted a Year Four progress report in September 2020, two years after when
the report should have been submitted to receive Year Five funding.34
The
original EcoHealth’s Year Four progress report that was presumably revised
should have been submitted to NIH in spring 2018. However, this report was not
included in the production to The Intercept or to us.
Sometime
during Year Four of the grant (June 1, 2017-May 31, 2018), the humanized mice
experiments with the chimeric viruses were carried out.35
The
Year Four progress report discussing these experiments are controversial
because of the rarity of a progress report being submitted two years late.
Given the strict NIH rules regarding the release of grant funds, it is believed
that the Year Four progress report may have replaced an earlier version of the
Year Four progress report.36
It
is highly unusual for a grantee to replace a progress report.
Contrary
to Dr. Tabak’s stated belief to bipartisan Committee staff during the June 28,
2021, briefing that all of EcoHealth’s grant-supported research was published,
and thus it was unlikely that EcoHealth would have much unpublished data,
Minority Committee staff was unable to find any published studies for EcoHealth’s
humanized mice experiment discussed in the grant. The humanized mice experiment
results EcoHealth reported to NIH, as described in the grant documents, showed
that the SHC014S virus seriously infected the mice and caused them to lose 20
percent of their body weight in six days.37
EcoHealth
and the WIV infected humanized mice with the WIV1 parental virus and three
chimeric viruses containing SHC014S, WIV16S and Rs4231S.38
At
two and four days post-infection, “viral loads in lung tissues of mice
challenged with all three chimeras reached >106 genome copies per/g,
significantly higher than related WIV1 infection (Fig. 6b). This demonstrates
that pathogenicity of SARS-related coronaviruses in humanized mice differs with
divergent S proteins, confirming the value of this model in assessing novel
SARS related coronavirus pathogenicity.”39 (Emphasis added).
33 EcoHealth grant documents at 189, available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-of-bat-coronavirus-emergence/
34 Mara Hvistendahl and Sharon Lerner, NIH Bat
Coronavirus Grant Report Was Submitted More Than Two Years Late, The Intercept,
(Oct. 1, 2021), available at
https://theintercept.com/2021/10/01/nih-bat-coronavirus-grant-ecohealth-alliance/
35 EcoHealth grant documents at 485-486 available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-of-bat-coronavirus-emergence/
36 Mara Hvistendahl and Sharon Lerner, NIH Bat
Coronavirus Grant Report Was Submitted More Than Two Years Late, The Intercept,
(Oct. 1, 2021), available at
https://theintercept.com/2021/10/01/nih-bat-coronavirus-grant-ecohealth-alliance/
37 EcoHealth grant documents at 486, available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-of-bat-coronavirus-emergence/
38 Id.
39 Id. The use of the word “confirming” suggests a
previous belief that the experiment would demonstrate increased pathogenicity
seen in the experiment’s results rather than simply showing reduced
pathogenicity, which was the purported justification that the experiment was
not GOF.
NIH’s
Re-Review of EcoHealth Grant Found Research Was Not Subject to the P3CO Risk
Analysis Framework Policy
Despite
the documents NIH produced to us in which EcoHealth’s Year Four progress
report, dated September 16, 2020, more than two years after when it should have
been submitted, NIH approved EcoHealth’s Year Five grant renewal with a Notice
of Award dated June 18, 2018.
Even
though the proposed humanized mice experiment would have been already conducted
during 2016 to 2017, NIH wrote on July 5, 2018, to EcoHealth reaffirming its
July 7, 2016, determination that EcoHealth’s proposed research was not a GOF
experiment under the HHS P3CO framework. In its July 2018 letter, NIH did not
cite any new or additional evidence to show the research was not subject to the
HHS P3CO framework.40
The
experiments to generate MERS-like or SARS-like chimeric coronaviruses, are not
subject to the HHS P3CO framework. The terms and conditions of the award have
been revised to indicate that should experiments proposed in this award result
in a virus with enhanced growth by more than 1 log compared to wild type
strains, you must notify your NIAID Program Officer, and Grants Management
specialist immediate and that further research involving the resulting
virus(es) may require review by the DHHS in accordance with the HHS PC30
Framework.41
In
its November 5, 2018, progress report to NIH for the period of June 1, 2014
through May 31, 2019, EcoHealth reported that the strains of the viruses it was
using in its experiments could represent a significant threat to public health
because they could escape existing vaccine and therapeutic treatments.42
Preliminary
Observations
Based
on the totality of these studies and reports made available so far, we make the
following preliminary observations:
• The revised 2017 HHS definition of
GOF research appears to be too narrow because it does not capture SARS-like or
MERS-like viruses that are very similar to SARS or MERS. On January 23, 2020,
Dr. Christian Hassell, the Chair of the HHS P3CO review group, expressed
concern about the narrow definition in the most recent meeting of NIH’s
National Science Advisory Board for Biosecurity (NSABB): “I’ll just probably be
more frank than may be appropriate - I think that’s too narrow. My view on this
thing is, don’t
40 July 5, 2018, NIH letter to EcoHealth (per notes
taken by Minority Committee staff Oct. 5, 2021 during bipartisan in camera review).
41 Id.
42 EcoHealth grant documents at 486, available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-of-bat-coronavirus-emergence/
use
too fine a filter.”43
No
additional meetings or communications have been taken in a year and nine months
by NIH to address Dr. Hassell’s concerns.44
• Both EcoHealth’s and NIAID’s
assessments that the experiment would be expected to show less pathogenesis
seem at odds with the stated goals of the research project to look for
dangerous viruses with pandemic potential. The assessments also turned out to
be wrong. Specifically, the humanized mice experiment with the SARS-like
coronaviruses showed more pathogenesis with three of the viruses, especially
the one labeled SHC014, which produced a 20 percent weight loss in the
humanized mice.45
As
previously mentioned, Baric et al warned about viruses containing SHC014 in
their 2015 publication.
• After the results of the 2015 Baric
et al paper, which showed an increase in pathogenesis with some viruses,
EcoHealth and NIAID should have examined the research proposal more closely
before reaching the conclusion that the expected results of the experiment
would be less pathogenic.
• It seems unlikely that EcoHealth and
NIAID were unaware of the findings in the 2015 paper. Thus, we are left with
the impression that both chose to document the research as less dangerous so
that EcoHealth could continue to receive its funding and NIAID could avoid
outside oversight of that research proposal.
• Neither the EcoHealth nor the NIAID
assessments reflected the careful weighing of risks and benefits of the
proposed potential GOF research.46
In
particular, NIAID’s assessment in 2016 did not explain the benefits of the
proposed research and how such benefits outweighed the risks, nor did NIAID
consider any biosafety and risk mitigation measures. The NIAID determination in
2018 that the research was not subject to the HHS P3CO framework lacked any
analysis or explanation supporting its determination and failed to address how
it concluded that there was no pandemic potential.
• Based on the available documents,
EcoHealth violated the terms of its grant. The chimeric virus used in the
humanized mice experiment produced more than one log of virus growth compared
to the WIV1 parental backbone.47
In
fact, it appears the experiment with the virus listed as SHC014 produced more
than 3 logs of comparative growth. Per their grant terms, EcoHealth was to stop
their experiment and notify NIAID.48
It
does not appear it
43 David Willman and Madison Muller, A Science in
the Shadows, The Washington Post (Aug. 26, 2021), available at
https://www.washingtonpost.com/nation/interactive/2021/a-science-in-the-shadows/
44 Confirmed with Dr. Hassell on August 13, 2021 in
a bipartisan Committee staff briefing.
45 Sharon Lerner and Mara Hvistendahl, New Details
Emerge About Coronavirus Research at Chinese Lab, The Intercept (Sept. 6,
2021), available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-of-bat-coronavirus-emergence/
46 June 8, 2016 EcoHealth letter to NIH (per notes
taken by Minority Committee staff Oct. 5, 2021 during bipartisan in camera
review); July 7, 2016 NIH letter to EcoHealth (per notes taken by Minority
Committee staff Oct. 5, 2021 during bipartisan in camera review).
47 See Andrew Kerr, Fauci-Funded Wuhan Lab Viruses
Exhibited Over 10,000 Times Higher Viral Load Than Natural Strain, Daily Caller
(September 9, 2021), available at
https://dailycaller.com/2021/09/09/ecohealth-alliance-gain-of-function-higher-viral-load-anthony-fauci/
48 There is no evidence that EcoHealth stopped the
experiment to notify NIAID as required. In discussing the results of this
experiment, EcoHealth never explicitly stated in the text of the progress
reports the amount of virus growth of the parental backbone, thereby masking
the comparison that might have attracted attention from a NIAID reviewer.
However, the bar graph in the grant documents shows that the parental backbone,
WIV 1, produced about 4.7 log10 genome copies per gram, two days after infection
compared to about 8 log10 genome copies per gram produced by the SHC014 strain
- more than three logs of growth, much more than one log threshold specified in
the grant terms.
did
either. As a result, NIAID’s oversight of the grant failed to detect the viral
growth issue and, notably, did not hold EcoHealth accountable for violating the
terms of its grant.
NIH
Funded the EcoHealth Grant After Suspending It
Since
April 2020, NIH has suspended all activities for NIAID grant R01AI110964 due to
EcoHealth’s grant award non-compliance.49
Among
other infractions, NIH advised EcoHealth in a July 8, 2020, letter that
EcoHealth had not satisfied its obligations to monitor the WIV’s activities and
had not reported its subawards as required. The grant activities remain
suspended and, as a result of such suspension, NIH made clear in its letter
that “no funds from grant R01AI110964 may be provided to or expended by
EcoHealth Alliance” until EcoHealth provides information and materials to NIH’s
satisfaction.50
On
July 13, 2020, NIH issued a revised award approval notice to EcoHealth for the
sixth year of the suspended project, despite NIH’s suspension of all grant
activities.51
Not
only did NIH approve the award, but based on a letter from EcoHealth, NIH
apparently increased the award amount by an additional $369,819. Despite NIH’s
notification to EcoHealth on July 8, 2020, that no funds would be provided, NIH
issued the payment of that increase to EcoHealth on July 13, 2020, even though
EcoHealth was not allowed to conduct activities under this grant during the
suspension. In its revised award notice to EcoHealth issued on the same date as
the $369,819 payment, NIH designated specific allocations of $76,301 for the
WIV, and $75,600 for the Institute of Pathogen Biology in Beijing, China.52
This
raises significant concerns regarding NIH’s oversight of grantees. This also
raises concerns that NIH funding of a suspended entity is contrary to the
Public Health Service Act and is possibly an Anti-Deficiency Act violation.53
At
a minimum, this expenditure is inconsistent with competent stewardship of
federal funds, and subverts compliance with the NIH suspension letter and the
NIH Grant Policy, which states: “Organizations or individuals that are
suspended… cannot receive NIH grants, be paid from NIH grant funds, whether
under a primary or lower-tier transaction (including trainees on NIH-supported
training grants), or otherwise participate during the period of suspension….”54
On
June 10, 2021, we wrote to you about our concerns that NIH issued a new $2
million award to EcoHealth in August 2020, while EcoHealth was a noncompliant
grantee with a
49 Committee staff have confirmed the grant status
on multiple occasions with NIH leadership.
50 NIH terminated the grant on April 24, 2020. On
July 8, 2020, NIH simultaneously reinstated and suspended the grant activities,
pending EcoHealth’s cooperation and compliance. Katherine Eban, The Lab Leak
Theory: Inside the Fight to Uncover COVID 19’s origins, Vanity Fair (June 3,
2021), available at
https://www.vanityfair.com/news/2021/06/the-lab-leak-theory-inside-the-fight-to-uncover-covid-19s-origins
51 2R01AI110964-06 is the renewal number assigned to
the sixth year of the NIH R01AI110964 grant project.
52 EcoHealth grant documents at 321, available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-of-bat-coronavirus-emergence/
53 31 U.S.C. 1341.
54 National Institutes of Health, Debarment and
Suspension, NIH Grants Policy Statement (Oct. 1, 2020), available at
https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.6_debarment_and_suspension.htm
suspended
NIH grant.55
In
the same letter, we also detailed our concerns that EcoHealth had never met its
requirements to report publicly its subawards to the WIV or to the Wuhan
University School of Public Health until NIH specifically instructed them to do
so during communications between April and July 2020. The effect of EcoHealth
withholding its financial reporting is that prior to and at the time of the
COVID-19 pandemic outbreak, the financial relationship between EcoHealth, NIH,
and the WIV was hidden from the public and not included in USASpending.gov
After
paying an illegible grant recipient in July 2020, the NIH in August 2020
announced its award of two multimillion-dollar grants to EcoHealth for NIAID’s
$3.05 million project number U01AI151797, and NIAID’s $1.2 million project
number U01AI153420.56
Based
on available information, NIH has not recovered the $369,819 payment to
EcoHealth. As recently as July 2021, NIH approved a $574,984 payment to
EcoHealth.57
Furthermore,
over $23.4 million has been paid to EcoHealth in its status as a potentially
ineligible grant recipient, by NIH, USAID, and DoD since the time NIH should
have reported its administrative suspension to www.SAM.gov.58
In
light of our concerns about NIH’s grant management and oversight, please
respond to the following by November 10, 2021:
1. Does NIH plan to stop funding EcoHealth
until it is compliant with NIH’s requests? If yes, please identify when you
will notify EcoHealth. If not, why not?
2. Does NIH plan to recover the money paid
to EcoHealth on its suspended grant? If yes, please identify when you will
notify EcoHealth. If not, why not?
3. Please identify who authorized the
$369,819 funding issued to EcoHealth on July 13, 2020, and the specific
authority for this funding.
4. Does NIH intend to enter the EcoHealth
suspension into the www.SAM.gov database that is intended for agency reporting
of temporary or permanent suspensions? If yes, when? If no, why not?
5. Please provide all funded and denied
grant applications, progress and final reports for all NIH grants awarded to
EcoHealth Alliance as a prime or subgrant recipient in unredacted form.
6. Please provide the following documents
related to grant award R01AI110964:
55 U.S. House of Representatives Energy and Commerce
Committee Republicans, Letter to NIH, Spotlight on COVID-19 Origin
Investigation, (June 10, 2021), available at
https://republicans-energycommerce.house.gov/wp-content/uploads/2021/06/06.10.21-Letter-to-NIH-Director-Collins.pdf
56 National Institutes of Health, NIH establishes
Center for Research in Emerging Infectious Diseases, News Releases (Aug. 27,
2020), available at
https://www.nih.gov/news-events/news-releases/nih-establishes-centers-research-emerging-infectious-diseases
57 USA Spending.gov, EcoHealth Alliance, Advanced
Recipient Search (Oct. 13, 2021) available at
https://www.usaspending.gov/award/ASST_NON_U01AI153420_7529
58 U.S. House of Representatives Energy and Commerce
Committee Republicans, Letter to NIH, Spotlight on COVID-19 Origin
Investigation, (June 10, 2021), available at
https://republicans-energycommerce.house.gov/wp-content/uploads/2021/06/06.10.21-Letter-to-NIH-Director-Collins.pdf
a. all documents that were not provided to
The Intercept, including the letter from EcoHealth on which NIH based its
decision to increase the award,
b. EcoHealth’s original application, and
c. all other original documents for which
only the revised versions were produced.
7. Please provide all correspondence
between EcoHealth and NIH, including any letter exchanges about NIH’s
identification of EcoHealth research that potentially included GOF experiments
and EcoHealth’s response, dated in May, June, and July of 2016 and July 2018.
Please also provide all correspondence between EcoHealth and NIH, including any
letter exchanges about humanized mice experiments conducted during Year Five of
the grant. Please also include another missing letter from EcoHealth to NIH
that was used as the basis to increase the award amount by $369,819.
8. Please provide an accounting of all
EcoHealth subawards, including contracts or any other agreements, to all
organizations and scientists located in or sponsored by China from the year
2000 to the present.
9. Please facilitate access for Committee
staff and the undersigned to EcoHealth’s genomic sequence data and/or database
of unpublished and published sequences.
10. Please provide all documentation
regarding NIH’s resource coordination with USAID, EcoHealth, DoD, and any other
communications in which NIH took steps to ensure no overlap of U.S. Government
agency funds for the same research was occurring.
11. Please provide EcoHealth’s original Year
Four progress report for the period of June 1, 2017 to May 31, 2018, that would
have been submitted in 2018.
12. Please provide the list of all NIH
personnel involved in the development of the HHS P3CO framework with an
explanation of each individual’s role.
13. What would be the purpose of conducting
humanized mice experiments other than to test whether a virus could infect
human cells?
14. Please make appropriate NIAID personnel
available to Committee staff to address questions about the handling of the
EcoHealth grant.
15. When did NIAID first learn that EcoHealth
had conducted the humanized mice experiment proposed in 2016?
16. Why did NIAID conduct an HHS P3CO review
of the EcoHealth research proposal if the experiment was already conducted?
17. Why were less risky alternative
approaches to EcoHealth’s proposed experiment not considered and discussed?
18. Please explain why NIAID concluded that
the EcoHealth grant was not subject to the HHS P3CO framework.
If
you have any questions, please contact Alan Slobodin or Diane Cutler of the
Minority Committee staff.
Sincerely,
Cathy
McMorris Rodgers
Republican
Leader
Brett
Guthrie
Republican
Leader Committee on Energy and Commerce
Subcommittee
on Health
H.
Morgan Griffith Republican Leader
Subcommittee
on Oversight and Investigations
cc:
The
Honorable Frank Pallone, Chairman
The
Honorable Anna Eshoo, Chair, Subcommittee on Health
The
Honorable Diana DeGette, Chair, Subcommittee on Oversight and Investigations
Ms.
Christi Grimm, Principal Deputy Inspector General, U.S. Department of Health
and
Human
Services
- -
- - -
CHAIRMAN
RANKING
MEMBER
ONE
HUNDRED SEVENTEENTH CONGRESS
Congress
of the United States
House
of Representatives
COMMITTEE
ON ENERGY ANDCOMMERCE
2125
RAYBURN HOUSE OFFICE BUILDING
WASHINGTON,
DC 20515-6115
Majority
(202) 225-2927
Minority
(202) 225-3641
February
14, 2022
Dr.
Francis Collins
National Human Genome Research Institute
National Institutes of Health
31
Center Drive MSC 2152
9000
Rockville Pike
Bethesda,
MD 20892-2152
Dr.
Collins,
Recently
disclosed emails revealed that in January 2020, virology experts told you and
Dr. Anthony Fauci that they believed COVID-19 had lab-made features and that
the virus may have escaped from a lab.1
However,
those same email communications, particularly when viewed in light of other
publicly available information, demonstrate an apparent effort by you and Dr.
Fauci not only to cover-up the concerns those virologists raised, but to
suppress scientific debate about the origins of COVID-19. It appears you and
Dr. Fauci may have done so to protect China and avoid criticism about
incredibly risky research that the National Institute of Allergy and Infectious
Diseases (NIAID) was funding at the Wuhan lab.
According
to emails released by House Oversight and Reform Republicans, there was
significant concern among virology experts that COVID-19 may have originated
from a lab.2
One
scientist told you he was “bothered by the furin site” and had a “hard time
explain[ing] that as an event outside the lab,” which led him to opine it was “70:30”
that the virus came from a lab; another scientist told you he “can’t think of a
plausible natural scenario”; a different scientist claimed that “some of the
features (potentially) look engineered”; and yet another said the “furin
cleavage site” struck him as unusual as it related to natural evolution and
that “if evolutionary origins…were to be discussed…only people with sufficient
information or access to samples to address it would be the teams working in
Wuhan.”3
1 Correspondence posted by House Oversight and
Government Reform Republicans (Jan. 11, 2022) available at
2 Id.
3 Id.
Rather
than allow for scientific review and robust debate, communications in these
emails show that you and Dr. Fauci appeared more concerned about protecting
certain relationships and institutional interests in collaborations in China.
In fact, the NIAID has had a full-time official, Dr. Ping Chen, stationed at
the U.S. Embassy in Beijing for several years to oversee and promote NIAID’s
interests in China and the emails show that your immediate concern was how
discussion of the lab leak theory would do “great potential harm to science and
international harmony.” Specifically, you were responding to an email chain
that included this statement from Dr. Ron Fouchier: “However, further debate
about such accusations would unnecessarily distract top researchers from their
active duties and do unnecessary harm to science in general and science in
China in particular.” You even went a step further and asked how NIH could work
to “help put down this very destructive conspiracy.” In contrast, there is no
evidence from the available emails nor has NIH provided any information to us
that indicates Dr. Fauci or you took action to investigate further the possible
lab origins of the pandemic.
Instead
of alerting national security experts to the potential threat that scientists
were questioning the origin of the SARS2 virus, you shut down debate about the
COVID-19 origin.4
We
are deeply concerned about your decision to suppress highly relevant information
when you received the early alert that the SARS2 virus could be a potential
threat. As the then Director of the NIH that includes NIAID’s multibillion
dollar biodefense program and the NIAID as an advocate for global sampling and
surveillance to detect potential pandemics, when the alert was in your hands,
you remained silent and worse, propagated a counter narrative that may have
hurt our government’s response in the early days of the pandemic.
We
oversee public health and are seeking the truth about how this pandemic started
so we can better prepare and hopefully prevent future pandemics. We have
significant concerns that your conduct, which appears to have been designed to
protect China and, in furtherance of that, to suppress certain scientific
information, occurred at a time when it was critical for government leaders and
decisionmakers to be aware of all relevant information and may have hurt our
COVID-19 response.
Accordingly,
in light of these concerns, please provide written responses to the following
questions by February 28, 2022:
1. Regarding your January 2020
communications with the virology experts referenced above:
a. How were the communications with the
virology experts initiated?
i. Did you initiate the communications
with the virology experts or did they?
ii. When were these communications
initiated? Please identify all parties to these communications and the specific
subject matters addressed in these communications.
4 Id.
b. What was the purpose for your
communications with these virology experts?
c. Please identify additional individuals
you consulted with about the origins of COVID-19 in January and February 2020.
d. How did you select the virology experts
to contact?
e. When did your communications with these
virology experts about the origins of COVID-19 end and why?
2. Did you brief anyone at the White
House, the U.S. Department of Health and Human Services (HHS), or anyone else
involved in the COVID-19 response about the communications with the virology
experts?
a. If you did, please identify who you
notified, when you notified them, and what information you provided to them.
b. If you did not, why did you withhold
such relevant information?
3. To what extent did preserving
international harmony (especially with China) affect your advice to the White
House, HHS, or anyone else involved in the COVID-19 response?
4. What is the purpose of having an NIAID
official posted at the U.S. embassy in China?
5. Please identify any NIAID
collaborations in China from January 1 to June 30, 2020.
6. During January 2020, were you in
contact with Chinese scientists about SARS CoV-2?
a. If so, how have these contacts
influenced you in the performance of your COVID-19 response duties?
7. Prior to the January 31, 2020, email,
did you know about the pangolin coronavirus sequence with a receptor binding
domain (RBD) similar to the one in SARS CoV-2?
8. Did the publication of pangolin virus
RBD impact your assessment on the origins of the COVID-19 pandemic? If so, why?
9. Did the publication on February 3,
2020, of the RaTG-13 bat coronavirus sequence that was 96 percent similar to
SARS CoV-2 impact your assessment on the origins of COVID-19 pandemic? If so,
why?
10. Were you involved with the February 4,
2020, emergency meeting at the National Academies of Science, Engineering, and
Medicine (NASEM) convened at the request of the White House?
a. If so, did you attend, what was your
role, and what was discussed?
b. Did the NASEM emergency meeting
influence your assessment of the origins of COVID-19?
c. Did you and/or the virology experts
discuss the NASEM emergency meeting in the communications?
11. Did you edit, make suggestions, or
influence in any way the publication of the proximal origin paper?
12. In a February 2, 2022, letter to HHS
Secretary Xavier Becerra and NIH Acting Director Lawrence Tabak, the House
Committee on Oversight and Reform Republicans noted that NIH forced an NIH
advisor to shred notes and other documents pertaining to the Wuhan Institute of
Virology (WIV) grants as early as 2014. That committee pointed to a November 5,
2021, email from a redacted source, which stated:
I signed a confidentiality agreement in which I
agreed not to discuss any grant with anyone except with other members of the
study section, and - once the meeting was over - that I would destroy any notes
that I had taken during the meeting (we did this by tossing them in shred box
in the meeting room).
This
email suggests that this redacted source served on a peer review panel for the
NIAID, and that the practice of shredding documents was not limited to grants
related to EcoHealth Alliance or the WIV. It may have been systemic.
What
are NIAID’s document retention rules for peer review panels scoring grant
proposals? Please provide the legal justification for any document shredding
practices at NIAID, and specifically NIAID peer review panels.
Sincerely,
Cathy
McMorris Rodgers
Ranking
Member
Brett
Guthrie
Ranking
Member Committee on Energy and Commerce
Subcommittee
on Health
H.
Morgan Griffith Ranking Member
Subcommittee
on Oversight and Investigations
INDEX
NO. 034252/2022
NYSCEF
DOC. NO. 47
RECEIVED
NYSCEF: 01/04/2023
EXHIBIT
23
August
19, 2022
The
Honorable James Comer
Ranking
Member, Committee on Oversight and Reform
U.S.
House of Representatives
Washington,
DC 20515
Dear
Representative Comer:
Thank
you for your interest in the work of the National Institutes of Health (NIH). I
write to you today in a continuing effort to be responsive to your inquiries
about NIH oversight of awards to EcoHealth Alliance (EHA).
As
you know, the National Institute of Allergy and Infectious Diseases (NIAID)
awarded EHA grant R01AI110964 (“R01 award”) after the application received a
meritorious score through the peer review process. This grant included three
sub-awards, including one to the Wuhan Institute of Virology (WIV) and had a
performance period starting on June 1, 2014. The renewal application for this
grant underwent peer review, and the Notice of Award was issued on July 24,
2019. The research approved under this grant sought to understand how bat coronaviruses
evolve naturally in the environment to become transmissible to the human population.
This type of research is a critical component of pandemic preparedness.
Identifying pathogens that have the potential to cause disease in humans allows
the research community to prepare for how to respond if these pathogens do
enter the human population.
NIH’s
Office of Extramural Research (OER) suspended EHA grant R01AI110964 on July 8,
2020, due to grant administrative non-compliance concerns. Over time, NIH
reviewed EHA’s compliance with requirements under the R01 award and requested
information and documentation from EHA to enable NIH to conduct its review.
NIH
also reviewed EHA’s compliance with requirements under two other NIH awards to
EHA, the Research Project Cooperative Agreements (“U awards”). See Table 1 for
a list of all current NIH awards to EHA.
Table
1: Current NIH Awards to EHA
Award
Number
Grant
Title
Performance
Period
R01AI110964 Understanding the Risk of Bat Coronavirus
Emergence
July
1, 2014-May 31, 2019;
Renewal:
June 1, 2019-
May
31, 2024*
U01AI151797 Understanding Risk of Zoonotic Virus Emergence
in Emerging Infectious Disease Hotspots of Southeast Asia
June
17, 2020-May 31, 2025**
U01AI153420 Study of Nipah Virus (NiV) Dynamics and
Genetics in Bat Reservoirs and of Human Exposure to NiV Across Bangladesh to
Understand Patterns of Human Outbreaks
September
15, 2020-June 30, 2025**
*This grant was suspended on July 8, 2020 and has
remained suspended.
**Specific award conditions imposed on January 6,
2022 but was never suspended.
As
NIH notified you on January 6, 2022, NIH sent a letter to EHA that day
conveying the
outcome
of its detailed administrative review of compliance under the U awards. NIH
identified a number of compliance issues, including inadequate oversight in
monitoring the activities of its subawardees, failure to report subawards to
the General Services Administration’s Federal Subaward Reporting System, and
errors in indirect rate charges. In cases of non-compliance, NIH’s approach is
generally to provide a grantee the opportunity to come into compliance in an
effort to preserve the research, when possible. This approach is consistent
with HHS grant regulations, which provide that in cases of non-compliance, a
funding agency can impose specific award conditions; and if the agency
determines that the non-compliance cannot be
remedied
by specific award conditions, then the agency may take more severe actions,
such as terminating an award in whole or in part.
Our
January 6, 2022 letter announced immediate imposition of specific award
conditions on the U awards to allow NIH to monitor these awards more closely.
The U awards were never suspended. In addition, the letter outlined areas where
EHA needed to improve its administrative policies and practices. NIH requested
EHA submit a Corrective Action Plan (CAP) to address these issues.
EHA
provided a proposed CAP to NIH on February 4, 2022. The CAP outlined steps EHA
would take to address the non-compliance NIH identified under the two U awards.
Between February and April 2022, NIH approved EHA’s CAP and EHA implemented the
CAP. Pursuant to the CAP, EHA revised the U subaward agreements to include
details on EHA’s procedures for access to subawardees’ records and financial
statements, data-sharing and management of awards, and a correction of the
Facilities and Administrative cost rate. EHA also provided NIH with new and
updated EHA policies that describe how, for all EHA projects, EHA will comply
with reporting requirements and other deficiencies identified by NIH.
I
write today to update you on EHA’s implementation of the CAP under the U
awards, the conclusion of NIH’s review of compliance under the R01 award, and
the next steps NIH will take with EHA. At this time, EHA has successfully
implemented the NIH-approved CAP for its active U awards, which includes
rewriting subaward agreements, and improving monitoring and reporting conflicts
of interest by its subawardees. Accordingly, NIH has determined that EHA was
able to resolve the problems identified with those awards. For the R01 award,
NIH identified the same issues that were present with the U awards (including
inadequate oversight in monitoring the activities of its subawardees, failure
to report subawards to the General Services Administration’s Federal Subaward
Reporting System, and errors in indirect rate charges), as well as reporting
delinquencies, such as the late submission of the fifth year progress report.
NIH has determined that these problems can be remedied by imposing specific
award conditions, because EHA demonstrated that it could resolve these same
problems under the U awards with the successful implementation of a CAP.
However,
NIH also identified one non-compliance under the R01 award that cannot be
remedied with specific award conditions. NIH has requested on two occasions
that EHA provide NIH the laboratory notebooks and original electronic files
from the research conducted at WIV. To date, WIV has not provided these
records. Under 45 CFR 75.371, “If a non-federal entity fails to comply with
federal statutes, regulations, or the terms and conditions of a federal award,
the HHS awarding agency or pass-through entity may impose additional
conditions, as described in § 75.207. If the HHS awarding agency or
pass-through entity determines that non-compliance cannot be remedied by
imposing additional conditions, the HHS awarding agency or
pass-through
entity may take one or more [enforcement] actions, as appropriate in the
circumstances[.]” 45 CFR 75.371. Such actions may include partly terminating
the federal award. Id. at 75.371(c).
Today,
NIH has informed EHA that since WIV is unable to fulfill its duties for the
subaward under grant R01AI110964, the WIV subaward is terminated for failure to
meet award terms and conditions requiring provision of records to NIH upon
request.
In
light of the cooperation from EHA and the subsequent substantial improvements
in administrative processes that EHA demonstrated with the two U awards, NIAID
will begin to engage with EHA to renegotiate the specific aims and objectives
of the R01 grant without the involvement of WIV. If an agreement is made, the
revised grant will be reviewed again in its entirety to ensure all applicable
policy and guideline requirements are met including the HHS Framework for
Guiding Funding Decisions about Proposed Research Involving Enhanced Potential
Pandemic Pathogens (P3CO) and other relevant policies and guidelines. A revised
Notice of Award will be issued, subject to specific award conditions and any
additional precautions that may be appropriate for inclusion, and the
suspension on the grant will be lifted. If revisions to the grant’s aims and
objectives cannot be revised to stay within the original peer reviewed,
scientific scope of the project, NIH reserves the right to request a bilateral
termination of the remainder of the award.
As
specific award conditions, NIH will maintain a higher level of oversight over
all EHA awards for a minimum of three years, including a doubling of the
frequency for the required scientific progress and financial reports, and a
requirement that EHA submit additional documents illustrating their subaward
monitoring activity. In addition, EHA will be required to conduct onsite
inspections of all of its subawardees every six months to confirm that all
terms of subaward agreements are being fully and appropriately executed. EHA
will also be required to submit updated subaward agreements under the revised
R01 award that address the deficiencies identified by NIH.
NIH
takes its oversight of grants very seriously and always considers what further
measures can be taken to strengthen routine oversight of grants at NIH. In
light of this compliance case, NIH has taken additional steps. NIH has
incorporated additional automated systems of controls for the timely receipt of
progress reports to ensure that the most recent information is received and
accepted by program officers. NIH has implemented program scripts in the NIH
grants system (eRA) that send additional reminders to grant recipients and NIH staff
of delinquencies if progress reports are either delayed or not fully reviewed
and accepted. Should this happen, the system establishes a “red bar” to funding
of the next non-competing renewal, which would prevent the award from being
processed until the “red bar” is resolved. NIH believes that these new measures
will further strengthen our oversight of grantees while continuing the
life-saving work done by NIH grantees.
NIH
is committed to ensuring responsible stewardship and accurate reporting of the
use of federal funds. In a continued effort to be transparent, NIH has attached
to this letter the communications between NIH and EHA regarding the
implementation of the CAP. I hope this information is helpful to you.
Sincerely,
Michael
S. Lauer, M.D.
Deputy
Director for Extramural Research National Institutes of Health
Enclosures:
First
letter from NIH to EHA on January 6, 2022
Second
letter from NIH to EHA on January 6, 2022 CAP proposed by EHA (in 2 parts)
NIH
response to EHA’s CAP
Follow-up
CAP documents submitted by EHA (in 5 parts)
Letter from NIH to EHA on August 19, 2022
EXHIBIT
30
FRANK
PALLONE, JR., NEW JERSEY
CHAIRMAN
CATHY
McMORRIS RODGERS, WASHINGTON
RANKING
MEMBER
ONE
HUNDRED SEVENTEENTH CONGRESS
Congress
of the United States
House
of Representatives
COMMITTEE
ON ENERGY AND COMMERCE
2125
RAYBURN HOUSE OFFICE BUILDING
WASHINGTON,
DC 20515-6115
Majority
(202) 225-2927
Minority
(202) 225-3641
February
24, 2022
Lawrence
A. Tabak, D.D.S., PhD. Acting Director
National
Institutes of Health
9000
Rockville Pike
Bethesda,
MD 20892
Dr.
Tabak,
We
write to continue our oversight of National Institutes of Health (NIH) grant
awards to EcoHealth Alliance (EcoHealth). On January 6, 2022, the NIH sent two
letters to EcoHealth related to its failure to comply with terms agreed upon
for its NIH grants.1 While we appreciate the NIH’s current enforcement efforts
to obtain EcoHealth’s compliance, new information from recently disclosed
information included in the recent NIH letters raises troubling concerns about
EcoHealth’s conduct upon which the NIH is either overlooking or taking
insufficient action.
Those
concerns include withheld data and possible double billing, missing laboratory
notebooks and electronic files related to humanized mice research at the Wuhan
lab, and EcoHealth’s private donations that may not have been reported to NIH.
These concerns raise the prospect of possible fraud that require the NIH’s
heightened attention.
Withheld
Data and Potential Double Billing
In
June 2014 and during the gain-of-function research pause in the United States,
NIH awarded grant R01AI110964 to EcoHealth for bat coronavirus research.
EcoHealth then entered into a subaward agreement with scientists at the Wuhan
Institute of Virology (WIV) for research assistance. During that time,
EcoHealth also received awards from other U.S. agencies, including as a
subgrant recipient from the U.S. Agency for International Development (USAID)
to support scientific collaboration at the WIV.2
1 Letters to EcoHealth Alliance (Jan. 11, 2022)
available at
https://republicans-oversight.house.gov/wp-content/uploads/2022/01/January-2022-EHA-SAC-CAP-letter-final1.pdf
2 Energy and Commerce Republicans, Letter to USAID
(June 28, 2021) available at
https://republicans-energycommerce.house.gov/wp-content/uploads/2021/06/2021.06.22-USAID-Origins-Letter.pdf
Through
its USAID project work, EcoHealth catalogued human and bat genomic sequence
findings into a database used to create predictive maps of potential disease
outbreaks and reported finding a high number of SARS-like coronaviruses in bats
sampled in China.3
EcoHealth
identified several novel bat coronaviruses.4
USAID
also supported sampling by EcoHealth and its collaborative partners of more
than 7,300 humans and animals in China.5
The
human specimens were obtained from individuals with symptoms of an infectious
disease meeting criteria that the most-likely cause had been ruled out through
laboratory tests and supporting data was available.6
Research
accomplishments in USAID PREDICT reports very closely resemble those reported
by EcoHealth to NIH in its progress reports. The similarities are striking and
include similar charts, graphics, sampling locations, and research discoveries.
For example, virus detection was described in the USAID-China PREDICT report
as, “Working in collaboration with NIAID-funded partners, we demonstrated that
some of the newly discovered bat-CoVs were able to bind to human cells, infect
them in vitro, and cause SARS-like disease in a lab animal model.”7
This
is a research accomplishment EcoHealth also reported in its NIH progress
reports.8
EcoHealth
reported having access to tens of thousands of wildlife samples as a result of
its NIH project and from a large multi-year contract from USAID for the PREDICT
project.9
Recently
published email documents show that Dr. Daszak worked to ensure that the
USAID-catalogued sequences were not attributed to the USAID work in GenBank,
the NIH genetic sequence database of all publicly available DNA sequences.10
In
emails acquired by U.S. Right to Know, an EcoHealth USAID collaborator at
Metabiota advised an EcoHealth staff member on April 20, 2020, that virus
sequences detected in China as part of the USAID project were submitted to
GenBank and scheduled for release in 10 days.11
The
EcoHealth staff member replied to delay uploading the sequences because some of
the sequences were ready for
3 USAID, PREDICT-Advancing Global Health Security at the Frontiers of Disease Emergence, (June 5, 2021) available at https://ohi.vetmed.ucdavis.edu/sites/g/files/dgvnsk5251/files/inline-files/PREDICT%20LEGACY%20-%20FINAL%20FOR%20WEB%20-compressed_0.pdf
4 Kirsten V.K. Gilardi, Jonna A.K. Mazet, The United
States Agency for International Development Emerging Pandemic Threat PREDICT
Project – Global Detection of Emerging Wildlife Viral Zooneses, Fowler's Zoo
and Wild Animal Medicine Current Therapy, Volume 9, Pages 110-116 (Sep. 28,
2018) available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7152072/
5 USAID, PREDICT-Advancing Global Health Security at
the Frontiers of Disease Emergence, (June 5, 2021)
available at https://ohi.vetmed.ucdavis.edu/sites/g/files/dgvnsk5251/files/inline-files/PREDICT%20LEGACY%20-%20FINAL%20FOR%20WEB%20-compressed_0.pdf
6 Id.
7 USAID Predict China, One Health in Action
(2009-2020) available at
https://static1.squarespace.com/static/5c7d60a711f7845f734d4a73/t/5f5fe4e59eeb3f245097cbae/1600120064528/FINAL+REPORT+COUNTRY-CHINA-FULL.pdf
8 EcoHealth grant documents available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
9 Id.
10 U.S. Right to Know, EcoHealth Alliance wanted to
block disclosure of Covid-19 relevant virus data from China (Jan. 10, 2022)
available at
https://usrtk.org/biohazards-blog/ecohealth-alliance-wanted-to-block-disclosure-of-covid-19-relevant-virus-data-from-china/
11 Id.
publication
and time was needed to check the data, and also because the China institution
must approve publication.12
Dr.
Daszak then wrote, “All - It’s extremely important that we don’t have these
sequences as part of our PREDICT release to Genbank at this point. As you may
have heard, these were part of a grant just terminated by NIH…Having them as
part of PREDICT will being [sic] very unwelcome attention to UC Davis, PREDICT
and USAID.”13
Dr.
Daszak’s response raises questions about project funding he received from NIH
and USAID for his work in China and the potential that both agencies were
funding the same research. Suspicions of potential duplication of funding are
further raised by the collaborator and staff logging the sequences as belonging
to the USAID project.
On
January 10, 2022, Dr. Daszak tweeted that sequences were discovered under NIH
funding and that all SARSr-CoVs were uploaded into GenBank then publicized in
the Nature Communications article referenced earlier that also identified
EcoHealth’s private and anonymous funding sources.14
Dr.
Daszak wrote, “All sequences of SARS-related coronaviruses discovered by
EcoHealth Alliance in China were sequenced using NIH funding and have been made
public in peer-reviewed scientific papers and via the publicly available
Genbank database. The Genbank accession numbers for over 600 sequences can be
found in the attached paper.” [Emphasis added].15
Dr.
Daszak’s tweet representing that “all sequences…have been made public”
contradicts the EcoHealth employee’s email stating that only some of the
USAID-funded sequences from China would be published. We question if Dr. Daszak
reported those sequences in the sequence data he reported as an accomplishment
under USAID funding. It is imperative for NIH to make available all genomic
sequencing data from Dr. Daszak and EcoHealth and compare EcoHealth
documentation submitted to USAID.
Questions
of grant coordination with another federal agency are also raised. In March
2018, EcoHealth submitted a bat coronavirus research proposal to Defense
Advanced Research Projects Agency (DARPA), entitled “Project DEFUSE: Defusing
the Threat of Bat-borne Coronaviruses.” The proposal included detailed plans to
fund research that, among other risky experiment techniques, would insert a
furin cleavage site into a bat coronavirus genetic sequence. The SARS-CoV-2
virus is a betacoronavirus that features a furin cleavage site in the spike
protein, a characteristic that has never previously been detected in this
family of coronaviruses. The function of the furin cleavage site in SARS-CoV-2
is significant because it is the essential mechanism for the virus entry into
human lungs. DARPA ultimately rejected the proposal later in 2018.
However,
in its Year Four NIH progress report submitted in April 2018, covering
activities between June 2017 and May 2018, EcoHealth reported that Peter Daszak
and WIV co-investigator Zhengli Shi introduced this project and discussed new
opportunities about predicting and preventing zoonoses with NIAID and the
Defense Advanced Research Projects Agency
12 Id.
13 Id.
14 Daszak, Peter@PeterDaszak Twitter, Jan 10, 2022
9:52 pm available at
https://twitter.com/PeterDaszak/status/1480734382558224388?s=20
15 Id.
(DARPA),
the National Academies of Science, Engineering and Medicine Forum on Microbial
Threats and with organizations in China.16
The
reference to DARPA in the Year Four progress report suggests that EcoHealth saw
linkage between the DARPA proposal and its NIAID research grant. It is unclear
whether the rejected DARPA proposal was funded elsewhere, and to what extent
this proposal or any other ideas EcoHealth discussed with DARPA informed any
EcoHealth communications with NIAID and/or any research activity funded by
NIAID.
Missing
Laboratory Notebooks and Electronic Files
In
a January 6, 2022, letter to EcoHealth, the NIH reiterated its request for the
laboratory notebooks and electronic files that led to the generation of bar
figures and accompanying texts portraying weight loss and death in humanized
mice experiments.17
The
NIH letter confirmed that EcoHealth reported to NIH that notebooks or files
created and retained by the sub-grantee, WIV, were not in EcoHealth’s
possession.18
EcoHealth
claimed it had forwarded the NIH’s request for those records to the WIV.19
Given the Chinese government’s lack of cooperation with global public health requests and its known punishment of Chinese scientific institutions and scientists for cooperating with others outside China, there is little reason to believe that the WIV will actually provide these notebooks and files. EcoHealth’s inability to substantiate these research experiments calls into question the validity of the entire research effort with the WIV, in addition to violating the terms of its NIH agreement. Because EcoHealth has received over $16.8 million from NIH since 2005 20
and
Dr. Daszak has worked as an NIH peer reviewer, the NIH grant requirements were
well known to them, so the deliberateness of their noncompliance should be
questioned.
Further,
EcoHealth’s admission that it did not have copies of the notebooks or the files
raises new troubling issues that need to be resolved by the NIH.21
Since
EcoHealth did not have notebooks or the files, the NIH needs to find out how
EcoHealth was able to certify the validity of all figures and texts of the
humanized mice experiment results reported in progress reports for Year Four
and Year Five.22
The
NIH needs to protect the integrity of the NIH grant oversight program and
sponsored research. Since EcoHealth claims the WIV created and retained these
records, presumably EcoHealth received documentation from the WIV to complete
its progress reports.23
To
dispel the notion of research cover-ups or fabrication and to prove how
EcoHealth
16 EcoHealth grant documents at page 273 available
at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
17 Letters to EcoHealth Alliance (Jan. 11, 2022)
available at
https://republicans-oversight.house.gov/wp-content/uploads/2022/01/January-2022-EHA-SAC-CAP-letter-final1.pdf
18 Id.
19 Id.
20 NIH Reporter, Query results for EcoHealth
Alliance (Jan. 13, 2022) available at
https://reporter.nih.gov/search/z_bHgzk69kCqeyiCfy-7fA/projects
21 Letters to EcoHealth Alliance (Jan. 11, 2022)
available at
https://republicans-oversight.house.gov/wp-content/uploads/2022/01/January-2022-EHA-SAC-CAP-letter-final1.pdf
22 EcoHealth grant documents available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
EcoHealth grant documents available at
https://s3.documentcloud.org/documents/21089573/priority-grants-for-foia-request-55058-first-look-institute-2_redacted.pdf
23 Letters to EcoHealth Alliance (Jan. 11, 2022)
available at
https://republicans-oversight.house.gov/wp-content/uploads/2022/01/January-2022-EHA-SAC-CAP-letter-final1.pdf
prepared
its certified progress reports, NIH should request that EcoHealth produce all
documentation relied upon to validate its progress reports.
Finally,
it is highly suspicious that EcoHealth and the WIV reported results from a
single risky experiment conducted in one year into two separate progress
reports for two different years. The research involved bat coronaviruses and
humanized mice. During the Year Four reporting period between June 2017 and May
2018, EcoHealth conducted one experiment that caused some ACE2 Receptor
humanized mice to get sick within six days after infection and die within two
weeks of infection. However, EcoHealth reported the sick mice in its Year Four
report (the first six days) and saved the lethal results (the full two weeks)
to report in Year Five, in a delayed submission that was not received by the
NIH until August 2021. The Year Five report covered experiments between June
2018 through May 2019.24
The
reporting of the humanized mice fatalities to NIH was delayed for three
years.25
Bifurcating
the reporting of experiment results raises the question of whether EcoHealth
and the WIV were covering up the deadly pathogenic results of risky research by
concealing the mice deaths for an extended period of time (especially during
the time of the grant renewal in mid-2019).
Further,
EcoHealth represented in its Year Five report that the experiments were
conducted between June 2018 and May 2019, evidenced by the statement, “In Year
5, we continued with in vivo infection experiments of diverse bat SARS-CoVs on
transgenic mice expressing human ACE2.”26 [Emphasis added].
EcoHealth’s
questionable representation of the experiment dates raises questions about
whether the humanized mice experiment results were stretched out into another
year’s progress report to provide filler in the report and divert NIH’s
attention away from the possibility of undisclosed research conducted in Year
Five (2019).
Questions
about the possibility of undisclosed Year Five research are heightened because
laboratory analysis was the only project activity EcoHealth planned during its
final year of the five-year grant award. In the grant research strategy
timeline and management plan section, EcoHealth reported that the duration of
its lab data analysis and modeling activities would span the final four years
of the project and conclude at the end of the award. No other research
activities were planned during the final project year.27
Other
discrepancies in EcoHealth’s Year Five progress report heightens concerns
arising from the missing substantiation of research. A close examination of the
Year Five progress report dated August 3, 2021, covering the June 1, 2018 to
May 30, 2019, project period shows that the chart examples are not in
sequential order.28
The
report contains two different charts that
24 Ecohealth Oct. 26, 2021 letter to NIH available
at
https://www.documentcloud.org/documents/21097880-ecohealth-letter-contesting-claims
25 EcoHealth grant documents available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
26 Id.. The wording suggests that EcoHealth was
continuing to conduct experiments, instead of organizing follow-up analysis of
an experiment already conducted in the previous award year.
27 EcoHealth grant documents at page 126 posted by
The Intercept (Sept. 8, 2021) available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
28 EcoHealth grant documents posted by The Intercept
(Oct. 21, 2021) available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
are
both labeled Figure 2, one on page 6 and the other on page 9.29
The
Figure 2 on page six is also missing letters from some sampling site locations.
For example, spaces are evident where the letter “I” should be in Jinning,
Yunnan and instead reads, “J nn ng, Yunnan.”30
On
Year Five report page 11, the chart examples skip from from Figure 4 directly
to Figure 8.31
Another
example from the Year Five report is how Figure 13 is followed by Figure 7. The
contents of some of the figures do not match what is described in the text. For
example, the text states Figure 7 shows rates of evolutionary transitions among
alphacoronavirus families during evolution, but the actual figure shows
immunofluorescence measurements for MERS-like CoVs.32
There
are other similar inconsistences between the figure numbers and what the text
says and what the figures show. For example, there are also two different
graphics that are labeled “Figure 1.”33
Finally,
there are inconsistencies in EcoHealth’s explanation surrounding the delayed
submission of the Year Five progress report to the NIH. In his letter to the
NIH of October 26, 2021, EcoHealth president Peter Daszak wrote that he did not
submit the Year Five progress report because he was locked out of the system
“starting” on July 24, 2019.34
However,
documents released under FOIA show Peter Daszak sent an email to the NIH that
said he “is” now able to submit the Year Five progress report on July 24, 2019,
and is about to do so.35
Private
Funding
With
respect to private funding, documents show that EcoHealth has been receiving
private donations that may not have been disclosed to the NIH.36
On
August 25, 2020, Nature Communications published Origin and cross-species
transmission of bat coronaviruses in China, authored by EcoHealth president
Peter Daszak and others.37
Research
funding sources are acknowledged as: award number R01AI110964 from the NIH
National Institute of Allergy and Infectious Diseases (NIAID); cooperative
agreement number GHN-A-OO-09-00010-00
29 EcoHealth grant documents, page 6 and page 9,
posted by The Intercept Oct. 21, 2021) available at
https://www.documentcloud.org/documents/21089573-priority-grants-for-foia-request-55058-first-look-institute-2_redacted
30 Id.
31 EcoHealth grant documents, page 11, posted by The
Intercept (Oct. 21, 2021) available at
https://www.documentcloud.org/documents/21089573-priority-grants-for-foia-request-55058-first-look-institute-2_redacted
32 EcoHealth grant documents, page 17, posted by The
Intercept (Oct. 21, 2021) available at
https://www.documentcloud.org/documents/21089573-priority-grants-for-foia-request-55058-first-look-institute-2_redacted
33 EcoHealth grant documents, posted by The
Intercept (Oct. 21, 2021) available at
https://www.documentcloud.org/documents/21089573-priority-grants-for-foia-request-55058-first-look-institute-2_redacted
34 EcoHealth letter posted by The Intercept (Nov. 3,
2021) available at
https://www.documentcloud.org/documents/21097880-ecohealth-letter-contesting-claims
35 Emails posted by White Coat Waste Project at 302,
Andrew Kerr, Gain of Function Communications Between EcoHealth Alliance and
NIAID, White Coat Waste Project (Nov. 4, 2021) available at
https://www.scribd.com/document/537027808/GainOf-Function-Communications-Between-EcoHealth-Alliance-And-NIAID
36 Latinne, A., Hu, B., Olival, K.J. et al., Origin
and cross-species transmission of bat coronaviruses in China, Nature
Communications (Aug. 25, 2020) available at
https://www.nature.com/articles/s41467-020-17687-3
37 Id.
from
the USAID Emerging Pandemic Threats PREDICT project, the Chinese Academy of
Sciences (XDB29010101), and National Natural Science Foundation of China
(31770175, 31830096).38
The
funding description for EcoHealth continues: “All work conducted by EcoHealth
Alliance staff after April 24th 2020 was supported by generous funding from The
Samuel Freeman Charitable Trust, Pamela Thye, The Wallace Fund, & an
Anonymous Donor c/o Schwab Charitable.”39
In
our review of available EcoHealth grant documents for NIH award R01AI11964,
EcoHealth did not disclose the three named or anonymous financial sources.40
However,
because NIH has refused to cooperate fully with Congressional oversight and
mostly released records under Freedom of Information Act (FOIA) requests to
private entities, our review may be limited.
NIH
terminated EcoHealth’s award R01AI110964 in April 2020 due to noncompliance.
The award was later reinstated and then immediately suspended on July 8, 2020.
On May 29, 2020, EcoHealth board member Randy Schekman of the Li Ka Shing
Center, University of California at Berkeley, emailed EcoHealth president Peter
Daszak that Schekman would be the intermediary for a $500,000 donation to
EcoHealth from an anonymous source to make up for the terminated NIH award:
Dear
Peter,
I
am part of the Rich Roberts group and helped to line-up more Laureates to join
the petition to Azar and Collins. We don’t expect a response from them but we
wish to make a constructive contribution to your essential work and have
resolved to help find private funds to offset your loss. Our first success is
with a foundation that makes anonymous contributions to various causes
including in support of biomedical science. I am pleased to report that this
group will provide the Ecohealth Alliance a grant of $500,000 to at least
partially offset the NIH funds that were withdrawn from your program. Since
they wish to remain anonymous, I will be happy to serve as the intermediary in
transfer of funds to your program. We can communicate about how to proceed.41
Instead
of trying to cooperate with the NIH to get back into compliance, EcoHealth
exploited the NIH’s grant suspension to boost fundraising and get donations
from private sources. We do not know the amount of private funding provided to,
or used by, EcoHealth to continue work on its suspended NIH grant, but the
notification of private funding in May 2020 and citation of private funding
sources in the August 25, 2020, Nature Communications indicates resources were
available to EcoHealth in lieu of the suspended grant award. Another recent
38 Id.
39 Id.
40 EcoHealth grant documents available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
EcoHealth grant documents available at
https://s3.documentcloud.org/documents/21089573/priority-grants-for-foia-request-55058-first-look-institute-2_redacted.pdf
41 U.S. Right to Know, EcoHealth Alliance emails:
University of Maryland page 422 (Nov. 18, 2020) available at
https://usrtk.org/wp-content/uploads/2020/11/Biohazard_FOIA_Maryland_Emails_11.6.20.pdf
example
of EcoHealth private funding is referenced in an August 31, 2020, publication
that cites the Ford Foundation, the David and Lucile Packard Foundation, and
Johnson & Johnson as additional private funding sources of EcoHealth.42
Additionally,
an email from EcoHealth spokesperson Robert Kessler to EcoHealth board members
noted how Dr. Daszak appearing on CNN with Chris Cuomo and on CBS “60 Minutes”
resulted in private donations:
P.S.
An unexpected reaction to the 60 Minutes story has been an outpouring of
support in my personal favorite form: donations. We’ve picked up more than $3,000
today alone with the donations still coming in. A couple dozen people have
created Facebook fundraisers in our name, as well. While most of these
donations are only small amounts, each represents a new supporter that the
development team can cultivate and a new advocate for our work. Overall, a
really exciting day for EcoHealth Alliance.43
Pursuant
to the NIH grants financial conflict of interest policy, in alignment with 42
C.F.R.
Part 50,
each
participating researcher is required “to submit an updated disclosure of
significant financial interests within thirty days of discovering or acquiring
(e.g., through purchase, marriage, or inheritance) a new significant financial
interest.”44
Significant
financial interest is defined as the aggregated value within the twelve months
preceding the disclosure that exceeds $5,000.45
EcoHealth
is responsible for ensuring that all individual investigators, including
subaward recipients, make all appropriate disclosures regarding other support,
affiliations, and financial interests.46
Likewise,
NIH is responsible for ensuring that its grant recipients comply with all
record and data retention requirements, including submission of records and
data to NIH.
By
virtue of funding EcoHealth’s research without considering undisclosed private
donations, NIH would have over-funded EcoHealth’s award and thus, would have
not funded other worthy research applications. The NIH needs to determine
whether EcoHealth complied with these requirements for private donations. Any
undisclosed conflict of interest also calls into question the scientific
integrity and objectivity of EcoHealth’s research.
In
light of our concerns, please provide written responses to the following
questions and copies of the following documents by March 24, 2022:
1. Will NIH investigate whether
EcoHealth’s research funded by NIH was also funded by USAID? If not, why not?
42 Roche, et al, Was the COVID-19 pandemic
avoidable? A call for a “solution-oriented” approach in pathogen evolutionary
ecology to prevent future outbreaks (Aug. 31, 2020) available at
https://doi.org/10.1111/ele.13586
43 U.S. Right to Know, EcoHealth Alliance emails:
University of Maryland page 443 (Nov. 18, 2020) available at
https://usrtk.org/wp-content/uploads/2020/11/Biohazard_FOIA_Maryland_Emails_11.6.20.pdf
44 C.F.R. Part 50
45 42 CFR § 50.603 Definitions,
https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50#p-50.605(b)
46 NIH Grants Policy Statement, Section 2.5.1
Just-in-Time Procedures (last accessed January 10, 2022) available at
https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.5.1_just-in-time_procedures.htm
2. Please provide copies of all NIH
correspondence to and from EcoHealth Alliance since the July 8, 2020, grant
suspension.
3. Is NIH seeking a copy of the Year 6
progress report for the EcoHealth grant (covering the 2019 -2020 timeframe)? If
not, why not? If so, please provide.
4. Please describe the NIAID’s
understanding of the DARPA proposal referenced in EcoHealth’s Year Four
progress report.
5. Please provide all emails,
correspondence, or any documents related to the EcoHealth’s discussions with
the NIAID about research proposals or ideas with DARPA.
6. We are troubled that research sponsored
by NIH must first be reviewed and approved by an institution in China before
NIH receives the data. Is this process a special arrangement NIH authorized for
EcoHealth? When did NIH become aware that a foreign institution was intervening
in the contractual relationship between NIH and an NIH grant recipient? Before
sponsoring research to be conducted in a foreign country, does the NIH evaluate
the likelihood that the government of such country will prohibit the NIH from
obtaining any materials or data related to such research?
7. Will NIH investigate how EcoHealth was
able to report the humanized mice experiment results in the Year 4 and Year 5
progress reports since (1) EcoHealth admitted it does not have copies of the
laboratory notebooks and electronic files; and (2) EcoHealth did not create or
retain these records? If not, why not?
8. Did EcoHealth provide the WIV with
access to the NIH eraCommons system for grantees?
9. How did NIH assess the conflicts of
interest in EcoHealth’s research involving its anonymous financial source and
the private financial sources referenced on page two of this letter?
10. Did EcoHealth disclose the private
donations to NIH? If not, what actions will NIH take to obtain this reporting?
If yes, how did NIH assess the conflicts of interest?
If
you have questions about this correspondence, please contact Alan Slobodin of
the Minority Committee Staff.
Sincerely,
Cathy
McMorris Rodgers
Ranking
Member
Brett
Guthrie
Ranking
Member Committee on Energy and Commerce
Subcommittee
on Health
Griffith
Ranking
Member
Subcommittee
on Oversight and Investigations
EXHIBIT
31
FRANK
PALLONE, JR., NEW JERSEY
CHAIRMAN
CATHY
McMORRIS RODGERS, WASHINGTON
RANKING
MEMBER
ONE
HUNDRED SEVENTEENTH CONGRESS
Congress
of the United States
House
of Representatives
COMMITTEE
ON ENERGY AND COMMERCE
2125
RAYBURN HOUSE OFFICE BUILDING
WASHINGTON,
DC 20515-6115
Majority
(202) 225-2927
Minority
(202) 225-3641
April
25, 2022
Lawrence
A. Tabak, D.D.S., PhD. Acting Director
National
Institutes of Health
9000
Rockville Pike
Bethesda,
MD 20892
Dr.
Tabak,
Our
review of EcoHealth Alliance’s reports about its humanized mice experiments at
the Wuhan Institute of Virology (WIV) using funds from the National Institutes
of Health (NIH) shows pervasive discrepancies, inconsistencies, and omissions
in its progress reports and renewal application that raise serious questions
about scientific and ethical misconduct, violations of NIH policies and
regulations, and possible false statements and fraud. Accordingly, we request
the NIH investigate Dr. Peter Daszak, the Principal Investigator of
R01AIll0964, and other EcoHealth officials to determine whether certain data
related to mice deaths and other material information were intentionally
withheld during the peer review process for EcoHealth’s grant renewal application.
A. History of Grant R01AIll0964
EcoHealth’s
National Institute of Allergy and Infectious Diseases (NIAID) grant R01AIll0964
was funded for June 2014 to May 2019. During this five-year term, EcoHealth was
required to submit annual progress reports to the NIAID. Such submissions
typically occurred around mid-April and were required before funding for the
following year was provided. On or around November 5, 2018,1
EcoHealth
prepared and submitted a renewal application to NIAID, and the grant was
renewed for another five years in May 2019. This renewal award was for $3.7
million plus a $369,819 increase over the first award.2
At
that point, EcoHealth received its funding for Year 6, the first year of its
renewal grant. However, the renewal and funding
1 This is based on what looks like a time stamp at
the bottom of the first few pages of the renewal application.
2 Letter from NIH Deputy Director for Extramural
Research Michael Lauer, MD to Drs. Aleksei Chmura and Peter Daszak, EcoHealth
Alliance (July 8, 2020)
http://downloads.vanityfair.com/lab-leak-theory/Daszak_7_8_20_Reactivation_and_Suspension.pdf
occurred
before EcoHealth attempted to submit its Year 5 progress report in late July
2019. EcoHealth claimed that it was locked out of the NIH system for submitting
its Year 5 progress report, which remained unsubmitted until 2021.3
In
April 2020, concerns emerged about EcoHealth-funded research at the WIV, and
NIH suspended the grant on July 8, 2020, which appears to remain suspended.4
B. Peer Review Process
Our
concerns over EcoHealth’s reporting of the humanized mice experiments and how
it affected review of its grant must be seen in the context of the NIH peer
review process. Unlike the general review of progress reports by the grant
officer, the goal of peer reviewers is to perform an in-depth look at the data
to see what the grant would accomplish over the next five years. All NIH grant,
fellowship, and cooperative agreement applications undergo review through a
two-tiered system of peer review, a competitive and committee-based process to
evaluate the applications.5
The
required peer review system was established pursuant to section 492 of the
Public Health Service Act (42 U.S.C. §289a), and federal regulations (42 C.F.R.§52).6
In
the first stage, the applications are received by the NIH Center for Scientific
Review (CSR), who then assigns each application that meets basic requirements
to both a potential awarding IC and an associated Scientific Review Group (SRG)
of the IC.7
The
potential awarding IC (Institutes and Centers) is the one whose mission best
aligns with the objectives of the research project.8
An
SRG is a peer-review committee composed of 12 to 22 scientists who are experts
in the relevant fields of research. No more than one-fourth of the members of
any SRG may be federal employees.9
The
SRG is responsible for evaluating a grant proposal on the basis of scientific
merit and potential impact of the research. After discussing the application,
each member gives the application a final score, and an overall impact score is
determined from the average of members’ final scores. The application is also
given a percentile ranking, based on how the overall impact score compares to
other applications reviewed by the SRG in the past year.10
In
the second stage, the funding decisions are refined by the National Advisory
Councils or Boards of the potential awarding ICs. Advisory Councils and Boards
are composed of scientific and lay representatives. These groups examine
applications recommended for funding,
3 EcoHealth’s explanation for the delayed submission
of the Year 5 report does not make sense. Dr. Daszak claimed that EcoHealth was
ready to submit its Year 5 progress report at the end of July 2019, but
EcoHealth was locked out by the NIH’s data system. However, even if this were
true, the question remains: Why didn’t EcoHealth simply submit its Year 5
progress report by email to its grant officer? Even though it would not have
been in the eraCommons system used by grantees, EcoHealth at least would have gotten
its submission to the NIAID until submission into the eraCommons system could
be figured out.
4 Letter from Dr. Michael Lauer, NIH to Dr. Peter
Daszak, EcoHealth Alliance (July 8, 2020).
5 NIH, Report of the Director of the National
Institutes of Health: Fiscal Years 2014 & 2015, p. 25,
https://report.nih.gov/biennialreport/NIH_Biennial_Report_2014-15_non508.pdf
6 NIH, Peer Review,” at
https://grants.nih.gov/grants/peer-review.htm (accessed April 4, 2022).
7 NIH, Peer Review,” at
https://grants.nih.gov/grants/peer-review.htm (accessed April 4, 2022).
8 Id.
9 NIH, Peer Review,” at
https://grants.nih.gov/grants/peer-review.htm (accessed April 4, 2022).
10 NIH, “Peer Review-Scoring,” at
https://grants.nih.gov/grants/peer-review.htm#scoring
place
their impact scores and percentile rankings in the context of the IC’s research
priorities, and then make recommendations for final funding decisions.11
C. EcoHealth’s proposed humanized mice
experiment
As
noted in our October 30, 2021, letter to NIH, EcoHealth first proposed testing
chimeric SARS-like viruses in a humanized mice experiment to evaluate
pathogenicity in the spring of 2016. The NIH approved this research in July
2016 with the condition that EcoHealth immediately stop its experiments and
report to the NIH if there was more than one log of virus growth in any of mice
groups infected with one of the chimeric viruses. Peculiarly, EcoHealth did not
specify in its proposal to NIH how pathogenicity would be evaluated in an
animal experiment, and NIH did not follow-up to ask for such information.12
In
addition to gain-of-function research concerns, it appears NIH approved an
animal experiment without knowing the number of animals that would be involved
and potentially harmed. Despite EcoHealth and NIH’s conclusion that there was
no potential gain-of-function concern (which seems counter to the purpose of
the grant),13
the
results of the experiments showed all three chimeric viruses were more lethal
compared to the WIV-1 virus.
Notably,
one condition that NIAID did impose on the research proposal related to
enhanced virus growth, per the grant documents:
NIAID
acknowledges that if any of the MERS-like or SARS-like chimeras generated under
this grant show evidence of enhanced virus growth greater than 1 log over the
parental backbone strain, Dr. Daszak will immediately stop all experiments w/
these viruses and provide the NIAID Program Officer and Grants Management
Specialist, and Wuhan Institute of Virology Institutional biosafety Committee,
with the relevant data and information related to these unanticipated outcomes.
(Emphasis added).
However,
NIAID requested that EcoHealth clarify the location of the experiment since
EcoHealth previously indicated that the experiment would be conducted at the
University of North Carolina (UNC). However, on June 27, 2016, Dr. Daszak
clarified that the experiment
11 NIH, Peer Review”, at
https://grants.nih.gov/grants/peer-review.htm (accessed April 4, 2022).
12 This is contrary to animal research reporting guidelines that state, “Clearly define all outcome measures assessed (e.g., cell death, molecular markers, or behavioural changes).” Nathalie Percie du Sert, et al, Reporting animal research: Explanation and elaboration for the ARRIVE guidelines 2.0, PLOS Biology (July 14, 2020) available at https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3000411
13 “Moreover, we are introducing progressively more
distant S glycoproteins into WIV1 (The RBD of Rs7327 differs from WIV1 in
several amino acid residues while RsSHC014 is even more distantly related
phylogenetically), so it seems progressively less likely that any of these
viruses would be more pathogenic or transmissible than the SARS-CoV.” June 8,
2016, EcoHealth letter to NIH (per notes taken by Minority Committee staff Oct.
5, 2021, during bipartisan in camera review).
would
be conducted at the WIV, and he assured NIH that the WIV would immediately
notify EcoHealth of such enhanced virus growth:
You
are correct to identify a mistake in our letter. UNC has no oversight of the
chimera work, all of which will be conducted at the Wuhan Institute of
Virology…. We will clarify tonight with Prof. Zhengli Shi14
exactly
who will be notified if we see enhanced replication…my understanding is that I
will be notified straight away, as [principal investigator], and that I can
then notify you at NIAID. Apologies for the error! (Emphasis added).15
Even
though EcoHealth received approval for the risky research from NIAID in the
early weeks of Year 3, EcoHealth and the WIV did not report the experiment
until the Year 4 report. It appears that during Year 3, EcoHealth arranged to
get the humanized mice for the experiment imported to China. More transgenic
mice were then constructed and bred before the experiment was conducted.16
D. EcoHealth’s Descriptions of Humanized
Mice Experiment
As
far as we are aware, neither EcoHealth nor the WIV published the details of
these experiments in scientific literature, nor are there indications that such
publication was even intended. Thus, available details of the experiment are
limited to three key documents that described aspects of the mice experiment:
the Year 4 progress report, the renewal application for NIAID grant
R01AIll0964, and the Year 5 progress report.
i. The Year 4 progress report (June
2017-May 2018)
The
experiment involved infecting four groups of humanized mice with different
SARS-like bat viruses, with three groups getting infected with chimeric
SARS-like viruses. During the Year 4 reporting period between June 2017 and May
2018, the WIV conducted one experiment that caused some Angiotensin-Converting
Enzyme 2 (ACE2) Receptor humanized mice to get sick within six days after
infection, and some to die within two weeks. However, EcoHealth split the
disclosure of the experiment’s data into two parts: (1) weight loss data and
viral load in lung tissue in the Year 4 report and the renewal application; and
(2) the deaths, viral load in brain tissue, and two photos of lung tissue in
the Year 5 report.
As
we stated in our February 24 letter, EcoHealth claimed in October 2021 that it
conducted a single risky virus infection experiment in one year, but split up
the reporting into two different years. The wording of the reports and the
renewal application can be read as if there were two experiments. The report
stated, “we continued with in vivo infection experiments.”17
If
the report accurately reflected Dr. Daszak’s claim, then the report should have
14 Dr. Shi leads bat coronavirus research at the
WIV.
15 Katherine Eban, “This Shouldn’t Happen”: Inside
the Virus-Hunting Nonprofit at the Center of the Lab-Leak Controversy, Vanity
Fair (March 31, 2022), Inside the Virus-Hunting Nonprofit at the Center of the
Lab-Leak Controversy | Vanity Fair
16 Year 3 Report, at 253.
17 EcoHealth Alliance Year 5 progress report at 15.
read
“we continued data analysis of in vivo infection experiments”. The plain
meaning of the text does not support Dr. Daszak’s assertion.
Further,
the term “experiments” is plural, incorrectly suggesting more than one
experiment. In the Year 4 progress report, the experiment was characterized as
“preliminary”, but, interestingly, the word “preliminary” does not appear in
the Year 5 progress report description. Yet, more significantly, the Year 5
report makes no mention of the weight loss data from the Year 4 report that
would show it was a continuation of the same study.18
According
to the Year 4 progress report:
In
Year 4, we performed preliminary in vivo infection of SARSr-CoVs on transgenic
mice that express hACE2. Mice were infected with 10^5 pfu of full-length
recombinant virus of WIV1 (rWIV1) and the three chimeric viruses with different
spikes. Pathogenesis of the 4 SARSr-CoVs was then determined in a 2-week
course.
Mice
challenged with rW IV1-SHC014S have experienced about 20% body weight loss by
the 6th day post infection, while rWIV1 and rWIV-4231 S produced less body
weight loss. In the mice infected with rWIV1-WIV16S, no body weight loss was
observed (Fig. 35a).19 (Emphasis added).
The
Year 4 (2017-2018) progress report disclosed weight loss results in the
infected mice (Figure 35(a) included below) and a graph showing virus growth in
mice lung tissue for the first few days during the two-weeks and then from the
“dead point” (Figure 35(b) included below).
However,
the graph showing the weight loss results only showed results up to 6 days
post-infection, even though it was a two-week experiment. Notably, it was on
the sixth day of the experiment that the first mouse death occurred according
to Figure 13(a) in the Year 5 report. For example, there is no weight loss data
for days 8, 10, 12, and 14 post-infection.20
The
graph showing the viral load in lung tissue also only showed measurements up to
six days (again without data for days 8, 10, 12, and 14) but then included
measurements at the “dead point”. However, the “dead point” was not defined or
explained. Most significantly, the lung graph did not imply mice deaths from
the virus. The mice deaths could have reflected the sacrificed mice made either
to obtain the lung tissue samples or to prevent further suffering from the mice
during the experiment in accordance with animal welfare requirements.
18 The Year 5 report included two photographs of
lung tissue sections to showcase the difference in pathogenicity between the
most lethal virus and the least lethal virus. However, such a visual would have
attracted more attention at the study panel review into the extent of the
virulence that EcoHealth appeared to be trying to conceal. EcoHealth should
have linked this photographic evidence with the viral load in the lung tissue
graph in the Year 4 report, but no linkage was made between the photographs in
the Year 5 report and the graph in the Year 4 report.
19 HHS docs at 297, Year 4 report at 24. EcoHealth
grant documents available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
20 EcoHealth may have chosen not to report
additional weight loss results because the mice were dying at such a high rate,
the data would be biased toward the heavier, healthier mice that survived. On
the other hand, if the mice mounted an immune response to the virus, then that
data was not shared.
Additionally,
Figure 35(b) showed viral growth in the experiment that implicated the NIH
policy of stopping the experiment if more than one log of viral growth
occurred. There is no evidence that EcoHealth complied with NIH’s condition to
stop this experiment since it continued past the point of excessive viral
growth and there was no evidence of stoppage or any notification to NIAID.
EcoHealth apparently reported the experiment in the Year 4 progress report well
after the experiment was completed. Overall, EcoHealth vaguely characterized
the experiment: “These results demonstrate varying pathogenicity of SARSr-COVs
with different spike proteins in humanized mice”.
ii. EcoHealth’s renewal application
(November 2018).
EcoHealth’s
application for competitive renewal sent later in 2018 for its grant included
the same Year 4 report data but conspicuously omitted the word “dead” from the
lung tissue graph. But this time EcoHealth provided some interpretation.
EcoHealth pointed out that the results demonstrated that “pathogenicity of
SARSr-CoVs in humanized mice differs with divergent S proteins, thus confirming
the value of this model in assessing novel SARSr-COV pathogenicity.”21
In
addition, EcoHealth mentioned that the WIV had vaccinated the humanized mice
infected with the SHC014 chimeric virus and the WIV-1 virus. The renewal
application stated that the vaccine did not reduce clinical symptoms in the
SHC014-infected mice, but the vaccine cross-neutralized two out of the four
monoclonal antibodies in the WIV-1–infected mice. However, none of this data
was actually shown nor any other substantiating details provided.22
Most
significantly, EcoHealth used the experiment results to help make the case for
grant renewal. EcoHealth asserted that its humanized mice work had three
implications for its R01 renewal:
(1)
some SARS related CoVs currently circulating in bats in southern China are
likely able to infect and replicate within people; (2) clinical outcomes of
infection may include SARS-like illness that is not treatable with monoclonal
antibodies nor preventable with experimental vaccines; (3) SARS related
coronavirus ability to bind human ACE2 is lost with S protein divergence
between 10 and 24 percent. Although no viruses within this range have so far
been described, these strains likely used hACE2 but could escape existing
vaccines and immunotherapeutics and represent significant public health
threats. In our R01 renewal proposal, we will actively seek to identify viruses
with this level of S protein divergence, characterize their binding targets in
vitro, and their capacity to produce SARS-like disease that evade immunotherapy
and vaccination in vivo. (Bolded in original).
21 EcoHealth Alliance grant renewal application at
162 available at Understanding the Risk of Bat Coronavirus Emergence - The
Intercept
22 Again, since there has been no publication of the
experiment and publication does not appear to have been intended. EcoHealth
could make these assertions in NIH documents without substantiation.
iii. Year 5 progress report (June 2018 – May
2019).
The
Year 5 progress report disclosed death data, a graph of virus load in brains of
infected mice, and two photographs of viral load impact on lung tissue of
infected mice.23
However,
the submission of EcoHealth’s progress report for Year 5 that included the mice
death data was delayed and not received by the NIH until August 2021.24
The
Year 5 progress report (due in September 2019, but submitted to NIH in August
2021) stated:
In
Year 5, we continued with in vivo infection experiments of diverse bat
SARSr-CoVs on transgenic mice expressing human ACE2. Mice were infected with 4
strains of SARSr-CoVs with different S protein, including the full-length
recombinant virus of SARSr-CoV WIV1 and three chimeric viruses with the
backbone of WIV1 and S proteins of SHC014, WIV16 and Rs4231, respectively.
Pathogenicity of the 4 SARSr-CoVs was evaluated by recording the survival rate
of challenged mice in a 2-week course. All of the 4 SARSr-CoVs caused lethal
infection in hACE2 transgenic mice, but the mortality rate vary among 4 groups
of infected mice (Fig. 13a). 14 days post infection, 5 out of 7 mice infected
with WIV1 remained alive (71.4%), while only 2 of 8 mice infected with rWIV1-SHC014
S survived (25%). The survival rate of mice infected with rWIV1-WIV16S and
rWIV1-4231S were 50%. (Emphasis added).
E. Dr. Daszak Claimed There Was Only a
Single Experiment
The
wording in the progress reports and the renewal application appeared to show
two experiments in different reporting years.25
As
a result, in October 2021, NIH wrote to EcoHealth mentioning the experiment
discussed in the Year 5 progress report and informed EcoHealth that the
research violated the one log virus growth policy.
In
its defense, EcoHealth claimed that it complied with the policy because
EcoHealth now claimed it was a single experiment conducted in Year 4 in which
some of the results were reported in the Year 4 progress report, with the
deaths results reported in the Year 5 progress report. In his October 26, 2021,
response,26
Dr.
Daszak claimed the humanized mice experiment discussed in both progress reports
was one study:
23 EcoHealth grant documents available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
24 Id.
25 According to one expert contacted by staff who is
familiar with such studies, two different experiments would have been standard
practice. The Year 4 experiment would have been a preliminary small study
assessing weight loss (probably with four or fewer mice per group, which is a
number of mice sufficient to provide interpretable weight-loss data but not
sufficient to provide interpretable survival-rate data), and a follow-up large
study (perhaps with 10 or more mice per group). However, this experiment was
conducted in China, not in the U.S.
26 EcoHealth Oct. 26, 2021, letter to NIH available
at
https://www.documentcloud.org/documents/21097880-ecohealth-letter-contesting-claims
Firstly,
Dr. Tabak’s letter appears to refer to our year 5 report, and we note that in
your email accompanying you also refer to a Figure 13 from that year 5 report.
However, as is visible in the pattern of viral genome measurements, this figure
closely resembles Figure 35 from our year 4 report, but with follow-up
histopathological and survival data added (both are inserted, below).27
The
reason for this is that both figures are from the same experiment – conducted
in 2018 and, as noted above, reported rapidly to NIH on 13th April 2018 in our
Year 4 report.28
In
his March 2022 interview with The Intercept, Dr. Daszak further explained how
there was only one humanized mice experiment.29
First,
he stated that EcoHealth Alliance essentially cut and pasted the report section
sent by the WIV on the experiment:
Here’s
what happens, it’s a very standard procedure: We are subcontracting to a lab in
China to do some work. Every year we have to file a report to NIH to tell them
what we’ve done for the year, how we’ve spent the money, and whether we’ve
achieved the goals of the grant. So, we contact our subcontractees and we say,
‘Send us the information. Let us know what successes you’ve had this year and
whether you’ve had problems and issues. Put it all in a report and send it to
us.’ And then we use that to produce a report for NIH. That’s why there are
some editing issues around that. We move them around a bit, and we send a final
report.
He
then detailed how the reporting of one humanized mice experiment was split
between two progress reports:
This
is a simple issue of Chinese nationals writing a report and then us drafting
our report to NIH. So there’s a word in there where they say we continued the
studies. That doesn’t mean they continued infecting mice with new viruses. No.
What it means is they continued doing the research on the one experiment that
they’ve done. And that continuation is a lot of work. So they did all the
pathology, which means at the end of the experiment, you take all the mice, and
you look at every organ in the body. You
27 While Dr. Daszak depicted the “pattern of viral
genome measurements” and the results in Figure 35 in the Year 4 report and in
Figure 13 in the Year 5 report as “closely” resembling each other, a closer
examination revealing data discrepancies shows otherwise. This is discussed in
a latter section of the letter.
28 EcoHealth grant documents posted by The Intercept
(Oct. 21, 2021) available at
https://theintercept.com/document/2021/09/08/understanding-the-risk-ofbat-coronavirus-emergence/
As we noted in a previous letter, EcoHealth was not
in compliance with the NIH policy even with the Year 4 progress report because
the experiment was not stopped when the excessive virus growth occurred while
it was being conducted. Instead, EcoHealth reported the experiment after it had
been completed.
29 Sharon Lerner and Mara Hvistendahl, Peter Daszak
Answers Critics and Defends Coronavirus Research, The Intercept (March 11,
2022), Peter Daszak Answers His Critics, Defends EcoHealth Alliance
(theintercept.com)
do
detailed microscopical analysis. It takes months. So that’s why it dragged on
because you’ve got months of after-the-experiment analysis. And we included the
mortality data as part of the pathology data. That’s completely normal”.30
F. Financial Pressures on EcoHealth
As
recently reported by Vanity Fair,31
EcoHealth
faced a “brewing financial crisis” in 2017 and 2018 leading up to the time
EcoHealth submitted its grant renewal application to the NIAID in 2018.
Ninety-one percent of EcoHealth’s funding came from the federal government,
with 71 percent of that funding from the PREDICT grant from the U.S. Agency for
International Development. The renewed PREDICT II grant was scheduled to end in
two years. EcoHealth did not know if this grant would be reauthorized. This
looming possibility was known within EcoHealth as the “PREDICT cliff.” These
financial concerns consumed EcoHealth in meeting after meeting.32
To
offset this potential loss of funding, EcoHealth sought a grant with the
Defense Advanced Research Projects Agency (DARPA) in March 2018, which was
ultimately declined. However, at a March 29, 2018, EcoHealth staff meeting, Dr.
Daszak expressed his concerns about the amateur nature of the DARPA submission,
calling it “a major failure on all accounts”33
and
he demanded a “change in culture” as “part of [a] mentaility [sic] to get
money.”34
Notably,
it was during this time of financial urgency and the push for a culture “to get
money” that EcoHealth submitted its Year 4 progress report on April 13, 2018,
and its grant renewal application in November 2018.
30 Dr. Daszak’s statement is contradicted by the
Year 4 report that included the lung pathology data but not the mortality data.
31 Katherine Eban, “This Shouldn’t Happen”: Inside
the Virus-Hunting Nonprofit at the Center of the Lab-Leak Controversy, Vanity
Fair (March 31, 2022), Inside the Virus-Hunting Nonprofit at the Center of the
Lab-Leak Controversy | Vanity Fair
32 Id.
33 Id.
34 Id.
G. The mice death cover-up
The
renewal application for the EcoHealth grant concealed the mice deaths by
reproducing the two figures from the Year 4 report, but deleting the word
“dead” from the term “dead point” in the lung tissue graph:
Figure 35 – Year 4 Report (with “dead point”)
However,
the renewal application for the EcoHealth grant shows that the word “dead” was
defaced and deleted, but still includes the DPI line for the weight loss graph
(Figure 6(b) is reproduced and enlarged for readability):
Figure 6 – Renewal Application (with defaced and
deleted “dead” from “dead point”)
In
the Year 5 report, EcoHealth has no problem including the word “dead” under the
brain tissue graph:
Figure
35 – Year 5 Report (with “dead point”)
There
is no apparent reason why EcoHealth was able to include the word “dead” in the
Year 4 and Year 5 report graphs, but not in the graph in the renewal
application. Without the word “dead” with Figure 6(b), the lung tissue graph
would not have implied mice deaths; it would have implied only increasing viral
loads. As such, this looks suspiciously tailored to delete this word in a
document that would be reviewed by subject matter experts in the peer review
process who were independent of NIAID.
Further,
the renewal application, unlike the Year 4 report, stated that the presented
information showed that the mice infected with SHC014 only had “mild” SARS-like
clinical signs that were not reduced by immune-therapeutic monoclonals that
reduce SARS pathogenicity or by vaccines. However, the Year 5 report with the
mice death data showed that the SHC014 produced a staggering 75 percent death
rate. Thus, the portrayal of the SHC014 infected mice as having mild symptoms
when EcoHealth would have known of the 75 percent death rate strongly suggests
EcoHealth intended to deceive the peer reviewers.
Finally,
the deletion of the word “dead” in Figure 35(b) suggests that EcoHealth
believed including “dead point” would have triggered questions from the peer
reviewers about the deaths. It appears the word “dead” was taken out to conceal
the deaths from the peer reviewers, which raises scientific and ethical
concerns.35
H. Why Concealing the Mice Deaths Mattered
EcoHealth
found itself with unpleasant choices. It could admit that it was doing
gain-of-function research, or risk losing money it desperately needed from
NIAID. Given the financial pressures it was facing and the culture of “getting
money” created by Dr. Daszak, the presentation of the humanized mice data in
the renewal application appears intentional.
35 S. Moran and R. Huneke, The Role of IACUCs in
Responsible Animal Research, ILAR Journal (November 2019),
https://academic.oup.com/ilarjournal/article/60/1/43/5618668
If
the mice deaths had been disclosed, it is reasonable to expect that the peer
reviewers would have noted these results and the discrepancies in the data when
the data of both Year 4 and Year 5 reports are combined. Had the peer reviewers
seen the mice death data from the survival rate graph held back for the Year 5
report, they would have known mice were dying at high rates from the chimeric
viruses in a risky experiment. There was a significant probability that
reviewers would have wanted to stop such risky research and not continue
EcoHealth’s funding.
I. Dr. Daszak’s Explanation for the
Delayed Mice Death Reporting is Suspect
In
his March 2022 interview with The Intercept, Dr. Daszak stated that the
reporting of the mice deaths was delayed because months of pathology work
needed to be done. This explanation does not make sense because EcoHealth was
able to include lung pathology work in the Year 4 progress report. The renewal
application, which appears to have been submitted to the NIH in early November
2018, was seven months after the April 2018 submission of the Year 4 report
data, presumably more than enough time to have done pathology work.
Additionally,
Dr. Daszak’s claims about the length of time needed for pathology work appear
dubious. Minority committee staff consulted with scientific experts who are
either board-certified in pathology or have conducted humanized mice
experiments with coronaviruses and staff found no support for the notion that
such pathology work would take months. In fact, two experts indicated that
pathology takes a week or so since tissues need to be fixed for 24 hours and
then processed and stained. One expert told staff that EcoHealth’s assertion
that reporting of survival data would need to be deferred until pathology work
was done was comical.
Even
if Dr. Daszak’s assertion were true, there is no basis that we are aware of
that justifies holding back the death data that EcoHealth already had. In fact,
animal welfare regulations suggest that it would be unethical to withhold or
delay reporting the death data. The WIV and EcoHealth could have, and should
have, reported the death data and told NIH that the pathology work was
continuing.
Using
the mice death data generated during Year 4 for the Year 5 report also raises
questions about how EcoHealth and the WIV actually spent the Year 5 funds for
laboratory research since no new mice experiments were apparently conducted in
Year 5 given EcoHealth’s claim of a single experiment conducted in Year 4. It
does not make sense that the pathology work for the lung tissue up to the “dead
point” was done in time for inclusion in the Year 4 report, but the pathology
work for the viral load in brain tissue up to the “dead point” could not be
done in time for the Year 4 report and/or the renewal application. It does not
explain why the death data could not have been included in the Year 4 report
since lung tissue data with a “dead point” were also submitted in the Year 4
report.
Dr.
Daszak’s explanation does not explain why the Year 4 report data submitted in
April 2018 were not updated with death data for the renewal application that
was sent months later in 2018. If Dr. Daszak’s statement about the delay in
reporting the deaths because of the time needed to do pathology work were true,
then there should have been no lung measurements up to the “dead point” of the
experiment included in the Year 4 report. Nor did Dr. Daszak make any
distinctions between the lung work and brain work on the length of time to do
the pathology work.
J. Discrepancies and Omissions in
EcoHealth’s Reports
i. “Dead point” Not Defined
As
we noted in our previous letter, EcoHealth’s Year 5 progress report was riddled
with errors, such as mislabeled graphs.36
Our
further examination of the Year 4 and Year 5 reports on the humanized mice
research shows the results of the experiment(s) have many discrepancies and
omissions. As already noted, the so-called “dead point” in the experiment was
not defined or explained.
ii. No Mention of Sample Size
In
addition, none of EcoHealth’s descriptions of the experiment mention the sample
size.
For
the Year 4 report and renewal application, there is no mention of sample size
of any kind, and the Year 5 report only noted that there were 9 mice in the
control group and 7 mice in the group that had the most deaths.37
However,
neither the number of mice in the other two groups nor the overall number of
mice in the study are mentioned. This is contrary to animal research reporting
guidelines that state “Specify the exact number of experimental units allocated
to each group, and the total number in each experiment. Also indicate the total
number of animals used”.38
By
omitting or keeping the mice number vague, EcoHealth was able to hide
additional mice deaths resulting from sacrifices made to obtain tissue samples
or to mitigate suffering.
iii. Discrepancies in Pathogenicity Results
In
the Year 4 report, the WIV 16S infected-mice group had no weight loss, an
indication of no pathogenicity. In the Year 5 report, the 16S infected group
had a 50 percent death rate while the WIV 1 infected control group had a 29
percent death rate. Thus, for the group infected with the 16S chimeric virus,
the experiment in the Year 4 report showed no pathogenesis in terms of weight
loss, but the full two-week study in the Year 5 report showed a 50 percent
death rate, evidence of pathogenesis. The WIV 1 group had a 29 percent death
rate, even though this group had more weight loss (more pathogenesis) than the
16S group had.
36 Letter from House Energy and Commerce Committee
Republican Leader Cathy McMorris Rodgers, Republican Health Subcommittee Leader
Brett Guthrie, and Republican Oversight and Investigations Subcommittee Leader
Morgan Griffith to Dr. Lawrence A. Tabak, Acting Director of the NIH (February
24, 2022).
37 Assuming the other two mice groups were of
similar number, the total number of mice used in a single study would have been
more than 30, not the typical number in a preliminary in vivo infection study.
Given the expense of mice and minimizing the number of mice sacrificed, the
number in a preliminary study would be much smaller, according to an expert
consulted by staff.
38 Nathalie Percie du Sert, et al, Reporting animal
research: Explanation and elaboration for the ARRIVE guidelines 2.0, PLOS
Biology (July 14, 2020) available at
https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3000411
The
lung tissue results were not consistent with the weight loss findings. The
group with no weight loss and the group with the highest weight loss had nearly
the same number of logs of virus growth at the “dead point” of the
experiment.39
In
the Year 4 report, in Figure 35(b), there is no bar for the 4231-infected group
at the dead point in the bar graph on the viral loads in lung tissue, although
the bar for the 4231 group is represented in measurements taken 2, 4, and 6
days post-infection. As noted before, during the time that mice deaths were
accruing, there were no results for days 8, 10, and 12, and it is inexplicable
why the 4231-infected mice data for the “dead point” would be missing in Figure
35(b).
The
viral load in brain results in Figure 13b were not consistent with the death
results in Figure 13a. The group infected with SHC014 that had the highest
death rate (75 percent) had less virus growth in the brain than the amount of
virus growth in the brain in the two groups that had a 50 percent death rate.
Groups with different death rates had similar viral loads in the brain
suggesting that the viral loads in brain tissue may not have been as pertinent
as viral loads in lung tissues in its association with pathogenicity. But this
issue was not distinguished or pursued.
iv. Missing Data
The
Year 5 report stated, “Viral replication was confirmed by quantitative PCR in
spleen, lung, intestine, and brain of infected mice.” However, the PCR viral
replication data for the spleen and intestine were not included in the report.
Perhaps if EcoHealth and the WIV had published the experiment in scientific
literature, complete data sets would have been provided.
However,
it has been more than four years since the experiment was conducted and we have
been unable to find any publication about this experiment. Notably, even Dr.
Daszak admitted EcoHealth did not have the lab notebooks or the electronic
files for the experiment and claimed that such records were in China.40
K. EcoHealth Also Masked Its Violation of
NIH Policy on Virus Growth
Even
with the Year 4 report’s focus on mice weight loss, EcoHealth violated the NIH
grant policy that required experiment stoppage when more than one log of viral
growth occurred
39 EcoHealth’s Year 4 report description of the mice
experiment only focused on the early lung viral loads that were consistent with
its assertion that the chimeric virus-infected mice had greater pathogenicity
than the WIV1-infected mice. However, EcoHealth’s description did not include
the later results in the experiment that were inconsistent with this pattern.
EcoHealth wrote, “2 and 4 days post infection, the viral load in lung tissues
of mice challenged with rWIV1-SHC014S, rWIV1-WIV16S and rWIV1-Rs4231 S reached
more than 10 to the 6 genome copies/g and were significantly higher than that
in rWIV1-infected mice (Fig. 35b). These results demonstrate varying
pathogenicity of SARSr-CoVs with different spike proteins in humanized mice.”
However, Fig. 35b also showed that 6 days post infection the rWIV1-infected
mice had viral loads only slightly less than the other infected mice. In fact,
at the dead point, rWIV1-infected mice had higher viral loads in lung tissue
than the load in the 4231 S group and almost the same viral load as the SHC014S
group.
40 Letters to EcoHealth Alliance (Jan. 11, 2022)
available at
https://republicans-oversight.house.gov/wp-content/uploads/2022/01/January-2022-EHA-SAC-CAP-letter-final1.pdf
with
the one of the chimera-infected mice groups compared to the viral growth in the
control group. The violation is supported by the bar graph in Figure 35(b)
showing the excessive viral growth in lung tissue. However, the text of the
report does not discuss mice deaths nor quantify the extent of viral growth.41
Moreover,
the weight loss graph stops at 6 days and not for the full two-week period. In
contrast, the survival graph in the Year 5 report covered the full 14 days.
It
is now apparent how this violation occurred. Contrary to its assurance to NIAID
in 2016 about the WIV reporting to Dr. Daszak “right away”, EcoHealth had no
real-time knowledge of this experiment. It appears EcoHealth simply benefited
financially by being a pass-through for the WIV.42
Based
on Dr. Daszak’s statement to The Intercept about cutting and pasting the WIV
excerpts into progress reports, EcoHealth did not know about the virus growth
until the WIV sent in its report section for the Year 4 report about the
experiment that was already completed.
The
concerns raised here have profound implications on the integrity of the peer
review process. More investigation needs to be conducted to obtain more
complete and accurate information about the humanized mice experiment. In
addition to investigating the above concerns, please respond to the following
by May 16, 2022:
1. Why did NIAID provide renewal grant
funding to EcoHealth before EcoHealth filed its Year 5 Progress Report?
2. Why did NIAID neglect or willfully
ignore EcoHealth’s missing Year 5 progress report for nearly two years?
3. Why would NIAID fund a study that does
not report its sample size? What are the scientific standards for these studies
to meet on detailing sample size?
4. Animal experiments are highly
regulated, and EcoHealth and the WIV should have very detailed records about
the mice experiments. Did NIAID monitor this grant for compliance with animal
welfare regulations or ABSL3 (Animal Biosafety Level 3) regulations? Why or why
not?
5. When NIAID reviewed EcoHealth’s
research proposal to study pathogenesis of SARS-related viruses in humanized
mice, did the NIAID approve only one experiment? Was EcoHealth authorized by
NIH to conduct as many as experiments as it wanted pursuant to the proposal
submitted to NIH? Other than the viral growth policy, were there any other
restrictions or conditions on EcoHealth’s authority in conducting the humanized
mice experiment?
41 EcoHealth only stated that the viral load in mice
infected with the three chimeras had “significantly higher” growth than that in
the WIV-1 infected mice.
42 EcoHealth would receive the financial benefit by
charging the grant for the WIV overhead and would hold some of that overhead
charge for itself.
6. Is it permissible for an NIH grantee to
withhold and delay reporting of data on deaths in an animal experiment? If so,
under what circumstances?
7. What animal welfare regulations applied
to the humanized mice experiment, and was EcoHealth in compliance with those
regulations?
8. If a grantee submits a research plan
involving an animal experiment on pathogenicity for NIH’s review, does the
grantee need to specify how pathogenicity is evaluated? Or can the grantee
evaluate pathogenicity through a survival study that could result in animal
deaths without explicitly informing the NIH?
9. Why did NIAID not seek details on the
kind of pathogenicity study that EcoHealth wanted to pursue with the WIV?
10. When was the EcoHealth application
reviewed by the SRG for renewal? When did NIAID finalize the decision?
11. What are the implications of grant
applicants selectively sharing data that may be material to the funding
decision? What is NIH policy in this area?
If
you have questions about this correspondence, please contact Alan Slobodin of
the Minority Committee Staff.
Sincerely,
Cathy
McMorris Rodgers
Ranking
Member
Brett
Guthrie
Ranking
Member Committee on Energy and Commerce
Subcommittee
on Health
H.
Morgan Griffith Ranking Member
Subcommittee
on Oversight and Investigations
cc:
The
Honorable Frank Pallone, Chair,
House
Energy and Commerce Committee
The
Honorable Anna Eshoo, Chair,
Subcommittee
on Health
The
Honorable Diana DeGette, Chair,
Subcommittee
on Oversight and Investigations
The
Honorable Christi Grimm, HHS Inspector General
Elena
Fuentes-Afflick, M.D., M.P.H.,
Home
Secretary, National Academy of Medicine
EXHIBIT
20
FRANK
PALLONE, JR., NEW JERSEY
CHAIRMAN
CATHY
McMORRIS RODGERS, WASHINGTON
RANKING
MEMBER
ONE
HUNDRED SEVENTEENTH CONGRESS
Congress
of the United States
House
of Representatives
COMMITTEE
ON ENERGY AND COMMERCE
2125
RAYBURN HOUSE OFFICE BUILDING
WASHINGTON,
DC 20515-6115
Majority
(202) 225-2927
November
30, 2022
Lawrence
A. Tabak, D.D.S, Ph.D.
Senior Official Performing the Duties of the Director
National Institutes of Health
9000
Rockville Pike
Bethesda,
MD 20892
Dr.
Tabak:
We
write to urge the National Institutes of Health (NIH) to respond to our
longstanding requests to provide us information related to the origins of the
COVID-19 pandemic, including matters related to National Institute of Allergy
and Infectious Diseases’ (NIAID) grant to EcoHealth Alliance and subgrant to
the Wuhan Institute of Virology (WIV), and other subjects. Some of these
requests have been outstanding for more than a year. NIH’s persistent lack of
transparency with members of its authorizing committee of jurisdiction is
troubling.
According
to its mission statement, a goal of the National Institutes of Health (NIH) is
“to exemplify […] the highest level of scientific integrity and public
accountability.”1
However,
given the overall lack of adequate responsiveness to our oversight letters, the
NIH is falling short of the goal set forth in its mission statement. Between
March 18, 2021 through October 31, 2022, we sent a total of twelve letters
requesting information from NIH that have gone largely unanswered related to
the origins of COVID-19 and NIH’s grant to EcoHealth Alliance, and three other
topics.2
As
a convenient reminder, we courteously summarize each of those letters below:
1 National Institutes of Health, Mission and Goals,
What We Do (accessed July 14, 2021) available at
https://www.nih.gov/about-nih/what-we-do/mission-goals
2 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Francis Collins, M.D., Ph.D., Director, NIH (March 18, 2021);
Letter from Committee Ranking Members (Full and Subcommittees, respectively)
Cathy McMorris Rodgers, Brett Guthrie, Morgan Griffith et al to Francis
Collins, M.D., Ph.D., Director, NIH (June 10, 2021); Letter from Committee
Ranking Members (Full and Subcommittees, respectively) Cathy McMorris Rodgers,
Brett Guthrie, Morgan Griffith to Francis Collins, M.D., Ph.D., Director, NIH
(July 21, 2021); Letter from Committee Ranking Members (Full and Subcommittees,
respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan Griffith to Francis
Collins, M.D., Ph.D., Director, NIH (August 24, 2021); Letter from Committee
Ranking Members (Full and Subcommittees, respectively) Cathy McMorris Rodgers,
Brett Guthrie, Morgan Griffith to Francis Collins, M.D., Ph.D., Director, NIH
(October 27, 2021); Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Francis Collins, M.D., Ph.D., Director, NIH (February 14, 2022);
Letter from Committee Ranking Members (Full and Subcommittees, respectively)
Cathy McMorris Rodgers, Brett Guthrie, Morgan Griffith to Lawrence A. Tabak,
D.D.S., PhD., Acting Director, NIH (February 24, 2022); Letter from Committee
Ranking Members (Full and Subcommittees, respectively) Cathy McMorris Rodgers,
Brett Guthrie, Morgan Griffith to Lawrence A. Tabak, D.D.S., PhD., Acting
Director, NIH (April 25, 2022); Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Lawrence A. Tabak, D.D.S., PhD., Acting Director, NIH (July 21,
2022); Letter from Committee Ranking Members (Full and Subcommittees,
respectively) Cathy McMorris Rodgers, Morgan Griffith to Lawrence A. Tabak,
D.D.S., PhD., Acting Director, NIH (August 11, 2022); Letter from Committee
Ranking Members (Full and Subcommittees, respectively) Cathy McMorris Rodgers,
Brett Guthrie, Morgan Griffith to Lawrence A. Tabak, D.D.S., PhD., Acting
Director, NIH (October 24, 2022); Letter from Committee Ranking Members (Full
and Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Lawrence A. Tabak, D.D.S., PhD., Acting Director, NIH (October 31,
2022).
March
18, 2021, Letter to Dr. Francis Collins:
On
March 18, 2021, we sent an eleven-page letter, based on what was known at that
time, requesting information related to where SARS CoV-2 originated and how NIH
grant dollars at the WIV were used.3
We
asked NIH to provide responses by April 19, 2021.4
Notably,
on April 28, 2021, at a hearing before this Committee’s Subcommittee on Health,
Dr. Francis Collins testified NIH was working diligently to reply to the
letter: “And we are working on answers to your letter with 29 questions and 40
footnotes and 11 pages. It is taking us a little longer than a few days
(emphasis added).”5
While
documents released in response to Freedom of Information Act requests suggest
that NIH had prepared a draft written response, NIH never sent us a written
response to our questions.
We
acknowledge that you provided a briefing to bipartisan committee staff on June
28, 2021, for one hour in response to some of the questions. However, only the
first 20 questions were covered. The other questions remain unanswered. As of
today’s date, November 30, 2022, 622 days later, NIH has not provided a written
response to the questions in the March 18, 2021, letter.
June
10, 2021, Letter to Dr. Francis Collins:
On
June 10, 2021, we wrote to strongly express support for a “comprehensive
investigation into the origins of the COVID-19 pandemic, including the
possibility of an accidental laboratory leak.”6 We identified several concerns
related to the financial management and oversight of the NIH grant to EcoHealth
Alliance and its subaward recipient, the WIV.7
We
3 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Francis Collins, M.D., Ph.D., Director, NIH (March 18, 2021).
4 Id.
5 Hearing on the ‘the Long Haul: Forging a Path
Through the Lingering Effects of Covid-19’, before the Subcomm. On Health, H.
Energy & Commerce Comm. (Apr. 28, 2021), https://energycommerce.house.gov/committee-activity/hearings/hearing-on-the-long-haul-forging-a-path-through-the-lingering-effects-of
6 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith et al to Francis Collins, M.D., Ph.D., Director, NIH (June 10, 2021).
7 Id.
asked
for written responses to our questions be submitted by June 24, 2021. To date,
NIH has not provided a written response.
July
21, 2021, Letter to Dr. Francis Collins:
On
July 21, 2021, we sent another letter reiterating our request for information
to our March 2021 letter, which NIH failed to provide substantive written
responses to.8
In
addition, the letter requested information, by July 28, 2021, about
NIH-supported gain-of-function research involving “humanized mice” as well as
briefings from NIAID officials related to a grant award to EcoHealth Alliance,
and an NIAID’s official visit to WIV.9
NIH
has not provided a written response to the specific questions outlined in the
July 2021 letter, although some information has emerged from subsequent NIH
correspondence with EcoHealth Alliance.
August
24, 2021, Letter to Dr. Francis Collins:
We
submitted an August 2021 letter again requesting information about NIAID’s
coronavirus grant to EcoHealth Alliance.10
Specifically,
the letter raised concerns about EcoHealth Alliance’s oversight of its
subgrantee WIV’s experiments to ensure compliance with biosafety
requirements.11
The
letter further repeated its request that NIAID officials be made available for
staff-level briefings and that NIH provide a response by September 7, 2021. To
date, NIH has not provided a written response.12
October
27, 2021, Letter to Dr. Francis Collins:
Based
on documents the Department of Health and Human Services arranged for the
Committee to review in camera, we highlighted in an October 27, 2021, letter
our concerns about NIH’s oversight of EcoHealth Alliance’s research proposal
that purported it was not conducting gain-of-function research.13
In
addition, the letter raised concerns EcoHealth Alliance failed to comply with
NIH’s grant terms yet continued to receive millions of dollars in grant
funds.14
NIH
was asked to reply to our questions by November 10, 2021, but to date, NIH has
not submitted a written response to this letter.15
February
14, 2022, Letter to Dr. Francis Collins:
On
February 14, 2022, we sent a letter about concerns that Dr. Collins, while
Director of NIH, may have taken steps to actively suppress scientific
discussion that COVID-19 could have
8 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Francis Collins, M.D., Ph.D., Director, NIH (July 21, 2021).
9 Id.
10 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Francis Collins, M.D., Ph.D., Director, NIH (Aug. 24, 2021).
11 Id.
12 Id.
13 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Francis Collins, M.D., Ph.D., Director, NIH (Oct. 27, 2021)
14 Id.
15 Id.
originated
from a research-related incident, not just from natural transmission.16 We
asked Dr. Collins for written responses to a series of questions by February
28, 2022, which to date, he has avoided answering.17 A similar letter was also
sent to Dr. Anthony Fauci, the Director of the NIAID. To date, neither NIH nor
NIAID have submitted written responses to these letters.
February
24, 2022, Letter to Dr. Lawrence A. Tabak:
On
February 24, 2022, we raised concerns with you that NIH failed to effectively
enforce its policies and regulations over EcoHealth Alliance.18
Specifically,
EcoHealth withheld attribution of data to another federal grant from NIH,
raising the possibility it was double-billing two federal agencies for the same
research. Additionally, EcoHealth Alliance’s inability to provide laboratory
notebooks and electronic files called into question the safety of the research
conducted on humanized mice.19
Additionally,
the letter expressed that, in contravention of federal regulations regarding
financial disclosures, EcoHealth Alliance may have hidden from NIH the
identities of its private donors. Several questions were requested to be
answered by March 24, 2022. To date, NIH has not sent a written response.
April
25, 2022, Letter to Dr. Lawrence A. Tabak:
On
April 25, 2022, we wrote to you raising concerns that EcoHealth Alliance was
potentially omitting key information in research allegedly conducted at WIV in
order to obtain a renewal of federal grant funding.20
Specifically,
information related to mice deaths (the higher death rates with mice infected
by chimeric viruses, a supposedly unexpected result) may have been withheld
from peer reviewers during the grant renewal’s application.21
These
nondisclosures may have prevented peer reviewers from examining the complete
research findings, thereby preventing them from questioning the riskiness of
the experiments conducted with federal grant funds.22
While
NIH has provided some information in a bipartisan briefing, many questions
remain unanswered. NIH has not provided a written response to this letter.
July
21, 2022, Letter to Dr. Lawrence A. Tabak:
Although
required by the NIH Reform Act of 2006, NIH has failed to convene the
Scientific Management Review Board (SMRB) since 2015.23
We
wrote asking why this Board, intended to make NIH more efficient and effective,
inexplicably stopped convening seven years ago.24
In
addition, we questioned whether funding intended for the SMRB, $488,901 per
year,
16 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Francis Collins, M.D., Ph.D., Director, NIH (Feb. 14, 2022).
17 Id.
18 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Lawrence A. Tabak, D.D.S., PhD., Acting Director, NIH (Feb. 24,
2022).
19 Id.
20 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Lawrence A. Tabak, D.D.S., PhD., Acting Director, NIH (Apr. 25,
2022).
21 Id.
22 Id.
23 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Lawrence A. Tabak, D.D.S., PhD., Acting Director, NIH (July 21,
2022).
24 Id.
was
being diverted elsewhere for the past seven years, thereby totaling $2.9
million.25 To date, NIH has not provided a written response.
August
11, 2022, Letter to Dr. Lawrence A. Tabak:
As
highlighted in our August 11, 2022, letter, we received inadequate responses in
2021 as to why NIH failed to remove an alleged sexual perpetrator disciplined
in three states from co-chairing an NIH steering committee, even after
receiving complaints from female scientists alleging the misconduct.26
We
reported that the high volume of harassment complaints lodged against NIH
grantees and NIH-supported researchers and raised questions about the NIH’s
handling of such complaints.27
We
requested you provide written responses to our requests by September 12, 2022.
To date, NIH has not provided a written response.
October
24, 2022, Letter to Dr. Lawrence A. Tabak:
Last
month we sent you a letter raising concerns about how NIH could contemplate
funding a new EcoHealth Alliance grant considering this organization’s past
noncompliance with regulatory requirements and grant terms.28
As
we noted, EcoHealth Alliance’s history of failing to substantiate scientific
experiments with material records and its slipshod oversight of its sub
awardee, the WIV, should have caused NIH to conclude that EcoHealth Alliance
could not be a responsible steward of federal grant funding.29
We
submitted several questions for you to answer by November 7, 2022, regarding
the NIH’s decision to renew its funding of EcoHealth Alliance.30
To
date, we have not received a written response from NIH to this letter.
October
31, 2022, Letter to Dr. Lawrence A. Tabak:
Last
month we sent you a letter requesting information related to a NIAID intramural
experiment that would enhance the more dangerous version of the monkeypox virus
by making the disease about 1000 percent more lethal in mice.31
The
more lethal monkeypox virus has about a 10 percent mortality rate in
unvaccinated people whereas the less lethal monkeypox virus has a mortality
rate of less than one percent.32 We requested a written response by November
14, 2022. To date, we have not received a response.
We
urge you to provide written responses to our longstanding requests from these
letters immediately, but no later than December 16, 2022.
25 Id.
26 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Morgan Griffith to
Lawrence A. Tabak, D.D.S., PhD., Acting Director, NIH (Aug. 11, 2022).
27 Id.
28 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Lawrence A. Tabak, D.D.S., PhD., Acting Director, NIH (Octo. 24,
2022).
29 Id.
30 Id.
31 Letter from Committee Ranking Members (Full and
Subcommittees, respectively) Cathy McMorris Rodgers, Brett Guthrie, Morgan
Griffith to Lawrence A. Tabak, D.D.S., PhD., Acting Director, NIH (Oct. 31,
2022).
32 Christina L. Hutson, et al., Dosage Comparison of
Congo Basin and West African Strains of Monkeypox Virus using a Prairie Dog
Animal Model of Systemic Orthopoxvirus Disease, 402 VIROLOGY 72-82 (2010),
available at https://www.sciencedirect.com/science/article/pii/S0042682210001650?via%3Dihub
Furthermore,
this letter serves as a formal request to preserve all existing and future
records and materials in your agency’s possession relating to the topics
addressed in this letter. You should construe this preservation notice as an
instruction to take all reasonable steps to prevent the destruction or
alteration, whether intentionally or negligently, of all documents,
communications, and other information, including electronic information and
metadata, that are or may be responsive to this congressional inquiry. This
instruction includes all electronic messages sent using official and personal
accounts or devices, including records created using text messages, phone-based
message applications, or encryption software.
Sincerely,
Cathy
McMorris Rodgers
Republican
Leader
Committee
on Energy and Commerce
Brett
Guthrie
Republican
Leader
Subcommittee
on Health
H.
Morgan Griffith
Republican
Leader
Subcommittee
on Oversight and Investigations
cc:
The
Honorable Frank Pallone, Chairman
The
Honorable Diana DeGette, Chair, Subcommittee on Oversight and Investigations
The
Honorable Anna G. Eshoo, Chair, Subcommittee on Health
Dr.
Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious
Diseases
