[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]
INVESTING IN PUBLIC HEALTH: LEGISLATION TO
SUPPORT PARENTS, WORKERS, AND RESEARCH
=======================================================================
HYBRID HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTEENTH CONGRESS
SECOND SESSION
__________
JUNE 29, 2022
__________
Serial No. 117-91
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Published for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
� __________
� U.S. GOVERNMENT PUBLISHING OFFICE
62-184 PDF WASHINGTON : 2026
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COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois CATHY McMORRIS RODGERS, Washington
ANNA G. ESHOO, California Ranking Member
DIANA DeGETTE, Colorado FRED UPTON, Michigan
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California BRETT GUTHRIE, Kentucky
KATHY CASTOR, Florida DAVID B. McKINLEY, West Virginia
JOHN P. SARBANES, Maryland ADAM KINZINGER, Illinois
JERRY McNERNEY, California H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont GUS M. BILIRAKIS, Florida
PAUL TONKO, New York BILL JOHNSON, Ohio
YVETTE D. CLARKE, New York BILLY LONG, Missouri
KURT SCHRADER, Oregon LARRY BUCSHON, Indiana
TONY CARDENAS, California MARKWAYNE MULLIN, Oklahoma
RAUL RUIZ, California RICHARD HUDSON, North Carolina
SCOTT H. PETERS, California TIM WALBERG, Michigan
DEBBIE DINGELL, Michigan EARL L. ``BUDDY'' CARTER, Georgia
MARC A. VEASEY, Texas JEFF DUNCAN, South Carolina
ANN M. KUSTER, New Hampshire GARY J. PALMER, Alabama
ROBIN L. KELLY, Illinois, Vice NEAL P. DUNN, Florida
Chair JOHN R. CURTIS, Utah
NANETTE DIAZ BARRAGAN, California DEBBIE LESKO, Arizona
A. DONALD McEACHIN, Virginia GREG PENCE, Indiana
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
DARREN SOTO, Florida JOHN JOYCE, Pennsylvania
TOM O'HALLERAN, Arizona KELLY ARMSTRONG, North Dakota
KATHLEEN M. RICE, New York
ANGIE CRAIG, Minnesota
KIM SCHRIER, Washington
LORI TRAHAN, Massachusetts
LIZZIE FLETCHER, Texas
------
Professional Staff
TIFFANY GUARASCIO, Staff Director
WAVERLY GORDON, Deputy Staff Director
NATE HODSON, Minority Staff Director
Subcommittee on Health
ANNA G. ESHOO, California
Chairwoman
G. K. BUTTERFIELD, North Carolina BRETT GUTHRIE, Kentucky
DORIS O. MATSUI, California Ranking Member
KATHY CASTOR, Florida FRED UPTON, Michigan
JOHN P. SARBANES, Maryland, Vice MICHAEL C. BURGESS, Texas
Chair H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont GUS M. BILIRAKIS, Florida
KURT SCHRADER, Oregon BILLY LONG, Missouri
TONY CARDENAS, California LARRY BUCSHON, Indiana
RAUL RUIZ, California MARKWAYNE MULLIN, Oklahoma
DEBBIE DINGELL, Michigan RICHARD HUDSON, North Carolina
ANN M. KUSTER, New Hampshire EARL L. ``BUDDY'' CARTER, Georgia
ROBIN L. KELLY, Illinois NEAL P. DUNN, Florida
NANETTE DIAZ BARRAGAN, California JOHN R. CURTIS, Utah
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
ANGIE CRAIG, Minnesota JOHN JOYCE, Pennsylvania
KIM SCHRIER, Washington CATHY McMORRIS RODGERS, Washington
LORI TRAHAN, Massachusetts (ex officio)
LIZZIE FLETCHER, Texas
FRANK PALLONE, Jr., New Jersey (ex
officio)
C O N T E N T S
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Page
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 2
Prepared statement........................................... 4
Hon. Brett Guthrie, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 6
Prepared statement........................................... 8
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 12
Prepared statement........................................... 14
Hon. Cathy McMorris Rodgers, a Representative in Congress from
the State of Washington, opening statement..................... 16
Prepared statement........................................... 18
Witnesses
Kirsten Bibbins-Domingo, Ph.D., M.D., M.A.S., Professor of
Epidemiology and Biostatistics................................. 22
Prepared statement........................................... 25
Answer to submitted questions................................ 162
Kevin Croston, M.D., CEO, North Memorial Health.................. 47
Prepared statement........................................... 49
Answer to submitted questions................................ 164
Tanika Gray Valbrun, Founder And President, The White Dress
Project........................................................ 56
Prepared statement........................................... 58
Answer to submitted questions................................ 170
Michael D. Shannon, Executive/President of Government Solutions,
Iptalons, Inc.................................................. 70
Prepared statement........................................... 72
Answer to submitted questions................................ 172
Desiree Sweeney, CEO, New Health................................. 79
Prepared statement........................................... 81
Answer to submitted questions................................ 179
Leslie R. Walker-Harding, M.D., F.A.A.P., F.S.A.H.M., Ford/Morgan
Endowed Professor, Chair Department of Pediatrics/Associate
Dean, University of Washington, Chief Academic Officer/Senior
Vice President, Seattle Children's Hospital.................... 90
Prepared statement........................................... 92
Answer to submitted questions................................ 186
Submitted Material
H.R. 2007, the Stephanie Tubbs Jones Uterine Fibroid Research and
Education Act of 2021 \1\
H.R. 3773, the Pediatricians Accelerate Childhood Therapies Act
of 2021 \1\
H.R. 5141, the Maximizing Outcomes through Better Investments in
Lifesaving Equipment for (MOBILE) Health Care Act \1\
H.R. 5442, the Fix Nondisclosure of Influence in Health Research
Act \1\
H.R. 5478, the Protecting the Integrity of our Biomedical
Research Act of 2021 \1\
H.R. 6305, the Protect America's Biomedical Research Enterprise
Act of 2021 \1\
H.R. 7565, the NIH Implementing a Maternal health and Pregnancy
Outcomes Vision for Everyone Act of 2022 \1\
H.R. 7845, the NIH Clinical Trial Diversity Act of 2022 \1\
H.R. 8151, the Building a Sustainable Workforce for Healthy
Communities Act \1\
H.R. 8163, the Improving Trauma Systems and Emergency Care Act
\1\
H.R. 8169, the Rural Telehealth Access Task Force Act \1\
Letter of June 29, 2022, from Patrick Hope, Executive Director,
Medical Imaging and Technology Alliance to Ms. Eshoo and Mr.
Guthrie, submitted by Ms. Eshoo................................ 136
Letter of June 28, 2022, from Patricia L. Turner, MD, MBA, FACS,
Executive Director, to Ms. Eshoo, et al., submitted by Ms.
Eshoo.......................................................... 138
Letter of June 29, 2022, from Stacey Y. Brayboy, Sr. Vice
President Public Policy and Government Affairs, March of Dimes,
to Ms. Eshoo and Mr. Guthrie, submitted by Ms. Eshoo........... 155
Statement of July 29, 2022, from Sateria Venable, Fibroid
Foundation, submittede by Ms. Eshoo............................ 159
----------
\1\ The legislation has been retained in committee files and is
available at https://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=114963.
Investing in Public Health: Legislation to Support Parents, Workers,
and Research
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WEDNESDAY, JUNE 29, 2022
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to notice, at 11 a.m. in the
John D. Dingell Room, 2123 of the Rayburn House Office
Building, and remotely via Cisco Webex online video
conferencing, Hon. Anna Eshoo (chairwoman of the subcommittee),
presiding.
Member present: Representatives Eshoo, Butterfield, Matsui,
Welch, Schrader, Cardenas, Ruiz, Dingell, Kuster, Kelly, Craig,
Schrier, Trahan, Fletcher, Pallone (ex officio); Guthrie
(subcommmittee ranking member), Burgess, Griffith, Bilirakis,
Bucshon, Carter, Dunn, Curtis, Crenshaw, Joyce, and Rodgers (ex
officio).
Also present: Representatives Clarke and Pence.
Staff present: Lydia Abma, Fellow; Hannah Anton, Staff
Assistant; Waverly Gordon, Deputy Staff Director and General
Counsel; Tiffany Guarascio, Staff Director; Mackenzie Kuhl,
Digital Assistant; Una Lee, Chief Health Counsel; Aisling
McDonough, Policy Coordinator; Meghan Mullon, Senior Policy
Analyst; Juan Negrete, Junior Professional Staff Member;
Kaitlyn Peel, Digital Director; Chloe Rodriguez, Clerk;
Charlton Wilson, Fellow; Alec Aramanda, Minority Professional
Staff Member, Health; Kate Arey, Minority Content Manager and
Digital Assistant; Sarah Burke, Minority Deputy Staff Director;
Seth Gold, Minority Professional Staff Member, Health; Grace
Graham, Minority Chief Counsel, Health; Brittany Havens,
Minority Professional Staff Member, Oversight and
Investigations; Jack Heretik, Minority Press Secretary; Nate
Hodson, Minority Staff Director; Peter Kielty, Minority General
Counsel; Emily King, Minority Member Services Director; Clare
Paoletta, Minority Policy Analyst, Health; Kristin Seum,
Minority Counsel, Health; Kristen Shatynski, Minority
Professional Staff Member, Health; and Olivia Shields, Minority
Communications Director; and Michael Taggart, Minority Policy
Director.
Ms. Eshoo. The Subcommittee on Health will now come to
order.
Due to COVID-19, today's hearing is being held remotely, as
well as in person.
For members and witnesses taking part remotely, microphones
will be set on mute to eliminate background noise. Members and
witnesses, you will need to unmute your microphone when you
wish to speak.
Since members are participating from different locations at
today's hearing, recognition of members for questions will be
in order of subcommittee seniority.
Documents for the record should be sent to Meghan Mullon at
the email address we have provided to your staff. All documents
will be entered into the record at the conclusion of the
hearing.
The Chair now recognizes herself for 5 minutes for an
opening statement.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Today our subcommittee is examined--examining 11 public
health bills that support patients, health workers, and
biomedical research. Seven bills are reducing disparities or
increasing access to healthcare services for medically under-
served populations. About 20 percent of Americans live in rural
areas, and are less likely to have health insurance, live
farther away from healthcare facilities, have limited access to
healthcare specialists, and face higher risks of death from
heart disease, cancer, diabetes, and stroke.
To address these inequities, we are examining
Representative Ruiz's bill, H.R. 8151, the Building a
Sustainable Workforce for Healthy Communities Act, which
invests in community health workers to address workforce
shortages in under-served communities.
H.R. 5141, the Mobile Health Act, introduced by
Representatives Lee and Hudson, and H.R. 8169, the Rural
Telehealth Access Task Force Act, introduced by Representatives
Pence and Craig, bring services to hard-to-reach populations
through mobile medical clinics and expanded access to reliable
broadband capabilities.
H.R. 8163, the Improving Trauma Systems and Emergency Care
Act, introduced by Representative O'Halleran, invests in trauma
centers to increase access for the rural Americans who do live
near a trauma center currently.
Race also affects outcomes. That is why I am pleased we are
considering H.R. 2007, the Stephanie Tubbs Jones Uterine
Fibroid and Research Act, sponsored by Representative Clark;
H.R. 7565 the NIH Improve Act, sponsored by Representative
Underwood; and H.R. 7845, the NIH Clinical Trial Diversity Act,
sponsored by Representative Kelly. These bills increase
research into diseases and populations that have been ignored
for too long.
I look forward to Dr. Bibbins-Domingo's expert testimony.
She chairs the National Academies Committee focused on fair
representation in clinical trials, and can explain NIH's vital
role in increasing diversity in trials.
Ms. Tanika Gray Valbrun will testify about her patient
advocacy work on behalf of African American women
disproportionately affected by uterine fibroids, including our
late colleague, Congresswoman Stephanie Tubbs Jones.
Another research bill is H.R. 3773, the--Pediatricians
Accelerate Childhood Therapies, the PACT Act. This is
bipartisan and bicameral legislation introduced by two doctors
on our Health Subcommittee, Drs. Joyce and Schrier. The PACT
Act invests in pediatric physician scientists and researchers
with a focus on opportunities for historically under-
represented biomedical researchers.
Finally, our hearing includes three bills authored by
Representatives Curtis, Bilirakis, Hudson, and Trone intended
to protect the integrity and security of the U.S. research--
biomedical research enterprise from foreign adversaries.
Taken together, this is a diverse slate of impactful bills
that will improve American healthcare from early research to
patient care, with a focus on reducing disparities and
protecting American ingenuity.
[The prepared statement of Ms. Eshoo follows:]
Prepared Statement of Hon. Anna Eshoo
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Eshoo. The Chair is now pleased to recognize Mr.
Guthrie, the ranking member of our subcommittee, for 5 minutes
for his opening statement.
OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH STATE OF KENTUCKY
Mr. Guthrie. Thank you, Madam Chair. I appreciate the
recognition. I hope everybody is doing well home working for a
few days, and I look forward to being back together.
Today's hearing includes an examination of the ongoing work
at the National Institutes of Health, and ensuring the U.S.
remains the leader in biomedical research. A few of the
proposals included in today's legislative hearing are designed
to promote greater oversight over how U.S. taxpayer dollars are
spent on federally funded biomedical research.
It is important to protect U.S. biomedical intellectual
property from being stolen by foreign governments. Some
adversarial governments such as the Communist Party of China
are using their own research programs to recruit researchers in
the United States who also receive U.S. taxpayer-funded
research dollars and take U.S.-funded IP back to China. This
scheme poses a very real threat to U.S. biomedical intellectual
property.
Perhaps the most widely reported example of this alarming
trend is Dr. Charles Lieber, a world renowned researcher and
former chair of Harvard's Chemistry and--Chemical Biology
Department. Dr. Lieber was charged with lying to Federal
investigators about his connection to the Chinese Communist
Party's Thousand Talents program, and about income he received
from Chinese Communist Party's aligned Wuhan University of
Technology.
This continues to be a problem. A watchdog agency published
a reported--a report earlier this month showing there are still
lingering research integrity issues that could significantly
undermine U.S. biomedical research if they are not
appropriately addressed. After concerns were raised regarding
NIH guarantees failing to make disclosure about ties to foreign
countries, the IG at the HHS surveyed over 770 grantees that
were collectively rewarded--that were collectively awarded over
$20 billion in grant funding from NIH in Fiscal Year 2020.
The findings were alarming. Of the 716 entities that
responded, the IG found that over two-thirds of those surveyed
failed to meet certain disclosure requirements set forth by the
NIH as a condition for receiving Federal funding. These
disclosure requirements are designed to protect the type of
activity that Charles--Dr. Charles Lieber was engaged in. These
include requiring entities to report all types of foreign
financial interests and support, training researchers about
their responsibilities, and how to make these disclosures and
performing reviews--to make determinations about whether
existing foreign financial interests could compromise the
federally funded research.
The IG report came at the heels of a years-long
investigation undertaken by top NIH officials to ensure U.S.
taxpayer research dollars were being spent appropriately. In
fact, the top oversight official at NIH charged with overseeing
the department's extramural grants program, Dr. Michael Lauer,
even confirmed these concerning--this concerning trend dating
back to 2016.
In one of the most egregious examples--Dr. Lauer himself
characterized it--an NIH-funded researcher failed to disclose a
$5 million startup package from the--a Chinese university to
both the NIH and to the American university employing this
researcher.
To the credit of NIH, in addition to the existing HHS
requirements, the agency issued guidance in 2019 expressly
stating grantees must report participation in a foreign talents
program like China's Thousand Talents program. The Trump
Administration Department of Justice even launched a China
initiative to combat malign foreign influence in U.S. research.
Despite of all this, more oversight is clearly needed to
protect the integrity of U.S. research dollars. I am glad we
are here today to finally discuss these issues. Taken together,
Mr. Curtis's, Mr. Hudson's, and Mr. Bilirakis's bills before us
today would help address the issues highlighted in the OIG's
report.
The bills would specifically require NIH to transparently
report to Congress the number of grantees investigated for non-
compliance with grant disclosure requirements; require HHS to
develop tools to effectively protect U.S. biomedical research;
and to explicitly require NIH grantees to disclose
participation in foreign talent programs as a condition of
funding, which is currently required by HHS, but not by Federal
law.
Above all, NIH can and should remain a primary vessel for
fundamental scientific research. We can ultimately unleash the
agency's full potential without stifling future research if we
effectively increase transparency on how these research dollars
are spent. I look forward to advancing these critical pieces of
legislation toward that end.
I look forward to addressing the other bills before the
committee this morning. I appreciate the witnesses for being
here.
[The prepared statement of Mr. Guthrie follows:]
Prepared Statement of Hon. Brett Guthrie
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Guthrie. And I will yield back, Madam Chair.
Ms. Eshoo. The gentleman yields back.
The Chair now is pleased to recognize Mr. Pallone, the
chairman of the full committee, for your 5 minutes for an
opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairwoman Eshoo. Today the
committee continues its critical work to improve our public
health systems, advance access to care, and enhance the
capacity, quality, and integrity of our country's biomedical
research system. And we will discuss 11 bills that collectively
address critical aspects of these public health issues.
Already this year we have passed legislation to reauthorize
the Food and Drug Administration's user fees, and to enhance
its ability to bring safe and effective treatments and devices
to market. We have authorized ARPA, the Advanced--ARPA-H, the
Advanced Research Projects Agency for Health to transform how
we detect, treat, and cure the deadliest diseases affecting
Americans. And last week the House overwhelmingly passed
bipartisan legislation to respond to the mental health and drug
overdose crisis.
And our bipartisan work to improve the health of all
Americans continues today. So we have four bills that address
the health needs of our rural and under-served communities.
One bill would allow federally qualified health centers to
use New Access Points Grants for establishing mobile health
units in order to increase access to healthcare in rural and
under-served areas.
Other bills will establish a task force to study barriers
to the adoption of telehealth technology in rural areas;
promote positive, healthy behaviors and outcomes for
populations in medically under-served communities through the
use of community health workers; and reauthorize grants for
trauma care to support the improvement of emergency medical
services and trauma care readiness and coordination--again,
particularly in rural areas.
We will also examine legislation that would continue to
fund the IMPROVE initiative through the Eunice Kennedy Shriver
National Institute of Child Health and Human Development. This
initiative reflects our shared bipartisan interests in
improving maternal health by advancing research that reduces
maternal mortality and morbidity, addresses disparities in
maternal health outcomes, and improves health for pregnant and
postpartum women before, during, and after pregnancy.
And we have legislation that will support and expand
research and awareness of uterine fibroids, a condition that
impacts as many as 80 percent of women.
Now, shortcomings in clinical trial diversity have created
knowledge gaps in our understanding of diseases, conditions,
treatments, and prevention. And these gaps impact healthcare
decisionmaking, risk reduction, our knowledge of treatment
outcomes, and the development of interventions and medications.
So we will also discuss bipartisan legislation that will
address these shortcomings by supporting and increasing
diversity in NIH-funded clinical trials.
Another bipartisan bill supports pediatric research awards
for early career pediatric researchers, and prioritizes
researchers who have been historically under-represented in the
field of pediatric medical research.
And we have three bills focused on security in biomedical
research. As we look to secure the integrity of our research
enterprise, we have to do so in a way that does not impede
global collaboration and scientific discovery. But many of us
will agree that the United States cannot and will not remain a
leader in medical research without attracting the brightest
minds across the world and working with the best institutions.
And we can both protect our national interests and remain a
world leader in biomedical research, in my opinion.
And I look forward to working with my Republican colleagues
on these bills.
So to the witnesses, thank you for joining us. A bunch of
bills, but these are all very important.
[The prepared statement of Mr. Pallone follows:]
Prepared Statement of Hon. Frank Pallone, Jr.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. And I appreciate, Chairwoman Eshoo, the fact
that we are having this legislative hearing today, and then can
move these because they are bipartisan. So I yield back. Thank
you.
Ms. Eshoo. The gentleman yields back.
The Chair is now pleased to recognize the ranking member of
the full committee, Representative Cathy McMorris Rodgers, for
your 5 minutes of--for an opening statement.
OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON
Mrs. Rodgers. Thank you, Madam Chair. The bills before us
today reflect the importance of the committee's authorizing
responsibilities over key public health programs.
We are discussing today about the threat to biomedical
research posed by our adversaries, and examining a few steps we
could take to address those threats. In the last few years
there has been numerous reports of FBI investigations into
researchers taking U.S. taxpayer-supported intellectual
property to China, not disclosing foreign connections, or
tampering with peer review process. We must address those
concerns and hold China accountable.
Mr. Curtis's bill, H.R. 5442, the Fix Non-Disclosure of
Influence in Health Research Act, which requires HHS to report
on how they address non-compliance with disclosure requirements
or research misconduct related to foreign influence.
Mr. Hudson's H.R. 6305, the Protect America's Biomedical
Research Enterprise Act, requires the Administration to
identify ways to improve intellectual property protection, and
develops strategies to prevent national security threats in
biomedical research.
Mr. Bilirakis's H.R. 5478, the Protecting the Integrity of
our Biomedical Research Act, requires NIH grantees to disclose
their participation in foreign talent programs.
I look forward to examining these bills to address and
understand what more NIH can be doing to address these threats,
and who has the responsibility--NIH or the grantees--for
protecting this information. These are common-sense bills, and
critical to protecting our national security. They also
complement work done in ARPA-H related to research security,
which just passed the House, to stop the Chinese Communist
Party's influence in our biomedical research.
If we don't do a better job of safeguarding our research,
both America's national security and our global leadership will
be at risk.
The pandemic has only made the need for action more urgent,
and I want to thank my colleagues on the Energy and Commerce
Committee for solutions to hold NIH and HHS accountable for
their responsibilities to protect national security.
In addition to provisions related to research integrity,
there are a number of other NIH bills we are considering today.
I have not been shy about my concerns with NIH. I am
concerned about a lack of accountability and response to
congressional oversight. Their authorization has expired. There
is no permanent director. And I think we need to have NIH
testify to do more of our oversight of how NIH is functioning
as a whole, before providing new authorizations for--of funding
of NIH. I have spoken with the Chair of the subcommittee about
that, and hope we can work in a bipartisan way to look at NIH
and rebuild trust that the NIH has broken.
And in addition to NIH, we will also be considering
solutions that increase access to healthcare services in under-
served and rural communities like my district.
Mr. Pence's Rural Telehealth Access Task Force Act will
help identify barriers to telehealth services in rural areas,
and better understand how to make telehealth more widely
available.
We are also considering the Mobile Health Care Act, which
allows community health centers to use their funding to
purchase mobile health clinics, as well as conduct facility
renovations and construction projects.
I understand the need for increased access to health
services, and appreciate how helpful mobile units have proven
to be in rural areas. However, I want to note that I am
concerned about permanently allowing funds to be used for
construction, instead of healthcare delivery. Community health
centers are an integral part of the healthcare safety net and
have received almost $38 billion over the last five years. This
includes supplemental funding provided through the public
health emergency. I am hopeful that we can come to a consensus
on this legislation, and work together to conduct oversight in
advance of the funding expiring next year.
I want to thank our witnesses for testifying. A special
thanks goes out to Desiree Sweeney. She is the CEO of NEW
Health in my district, based in Colville, Washington. It is
great to have her join us today.
I also want to emphasize the importance of oversight and
the topical hearings before legislating, including having
Federal agencies come before this committee to comment, discuss
programs and other related initiatives. I look forward to that
happening.
Just a big thank you to all the Members for putting forward
such thoughtful solutions to these important public health
issues. Thank you, and I yield back.
[The prepared statement of Mrs. Rodgers follows:]
Prepared Statement of Hon. Cathy McMorris Rodgers
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Eshoo. The gentlewoman yields back.
Pursuant to committee rules, all Members' written opening
statements shall be made part of the record.
I now would like to introduce our witnesses. We have a
superb panel of witnesses.
Dr. Kirsten Bibbins-Domingo is a professor of epidemiology
and biostatistics and the Lee Goldman, M.D. endowed professor
of medicine at the University of California, San Francisco.
Welcome to you.
Dr. Kevin Croston is the chief executive officer of North
Memorial Health. He is testifying today on behalf of the Trauma
Center Association of America.
Ms. Tanika Gray Valbrun is the founder and president of the
White Dress Project.
Mr. Michael Shannon is the executive and president of the
Government Solutions at IP Talents, Incorporated. He is also
the former director of the Office of Management Assessment for
the National Institutes of Health.
Ms. Desiree Sweeney is the chief executive officer of NEW
Health.
Dr. Leslie Walker-Harding is the Ford/Morgan endowed
professor and chair of the department of pediatrics at the
University of Washington. She is also the chief academic
officer and senior vice president at Seattle Children's
Hospital.
Thank you to each one of you. It is an honor to have you
with us today, and we look forward to your testimony.
For witnesses testifying in person, you are probably
familiar with the lights in front of you. You have 1-minute
remaining when the light turns yellow. Please stop when the
light turns red.
Dr. Bibbins-Domingo, you are now recognized for 5 minutes,
and thank you again for joining us.
STATEMENT OF KIRSTEN BIBBINS-DOMINGO, PH.D., M.D., M.A.S.,
PROFESSOR OF EPIDEMIOLOGY AND BIOSTATISTICS AND THE LEE
GOLDMAN, M.D. PROFESSOR OF MEDICINE, UNIVERSITY OF CALIFORNIA,
SAN FRANCISCO; KEVIN CROSTON, M.D., CEO, NORTH MEMORIAL HEALTH;
TANIKA GRAY VALBRUN, FOUNDER AND PRESIDENT, THE WHITE DRESS
PROJECT; MICHAEL D. SHANNON, EXECUTIVE/PRESIDENT OF GOVERNMENT
SOLUTIONS, IPTALONS, INC.; DESIREE SWEENEY, CEO, NEW HEALTH;
AND LESLIE R. WALKER-HARDING, M.D., F.A.A.P., F.S.A.H.M., FORD/
MORGAN ENDOWED PROFESSOR, CHAIR DEPARTMENT OF PEDIATRICS/
ASSOCIATE DEAN, UNIVERSITY OF WASHINGTON, CHIEF ACADEMIC
OFFICER/SENIOR VICE PRESIDENT, SEATTLE CHILDREN'S HOSPITAL
STATEMENT OF KIRSTEN BIBBINS-DOMINGO, Ph.D., M.D., M.A.S.
Dr. Bibbins-Domingo. Thank you very much. Chairwoman Eshoo,
Ranking Member Guthrie, and members of the committee, thank you
for the opportunity to testify today.
I am a general internist and a professor at the University
of California, San Francisco. I am here today speaking in my
capacity as a physician scientist, and as someone who has
personally faced the importance of diversifying clinical
research.
Two thousand 17 was the year that the issues before this
committee became urgent for me. I was then the chair of the
U.S. Preventive Services Task Force, an independent body
charged by Congress with generating evidence-based guidelines
on the use of preventive services. During my tenure we issued
recommendations on diabetes, breast cancer, colorectal cancer,
lung and proState cancer.
In my discussion with patients and clinicians on our
recommendations, I inevitably encountered a similar pattern of
questions: How confident are you that these recommendations
apply to me and to patients like me? Were these studies
conducted in clinics like mine? You are recommending screening
for diabetes and those who are overweight and obese, but my
Asian patients seem to develop diabetes at lower weight. What
about them? What about my Latino patients who develop diabetes
at younger ages, or my Black patients, who develop colorectal
cancer at younger ages? Shouldn't we start screening them
earlier?
My recurring response was, unfortunately, we just don't
have the studies in these populations that allow us to say with
certainty whether or how to adapt our guidelines.
In 2017, this was also the year my father lost his battle
with proState cancer. My father was a career Army officer, a
veteran, and a strong supporter of science and medicine. He had
even served as a lay reviewer for a committee on Federal
funding for proState cancer research.
He had had excellent medical care, but as his journey with
proState cancer came to an end, the stark absence of Black men
like my father in proState cancer research became acutely
distressing to me.
ProState cancer is the most common cancer in all men in the
U.S. Black men, who make up 13 percent of the population of
men, are nearly twice as likely to get proState cancer, and are
more than twice as likely to die once diagnosed. Yet Black men
make up only five percent of the participants in prevention
studies, and a strikingly low 2.4 percent of participants in
late-stage treatment studies.
I recently chaired a National Academies report on improving
representation in clinical trials and clinical research. I
would like to leave this committee with the three main
takeaways from that report.
No. 1, failing to achieve a more diverse clinical research
ecosystem is costly. It costs us in terms of scientific
innovation and the generalizability of our research. It costs
us because it deprives patients of state-of-the-art treatments
that are often only available through clinical trials. It costs
us in the trust we seek to build in the medical and scientific
enterprise across all communities in the U.S.
The data is clear that many want to participate in clinical
studies but are simply never asked. And it costs us in dollars.
Our economic analysis demonstrated that the financial and
social costs of health disparities in the U.S. are in the range
of hundreds of billions of dollars over the next three decades.
Addressing health disparities is complex, but better
representation in clinical studies may help address this issue.
And if only modestly so, the value would be worth billions.
No. 2, despite more than three decades of stated commitment
to this issue across Federal agencies, very little progress has
been made. This is an issue that seemingly everyone supports,
but no one is held accountable for its progress. And yet
Federal agencies operating in a coordinated fashion could have
immense power to improve representation. The Federal Government
is the largest funder of research. It is the regulator of
processes of scientific research. It is the gatekeeper to
monetizing scientific discovery. And it is the purchaser of new
drugs and devices. More coherence in Federal policy to align
investment and accountability could achieve the goals of
inclusive science.
No. 3, Congress has a particularly important role right now
to move us beyond the status quo, to ensure a coordinated
Federal response to this issue across Federal agencies, to
increase accountability toward stated goals, to ensure that we
have adequate data collection so that we can mark our progress
in a transparent and open manner, and to align incentives for
all in the research ecosystem to enable progress be made more
quickly.
Whether you are motivated by the goal of producing the
highest quality science, or by pursuit of fairness and equity
in how science translates to better health for our patients, or
by the enormous economic toll of health disparities in the
U.S., I urge the committee to approach the issue of improving
representation and inclusion in clinical research with the
urgency it deserves.
Thank you very much.
[The prepared statement of Dr. Bibbins-Domingo follows:]
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Ms. Eshoo. The--thank you, Dr. Bibbins-Domingo.
The Chair now recognizes Dr. Croston for 5 minutes.
STATEMENT OF KEVIN CROSTON, M.D.
Dr. Croston. Chairman Pallone, Ranking Member McMorris
Rodgers, Chairwoman Eshoo, Ranking Member Guthrie, members of
the subcommittee, thank you for holding this hearing on the
Improving Trauma Systems and Emergency Care Act, H.R. 8163.
My name is Dr. Kevin Croston, I am the chair-elect of the
Trauma Center Association of America, also called TCAA. I am
the chief executive officer of North Memorial Health, a health
system in the Minneapolis/St. Paul area of Minnesota, and a
practicing general surgeon. Thank you for inviting me to speak.
TCAA is a non-profit, 501(c)(6) association representing
trauma centers and systems across the country, and is committed
to ensuring access to lifesaving trauma services and the
financial health of our trauma centers.
For a little background, let me walk through a couple of
quick definitions.
Traumatic injury is the leading cause of death for people
under the age of 44, and the fourth leading cause of death of
all age groups in the United States, claiming more than 270,000
lives annually. And in 1920 and 1921
[sic], incidentally, COVID-19 surpassed traumatic injury as
the third leading cause of death.
According to the World Health Organization, the leading
causes of traumatic injury and death, including traffic
accidents, murder, and suicide, are expected to increase
substantially in the coming years, placing all three among the
top 20 causes of death in the world by 2030.
Trauma centers play a key role in reducing these numbers.
Care at a level 1 trauma center lowers by 25 percent the risk
of death for injured patients, compared to treatment received
at non-traumatic centers. In other words, the routine hospital
emergency departments. This is because trauma centers are
uniquely qualified to provide comprehensive, high-level acute
care for patients with the most extreme injuries, regardless of
the--a patient's ability to pay. We have people waiting for
their arrival, and we have specialists, a panel of specialists,
available at all times.
Trauma systems are--by contrast, they represent
comprehensive networks and infrastructure to provide optimal
care for injured patients, encompassing a wide spectrum, from
injury prevention efforts, coordinated pre-hospital care,
integrated networks of trauma centers for acute and
rehabilitative care, to a concerted research agenda.
Regarding patient access and trauma center financing, there
remains a significant geographic variation in the availability
and accessibility of trauma care. A little over 46 million
Americans lacked access to a level 1 trauma center within the
golden hour, the 60-minute period following traumatic injury
during which there is the highest likelihood that prompt
medical procedures will prevent death.
This deficiency is particularly acute in our Nation's rural
areas, as well as among some traditionally vulnerable
populations--for example, minorities, recent immigrants, et
cetera, and trauma center closures disproportionately affect
communities with higher proportions of minorities, the
uninsured, and people living in poverty.
According to the--an Avalere study commissioned by the
Trauma Center Association of America, trauma centers report
numerous financial pressures, including Federal payment
reductions; increased trauma care demands, particularly among
the geriatric population and from opioid-related trauma cases;
the need to cover vast geographic regions; difficulty
attracting and maintaining high-quality trauma physicians and
other staff due to the strains of the 24-hour trauma service
availability and the staffing crisis that resulted from COVID-
19.
The Improving Trauma Systems and Emergency Care Act, H.R.
8163--in history, in 2010 Congress authorized hundreds of
millions of dollars per year in Federal grants to support and
sustain trauma care and systems nationwide. However, Congress
has not appropriated any of the funding authorized for these
programs. The Improving Trauma Systems and Emergency Care Act
would reauthorize, reorganize, and modernize Federal grant
programs for the purposes of awarding pilot grants for trauma
centers, supporting trauma care readiness and coordination, and
awarding grants to improve trauma care in rural areas.
There are three areas of the Act. The pilot grants for
trauma centers requires the Assistant Secretary for
Preparedness and Response to award ten multi-year contracts or
competitive grants to states, tribes, or tribal organizations,
or level 1, 2, or 3 trauma centers, or other eligible entities
or consortia. These strengthen the trauma system coordination
and communication. They improve situational awareness, develop
and disseminate evidence-based practices across facilities, and
conduct activities to facilitate research.
It also lowers the barrier for entry by providing--by
lowering awardees the current requirement in--statutory for
Federal--non-Federal matches from 1 for each $3 of Federal
funds to one for every five.
Grants to improve trauma care in rural areas reauthorizes
the Secretary of Health and Human Services to improve trauma
care in rural areas, and by supporting research and
demonstration projects.
And last, the trauma care readiness and coordination piece
of this legislation requires ASPR again to support states and
consortia to coordinate and improve emergency services and
trauma care during a public health emergency by disseminating
information in a more friendly way.
Ms. Eshoo. Doctor----
Dr. Croston. So, in conclusion----
Ms. Eshoo. Your time has expired. You want to just offer
another sentence to close?
Dr. Croston. Yes, thank you. Sorry about that.
Thank you again for your consideration of this important
legislation, and for the opportunity to testify before you
today. I am happy to answer any questions the subcommittee may
have. Thank you for your time.
[The prepared statement of Dr. Croston follows:]
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Ms. Eshoo. Thank you.
The Chair now recognizes Ms. Gray Valbrun for your 5
minutes of testimony.
STATEMENT OF TANIKA GRAY VALBRUN
Ms. Valbrun. Chairman Pallone, Ranking Member McMorris
Rodgers, Subcommittee Chairwoman Eshoo, Subcommittee Ranking
Member Guthrie, and members of the committee, my name is Tanika
Gray Valbrun, president and founder of the White Dress Project.
The mission of the White Dress Project is to raise global
awareness about the uterine fibroid epidemic through education,
research, community, and advocacy. It is my absolute honor to
testify in support of H.R. 2007, the Stephanie Tubbs Jones
Uterine Fibroids Research and Education Act of 2021.
H.R. 2007 is named in honor of the late Congresswoman Tubbs
Jones, who not only championed women's health issues, but also
suffered from uterine fibroids herself. I am proud to call her
son, Mervyn Jones, who is here with us today, a dear friend and
supporter of the White Dress Project.
H.R. 2007 is a critical step to improve research into this
public health crisis, to garner data, and improve health
outcomes for those living with fibroids. The critical need to
address fibroids is neither a Democratic or Republican issue,
as demonstrated by the Senate companion bill, but it is a
health issue that impacts many women, whether they live in
rural or urban America.
According to NIH, the U.S. economic burden of fibroids is
estimated at $34 billion annually. Yet scientists know very
little about the genomics that underlie uterine fibroids.
As the only surviving child of a mother who lost twins due
to fibroids, my personal struggle with fibroids has been
debilitating, and gravely impacted my quality of life. Since
age 14, I have experienced heavy menstrual bleeding. I have had
more than six blood transfusions due to severe anemia. I have
had excessive cramping and bloating for much of my life, and
many times appearing to be more than four months pregnant. I
have missed out on social functions, time with my family, days
off work. I was nicknamed Bag Lady because I would always have
a bag of clothes with me, just in case I had an accident. I
have never bought a car with cloth seats, only leather to
easily remove stains; multiple days in the month calling out
sick from work because I was just too tired to go; and never,
ever wearing white.
I decided to seek treatment for my fibroids, and I was told
that I needed a hysterectomy the first time I saw a doctor. I
had to find more options, because I knew I wanted to be a
mother. In July 2013 I had 27 grapefruit-sized fibroids removed
in an emergency surgery. In 2018 I had to have another surgery
for fibroids. And today, as I speak before you, I still have
fibroids. And it has impacted my journey to be a mother.
After my surgery I knew that I wanted to be a champion, so
I started the White Dress Project. In research conducted by our
organization and Healthy Women, we found that race plays a
significant role in fibroid outcomes and quality of life among
women living with fibroids. They are more common in Black women
than White, Hispanic, or Asian women. And fibroids typically
develop in Black women at a younger age, grow larger, and cause
more severe symptoms than for women of all other races.
Black women are more likely to be hospitalized, more likely
to have fibroids surgically removed, seven times more likely to
have a myomectomy, and two-and-one-half times more likely to
have a hysterectomy, compared to White women.
Fibroids also tend to have a disproportionate impact on
women living in rural areas. Typically in rural areas, access
to trained OB-GYNs who feel comfortable performing certain
procedures and appropriate testing is severely limited.
I would also like to address the lack of diversity in
clinical trials. Genetic studies on fibroids, particularly for
Black women, have been limited for a variety of factors,
leaning toward a mistrust of the medical community as a result
of Tuskegee syphilis studies and the Henrietta Lacks cancer
cells processing. Thus I fully support H.R. 7845.
In conclusion, almost 20 years ago, in a 2007 op ed, the
late Congresswoman Tubbs Jones wrote, ``Women deserve better,'`
and I absolutely believe they still do. By passing H.R. 2007,
Congress would be taking a step toward prioritizing the
healthcare and quality of life for women across the United
States.
A special, special thank you to Congresswoman Yvette D.
Clarke for her unwavering advocacy of this issue, and for
serving as a congressional champion.
To the committee, I sincerely thank you for listening to my
testimony today and your support of H.R. 2007 to improve the
lives of millions of women who are dealing with uterine
fibroids.
And thank you to everyone who has shared their story. We
must continue to share.
[The prepared statement of Ms. Valbrun follows:]
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Ms. Eshoo. Ms. Valbrun, thank you for your superb
testimony. You really honor our late colleague, Tubbs Jones,
and I want to welcome her son to our hearing today, as well. So
a very special thanks to you.
Mr. Shannon, you are recognized for your 5 minutes of
testimony.
STATEMENT OF MICHAEL D. SHANNON
Mr. Shannon. Good morning, Chairman Pallone, Ranking Member
McMorris Rodgers, Ranking Member Guthrie, and Chairwoman Eshoo,
and members of the subcommittee. I am speaking today as an
expert witness on oversight and internal controls reinforcing
research security associated with federally funded research and
development.
I am president of the Government Solutions for IPTalons,
Inc., which is a managed service risk and research security
company. I am formerly a member of the Senior Executive Service
and Director of the Office of Management Assessment for the
National Institutes of Health. I thank you for the opportunity
to appear before you, and discuss three pieces of legislation
related to disclosure requirements, participation in foreign
talent programs, and protecting America's biomedical research
enterprise.
I am not representing the NIH or the Federal Government,
but rather appear before you as a citizen with unique knowledge
of government oversight and expertise in the subject matter at
hand. Any comments I may make related to operations in my
statement here or during questions are limited to my experience
up to the time that I left my position in January 2021.
I left Federal service to engage more directly in the
protection of the U.S. research enterprise from risk associated
with non-compliant actions and malign foreign activity intended
to take advantage of those actions. I joined my business
partner, Allen Phelps, in building IPTalons to provide
specialized research security services, training, and tools in
support of this aim, as recognized thought leaders in this area
were regularly asked to assist in identifying solutions
balancing the burden on awardees with the need for stewardship
and accountable due diligence.
International collaboration is absolutely essential for
innovation, discovery, and the benefit of science to all
humankind. Transparency and reciprocity are the glue holding
mutually beneficial research relationships together. As with
any endeavor, trust and due diligence protects efforts and
promotes best outcomes.
I have provided an extended review of the legislation in my
written response, but would like to speak to some specific
points here.
We have all heard FBI Director Wray correctly say we cannot
arrest our way out of this issue. The rest of that statement
could be because the issue of conflicts of interest,
commitment, and foreign influence are often primarily
compliance issues. Early emphasis on criminality rather than
compliance resulted in many missed opportunities and--to
remediate risk, and contributed to an inaccurate perception of
the actual scope and scale of the problem, by pointing to just
a few high profile events as indicia of a smaller problem.
We have heard some tout resignations and terminations as a
sign of activity and success. However, a loss of a researcher
is not a win for anyone. Focus on terminations and resignations
often fails to address compliance, can lead to a lost
opportunity to understand the full impact of the risk, and
foments distrust among researchers and research
administrations. We advise a restorative approach. Focus should
be on restoring and maintaining compliance whenever possible
and appropriate among federally funded research programs and
persons.
Unreported affiliations and support have been a persistent
problem for over two decades because of a lack of consistent
oversight and internal controls. Individuals and nation State
actors have exploited the open and collaborative environment.
The issue is one of individuals making decisions, wittingly or
unwittingly, influenced or independently, leading to non-
compliance.
Research security programs must be a part of the pre-award
process and periodic reporting cycle to identify potential risk
of unreported affiliations and support. Applicant organizations
and awarding agencies must better validate certifications of
complete and accurate submissions at the application and
throughout the life of the award.
There is concern about discriminatory activity targeting
specific persons and ethnicities. Avoiding prejudice is
essential, and focus on conduct is the only valid indicator of
misconduct. Unfortunately, these allegations have also been
used to deflect attention from exploitive activity. It is
important to understand that this issue is about conduct, not
culture. Allen and I have conducted thousands of investigations
on these issues. And although one State is, by far--nation
State is, by far, the most prolific offender, offenders are of
all stripes.
Legislation, policy, and guidelines should focus on
requiring and enabling authorities to fix and find issues--find
and fix issues. Where violations of law is found, proper
referral is made. However, in most cases, restoration to a
compliant posture is possible.
As much as possible we must focus on the elimination of
risk, rather than people, because it is more appropriate to the
threat and essential to U.S. research, innovation to retain
those persons and their contributions mindfully and
accountably. Congress should demand stewardship and due
diligence on behalf of the U.S. taxpayer as a requirement for
an awarding agency and a condition for award recipients. The
bills before you take steps in the right direction.
I thank you for the opportunity to appear before you, and I
am happy to answer any questions you may have.
[The prepared statement of Mr. Shannon follows:]
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Ms. Eshoo. Thank you, Mr. Shannon.
I am now pleased to recognize Ms. Sweeney for your 5
minutes of testimony.
STATEMENT OF DESIREE SWEENEY
Ms. Sweeney. Thank you. First of all, I want to say thank
you, Chairwoman Eshoo, Ranking Member Guthrie, Chairman
Pallone, Ranking Member McMorris Rodgers, and members of the
committee. Thank you for the opportunity to testify today.
My name is Desiree Sweeney, and I am the chief executive
officer at NEW Health. We are a community health center serving
rural northeast Washington State. We were founded in 1978, and
today we provide primary medical, dental, behavioral health,
and pharmacy services to more than 16,000 patients annually,
and employ over 150 staff members. Three-quarters of our
patients are insured through Medicaid and Medicare, or are
uninsured. With--80 percent of our total patients are low
income. We operate seven medical and three dental locations
within our three rural counties, which are connected by three
mountain passes. One of our counties we serve meets the
frontier definition of fewer than seven people per square mile.
NEW Health is part of a system of 1,400 community health
centers that make up the largest primary care network in the
Nation, serving nearly 29 million patients.
Health centers have been able to thrive because of the
incredible support this committee has shown over the 50-year
history of the program. In the spring of 2020, NEW Health
purchased a mobile clinic that is equipped to provide both
medical and dental services. While we are rural, our population
is rapidly increasing, and we are at capacity and utilizing the
space of all of our locations, and are quickly working to
expand physical space.
As a health center serving communities in rural and
frontier communities, we have to also recognize that not all of
these communities can support a full time brick-and-mortar
site. Our new mobile clinic is a cost-effective alternative
that breaks down transportation and access barriers for our
patients by going beyond the traditional four walls of the
clinic. The communities that we serve are home to a high number
of older adults. Bringing healthcare services closer to our
patients' homes is essential to help patients gain access to
care.
While some of our communities have access to fiber
internet, the vast majority of our service area have
historically lacked internet and adequate cell phone signal.
Broadband infrastructure development is a high priority in
northeast Washington, but until we have better infrastructure
many residents have limited access to telehealth and must
access healthcare services in person. The mobile clinic expands
our ability to connect patients with healthcare.
Importantly, the mobile clinic allows for services to be
tailored to specific populations. When we evaluated our
community gathering locations in our rural communities to
evaluate where to--we could take the mobile clinic, the most
common public locations included our K through 12 schools, our
libraries, and our VFW halls.
With nearly ten percent of our population residing in our
service area being veterans, some individuals are mistrustful
of a brick-and-mortar clinic, and we are hoping to reach these
patients through the mobile clinic when it is parked at their
local VFW.
Every year our region in Washington State is impacted by
wildfires. These camps are often set up in remote locations.
And if we could have that mobile clinic closer to that, then we
could ensure the safety of the firefighters.
I want to thank the committee for considering H.R. 5141,
the Mobile Health Care Act. I, along with National Health
Service, National Association and Community Health Centers
support this bill because it will authorize mobile units
specifically as part of HRSA's New Access Points Grant
authority. The bill will facilitate more mobile units and
provide greater care in the community.
I would also like to speak to the Building a Sustainable
Workforce for Healthy Communities Act. In 2023 we will bring in
community health workers in the role of a patient navigator.
Our navigators will focus on social determinants of health by
connecting patients with food, housing, and other resources. It
is important for these positions to understand local needs and
be a trusted resource.
Many of our patients rely on firewood in the winter months,
and we have even had patients who have run out of firewood, and
we were able to connect them to local resources. Developing
funding mechanisms to increase the utilization of community
health workers would help health centers and other
organizations in serving low-income and vulnerable patients.
H.R. 8151 will ensure continued resources for the important
work of community health workers and support primary care at
1,400 health centers across the country.
Again, I appreciate the opportunity to share my thoughts
and experiences from NEW Health as the committee debates these
pieces of legislation. I know our patients will benefit from
the new mobile clinic, and believe health centers across the
Nation will also benefit with the mobile act passed.
Additionally, H. 151
[sic] would able increased utilization of community health
workers.
Thank you, and I welcome any questions.
[The prepared statement of Ms. Sweeney follows:]
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Ms. Eshoo. Thank you, Ms. Sweeney.
The Chair is now pleased to recognize Dr. Walker-Harding
for your 5 minutes of testimony.
STATEMENT OF LESLIE R. WALKER-HARDING, M.D., F.A.A.P.,
F.S.A.H.M.
Dr. Walker-Harding. Wonderful. Good morning, Chairwoman
Eshoo, Ranking Member Guthrie, and members of the subcommittee.
And thank you for convening this hearing on this most important
topic, and for inviting me as a witness.
My name is Leslie Walker-Harding, and I serve as chair of
pediatrics at the University of Washington School of Medicine,
and as senior vice president and chief academic officer at
Seattle Children's Hospital. I am a practicing adolescent
medicine pediatrician. I serve as an executive committee member
of the Pediatric Scientists Development Program, run by the
Association of Medical School Pediatric Department Chairs. And
I serve as a member of the Steering Committee on the Coalition
of Pediatric Medical Research.
I will focus my testimony primarily on H.R. 3773, the
Pediatricians Accelerate Childhood Therapies Act, which is led
by Dr. John Joyce and my good friend--and the only pediatrician
serving in Congress today--Dr. Kim Schrier. And that was co-led
by another health policy leader from Washington State's
delegation, Ranking Member McMorris Rodgers in the last
Congress.
The PACT act, as well as the NIH Clinical Trial Diversity
Act, which is also on the agenda, focuses on three core
principles that are needed to achieve more research
breakthroughs for children and other populations.
First, the PACT Act recognizes that a robust pediatric
research workforce, including a pipeline that produces early
career researchers, is fundamental to achieving breakthroughs
that will lead us to new therapies and cures for children.
Simply put, if we don't attract and retain the next generation
of pediatric scientists to the field, children and adolescents
will continue to suffer the effects of diseases and syndromes
that impact them through adulthood.
The PACT Act also recognizes that our pediatric research
workforce needs to better reflect the diversity of our Nation's
children. The lack of diverse representation in pediatric
researchers limits the diversity of questions asked and
studied, resulting in fewer solutions to be applied to improve
the health of all children.
And the NIH Clinical Trial Diversity Act recognizes that
our clinical trials need to better reflect our Nation's
population, particularly when it comes to the very patients
that candidate therapies are intended to treat. The core of the
PACT Act would authorize the National Institutes of Health to
create a career development award that focuses on developing
early career researchers who are focused on pediatrics,
particularly those researchers from populations that have been
historically under-represented in the field.
Supported by the American Academy of Pediatrics and the
Children's Hospital Association, let me briefly describe the
challenges that we are navigating. Developing our next
generation of researchers is a top priority of my institution.
We have several programs focused on this initiative.
To attract a wide range of early career scientists with
diverse lived experience at Seattle Children's, we created 3-
year awards to support MDs and PhDs just after the completion
of their post-graduate training, so they can benefit from
mentorship and funded needing--needed to be successful in
acquiring NIH funding. Unfortunately, programs developing
promising pediatric researchers into impactful scientists are
not sustainable or feasible for most academic or children's
hospital programs to fund indefinitely. We need the PACT Act to
supplement what our institution and others are doing.
Pediatric research faces a number of particular challenges
that are unique or more pronounced compared to other fields.
Children are a smaller proportion of the overall population,
and thus pediatrics has a more challenging time competing
against fields focused on adults. Children's hospitals are more
heavily reliant on public programs, notably Medicaid and CHIP,
which pay less than commercial payers and Medicare, and often
do not cover the full cost of clinical care, leaving less
revenue to devote to research activities.
To fix these challenges, I urge Congress to enact the PACT
Act, which would create a career development award program to
support outstanding early career researchers focusing on
pediatric research. Awards would go to individual researchers,
and could also support training programs involved--involving
research entities and minority-serving institutions to help
develop more researchers from under-represented populations. By
focusing awards on individual researchers, the program would
favor--not favor only those in largest institutions, but cast a
broad net for talent.
You might ask, ``Why now?'` Not acting now to create this
opportunity that builds upon the 21st Centuries Act
[sic] would only set us further back in the overall health
of the Nation. Science is at a crossroads with technological
advances and with ARPA-H passing the House last week. The
country is poised to leap ahead with biomedical innovation, as
we did in technology with DARPA. A shortage of pediatric
researchers to engage in this scientific renaissance will
prevent us from realizing our potential to discover major
breakthroughs and cures for children that result in advances
over the lifespan.
I thank you for including the PACT Act on this agenda, and
I look forward to answering any questions on the bill.
[The prepared statement of Dr. Walker-Harding follows:]
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Ms. Eshoo. Thank you, Dr. Walker-Harding.
And to each of our witnesses today, you have more than
enhanced this hearing with your expertise.
We will now move to members' questions. I recognize myself
for 5 minutes, first to Dr. Bibbins-Domingo on clinical trial
diversity.
Doctor, the House recently passed the DEPICT Act
legislation that I wrote to increase clinical trials diversity
by requiring drug sponsors to submit to the FDA a diversity
action plan for later-stage pivotal trials. Would you share for
a moment why it is important for researchers to also consider
and plan for diverse participants in earlier trials, including
trials funded by the NIH?
And do you support 7845 and 6586 becoming law? And if you
don't, why?
Dr. Bibbins-Domingo. Thank you very much for those
questions.
I am really pleased that there--at the efforts to spur the
type of diversity and inclusion in trials from the drug
companies that are seeking approval from the FDA. To really
achieve our goal, though, we have to have diversity and
inclusion at all phases of research. And that is why it is very
important that there be a focus on the NIH. The NIH is the
largest funder of the research that really underlies all of our
drug discovery. It is the basis on which we know information
that goes into how we develop drug trials.
Quite simply, we need to have studies in the populations
for whom our drugs, our devices, all of our innovations are
intended. And so from purely a standpoint of generalizability,
we should be including the populations who are affected by the
diseases and the conditions that we are seeking to try to
understand, and then develop drugs, devices, other
interventions to be able to do. So a focus on the NIH is very
appropriate.
Simple things like genetic diversity, which one of the
speakers talked about, our genetic studies are mostly in White
populations. And so just on that basis alone, we are often
times not considering the full diversity and heterogeneity that
might underlie genetic basis for some types of conditions----
Ms. Eshoo. Great, thank you very much.
To Dr. Walker-Harding on pediatric research, I was really
taken aback to learn from your testimony that, despite being
several years into recruitment of the NIH's precision medicine
All of Us program, that the program has yet to implement a
child recruitment strategy. After the delay of the COVID
vaccine for the pediatric population, I think that there are
many Americans that are fed up with kids being a second thought
when it comes to medical research.
What should the NIH be doing to include more children in
All of Us?
And how will the PACT Act improve pediatric research?
Dr. Walker-Harding. Wonderful. Thank you. Yes, I share some
of the same feelings.
I think one of the things is to think about kids. A lot of
times, as I mentioned, there are so many more adult illnesses
and people working in adult medicine that pediatrics sometimes
is thought of second, and especially in research. Even in the
IRB, people worry, should we be looking at kids first?
Shouldn't we look at adults? It is safer. It--you know, it is
just different. It is not safer.
Ms. Eshoo. But what should the----
Dr. Walker-Harding. And I----
Ms. Eshoo [continuing]. NIH--excuse me----
Dr. Walker-Harding. Yes.
Ms. Eshoo. What should the NIH be doing to include more
children in this program, which is called All of Us?
Dr. Walker-Harding. I think we have to start putting the
plans together to actually have them start being recruited,
doing the actual work.
I think there has been a lot of time in planning, and less
in doing--actually just signing people up and getting them
there. The people are there. People want to enroll their kids.
We just have to start doing it.
Ms. Eshoo. OK, well----
Dr. Walker-Harding. And I think the PACT Act--what I would
say, too--the PACT Act is important because we need the
researchers who are interested in pediatric research ready, and
standing ready to interpret and make sense out of the data that
is collected.
Ms. Eshoo. OK. Thank you very much.
I will yield back and recognize the ranking member of the--
of our health subcommittee, Mr. Guthrie, for your 5 minutes of
questions.
Mr. Guthrie. Thank you, Madam Chair. What a great hearing,
and what wonderful testimony: pediatric research; focusing on
women's health; diversity in our studies to make sure we get
our studies that reflect the makeup of America is absolutely
important. So thanks for doing that.
I am going to focus on the security of our intellectual
property and NIH in my questions. And these are to Mr. Shannon.
You know, there was an IG study that looked at 770
grantees, 617 responded. Two-thirds of the respondents found
certain issues with disclosure about investment in foreign--of
the proper disclosures. That means 153 didn't even respond. And
I think, being a statistics person myself, you can probably
figure that population is biased by people who, if you didn't
respond, either you just didn't make the effort or you have
something to hide for not responding. So I think we could even
assume it is a higher number than two-thirds.
So the question is, why isn't the NIH taking this more
important--making it more important to them? It just--are they
willfully turning their eye? Is it--or are they just
indifferent, and why is this such an issue that we
[inaudible] before?
And also, I think, as we move these bills forward, if 153
grantees just don't respond to the IG, maybe we should look at
banning them from future research if they don't respond to the
IG as we move forward.
But--so Mr. Shannon, why is the NIH so lax in this area?
Mr. Shannon. Well, there are a couple of thoughts to that.
I don't think it is a willful--necessarily, in all cases, a
willful desire to avoid answering the question. I think, first,
the question has not been asked for quite some time.
I also think that it is difficult to have a cohesive plan
when there is no specific cohesive strategy to address this.
Awardee compliance absolutely should be--they should be
held accountable for compliance. And they have requirements
under the grants policy statement and the grant agreement that
they have signed to receive those funds. And the----
Mr. Guthrie. Well, let me just--I am going to interrupt.
Mr. Shannon. Yes, sir.
Mr. Guthrie. But you said that this question hasn't been
asked in quite some time. It is asked in every grant, isn't it?
Mr. Shannon. Oh, that is correct.
Mr. Guthrie. OK.
Mr. Shannon. I was specifically thinking of the question of
conflicts of interest and the like that--those questions are
asked in general in every grant. And some of the legislative
efforts here today get more specific, although I caution
against specific titles for various programs, because, on a
wider perspective, to avoid that, you just change the title.
But awardees struggle from everything from the increased
burden of being able to provide this oversight. Their sense
that I am hearing from them often times is, well, this hasn't
been something that has been paid attention to. And that is,
quite frankly, true. There has not been an initiative to
provide the type of in-depth oversight or accountable process
to audit whether or not--and validate and verify whether or not
those certifications are complete and accurate when they are
answering that question.
So--and we see the numbers even larger, perhaps, that--
based on our company's investigative research, just our data
alone, indicate that up to 85 percent of U.S.-based researchers
with federally funded research have some type of foreign
affiliation that is--may not be reported. Now, not all of those
are--that is not an indictment of anyone. Not all of those are
bad. But those all indicate the potential for non-compliance.
And that is why my emphasis was on compliance.
Mr. Guthrie. Thank you. I think--yes, I was going to ask
you that next. Just because it has foreign connections doesn't
make it necessarily bad research.
What do you think the risk is of--out there, since we are
not getting the disclosure we are supposed to be receiving? And
hopefully these bills will actually force NIH to do that.
What do you think the risk is out there that, if researcher
A is working with researcher B that has--in a common interest
to solve a problem for humanity that is--from a foreign
country, that is fine. But if researcher A is working with
researcher B, who is from an antagonistic country, or a country
that is an adversary for ours, that is an issue and risk. What
do you think is the actual risk out there?
I have about a minute left, less than a minute. If you
would just talk about the actual risk that we are facing, and I
will yield back after you finish.
Mr. Shannon. Certainly. The risk is substantial,
particularly from non-compliance. The key is transparent and
reciprocal relationships. Everybody wants international
collaborations. We all benefit from that, and that is the way
it should be. But when that relationship is not transparent or
reciprocal, or an individual is seeking to benefit themselves
as a result of that, that is where you fall into problems. So
the risk is----
Mr. Guthrie. And how common do you think that is? I am
sorry. How common do you think that is--the second version you
just said.
Mr. Shannon. As I said, our data suggests 85 percent have
some type of foreign affiliation. The percentage of those who
are doing that intentionally to enrich themselves is probably
at about five percent, based on our investigative data.
Mr. Guthrie. OK. Thank you. Thank you, you finished right
on time.
My time is up and I yield back. Thank you, Madam Chair.
Thanks for your testimony, and all of the other witnesses,
as well.
Ms. Eshoo. The gentleman yields back. The Chair is now
pleased to recognize the chairman of the full committee, Mr.
Pallone, for your 5 minutes of questions.
Mr. Pallone. Thank you, Chairwoman Eshoo. My questions are
related to the NIH Clinical Trial Diversity Act of 2022.
Earlier this year we considered clinical trial diversity
policies in the FDA user fee package. And without clinical
trial diversity, we lack robust data on the very groups that
the drug device or biological product was intended to help, and
the populations most impacted by certain diseases. So I wanted
to ask Dr. Bibbins-Domingo.
In your testimony you say that Congress has a particular
role right now to move us beyond the status quo. And I wanted
to ask, what is the role that Congress has, in your opinion?
And then what is the cost of not improving diversity in
clinical trials, economically and otherwise, if you would?
Dr. Bibbins-Domingo. Yes, thanks for that question. I think
what is lacking is coordination across the various agencies,
Federal agencies, that have a responsibility for funding, for
regulating, and for oversight of our clinical research
enterprise.
Right now, one of the most shocking things in our report
was that we couldn't find the information. You can't find the
information right now today on how many--on the demographics of
people who participate in clinical research in the U.S. You can
find from the FDA those drugs that have been approved, and the
demographics of those, but we don't know anything about all of
the studies that are out there. It is very hard to find those
things, even with clinicaltrials.gov reporting.
And so I would urge there be an annual report to Congress.
That is one of the recommendations in our report that has--
across these agencies can really highlight across various
characteristics, demographic characteristics, regional
characteristics, participation in the clinical research
enterprise, the progress that is made over time because that is
what is needed. The data, the accountability, and the reporting
is needed in order for these Federal agencies to work together
to achieve these goals.
Mr. Pallone. All right. Thanks a lot. I wanted to shift
gears and speak briefly about some of the barriers to care that
low-income populations face, and how H.R. 5141--that is
Representative Lee's Mobile Health Care Act--may help to
improve access.
So, Ms. Sweeney, in your testimony you mentioned that NEW
Health serves--or N-E-W Health service--serves a rural area
where transportation is a problem. And given the low-income
population you serve, I assume a lot of your clients don't have
access to reliable transportation. Is that right?
I mean, you can just say yes or no, but is that correct?
Ms. Sweeney. Yes, that is correct.
Mr. Pallone. OK.
Ms. Sweeney. We do not have public transportation.
Mr. Pallone. All right. So can you describe how you have
been able to use your new mobile health unit to increase access
to care?
Ms. Sweeney. So we received our mobile unit. We ordered it
in 2020. And because of manufacturing we received it just
recently this year. And so we are currently using that
programing. So we haven't rolled it out to date, but when we do
that programing, then we will definitely address that. So we
have already done the planning and the conversations.
And you know, food banks are one area that we have really
identified that patients can access. And so we have already
talked to our stakeholders and partners at food banks, the K-
through-12 schools, and the VFWs to get that programing. So
that will be one way that we have--you know, we will be able to
address those barriers.
And then the second way, as we learned during the pandemic,
when we really needed to get out into hot spots and hot zones,
we can definitely deploy that out into our units. And so we
have already worked with our local health district to identify
future opportunities to support health needs as they arrive.
Mr. Pallone. All right, then. Let me ask you one more--one
last question.
Your clinic used Federal COVID funds to set up the mobile
clinic, but the Mobile Health Care Act, you know,
Representative Lee's bill, would allow the New Access Points
funds to be used to establish similar mobile clinics.
So how important was this Federal funding in helping NEW
Health to set up a mobile clinic? I mean, would you have been
able to do it without it?
Ms. Sweeney. We would not. We had been watching and had
internal strategy conversations to how would we be able to
afford a mobile unit. We identified a need, but we just weren't
able to bring it on with the funding that we had.
And so, with the opportunity of the COVID funding, we were
actually able to bring that need and that service line into our
communities.
Mr. Pallone. I am just asking you, because I think, you
know, we want to highlight that, you know, Federal support is
critical to help, you know, that that is really important, you
know, in order for you to get up and running, and others that
would be similarly affected. So thanks again.
Thank you, Madam Chair.
Ms. Sweeney. Thank you.
Ms. Eshoo. The gentleman yields back.
The Chair now recognizes the ranking member of the full
committee, Mrs. McMorris Rodgers, for your 5 minutes of
questions.
Mrs. Rodgers. Thank you, Madam Chair. I join in thanking
all the witnesses for your testimony today. Very helpful and
insightful. I wanted to start with Mr. Shannon.
The Protect America's Biomedical Research Enterprise Act
requires the Department of Health and Human Services to
evaluate ways to better protect intellectual property and
sensitive medical information used in biomedical research from
national security risk and related threats. Would you explain
the differences between compliance research and security and
research as it relates to foreign influence and other
conflicts?
And do you think that there needs to be more awareness in
the research community about these differences?
And what are the roles of the individual research
institutions and academia versus the role of Federal agencies
in these matters?
Mr. Shannon. Certainly. Thank you for the question.
So there is a difference between research integrity and
research security, and that is kind of a distinction that I
think your question gets after.
Research integrity. I had a conversation with Dr. Nakamura
when I first joined NIH. He was the director of the Center for
Scientific Review, and he was concerned about misconduct among
scientists. And I said, ``What kind of misconduct, like data
manipulation or plagiarism?'`
He said, ``No, that is research integrity.'` And so he
explained that we were talking about scientist--non-scientific
misconduct.
Well, fortunately, we came up with a much easier way to say
that: research security. Research security focuses on the
protection of the information, the--ensuring that the access to
information is not abused, and that the process has integrity,
but for the purpose of ensuring that it is a closed system.
So when you--when an awardee or an applicant submits a
grant application to the peer review, for example, that they
know that their intellectual property is going to be protected
by the agency they have submitted it to, and trusts that they
will get a fair hearing, and there will be a fair playing
field. We know that that has not always been the case. Peer
review is an amazing process, but it has some vulnerabilities.
Similarly, at the university level or at the awardee level,
whether it is lab or university, the integration of a security
review into the pre-award process is almost never done. It is
starting to be done. But prior to recent events, it has not
been.
And so why is that important? Well, there are implications
when you receive certain types of awards that can affect the
cost on that award. And research security is one of those,
depending on the level and sensitivity of the award to be
granted.
So it also encompasses things like ITARs and CFIUS
protection of information that might be limited or restricted
by Commerce or the State Department.
Mrs. Rodgers. OK.
Mr. Shannon. So all of those things, rolled in, contribute
to the security posture.
Mrs. Rodgers. Thank you. I--as you know, the Fix
Nondisclosure of Influence in Health Research Act, H.R. 5442,
requires NIH to report actions taken to ensure compliance with
foreign influence disclosure requirements. However, there are
many non-compliance cases which do not include questions of
undisclosed conflicts.
Are there other areas vulnerable to conflicts that would
benefit from increased transparency and disclosure, such as the
peer review process?
Mr. Shannon. Definitely the peer review process, and
certainly, at the awardee level, those persons submitting those
applications need to--there needs to be a way--and there is--to
vet and identify or verify what is disclosed. Right now it is
an honor system. And most people are honorable within that
system. However, when it is purely an honor system, those who
are dishonorable tend to be able to take advantage of that.
I would also say it is important that not just at the award
level do you need to have that kind of protection, but also
intramural programs. NIH, for example, has a very large
intramural program. They are faced with the same challenges as
the research awardee community. So that is----
Mrs. Rodgers. Thank you.
Mr. Shannon [continuing]. Another area that I would point
out.
Mrs. Rodgers. Good, good. I appreciate your insights there.
I just have some other questions I want to ask, too.
Mr. Shannon. Certainly.
Mrs. Rodgers. Ms. Sweeney from my district, the Rural
Telehealth Access Task Force Act will create an inter-agency
task force to help identify barriers to telehealth services in
rural areas. I wanted to ask if you would speak to how NEW
Health has utilized telehealth, and any barriers that you have
faced along the way.
Ms. Sweeney. Yes. I think one of the most important things
is to recognize, as you know, being in our district, many of
our constituents still have dial-up internet and cell phone
service is not 5G, it is 3G at best, if we have service. So
thank you for that question.
Broadband investments are critically needed for how--for
our service area. And I support this bill because it would look
at how we address barriers to adoption of telehealth. So even
at the height of our pandemic, our telehealth was about four
percent of our patient population, at best, and the majority of
those were telephonic because our patients just did not have
access to that. And so, you know, we really understand those
challenges, and broadband is just such a challenge.
One thing I want to address, too, is the lack of
infrastructure. And so----
Ms. Eshoo. The gentlewoman's time has expired. This is an
important area. Maybe someone else can continue pulling this
thread. So we need----
Mrs. Rodgers. Thank you.
Ms. Eshoo [continuing]. To go to--yes.
Mrs. Rodgers. I yield back.
Ms. Eshoo. The gentlewoman yields back to--the Chair
recognizes the gentleman from North Carolina, Mr. Butterfield,
for your 5 minutes of questions.
Mr. Butterfield. Thank you, and good morning, Madam Chair.
It is good to see all of you this morning. And thank you to the
Chair for your leadership. And thank you for convening us, and
just leading this subcommittee into great, great destinations.
You have done great work during this session, and we thank you
so very much.
And to the chairman of the full committee, and to both of
the ranking members, thank you as well for your service.
This committee--let me just say to the witnesses--and thank
you for your testimony. I heard all of your testimoneys, and
they were very powerful and very relevant. And just thank you
for your resource and for your intellect.
Let me just start with Dr. Bibbins-Domingo.
Dr. Domingo, this committee has a very, very strong record
of supporting clinical trial diversity measures. And I am so
glad to see the NIH Clinical Trial Diversity Act's inclusion in
today's hearing is now before us.
I have worked with Dr. Francis Collins over the years, and
we are going to miss him dearly. But every time we met with Dr.
Collins he would always stress the importance of including
minorities--African Americans, if you will--in clinical trials.
And so this bill that we have today will help move the needle
on health disparities by building on NIH's current work to
strengthen participation in clinical trials by unrepresented
populations.
And so my question to you is, in your testimony you stated
that lack of representation may compound low accrual that
causes many trials to fail. You also stated that under-
represented populations are just as likely to want to
participate in clinical trials as other groups, if they are
given that opportunity. And so I am interested in the
connection, if you will, between these two statements.
Dr. Bibbins-Domingo. Yes, thank you very much. It is often
times a misunderstanding to say that we face the State of
under-representation because these communities and these
populations don't want to participate in studies. And we often
talk about the past wrongs. Those are really important issues,
and we have to do everything to build trust.
But the data on this is quite clear, that when people are
asked, minority populations are no more likely or less likely
to want to participate in studies. And in fact, in many cases
for conditions that they are affected by, they are more likely
to want to participate. We do----
Mr. Butterfield. Well, can you explain----
Dr. Bibbins-Domingo [continuing]. Have to address many of
the barriers----
Mr. Butterfield. Yes, that is----
Dr. Bibbins-Domingo. Go ahead.
Mr. Butterfield. Yes. Can you explain how NIH Clinical
Trials Diversity Act will encourage participation in early
stage clinical trials, and how that participation will help
solve the problem?
Dr. Bibbins-Domingo. Yes. I think that we have to basically
not put the burden on the communities that are not
participating, but rather put those processes in place at the
funding level at the NIH, and then with the investigators to
say this is a priority, and therefore we need to invest and
enroll these populations and, as funders, need to hold those
accountable who have received NIH funding.
And I think, by----
Mr. Butterfield. Thank you.
Dr. Bibbins-Domingo [continuing]. Setting the clear
targets, this will achieve those goals.
And I do think this is also an issue of accrual for trials.
As you probably know, many trials don't reach their accrual
targets. And it is important that, if we build the
infrastructure to enroll the populations that should be
represented, we likely will have more of an opportunity to
actually reach those targets.
Mr. Butterfield. Thank you. Let me now move over to Dr.
Walker-Harding.
Dr. Harding, I would like to pivot, if I can, to the
research security policies before us today. Research security.
The contributions of immigrants to the American scientific
landscape cannot be understated. Since the year 2000, American
immigrants have won 39 percent of U.S. Nobel Prizes in physics
and chemistry and medicine. It is clear that our Nation's
institutions and universities benefit greatly from foreign
biomedical workers.
And so the bills before us seek to promote the security of
federally funded biomedical research by evaluating better ways
to protect intellectual property and sensitive medical
information and other biomedical research and development of
products from national security risk and threats. And so I
agree that we must protect our research enterprise, but we must
do so with a balanced approach that does not impede America's
position as a trustworthy global partner and leader.
It looks like I am running out of time. I am not going to
be able to get through my question, Madam Chair. I am very
respectful of time, and so thank you so very much. I yield
back.
Ms. Eshoo. The gentleman yields back. And thank you, Mr.
Butterfield. We are just going to so miss you. I don't know how
else to say it. You are such a----
Mr. Butterfield. Thank you.
Ms. Eshoo [continuing]. Really a high-value member of our
subcommittee. Thank you to you.
Mr. Butterfield. Thank you so much.
Ms. Eshoo. The Chair is pleased to recognize one of the
doctors on our subcommittee, Dr. Burgess of Texas, for your 5
minutes of questions.
Mr. Burgess. Thank you, Chair Eshoo. Thank you for having
this hearing today.
Every one of these witnesses today is fascinating. There
won't be enough time to get to all the questions that I have in
front of me. And I would just tell each of you, you can expect
questions for the record to be coming your way.
I just want to underscore something that our ranking
member, Cathy McMorris Rodgers, said at the outset of this
hearing. We are--we have got 11 public health bills in front of
us. Most of them will concern the Department of Health and
Human Services, the National Institute of Health, and we have
no Administration witnesses in front of us. And in fact, over
the term of this Congress we have had very little in the way of
participation of Administration witnesses at a time when we are
in a once-in-a-century pandemic.
Chairman Pallone, I have written to you several times about
what appears to be the passivity of this committee--which is
unfortunate, because we are one of the premiere research
committees in the U.S. House of Representatives. But we--I
don't feel we have done our work.
Today we had an opportunity to perhaps hear from some of
those agencies. But again, we are not. We do have good
witnesses, and I don't want to diminish what they are bringing
to the discussion, but there is a lot of work that is left
undone.
And so let me just point out that Chairwoman DeGette, in an
Oversight and Investigations Subcommittee hearing a year ago
promised a hearing--promised to me, individually--a hearing on
the originations of the coronavirus, the COVID origination
hearing. And to the best of my knowledge, we have not had such
a hearing. And again, we desperately need it.
Mr. Shannon, who is with us here today, certainly your
expertise is one that we value. I think you bring a lot to the
discussion. Let me just ask you, since you worked at the NIH
until January 2021, do you think the NIH considers itself to be
a leader in global health research?
Mr. Shannon. I do. NIH is a global collaborator, and
rightfully so.
I think the--although I think the U.S. is more innovative
than most, it doesn't have a corner on the market of good
ideas. So I think that is an important consideration, that we
must have international collaboration. But we have got to do
our due diligence to protect that collaborative relationship,
and make sure that it is transparent and reciprocal.
And there are some--there are solutions. You know, a
national research security standard, for example, would be very
helpful to help NIH have a cohesive strategy, and even
consideration of expansion of the IG opportunity. So there are
things that can be done to help NIH be even more diligent in
their global activities, which are absolutely necessary to the
benefit of our research and development enterprise.
Mr. Burgess. Well, thank you. You actually anticipated and
answered my next question, but it just underscores the point:
the NIH is going to be collaborating with foreign entities and
researchers, and we have to have the proper measures and
procedures in place to--certainly to protect Americans. But as
we have seen in the global pandemic, we want to be certain we
protect the world at large.
Let me just ask you this. To your knowledge--and I realize
that you concluded your term in January 2021 with the NIH, but
did the United States federally fund gain of function research?
Mr. Shannon. I--sir, I have no idea. I am not--I wasn't
privy to any of the discussions on the scientific side of
things. I was oversight and compliance.
A question on whether or not a grant was appropriately used
on any type of deliberative research would be brought through
the extramural research compliance arena.
Mr. Burgess. Well, let me--my time is going to run out, so
let me ask you this question. Would it have been appropriate to
engage in this type of research in an adversarial country?
And I think we have to agree that China, Russia, and Iran
would be adversarial countries. Would that be problematic, if
research was conducted in one of those labs?
Mr. Shannon. Again, sir, I think there are circumstances
where international collaboration may include countries that
are adversarial or not.
You know, again, the decision and discussion process
through the peer review and the laws and requirements that
allow what type of research to be done, I don't have knowledge
on whether or not----
Mr. Burgess. Let me----
Mr. Shannon [continuing]. That grant in particular, the
focus----
Mr. Burgess [continuing]. Because it was two years ago the
city of Houston, where the Chinese consulate--they had to call
the fire department, because they were burning records in open
trash barrels. And apparently, the fire was so large that it
attracted attention.
Ms. Eshoo. The gentleman's time has expired.
Mr. Burgess. Well, I will followup, Mr. Shannon, in
writing.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. But I mean, it is this type of activity that
leads the casual observer to be suspicious of some of these
actions.
And I thank our witnesses, all of our witnesses.
Ms. Eshoo. The gentleman yields back.
It is a pleasure to recognize the gentlewoman from
California, Ms. Matsui, for your 5 minutes of questions.
Ms. Matsui. Thank you very much, Madam Chair, for holding
this hearing. And thank you for the witnesses for your
testimoneys today. I know 5 minutes goes quite quickly, so I
will just jump into the questions.
Ms. Sweeney, this is for you. A growing number of
healthcare organizations have hired community health workers to
provide social support, care coordination, and advocacy for
high-risk patients. These workers are often trusted individuals
from local communities who understand how people live and work.
Ms. Sweeney, why is this local perspective important for
the work of your patient navigators?
And does having a workforce that reflects the community
impact your health center's ability to provide whole-person
care?
Ms. Sweeney. Yes. So I do believe that the community health
workers can better facilitate improved health outcomes because
it is a natural trust within many of our communities, whether
they are rural patients--you know, we talk about equity for our
immigrant patients, people of color. Everyone can really talk
about their journey.
And so helping them support and identify resources--because
sometimes it is really challenging. People are prideful, and
they don't want to say, ``I need help with food, I don't need--
I need help with resources.'` And so someone that can be in
that role that is not telling them take their medications for
their A1C, but just saying, you know, ``How can I help you with
things that are outside of healthcare,'` is really going to be
a very important component.
Some of our patient navigator work will also be to support
patients in navigating the health exchanges and understanding
things, whether it is identifying--literacy is a barrier to it,
whether it is digital literacy--that is a big thing in our
area. So our geriatric population doesn't know how to use a
computer.
Ms. Matsui. Thank you very much. Health centers in my
district also continue to really face workforce challenges. Can
you describe the shortcomings in reimbursement for community
health workers, and how Congress might help address these
obstacles?
Ms. Sweeney. Yes, I think that is a great question.
Currently, to my knowledge, in Washington State we don't have a
reimbursement mechanism for that. So it is something that, you
know, we are having to self-fund.
Ms. Matsui. OK.
Ms. Sweeney. And so those gaps are always challenging to
try to fill.
Ms. Matsui. OK----
Ms. Sweeney. So you can recognize the need, but you need to
figure out how to sustain the program financially.
Ms. Matsui. Sure. Thank you very much. This question is for
Dr. Bibbins-Domingo.
I am pleased that today's hearing continues this
committee's work to promote clinical trial diversity. You know,
clinical research is no exception to the rapid pace of
healthcare innovation, as trial sponsors look for new ways to
improve the speed and experience of clinical trials for
patients and providers.
During the pandemic we have seen an uptick in adoption of
decentralized clinical trials, as longstanding regulatory
barriers to telehealth and conducting trial activities remotely
[inaudible] way for the duration of the public health
emergency.
Dr. Bibbins-Domingo, in your view, how might telehealth fit
into the conversation around what Congress can do to better
coordinate Federal efforts that promote equitable clinical
research?
Post-pandemic, do you see telehealth continuing to play an
increasingly important role in recruiting and retaining diverse
participants for clinical trials?
Dr. Bibbins-Domingo. Thank you very much for that question.
I actually think that the pandemic, in its way that it was
disruptive, allowed new innovations to actually flourish, and
telehealth is certainly one of them.
I can--speaking as a clinician, I can say telehealth has
been remarkable in allowing us to increase our access.
I will also say that new technologies also have to be
adapted to the goals that we are trying to achieve. For me and
my population--I serve in an urban safety net setting--we
don't--most of my patients don't use telehealth. They use the
telephone, unfortunately. And so we always have to be ensuring
that our new technologies also work for all of the populations
that we are trying to have them achieve. They increase access.
We can reach rural populations, people who can't come in, in
much better ways. That is remarkable. But then also making--we
have to build in the types of investment that ensures that new
technologies are actually available to all of those that we
want to include in care and in our studies.
So I am all in favor of technologies. I think that they are
remarkable and increase access, but we also have to make them
equitable, as well.
Ms. Matsui. Well, absolutely. And that is part of the
challenge, because, as we have more access, we know that there
are disparities in all of the access, too. So thank you very
much. I do look forward to Congress advancing legislation that
really supports leveraging telehealth in an equitable manner as
a tool across the healthcare sector.
Thank you, Madam Chair. My time has disappeared. I yield
back.
Ms. Eshoo. It goes by quickly. The gentlewoman yields back.
The Chair is pleased to recognize the gentleman from
Virginia, Mr. Griffith, for your 5 minutes of questions.
Mr. Griffith. Thank you, Madam Chair. And I just want to
say I agree with the questions and the answers just given to--
by Ms. Matsui, and then the answers that were given. Both Ms.
Bibbins-Domingo and Ms. Sweeney have mentioned that a lot of
folks in their areas--and in my area, as well--use telephonic
forms of telehealth. And we have to figure out how to make
reimbursement for both the computer version and continue to
reimburse or do better ways of reimbursing for telephonic.
All right, let me move on to Mr. Shannon.
Mr. Shannon, EcoHealth Alliance, an NIH grantee during the
time that you were there--at least it started then--recently
acknowledged that it is waiting for its sub-grantee, the Wuhan
Institute of Virology, to release electronic files and lab
notebooks associated with a key experiment on coronavirus and
doing coronavirus research prior to 2020, which was supported
by the NIH grant. It seems weird and perverse to me that an NIH
grantee cannot or will not produce the substantiating materials
from an experiment paid for by the United States. Wouldn't you
agree, yes or no?
Mr. Shannon. Yes, I would agree.
Mr. Griffith. Shouldn't NIH grantees be required to retain
a copy of all research records? And when I say ``grantees,'` I
mean grantees and sub-grantees. Shouldn't they be required to
retain a copy of all research records, electronic files, and
laboratory notebooks generated by a foreign sub-grantee, and be
required to make such data available upon request to the NIH
and/or from Congress, yes or no?
Mr. Shannon. Yes, and the requirement exists.
Mr. Griffith. Then how come we can't get these records from
the Wuhan lab?
Mr. Shannon. I don't know the answer to that, sir. I can
tell you that the NIH grants policy statement--section 8.4.2,
specifically--requires that any record reasonably considered to
be pertinent to the grant must be retained and available.
And in fact, the grantee and--or the awarding recipient
and--is responsible for compliance across the board. They
have--they actually have to----
Mr. Griffith. OK.
Mr. Shannon [continuing]. Keep their people available
[inaudible]----
Mr. Griffith. Let me move on. We have had a number of
issues with this type of thing with EcoHealth Alliance. And at
one point they were banned from getting new money on that
grant, but then the NIH gave them a grant for something else.
When we have somebody who is not complying or not making
their sub-grantees comply, shouldn't we ban them from getting
new grants in the future?
Mr. Shannon. Well, I think there is absolutely a case to be
made that stewardship should be a----
Mr. Griffith. I take that as a yes, and I apologize.
Mr. Shannon. OK.
Mr. Griffith. I would love to talk to you for hours, but I
only have 5 minutes.
Also, as a former director at the NIH, and an NIH advisor
to the FBI, how big of a problem is non-disclosure of foreign
interests?
Under current requirements, should it have been disclosed
when EcoHealth Alliance received their NIH grant that they had
a partnership with the Wuhan Institute of Virology?
Mr. Shannon. Generally, all disclosures of support or
activity and location of performance are supposed to be
disclosed. That is a requirement of the grant in the grant's
policy----
Mr. Griffith. Since you were there at that time--and I know
you may not remember, but do you know if that was disclosed at
the time of the grant on coronavirus to EcoHealth Alliance?
Mr. Shannon. I do not. Those grant compliance areas fall
under the auspices of
[inaudible]----
Mr. Griffith. Yes, I heard your answer to Dr. Burgess, and
I thought that was fine. Again, I hate to cut you off, but I
have got to move on.
What is the China military civil fusion strategy, and how
is it relevant to the threats facing biomedical research by the
U.S. in China?
Mr. Shannon. It is a--the MCF for military civil fusion
strategy is a major driver of the Chinese Communist Party in
their efforts to create a technologically advanced military to
promote economic benefit beyond, and replace the U.S. as a
premier economic powerhouse. So the focus is on targeting
critical infrastructure, including biomedical, and there is a
purposeful attempt to do that, to gather information that way.
And the focus is also recognizing that the way we look at
the right and wrong of it is probably not the way they do. They
don't see it as their job to comply----
Mr. Griffith. Yes, I mean, let me----
Mr. Shannon [continuing]. But for us to----
Mr. Griffith. Let me--hang on. Let me finish up, and I do
apologize. I could talk to you for hours.
But do you think, looking at Wuhan Institute of Virology,
that they are, in fact, a part of this strategy? I do. Do you?
Mr. Shannon. I don't have any knowledge to demonstrate that
that is the case. But I know, if you----
Mr. Griffith. But you would--yes or no, you would be
surprised if they were not a part of it, wouldn't you?
Mr. Shannon. I would be surprised if they were not part of
the--both the military and party.
Ms. Eshoo. The gentleman's time has expired.
Mr. Griffith. Thank you.
Mr. Shannon. Yes.
Mr. Griffith. I appreciate it.
Ms. Eshoo. The gentleman's time has expired.
The Chair is pleased to recognize the gentleman from
California, Mr. Cardenas, for your 5 minutes of questions.
Mr. Cardenas. Thank you very much, Chairwoman Eshoo, and
also Ranking Member Guthrie, for holding this important
hearing, and I really appreciate this opportunity to discuss
these matters with these experts on their expert opinions and
their experience that collectively goes far beyond many, many
communities.
So we are very fortunate to have all of you witnesses. So
thank you so much.
I am thrilled to see that the NIH Clinical Trial Diversity
Act is being considered today. And I want to thank committee
leadership, as well as the bill's lead author, Representative
Robin Kelly, for ensuring this bill's inclusion at today's
hearing.
If we are serious about demanding that clinical trials are
reflective of all communities served, we need to implement
policy that impacts each of the relevant agencies, including
those that provide resource for trials. The NIH funds clinical
trials, including those in phase one, as well as those that
will not apply for FDA approval, which would include studies on
potential behavioral health interventions, for example.
As a clinical cog in the broader clinical trial system, NIH
must also hold to certain standards to ensure diversity and
representation for all. Not only would the bill require NIH to
develop measurable recruitment and retention goals based on
disease prevalence, it would also ensure less burdensome
followups and launch a public awareness campaign across Federal
agencies related to research participation opportunities.
I am going to be asking my first question to Dr. Bibbins-
Domingo.
Given that context, I want to ask you, as a witness, as--a
bit about the importance of clinical trial diversity broadly,
and the focus on NIH specifically. Dr. Bibbins-Domingo, thank
you for joining us today. I understand that clinical trial
diversity is a personal issue with you, as we heard in your
testimony. And I am grateful that you are willing to share the
story with us and all of America.
Failing to diversify clinical trials has a serious cost,
both in terms of people, in livelihoods, and in dollars and
cents. In your testimony you note that an economic analysis by
the National Academies found that ``lack of representation may
cost the U.S. hundreds of billions'`--that is billions, with a
B--``of dollars over the next three decades as a consequence of
U.S. health disparities.'`
My question to you is, can you explain this connection
between clinical trial diversity and cost?
And why is the NIH a key player in addressing the
shortfalls in the diversity of clinical trials?
Dr. Bibbins-Domingo. Thank you very much. Yes. So our
analysis that we commissioned for this report examined the
three common conditions--heart disease, hypertension,
diabetes--and asked what does the disparities, the big gaps
that we have in the U.S. across White, Black, and Latino
populations for these conditions, and how much does it cost us
in terms of life years lost, people with disability, and work
loss--people who are not productive members of society? These
are now costs that, over a 30-year period, approach $1
trillion, frankly.
Now, disparities in health outcomes like that are actually
multi-factorial. They are not all going to be addressed by
improving diversity in clinical trials. But if clinical trials
and clinical research, which is important, only addressed a
small fraction, let's say 1 percent, the benefits to society in
terms of life years gained, productive life years gained, would
be on the order of hundreds of billions of dollars. This is an
analysis restricted to a few conditions and a few disparities,
but it does highlight how big an economic toll that is, and
does suggest that research, which we do think is important in
this country--that is why we fund it--for improving health is
important for addressing this, even if it only plays a small
role in that.
Mr. Cardenas. What are the dangers of prolonged mistrust in
our scientific processes?
And how can proposals like the NIH Clinical Trial Diversity
Act help to close that gap?
Dr. Bibbins-Domingo. Yes. We have a very important gap in
trust, mistrust, distrust that we have seen really highlighted
through the pandemic.
A lot--this is actually reinforced by the fact that we are
not engaging communities in the participation in our scientific
and medical enterprise. People don't accept a new vaccine
because it really hasn't been studied in people like them. And
I think that we--often times we miss the opportunity to
reinforce trust by engaging communities in all aspects of our
medical and scientific enterprise. And this is just one aspect
that I think is--and an important feature of why representation
is important.
Mr. Cardenas. Thank you. It is clear that we need to take a
holistic approach in making clinical trials more diverse. It is
an urgent issue, and I appreciate all of your thoughtful
responses.
Madam Chair, my time has expired, and I yield back.
Ms. Eshoo. The gentleman yields back.
The Chair is pleased to recognize the gentleman from
Florida, Mr. Bilirakis, for your 5 minutes of questions.
Mr. Bilirakis. Thank you, Madam Chair. I appreciate it very
much. This is a great hearing, as always. And I really do want
to talk about this particular issue, and I thank the witnesses
for their testimony today. So this is a bipartisan hearing, and
I appreciate the witnesses again being here today. In
particular, Madam Chair, I want to thank you for putting up for
consideration my bill, H.R. 5478, the Protecting the Integrity
of our Biomedical Research Act, which will provide transparency
and accountability at the NIH--so very important.
American taxpayers deserve to know when their money is
being used improperly, when it is being used to benefit foreign
governments. My legislation would provide an extra layer of
protection and increased transparency for our Federal research
grants by requiring full disclosure of foreign talent programs
as a condition of receiving extramural biomedical research
grant funds.
In fact, GAO has been warning research institutions over
the past few years with the concerns about inappropriate
influence of foreign entities on NIH researchers. That is why I
am grateful to have Mr. Mike Shannon, an expert in this field
who previously worked as a senior executive at NIH.
And thank you for being here, Mike, today. I have a couple
of questions for you, Mr. Shannon. Thank you for your
testimony, again, and for providing specific feedback on how to
better improve the three bills who have--who were on the docket
today. So we really appreciate it with regard to research
integrity.
Can you expand more on the need to ensure we are capturing
the full gambit of bad actors in this space, particularly those
looking to subvert potential new requirements under the bill?
And that is why we have these hearings, to even improve our
bills that were filed. So, please, if you can answer that
question, Mike, I would appreciate it.
Mr. Shannon. Certainly. There are a great many types of
influence that can be wielded, and that can include financial
remuneration, additional payments. And those are often
understood that they need to be reported. What is not clear,
and what has been not universally done is the complete and
accurate reporting of all support.
So we know that the Health Education Act section 117
requires the reporting of gifts, and we know that my colleague
there who heads that arena recognizes the vast under-reporting
that has been happening there. But that is another indicator of
where support can be used to influence.
We have also seen in investigations where individuals who
are--who may have family members in the foreign nation, they
may be coerced. They may be encouraged, either with threats to
that family or just an honor threat, that you are embarrassing
our family, that sort of thing.
So it really spans the gamut of what is going to inspire
and influence someone to be willing to take that step, and
whether it is for self-enrichment or some type of reputational
self-preservation, it is a large issue. Again, we see it as
primarily a compliance issue. There are law enforcement
instances. We have got to make sure we charge the appropriate
charges when there is a law enforcement incident. It is much
more of an espionage kind of effort than it is, you know, the
common criminal.
But on the compliance side there is a solution, and there
is a mechanism to restore, rather than remove individuals and
then put in place due diligence to observe and ensure that that
conduct does not continue.
Mr. Bilirakis. Thank you very much. I didn't want to
interrupt you, because this is such good information for us.
You also rightly point out that this issue may be addressed
in the American--the America COMPETES Act. And I want to
reiterate that H.R. 5478 builds on bipartisan provisions
included in the original USICA bill sponsored by Senator
Schumer.
I also helped lead a bipartisan letter to NIH, with some of
my fellow colleagues on this committee, addressing this topic
in response to specific incidents regarding inappropriate
influence. You addressed that to a certain extent,
inappropriate influence from the Chinese Communist Party within
our biomedical research grants. We must better address this.
I am not sure if we have time for this, but I am going to
give you the question.
And then, Madam Chair, if you want to cut me off, that is
OK, because he will respond to me.
Can you discuss the importance of internal buy-in within
NIH and HHS, which we know is traditionally resistant to
change?
And can you tell me how we can provide better oversight of
compliance in this area?
Ms. Eshoo. The gentleman's time----
Mr. Bilirakis. Yes.
Ms. Eshoo [continuing]. Has expired.
Mr. Bilirakis. Yes, I will yield back----
Ms. Eshoo. But I think that your question----
Mr. Bilirakis [continuing]. So we can get a response----
Ms. Eshoo [continuing]. Can be submitted to the witness
to----
Mr. Bilirakis. Absolutely.
Ms. Eshoo [continuing]. Respond in writing.
[The information appears at the conclusion of the hearing.]
Voice. Welch is back.
Ms. Eshoo. Pardon me?
Voice. Welch is back.
Mr. Bilirakis. Thank you.
Ms. Eshoo. The Chair is now pleased to recognize the
gentleman from Vermont, Mr. Welch, for your 5 minutes of
questions.
[Pause.]
Ms. Eshoo. Mr. Welch?
Mr. Welch. I thank you very much, Madam Chair. I appreciate
the hearing, but I actually do not have any additional
questions. Thank you very much.
Ms. Eshoo. OK, then we--the Chair now recognizes the
gentleman from California, Dr. Ruiz, for your 5 minutes of
questions.
Mr. Ruiz. Thank you for holding this important hearing.
Just real quickly, I will take the personal privilege of
sending a shout out to the multitude of interns in my office
watching live on screen right now. Thanks for being here.
As we have seen throughout the pandemic, there are critical
gaps in our public health infrastructure. We are presented with
an opportunity at this moment, as we move forward, to learn
from this experience. I truly believe that we are at a critical
juncture as a country. If we don't course correct now, even
after everything we have seen and experienced throughout the
past two years, then I fear we won't ever have the will to do
it. And yes, to do it right, we will have to invest in our
public health infrastructure.
But inaction costs more than action, and we end up with
sicker communities. As a doctor and a public health expert, it
is hard for me to even narrow down priorities in the public
health space because there are so many critical issues to
address, like the need for a better public health education
system, especially for our harder-to-reach communities, to
empower them to make better decisions to protect their health,
or even the ever-worsening provider shortage, or generally the
way our healthcare system focuses on curing severe, expensive
sickness, but not preventing it, or how we balk at spending
money on things that will prevent disease, even if it saves us
money down the road.
What I would like to talk about today, the utilization of
community health workers, or promotoras, helps address a number
of these critical issues. Greater utilization of community
health workers is not a silver bullet to solve our public's
health system. There is no one silver bullet here, but they can
go a long way to keeping our communities healthier.
As you know, community health workers understand local
needs and can give people tools and resources to achieve better
health and well-being. This may include helping patients manage
chronic diseases, connecting them with social services
organizations, or making sure a patient has a proper storage
for their medication.
Proactively addressing root causes of poor health is not
only better for the health of our communities, but it actually
saves money. In fact, research has shown that utilization of
community health workers saves $2.47 for every dollar spent.
So if community health workers saves us money and improves
health, I think that investing in policies that increase
utilization of them is a no-brainer. My bill, H.R. 8151, the
Building a Sustainable Workforce for Healthy Communities Act,
will reauthorize a competitive grant program to support State
and local governments, tribal organizations, and community-
based organizations, and expanding community health worker
programs in under-served areas. The grants are intended to
serve communities that experience higher rates of chronic
disease, infant mortality, maternal morbidity and mortality,
and health professional shortage areas.
The bill also expands the services that community health
workers can provide under this grant, such as using community
health workers to educate, guide, and provide home visitation
services for chronic diseases and postpartum care.
Under my bill, the community health workers will also be
able to conduct outreach and education to communities that
require additional support during public health emergencies.
Ms. Sweeney, what are some services that you intend for the
patient navigators, as described in your testimony, to provide
into the future as NEW Health works to get their community
health worker programs off the ground?
Ms. Sweeney. Thank you. So I think, for us, really, you
know, everyone's barriers are different, and they are all the
same at the--at many community health centers. So for us to
identify those social determinants of health and what are the
barriers to patient, whether it is compliance, comprehension,
healthcare, access, trust--and so we will really utilize these
patient navigators to help build the trust within the community
to eliminate barriers to care, whichever barrier that is.
And so I think, really, for them to identify those social
determinants of health and non-compliance--you, as a clinician,
recognize non-compliance doesn't always mean obstinance. It
could be financial barrier, or a comprehension barrier.
Mr. Ruiz. Or a failure and non-compliance of a system that
doesn't give--take into consideration those barriers, which is
their responsibility to do so.
Ms. Sweeney. Right.
Mr. Ruiz. So I--you know, before we leave I would also like
to thank the committee for including H.R. 5141, the Mobile
Health Care Act, in this hearing, and for my colleague,
Congresswoman Lee, on her leadership on this important issue.
Giving health centers the ability to invest in mobile
clinics will help them reach the most under-served areas by
taking healthcare directly to the communities. I have
participated multiple times in these mobile health clinics, and
have even driven some of these RVs out into our most under-
served areas in my district throughout my medical career.
And with that, I yield back.
Ms. Eshoo. The gentleman's time has expired.
The Chair is pleased to recognize the gentleman from
Indiana, Dr. Bucshon, for your 5 minutes of questions.
Mr. Bucshon. Well, thank you, Chairwoman Eshoo and Ranking
Member Guthrie. Today's hearing covers a variety of important
issues, many of which are particularly relevant, given that we
have experienced and learned--what we have experienced and
learned over the last couple of years.
The COVID-19 pandemic has taught us a lot about what our
public health agencies and our healthcare systems can do well.
But it has also provided some startling examples of
deficiencies Congress needs to address. The bills before us
today represent just a small portion of that work.
I appreciate that my colleagues, Representatives Bilirakis,
Curtis, and Hudson, have introduced bills to address some of
the issues we are seeing with oversight of Federal funding for
scientific research.
To be clear, I strongly support Federal funding for
research. I learned in my early days of Congress, leading the
Science, Space, and Technology Subcommittee responsible for the
National Science Foundation, that we cannot rely on the private
sector for all such work. But when taxpayer dollars are being
used, we must pay close attention to the quality of the work
being done, and we must have adequate and frequent oversight of
all Federal agencies funding scientific research.
Mr. Shannon, your written testimony provides many solid
observations about how we can improve that quality,
particularly when it comes to foreign influence. Do you believe
that, if we enact the proper guardrails, the United States can
continue to safely and responsibly fund biomedical research
projects, not only in the U.S., but internationally?
Mr. Shannon. Yes, I do. I think, though, that the--although
the reporting requirements that are in the bills are absolutely
essential and important for accountability and oversight, I
think you also need to look at the IG axiom of what gets
checked gets done. And so, if there aren't periodic audits for
compliance and looking at all of those conditions for award,
then those will fall by the wayside, and we may find ourselves
with a similar problem in the future.
Mr. Bucshon. Yes. I mean, I, in general, have been, you
know, shocked by the revelations of the lack of compliance and
reporting that we have seen across the United States and
academic institutions, particularly as some of those cases were
mentioned, and the lack of oversight potentially that we have
had.
And it does amaze me in Congress, I mean, how many things
that in hearings like this you hear have happened, and you just
can't understand why the law hasn't been followed. And
primarily, I think a lot of that is, you know, it is Congress's
responsibility to occasionally provide adequate oversight of
basically everything that we do, particularly when taxpayer
dollars are involved.
I am also grateful for the legislation like H.R. 7565, the
IMPROVE Act, which provides authorization for a research
initiative designed to mitigate preventable maternal morbidity
and mortality. We have heard it, this subcommittee, the
shocking data coming out across the country about the
increasing maternal mortality, particularly in certain areas of
our country, and the racial and ethnic disparities in that
issue--on that issue, and I know we are all trying to address
that.
My State of Indiana has one of the highest rates of
maternal mortality in the country, and it led me to advocate
for the TRIUMPH for New Moms Act, a piece of legislation that
Representative Barragan and I were able to pass in the House,
that was included in the mental health package last week. That
bill focused specifically on mental health challenges that
often plague pregnant and postpartum women.
The IMPROVE Act would further build on efforts to support
them.
Dr. Bibbins-Domingo, I don't have a specific question, but
I want to comment on some things you have said. You have
advocated for broader participation of women in clinical
studies, and your testimony makes many critical points about
the need for greater clinical trial diversity. Dr. Ruiz, who
just recently asked questions, and I introduced H.R. 5030, the
DIVERSE Trials Act, to improve diversity in clinical trials and
a couple of other things. And the Senate actually has a
companion bill, S. 2706, introduced by Senators Menendez and
Tim Scott.
So I do agree also that telemedicine gives us a potential
opportunity to increase the diversity in clinical trials, as
you pointed out. And I know, as a medical doctor myself,
different populations of people respond differently to
medications, and they have different health issues that cannot
be adequately assessed unless you actually study those
populations.
So with that, Madam Chairwoman, I yield back the balance of
my time.
Ms. Eshoo. The doctor yields back.
The Chair is pleased to recognize the gentlewoman from
Michigan, Mrs. Dingell, for your 5 minutes of questions.
Mrs. Dingell. Thank you, Chairwoman Eshoo and Ranking
Member Guthrie, for convening today's bipartisan legislative
hearing, with so many important bills that support our Nation's
healthcare system, the workforce, and research enterprise.
The issues that today's witnesses and my colleagues on
committee have discussed are so critical to addressing gaps in
care and ensuring traditionally under-served groups are able to
access quality, affordable healthcare in a timely manner. There
are issues that are critically important to communities in my
district, which has a very large Middle East and North African
population. We have heard from concerned residents and
community groups that the lack of such services are barriers to
quality health and health equity for MENA residents.
Ms. Sweeney, community health centers play a critical role
in addressing health equity, both in my district but across the
country. Could you speak to the importance and effectiveness of
culturally and linguistically appropriate services,
particularly for immigrants, refugees, and individuals with
limited English proficiency?
Ms. Sweeney. Yes, that is a great question, and I think
that health centers have done a really great job of, you know,
working toward that and addressing that by being community
driven. And so we can better adapt to our patients' needs
because you can't always understand what someone is going to
need until they come and seek care with you. And so community
health centers have really been known to build that trust
within our patients, and to be community focused. And I think
that is really a benefit to help support equity within our
health center network, no matter where we are located in the
U.S.
Mrs. Dingell. Thank you for that. It is important to note
that MENA Americans, like those in my district, are not
currently recognized as a distinct community under the Public
Health Service Act. This is why I have joined my colleagues,
Representative Tlaib, Eshoo, and Kelly, to introduce the Health
Equity in MENA Community Inclusion Act of 2022, which would
amend the Public Health Service Act to address this issue.
But I would also like to highlight the 340B drug pricing
program, which is critically important to ensuring community
health centers in my district--and again, across the country--
that they are able to provide quality health access to be able
to provide quality care to my constituents.
Ms. Sweeney, how has the 340B program helped NEW Health
provide quality care to the beneficiary it serves?
And can you talk about the program's impact on under-served
communities specifically?
Ms. Sweeney. Yes, thank you. That is a great question.
The 340B program is incredibly important to health centers
across the country. You know, by law and mission we must
reinvest all savings of the 340B program back into the patient
care.
So I think a couple of examples we could do is telehealth.
When the pandemic first broke out, we just really didn't even
know how it was going to be reimbursed, how that was going to
be paid. And so having that opportunity to utilize that cost
savings to do right by the patients in that time of need was
essential.
And those needs for the under-served and vulnerable
populations will always continue. And so being able to have
that opportunity to reinvest that, and protect that savings for
our most vulnerable patients is essential. And it is the
mission of everything we do. And we--it is really extremely
important to the health center sustainability.
Mrs. Dingell. I thank you, and I thank you for all that you
do.
One thing that is important to note is that a number of
major prescription drug manufacturers have arbitrarily decided
to restrict their participation in the 340B program since the
summer of 2020. It is an issue I am hearing about from my
constituents who receive healthcare through the community
healthcare centers, which have faced cutbacks in services as a
result of the pharmaceutical companies overcharging these very,
very, very critical safety net providers. It has a real impact
on the access to care and pharmacy actions here need to be
addressed moving forward.
Thank you, Madam Chair. And with that I yield back.
Ms. Eshoo. The gentlewoman yields back.
The Chair is pleased to recognize the pharmacist on our
committee, the gentleman from Georgia, Mr. Carter, for your 5
minutes of questions.
[Pause.]
Ms. Eshoo. Are you there, Mr. Carter?
Voice. [Inaudible] Curtis.
Ms. Eshoo. Pardon me?
Voice. Curtis is next.
Ms. Eshoo. Who?
[Pause.]
Ms. Eshoo. Mr. Curtis of Utah, you are recognized for your
5 minutes of questions.
Mr. Curtis. Thank you, Madam Chair.
Ms. Eshoo. I don't know what happened to Carter.
Mr. Curtis. Thank you, Madam Chair.
I am, like many of my colleagues here, deeply concerned by
the foreign influence in our research institutions through
China's Thousand Talents program. My bill before us today,
which I am grateful that many have acknowledged, the Fix
Nondisclosure of Influence in Health Research Act, or Fix NIH
Research Act, would shine a light on these
[inaudible] influence operations. The Fix NIH Research Act
is currently in the China package, and I urge my colleagues on
the conference to maintain its inclusion and pass it into law
in the coming months.
I served on a GOP China task force in 2020. I lived in
Asia. I have a great appreciation for the language, the
culture, and the people. But that being said, the final report
of the China task force found that the CCP has a coordinated
global campaign to recruit overseas science and technology
experts through talent programs like Thousand Talents and other
efforts to obtain knowledge and IP through coercive and
fraudulent means. The CCP's talent programs, rather, require
participants to operate in secrecy and, in some cases,
contractually obligate participants to legally--illegally
transfer information and property.
In 2019, a massive espionage campaign to steal advanced
biomedical research was exposed at a prominent and cutting-edge
research facility in Houston. Multiple scientists were caught
sending research back to the CCP's government, or plotting to
do so. This brazen act is just the tip of the iceberg of the
CCP's wide-scale espionage efforts here in the United States,
especially through their talents--Thousand Talents program.
In December 2021, the Chair of Harvard's Department of
Chemistry and Chemical Biology was convicted by a Federal jury
in connection with lying to Federal authorities about his
affiliation with the People's Republic of China's Thousand
Talents program and the Wuhan University of Technology in
Wuhan, as well as failing to report large sums of money he
received from Wuhan University of Technology, while
simultaneously receiving Federal grants from NIH and DoD.
Mr. Shannon, can you explain why it does matter that
researchers who are working for Chinese-affiliated entities are
also getting grants from the United States?
And why does this compromise the integrity of research, or
how does it compromise national security?
Mr. Shannon. Yes, it certainly matters. When scientific
information is submitted for potential award to advance our
research and development capabilities, the intent is for the
benefit of all, from a U.S. perspective. When you have
individuals who either work in a dual funding capacity, or have
a conflict of interest or a conflict of commitment, that can
result in less effort being given to the U.S. research.
It can also cost in the way of the training and mentorship,
where a scientist who may be deciding to work in this capacity
and be--enrich themselves, their effort is focused elsewhere,
not on the primary effort here. And that is not the agreement
that they entered into when they received that grant award.
From a national security perspective, it absolutely matters
because not--in most of these cases it is not a transparent or
reciprocal arrangement. And so it is not to the benefit of the
global health, or to the benefit of the U.S., who is funding
the effort often times. It inures to the benefit of another
nation. In many cases--in our investigative statistics we see
that is primarily the Communist Party in China. That effort
directly impacts our ability to be innovative, our ability to
be ahead of the curve, and to seek that innovation and
commitment from the funds that we invest.
Mr. Curtis. Thanks, Mr. Shannon.
I would also like to just re-emphasize my appreciation to
my colleagues who have supported this bill. And, Madam Chair, I
yield my time.
Ms. Eshoo. The gentleman yields back.
The Chair is pleased to recognize the gentlewoman from New
Hampshire, Ms. Kuster, for your 5 minutes of questions.
Ms. Kuster. Great. Thank you so much, Madam Chair.
Creative approaches to delivering care are essential to
reach all communities and vulnerable populations, including
those who are experiencing inconsistent housing, who may live
far from medical facilities, and who don't have access to
transportation, or may lack connection to a medical provider.
That is why legislation such as the Mobile Health Care Act is
so key to improving health.
As the founder and co-chair of the Bipartisan Addiction and
Mental Health Task Force, I am proud to say that we included
the Mobile Health Care Act as part of our legislative agenda
for the 117th Congress. Providing financial support to health
centers, establishing mobile health units in rural and under-
served communities is an evidence-based approach to close
significant gaps in physical and mental healthcare.
In my home district, Lamprey Health Care in Nashua, New
Hampshire uses a mobile van to meet patients where they are,
helping to remove barriers to establish primary care, provide
behavioral healthcare, and respond to COVID-related concerns.
Some days this means providing services to school children
onsite to ensure minimal disruption of their school day, and
other times this means leveraging the unit and expanded
telehealth flexibilities to connect patients with substance use
disorder to proper support.
At a time when workforce recruitment and retention is such
a challenge, folks at Lamprey have expressed greater job
satisfaction with the opportunity to work directly with
patients through the mobile health unit. The Mobile Health Care
Act will empower other health centers to follow organizations
like Lamprey to expand their services.
Ms. Sweeney, what populations would benefit most from more
health centers being able to use a mobile unit to deliver
public health and healthcare services?
Ms. Sweeney. Thank you. That is a great question.
So we are going to be able to provide dental exams,
extractions, fillings, and sealants for patients perhaps who
cannot access those. So when you talk about that K-through-12
group who have to miss school to go to a dental exam, or their
parents have to take time away from work, so that is one
specific population.
And then, when we really talk about ten percent of our
total population being veteran population, and their needs
being in--you know, where they are apprehensive to come into an
institution or a brick and mortar, so we really think bridging
that VFW with the veterans population are two very strong
populations.
And then, of course, anyone that has transportation or
mobility issues.
So also, we also talk about in our area we have wildfires.
And so when those camps are deployed, they are often times not
close to an urban area. And so those firefighters are charged
to have to leave the area for healthcare. And so we will be
able to target specific populations and respond to various
needs, not just healthcare or pandemic, but also natural
disasters or anything that could be impacting us.
And I think that is really going to be beneficial for all
community health centers, to have access through a mobile unit,
to really deploy resources to where it is most needed in the
short term, and then long term for our youth and veterans.
Ms. Kuster. Great. And could you speak to how mobile health
units will improve mental healthcare in rural communities, as
well as addiction treatment?
Ms. Sweeney. Yes. So as we know in--the increasing mental
health needs and lack of resources, if we could deploy those to
people where they are at on their journey--and I think you had
made that comment--you know, we want to meet people where they
are at in their journey in crisis, because it doesn't always
happen Monday through Friday, 8 to 5. And so, if we can, deploy
those resources where our patients are.
And then addiction resources, if there is an area in our
service area that has a higher-than-normal resource allocation
needed, we could deploy that more cost effectively and more
timely than trying to install a brick-and-mortar rapidly.
Ms. Kuster. Do you use the medically assisted treatment? Is
that something that you have deployed for addiction, for
substance use disorder?
Ms. Sweeney. We have medication-assisted treatment support
services, and we utilize our referral network in our critical
access hospital in the county. So we participate in the
substance use disorder healthcare system in our region with our
health department, our critical access hospital, and our rural
health clinics.
Ms. Kuster. Great. Well, I will just say from personal
experience here and elsewhere, that that would be really,
really helpful. And I urge my colleagues to support the bill,
and I thank the Chair for including it in the package.
And with that I yield back.
Ms. Eshoo. The gentlewoman yields back.
The Chair is pleased to recognize the gentleman from
Pennsylvania, Dr. Joyce, for your 5 minutes of questions.
Mr. Joyce. Thank you for convening this important
legislative hearing, Chair Eshoo and Ranking Member Guthrie.
I would also like to thank the committee for including
legislation that I introduced along with my colleague, Dr.
Schrier, H.R. 3773, the Pediatricians Accelerated Childhood
Therapies, or PACT.
[Inaudible] legislation will codify efforts to coordinate
pediatric research
[inaudible] NIH research institutes, and will invest in
supporting early career researchers to help ensure a health
pipeline of new individuals working in this critical field.
As we saw during the debate of H.R. 7666 last week,
pediatric populations have borne the brunt of the upheaval in
our daily lives during the COVID-19 pandemic, and we will be
dealing with the aftermath of this for years going forward.
When speaking to hospitals in Philadelphia, specifically the
Children's Hospital of Philadelphia, we hear this confirmed,
particularly in the space of behavioral health.
Ensuring a strong supply of pediatric researchers,
including physician scientists who focus on clinical,
translational, pharmaceutical, these areas of research are so
absolutely important.
[Audio malfunction.]
Mr. Joyce [continuing]. That emphasis at this point in
time.
My first question is for Dr. Walker-Harding.
Would you please speak a bit more to the challenges that
you are seeing in the field, particularly when it comes to
retaining researchers in pediatric academic research areas?
And what are the stressors that you are seeing from people
that they are experiencing in this field that often force them
to leave the field?
Dr. Walker-Harding. Thank you so much for that question.
Yes, we are seeing a lot, especially--some of the same
things you are seeing in Children's Hospital, Philadelphia we
see at the University of Washington and across the country.
It is--first of all, less people go into pediatric research
to begin with. And if they don't have the funding, if you are
talking about a physician scientist who also wants to see
patients, being able to balance seeing patients, trying to get
funding--and if you are a woman, trying to take care of your
kids at home, especially during COVID--this has been a stress.
It is really hard to get that support.
Universities, children's hospitals don't have the same kind
of funding to support early career researchers. And so what
happens is they start out with great ideas, trying to work on
it, have difficulty finding funding for pediatric research,
have difficulty supporting their time to do that work. And they
slowly move out of that space, and we lose the critical people
who are seeing patients who can answer the questions that they
are seeing because they are trained to do so. But without the
funding----
Mr. Joyce. Thank you for your insight----
Dr. Walker-Harding [continuing]. Without--we can't take
care of them.
Mr. Joyce. Thank you. I would now like to turn the issue to
NIH research vulnerability, and what could be done to address
the threats presented by the Chinese Communist Party.
In the last few years we have seen an alarming uptick in
malign foreign influence in our Nation's biomedical research. I
am pleased to see that we are taking up bills related to fixing
this problem today. And I would urge that we also look at
legislation like H.R. 5626, the Safe Biomedical Research Act,
which I introduced aimed at this issue, as well.
Mr. Shannon, in your experience, how important is it for
the NIH to have strong standards on cyber and technology
practices to safeguard sensitive information?
Mr. Shannon. It is very important, and I think they have
taken some great steps toward working in that direction on the
cyber side.
But we are also--you know, the large portion of this
problem is behavioral-based. And so there is a nexus between
cyber activity and behaviors, because a lot of those behaviors
happen in the cyber space. So being able to observe that and
react to it is critically important.
Mr. Joyce. [Inaudible] that the NIH has those strong
standards on cyber and technology practices to safeguard the
sensitive information?
And do you believe that those standards exist today, and
are properly enforced?
Mr. Shannon. I am not an expert in the NIH cyber policies.
I worked very closely with them on investigations and audits.
But I can tell you that they have a strong, committed team that
does a great job in that regard. So I can't speak to the
specifics of their cyber policies, but I know that they have
been continually working to address that. And after the GAO
audit that occurred a couple of years ago, I think they are in
an even stronger position today.
Mr. Joyce. I think we need that strong position.
Madam Chair, I see my time has expired, and I yield.
Ms. Eshoo. The gentleman yields back.
The Chair is pleased to recognize the gentlewoman from
Illinois, Ms. Kelly, for your 5 minutes of questions.
Ms. Kelly. Thank you, Madam Chair. I am so thankful for
this committee's leadership in advancing important clinical
trial diversity policy with the Food and Drug Administration of
2022. However, real progress on clinical trial diversity will
require a multi-faceted approach across Federal agencies, as
you know well.
While the DEPICT Act focuses on FDA policy to increase
clinical trial diversity, there is a need for similar policies
to be implemented at the NIH. The NIH is the largest funder of
biomedical research in the world, investing $41.7 billion
annually on biomedical research.
I am proud to have introduced the NIH Clinical Trial
Diversity Act with Representative Fitzpatrick and my E&C
colleagues, Representatives Cardenas, Butterfield, and Clarke.
This bipartisan bill builds on current NIH policy, and provides
a framework for NIH to work with sponsors so they can meet
their clinical trial diversity goals. This bill would ensure
that NIH-sponsored clinical research develops effective
treatments for diseases and conditions across diverse
populations.
Dr. Bibbins-Domingo, in your testimony you discuss the
importance of including diverse populations at the outset of
clinical trial research to ensure that all communities have
access to innovative treatments. Could you please speak to the
importance of including diverse populations in phases one and
two of clinical trials?
Dr. Bibbins-Domingo. Thank you for that question. It is
important that we create an infrastructure that includes
diverse populations at all phases of our research, including
the formative phases and the--all of the early phases of
clinical trials for--the reason is that this research should be
generalizable to the populations for whom it is intended.
Focusing on the earlier phases, especially by focusing on
the NIH and the types of research that it funds, will actually
reinforce the institutions that actually enroll individuals in
research to create that types of infrastructure locally to make
enrollment in studies easier.
It is true that in early phases of research, when the
numbers are small, you don't--they are not often powered to
look for differences between groups. But looking for
differences between groups is not the only reason we want to
include diverse populations in research. We want to do them at
the discovery phases, at the genetic phases, at the mechanistic
phases, and at all phases to think about generalizability. And
investing in the infrastructure at all phases actually will
enhance our ability to recruit in those late-phase clinical
trials, where we sometimes do want to explore differences in
drug efficacy across populations.
So I really applaud the focus on FDA and NIH, and think
that they can work in synergy.
Ms. Kelly. Why is it important for NIH-funded trials
investigating behavioral intervention for mental health and
substance abuse use disorders will also be required to develop
clear and measurable clinical trial diversity goals?
Dr. Bibbins-Domingo. Thank you. For the same reason. A
focus simply on just the drugs and devices really ignores the
fact that so much of what we do in clinical medicine to improve
health is informed by funding that the NIH gives to
investigators for things like mental health interventions, for
things like implementation science, for things like substance
use. All of those that may not have a pharmaceutical at the end
of the pipeline, but are just as critically important that we
use evidence-based practices to inform our care.
For those things that you mentioned--mental health,
behavioral health, substance use--we know that there are huge
disparities in those arenas, as well. And having research that
addresses these issues in the populations that are affected are
hugely important for addressing the health needs in those
populations.
Ms. Kelly. Thank you.
Dr. Walker-Harding, can you please elaborate on the need
for alternative followups to increase clinical trial
participation of rural and linguistically diverse individuals?
Dr. Walker-Harding. Sure, it--different from adult
medicine, pediatric specialists, pediatric researchers are not
in rural areas. They have to travel sometimes for hours,
especially where I am at, two to three hours a week for
essential care. If you have to do that, you really need to have
other ways of having them engage in research, because it is an
extraordinary burden to have to keep coming back and forth from
rural and remote areas.
If you are linguistically diverse, you need to be able to
understand in your own language and culturally what a research
project----
Ms. Eshoo. The gentlewoman's time has expired.
Dr. Walker-Harding [continuing]. Would be doing to help
your child.
Ms. Eshoo. The gentlewoman's----
Dr. Walker-Harding. So----
Ms. Eshoo [continuing]. Time has expired.
Ms. Kelly. Thank you.
Ms. Eshoo. The Chair now recognizes the gentleman from--is
Mr. Carter with us?
There you are. The gentleman from Georgia, Mr. Carter, for
your 5 minutes of questions.
Mr. Carter. Thank you, Madam Chair, and thank all of the
witnesses for being here. We appreciate your participation.
Full disclosure, I am a pharmacist by profession. And as a
healthcare professional, I know that accessibility and
affordability in healthcare are extremely important to our
country. If we are going to talk about public health, we have
to make sure that patients continue to have access to
pharmacies.
You know, pharmacists are the most accessible healthcare
professionals in America. Ninety-five percent of all Americans
live within five miles of a pharmacy. And that is extremely
important to make sure that we have accessibility to healthcare
professionals. That is why I was happy and pleased to introduce
H.R. 7213, the Equitable Community Access to Pharmacist
Services Act, a bipartisan piece of legislation introduced in
our committee. And I look forward to making sure that this
legislation gets a hearing, and that it gets passed, because it
will continue to give us access to pharmacies, and that is very
important. And I am looking forward, as I say, to working with
this committee to try to do that.
Mr. Shannon, I want to ask you. First of all, it was
revealed in April that recently disclosed documents that the
Wuhan Institute of Virology had an agreement with the
University of Texas's Medical Branch's Galveston National
Laboratory to collaborate on scientific research with the
Chinese lab, and that it entitled the Chinese to ask the Texas
lab to destroy any secret files.
It also--in addition to that, EcoHealth disclosed to the
NIH that the NIH-funded research files under their grant were
in the custody of the Wuhan lab, and that EcoHealth would need
to get permission from the Wuhan lab in order to turn over the
records to the NIH. Again, this is EcoHealth, who got a grant
from NIH. NIH wants some information, and now EcoHealth tells
them they got to get permission from Wuhan in order to get that
information.
Mr. Shannon, my question for you is are you concerned about
these side agreements between the NIH grantees--that is, those
who are getting money from the NIH, the National Institutes of
Health, a federally funded program--are you concerned about
those side agreements between them and the Chinese research
partners that preclude the NIH from getting access to NIH-
funded data?
Mr. Shannon. Yes, that is in conflict with the regulations,
the grants policy statement that requires that those records be
available if they are considered pertinent to the grant. And so
if there is a nexus between the grant funding that the one
entity received, and they sub-award something out of that, then
that requirement extends. That is--so yes, I would be very
concerned with that.
But it does go to the whole question of persons accepting
risk at a level beyond their authorities, or unbeknownst to
their organization, and not being able to account for those
things. So that is part of the broader issue of these
agreements, not only between organizations, but individuals, as
well.
Mr. Carter. Do you think there are any national security
concerns with an agreement like this?
And if there are, how can that be addressed?
Mr. Shannon. Well, I think when you are talking about
research that is funded for critical infrastructure
technologies, that certainly falls into the realm of a national
security concern.
The compliance aspect of this is absolutely something that
needs to be addressed to ensure that there is compliance. And
as I have said, the rules have been there for a long time. And
NIH is not incorrect when they say, ``Nothing has changed, the
rules have been there,'` although they put out clarifying
guidance to those rules, which is important to make sure it is
clear.
But--and you have got great people doing great things
trying to get after this. But what gets checked gets done. And
if it is not checked, it is not getting done. So periodic
audits, periodic reviews, some type of stewardship score
perhaps as consideration for an award, not to disrupt what
science is awarded, but to perhaps result in additional
conditions on award, would be helpful.
Mr. Carter. Right. Well, let me ask you this. Shouldn't an
NIH grantee--that is, someone who has gotten a grant from the
NIH--the NIH, of course, being federally funded by taxpayers'
money, shouldn't they be publicly accountable, especially to a
congressional inquiry?
Mr. Shannon. Well, I think it is--they are accountable
through their awarding agency. I think it would be difficult to
have direct accountability for reporting from the vast number
of awardees, and then being cognizant also of Congress's
previous priorities of reducing burden on the grantee.
I think the appropriate mechanism is through the awarding
agency, and that awarding agency being clear on what Congress
wants to know, and making sure they get----
Ms. Eshoo. The gentleman's time has expired. The Chair is
pleased to recognize, if she is available, Congresswoman Craig
of Minnesota.
Are you on?
All right. I don't see or hear her. We will go to
Congresswoman Schrier, Washington State, for your 5 minutes of
questions.
Ms. Schrier. Well, thank you, Chairwoman, and thank you to
our witnesses for joining us today and for your excellent
testimoneys.
Today I would like to focus on the Pediatricians Accelerate
Childhood Therapies Act of 2021, or the PACT Act, this
bipartisan legislation that I was really happy to co-lead with
my friend and colleague, Dr. Joyce, who you just heard from.
And the PACT Act of 2021 would require NIH to make awards
specifically to early career pediatric researchers, creating a
pipeline of research--researchers, as you have heard, to
advance childhood therapies.
This bill would also coordinate research at national health
research institutions through the Trans-NIH Pediatric Research
Consortium.
Dr. Walker-Harding. First, it is wonderful to see you
again. Thank you for your devotion to children and families in
Washington State. And thank you for highlighting the PACT Act
in your testimony. You really highlighted how important it is
to support research early in pediatric careers, especially
given the tight timeline that researchers have to demonstrate
that they can win independent research funding.
And in prior conversations, you have also made the case for
supporting pediatric research at children's hospitals and
universities so that we can keep research in academic
institutions, and not lose all of that talent to the private
industry.
Of course, you and I know pediatric research is vital to
finding causes and treatments for conditions that affect
children like pediatric cancer, autism, brain injury,
infectious diseases, metabolic disorders. But even with this
tremendous need and increased investment at NIH, there has been
a decline in pediatric researcher slots at NIH.
Can you talk about how this has affected Seattle
Children's?
Dr. Walker-Harding. Yes, this has resulted in us having
less ability to recruit people with great minds that are coming
out wanting to do research without the funding. This is very
much restricted, the spaces that people can do this research. I
think that we have to be able to have what the PACT Act
underscores: individual research, funding support. It gives
security to the early researcher early on, when they are really
in that tenuous point of can they do this work, especially for
people who are coming from under-represented places where they
haven't, you know, gotten the support that they needed to be
successful.
Ms. Schrier. Thank you. And, you know, you noted this
impact of kind of getting people that acceleration, that boost,
early on. Can you talk about some of the challenges that early
career pediatric researchers might face at the beginning of
their careers, and how this legislation helps?
Dr. Walker-Harding. Yes, we really saw it play out in
COVID.
You know, early on in--when you are trying to balance being
a clinician, being a researcher, and, you know, especially if
you are a woman and you have to care for the family, trying to
figure out the time that you have to actually ask a question,
do the research, get your partners, get your mentors in place,
it really takes a lot time and work. And if you don't have the
funding to give you that time, and you don't have the mentors
that the funding allows, you just--it is really hard for people
to keep up.
And so we have seen people want to switch from being a
researcher to being a clinician, which is fine, except we are
losing that mind, and we need all of the minds we can find to
focus on pediatric research.
Ms. Schrier. Thank you.
And I think about the impact, for example, of autism on an
entire family, like how kids' health affects adult--all the
adults around them. And I am interested in your comments about
how the diseases and conditions of childhood are often--excuse
me, of adulthood are often rooted in the pediatric years, and
how this stronger commitment to pediatric research and the
pediatric workforce can help all through life and into
adulthood.
Can you elaborate a little bit on that [inaudible]?
Dr. Walker-Harding. Absolutely. It is--most of the health
concerns that we deal with in adults have their underpinnings,
origins, or beginnings in pediatrics. If you are talking about
heart disease, diabetes, obesity, substance use, depression,
cancer, you know, all of those things, if we are going to pay
attention to them in pediatrics, could be mitigated, decreased,
eliminated.
We have to start thinking about how we developmentally look
at how we are going to address health problems in this country,
so that we can prevent and have treatments for them, instead of
just waiting for people to have a disease and work toward it.
That is critical in pediatric research.
Ms. Schrier. Thank you. I really appreciate it. It is one
of the reasons that I talk so much about, for example, using
our nutrition programs effectively to really channel kids to
liking fruits and vegetables and the things that will stave off
those adult diseases later. So thank you again.
I yield back.
Ms. Eshoo. The gentlewoman yields back. It would be good to
know how many pediatric researchers we have in the country
today, in comparison to others.
The Chair is now pleased to recognize the gentleman from
Texas, Mr. Crenshaw, for your 5 minutes of questions.
Mr. Crenshaw. Thank you, Madam Chair. I thank you to the
ranking member for holding this hearing today, and thank you to
the panel of witnesses for being here. My questions are for
Michael Shannon, so I will premise this with these following
facts.
The U.S. Government estimates that every year China steals
$225 billion worth of things like patents and trade secrets
from American companies. The Chinese consulate in Houston was
shut down because it had become a hotbed of spying and
intellectual property theft in both the energy and medical
sectors. The FBI raided MD Anderson and several of our other
prestigious medical institutions because of incidents where
Chinese spies were physically stealing data sets and samples
from our medical labs.
So my question is, has the U.S. Government been successful
in actually prosecuting these types of cases?
Mr. Shannon. In some cases, yes. And those have been widely
publicized. Where they have not been successful was early on
focusing on this issue from a counter-intelligence perspective,
when it is much more an espionage type of issue, when you get
beyond the compliance questions, and you get into the actual
action with the intent to do something and to violate the law.
So they have found success. I think the refocus of the
Federal Bureau of Investigation on the broader spectrum, to
focus on those types of activities that are espionage-like, or
result in a theft of IP, or are foreign agent action is a much
better approach, and I think they will find success that way,
even greater success that way.
Mr. Crenshaw. OK. And for the times that they do have
trouble prosecuting, what exactly are the challenges to
prosecuting these cases? Why are they difficult?
Mr. Shannon. Well, I think early on a couple of issues.
First, again, the use of the 1001 charge, 18 U.S.C. 1001,
lying on a Federal document or something of that nature, it is
not a very strong charge when brought by AUSAs, as I understand
it. It is not a very popular charge for them to bring. That is
one challenge.
The other is the--that a large portion of this is
compliance and procedural misconduct. So things that were
brought forward criminally might have been better dealt with
administratively. You know, again, as they are refocusing their
efforts and focusing on an espionage and foreign agent-type
focus when the evidence suggests that, I believe they will find
greater success.
Mr. Crenshaw. Chinese institutions and individuals gave
about $1 billion to U.S. universities from 2015 to 2019 to
incentivize soft collaboration between U.S. institutions and
Chinese research institutions. How is China--how are Chinese
institutions designing these collaboration activities to avoid
prosecution by the U.S. Government?
Mr. Shannon. Well, it has been a concerted effort for a
couple of decades, and it has been built over time. It is a
generational issue. So you have got researchers who grew up
being taught how to do this.
There are contract agreements that come into play that make
demands on individuals. And once you have accepted that
remuneration, you are kind of in the trap. And so that--the--
they are also instructed--or once we started identifying these
issues, we found instructions that indicated how they would try
to avoid that: first deny that it is you; say that it is--you
know, it is something other than what it is, you didn't know;
or, where we were somewhat vulnerable, the policy wasn't clear,
or I wasn't told, which is why training and education is a big
part of the solution, as well.
Mr. Crenshaw. So is it better distinctions and disclosure
requirements and peer review? Will that help?
Mr. Shannon. Well, I think the disclosure requirements are
there. It is just there hasn't been, until recently--and some
of the tools that we deploy can rapidly identify those
potential conflicts that are out there with potential threat
actors. And risk rating that, and then addressing those risks,
starting from a compliance perspective--if you identify a
relationship like that, does--did the employer know about it?
And if they didn't know about it, are they OK with it?
Again, it is people accepting risk at a level that is above
their authority to do so on behalf of their organization that
is causing a lot of these problems. So being able to put
internal controls, ensuring that there is accountability.
I have advocated also for, again, research security or--and
other considerations as sort of a stewardship consideration for
additional grant conditions.
All of those things will help motivate awardees to take
that step. There is a tuition cliff coming. They are going to
be relying on research to fund their organizations. It is
important for them to be competitive, and those with the best
research security should have the best opportunity to be those
trusted partners for those investments.
Mr. Crenshaw. I appreciate your time. It looks like I am--
and I am out of it.
I yield back. Thank you.
Ms. Eshoo. The gentleman yields back.
The Chair is pleased to recognize the gentlewoman from
Minnesota, Ms. Craig, for your 5 minutes of questions.
Ms. Craig. Well, thank you so much, Chairwoman, and thank
you for holding this important hearing, as well as to our
witnesses for being here today.
Many of the bills up for discussion today focus on the
healthcare issues most important to my constituents, including
the unique barriers facing rural communities, and how we can
best address them. Americans living in rural communities are
more likely to travel long distances to access care. They are
more likely to be uninsured or under-insured. And they face
skyrocketing costs that serve to a--as a barrier to access.
On top of that, healthcare workforce shortages are
increasingly widespread, and hospitals in rural communities
have been closing at a high rate for decades. But like many
districts, access to broadband has been a significant issue
that only deepens these disparities.
With that, Ms. Sweeney, in your testimony you spoke about
the lack of broadband access in the area that NEW Health
serves. How would better infrastructure and the adoption of
telehealth technology strengthen your ability to serve your
patients?
Ms. Sweeney. Yes, thank you for that question. I think it
is best illustrated by an experience.
And so every day at 3:30 our internet broadband for my
healthcare physicians was declining, and our EHRs would really
bog down. So as our IT department further analyzed what was
going on, what happens at 3:30 in most of our areas? Our
students are getting out of school and they are coming home. So
they are jumping on their gaming systems, and competing for
that same broadband that we are trying to do our health
records, and it really became problematic.
And so in rural communities we are competing for that same
broadband. We don't have dedicated lines, we don't have fiber.
Like I mentioned earlier, we have some of our communities that
are still on dial-up internet. And so it is really just a big
challenge for our employee--or our--excuse me, our patients as
a whole. So it limits our ability to build out that telehealth.
So we did talk about telephonic as an opportunity we have
utilized. But I think, too, the cost prohibitive nature of our
ISP providers, and so the cost for rural broadband for our
constituents, is much higher than it is for our urban partners.
And so much so we had utilized the USAC funding historically
this last year. Our broadband provider did not submit a bid.
There is nothing we can do about it, so our cost for broadband
will go back up to its original cost, which is--takes a
significant part of our budget, and takes away from our primary
care resources because we have to fill that budget shortfall.
Ms. Craig. Thank you so much, Ms. Sweeney. And I was sort
of chuckling here as you were talking about competing with kids
for broadband coverage. I--as the mother of four sons, I
certainly can remember those days of competing with Xbox and
other gaming systems. So thank you for that.
Dr. Croston, how can deployment of broadband funding
through Federal programs help improve access to trauma care,
particularly in rural areas?
Dr. Croston. Thank you, Representative Craig. Certainly,
having visual connections to remote emergency room sites would
provide the opportunity to give better guidance and help triage
more effectively.
The biggest problem rural areas face is getting to
definitive care as quickly as possible, and sometimes that
means a short stay in an emergency room remotely, and sometimes
people would prefer to recover at home if it is at all
possible.
So having access to telehealth or a connection to a level
one trauma center and staff there might provide support that
would be needed to keep people locally, when possible. So it
should work both ways.
Ms. Craig. Thank you so much for that. I know that
telehealth accessibility is an issue we can all agree should
demand more Federal attention.
And I was proud to introduce H.R. 8169, the Rural
Telehealth Access Task Force Act, with my colleague,
Congressman Pence. This bill will form an HHS-led task force to
study barriers to telehealth access and identify potential
solutions.
I am really proud of the investments most recently that we
are making in many of our states through the bipartisan
infrastructure bill to expand access to broadband, to the
internet, and I look forward to continuing to work with each of
you to make sure that it reaches all Americans.
And with that, Madam Chair, I am going to yield my 5
seconds back to you.
Ms. Eshoo. I appreciate it. The gentlewoman yields back.
It is a pleasure to recognize the gentlewoman from
Massachusetts--almost last, but not last at all--a great member
of our subcommittee, Congresswoman Trahan.
Mrs. Trahan. Well, thank you, Madam Chairwoman, and thank
you to the witnesses here today.
Throughout the COVID-19 pandemic, community health centers
across the Nation have delivered lifesaving care to the
American people. Ms. Sweeney, in your testimony you recognize
that not all communities can support a full-time, brick-and-
mortar health center site, and that your new mobile unit has
been a cost-effective alternative that breaks down
transportation and access barriers to your patients.
In my district few have done more to serve numerous patient
populations before and throughout the pandemic than the
hardworking men and women at the Greater Lawrence Family Health
Center, the Lowell Community Health Center, and Community
Health Connections in Fitchburg, Massachusetts. And since 2017,
the Greater Lawrence Family Health Center has utilized mobile
health units to connect with the homeless population in
Lawrence. This population does not typically access the brick-
and-mortar health center, but instead they rely on the health
centers--two mobile units to receive substance use disorder
treatment, behavioral healthcare, primary care, and acute care.
These mobile units also screen for social determinants of
health to get vulnerable populations access to necessities like
food and housing.
The Lowell CHC currently does not have a formal mobile
health clinic. However, they host numerous preventative
screenings and COVID-19 vaccination clinics in the community,
which have been very successful, and have demonstrated the
ability to close disparities in access to such services. Lowell
CHC is currently exploring expanding this model as a mobile
health clinic.
So the Mobile Health Care Act will achieve the goal of
allowing more health centers the flexibility to acquire and
develop innovative mobile clinic solutions to serve some of the
hardest-to-reach populations such as veterans, homeless
individuals, agricultural workers, and those in remote areas.
So, Ms. Sweeney, if you could, just describe how the Mobile
Health Care Act helps health centers like Lawrence and Lowell
and Fitchburg either buildup or establish their mobile health
units.
Ms. Sweeney. Yes, that is--thank you for asking that
question. So the legislation enables mobile units to qualify as
a new access point, regardless of whether it is associated with
a permanent site. This designation and funding flexibility will
facilitate more mobile units being utilized by health centers,
and getting our patients access where they need access.
So it takes a really--you know, aligning it to a site, and
we can more easily get it to multiple sites within our service
area. Like we mentioned earlier, we are three-county location,
so we can better serve patients more cost effectively.
Mrs. Trahan. And Ms. Sweeney, in your testimony you also
discuss the critical workforce shortages and the high staff
turnover health centers grapple with daily. What are some of
the difficulties your health center faces in staffing your
mobile unit?
And then what Federal resources do health centers across
the Nation need to overcome these workforce barriers to be able
to continue providing culturally competent and quality care to
their under-served patient populations?
Ms. Sweeney. Yes, so our mobile unit has actually been a
very positive thing when we are talking about provider burnout,
that people are looking forward to a care model that is--you
know, more readily meets the patient's needs. And so our plan
for our existing clinical staff is to roll out our existing
staff into the mobile clinic, and then we will look at
evaluating a dedicated mobile clinic staff team individually.
And so it is important to note that our workforce
challenges predated COVID. And so our workforce challenges are
not just limited to clinical positions. It is across all
things. So we need resources for those capital projects, for
workforce development programs.
And again, community health centers have multiple gaps that
we are trying to do. And in our testimony we did talk about NEW
Health University, our strategic workforce program. So we are
very excited about our initial results with that, and how we
are overcoming not only our mobile staffing, our behavioral
health staffing, and our general staffing challenges in
general.
Mrs. Trahan. Well, it is such an important time. And I am
thrilled to see this piece of legislation, you know, move
forward with the support--and also your testimony, which
validates the need for getting beyond the brick-and-mortar
clinic.
Thank you so much, Madam Chair. I yield back.
Ms. Eshoo. The gentlewoman yields back. That concludes
members of the subcommittee questioning. And I now would like
to recognize a member of the full committee, the gentlewoman
from New York.
And we are very grateful to you, Congresswoman Clarke, for
H.R. 2007, named for our late colleague, Stephanie Tubbs Jones.
So it is a pleasure to have you with us. You can waive on to
this subcommittee any time you would like. You are recognized
for 5 minutes of questions.
Ms. Clarke. And I thank you very much, Madam Chair, for
including a piece of legislation in this hearing that not only
holds great personal significance to me, but is especially
important during a time where women's basic reproductive rights
are under attack.
Let me thank the witnesses. This has been a fascinating
hearing, and has really driven home the challenges we face as a
multi-ethnic, multi-racial, multi-religious society.
My legislation, H.R. 2007, the Stephanie Tubbs Jones
Uterine Fibroid Research and Education Act, is named in tribute
to our dear colleague, friend, mentor, the late, great
honorable Congresswoman Stephanie Tubbs Jones. We know that,
during her tenure in Congress, this legislation was one of her
top priorities, as Black women are disproportionately impacted
by uterine fibroids more than any other women. And she would
often say, as has been stated by our witness, that Black women
deserve better.
And myself personally living through my own challenges with
uterine fibroids, I think often times about the millions of
marginalized women who possess little to no means for
treatment, and can--and cannot access any solutions for their
pain and suffering, and they are suffering in silence.
For my colleagues who may not be as in-tuned, uterine
fibroids are non-cancerous growths on the uterus, and are among
the country's most common gynecological conditions. About 26
million women and girls in the United States between the ages
of 15 and 50 have fibroids, with more than 15 million
experiencing what is classified as severe symptoms. And no
group of women suffer more from fibroids than Black women, who
are at an increased risk compared to their White counterparts
to get fibroids at a younger age, and suffer with more severe
symptoms.
It is estimated that fibroids cost the healthcare system
between 5.9 billion to $34.4 million each year
[sic] in productivity.
This issue has not received the attention nor the funding
it deserves. And increasing awareness on uterine fibroids is
critical to our efforts to address the national maternal
mortality crisis and prevent pregnancy-related deaths. We must
allocate funding toward research and education, so that those
being impacted are receiving the proper care that they deserve.
But in doing so, we can close the gap on this glaring disparity
that has been disproportionately borne out in the lives of
Black women.
Last, I would like to thank and recognize the work of the
Fibroids Foundation, the White Dress Project, and other
organizations and individuals that continuously and tirelessly
advocate and create awareness about this condition.
Let me say, Madam Chair, that it is critical that we look
at the whole woman and the healthcare. These are the most
important reproductive years in the lives of women. And to be
afflicted with such a condition during that time is devastating
in many ways, and dangerous in others.
So I would like to direct my first question to Ms. Tanika
Gray Valbrun.
Tanika, thank you for being here today and sharing with the
committee your personal experiences with fibroids. Why do you
believe we need to research and disseminate public information
on fibroids?
Ms. Valbrun. Thank you so much, Congresswoman, for your
advocacy and for sharing your story.
It is imperative that we collect data and research so that
we can know what is happening with this condition. On a very
base level, there is so much information that we still don't
know for the general public. A lot of women still don't know
that a lot of times the symptoms they are experiencing are as a
result of uterine fibroids.
So for this condition, there are just base definitions and
clinical studies that need to be done so that we are aware of
what is happening with this condition, and really that we can
educate people. There is really----
Ms. Clarke. And could you----
Ms. Valbrun [continuing]. Just a lot of lack of awareness.
Ms. Clarke. And could you elaborate on how disruptive
uterine fibroids can be to a woman's overall workplace
performance and quality of life?
Ms. Valbrun. Yes, absolutely. Quality of life is one of the
biggest symptoms. The impact on quality of life is one of the
biggest symptoms of uterine fibroids. Taking multiple days off
work, not feeling comfortable, having stains and embarrassment,
as I spoke about in my testimony.
So it really is something that is daunting, and that many
women have to think about when they think of their social life,
when they think of the jobs they are going to get, even
sitting--standing up from a chair can be a crucial part in a
woman's life when she is dealing with fibroids.
Ms. Eshoo. The gentlewoman's----
Ms. Valbrun. So it is----
Ms. Craig. Thank you. I have run out of time. I appreciate
it.
Ms. Valbrun. Yes.
Ms. Craig. Madam Chair, I yield back. Thank you.
Ms. Eshoo. The gentlewoman yields back. I wanted to be a
little more generous with your time, because you have waited
since 8 a.m. or 11 a.m. to join us today.
That now concludes our hearing. I want to thank, on behalf
of all of my colleagues, Dr. Bibbins-Domingo, Dr. Croston, Ms.
Gray Valbrun, Mr. Shannon, Ms. Sweeney, and Dr. Walker-Harding
for your very important and highly instructive testimony today.
Please know that members have ten business days to submit
additional questions for the record. And so I ask the witnesses
to please respond promptly to any questions that you receive.
And I do have a submittal of documents to the record. I
request unanimous consent to enter the following documents into
the record: a letter from the Medical Imaging and Technology
Alliance in support of H.R. 2007; a letter from the American
College of Surgeons regarding H.R. 8163; a letter from the
March of Dimes in support of H.R. 7565 and H.R. 2007; a
statement from the Fibroid Foundation on H.R. 2007.
Does the ranking member join me in the unanimous consent
request?
Mr. Guthrie. Yes, Madam Chair. We have no objections on our
side.
Ms. Eshoo. OK. Without objection, so ordered.
Ms. Eshoo. Thank you very much, Mr. Guthrie.
And not seeing anything else to come before the
subcommittee this morning, I want to thank all of my colleagues
for your important work. I am so proud of this subcommittee and
what each member brings forward to make a difference to the
people of our country.
So at this time, in gratitude and respect for the rest of
your day, the subcommittee is adjourned.
[Whereupon, at 1:58 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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