[Senate Hearing 118-204]
[From the U.S. Government Publishing Office]
S. Hrg. 118-204
NOMINATION OF MONICA BERTAGNOLLI
TO BE DIRECTOR OF THE NATIONAL
INSTITUTES OF HEALTH
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING THE NOMINATION OF MONICA BERTAGNOLLI TO BE DIRECTOR OF THE
NATIONAL INSTITUTES OF HEALTH
__________
OCTOBER 18, 2023
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
54-494 PDF WASHINGTON : 2024
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
BERNIE SANDERS (I), Vermont, Chairman
PATTY MURRAY, Washington BILL CASSIDY, M.D., Louisiana,
ROBERT P. CASEY, JR., Pennsylvania Ranking Member
TAMMY BALDWIN, Wisconsin RAND PAUL, Kentucky
CHRISTOPHER S. MURPHY, Connecticut SUSAN M. COLLINS, Maine
TIM KAINE, Virginia LISA MURKOWSKI, Alaska
MAGGIE HASSAN, New Hampshire MIKE BRAUN, Indiana
TINA SMITH, Minnesota ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico MITT ROMNEY, Utah
JOHN HICKENLOOPER, Colorado TOMMY TUBERVILLE, Alabama
ED MARKEY, Massachusetts MARKWAYNE MULLIN, Oklahoma
TED BUDD, North Carolina
Warren Gunnels, Majority Staff Director
Bill Dauster, Majority Deputy Staff Director
Amanda Lincoln, Minority Staff Director
Danielle Janowski, Minority Deputy Staff Director
C O N T E N T S
----------
STATEMENTS
WEDNESDAY, OCTOBER 18, 2023
Page
Committee Members
Sanders, Hon. Bernie, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Cassidy, Hon. Bill, Ranking Member, U.S. Senator from the State
of Louisiana, Opening statement................................ 3
Witness
Bertagnolli, Monica, to be Director of the National Institutes of
Health, Bethesda, MD........................................... 7
Prepared statement........................................... 8
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Marshall, Hon. Roger:
Bayh-Dole Op-Ed in The Washington Post, April 11, 2002....... 38
QUESTIONS FOR THE RECORD
Response by Monica Bertagnolli to questions of:
Senator Sanders.............................................. 39
Senator Kaine................................................ 40
Senator Hickenlooper......................................... 40
Senator Markey............................................... 41
Senator Casey................................................ 42
Senator Lujan................................................ 43
Senator Cassidy.............................................. 44
Senator Paul................................................. 53
Senator Collins.............................................. 58
Senator Murkowski............................................ 58
Senator Braun................................................ 60
Senator Marshall............................................. 60
Senator Tuberville........................................... 61
Senator Mullin............................................... 63
Senator Budd................................................. 64
NOMINATION OF MONICA BERTAGNOLLI
TO BE DIRECTOR OF THE NATIONAL
INSTITUTES OF HEALTH
Wednesday, October 18, 2023
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10 a.m., in room
430, Dirksen Senate Office Building, Hon. Bernard Sanders,
Chairman of the Committee, presiding.
Present: Senators Sanders [presiding], Murray, Casey,
Baldwin, Kaine, Hassan, Smith, Lujan, Hickenlooper, Markey,
Cassidy, Collins, Murkowski, Braun, Marshall, Romney,
Tuberville, Budd, and Barrasso.
OPENING STATEMENT OF SENATOR SANDERS
The Chair. All right. Let's go. Okay. Thank you all for
being here and the Senate Committee on Health, Education,
Labor, and Pensions will come to order. This morning, we will
be considering the nomination of Dr. Monica Bertagnolli to
serve as the Director of the U.S. National Institutes of
Health.
Let me begin by welcoming Dr. Bertagnolli to our Committee.
We look forward to hearing from you and we thank you for being
here today. And I see you have brought along a fellow Wyomian--
or is that what it is? We welcome Senator Barrasso as well.
The NIH, with a budget of more than $47 billion, is the
largest funder of medical research in the world. This research
has led to new treatments and prescription drugs that have
significantly improved the lives of Americans and people
throughout the entire world, and I think all of us, every
single American should be very proud of those accomplishments.
But having said that, let me say a few words about my
concerns. I don't have to tell any American that the health
care system in our Country is broken and it is failing. We
spend almost twice as much per capita on health care as any
other industrialized nation, yet we have 85 million people who
are uninsured or underinsured.
We don't have enough doctors, nurses, dentists, mental
health specialists. Our life expectancy is lower than other
major countries and is actually in decline today. And very
relevant to the hearing that we are conducting right now, we
spend as a nation the highest prices, we pay the highest prices
in the world for prescription drugs, in some cases 10 times
more than the people in other nations, while the largest drug
companies made over $112 billion in profits last year and pay
their CEOs exorbitant compensation packages.
One out of four Americans cannot afford to pay for the
medicine they need, and thousands of families face financial
ruin as they pay prices that they cannot afford for the
prescription drugs that keep them alive.
Think about it for one second. Millions of people get sick.
They go to the doctor. Doctor writes out a prescription. They
cannot afford to fill the prescription the doctors write. How
insane is that? But it is not just the high cost of
prescription drugs impacting individuals.
In the largest hospital in my State of Vermont, and I don't
think it's terribly different elsewhere, the high cost of
prescription drugs account for 20 percent of the overall budget
for the hospital, and that drives insurance costs up as well.
Prescription drugs impact hospital costs big time. In other
words, the outrageously high cost of prescription drugs in
America is a crisis and it must be addressed.
Adding insult to injury, not only has the Federal
Government not effectively regulated the price of prescription
drugs, but the taxpayers of this country have over the years
provided hundreds of billions of dollars in research and
development into new prescription drugs that have provided
enormous benefits, financial benefits to some of the most
profitable pharmaceutical companies in the country.
For example, in America today, the median cost of new
cancer drugs has gone up by more than 300 percent over the past
decade, even though 85 percent of the initial foundational
cancer research was funded by the U.S. taxpayer.
We are putting money, rightfully so, into research to deal
with cancer, and yet we pay outrageously high prices. In June,
this Committee released a report that found that the average
price of new treatments that NIH scientists helped invent over
the past 20 years is $111,000. In virtually all cases, American
taxpayers are paying far more than people in other countries
for the exact same medicine that the NIH and taxpayers helped
develop.
Here are just a few examples from this report. Astellas and
Pfizer charge Americans with prostate cancer over $165,000 for
XTANDI, while the exact same drug can be purchased in Japan for
just $20,000. This is a drug developed by American taxpayer
dollars. Johnson and Johnson charges Americans with HIV $56,000
for SYMTUZA, while the same exact treatment can be purchased in
the UK for just $10,000--a product developed with U.S. tax
dollars.
Gilead charges Americans with non-Hodgkin's lymphoma
$424,000 for Yescarta, or the exact same therapy can be
purchased in Japan for just $212,000. And the list goes on, and
on, and on. We pay for the research, drug companies develop the
drug, they make billions, and then they charge us the highest
prices in the world for the product. One last example.
After receiving $12 billion from the Federal Government,
Moderna has quadrupled the price of the COVID vaccine, a
vaccine that was literally co-invented by NIH scientists, to
$128, while the exact same medicine--same vaccine will be
available in Europe for as little as $26. Really? Anybody here
think that vaguely makes sense?
We developed the research. We pay for it. We pay the
highest prices of the world, how people can't afford it--
doesn't make sense to me. In my view, at this very difficult
moment for American health care, and we are in a crisis
situation, we need a NIH Director who is prepared to take on
the greed of the pharmaceutical industry and use every tool at
his or her disposal to substantially lower the outrageous cost
of prescription drugs.
The 1,800 well-paid lobbyists from the pharmaceutical
industry who are all over this place may not be happy about
that thought, but that is precisely what the American people
want. The status quo is not working. We need fundamental
changes in the way that the NIH addresses the crisis of
prescription drugs.
We need NIH directors prepared to reinstate and expand the
reasonable pricing clause, make sure the pharmaceutical
companies set reasonable prices for new prescription drugs
developed with taxpayers, etcetera, etcetera. The whole lot of
things the NIH can do. Now, is the NIH alone going to solve the
problem?
Of course not. Other agencies, the Administration has got
to be active as well. You know, the media describes what goes
on in Congress as we are a very divided nation. Well, we are.
But I will tell you this, whether you are a Conservative
Republican, a Progressive, a Democrat, or an Independent, you
know what we all agree on?
Every poll tells us that. And that is they want--the
American people want Congress to deal with the outrageously
high cost of prescription drugs. That is what we have got to
do. Senator Cassidy, you are recognized for your opening
remarks.
OPENING STATEMENT OF SENATOR CASSIDY
Senator Cassidy. Thank you, Chair Sanders. Today, the
Committee considers the nomination of Dr. Monica Bertagnolli to
be the next Director of the National Institute of Health. And
Dr. Bertagnolli, thanks for being here.
Thanks for taking on this job and going through this
Committee, which I know must be stressful, but again, very
pleased to have you. You have an incredibly impressive resume,
and I say that as a physician who formerly was in academics but
has no resume that compares with yours and is reflected by the
support that you have from the scientific community.
There is no questions regarding scientific qualifications,
but there are people that will ask questions regarding your
overall ability to lead the NIH in the next phase, and this is
what my remaining remarks will be about.
Everybody knows the NIH's role in strengthening America's
biomedical research and supporting public health, especially
during a crisis. Unfortunately, it became a lightning rod for
partisan debates during the COVID-19 pandemic, and that eroded
the trust between the NIH and the public.
First and foremost, you will be tasked to rebuild the
relationship with Congress and the public, being a leader that
represents the interests of all Americans and not just of the
scientific community.
This means making the agency more transparent and
accountable to Congress while also advancing cutting edge
science, effectively communicating to the American people, and
rebuilding trust between public health officials and the
biomedical research community.
The NIH Director must also protect and strengthen the
valuable public, private partnerships that make up our
biomedical research enterprise. And sometimes our public,
private partnership was underestimated, but clearly, the
private and the public partnership has been what has made the
United States a leader in innovative drugs.
Last month, I issued a request for information from
stakeholders on modernizing the NIH, and this will include buy
in from all. I look forward to hearing from you about your
vision for the agency and how you shall achieve. Now, during
our meeting, we spoke about bioethical issues, including fetal
tissue and embryonic stem cell research, and the use of
hormones and other gender transition interventions on children.
Frankly, at times you avoided getting into specifics,
citing a lack of expertise. But as the Director, you will have
to have this expertise. You will need to be prepared to weigh
in on topics that are not in your research specialty, but
across the entire enterprise, making the policy decisions that
will shape the direction of biomedical research.
While you will consult with experts and take input from
your institute directors, you are ultimately the person who
decides. I point out that this hearing is apparently happening
today, it was not going to otherwise, because of a publicly
acknowledged deal the Biden administration cut with Chair
Sanders to implement partisan drug pricing policies in exchange
for advancing your nomination.
Biden administration officials told us in a hearing earlier
this year that policies similar to those in the deal that have
been reported could risk future partnerships between the
Government and the private sector. By the way, future
partnerships critical to generating the cures important for
cancer and Alzheimer's and for the next pandemic.
The partnerships that are the foundation of the U.S.
biomedical research enterprise, which, by the way, leads the
world in developing these cures. It is concerning that the
Administration would jeopardize the long term success of this
enterprise for the short term goal of advancing your
nomination.
Last week, I asked President Biden and Secretary Becerra
for a full accounting of any deals cut with Members of Congress
relative to advancing your nomination. At 5.43 p.m. last
night--this is kind of the problem. At 5.43 p.m. last night, I
received basically a form letter that provided no information
and intentionally ignored the request it was supposedly
responding to. The Administration was not forthcoming about any
deals with Members of Congress, even though some of those
details have been reported in the press.
Now, Senators expected to vote in your confirmation should
be aware of any such deal prior to the nomination. That is not
you, it is the process. And we speak about the breakdown of
trust is like rhetoric, inflammatory rhetoric, which is true,
true, true, but not related, is driving a process by the
Administration on something that we should know about, but we
are not being told.
Another example, in June, Senator Tuberville and I sent the
Acting NIH Director a letter about NIH funded projects that
resulted in the death of two adolescents. We didn't get a
response to that letter till September 15th, a week after the
Biden administration struck the deal to move your nomination. I
believe you when you say that you are committed to transparency
and rebuilding the NIH's relationship with Congress.
I appreciate that commitment, but I have concerns given the
Administration's history of failing to respond to congressional
oversight requests, particularly from Members of this Committee
who are responsible for that oversight.
Rebuilding NIH's relationship with Congress will require a
strong Director who can overcome partisan divisions, overcome
the Administration's deliberate stonewalling of requests from
Members of this Committee for that information pertinent to the
work of this Committee, and work with both Republicans and
Democrats to improve trust in our Federal health institutions.
That means being open and responsive to this Committee,
which will directly oversee your work as NIH Director, if you
are confirmed. I look forward to hearing how you shall fulfill
these parts of the job and move the NIH forward. I thank you,
and with that, I yield.
The Chair. Thank you, Senator Cassidy. And now, I would
like to welcome our nominee, Dr. Monica Bertagnolli has served
as the Director of the National Cancer Institute since October
2022.
Prior to that role, Dr. Bertagnolli was a surgeon at
Brigham and Women's Hospital and the Richard E. Wilson
Professor of Surgery of the Field of Surgical Oncology at
Harvard Medical School. Dr. Bertagnolli is a longtime member of
the American Society of Clinical Oncology, where she has served
as both President and a member of the Board of Directors.
I thank her for being here today, and I now turn it over to
Senator John Barrasso to introduce her.
Senator Barrasso. Well, thanks so much, Mr. Chairman. And I
am pleased to welcome to the Senate and to the Committee Dr.
Monica Bertagnolli, who is a fellow physician and a Wyoming
native.
President Biden has nominated her to be the Director of the
National Institutes of Health, and it is certainly not every
day that one of Wyoming's very own is nominated for such a high
position in our Nation. Dr. Bertagnolli has devoted her entire
life to medicine and medical research.
She earned a Bachelor's degree in Engineering from
Princeton University, graduated from the University of Utah's
Medical School, and completed her surgical residency training
at Brigham and Women's Hospital in Boston.
She then went on to be a research fellow in tumor
immunology at the Dana-Farber Cancer Institute in Boston, and
she later served as the Chief of Surgical Oncology for over a
decade. She has continued caring for patients at Brigham and
Women's Hospital while being a renowned cancer researcher.
She has also served as a Professor in Surgical Oncology at
Harvard Medical School. She has trained not only the next
generation of doctors, but also cancer researchers. And this
makes her a perfect fit to serve as our current Director of the
National Cancer Institute.
While many may know that she is a well-respected physician
and researcher that she is, Wyoming knows her as part of a
multi-generation ranching family, and I am proud to say that
she has never forgotten where she came from.
As I have traveled and met with folks across Wyoming, in
the Mountain West, I have heard of her great work, not only as
a doctor, but also on the ranch. So that includes the ranch
neighbors. If you want to know about somebody, you talk to
their neighbors and their ranching neighbors.
They speak of her grit, her endurance, and her
determination. Her commitment to the land and the livestock
speaks volumes about her character and her courage. She
understands the needs of rural health and of frontier medicine.
She has used her background, medical as well as the values
that she learned growing up, to improve health care for all
Americans. She serves as an adviser to the Huntsman Cancer
Institute in Salt Lake City, Utah, which is a designated cancer
institute for Wyoming.
She also advised Huntsman on how to reach patients in rural
areas. She focused on reducing burdens on patients by using
local cancer treatment clinics. One is in the Sweetwater
Regional Cancer Center in her hometown of Rock Springs,
Wyoming. Her firsthand experience in accessing health care in
rural America gives her a perspective that is often lacking in
Washington.
She has an extensive track record of cultivating private,
public partnerships to push medical innovation forward. I know
this background will serve her well as the Director of the
National Institutes of Health. I have tremendous appreciation
and admiration and respect for Dr. Bertagnolli.
With that being said, Mr. Chairman, I do have serious
concerns about the way this Administration has handled the
COVID pandemic, has politicized Government agencies such as the
NIH, has attacked health innovation through the Inflation
Reduction Act.
I think it is important that this position be filled with
someone with a critical and an open mind, ready to tackle the
important challenges ahead. And for all these reasons, Mr.
Chairman, I support the nomination of Dr. Monica Bertagnolli to
serve as the Director of the National Institutes of Health.
Thank you, Mr. Chairman.
The Chair. Thank you, Senator Barrasso.
Senator Cassidy. Mr. Chairman, can I ask a quick question.
Do you have to be Italian to be from Wyoming? You know what I
am saying? I am just thinking that.
[Laughter.]
Senator Barrasso. Well, in a bipartisan way----
[Technical problems.]
Senator Barrasso. Well, Mike Enzi, Republican. There was a
former Congressman, Tito Ron Calio, who is also from Rock
Springs, Wyoming. So, it helps.
[Laughter.]
The Chair. Okay. With that introduction, Dr. Bertagnolli,
the stage is yours, please. Welcome. Turn the mic on, please.
STATEMENT OF MONICA BERTAGNOLLI TO BE DIRECTOR OF THE NATIONAL
INSTITUTES OF HEALTH, BETHESDA, MD
Dr. Bertagnolli. There we go. Chairman Sanders, Ranking
Member Cassidy, and Members of the Committee, thank you for
considering my nomination to be Director of the National
Institutes of Health. It is an honor to appear before you today
to share my vision for the NIH.
I want to thank President Biden for trusting me with this
nomination, and Senator Barrasso for the very kind
introduction. I also want to thank my husband, Alex, and my two
children for their unwavering support and unqualified love. I
grew up on a ranch in Southwestern Wyoming.
My early inspiration was my uncle. He was a primary care
physician whose practice included traveling across the entire
state, it is a big state, to provide expert care to veterans,
and it was his devotion to his patients that inspired me to
pursue medicine. Like millions of Americans, when my father had
cancer, the care he needed was hundreds of miles away.
I have seen firsthand what it means to deliver care to
those living in rural communities. I have spent my entire
professional life working to improve cancer prevention and
treatment. I have done this as a surgical oncologist,
researcher, as a professor of surgery helping to train the next
generation of doctors and scientists.
As a physician scientist, I have run major clinical trials,
helped to advance innovative research, and pushed hospitals and
institutions to make sure that the most effective treatments
are available to all patients.
For the past year, I have had the tremendous privilege of
serving as the Director of the National Cancer Institute and
working toward the President's Cancer Moonshot goal to end
cancer as we know it. My experience has given me great
appreciation for the inner workings of NIH and for what more is
possible.
Recently, though, I found myself in a different position,
as a patient when I was diagnosed with breast cancer. I was
fortunate to have my cancer diagnosed very early. I have
completed my treatment. My prognosis is excellent. I also had
access to outstanding care, knowing full well that not every
patient has that same chance.
Most importantly, every treatment I received was supported
by NIH funded research. I am grateful beyond words to the
patients who joined the clinical trials before me, the doctors,
and researchers who were able to use that information to make
the best decisions. There is so much that excites me about the
possibility of leading the extraordinary team at NIH, if
confirmed.
First, there has never been more potential for progress
than what we have today. We just need to harness it. NIH can
and must support research that is equitable and accessible to
all populations, and this includes dramatically increasing
clinical trials that reflect the full diversity of Americans,
because we know that is what yields the best results. We should
capitalize on new innovations in uncovering fundamental
biology, in health information technology, and in exciting new
data analytics.
We must interrogate the broad range of behavioral and
social science challenges we face today, while laying the
foundation to address new issues that will arise in the future.
Second, we have an unprecedented opportunity to embrace and
increase access to innovation.
As a physician researcher for more than 30 years, I have
seen the transformative power of NIH research to produce
results that save lives. But I have also seen the patients
whose prospects were compromised by preventable factors.
We should be able to guarantee that the American people are
getting a return on their investment by ensuring that health
care innovations are available and affordable for everyone.
Finally, we must restore faith and trust in our Nation's top
scientists.
I am committed to ensuring that NIH continues to be the
steward of our Nation's medical research and a force of
innovation and discovery. But we must also continue to support
education in all fields of biomedical research and to inspire
young people to become doctors and scientists so that our
critically important work will continue for generations. None
of this NIH can do alone.
I look forward to partnering with Congress and many others
to advance discovery and apply the results of our research to
better the lives of every American. Again, I want to thank you
for the opportunity to appear before you today, and I look
forward to your questions.
[The prepared statement of Dr. Bertagnolli follows.]
prepared statement of monica bertagnolli
Chairman Sanders, Ranking Member Cassidy, and Members of the
Committee, thank you for considering my nomination to be Director of
the National Institutes of Health (NIH). It's an honor to appear before
you to share my vision for the NIH.
I want to thank President Biden for trusting me with this
nomination and Senator Barrasso for the kind introduction. I also want
to thank my husband, Alex, and my two children for their unwavering
support and unqualified love.
I grew up on a ranch in southwestern Wyoming. My early inspiration
was my uncle, a primary care physician whose practice included
traveling across the state to provide expert care to veterans--and it
was his devotion to his patients that inspired me to pursue medicine.
Like millions of Americans, when my father had cancer, the care he
needed was hundreds of miles away, and prohibitively expensive, so I
have seen firsthand what it means to deliver care to those living in
rural communities.
I have spent my entire professional life working to improve cancer
prevention and treatment. I have done this as a surgical oncologist,
researcher, and as a professor of surgery helping train the next
generation of doctors and scientists. As a physician-scientist, I have
run major clinical trials, helped to advance innovative research, and
pushed hospitals and institutions to make sure the most effective
treatments were available to all patients.
For the past year I have had the tremendous privilege of serving as
the director of the National Cancer Institute and working toward the
President's Cancer Moonshot goal to end cancer as we know it. My
experience has given me new appreciation for the innerworkings of NIH,
and what more is possible.
More recently though, I found myself in a different position: as a
patient, when I was diagnosed with breast cancer. My prognosis is very
favorable. I was fortunate to have my cancer detected early. I also had
access to excellent care, knowing full well that not every patient has
that same chance. Most importantly, every treatment I have received was
supported by NIH-funded research. I am grateful beyond words to the
patients who joined clinical trials before me and the doctors and
researchers who were able to use that information to make the best
decisions.
My fidelity to ensuring that high-quality, affordable care is
available to everyone is informed by my own life experiences. If
confirmed, I will work every day to enhance health, lengthen life, and
reduce illness for all Americans--and in so doing, fulfill the mission
of the NIH.
There is so much that excites me about the possibility of leading
the extraordinary team at NIH.
First, there has never been more potential for progress than we
have today--we just need to harness it. NIH can and must support
research that is equitable and accessible to all populations regardless
of income or zip code--that includes dramatically increasing clinical
trials that reflect the diversity of Americans because we know that's
what yields the best results. We should also improve the experience of
people and communities whose health depends on the knowledge that
cutting-edge research brings. We should capitalize on new innovations
in uncovering fundamental biology, in health information technology,
and in exciting new data analytics. And we must interrogate the broad
range of behavioral and social science challenges we face today while
laying the foundation to address new issues in the future.
Second, we have an unprecedented opportunity to embrace and
increase access to innovation. As a physician-researcher for more than
30 years, I have seen the transformative power of research to produce
results that save lives, but I've also seen the patients whose
prospects were compromised by preventable factors. As we work to bring
innovation to patients, we must ensure that we deploy NIH's research
further, and wider, and that we deliver results that work for everyone.
Throughout all this, we should be able to guarantee that the American
people are getting a return on their investment by ensuring healthcare
innovations are available and affordable for everyone.
Finally, we must restore faith and trust in our Nation's top
scientists. NIH is the steward of our Nation's medical research, and I
am committed to ensuring that NIH continues to be a force of innovation
and discovery. To do that, we need to make science accessible to all
communities and inspire young people to become doctors and scientists,
to continue this critically important work for generations.
None of this NIH can do alone. I look forward to partnering with
Congress, and many others, to bring research into every community and
apply the results to better the lives of every American.
Again, I want to thank you for the opportunity to appear before you
today. I look forward to your questions.
______
The Chair. Dr. Bertagnolli, thank you so much for being
with us. Let me begin the questioning by picking up on a point
you just made, and you put in your written remarks as well. You
said, and I quote--and it goes without saying that everybody
here wishes you the very best in your struggle with breast
cancer.
Dr. Bertagnolli. Thank you.
The Chair. You said, and I quote, ``every treatment I have
received was supported by NIH funded research,'' correct?
Dr. Bertagnolli. Correct.
The Chair. Can you give us some idea, based on your
expertise, about how much treatment for breast cancer costs in
this country today? Somebody has breast cancer over a period of
years, how much is it going to cost?
Dr. Bertagnolli. Chairman Sanders, that is a widely
variable result. I truly could not give you an estimate because
breast cancer is incredibly complicated and can range anything
from a simple surgery to years and years and years of very
extensive----
The Chair. Would I be wrong in saying that for some
individuals, it will cost hundreds of thousands of dollars for
treatment?
Dr. Bertagnolli. I believe that is correct.
The Chair. What do you say, as a physician yourself, to
somebody who was undergoing treatment for a drug or treatment
that was developed by taxpayer dollars that they can't afford
or are going to go deeply in debt to pay for?
What does one say to a person to say thank you for your tax
dollars developing the drug, but I am sorry you can't afford
the treatment you need to save your life. How does one respond
to that person?
Dr. Bertagnolli. Yes. Chairman Sanders, I have to tell you
that I have sat in a clinic next to patients of my own who, for
one reason or another, could not afford their treatment. It is
a tragedy.
I sincerely appreciate you championing the cause of
affordable and accessible care for all Americans. And if
confirmed, I will work with you to the fullest extent of my
abilities to also ensure that is the case.
The Chair. Well, thank you for your thoughts. Let me be
rather specific. If you are confirmed to be the next NIH
Director, will you commit to reinstating and expanding the
reasonable pricing clause in NIH contracts?
In other words, if the Federal Government puts money into
the research and development of a drug, will you insist that
the price that drug is charged in America is not higher than it
is charged in other countries around the world given the fact
that we paid for the research and development?
Dr. Bertagnolli. Chairman Sanders, I can say that I myself
believe that the American people deserve a fair return on the
investment that Congress has placed within the National
Institutes of Health and the research that we do.
I will commit to working to make sure that the benefits of
our research are affordable and available to all the American
people. I cannot give further specifics at this time about the
execution of that plan.
The Chair. You are not prepared to tell us that when
taxpayers spend billions on a drug, they will not be asked to
pay the highest prices in the world for what they paid for?
Dr. Bertagnolli. Chairman Sanders, I am more than prepared
to say that I will do whatever I am able to bring--make sure
that affordable and accessible care is available for everyone
who needs it.
The Chair. Doctor, Astellas and Pfizer are charging
Americans with prostate cancer over $165,000 for XTANDI, while
the exact same drug can be purchased in Japan for just $20,000.
$165,000, $20,000 in Japan.
This is a drug that was developed by NIH funded scientists
at UCLA. Do you think the price of XTANDI is reasonable? Should
we be paying eight times more for a drug that taxpayer dollars
developed than the people in Japan?
Dr. Bertagnolli. Chairman Sanders, my focus is on making
sure that the American people have access, and availability,
and can afford the health care that can save lives, and that is
what I will make a commitment to.
The Chair. Right now, we pay by far the highest prices in
the world for prescription drugs. The results are higher
insurance premiums, higher hospital costs, then millions of
people not able to get the drugs they desperately need.
Will you commit to us that you will work to make sure that
Americans do not pay higher prices for prescription drugs in
this country than people around the world?
Dr. Bertagnolli. Chairman Sanders, it would be a great
honor to be able to work with you to make sure that the
American people have access to the care that they need to live
long and healthy lives.
The Chair. Okay. My time is up.
Senator Cassidy.
Senator Cassidy. I defer to Senator Collins.
Senator Collins. Thank you very much, Senator Cassidy.
Welcome, doctor. The National Cancer Institute that you
currently lead has the largest budget and research program of
the 27 institutes and centers at the NIH.
Cancer research is vitally important, and I strongly
support it. I am interested in how you will balance NI--NCI
priorities while making any NIH wide budget decisions. For
example, President Biden's budget request proposes a
substantial increase for the NCI, but it flat funds research
for Alzheimer's disease and diabetes, which collectively affect
more than 40 million Americans.
If confirmed, how will you balance your background in
cancer research and your leadership at NCI with the need to be
fair in evaluating agency wide priorities?
Dr. Bertagnolli. I will thank you for that question,
Senator Collins. And I will say that, first of all, if
confirmed, my commitment as NIH Director is to the health and
vitality of every single American.
But I can give you some specifics to address your specific
question. How does a cancer surgeon really lead an organization
that deals with the huge spectrum of conditions that the
American people face? I have two answers to that.
First, as a cancer doctor, I took care of patients of all
ages, all walks of life, all different health states. I am very
familiar to working with colleagues in cardiology, in mental
health, in opioid use disorder, in kidney disease to take care
of my patients with cancer.
I feel very comfortable engaging with the broadest possible
team of researchers focused on bringing health to people. But
second, one of the things that to me is the most exciting about
the opportunity to lead the organization is the fact that so
many of the diseases that we are working on, individual
diseases in our relative silos, really have many common
elements.
The need to access--to have care access to every community,
but even down to the biology. So, what I want to--my field of
research was in inflammation and how inflammation causes
cancer. Well, guess what? Inflammation is one of the major
inciting factors behind Alzheimer's disease, behind autoimmune
disease, behind long COVID, behind arthritis. So many things.
Both on a scientific level and on the taking care of human
beings level, I am really excited for this opportunity to lead
NIH.
Senator Collins. As you know from our discussion in my
office, I would like to see NIH fund more projects and more
research looking at the role of inflammation in Alzheimer's
disease, for example, instead of just funding amyloid plaque,
important though that is, research. We have had that
discussion.
My time is growing short, so let me switch to diabetes.
Along with Senator Murray and Senator Shaheen, I had the honor
of co-hosting again this year at the JDRF Children's Congress
this summer, and the NIDDK Director, Dr. Griffin Rogers said
that with continued research, it is possible to imagine that
people could lead a life free of the burden of type 1 diabetes
and its complications, which is very exciting.
We have, as you know, a special diabetes program that is up
for renewal, and this Committee has overwhelmingly approved its
reauthorization. I want to make certain that you understand
that program is intended to supplement and not supplant the
regular appropriations. Part of the program goes for type 1
diabetes.
Part of that program goes for type 2 diabetes, with a
special focus on Native Americans and Alaskan Americans. So, I
would like to hear your reassurance that you do understand that
is additional funding.
Dr. Bertagnolli. Oh, thank you, Senator. I will just say
that the researchers and team at the NIH are deeply grateful
for the resources we get from Congress that allow us to serve
people and embrace with the greatest enthusiasm particular
communities and efforts that focus on serving people. So, thank
you.
Senator Collins. Thank you.
The Chair. Senator Murray.
Senator Murray. Thank you very much. Welcome, Dr.
Bertagnolli. Really nice to see you. And thank you so much for
your willingness to take on this position at a really critical
time, because, as you know, NIH has an absolutely critical
mission supporting medical research and making groundbreaking
discoveries that really help everyone stay healthy and keep our
Nation competitive and give patients hope for the future.
Really appreciate your being here and your willingness to
go through this process and lead this agency. The agency also
does really critical work, in coordination with a lot of other
agencies, to protect public health and prepare for--our Nation
for pandemics and a lot more.
Again, thank you. Let me start by asking you, I know at the
National Cancer Institute you have done a lot to address cancer
related disparities for women. So, in that vein, I wanted to
ask you today, across NIH programs and initiatives, do you plan
to strengthen research to specifically improve women's health
inequities, including women's midlife health--outcomes?
Dr. Bertagnolli. Thank you for that question, Senator. It
is very clear that there are many health issues in women that
are understudied, that really lack knowledge and deserve to
have spotlight shine on them and renewed efforts to be able to
provide data to support women's health.
I can give you a couple of examples that are really top of
mind for me. We have a maternal health, I think it is fair to
say, crisis. We had 750 women die either during childbirth or
for 1 year after childbirth in 2019. In 2021, it was 1,200.
Why? We have to understand that.
That is like--that is kind of an immediate need that rises
to the top. But there are many other things. The whole life
cycle of women's health, from childhood all the way through
senior adulthood.
That we know women are different. They react to diseases
different. And we know that we lack the data to know how to
best care for them. So, you raise a commitment that--something
I can easily commit to and say it is very important to me.
Senator Murray. Good. Thank you. And I am working with a
number of other women Senators on some midlife health outcomes,
so I will follow-up with you on that. I think that is really
critical that we look at as well.
But let me focus on something you just said, and that is
the maternal health crisis. That is something I spent a lot of
time on. It is a huge issue facing women, as you just
mentioned, especially since the Dobbs decision.
I wanted to ask you, what can NIH do to improve maternal
health outcomes, specifically talk about that for especially
Black and Native American women who face some of the highest
mortality, maternal mortality rates in our Nation? Can you talk
a little bit more about that?
Dr. Bertagnolli. Yes, thank you very much. So, I think this
raises the issue--it is a twofold issue. It is an issue of
understanding how to care for women during the time of
childbirth and immediately afterwards make sure that their
health is optimal. But it also raises an issue of disparities
in access to care and in engaging with people as physicians and
caregivers, being able to listen to them, to understand them
and to relate to them.
I think that the maternal health crisis raises not only
important biological and medical care issues, it raises really
important social issues. We need to understand people and their
social makeup if we are going to help them best.
Senator Murray. Okay, great. And we will work with
following you up on that as well. But let me ask you about the
fentanyl crisis and the opioid epidemic. Communities are
really, as you know, hit hard by that.
The Lummi nation lost five members of their tribe to
fentanyl overdoses in just one week. And King County has seen a
record number of fentanyl overdose deaths this year. So, I
wanted to ask you, if confirmed, how will you work to support
research that addresses inequities in access to quality mental
health care and treatment for substance use disorders through
NIH programs and support those underserved communities that are
really harmed by the national mental health crisis and the
rising rate of opioid overdose deaths?
Dr. Bertagnolli. Yes. Thank you very much for your
championing this issue. I myself have lost patients to the
opioid crisis, so I have seen what it does. Absolutely
devastating tragedy for our communities.
It has increased so much over the last years, and
disproportionately affects certain communities, although really
has spread across the entire spectrum of our Nation. I can
commit to working with you and on continuing the great
awareness that the NIDA has for understanding this issue deeply
in ways that bring solutions to the people who need it.
Like many things, it has to do with not only medical care
and understanding better treatment, it deeply has to do with
getting that treatment to the people who need it.
Senator Murray. Thank you. Thank you very much, Mr.
Chairman.
The Chair. Thank you.
Senator Cassidy.
Senator Cassidy. I defer to Senator Tuberville.
Senator Tuberville. Thank you, Senator. Doctor, thanks for
being here. Congratulations on your nomination. Before I start,
I would like to say something about your nomination. It is
really nothing against you.
I would like to take the opportunity to draw a comparison
between this nomination and other nominations pending in the
Senate, ones that I am holding from passing by unanimous
consent. Your predecessor, Dr. Collins, was approved by
unanimous consent in 2009, only 4 weeks after being nominated.
The HELP Committee did not even hold a regular hearing like
this. You have faced a much different confirmation process.
Your nomination was held up by Chairman Sanders, which is his
prerogative.
We have no--we have had no confirmed NIH Director for 21
months. Back in June, Chairman Sanders publicly vowed to oppose
your nomination until he received the Administration's
comprehensive plan on lowering drug prices, which we all know
that is what he is about, and a lot of us are about.
As I recall, he promised to hold up not only your
nomination, but all HELP related nominations going through the
HELP Committee. As a Senator, he has a right to do that. He
wanted a policy concession from the Biden administration, and
apparently he got one. I was one of the many who want us to
have a confirmed NIH Director.
A lot of people have wanted us to have a confirmed
Director. It is not unusual, but I don't remember any Democrats
saying the sky was falling because we didn't have a confirmed
NIH Director, because this is a very important position. I
don't remember Democrats calling the Chairman names or even
threatening him.
I don't remember anybody wanting to change the rules of the
Senate because of it. I didn't really say a word about it. If
it weren't for hypocrisy around this place, I don't think we
could have anything to do. Chairman Sanders got what he wanted.
On September 8th, Chairman Sanders announced at the White
House met his demands and he announced this hearing. Chairman
Sanders used his prerogative as a Senator. I don't have all the
details of the concessions the Biden administration made
Chairman Sanders, but I respect his rights as a Senator.
Frankly, I appreciate Chairman Sanders' defense of the
Legislative Branch.
We ought to legislate around here. That is what we were
sent here to do. We weren't elected to just outsource our jobs
to Joe Biden or any other President. Mr. Chairman and I don't
agree on everything, but at least he is standing up for what he
believes in and the power of the Senate.
I will get off my horse now and ask you a question. This
very,--being an educator, this really touches me here. The NIH
funded a recent study about the psychosocial functioning in
transgender youth after 2 years of hormones.
According to the letter NIH sent to Ranking Member Cassidy
and me, the research seeks to understand the physical and
psychosocial effects of medical intervention to evaluate the
effectiveness of existing medical treatments already in use
among transgender youth.
As you know, two young people committed suicide who were
part of the study. That is obviously a tragedy. But what
concerns me even more is the fact that the NIH was funding this
research. And beyond that, I believe the NIH even called the
study a success.
That is sick. It sounds to me like the NIH totally dropped
the ball on quality control and oversight. So, if confirmed,
how would you make sure nothing like that ever happens on your
watch?
Dr. Bertagnolli. First, Senator, I really thank you for
your affirmation of the critical importance of NIH and what we
are--and that we are here to serve the American people, and
just how critical that is and how important this job is.
To that end, in response to your question, we have the
greatest responsibility to ensure two things. First, that we
serve all people, all people, all walks of life, and that we
really are here to achieve the health of all.
But that No. 2, any research that we do that involves human
beings, people, is conducted according to the highest ethical
principles so that we make sure that the research is intending
to do no harm, to achieve benefits, and is done in ways that
have maximum respect for the dignity of people.
If confirmed as NIH Director, I will affirm to you that
will be my mode of action and my highest priority for all human
research.
Senator Tuberville. Thank you. One more quick question,
Chairman. The NIH used to be universally respected,
nonpolitical organization before COVID, but that trust has been
broken, especially in rural parts like my State of Alabama.
You are from a rural Wyoming, so you get the real
perspective, and you understand just how much people in those
parts of the country in particular have lost confidence in our
public health institutions. They feel totally overlooked. What
would you do as NIH Director to help gain back some of that
respect in rural areas?
Dr. Bertagnolli. Thank you so much for that question, and I
will be very, very brief. Two things. No. 1, I believe deeply
in the doctor, patient relationship. That is incredible value.
That is trust.
A patient comes and puts their life in the hands--and their
health in the hands of their doctors. And anything that we can
do to strengthen the doctor, patient relationship is something
that we should pursue to the fullest extent possible.
Then second, I believe in education at all levels, being
very--and relating--our patients joining us in research to the
fullest extent possible. Not science here and people here, but
people joining us to do science. I think that also engenders
great trust in the process if it is done in a respectful and
appropriate way.
The Chair. Thank you.
Senator Kaine.
Senator Kaine. Thank you, Chair Sanders. And
congratulations, Dr. Bertagnolli. I am happy to support your
nomination. Every time a representative of the NIH comes before
us, I asked for an update on the Recovery Initiative.
Congress provided NIH with $1.15 billion in funding to
advance understanding, prevention, and treatment of the long
term effects of COVID, including long COVID. And this is a
topic very important to me because I live with a mild form of
long COVID.
Because I have been public about that, I hear from people
every day. In this body, I have colleagues, a former Senator or
colleague, former colleague, Senator Inhofe, Senator Young have
talked about long COVID experiences.
My wife went to a lawyer last week with a friend of ours to
help her file for bankruptcy because her treatments for long
COVID that knocked out her balance now leave her in a situation
where if she doesn't file for bankruptcy, she could lose her
home.
I was at an event Monday and a technology CEO came up and
talked to me about his wife's experience with acceleration and
deceleration of her heart rate, which is fairly common long
COVID symptom.
About 5.3 percent of Americans now have long COVID, and of
those--that group, 80 percent suggest that their long COVID
significantly limits life activities. Americans depend on
research coming out of NIH to help understand how to treat,
cure, prevent symptoms that are often debilitating.
It frustrates and saddens me to hear how many long COVID
folks who are dealing with it have both had a negative impact
on their life, but often face skepticism and disbelief as they
describe their symptoms to employers and others.
I am also frustrated when I hear long COVID sufferers
indicate that NIH isn't doing enough on the issue and that
their voices aren't being heard. Let me tell you what patient
advocates tell me.
That NIH isn't considering the input of those living with
long COVID in the design and enrollment of long COVID clinical
trials. That NIH is not as responsive as it should be to
advocate outreach. That with Recover being spread across
multiple institutes, there is a lack of clear leadership, and
the initiative lacks kind of a point person that is held
responsible for decision-making.
There is a lack of transparency in the budget and future
plans for the initiative. Dr. Bertagnolli, I know your work in
the cancer institutes has not put you directly into this space,
and so your knowledge of the inner workings of the Recovery
Initiative are limited at this time.
But should you be confirmed as Director, I ask that you
continue to work with me to address the concerns of those
living with long COVID, including that you commit to meeting
with patient advocates to discuss these issues.
Dr. Bertagnolli. Senator Kaine, thank you very much for
that question. And I can absolutely confirm that I will work
with you on this issue. I think this is one of the greatest
tragedies we have recently seen.
I will tell you one thing that is something I live by in my
research, I love the expression, nothing about us without us.
This comes from the people with lived experience community. We
call them the patient advocates.
I love that expression because it really is the way we need
to do our science. Not only are we then serving them because we
are listening to them, but all the other issues of trust and
accountability and respect for the people we serve happen when
you do that. So you have hit something that goes to my core,
and I would be delighted to work with you.
Senator Kaine. Thank you. Thank you very much. Next topic I
want to ask you about is pediatric cancer research.
Along with Senator Moran and 13 other bipartisan Members of
this body--of this Committee and the full body, we introduced a
bill called the Gabriella Miller Kids First Research Act 2.0 to
reauthorize a program that is aimed at combating childhood
cancer.
The legislation is the result of continuing efforts by the
Miller family to fight childhood cancer. And their revelation
to me 10 years ago that of the NIH research budget, only a
very, very tiny percent, less than 1 percent was devoted to
pediatric research in the cancer space. I am pleased to say
that the bill was voted out of Committee last month with a very
strong bipartisan support.
I know you are familiar with the challenges in combating
childhood cancer, in particular. As Congress looks to
reauthorize the critical program, can you tell me how NIH will
continue to expand its efforts using data sharing to speed up
research, for example, particularly for childhood diseases such
as pediatric cancers?
Dr. Bertagnolli. Yes, thank you. And this has been a major
focus of my work since coming to NCI and would absolutely be
carried over at NIH.
I just, since time is brief, the beautiful, beautiful
Gabriella Miller, when she looked into that camera, I am sure
you have seen it, looked into that camera, and I am
paraphrasing, I don't remember exactly, but she looked in that
camera and she says, quit talking, get working or something
like that.
It just gets to your heart, and we take that very seriously
and that is what inspires us to go forward.
Senator Kaine. Thank you very much. I yield back.
The Chair. Thank you.
Senator Cassidy.
Senator Cassidy. I defer to Senator Marshall.
Senator Marshall. All right. Thank you, Senator Cassidy.
Mr. Chairman, I want to submit for the record first an Op-Ed in
The Washington Post, April 11th, 2002, by a Democrat Senator
from the great State of Indiana, Senator Birch Bayh, and, of
course, one of my boyhood heroes, the late great Senator Bob
Dole from the State of Kansas. And it is an Op-Ed about the
Bayh-Dole Act.
[The following information can be found on page 38 in
Additional Material:]
Senator Marshall. I am sure Dr. Bertagnolli you are
familiar with this, that this encourages, entices the private
practice to seek public, private research collaboration rather
than poking on its own proprietary research. If confirmed, will
you commit today to uphold the integrity and intent of Bayh-
Dole?
Dr. Bertagnolli. Thank you, Senator. And I, if confirmed, I
will commit to uphold the integrity of the Bayh-Dole Act.
Senator Marshall. Thank you. Next, I want to talk about
research. In 2022, nearly half of all NIH funding went to
institutes in just five states, and they happened to all be on
the coasts. I think that when we send all that research in one
or two geographical locations, you have incest, you have a
decreased randomness of thought, and it pickles things up.
The University of Kansas Cancer Center second to none NCI
designated comprehensive cancer center since 2012. The Kansas
State University received NIH funding in 2021 to support it
becoming a national leader in emerging infections.
Children's Mercy Research Institute in Kansas City,
advancing the genomic medicine, developmental behavioral
health, and pediatric brain cancer research. Will you commit to
actually correcting these issues so innovative research in the
Midwest are equally prioritized?
Dr. Bertagnolli. Thank you, Senator. And not only will I
commit, I can give you an example of where my past work has
really already tried to achieve this.
When I ran a cancer clinical trials group, one of my main
goals was to make sure those trials reached as many communities
as we possibly could, and we partnered with a wonderful
physician practice in Laredo, Texas, serving the border
community, a wonderful physician who served the Oglala Sioux
community at Pine Ridge Indian Reservation, and a wonderful
oncologist in my own hometown of Rock Springs, Wyoming.
I agree with you completely, NIH research has to reach
everywhere, and there are many, many centers of great
excellence that we should have the ability to engage.
Senator Marshall. Okay. Well, my next question is a lot
tougher one. And Dr. Bertagnolli, you and I both protect a very
honored profession.
When I think about the horrors of medicine, the great
horrors of medicine, the things we got wrong, think of
bloodletting, I am afraid that 100 or 200 years from now, those
same historians are going to go back and compare irreversible
mutilation of adolescents for transgender surgery,
irreversible, emphasizing, and giving them irreversible
medication is going to be one of those two horrors that they
are going to be talking about.
They are going to be talking about bloodletting and the
horrification of disfiguring surgery for people that 80 percent
of them just in a couple more years, once they have some
hormones of their own, are going to say maybe that wasn't a
good idea. And before you answer this question, I want you to
think about the oath that you and I took. And it is way over
quoted, but it is above all, do no harm.
Above all, do no harm. So here is my question, should
taxpayers fund gender reassignment experiments or research that
are purely cosmetic, where you destroy healthy tissue and
organs, or when they use FDA approved products off label with
significant negative, irreversible impacts?
Again, this off-label use isn't treating diseases or
illnesses. Should taxpayer funds be used to do research or fund
these irreversible, horrifying, irreversible procedures and the
use of these hormones off-label?
Dr. Bertagnolli. Senator, thank you very much, because it
is very clear that you are--share my concern over the well-
being of the LGBTQ community, especially young, vulnerable
people. What I can tell you is that if confirmed, I will commit
to leading NIH to conduct the research that will achieve the
very best health for these vulnerable and special individuals.
Senator Marshall. I am sorry to cut you off, but right
there, do you believe that it is Okay to fund this type of
research where these irreversible procedures are being done? Do
you think there is any experiment that you can think would
justify irreversibly damaging these poor little boys and girls
who are 14, 15 years old? Would you fund that type of research?
Dr. Bertagnolli. Any research that we do, Senator, with
regard to human subjects has to be done in a way that does no
harm and produces the maximum benefit to the people that are
participating in the research. And that will be the principle
with which I approach any research, especially for this
vulnerable population.
Senator Marshall. Thank you. I yield back.
The Chair. Senator Smith.
Senator Smith. Thank you, Chair Sanders, and Ranking Member
Cassidy. And thank you so much, Dr. Bertagnolli, for being
here. It is wonderful to see you again, and I am just delighted
to have the opportunity to support your nomination on this
Committee and also as we move you forward to confirmation.
I would like to actually follow-up on something that
Senator Barrasso started with and focused on, which is your
personal experience in Wyoming, experience in rural America. I
am not going to ask you about the ranch, although I would be
tempted to. But I think it meshes with a very clear policy
interest of mine, which is around our rural health and a focus
on rural health.
We know that in health care settings across the country
there is a real shortage of health care workers and that this
effect is really felt particularly intensely in rural
communities that are struggling to maintain hospitals and
maintain access to care.
Now, we have had some important innovations over the last
several years, I would point specifically to telehealth, as a
way of delivering care, but could you please just talk with us
a bit about, as you think about your own personal experience in
rural communities, how can the NIH ensure access to the most
advanced medical research and other treatments, regardless of
and especially if you live in small towns and rural places in
this country?
Dr. Bertagnolli. Well, thank you so much for that question.
Our job is not done if we just produce an effective treatment
or an effective approach--the job is not nearly done.
Our job is only done when people are living long and
healthy lives free--and so. That means that a critical area of
NIH research needs to be health care delivery research. And I
will just give you a quick personal note. Town where my parents
lived in central Wyoming, no hospital within 100 miles.
Through city, through state, community, Federal, and tribal
participation there is a new hospital being built there, and I
am committed to seeing that new center in that new location be
brought into the research enterprise so that we can understand
how these kinds of Federal, state, tribal partner--community
partnerships can be brought to bear to be able to deliver
better care. Just one example.
Senator Smith. Well, that is great, and you--I appreciate
what you are highlighting, which is the importance of
partnerships, but also the real importance of NIH attention to
training and research opportunities in rural communities,
because I think there is a lot of good data to show that if you
are trained in a rural place, then you are much more likely to
stay in that rural place.
There are good examples, good best practices for how to do
that. And I have to say I share Chair Sanders's concerns
about--our challenge is delivering care in this country. And
so, I think there is lots for us to work on there.
Another area that I want to just touch on before I wrap up
is the importance of focusing on research around mental health
care. This is something that, again, is a very, very important
issue to me. Less than 5 percent of the NIH's health budget
goes to the National Institute of Mental Health.
Less than 5 percent of the overall budget, while one in
five or about 20 percent of Americans are going to experience
some sort of mental health issue every year. So, we know that
mental health and physically--physical health are not like two
completely separate things. That is brain health and the rest
of your body health.
Could you talk a bit about how you view the NIH's role in
focusing on that connection between mental and physical health,
brain health and the rest of your body health? And given this
low percentage of funding, how can the NIH advance research on
mental health?
Dr. Bertagnolli. Oh, thank you. I think, first of all,
mental health affects every single disease we treat.
Senator Smith. Yes.
Dr. Bertagnolli. It affects whether--how someone can manage
their cancer journey. It affects how somebody can--who has got
kidney failure is able to get the needed care. It affects every
single thing we do.
One of the things that I am really excited about, if
confirmed on taking on the role, is to really focus on all of
these interactions between the various institutes where there
are common themes that need to be addressed in--or even in
order to treat these of individual diseases.
Mental health is overarching and really needs to get into
every research institute. That is No. 1. And then No. 2, that
will also help us best leverage the funding that goes into the
Mental Health Institute, being able to pull on that for--
through the resources throughout the entire NIH.
Thank you for your advocacy and raising this really
important issue of raising awareness.
Senator Smith. Thank you. Thank you very much, Mr. Chair.
The Chair. Thank you, Senator.
Senator Cassidy.
Senator Cassidy. I defer to Senator Budd.
Senator Budd. Thank you, Ranking Member, Mr. Chairman. Dr.
Bertagnolli, thank you for being here. Congrats on your
nomination. It is a great state you come from.
Research tells us that children in the womb respond to and
that they can feel pain at 12 weeks, and fetal anesthesia is
recommended for surgeries at 13 weeks.
Doctor, before obtaining consent for a fetal tissue
donation, will you commit to requiring NIH contractors and
grantees that they explicitly inform mothers that their child
will feel pain during an abortion by 12 weeks of pregnancy?
Dr. Bertagnolli. Thank you for raising this issue, Senator.
I believe that it--the policies and procedures that govern any
research with fetal tissues really prohibit any discussion
whatsoever with the mother toward even the possible use of such
tissue for research. So, it would not be acceptable for me to
affirm this. That interaction is not allowed to take place.
Senator Budd. Thank you. Chairman, I yield back.
The Chair. Senator Hassan.
Senator Hassan. Thank you, Mr. Chairman. And thanks to you
and Ranking Member Cassidy for this hearing. Dr. Bertagnolli,
it is so good to see you and congratulations on your
nomination.
Thank you for your willingness to serve. I want to follow-
up on a line that you heard from Senator Murray and just now
from Senator Smith. The National Institute on Drug Abuse at the
NIH plays a vital role in responding to emerging trends in
substance use and addiction.
This institute has contributed substantially to our
understanding of medication assisted treatments for opioid use
disorder and help validate the effectiveness and safety of
evidence based medications to treat addiction, such as
buprenorphine. As a result of NIH's leadership, buprenorphine
is now widely accepted as a gold standard of care for
individuals struggling with opioid use.
Last year, I worked with Senator Murkowski to pass into law
the Mainstreaming Addiction Treatment Act, which eliminated an
unnecessary hurdle for providers who are prescribing
buprenorphine and further expanded access to this lifesaving
treatment.
However, despite this push to increase access, research
shows that high levels of stigma and lack of provider education
still stand in the way of individuals receiving medication
assisted treatment. Doctor, can you tell us how you will
develop strategies to eliminate the stigma around medication
assisted treatment?
Dr. Bertagnolli. Oh, thank you for that question. And yes,
I think that the overall issue of substance abuse is, first of
all, it is a tragedy. And second of all, that tragedy is
compounded when on top of it there is also stigma associated
with the disease.
That stigma needs to be combated at every step. I always
fall back to, what is the first and most important
relationship? That is the treating physician and the patient
together. I think trust between those two individuals is
absolutely key trust and support.
But then I also think we can do more to raise community
awareness in every regard. And this is yet another area of what
is the best way, the most respectful way, the most appropriate
way to garner community support for individuals battling
substance abuse.
This is another really important area of research to make
sure that we know how to do it respectfully and well.
Senator Hassan. Well, thank you. Would you commit to
continuing to grow the National Institute on Drug Abuse's work
on treatment for substance use disorders?
Dr. Bertagnolli. I will commit to working with you to fully
pursue work at NIH to end the scourge of substance abuse.
Senator Hassan. Thank you. I want to move to a different
topic. Antibiotic resistance is a serious emerging threat to
global public health. In July, you and I discussed the NIH's
important role in antimicrobial resistance research and
development.
We need to work together to encourage the development of
new medications that are able to treat infections that are
unresponsive to current antibiotics. Doctor, how do you
envision NIH's role in the public, private partnership to
combat antimicrobial resistance?
Dr. Bertagnolli. Certainly, this is a critical issue for
drug development and has--which has been successful in a long
time--to a certain degree in being able to head off the
continual problem of antimicrobial resistance, and I fully
support any research that can help us get to that aim for
people.
I will also add that like virtually everything we do in
medicine, there is also a social and an educational component
to this, right. So, it is not just finding a new drug to beat
the bug. It is making sure that prescribing practices for
antibiotics or use in agriculture, all of these other efforts
that really are--can be--can make the problem worse and
perpetuate the problem also need to be an area of our research
to be able to combat.
Senator Hassan. Well, I thank you for that. Are there other
new strategies that you could be looking at to improve clinical
trials for new antimicrobial medications? Because I understand
the last point you made, but I think we also need to make sure
that we are continuing the research so that we have new classes
of these medications.
Dr. Bertagnolli. Yes, thank you. This is a very important
issue for clinical trials. I will also just take it as a side
to say we have so much work to do in the clinical trials arena.
One of the other commitments I want to make is for clinical
trials, since it has been one of my core expertise, that are
faster, more inclusive, more--and more responsive to the needs
of people. It is one of the major initiatives that I would like
to see happen at NIH.
Senator Hassan. Well, I appreciate that. I just also want
to look forward to working with you. I am interested in
bipartisan approaches to support innovative microbial--
antimicrobial research, including through leveraging the tax
code, and I really look forward to working with you and the
rest of the department to achieve this goal. Thank you, Mr.
Chair.
[Technical problems.]
Senator Cassidy. I defer to Senator Murkowski.
Senator Murkowski. Thank you both to the Chairman and to
the Ranking Member. Doctor, thank you for being here and taking
our questions. I appreciate the response that you have just
provided to Senator Hassan about clinical trials.
I am very invested in and very focused on what is happening
within clinical trials for ALS. I have got a personal
connection. I think so many of us do have a personal connection
and we recognize just really the horrific progression of that.
I will submit to you a pretty specific question about how
we can make ALS clinical trials more efficient, looking for
perhaps alternative sources to better or more precisely measure
ALS progression.
But it is what you have just said about leaning into this
and placing a priority on it is something that I appreciate,
and I look forward to further conversations with you on that.
You have already responded to questions that I had.
Senator Smith asked about rural health. That is obviously
something that coming from Alaska, we would certainly encourage
greater research in rural areas that don't have care delivery
sites.
One of the other issues that I wanted to bring up was what
Senator Murray raised with menopause research. I was able to
meet with some advocates just a few weeks ago. And, it is just
shocking to me to know that one of the life stages in women,
whether you like it or not, is menopause and how little we
actually know about the impacts and many of the treatments for
health--for adverse health conditions that are associated with
menopause in particular. Let me ask my question about
infectious diseases.
We, in Alaska, are plagued and have been for a long period
of time, but it continues throughout our state. We see
preventable chronic infectious diseases, particularly
tuberculosis and hepatitis C.
As of 2021, Alaska had the highest incidence of TB in the
country. Again, we have very rural areas. Hep-C, the rates
there have been increasing statewide now for two decades
despite the availability of the curative treatments. I have
been in small rural airports and run into public health workers
that are there just solely and specifically to monitor what we
are seeing with hepatitis C.
I would ask how the NIH would approach coordinating with
other Federal agencies, whether it is the state, the local, the
tribal Governments to do more with eradicating these chronic
infectious diseases, not only tuberculosis and hep-C, but the
sexually transmitted infections as well.
Because again, this is an area where we see rates that are,
in my view, beyond intolerable. So, whether there are
possibilities for cheap point of care testing for STI. Talk to
me a little bit about what progress we could make or what we
could hope for.
Dr. Bertagnolli. Oh yes, thank you, Senator. I am not an
infectious disease specialist, and I was not previously aware
of these unique features of the citizens of Alaska.
Senator Murkowski. It is rough.
Dr. Bertagnolli. Yes. I can comment briefly, though, and
say that certainly for hepatitis C and tuberculosis, and
perhaps even for sexually transmitted diseases, that the two
keys to managing when it is prevalent within a population are
diagnosis, detection. I mean, hepatitis C can be silent for
decades and people don't realize they have it, so they don't
get the proper treatment.
The same with tuberculosis. Many workplaces institute
routine screening. Certainly, if you work in the hospital, you
get screened every single year, and it is through that
screening--and to identify individuals that need treatment, are
a really important part of control. Instituting the best
approaches for that.
Again, I have to defer to colleagues who are experts in
infection control, but I would be very pleased, if confirmed,
to work with you to address these specific issues for the
people of Alaska.
Senator Murkowski. Well, and we do have some great experts
that are on the ground who are very familiar with this. But it
is the coordination that I am hoping that we will be able to
see between Federal, tribal, state, local. So, thank you very
much. Thank you, Mr. Chairman.
The Chair. Thank you.
Senator Casey.
Senator Casey. Mr. Chairman, thanks very much. Dr.
Bertagnolli, thank you for putting yourself forward for this
position, especially at this time with so many challenges that
we face as a Nation. For more than a decade, I have led the
annual bipartisan appropriations letter advocating for funding
for the National Institutes of Health.
Most recently working with Senator Tillis on a letter that
was joined, we were joined by 56 other United States Senators.
And at the end of that letter this year, we say, and this is
just quote in one part of the letter, ``if we are to continue
grappling with emerging threats, as well as improve the health
of Americans and the quality of their lives, we must continue
to invest in biomedical research that has a potential to save
money, improve lives, and offer an economic return for our
Nation.''
We are proud to be able to do that and we will continue to
advocate for robust funding for the National Institutes of
Health. I don't have to remind anyone the reach and the scope
of the National Institutes of Health.
They literally touch the lives of every American, and we
are at a time where there is both enormous potential for
advancements in health science, but also great, great
challenges such as the risk of disinformation and the decreased
trust in medical experts.
The National Institutes of Health in my home State of
Pennsylvania provides tremendous value despite those challenges
that I mentioned. Pennsylvania researchers successfully compete
for thousands of grants each year, totaling over almost $2.5
billion.
The funding directly supports more than 28,900 jobs in
Pennsylvania and also contributes to a thriving life sciences
sector in the state. So, we have a lot at stake as a
commonwealth, but also for our Country.
I want to commend the work that you have done at the
National Cancer Institute related to pediatric cancers,
diseases which were almost universally fatal decades ago, but
which are now largely survivable thanks to investments in
research.
If confirmed, how will you work to ensure that the NIH is
continuing to invest in children's health and that children are
being appropriately represented in clinical studies?
Dr. Bertagnolli. Yes. Thank you very much for that
question. There has long been, I think you--I can--you
recognize that children have been definitely understudied and
certainly the conditions that affect them have not been--not
received as much attention from the pharmaceutical industry as
some adult diseases.
What can we do at NIH? A couple of things. First of all,
recognizing the importance of developing collaborative
mechanisms that bring pediatric cases together for study and
knowledge. Pediatric--many pediatric cancers are rare diseases,
and one of the great successes that we have had at NCI has been
to bring together a community of patients, researchers, and
caregivers around bringing together data from those taking care
of pediatric cancer cases across the nation.
But it doesn't obviously stop at NCI. Every single disease
center needs to focus on the youngest Americans, making sure
that we address their needs with clinical trials that are
targeting the--targeting the diseases that they suffer from.
Last thing I will say, prevention. Prevention is key.
All of us need to prevent. Prevention has to start when we
are children, right. And so, not only targeting diseases that
kids have, but targeting new strategies to make sure they get
the preventive therapies that can last them a lifetime, I think
are one of the strongest ways we can influence their health
overall.
Senator Casey. Thank you very much, doctor. I wanted to
finally ask you about work that I have done with regard to rare
disease patient groups over the years.
One challenge that has come up repeatedly is the difficulty
in demonstrating that a potential therapy is effective due to
poor natural histories of those--of these rare and ultra-rare
diseases.
Can you talk about the role NIH can play when working with
the FDA to support research into rare diseases that can help
advance our understanding and support the development of safe,
effective therapies?
Dr. Bertagnolli. Yes. Thank you, Senator. I can give you a
very specific example of this one. The NIH Clinical Center is
an absolute treasure.
There is a program at the NIH Clinical Center today that I
can speak to most easily because it has to do with pediatric
cancers, that takes very rare pediatric--people with very rare
pediatric tumors, assemble the team all the way from basic
biology to clinical trials, importantly has--and partners,
public, private partnerships and partners to bring together a
community to be able to treat that disease.
Those individuals all come to the clinical center so that--
throughout the nation. It is incredibly moving when you see
people who have a rare disease or children with a rare disease,
their families there, for the first time meeting another person
who has that really rare disease, it is an incredibly moving
experience, and that community built around that, centered
around our clinical center is making tremendous progress one by
one.
I would like to see that model scaled dramatically.
Senator Casey. Thank you, doctor. Thank you, Mr. Chair.
The Chair. Senator Cassidy.
Senator Cassidy. Hey, Dr. Bertagnolli. I have got lots of
questions, so if I interrupt you--please be tight with your
answers, and if I interrupt you, I will apologize in advance.
You said during your staff interview you support the
reasonable pricing clause included in the recent contract with
BARDA, but you were not familiar with the NIH experience in the
90's. Clinton administration NIH Director Harold Varmus stated,
when rescinding the policy, extensive review indicates that the
pricing clause has driven industry away from potentially
scientific--potentially beneficial scientific collaborations,
and eliminating the clause promotes research that enhances the
health of the American people.
Research America, an alliance of hundreds of organizations
advocating for biomedical research, expresses concerns about
the policies that would ``discourage the uptake of
breakthrough--discourage the uptake of breakthrough discoveries
by the private sector. This would be detrimental to patients.''
Would you apply reasonable pricing clauses to NIH contracts if
confirmed?
Dr. Bertagnolli. Ranking Member Cassidy, my absolute utmost
priority would be securing effective treatments----
Senator Cassidy. That is not my question. My question,
would you apply reasonable contract pricing clauses to NIH
contracts?
Dr. Bertagnolli. I cannot commit to any specific action at
this time.
Senator Cassidy. I am asking you to commit to not an
action.
Dr. Bertagnolli. But I will work with you on this issue
because I share your desire to make sure people have access to
the treatments----
Senator Cassidy. Of course, my concern is, based upon Dr.
Varmus's experience, that if you do institute, you are going to
stop the translation of basic research to taking care of
patients.
This is not something that we need to kind of pussyfoot
around. History tells us that if you do it, patients are
damaged despite whatever rhetoric would be out there. So, I
hope that you would be more forthright in your kind of
embracing this issue. We have got scientific evidence.
My gosh, if we are doctors, we should actually look at the
evidence, not listen to the rhetoric. I say that because I know
that patients are going to be damaged by this and that should
be our highest calling. I don't mean to rag, but I just get
frustrated. Okay. Also, what about march-in rights?
You mentioned that you want to lower cost. People argue for
march-in rights. Your predecessor, Francis Collins,
consistently said during his tenure that the NIH does not have
authority to use march-in rights to lower drug prices. It goes
against congressional intent if you only use it to lower drug
prices. Do you support using march-in rights to ``lower drug
prices''?
Dr. Bertagnolli. Again, Ranking Member, I cannot commit to
any particular policy right now. In my----
Senator Cassidy. No, the law specifically gives you three
ways to use it and one of them does not include lowering drug
prices. I mean, we are just asking you, are you going to follow
the law? That would be the action.
Dr. Bertagnolli. I will follow all the laws of our land,
certainly. And again, my goal will be to make sure that people
get the treatments that they need.
Senator Cassidy. Sounds good. Sounds like--with that
answer, you are answering my previous question that you
wouldn't do the other thing. Let me ask you about another
issue.
Secretary Becerra chose not to continue an NIH ethics
advisory board reviewing extramural fetal tissue research for
appropriateness during the previous Administration. Presumably
a panel like this would help achieve what you tell me your
preference is of ensuring fetal tissue is only used as a last
resort.
I am told there were members of this board who supported
fetal tissue research but still rejected some of the research
projects put forward by NIH for the board's review because of a
lack of informed consent.
Now, you stressed the importance of informed consent in an
earlier answer. These pro-fetal tissue advocates rejected these
proposals because of the lack of informed consent, but
Secretary Becerra has discontinued this board, providing that
safeguard. Do you agree with Secretary Becerra's decision to
not continue this board?
Dr. Bertagnolli. Senator, I do not have enough information
about those specific actions to really comment on Secretary
Becerra's decision. What I can affirm for you is that any
research needs to be conducted according to the most stringent
ethical principles----
Senator Cassidy. I accept that, but this board was making
sure that was the case and it rejected some of those. It was
the mechanism by which you, what you were telling me was
actually executed. The informed consent was not done. If we
stipulate my, as a theoretical, that what I laid out, the facts
are correct, would you support reinstituting the board?
Dr. Bertagnolli. Again, I can't comment on the specifics of
that activity. I can just say that if confirmed, I will uphold
the principles of ethical human research.
Senator Cassidy. It has been 4 years almost since the
COVID-19 pandemic began. We still actually don't know where the
virus originated. Many studies and reports have explored
plausible alternatives.
Experts agree that further research is needed. Do you
believe the Federal Government should do everything it can to
determine the cause of COVID-19, including the possibility it
emerged from a lab that was conducting gain of function
research?
Dr. Bertagnolli. Ranking Member Cassidy, I think no one
wants to know what the true origin of the last COVID pandemic
was more than the biomedical research community----
Senator Cassidy. How will you accomplish that?
Dr. Bertagnolli. To the fullest extent of our ability to
gather the data, and have access to the data, and make a
valid----
Senator Cassidy. Making it public?
Dr. Bertagnolli. Make data that we have available public
and accountable to the American people, yes.
Senator Cassidy. Okay. I yield.
The Chair. Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chair. Dr. Bertagnolli,
welcome to the HELP Committee, and congratulations on your
nomination. A number of us on the HELP Committee are also on
the Appropriations Committee and I want to address the budget
for the Fiscal Year 2024.
Despite the challenges that we had faced in writing a Labor
HHS appropriations bill because it included the availability of
less funding overall than we had in Fiscal Year 2023, our
bipartisan Fiscal Year 2024 bill builds on our long standing
commitment to NIH and biomedical research in general.
We secured critical increases in our bill for some of the
agency's most important programs, $100 million increase for
mental health research, $100 million increase for Alzheimer's
disease research, $60 million increase for cancer research, and
$12 million for a new palliative care research program.
As a cancer researcher, I wonder if you can describe how
the recent investments in NIH, and specifically in cancer
research, have advanced care for patients and improved
outcomes.
But I also want to have--challenge you to talk about the
impact that the House passed--I am sorry, not the House passed,
the House bill that is pending that has drastic cuts in
biomedical research, how you would tackle that if that became
law.
Dr. Bertagnolli. Thank you, Senator. First, let me say that
I speak for everyone at NIH to say that we are deeply grateful
for what we receive from the Federal Government in order to
conduct our research.
No. 2, let me speak as a physician to say that over my 30
plus years of being a physician, I have seen the tremendous
advances that have been made as a result of NIH funding. I am
not going to take down the clock in the many advances that have
happened just in the last year. Just let me assure you that
people are living better, longer as a result of NIH research.
I think that you are also asking to address how changes in
funding will impact what we do. I will just say that every
penny we get, we will use to the fullest extent possible to
secure health for the American people.
We will focus on the issues that Congress brings to us as
important, and I really embrace working with you on those key
issues. And then finally, if our budget--there is a chance that
our budget will force us to leave opportunities on the table,
because the opportunities are enormous. And I will just leave
it there.
Senator Baldwin. Okay. There have been two biosafety
incidents involving the H5N1 virus at the University of
Wisconsin, Madison.
In both cases, there was a lack of guidance and oversight
from NIH, which I find very, very concerning. As Chair of the
Labor HHS Appropriations Subcommittee, I worked to secure
language and funding focused on this issue in our bipartisan
Fiscal Year 2024 bill.
In addition to directing NIH to articulate the roles and
responsibilities of investigators and in institutions
conducting this research, the Fiscal Year 2024 bill would
establish for the first time an office at NIH to serve as a
resource and to provide tools and guidance to the research
community.
Dr. Bertagnolli, what steps would you take to enhance the
oversight of NIH funding research involving potential pandemic
pathogens?
Dr. Bertagnolli. Thank you very much for your advocacy for
this very, very important issue. Potential pandemic pathogen
research stands to achieve great benefit for people by allowing
us to respond immediately and save lives, but it also has risk.
I can commit to you, if confirmed as NIH Director, that I
will fulfill the highest possible oversight for programs that
engage in this kind of research--review and oversight to make
sure that they are conducted safely and achieve the benefit we
know, we can see for the American people.
Senator Baldwin. Thank you, Mr. Chair.
The Chair. Senator Markey.
Senator Markey. Thank you, Mr. Chairman, very much. Let me
just begin by saying that LGBTQ people are living in a national
state of emergency. More than one in two transgender and non-
binary youth have seriously considered attempting suicide.
When elected officials use their bully pulpit to target
gender affirming care or create barriers to evidence based
lifesaving treatment and fuel the fire of the youth mental
health crisis, this is a driving force in a nationwide campaign
of discrimination, and it is unacceptable to LGBTQ youth, young
people.
Let me just say this very clearly, trans rights are human
rights, and I am never going to stop fighting for essential
research and investments in the care which you need to make
sure that everyone is free to exist as their authentic selves,
and we won't rest until you are free to live openly,
authentically, and safely.
Doctor, thank you for being here today. I have heard from
many people in Massachusetts, including many oncologists, about
your excellent work and your leadership, and it is clear that
you have a commitment to public investment to drive research
that will improve Americans' health, treat illness, and to cure
disease.
Last year, Congress passed my bipartisan Children Media and
Research Advancement Act requiring the National Institutes of
Health to conduct research on technology and media's effects on
infants, children, and adolescents, and provided the NIH with
$15 million to launch this program.
We already know that big tech's exploitation of younger
users is driving a mental health crisis, and this research will
further document the serious harms caused by the online
platforms' insatiable appetite for children and teens' personal
Information.
Doctor, if confirmed, will you commit to prioritizing that
research? We have an epidemic, a mental health epidemic amongst
teens and adolescents in America.
Dr. Bertagnolli. Thank you, Senator Markey. As the parent
of very recently teenagers, I can certainly comment to a great
concern about the amount of time spent in front of computers
and the worry of a parent as to what that really is doing.
I can commit to you that this is a very important issue for
NIH research, understanding what this new technology means for
our young people, really everyone, but certainly more of a
focus on the young.
I also know that this is an issue that is a great concern
for our Surgeon General, and I also looking--look forward to
working with others across HHS on this issue.
Senator Markey. Yes, the Surgeon General has identified the
problem. Senator Cassidy and I already have, coming out of the
Commerce Committee successfully, an upgrade of the protections
for kids online up to age 17, and we are hoping to move that on
the Senate floor.
But we also need the documentation from NIH as to the
underlying pathology which is being created as we sit here
right now. Since the passage of the National Alzheimer's Plan
Act and Alzheimer's Accountability and Investment Act that
Senator Collins and Senator Warren--Warner and I have worked
on, NIH research has contributed to significant advancements to
understand and treat Alzheimer's, yet we have a ways to go.
We are just beginning to understand the impact of air
pollution and environmental justice on the brain. Black, brown,
disabled, and rural Americans face discrimination and other
barriers to access to treatment, including expensive treatments
or long travel times to care.
Family caregivers still struggle every day with providing
care to their loved ones with Alzheimer's. Doctor, can you just
tell us how you view the NIH's role in continuing to lead
Alzheimer's research in new directions, center equity, and
access and support to family caregivers who are so often at the
frontlines of providing care.
Dr. Bertagnolli. Thank you so much, Senator, for that
question. It raises many issues that I will just go back to
maybe my core approach to things such as this.
First, understanding the biology of what has produced this
condition. And that means going all the way back, maybe even
into very early years of life, so that we can think about
prevention rather than treatment. That is really critical and
encompassing a very broad population of people to inform that.
Next, though, dealing with what we have today, people who
are really suffering families for which this is a tremendous
burden and having difficulties. Developing new treatments that
can work now for people suffering from the disease.
As you have already said, it is part of NIH to think about
care delivery, and that means delivering for the caregivers,
taking care of the caregivers, because they are a really
important part of what helps us achieve health.
Senator Markey. Thank you. And again, our goal is to
continue to increase funding for NIH. Research is medicine's
field of dreams from which we harvest the findings that will
give hope to families, that we can find a cure for Alzheimer's.
And NIH is really the National Institutes of Hope for all those
Alzheimer's families. Thank you. Thank you, Mr. Chairman.
The Chair. Senator Braun.
Senator Braun. Thank you, Mr. Chairman. Last week, the
House Oversight Committee subpoenaed Acting NIH Director Tabak
for documents relating to the investigation of Dr. Moran.
Dr. Moran is a top adviser to Dr. Fauci who is accused of
using a personal email to avoid public accountability, and
according to him, delete anything he did not want to see in The
New York Times regarding the origins of COVID.
The Subcommittee released emails allegedly from Moran's and
requested information in June and again in September. If
confirmed, will you comply with any subpoenas the House sends
to you relating to the origins of COVID-19?
Dr. Bertagnolli. Oh, thank you, Senator Braun. And I just
can reassure you that I take Congress's responsibility for
oversight for the NIH, and if confirmed, my responsibility as
Director of the NIH to be compliant with policies regarding
that oversight extremely seriously. I can confirm that if I
assume the position, to be accountable and transparent, and to
work with you to resolve these important issues.
Senator Braun. Have you ever spoken to Dr. Moran about the
COVID-19 pandemic?
Dr. Bertagnolli. No, Senator. I don't know Dr. Moran.
Senator Braun. Will you commit to not use a personal email
for official NIH business, or to try to shield conversations
from the American public?
Dr. Bertagnolli. Yes, Senator. Absolutely.
Senator Braun. Also, I would like to comment before I got
one more question for you. Senator Hawley and I actually passed
legislation asking the White House to release all the material
they hold in classification on the origins of COVID-19. There
is a law out there, and they have not complied with that.
We are still trying to get them to comply with that law.
And remember, you are working for that Administration. So, this
one is a question in terms of any relationship you have got
with big pharma.
I think you have received millions of dollars from big
pharma to support your research, and you sat on the board of
several companies receiving stock options and bonuses. Our
Country relies on its public officials to have their best
interests in mind when performing their duties as public
servants.
How can the American people be sure that as NIH Director
you would be focused on the job at hand rather than boosting
the business of any past associates in the pharmaceutical
industry?
Dr. Bertagnolli. Thank you for that question. I just want
to confirm for the record that the funding that I received from
pharmaceutical companies was to conduct research. That none of
that formed my own personal salary.
The only salary I received during that work was from
Brigham and Women's Hospital, a salary set based on my academic
rank. I have one instance of receiving a payment directly from
a pharmaceutical company. It was for service on the board of
directors of a single pharmaceutical company.
But finally, the more important question. I completely
agree with the need to have one goal, one constituency that I
am serving, and that is the health of the American people, and
I will----
Senator Braun. Thank you for that. One quick final question
here. I think you have signed an agreement with Senator Warren
about what you might do after this post.
From the information I have got is that you won't seek
employment or compensation from any pharmaceutical company. Is
that correct? And does that mean then, if you do, you will turn
down those offers?
Dr. Bertagnolli. Well, the agreement with Senator Warren is
designed to assure the American people and to Congress that I
will act with the goal of the very best interests of the
American people, if confirmed for this job.
I have agreed for a time of 4 years after stepping down in
Government that I will not accept employment at a major
pharmaceutical company.
Senator Braun. Thank you very much.
The Chair. Senator Hickenlooper.
Senator Hickenlooper. Thank you, Mr. Chair. And thank you,
Ms. Bertagnolli. Appreciate your service and be willing to step
in at this key time. Emerging Technologies, AI is top of mind.
They are becoming ingrained into various parts of our lives.
Health care is absolutely no exception.
AI is primed to assist with trial design, real time
monitoring, predictive analysis, go down all the different
aspects of clinical trials which are so expensive. I think we
all have agreed, over a long period of time, that the cost is a
barrier to progress.
Dr. Bertagnolli, do you think that the advent of AI will
help create efficiencies in our clinical trial systems, and are
there particular pitfalls we should be mindful of when
considering technology in trials?
Dr. Bertagnolli. Yes. Thank you very much for that
question. Machine learning approaches, artificial intelligence
are really wonderful new computational methods that we are all
very, very excited about.
We have long had the scale of data that we just do not
allow us to analyze it properly. However, the more we learn,
the more we use these techniques, the more we realize that they
have to be like any tool used in a very careful and responsible
manner, particularly when it comes to human research.
The short answer is yes, absolutely. This is very exciting,
but with a qualifier that the design, and conduct, and type of
data used to train these models need to be very, very carefully
considered to make sure we are getting the results that really
matter and are meaningful for all people.
Senator Hickenlooper. Any specific pitfalls that you would
want to put on the record?
Dr. Bertagnolli. I think that, I guess the most serious one
that we hear about a lot is an AI method that might be designed
and trained on one particular ethnic group or one particular
category of people who have perhaps more access to treatment
than in other, and then it gets a result that continues to
disadvantage others who need to be included in that kind of
research.
I think that is one really serious one. But there are many.
It is a computational method, after all, and it has to--it has
to be doing what we want it to do.
Senator Hickenlooper. Right. And oftentimes the algorithms
aren't as transparent as some of us might like it.
Dr. Bertagnolli. Exactly. Exactly. Thank you.
Senator Hickenlooper. Harvard and Brigham and Women's
Hospital created the Multi-Regional Clinical Trials Center.
Obviously, you are very familiar with given your time at both
institutions.
The Center's prime focus is improving the safety and
efficacy of global clinical trials. They have trained
representatives literally from dozens of countries, what is
good clinical process and what is good clinical practice. This
leadership, I think, is critically important and often
underestimated the significance of it.
We live in an interconnected, wonderfully diverse world,
but that interconnectedness and diversity does have its own
challenges as well. And I think we should be making sure that
we utilize all available data to inform our research decisions.
What more do you think that NIH could be doing to encourage
the use of safe and rigorous global clinical trials?
Dr. Bertagnolli. Thank you for that question. I actually
have personally conducted global clinical trials in the area of
cancer, and that was done through the use of very careful
protocols that delivered data in very careful formats and that
also monitored sites so that we knew exactly what care was
being delivered as part of the trial that was testing a
treatment.
Those, for things that really matter, that level of quality
is very, very important. I will just add parenthetically,
though, there are other things that we can do in public health
globally that don't necessarily need to fit into that very
tight model, so we should look at everything that we can to
help inform our work.
Senator Hickenlooper. Could not have said that any better
myself. And I think that Dr. Bertagnolli's eagerness and
optimism is a reflection of her Western roots, which I have
great appreciation for. I have other questions, but I will
submit them on written record, and thank once again the witness
for being here, for your commitment to public service, and turn
back to the Chair.
The Chair. Thank you.
Senator Lujan.
Senator Lujan. Thank you, Mr. Chairman, and to our Ranking
Member for this important hearing and this conversation.
Dr. Bertagnolli, it is an honor to be with you today, and I
want to begin by recognizing and thanking you for your help in
providing archived data from the National Cancer Institute
regarding radiation exposure from atmospheric nuclear testing
in Western states, especially as we have an opportunity to
provide more support for these families across the country.
I am very honored to have worked with Senators Hawley and
Senator Crapo with the support of 61 of our colleagues for the
inclusion of these provisions in the National Defense
Authorization Act. Thank you for that as well. Dr. Bertagnolli,
the Institute Development Award, IDeA, with a small e, if you
will.
The program plays a huge role in building capacity in
biomedical research across the entire State of New Mexico. For
example, the New Mexico networks of biomedical research, which
are located on the New Mexico State University campus, provides
a collaborative biomedical research environment for more than
10 other institutions across my state.
Despite the program targeting half of the country, IDeA's
budget is around 0.9 percent of the overall NIH budget. If
Congress were to provide additional funding specifically for
IDeA, how would you, as NIH Director, expand the program?
Dr. Bertagnolli. Well, first of all, thank you, Senator
Lujan. First of all, I would be delighted because as I think
you have already heard in this hearing, I really want to see
NIH research expand to encompass all of our Country, not just a
few advantaged locations.
I would look forward to expanding that program, not only by
partnering with the outstanding academic institutions within
the IDeA states as they grow out their educational and research
outreach programs, but also for programs that we have that are
national infrastructure, such as the National Clinical Trials
Network, and other infrastructure that literally goes down into
individual communities.
It would be very welcome and quickly applied into action.
Senator Lujan. I appreciate that. And on the same note, do
you support increasing IDeA program's state participation
across other major research programs beyond the currently
available mechanisms to programs such as those supporting
biomedical research facilities, instrumentation, and training?
Dr. Bertagnolli. Yes, Senator. I view this as one way we
can engage more of the American people in the research that we
conduct, and I think it would be very positive.
Senator Lujan. I appreciate that. You touched on this with
your previous response around clinical trial diversity, and I
appreciate your commitment to increasing clinical trial
diversity participation.
An opportunity still exists to increase diversity among
research staff that would have implications for diversity in
research participants. A clinical research workforce that
itself is diverse, is better able to prioritize, connect, care
for, and successfully recruit a diverse participant population
in research.
How will you ensure that NIH is granting funding to
clinical trial research staff that reflect the people impacted
by the study's conditions?
Dr. Bertagnolli. Yes. Thank you. This is a priority. It is
a priority. Why? Because we know that, as you have already
alluded to, a diverse research staff, like a diverse care
staff, brings excellence, really brings better outcomes for the
people that we serve.
How are we doing this specifically? Targeting programs to
identify very talented individuals who come from diverse
backgrounds, giving them opportunities to participate, and then
supporting them through educational and other support programs
to make sure that they succeed.
There are numerous efforts like this across all of NIH, and
I would like to see this expanded even more.
Senator Lujan. I appreciate that. And, Mr. Chairman, I have
some other questions I will submit into the record, and I yield
back.
The Chair. Thank you very much.
Senator Cassidy, you wanted a second round?
Senator Cassidy. Yes, please. Dr. Bertagnolli, you had said
that you would maintain the Biden administration's policy for
allowing fetal tissue research, but that it should only be used
as a last resort. How could you ensure that fetal tissue is
only used as a last resort?
Dr. Bertagnolli. Thank you, Senator. Understanding the
great sensitivity of many people and passionate feelings of
many people on the issue of fetal tissue research, I would want
to be very respectful of that.
Again, if confirmed as NIH Director, my job is to serve
everyone, including the communities who care deeply about how
that tissue are used.
Absolutely, I would follow the laws of the land in every
aspect, and I would also follow within the laws of the land,
the dictate is we are trying to achieve maximal good for
people. We are trying to cure major diseases. That is our
highest goal. But we need to do it with respect and obviously
follow the law.
Senator Cassidy. But let me ask, because that slippery
slope, we are doing this for an end and therefore the means are
justified. The specific question was, how would you ensure that
fetal tissue is only used as a last resort?
Dr. Bertagnolli. Thank you. I would follow our principles
of review and oversight over the use of this tissue, which I
understand is very stringent and asks that particular question
as--by the review boards is one aspect of approving its use.
Senator Cassidy. Okay. Now I am going to ask you some
questions related to obesity. My state, unfortunately, is 50th
or 49th in terms of obesity. So, I am told that the amount of
funding directly for obesity--and by the way, we know this, but
just for context, obesity is a major driver of health
disparities, disproportionately affecting the poor, those of
color, but also whites.
It is a major driver of morbidity from heart disease, from
cancer, from COVID-19. We know that. I am told that the funding
at NIH that is specific for obesity is only about $100 and
roughly $1.2 billion a year, about 2.5 percent of the budget.
Again, but a major driver of health disparities, and of
morbidity, and of all the things that you and I know of. So
arguably, funding for obesity has lag--is lagging way behind
funding for other conditions relative to its impact upon
society.
How can we better address this issue? Would you commit to
increasing funding for obesity? How do we better address the
foundation--foundational, translational, and implementation of
research for obesity?
Dr. Bertagnolli. Thank you, Senator. Thank you very much. I
will say that from my current position as the Director of the
National Cancer Institute, obesity and the rising obesity
epidemic is one of the major causes of cancer in the United
States.
We recognize this. And there has been a tremendous amount
of work done by NCI to identify the ideology of this, how
obesity drives cancer, and how that can be overcome. So, I
can't speak to the way the funding has been distributed now,
but I can assure you that this is yet another one of those
topics that does not belong in a silo, for which we have got to
work across all of the institutes that can have a piece of
owning this problem.
Then the last thing I will say, again, stigma, making sure
that people who suffer from this condition are respectfully
included as being part of the solution to the problem.
Senator Cassidy. I accept that. One suggestion, I am told
that nutrition obesity research centers have kind of funding
which is kind of stagnant. And just to increase that funding
would be a place to start.
Again, if we are talking about something which is driving
cancer, heart disease, hip replacement, you name it. I used to
tell my medical students, obesity is here, and it has a hydra
head. We seem like we just focus more on the manifestations
than we do on the creature itself. If we address the creature
itself, we address all these. That seems to have been lost. If
you could address that, that would be great.
Dr. Bertagnolli. If confirmed, I would be really delighted
to work with you on this. I agree that this is a very serious
health problem that takes a multifaceted approach, and I agree
that is something that we need to work on and would love to
work with you on.
Senator Cassidy. Thank you. I yield.
The Chair. See, I knew, Senator Cassidy, that if we waited
long enough, there would be an issue we would agree on, and
obesity certainly is an epidemic. It is impacting diabetes and
a host of other issues, and something this Committee must and
will deal with on this. There is an issue that we didn't touch
upon today.
I have raised my deep concerns that there are many millions
of Americans who cannot afford the outrageous cost of
prescription drugs in this country, and that is something that
the NIH must deal with.
But there is another issue that we didn't talk about, and
that is that we look at the global situation, we look at
developing countries and millions of people throughout the
world who are struggling to feed their families.
What we find is that many of the prescription drugs
consumed are consumed in developed--in the developed world. The
poor people around the world cannot afford the medicines they
need. Medicines, by the way, which may cost a few cents to
produce. And they don't get it, and they die, or they suffer.
The--sorry, all right. Okay. Thanks. Last May, President
Biden announced that the U.S. Government would share some NIH
funded COVID patents with the World Health Organization to
expand access in low and middle income countries.
If confirmed, will you build on this commitment and make
sure that medicines developed with NIH dollars are accessible
and affordable in low and middle income countries? Will you
ensure NIH funded technology is shared with manufacturers in
developing countries so that they can produce the medicines
that people need at a price they can afford?
Dr. Bertagnolli. Senator, I will. I can confirm that I
will. I share your concern. I share your passion for bringing
life giving care to not just the United States, but the world.
And I will work with you on this issue.
The Chair. All right. I would hope that you would
appreciate that in some cases these drugs cost a few pennies to
manufacture and yet they are not getting it to people for whom
it might be life or death. That is something that you will pay
attention to?
Dr. Bertagnolli. I will--confirm that I will be very
delighted to work with you on this issue. It is critically
important.
The Chair. Okay. Well, thank you very much, Dr.
Bertagnolli, for being with us today. That concludes our
hearing. As a reminder, the Committee will have a markup next
Wednesday, the 25th, on this nominee and a few others.
For any Senators who wish to ask additional questions,
questions for the record will be due tomorrow, Thursday, the
19th at 5.00 p.m. The Committee stands adjourned.
------
ADDITIONAL MATERIAL
The Washington Post
our law helps patients get new drugs sooner
By: Birch Bayh and Bob Dole
April 11, 2002
As co-authors of the Bayh-Dole Act of 1980, we must comment on the
March 27 op-ed article by Peter Arno and Michael Davis about this law.
Government alone has never developed the new advances in medicines
and technology that become commercial products. For that, our Country
relies on the private sector. The purpose of our Act was to spur the
interaction between public and private research so that patients would
receive the benefits of innovative science sooner.
For every $1 spent in government research on a project, at least
$10 of industry development will be needed to bring a product to
market. Moreover, the rare government-funded inventions that become
products are typically five to 7 years away from being commercial
products when private industry gets involved. This is because almost
all universities and government labs are conducting early stage
research.
Bayh-Dole did not intend that government set prices on resulting
products. The law makes no reference to a reasonable price that should
be dictated by the government. This omission was intentional; the
primary purpose of the act was to entice the private sector to seek
public-private research collaboration rather than focusing on its own
proprietary research.
The article also mischaracterized the rights retained by the
government under Bayh-Dole. The ability of the government to revoke a
license granted under the act is not contingent on the pricing of a
resulting product or tied to the profitability of a company that has
commercialized a product that results in part from government-funded
research. The law instructs the government to revoke such licenses only
when the private industry collaborator has not successfully
commercialized the invention as a product.
The law we passed is about encouraging a partnership that spurs
advances to help Americans. We are proud to say it's working.
The writers are, respectively, a former Democratic Senator from
Indiana and a former Republican Senator from Kansas.
______
QUESTIONS FOR THE RECORD
Response by Monica Bertagnolli to Questions of Senator Sanders, Senator
Kaine, Senator Hickenlooper, Senator Markey, Senator Casey and, Senator
Lujan
senator sanders
Question 1. In some cases, the National Institutes of Health (NIH)
owns the underlying patents for key drugs, but then gives away
exclusive control over the drug to pharmaceutical companies. For
example, the National Cancer Institute (NCI) is on the verge of giving
an exclusive license to a small biotech linked to a former NCI employee
for a promising cancer treatment that may cost Medicare billions of
dollars, even as NIH invented the treatment, currently manufactures the
treatment, and runs clinical trials. One report called this exchange
``The NIH's `How to Become a Billionaire' Program.''
a. If confirmed, how would you ensure publicly owned inventions
are not given away? Will you commit to only offer exclusive
licenses when they are ``reasonably necessary to provide the
incentive for bringing the invention to practical
application,'' as required under 35 U.S.C. Sec. 209(a)(2)?
Answer 1. I commit to fully complying with all the laws that govern
my role as the NIH Director including the requirements of Section 209
that you point out. I recognize the importance of making certain that
the taxpayer sees a fair return on their investment in the science and
innovation that NIH produces with taxpayer funding. To that end, I
agree that the private sector must not realize unfair profits that are
the result of publicly funded research. I commit to working with you
and the HELP Committee in an effort to execute on these shared goals. I
want to reiterate too that NIH's role isn't just to identify medical
care innovation and understand the best treatment, but to ensure that
we can deliver that care and treatment to all people who need it in a
way that is affordable and accessible.
Question 2. In addition to march-in rights, the NIH has failed to
use other tools that could make medicines affordable. Will you commit
to using ``royalty-free'' rights to introduce additional low-cost
producers, under 35 U.S.C. Sec. 202(c)(4), for medicines developed
with Federal funding?
Answer 2. If confirmed as NIH Director, I will use all the tools at
my disposal to expand access to the treatments and technologies
developed using NIH research to reach the patients that need them
across the United States. To achieve this goal, I would consider the
use of ``royalty-free'' rights as one mechanism to potentially help
lower the cost of medicines.
Question 3. NIH currently does not disclose critical information
the public needs to assess how much drugs cost to develop. Will you
commit to publicly reporting the full, disaggregated costs of taxpayer-
funded clinical trials?
Answer 3. I firmly recognize the importance of transparency,
especially when it comes to taxpayer spending. If confirmed as NIH
Director, I look forward to working with you and the HELP Committee to
identify ways to further increase transparency around taxpayer-funded
clinical trials.
Question 4. The ``Stevens Amendment'' requires recipients of
taxpayer dollars to disclose how much of their own money they are
putting into projects that receive Federal funding. Will you commit to
following the law, so that the public is given timely and useful
information about the respective contributions of the Federal
Government, compared to private partners, for new treatments and cures?
Answer 4. I commit to fully following the law. If confirmed as NIH
Director, I look forward to being a faithful steward of taxpayer
dollars and ensuring that we do the most with every penny we are given.
I firmly believe that transparency and accountability are paramount to
restoring trust and faith in the agency.
Question 5. Over 4,000 clinical trials, including many that are
funded by NIH, violate existing reporting requirements under Federal
law. Will you commit to withholding grant money to responsible parties
who fail to comply with ClinicalTrials.gov reporting requirements?
Answer 5. I commit to fully following the law. If confirmed as NIH
Director, I will work with the NIH team to ensure that NIH takes
appropriate action in situations where grant recipients have failed to
meet reporting requirements.
Question 6. If confirmed, will you support routinely licensing
technologies invented by government scientists and through taxpayer
funds to health and humanitarian organizations like the Medicines
Patent Pool in order to promote access to life-saving medicines in low-
and middle-income countries?
Answer 6. If confirmed as NIH Director, I commit to using all the
tools at my disposal to increase access to technologies and techniques
developed through taxpayer investment to reach as many people in need
as possible, in the United States and with our partners around the
world.
Question 7. In addition to many topics, the National Institutes of
Health (NIH) plays an important role in primary care research.
Currently, the NIH spends approximately $108 million on primary care
research, which accounts for less than 0.2 percent of NIH's overall
funding. When comparing spending to delivery of care, the U.S. spends
5-7 percent on primary care while approximately 50 percent of doctors'
visits are with primary care. This amounts to a disproportionately
small investment in research compared to the amount of care delivered
in the primary care setting.
a. Patient interaction with primary care equates to better
quality and life and better health outcomes. However, without a
single Federal entity charged with coordinating and advancing
primary care research, primary care clinicians must rely on
research from other health care settings, such hospitals, sub-
specialty groups, or single disease states to inform their
thinking around the delivery of care.
b. Dr. Bertagnolli--do you believe that there is a greater role
for the NIH when it comes to coordinating and advancing primary
care research? How as NIH director would you ensure that NIH
can play a role in advancing primary care research?
Answer 7. I agree, primary care is critical to good overall health
and if confirmed, I look forward to working with you on this.
senator kaine
Question 1. Despite progress in recent decades to reduce smoking
rates, the public health impact of the mortality and morbidity
associated with smoking remains staggering. In fact, according to a
recent report from the Centers for Disease Control and Prevention, over
28 million U.S. adults currently smoke. Unfortunately, too many smokers
seek to quit, but are unsuccessful in their quit attempts. Dr.
Bertagnolli, efforts to address the smoking rate in the U.S. cuts
across many Federal agencies. Where do you see NIH's role in reducing
smoking rates?
Answer 1. NIH supports research on tobacco use prevention,
including projects in regulatory science, addiction, tobacco control,
health effects, cancer prevention, and behavioral studies. NIH-
supported research shows that menthol in cigarettes makes it easier to
start smoking by reducing the harshness of tobacco. To help inform the
FDA's tobacco regulatory priorities, NIH and FDA have a unique
interagency partnership called the Tobacco Regulatory Science Program
(TRSP), administered through the NIH Office of Disease Prevention. In
April 2022, TRSP-sponsored research was cited in FDA-proposed rules to
prohibit menthol as a characterizing flavor in cigarettes and ban all
characterizing flavors (other than tobacco) in cigars.
senator hickenlooper
Question 1. The CDC has found that Black women are two to three
times more likely to die from pregnancy-related complications than
white women--with many of these deemed ``preventable.'' The NIH has
significantly prioritized maternal health research, across various
Centers. Dr. Bertagnolli, if confirmed, how will you make sure that the
results of this research are clearly disseminated to providers,
educators, and most of all, patients?
Answer 1. This issue is a top priority for NIH, and would be one of
my priorities if confirmed. NIH has a number of initiatives and
activities dedicated to addressing maternal health. The Implementing a
Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE)
Initiative supports research to reduce preventable causes of maternal
deaths and improve health for women before, during, and after delivery
with a special emphasis on health disparities and populations that are
disproportionately affected, such as racial and ethnic minorities, very
young women and women of advanced maternal age, and people with
disabilities. I want to reiterate too that NIH's role isn't just to
identify medical care innovation and understand the best treatment, but
to contribute to efforts that ensure that we can deliver that care and
treatment to all people who need it in a way that is affordable and
accessible. This is critically important for maternal health care,
especially in communities of color who have been impacted by the
maternal health crisis.
Question 2. Dr. Bertagnolli, what is your philosophy toward
entering into public-private partnerships and, if confirmed, what will
your approach to these partnerships be?
Answer 2. The NIH funds primarily basic, translational, and early
stage clinical research and relies on partnership with private sector
to bring discoveries to market. Public-private partnerships can be an
effective tool for ensuring that the research that NIH conducts is
translated into techniques and treatments that improve the health
outcomes for people across the United States. My experience as
researcher and as Director at the NCI only underscores and validates
this view for me. I look forward to working with you to ensure that
public private partnerships at NIH reflect a balanced partnership
between the private sector and the American people.
Question 3. Valley Fever is an infection caused by a fungus
primarily found in the soil of the semi-arid desert regions of the
southwestern United States, including Colorado. Thanks to climate
change, Valley Fever has been diagnosed in every state. When the soil
is disturbed, the fungus can become airborne and inhaled, ultimately
causing infection.
a. Last year, the World Health Organization released a
troubling report identifying the top fungal priority pathogens
to serve as a guide to research, development, and public
health. Listed among those priority pathogens, were
coccidioides (Valley Fever). Studies have used climate
projections to model Valley Fever's expanding geographical
range. It found that by 2100, the affected areas will more than
double, and the number of people who will become sick will
increase by 50 percent.
b. Given these alarming projections, do you agree that Valley
Fever poses a real threat to human and animal health?
Answer 3. The National Institute of Allergy and Infectious Diseases
(NIAID) is committed to advancing research on Valley fever, including
the development of a safe and effective Valley fever vaccine. The
increasing threat that Valley fever poses to public health underscores
the urgent need for the development of safe and effective medical
countermeasures. If confirmed, I look forward to working with you to
advance this research.
senator markey
Question 1. It is estimated that in 2021 around 2.5 million adults
in the U.S. had an opioid used disorder. Medication-assisted treatment
(MAT) has been proven to be safe and effective in treating opioid use
disorders (OUDs), yet research published in August 2023 in the Journal
of the American Medical Association found that only 1 in 5 adults
received MAT to threat their OUD. Last year, Dr. Nora Volkow, Director
of the National Institute on Drug Abuse, affirmed that American doctors
should ``absolutely'' be allowed to prescribe methadone directly to
patients. Allowing physicians who are board certified in addiction
medicine and addiction psychiatry to prescribe methadone is consistent
with the bipartisan Modernizing Opioid Treatment Access Act.
a. How will you commit to working across agencies to implement
research findings at NIH to improve access to OUD medications
like methadone?
Answer 1. The opioid crisis has been devastating for so many
communities and if confirmed, I look forward to working with you and my
colleagues across the Administration to combat this crisis. I agree,
there is a need to continue to expand access to evidence-based
treatments for opioid use disorder (OUD), and increase access to
naloxone for overdose reversal. With funding from the NIH HEAL
Initiative, NIDA has significantly expanded its support of rapid,
multi-site clinical trials; medication development; implementation
science; and additional priority areas to address the overdose crisis.
Question 2. This summer was the hottest ever recorded; 21 of the 30
hottest days ever recorded occurred in July of this year alone. Climate
change not only wreaks havoc on our physical environment, but on our
individual health and our health systems. Extreme heat is responsible
for almost 235,000 emergency department visits and over 56,000 hospital
admissions, resulting in almost $1 billion in associated health care
costs. How would you lead the NIH in approaching climate change from a
public health perspective from a strategic and funding perspective?
Answer 2. Everyone is affected by the changes we are seeing in the
climate. Climate change is creating new risks to human health, safety,
quality of life, and economic growth. NIH launched the Climate Change
and Health Initiative (CCHI) in December 2021 and expanded the research
portfolio with fiscal year 2023 funds to understand health impacts,
inform intervention science, and ensure health equity to develop the
knowledge communities need to adapt and prevent further health impacts
from climate disasters. The Initiative is funding transdisciplinary
biomedical research and training to build a diverse workforce that can
identify risks, optimize mitigation health benefits, and develop
interventions to reduce or prevent impacts from climate change. This
NIH-wide initiative on Climate and Health is just one way the NIH is
moving toward integrating data on environmental factors more completely
into our studies of many diseases. If confirmed, I look forward to
working with you to address the public health aspects of climate
change.
Question 3. Massachusetts was recently selected to be one of ARPA-
H's two satellite hubs. The Investor Catalyst Hub will allow for
collaboration among researchers, entrepreneurs, and investors to
facilitate innovative health research and expedite breakthroughs in
medical research. How do you plan to leverage NIH's new agency, ARPA-H,
and the innovation hubs to facilitate research into emerging
technologies, including artificial intelligence and machine learning?
Answer 3. ARPA-H was proposed as a new entity in the fiscal year
2022 President's Budget Request and was established in the Consolidated
Appropriations Act, 2022. ARPA-H has a distinct, but complementary
mission to NIH. If confirmed, I look forward to continuing to work
closely with ARPA-H to ensure there is effective coordination on
research as well as leveraging expertise of both organizations.
senator casey
Question 1. The National Institute of Minority Health and Health
Disparities recently designated people with disabilities as a ``health
disparities population.'' This was a highly sought after designation by
the diverse disability communities across the country. The designation
has the potential to address a decades-long wrong of excluding people
with disabilities as a population to be included in health research.
What steps will you take to implement the designation and to ensure
people with disabilities in the research conducted across all NIH
institutes and their activities?
Answer 1. This designation recognizes the importance and need for
research advances to improve our understanding of the complexities
leading to disparate health outcomes and multilevel interventions and
is one of several steps NIH is taking to address health disparities
faced by people with disabilities and ensure their representation in
NIH research. I also want to stress that as a mother of a son with
disabilities, this is an important issue to me on a personal and
professional level and if confirmed, I look forward to working with you
to ensure people with disabilities are included in research conducted
across NIH.
Question 2. I have heard from many patients and families about the
terrible burden of sepsis--children who have died, adults who have lost
limbs, and other serious outcomes. There are common themes to their
stories: misdiagnosis, delayed diagnosis, and racial and age
disparities in outcomes for sepsis patients. How can the NIH contribute
to a better understanding of the causes of sepsis, and further the
timely identification and treatment of sepsis for all sepsis patients?
Answer 3. NIH supports many studies focused on sepsis, some of
which are clinical trials that will evaluate the effectiveness of
potential treatments. Other scientists seek molecular clues in
patients' blood that could diagnose sepsis early or predict who might
be more prone to the condition, allowing doctors to prevent it. Some
try to find ways to estimate when and how a sepsis patient's condition
will decline, or if a certain therapy is appropriate for particular
patients. Still others examine sepsis in specific populations, such as
premature babies; people with known risk factors, such as diabetes,
cancer, or kidney or liver disease; or long-term sepsis survivors. If
confirmed, I look forward to continuing to working with you on this
issue.
Question 3. We know that early screening and detection of cancer is
critical to ensure timely treatment, but many people either aren't
receiving recommended screenings on time, or experience delays between
screening and diagnosis. If you are confirmed, what further actions do
you believe NIH can take to advance our research and practice of early
screening for different types of cancer, and where do you see the
greatest potential for improvement?
Answer 3. This is a critically important issue. As a breast cancer
patient myself, I know that my own hopeful prognosis is directly linked
to the fact that I caught this disease in its early stages. Increasing
uptake of cancer screening is an important priority across the National
Cancer Institute (NCI). NCI supports several key programs,
partnerships, and individual research grants that aim to increase
screening access and uptake. To give one example of many, the
``Accelerating Colorectal Cancer Screening and Follow-up through
Implementation Science (ACCSIS)'' Program is a Cancer Moonshot
Initiative that supports research to improve colorectal cancer
screening, follow-up, and referral for care among populations that have
low colorectal cancer screening rates. NCI is also supporting several
research efforts to reduce barriers and increase uptake of cervical
cancer screening, including in rural areas. Activities to increase
cancer screening in rural regions are also part of NCI-Designated
Cancer Centers' Community Outreach and Engagement efforts. There
continues to be critical work in this field that NIH is well equipped
to lead.
Senator Lujan
Question 1. Minority-Serving Institutes (MSIs) are institutions of
higher education that serve significant percentages of students from
historically underrepresented communities. MSIs are unique in that they
all support the common mission of meeting the needs of the communities
they serve to ensure access and retention among institutions of higher
education.
a. How can the NIH support and leverage MSI strengths and
capabilities to ensure they are able to keep up with other
large research institutions and contribute to the larger
biomedical research enterprise? What would you do as NIH
Director to better support MSIs?
Answer 1. Increasing diversity both in the communities that NIH
serves and in researchers and scientists who make up NIH is a top
priority for me. Throughout my career I have worked with diverse
communities and different types of providers. We know that a diverse
research staff like a diverse care staff brings scientific excellence
and brings better outcomes for the people that we serve.
The Research Centers in Minority Institutions (RCMI) program
develops and strengthens the research infrastructure necessary to
conduct state-of-the-art biomedical research and foster the next
generation of researchers from underrepresented populations. It
provides grants to institutions that award doctoral degrees in the
health professions or health-related sciences and have a historical and
current commitment to serving students from underrepresented
populations. If confirmed, I look forward to working with you to better
support MSIs and other efforts to support underserved communities.
Question 2. Valley Fever is an infection caused by a fungus
primarily found in the soil of the semi-arid desert regions of the
southwestern United States, is endemic in New Mexico, and has been
diagnosed in every state. When the soil is disturbed, the fungus can
become airborne and inhaled, ultimately causing infection.
a. Last year, the World Health Organization released a report
identifying the top fungal priority pathogens to serve as a
guide to research, development, and public health. Listed among
those priority pathogens, were coccidioides (Valley Fever).
b. Given these reports, do you agree that Valley Fever poses a
real threat to human and animal health? Do you commit to
prioritizing research to prevent and treat Valley Fever and
other fungal infections?
Answer 2. The National Institute of Allergy and Infectious Diseases
(NIAID) is committed to advancing research on Valley fever, including
the development of a safe and effective Valley fever vaccine. The
increasing threat that Valley fever poses to public health underscores
the urgent need for the development of safe and effective medical
countermeasures. If confirmed, I look forward to working with you to
advance this research.
Question 3. In the past decade, we have seen a growing body of
research pointing to promising implications for the use of psilocybin-
assisted therapy in the treatment of mental health. When it comes to
improving and expanding access to mental health treatment, I am in
favor of thinking creatively.
a. How can NIH expand the resources available for research
focusing on psilocybin-assisted therapy, and would you be
supportive of such measures as director?
Answer 3. I enjoyed the opportunity to talk with you about this
issue during our meeting this summer. Natural therapies such as
psilocybin offer a new and interesting avenue for research. We can and
we must do more to address mental health issues and trauma in
Americans, and that includes research into new treatments.
Some types of psychedelic drugs, such as psilocybin, have shown
promise as therapies for treatment-resistant depression and post-
traumatic stress disorder. Important research questions remain, and the
NOH funds more than 70 currently active projects on the therapeutic use
of psychedelics. If confirmed, I look forward to working with you on
this issue.
Question 4. Diet-related diseases including obesity, diabetes, high
blood pressure, heart disease, and stroke disproportionately impact our
Native communities.
a. As Director, how will you advance NIH's research investments
in nutrition security, diet-related diseases, and diet-related
health disparities in the U.S.?
Answer 4. This is a critical issue and if confirmed, I look forward
to working with you to address diet-related diseases, as well as other
areas where Native communities are facing disparate impacts. Health
conditions linked to poor diet constitute the most frequent and
preventable causes of death in the U.S. and are major drivers of health
care costs. The Office of Nutrition Research (ONR) lead NIH-wide
coordination and development of new collaborations focused on nutrition
research within and outside NIH. ONR's Food Is Medicine Initiative
includes support for nutrition science research addressing medically
tailored meals and groceries, produce prescriptions, nutritious food
referrals, culinary medicine programs, and teaching kitchens.
I will also add that from my current position as the director of
the National Cancer Institute, the rising obesity epidemic is one of
the major causes of cancer in the United States. We recognize this, and
there's been a tremendous amount of work done by NCI to identify the
ideology of this--how obesity drives cancer and how that can be
overcome.
Question 5. The topic of diet and its impact on our health does not
belong in a silo and is one in which we must work across all of the
institutes.
a. In 2015, the NIH announced plans to end chimpanzee research
and retire all government-owned chimpanzees in laboratories to
sanctuary following an Institute of Medicine report that
determined that chimpanzees are unnecessary for most biomedical
and behavioral research. As you may know, there are still 28
chimpanzees stuck at the Alamogordo Research Facility in New
Mexico after the NIH reversed its decision and announced in
2019 that it will not be retiring government-owned chimpanzees
to sanctuary.
b. What is your plan as Director to carry out the promise made
by the NIH to retire all chimpanzees to sanctuary as the CHIMP
Act (passed by Congress in 2000 and reauthorized in 2013)
requires by law?
Answer 5. I appreciated the chance to learn about this issue during
our conversation this summer and I am committed to carrying out the
goals of the CHIMP Act to ensure that these chimpanzees get the
sanctuary and care they deserve.
______
Response by Monica Bertagnolli to Questions of Senator Cassidy, Senator
Paul, Senator Collins, Senator Murkowski, Senator Braun, Senator
Marshall, Senator Tuberville, Mullin and, Senator Budd
senator cassidy
Leadership and Vision
Question 1. During your nomination hearing, I asked you about your
ability to lead NIH through its next phase. This will require effective
leadership that can make policy decisions and stand up for the best
interests of the agency and the patients NIH research serves.
a. What role does the NIH Director have in making policy
decisions for the agency?
b. If confirmed, how will you make policy decisions for the
agency?
c. Will you defer to the White House and other political
appointees at the Department of Health and Human Services?
Answer 1. The NIH Director is responsible for ensuring that the
overall NIH community never loses sight of the core principles that
guide the NIH's mission: to seek fundamental knowledge about the nature
and behavior of living systems and the application of that knowledge to
enhance health, lengthen life, and reduce illness of people across the
United States. If confirmed as NIH Director, I will always make
decisions, with full fidelity to the laws passed by Congress and signed
by the President, that serve to further this mission.
Question 2. If confirmed, what will your top priorities be as NIH
director?
Answer 2. If confirmed to serve as NIH director, my top priorities
include:
Ensuring that NIH supports research that is equitable
and accessible to all populations--that includes dramatically
increasing clinical trials that reflect the diversity of
Americans because we know that's what yields the best
scientific results. This is critical to capitalizing on new
innovations in uncovering fundamental biology, in health
information technology, and in exciting new data analytics. And
we must interrogate the broad range of behavioral and social
science challenges we face today while laying the foundation to
study and address new issues that will arise in the future.
Embracing and increasing access to innovation. As a
physician-researcher for more than 30 years, I have seen the
transformative power of NIH research to produce results that
save lives, but I've also seen the patients whose prospects
were compromised by preventable factors. We should be able to
guarantee that the American people are getting a return on
their investment by ensuring that healthcare innovations are
available and affordable for everyone.
Restoring faith and trust in our Nation's top
scientists and scientific integrity. I am committed to ensuring
that NIH continue to be the stewards of our Nation's medical
research and a force of innovation and discovery. We must also
continue to support education in all fields of biomedical
research and to inspire young people to become doctors and
scientists, so that our critically important work will continue
for generations.
Question 3. What specific actions will you take in your first few
months as director to achieve each of these priorities?
Response: If confirmed as NIH Director, I would take the following
actions to address each priority:
Ensuring that NIH-supported research is equitable and
accessible to all populations: This goal must be embraced
across all NIH programs. To ensure this, I will first work with
the Director of NIH's National Institute on Minority Health and
Health Disparities to develop and disseminate a set of guiding
principles that all NIH program leaders can adopt to achieve
this goal. This goal and principles for execution will be
addressed in all of my initial planning meetings with NIH
Institute and Center Directors, and I will require each to
provide a plan for how their Institute or Center will make
significant progress to eliminate health inequities. Finally,
if confirmed as NIH Director, I will monitor progress toward
this critical goal throughout my entire tenure and hold all
leaders accountable for progress.
Embracing and increasing access to innovation: If
confirmed, I will lead with the mandate that every effort
undertaken by NIH must be viewed through the lens of ``how does
this directly and significantly improve the health of our
Nation?''. This means that, beginning with the initial planning
phases, I will require that every major project consider and
account for how, if successful, its products and services will
be effectively adopted by the Nation's biomedical research and
health care delivery communities to serve all who can benefit.
Restoring faith and trust in our Nation's top
scientists: The NIH Director has a powerful position as the
leader of the world's largest biomedical research institute. It
is critical that the Director use this position to engender
trust by ensuring that all funds received from the American
people are responsibly managed to provide clear and tangible
benefits to our citizens, that all NIH activities are conducted
according to the highest possible ethical standards, and that
NIH work is executed in a transparent and accountable manner.
If confirmed, one of my first actions will be to broadly
communicate NIH's commitment and my personal commitment to
these principles. In addition, I consider our front-line health
care providers and educators to be key partners in restoring
people's trust in science. If confirmed, I will develop a
program to engage and support these partners so that they are
able to communicate the value of biomedical research widely and
effectively.
Question 4. Based on your time at NCI and your career as an
investigator, do you see any specific opportunities for improvement
within NIH or areas in need of reform? If so, please explain in detail.
Answer 4. There are always opportunities for reform and improvement
and, if confirmed as NIH Director, I look forward to helping lead NIH
during this next phase. I believe we need a major focus on our clinical
trial operations so that clinical trials can be better, faster, and
more inclusive of the population which we serve.
We also need to pay attention to our data collection and use
throughout all of NIH and do an assessment of who we are reaching to
understand how we can continually track and monitor progress to address
disparities.
In addition, I want to carefully revisit the distribution of
funding to institutions and individuals across the U.S. with a focus on
making sure we buildup outreach to Institutional Development Award
(IDeA) states and other research teams that have been historically
under supported by NIH. NIH research has to reach everywhere; and there
are many, many centers of great excellence across the country that we
should engage in order to most effectively advance science.
Question 5. As you know, NIH has a decentralized structure in which
individual institute and center directors retain substantial power.
a. How do you intend to navigate this dynamic as NIH director
and lead the agency as a whole?
Answer 5. I firmly believe collaboration with and between the
individual institutes and centers will be critical. As NIH Director, I
intend to put forward a new initiative on data sharing which will
establish the policies and infrastructures as well as the central
support system to allow institutes and centers to better coordinate and
share data from the broad research community.
I also believe there is an opportunity to reimagine the National
Library of Medicine as a knowledge center for the world. Finally, there
is an opportunity for NIH to lead in developing best practices on how
to leverage artificial intelligence and machine learning. These
activities, alongside many others, will help eliminate silos and ensure
that we are maximizing NIH to its fullest potential.
Question 6. Under current law, NIH is required to maintain a
Scientific Management Review Board (SMRB) to advise on NIH's structure
and operations. However, the SMRB was last chartered in 2011 and has
not been effectively leveraged.
a. Will you commit to reestablishing and fully utilizing the
SMRB?
b. If so, what specific areas related to NIH's structure and
operations would you charge the SMRB with reviewing?
Answer 6. If confirmed, I commit to review the groups that advise
the NIH Director to ensure that we can ensure that NIH's operation and
structure is run effectively with the maximum benefit to the American
people.
Question 7. One of the statutory functions of the NIH director is
to conduct priority-setting reviews and provide direction on institute
and center operations.
a. What steps will you take to carry out these
responsibilities, if confirmed?
b. What criteria will you apply to prioritize institutes and
centers for review?
Answer 7. If confirmed, I commit to ensuring proper stewardship of
taxpayer funds. NIH priority setting principles include funding
meritorious science, portfolio balance, and balancing public health
needs with scientific opportunities. Scientific priority setting at NIH
encourages input from a range of sources, including the research
community; public forums; the Advisory Committee to the NIH Director;
U.S. Congress; Administration objectives; and consultation with
advocacy groups, professional societies, and research participants. The
NIH Director provides overall leadership to the Institutes and Centers
(ICs) and the Office of the Director (OD) offices, especially on
efforts involving several components of the agency. Strategic plans
developed by individual ICs and OD offices, committees composed of
representatives from multiple ICs, and interagency working groups
describe a multitude of scientific priorities and themes of interest to
the agency. If confirmed, my guiding principle will be to conduct all
of these activities in a manner that achieves maximal health benefits
to the American people and the world.
Question 8. You've spoken about your interest in establishing
agency-wide systems to leverage data analytics, artificial
intelligence, and machine learning.
a. How will you balance these goals with protecting the privacy
and security of human subject data and ensuring appropriate
informed consent?
Answer 8. Data science is foundational to NIH's acceleration of
biomedical research. NIH supports innovative technologies and promotes
best practices in data science to streamline data access, facilitate
data management, and enhance data interoperability through the adoption
of data standards, the use of unique persistent identifiers, and common
data elements. NIH supports capabilities to broaden the use of clinical
and healthcare data while preserving participants' anonymity and
enhancing informed consent. New technologies capture and analyze the
rich and abundant data from wearable monitors as an integral component
of telehealth and are collected in the All of Us program and others.
I also want to emphasize the importance of informed consent and
individual participation in the research process as fundamental to our
strategy. In addition, data safety and security of data are critical,
and we must take all required measures to assure this. If confirmed, I
look forward to working with you to ensure that while we enhance our
data science capabilities, that we also protect the privacy and
security of individuals while continuing to collaborate and data-share
to further break down silos at NIH.
Bioethics Issues
Question 9. Do you believe that Congress, or NIH and the scientific
community, should set the policy for whether embryonic stem cells or
fetal tissue are acceptable to use in research?
Answer 9. As NIH Director, I will follow the laws, including with
respect to this type of research.
Question 10. What safeguards would you use to ensure that human
fetal tissue is used as a last resort?
Answer 10. If confirmed, I commit to fully upholding the principles
and established standards of ethical human research. I recognize and
appreciate the great sensitivity and passionate feelings of many people
on the issue of fetal tissue research, and I want to be respectful of
that. As I shared before the Committee, it is my belief that my job is
to serve everyone, including the communities who care deeply about how
fetal tissue is used. As NIH Director, it is my responsibility to
follow the laws of the land in every aspect and ensure that while we
work to achieve the maximal good for people, we do so in a way that
follows our principles of review and oversight of fetal tissue.
Question 11. During your nomination hearing, you said you would
lean upon the principles of ethical human subjects research and
institutional review boards (IRB) to ensure that fetal tissue research
is conducted appropriately. However, as is clear in the findings of
NIH's Human Fetal Tissue Research Ethics Advisory Board in Fiscal Year
2020, even proposals that successfully pass IRB and peer review can
lack sufficient ethical protections, particularly around informed
consent.
a. If you continue to permit the use of fetal tissue in
research, how specifically would you ensure NIH-funded
researchers are doing so in a responsible and consistent
manner?
Answer 11. If confirmed, I commit to prioritizing this issue and as
a first step, reviewing the findings of the NIH's Human Fetal Tissue
Research Ethics Advisory Board in Fiscal Year 2020 as well as providing
review when future fetal tissue research comes before the NIH for
review to assure fidelity to the highest ethical standards.
Question 12. In your role at NCI, is there currently or has there
been past work done with embryonic stem cells?
Answer 12. The NIH Research Online Reporting Tools (RePORT)
includes reporting on NIH-supported research projects by various
research topics and categories. This includes reporting on projects
studying human embryonic stem cells and non-human embryonic stem cells
to advance biomedical research across diseases and conditions,
including cancer. This response addresses NCI-supported research
projects utilizing human embryonic stem cells. In fiscal year 2022, the
last year for which NIH has final data, the Institute supported twenty-
four projects involving human embryonic stem cell research. Projects
were supported based on scientific merit and in accordance with NIH
policies.
Question 13. In your role at NCI, is there currently or has there
been past work done with fetal tissue?
Answer 13. In fiscal year 2022, the institute supported five
projects studying human fetal tissue to advance cancer research.
Projects were supported based on scientific merit and in accordance
with NIH policies.
Question 14. Have you conducted research in your personal capacity
using fetal tissue or embryonic stem cells?
a. If so, please provide the dates such research was conducted
and the outcome of this research.
Answer 14. I have never used embryonic stem cells. I used fetal
tissue once in approximately 1988 under the direction of a senior
scientist when I was a trainee in a research lab in the Department of
Tumor Immunology at the Dana Farber Institute. The research studied how
T cells could be programmed to eliminate tumors. As a first step, we
needed to understand how T cells could be programmed to eliminate
abnormal cells and the only way to do that was to look at T cells of
fetal tissue because these had not yet encountered any type of abnormal
or ``foreign'' cell. The result was that we found no difference in the
way fetal T cells responded to our approaches to eliminate tumors than
in regular adult T cells and, as a result, we did not do any further
research using fetal tissue.
Question 15. If confirmed, will you continue to allow NIH-funded
research to use NIH-approved embryonic stem cell lines? If so, why?
Answer 15. If confirmed as NIH Director, it is my responsibility to
follow the laws and ensure that, as we work to achieve the maximal good
for people, we do so in a way that follows our principles.
Question 16. On August 31, a new stem cell line was submitted for
NIH review. There are already 502 NIH-approved stem cell lines.
a. What is the scientific value of continuing to approve new
lines?
b. At what point do you believe there will be enough stem cell
lines?
c. What steps can NIH take to advance the transition away from
using embryonic stem cells and fetal tissue in biomedical
research?
Answer 16. Newer human embryonic stem cell lines are being derived
under conditions that are better for clinical use, such as reduced
exposure to animal products. Future embryonic stem cell lines may also
have mutations associated with particular diseases and enable research
on those disease mechanisms.
We do not know where the next cure or treatment will come from, and
maximizing access to diverse tools, methods, and experimental systems
is critical for enhancing the likelihood of success in advancing the
NIH mission. I am committed to upholding the highest standards in
research as a responsible steward of public funds.
Question 17. This March, you retweeted a tweet from the official
HHS Twitter account stating that ``transgender health care is health
care. PERIOD.''
a. Do you stand by this tweet?
Answer 17. As shared in my opening statement, I believe we must
provide care for all people, including trans individuals, to ensure
that they can live healthy and productive lives. How to best achieve
these outcomes is a private decision between a doctor and their
patient.
Question 18. If so, please explain. You have suggested that you
would permit NIH to proceed with research on transgender youth, citing
a lack of available science. As you know, I have expressed serious
concerns about an NIH-funded observational study on transgender youth
where two participants died by suicide.
a. How would you ensure that future studies on this issue,
especially involving children, would be safe and live up to
ethical scrutiny?
Answer 18. Like you, I share deep concern over the mental health of
young people, particularly those in the LGBTQ+ community who face
unique challenges. If confirmed, I will ensure that NIH takes seriously
the protection of participants in NIH-funded clinical research while
also better understanding the impact of medical treatment in
transgender youth.
Question 19. While I appreciate that NIH has to date only funded
observational studies related to transgender youth, NIH is responsible
for the health and well-being of all participants in NIH-funded
research. The use of observational studies rather than interventional
studies does not absolve NIH and its investigators of this
responsibility.
a. What specific steps will you take as director to ensure that
participants in taxpayer funded NIH studies, including
observational research, are fully protected in keeping with the
spirit of the Common Rule, not just complying with the letter
of the law?
Answer 19. If confirmed, I will ensure that NIH takes seriously the
protection of participants in NIH-funded clinical research while also
better understanding the impact of medical treatment in transgender
youth. To underscore this, I firmly believe any research that we do
with regard to human subjects has to be done in a way that does no harm
and produces the maximum benefit to the people that are participating
in the research. And that will be the principle with which I approach
any research, especially for this vulnerable population.
Question 20. As a researcher, do you believe that biological sex is
a relevant variable that must be considered in biomedical research?
Answer 20. Consideration of biological sex may be critical to the
interpretation, validation, and generalizability of research findings.
Adequate consideration of all sexes in experiments and disaggregation
of data by sex allows for sex-based comparisons and may inform clinical
interventions. Appropriate analysis and transparent reporting of data
by sex may therefore enhance the rigor and applicability of preclinical
biomedical research. NIH expects that sex as a biological variable will
be factored into research designs, analyses, and reporting in
vertebrate animal and human studies.
Question 21. As the head of NIH, would you maintain the current
policy that requires biological sex be factored into research design,
analysis, and reporting?
Answer 21. Consideration of sex may be critical to the
interpretation, validation, and generalizability of research findings.
Adequate consideration of both sexes in experiments and disaggregation
of data by sex allows for sex-based comparisons and may inform clinical
interventions. Appropriate analysis and transparent reporting of data
by sex may therefore enhance the rigor and applicability of preclinical
biomedical research. NIH expects that sex as a biological variable will
be factored into research designs, analyses, and reporting in
vertebrate animal and human studies.
Question 22. How will you ensure that research is not compromised
as a result of external pressures to regard sex as a social construct
versus a biological variable?
Answer 22. As listed on nih.gov, sex is a biological category based
on reproductive, anatomical, and genetic characteristics, generally
defined as male, female, and intersex. Meanwhile, gender is a social
construct that varies from society to society and can change over time.
As NIH director, I look forward to prioritizing the importance of
studying LGBTQ+ communities, a population that has been historically
understudied.
Other Policy Issues
Question 23. NIH funding for obesity and related research is
significantly low relative to the burden of disease in the United
States. This is particularly concerning, given that obesity strongly
correlates with other diseases and conditions in which NIH invests
billions each year.
a. If confirmed, how will you prioritize obesity, from basic
science to clinical research, across NIH and improve the output
of existing NIH funding for this work?
Answer 23. From my current position as the Director of the National
Cancer Institute (NCI), I recognize that obesity and the rising obesity
epidemic is one of the major causes of cancer in the United States.
There has already been significant work done by NCI to identify the
etiology of this--how obesity drives cancer and how that can be
overcome. Much more needs to be done, however, for cancer as well as
for many other disease states associated with obesity and metabolic
syndrome. If confirmed, I can assure you that this is an area where we
will work across all of the Institutes to address this problem.
Question 24. Your predecessor made a commitment to retire all NIH-
owned and--supported chimpanzees to the Federal sanctuary at Chimp
Haven in Louisiana, as mandated by the CHIMP Act.
a. How do you plan to prioritize the transfer of the remaining
chimps at Alamogordo Primate Facility, as well as other
facilities that still possess NIH-owned or NIH-supported
chimpanzees, to their long overdue retirement at Chimp Haven?
Answer 24. I remain committed to carrying out the goals of the
CHIMP Act to ensure that these chimpanzees get the sanctuary and care
they deserve.
Question 25. How can we support the recruitment and retention of
young investigators?
a. What specific strategies would you consider implementing to
accomplish this goal?
Answer 25. My greatest accomplishment to date has been helping
train the next generation of scientists. These are the physicians,
surgeons, and scientists who are tackling the most ambitious and
complex issues in medicine today. As a clinical researcher, I know what
it takes day-to-day to run laboratories on the cutting edge of science
and as a leader, I've been proud to help harness structural changes at
hospitals and institutions to make sure that we are bringing these
treatments to Americans as effectively and efficiently as possible.
NIH has various programs to enhance support of early career and
postdoctoral researchers. This is a top priority for me, and I look
forward to working with you to further cultivate and support talent
entering the biomedical and behavioral research workforce.
Question 26. How can NIH be more supportive of researchers from
outside the traditional NIH grantee community who want to contribute to
cross-cutting biomedical research?
Answer 26. NIH is committed to funding meritorious research,
regardless of the source of the proposal. If confirmed, I will remain
committed to increasing equity of the research we fund. Notably, NIH
just announced simplified peer review criteria which has the goal of,
among other things, minimizing the effect of reputational bias and
ensuring the best proposals from a scientific perspective rise to the
top.
Question 27. How will you bolster cybersecurity protections across
the agency, particularly related to research participant data?
Answer 27. Data science is foundational to NIH's acceleration of
biomedical research. NIH supports innovative technologies and promotes
best practices in data science to streamline data access, facilitate
data management, and enhance data interoperability through the adoption
of data standards, the use of unique persistent identifiers, and common
data elements. NIH supports capabilities to broaden the use of clinical
and healthcare data while preserving participants' anonymity and
enhancing informed consent. New technologies capture and analyze the
rich and abundant data from wearable monitors as an integral component
of telehealth and are collected in the All of Us program and others. If
confirmed, I will require optimal safety and security procedures for
all sensitive data, and, as this landscape is constantly shifting, I
look forward to working with you to ensure we have the right balance of
data and security.
Question 28. What opportunities do you see to improve NIH's
relationships and collaborations with other agencies?
Answer 28. NIH's collaborative efforts with other HHS agencies as
well as across government are vital to transforming fundamental
scientific and technical information into effective, knowledge-based
approaches that advance the health and safety of the public, such as
disease treatments, preventive interventions, protective health
policies and regulations, and public health campaigns. In turn, the
information provided by other HHS agencies on public health needs
informs the policies and priorities of NIH-funded research. If
confirmed, I look forward to working with my colleagues across HHS and
the U.S. Government to improve the health of the American people.
Question 29. How can NIH help better position the U.S.
internationally, particularly in the context of China and other
countries' biotech ambitions?
Answer 29. As the world grows increasingly connected, NIH remains
committed to developing and sustaining relationships with partners
around the globe. Recent events, including the COVID-19 pandemic, have
illuminated the importance of a coordinated approach to global health
aligned with humanitarian and scientific values. Geographic boundaries
do not prevent infectious disease spread, nor should they prevent the
advancement of research on such diseases. For this reason, NIH
collaborates internationally with foreign governments and
organizations.
The safety, security and health of our people are our highest
concern, and as we work across borders, it is imperative that NIH
uphold the highest standards of oversight and accountability while
continuing to further NIH's leadership as the world's premier medical
research institute.
Question 30. As you likely know, Louisiana is an Institutional
Development (IDeA) Program state, as are many states represented on
HELP. Despite these investments in research capacity building, no
Louisiana institutions rank in the top 50 NIH funding recipients, and
relatively few institutions in the top 50 represent rural or
underserved patients. While you've spoken generally about your
commitment to making sure NIH research reaches more Americans, I would
like more specifics.
a. How specifically will you work to more evenly distribute NIH
extramural research funding across the country?
Answer 30. Growing up on a ranch in Wyoming, I have seen firsthand
what it means to deliver care to those living in rural communities. NIH
can and must support research that is equitable and accessible to all
populations, and this will be a top priority of mine. The Institutional
Development Award (IDeA) has been critical to building research
capacity, supporting competitive basic, clinical, and translational
research, faculty development, and infrastructure improvement, in
states that historically have had low levels of NIH funding. If
confirmed, I look forward to working with you to continue to make sure
all states and communities are participating in the research
enterprise.
Question 31. You've spoken before about your experience growing up
in a rural area.
a. What ideas do you have to improve rural access to clinical
trials?
b. How do you plan to implement these ideas at NIH?
c. What other opportunities do you see to modernize clinical
trials, and how can NIH better coordinate with FDA?
Answer 31. Growing up on a ranch in Wyoming, I've seen how rural
communities and underrepresented groups have too often lacked access to
quality care. When my father had cancer, there was no one within 200
miles who could get him the care he needed. His story is all too
familiar and is the story of millions of Americans who can't access or
afford health care. I've spent my career searching for and implementing
ways to take our discoveries and turn them into better health for
people everywhere. As the leader of a large national clinical trial
collaborative, I have seen firsthand how working with local providers,
including tribal providers, expands access to patients in rural areas.
NIH can and must truly support research at the community level,
research that is inclusive and accessible to all populations regardless
of county or zip code.
Question 32. What steps will you take to improve the rigor and
reproducibility of NIH-funded research?
Answer 32. Two of the cornerstones of science advancement are rigor
in designing and performing scientific research and the ability to
reproduce biomedical research findings. This is a top priority for me
and if confirmed, I look forward to working with you.
Question 33. How can NIH research become more outcomes-driven,
particularly in terms of improving the utility and success of its
clinical research (e.g. having more NIH-funded trials producing well-
powered results)?
Answer 33. NIH is committed to supporting clinical research studies
that are more transparent, efficient, faster, more inclusive, and more
responsive to the needs of people and build trust. At the heart of
every clinical study are the study participants who contribute their
time and energy to help make it a success.
NIH has long recognized that the public is an equal partner in the
research it supports, and it is critical to have meaningfully public
engagement them in the planning, implementation, and dissemination of
research. In addition, NIH is employing new methodologies and study
designs to ensure that clinical trials are well-powered and produce
meaningful results. NIH is committed to enhancing our scientific
research review process to ensure that the highest quality clinical
research is funded. If confirmed as NIH Director, I look forward to
working with the NIH community to uphold these objectives.
Question 34. What role, if any, do you believe NIH has to play in
the drug pricing debate?
Answer 34. The NIH funds primarily basic, translational, and early
stage clinical research and relies on partnership with private sector
to bring discoveries to market. I share concerns about high drug prices
and the burden they place on patients and families, particularly the
uninsured and the underinsured. Patient access to new therapies is
something that NIH should be thinking through, including ways to engage
the community, address broader concerns about price, and ensure good
stewardship of taxpayer dollars. I look forward to working with you to
address this issue if confirmed as the NIH Director.
Question 35. During the hearing you noted that if confirmed as NIH
director you would work to ensure that the ``benefits of our [NIH]
research are affordable and available'' to the American people. Given
that NIH does not have a role in determining access or prices for
agency-funded products, what actions were you referring to by this
comment?
Answer 35. If confirmed, one of my top priorities will be
increasing access to innovation. As a clinician-researcher for more
than 30 years, I have seen the transformative power of experimental
therapy in saving lives, but I've also seen the patients whose cancer
could have been successfully treated but was compromised by preventable
factors--including late diagnosis or inability to access or afford
health care. As we work to bring innovation to patients, we must ensure
transparency and accountability for taxpayer-funded research,
guaranteeing that the American people are getting a return on their
investment with health care innovation that is both accessible and
affordable.
Question 36. Several Members of our conference have expressed
frustration over a lack of transparency from NIH on document request
and other inquiries related to gain-of-function research.
a. What steps do you plan to take to improve the responsiveness
and transparency of NIH to Congress?
Answer 36. I deeply respect the oversight functions of Congress and
its role in improving current policies and programs. I am committed to
ensuring that NIH is appropriately responsive to congressional
oversight requests consistent with the constitutionally mandated
accommodation process.
Question 37. What opportunities do you see for more targeted
research on rare and orphan diseases?
Answer 37. While individual rare diseases are uncommon, they
collectively affect 25-30 million Americans. NIH has several programs
that support rare disease research. The National Center for Advancing
Translational Sciences (NCATS) established the Division of Rare Disease
Research Innovation, which facilitates and coordinates NIH-wide
activities involving research for a broad array of rare diseases. This
division develops and maintains a centralized data base on rare
diseases, coordinates and liaises with organizations worldwide
concerned with rare diseases research and orphan products development,
and advises the Office of the Director on matters related to NIH-
sponsored research involving rare diseases. One example of this
research is Rare Disease Clinical Research Network, which is funded by
NCATS and 9 other Institutes and Centers (ICs). If confirmed as NIH
Director, I intend to continue the important work the agency is doing
to address rare diseases.
Question 38. Several years ago, the NIH launched the NIH Pediatric
Research Consortium to better coordinate pediatric research activities
across multiple Institutes and Centers.
a. If confirmed, will you commit to review the activities of
the consortium and publicly report on its outcomes, as well as
potential process improvements to ensure it is achieving its
stated aims and objectives?
Answer 38. NIH support for pediatric research currently totals more
than $4 billion. The NIH Pediatric Research Consortium (N-PeRC) aims to
harmonize these activities across institutes, explore gaps in the
overall pediatric research portfolio, and share best practices to
advance science. The consortium meets several times a year to discuss
scientific opportunities and potential new areas of collaboration,
including efforts to enhance research training for the next generation
of pediatricians. If confirmed, I would be pleased to work with you to
advance pediatric research at NIH.
Question 39. Currently, policies such as paylines, success rates,
and impact scores used in the review process vary widely across NIH.
a. Should NIH take a more unified approach to funding policies
across its institutes and centers?
b. What steps would you take to make NIH's funding strategy
more transparent for applicants?
Answer 39. Following NIH's rigorous two-stage peer review process,
IC Directors make final funding decisions taking into consideration the
research program priorities of their ICs in the context of the existing
funding portfolio. A one-size-fits-all approach may not be successful
in achieving the goals of each IC. If confirmed, I am committed to
identifying potential areas in which NIH can be more transparent about
its funding process and strategy, while following all applicable laws
and regulations.
Question 40. Do you anticipate that NIH will change any of its
operations or focus areas in response to the creation of ARPA-H?
Answer 40. ARPA-H was proposed as a new entity in the fiscal year
2022 President's Budget Request and was established in the Consolidated
Appropriations Act, 2022. ARPA-H has a distinct, but complementary
mission to NIH. If confirmed, I look forward to continuing to work
closely with ARPA-H to ensure there is effective coordination on
research as well as leveraging expertise of both organizations.
Question 41. How will components of NIH, such as the National
Center for Advancing Translational Sciences and the Common Fund, that
also support high-risk high-reward research, differentiate themselves
from ARPA-H?
Answer 41. ARPA-H has a distinct, but complementary mission to NIH,
including the work of the National Center for Advancing Translations
Sciences and the Common Fund. If confirmed, I look forward to
continuing to work closely with ARPA-H to ensure there is effective
coordination on research as well as leveraging expertise of both
organizations.
Ethics
Question 42. If confirmed, do you commit to providing the
Committee, including minority Members, with information and/or
documents in the requested timeframe?
Answer 42. I deeply respect the oversight function of Congress,
including this Committee, and its role in improving current policies
and programs. I am committed to ensuring that NIH is appropriately
responsive to congressional oversight requests consistent with the law
and the Constitution.
Question 43. If confirmed, do you commit to providing the
Committee, including minority Members, with briefing requests from you
and/or your staff, within the requested timeframe?
Answer 43. I deeply respect the oversight function of Congress,
including this Committee, and its role in improving current policies
and programs. I am committed to ensuring that NIH is appropriately
responsive to congressional oversight requests consistent with the law
and the Constitution.
Question 44. Do you commit to providing the Inspector General and
the Government Accountability Office with any information, briefings,
and documents they may request?
Answer 44. If confirmed as NIH Director, I am committed to working
in good faith with all entities that are responsible for conducting
oversight of NIH, including Congress, the Office of the Inspector
General, and the Government Accountability Office.
Question 45. Do you commit to not seeking a waiver from your ethics
pledge?
Answer 45. As part of the Biden-Harris administration ethics
pledge, I have committed to recusing myself for 2 years from all
particular matters involving specific parties involving my former
employer or former clients. As I do in my current position as NCI
Director, I will also continue to work with the agency's ethics
officials--if confirmed--to identify and resolve any potential
conflicts of interest. Any matters involving specific parties involving
my former employer or former clients will be handled by the appropriate
entities at NIH without my participation. If confirmed, I am committed
to bolstering public trust in government and rendering decisions based
on the best available data and science.
senator paul
Question 1. Congress is running a $1.7 trillion deficit. The
Federal debt is about 100 percent of GDP. To address our fiscal crisis,
I have proposed legislation, the ``five penny plan,'' to apply modest 5
percent spending reductions across the Federal Government. The NIH has
a budget of $44 billion, and this year it received a budget increase of
9 percent. Over its lifetime, the NIH has received average annual
budget increases of 11 percent. The economy is not growing that fast.
Taxpayers' incomes are not growing that fast. Can you commit to
recommending options for reducing NIH spending so that the NIH can do
its part to eliminate the Federal deficit?
Answer 1. NIH investment drives growth of the whole biomedical
research enterprise. Discoveries arising from NIH-funded research
provide a foundation for the U.S. biomedical industry, which
contributes over $69 billion to the U.S. GDP each year and supports
over 7 million jobs. As NIH Director, I commit to always being a
faithful steward of taxpayer dollars, to ensure we use every penny to
its fullest extent, and root out waste, fraud, and abuse to ensure
fidelity to that mission.
Question 2. How will you address redundancies in research topics
across the institutes and centers within the NIH to ensure that
taxpayers receive the maximum benefit for their money?
Answer 2. I take seriously the stewardship of taxpayer dollars,
including minimizing redundancy of research. If confirmed, I will work
with Institute, Center, and Office Directors to consider strategies for
research prioritization and reducing redundancy, potentially through
leveraging novel technology.
Question 3. To compete scientifically with other advanced nations,
we must not allow science to become politicized or dictated by
ideology. We advance scientific knowledge by challenging prevailing
assumptions, yet today it is more difficult to get an NIH grant that
challenges prevailing (and politically correct) assumptions on a range
of issues, including (1) the long-term health effects of puberty
blockers on minors; (2) quality research on whether gender transition
surgery is beneficial or harmful; (3) randomized controlled studies on
the efficacy of face masks to prevent the spread of upper respiratory
viral illnesses such as COVID-19; and (4) randomized controlled trials
to investigate whether repeatedly getting booster vaccinations against
upper respiratory viruses such as COVID-19 are effective or whether
they yield diminishing returns because of immune imprinting and immune
exhaustion. If confirmed, what policies will you put in place at the
NIH to prevent or reduce confirmation bias in decisions about issuing
research grants?
Answer 3. As scientists, eliminating confirmation bias is one of
the most important things we can and must do in our line of work.
Without challenging our preconceived notions, we risk our ability to
innovate and deliver for the American people. If confirmed as NIH
Director, I believe it is imperative that I model a transparent
research atmosphere where colleagues feel comfortable challenging the
status quo and disagreeing with one another. We must not be afraid of
hard conversations. If confirmed, I look forward to working with you to
determine the best policies and practices to deliver on that mission.
Question 4. As a director of a research funding organization, is it
appropriate for the NIH Director or any institute director within the
NIH to advocate for specific public health policies or policies that
may discourage open scientific debate, as scientists are afraid to
contradict those that control their research funding?
Answer 4. This question is paramount to what it means to be a
leader, both at NIH and beyond. It is the responsibility of NIH
leadership across the institutes to help inform and shape the issues
facing Americans health and well-being, while continuing to ensure that
they foster an environment that allows for disagreement and candid
discussion.
Scientists must always encourage open scientific debate and have
the courage to challenge the status quo. As history has taught us,
science is always changing, and we must be ready to reevaluate the
conclusions that came before in light of new evidence. The most
dangerous attitude in science is one that stifles our ability to
question. It is my goal to be a role model in this space.
Question 5. A 2022 Swedish study reviewed ``published data on bone
development in transgender adolescents, focusing in particular on
differences in age and pubertal stage at the start of puberty
suppression, chosen strategy to block puberty progression, duration of
puberty suppression, and the timing of re-evaluation after estradiol or
testosterone administration. Results consistently indicate a negative
impact of long-term puberty suppression on bone mineral density,
especially at the lumbar spine, which is only partially restored after
sex steroid administration. Trans girls are more vulnerable than trans
boys for compromised bone health.'' \1\ Do you believe the long-term
safety of gender affirming therapy in minors, including pharmaceutical
administration, has been established by the FDA?
---------------------------------------------------------------------------
\1\ Ciancia S, Dubois V, Cools M. Impact of gender-affirming
treatment on bone health in transgender and gender diverse youth.
Endocr Connect. 2022 Sep 28;11(11):e220280. doi: 10.1530/EC-22-0280.
PMID: 36048500; PMCID: PMC9578106.
a. If not, should gender affirming therapy in minors be
---------------------------------------------------------------------------
considered experimental and subject to FDA oversight?
b. Do you believe gender affirming therapy should require the
consent of a parent or legal guardian?
Answer 5. As current NCI Director and NIH Director nominee, I can't
speak to FDA's role on this issue. If confirmed as NIH Director, my
role may include providing data on gender affirming therapy and its
impact, but it would not extend to the parental/guardian consent
structure of personal medical decision that exist outside of NIH.
Question 6. Does the NIH fund, request, direct, and/or otherwise
facilitate classified life sciences research?
Answer 6. To my knowledge as NCI Director, NIH does not fund,
request, direct, or otherwise facilitate classified life sciences
research.
Question 7. It is widely accepted that pandemics can come from
nature, from laboratory accidents, or from deliberate releases by
humans. Are you aware of the NIH or any other agency performing a
formal cost-benefit analysis to inform decisions on whether to create
or publicly identify a new potential pandemic pathogen?
Answer 7. As NCI Director, I am not aware of the NIH or any other
agency performing such an analysis.
Question 8. In the past, the NIH has failed to fully comply with
its requirements for oversight of enhanced potential pandemic pathogens
research mandated by the HHS P3CO Framework. If confirmed, how will you
ensure that enhanced potential pandemic pathogens research proposals
are forwarded to HHS for the risk-benefit and risk-mitigation review
mandated by the HHS P3CO Framework, and how will you ensure that
officials who failed to do so under your predecessors are held
accountable?
Answer 8. Potential pandemic pathogen research stands to achieve
great benefit for people by allowing us to respond immediately and save
lives, but it also has risk. If confirmed as NIH Director, I am
committed to adhering to all relevant oversight policies and protocols
for programs that engage in this kind of research, to make sure that
they are conducted safely and achieve the benefit we know we can see
for the American people.
Question 9. Do you believe Federal oversight of synthetic
bioengineering gain-of-function research is adequate? If not, what
reforms would you like to see?
Answer 9. I believe we can and must continually revisit and review
our policies as science advances to ensure that we are identifying
areas for improvement. If confirmed as NIH Director, I look forward to
reviewing our polices and identifying any areas for reform.
Question 10. If Congress finds that the COVID-19 pandemic
originated from a laboratory-acquired infection of a virus that had
been part of gain-of-function experiments, would you support a ban on
viral gain-of-function research funding by the NIH? If not, why not?
Answer 10. I am committed to working with Congress on all efforts
to improve biosecurity policies and to enhance our pandemic
preparedness.
Question 11. HHS initiated debarment of the Wuhan Institute of
Virology from receiving Federal funding for the next 10 years. However,
according to the NIH website, over two dozen other animal labs in
China, including many with ties to the Chinese Communist Party (CCP),
are currently eligible for more taxpayer funding. Additionally,
Government Accountability Office (GAO) audits in March and June 2023
detailed problematic NIH loopholes that exempt labs in China and other
foreign countries from oversight and transparency required of U.S. labs
that receive taxpayer dollars. A recent review of Federal spending
identified millions of U.S. tax dollars still being sent to Chinese
animal labs for virus experiments, including at several labs run by or
tied to the CCP. Do you think the NIH should be sending tax dollars to
labs in China?
a. Do you think it makes sense for the NIH to exempt labs in
China, Russia, and other foreign countries receiving taxpayer
dollars from adhering to the same reporting, oversight and
biosafety rules that govern domestic labs, especially ones
handling dangerous pathogens?
Answer 11. NIH supports research to better understand the
characteristics of animal viruses that have the potential to spill over
to humans and cause widespread disease. We must collaborate with
researchers in other countries where these sorts of viruses are
prevalent because once a virus spreads to humans, it is not contained
by geographical boundaries. The body of research on pathogens and
infectious diseases is what has made it possible for the U.S.
Government to move so quickly to get a COVID-19 vaccine in an
unprecedented timeframe. Countless lives have been saved as a result.
In addition, if confirmed as NIH Director, I will be committed to
upholding all critical policies related to scientific review,
monitoring and accountability, no matter the location of the research.
Question 12. Some of the boards overseeing NIH-funded clinical
trials continue to mandate COVID-19 vaccination even though vaccination
status is not germane to the research being conducted or the data being
analyzed. Do you think it is ethically problematic for boards that are
entrusted with overseeing clinical trials to mandate COVID-19
vaccination during study enrollment even when vaccination status is not
relevant to the integrity of the data?
a. Will you commit to ensuring that NIH funding recipients do
not discriminate against unvaccinated candidates for
participation in clinical trials?
Answer 12. NIH does not have a blanket policy requiring COVID
vaccination for participation in clinical trials, but specific trials
may have additional requirements that are set by the clinical trial
sponsor based on the information that is being gathered for that
particular trial.
Question 13. If confirmed, how will you ensure that congressional
requests for information are answered promptly and in full, and how
will you ensure that officials who failed to do so under your
predecessors are held accountable?
Answer 13. I deeply respect the oversight function of Congress and
its role in improving current policies and programs. I am committed to
ensuring that NIH is appropriately responsive to congressional
oversight requests consistent with constitutionally mandated
accommodation process.
Question 14. Will you publicly commit to releasing all records
requested by Members of Congress?
Answer 14. I deeply respect the oversight function of Congress and
its role in improving current policies and programs. I am committed to
ensuring that NIH is appropriately responsive to congressional
oversight requests consistent with the constitutionally mandated
accommodation process.
Question 15. The next NIH Director will be tasked with leading the
development of the agency-wide strategic plan for fiscal years 2026-
2030. As you know, this is an important responsibility that sets out
agency priorities for the next 5 years. During the previous strategic
planning process, the NIH only gathered stakeholder input on a short,
rough framework of the proposed strategic plan, preventing the public
from providing feedback about specific language or programmatic
details. In addition, it is unclear how that input was considered as
the agency developed its final strategic plan. Given the tremendous
amount of taxpayer money spent to fund the agency's work, the public is
due the opportunity to comment on a full draft plan and transparency on
how that feedback is incorporated into the final strategic plan. To
ensure public accountability, how will you enhance transparency and
opportunities for stakeholder input during the development of the
upcoming NIH Strategic Plan?
Answer 15. NIH is the steward of our Nation's medical and
behavioral research, and I am committed to ensuring that NIH continues
to be a force of innovation and discovery. To do that, we need to
rebuild trust in science and engage with the American people
transparently and consistently in our efforts. I look forward to
engaging with the broadest possible group to bring health solutions to
the American people.
Question 16. Is it reasonable for intramural NIH scientists to
receive patent royalty payments for their taxpayer-funded research
discoveries?
a. If you believe royalties are appropriate to attract top
scientists to the NIH, can you explain how it helps science in
this country if the NIH recruits the top scientists away from
universities and other research institutions around the
country?
Answer 16. The Federal Technology Act of 1986 authorizes government
agencies to license their inventions in exchange for royalties that the
agency can use to fund further research. NIH typically receives annual
minimum royalty payments and a percentage of the sales of the end-
product. The law requires that NIH pay a portion of the royalties it
receives to the inventors according to a statutory formula (15 U.S.C.
3710c) and the remainder to the NIH Institutes where the inventions
were made. NIH-funded universities and research hospitals have similar
programs governed by the Bayh-Dole Act of 1980 (35 U.S.C. 202(c)(7).
Royalties to NIH also pay for the cost of obtaining patents. If
confirmed as NIH director, I would ensure that all NIH policies are
consistent with the law.
Question 17. Many academic scientists receive funding from both the
government and the pharmaceutical industry. Does this funding mechanism
create a potential conflict of interest?
a. Should the NIH try to ensure that there are academic
scientists who are independent of the pharmaceutical industry?
b. How can such scientific independence be accomplished?
Answer 17. NIH requires the disclosure of all sources of research
support, foreign components, and financial conflicts of interest for
senior/key personnel on research applications and awards. NIH uses this
information when making its funding decisions to determine if the
research being proposed is receiving other sources of funding that
could be duplicative, has the necessary time allocation, or if
financial interests may affect objectivity in the conduct of the
research. I am committed to ensuring proper stewardship of taxpayer
dollars.
Question 18. Should the NIH coordinate its research activities with
pharmaceutical companies?
Answer 18. The NIH funds primarily basic, translational, and early
stage clinical research and relies on partnerships with the private
sector to bring discoveries to market. Coordination with private
companies, like those in the pharmaceutical industry, can lead to
accelerated innovation toward techniques and treatments that improve
the health outcomes for people across the United States. I believe,
however, that NIH must always ensure that companies do not unfairly
profit from the investment that taxpayers have made into NIH for the
public good, and that public investment yields public benefits. I look
forward to working with you to ensure that NIH coordination with
private industry remains a balanced partnership between the private
sector and the American people.
Question 19. Documents obtained by the independent watchdog group
OpenTheBooks revealed that between 2009 and 2021, approximately 54,000
royalty payments totaling $325.8 million were paid by third party
entities to NIH researchers credited as co-inventors. However,
important information including the sources of the payments was
redacted by the NIH. To avoid the appearance of conflicts of interest,
will you commit to disclose publicly any royalty payments to NIH
researchers by third parties, including the sources of those payments?
Answer 19. If confirmed, I am committed to transparency, and
ensuring that the NIH provides information to the public consistent
with applicable law.
Question 20. A bill I introduced, the FDA Modernization Act 2.0,
which became law on December 29, 2022, amended the Federal Food, Drug,
and Cosmetic Act to remove an outdated animal testing mandate and give
drug sponsors the freedom to use modern alternatives to animal testing
to assess the safety and effectiveness of new drugs. Unfortunately,
despite the change in law, there have been several recent examples of
expensive testing on dogs and other animals that were commissioned by
the NIH and only canceled and determined to be unnecessary after
criticism from Congress and independent watchdog groups. How would you
improve the current review system to ensure the NIH does not spend
taxpayer dollars wastefully on drug tests on animals that are no longer
required by law?
Answer 20. All animals used in NIH-funded research are protected by
laws, regulations, and policies to ensure the smallest possible number
of subjects and the greatest commitment to their welfare. This includes
ensuring that harm and distress is minimized as much as possible.
Domestic institutions receiving funds from the Public Health Service
(PHS) must conduct research involving live vertebrate animals in
accordance with the PHS Policy on the Humane Care and Use of Laboratory
Animals (PHS Policy). The PHS Policy requires all institutions to
comply, as applicable, with the Animal Welfare Act and other Federal
statutes and regulations relating to animals. Compliance with this
Policy is a collaborative effort between the NIH, scientific
investigators, and research institutions.
The NIH Office of Laboratory Animal Welfare (OLAW) provides
oversight of compliance with the PHS Policy in all NIH-supported
research that involves vertebrate animals. All institutions that
conduct PHS funded research, testing, or training are responsible for
ensuring animal welfare and are obligated to protect the Federal
investment in these activities. OLAW investigates allegations
concerning animal welfare and appropriate animal care in NIH-funded
studies. NIH-funded institutions must report promptly to OLAW any
violation of the PHS Policy. OLAW considers these reports and requires
the institution to make appropriate corrections and to prevent further
violations.
If confirmed as NIH Director, I will work to ensure NIH continues
to comply with all applicable laws and policies and continues to
support the use of alternatives to animal testing, when appropriate.
senator collins
Question 1. The next generation of biomedical scientists are key to
helping us unlock cures for diseases such as Alzheimer's, diabetes, and
cancer. A robust research ecosystem that supports the post-doctoral and
early career workforce is critical and ensures that the NIH retains its
place as the world's leading biomedical research agency. For example,
post-doctoral researchers at MDI Biological Laboratory in Bar Harbor
are studying how diet and nutrition can increase lifespan and protect
against age-related diseases. What are your plans to support post-
doctoral training initiatives across NIH?
Answer 1. My greatest accomplishment to date has been helping train
the next generation of scientists. These are the physicians, surgeons,
and scientists who are tackling the most ambitious and complex issues
in medicine today. As a clinical researcher, I know what it takes day-
to-day to run laboratories on the cutting edge of science and as a
leader, I've been proud to help harness structural changes at hospitals
and institutions to make sure that we are bringing these treatments to
Americans as effectively and efficiently as possible.
NIH has various programs to enhance support of early career and
postdoctoral researchers. This is a top priority for me, and I look
forward to working with you to further cultivate and support talent
entering the biomedical and behavioral research workforce.
Question 2. NIH has a long and venerable history of Institutional
research. What is your vision for the evolving role of intramural
research programs, and what changes in emphasis or operation do you
plan?
Answer 2. NIH's Intramural Research Program conducts distinctive,
high-impact laboratory, clinical, and population-based research,
facilitates new approaches to improve the health though prevention,
diagnosis and treatment, responds to public health emergencies, and
trains the next generation of biomedical researchers. If confirmed, I
look forward to continuing this important work.
Question 3. There is considerable concern about the ever-increasing
cost of biomedical research. Yet the NIH has not followed with an
associated increase in individual extramural research support,
specifically for R01 grants, the staple support for individual academic
research programs. How will you meet this challenge?
Answer 3. NIH understands and is aware of the increasing fiscal
pressures that institutions and scientists face when conducting
biomedical research, including the effects of inflation on the costs to
do research (see for example this recent publication). If confirmed as
NIH Director, I will work closely with you and with IC Directors to
implement approaches that enable us to fund as many scientists as we
can, while also assuring that those scientists who are funded have
enough support to be successful.
senator murkowski
Question 1. One of my priorities in the Senate is trying to find
ways to help end ALS. I have a personal connection to the disease. One
of the problems with clinical trials and ALS is the endpoint, the ALS
FRS score. It is currently the only accepted endpoint in ALS clinical
trials because until now, there really hasn't been any better way
developed to measure progression. However, technology has progressed
and ALS clinical trials are starting to bring promise. I would
appreciate a commitment to working with NINDS to develop and sponsor
programs to measure ALS progression using alternative methods of ALS
progression, to determine if they would provide a better measure of ALS
progression and clinical endpoints. Alternatives could include
progression of movement with muscle accelerometers, progression of
speech with voice recordings, which have been used in several ongoing
natural history studies in the ALS community.
a. If there were more precise measures of ALS progression
within ALS clinical trials, it could bring us closer to finding
a treatment for ALS. The subjective ALS FRS score alone will
not lead us to clinical trial success. Newer technologies will
bring us closer much faster. Can I get your commitment to
working on this issue, and to make ALS clinical trials more
efficient?
Answer 1. ALS is a devastating fatal disease, and it is so
important to be able to accurately track its effects in individual
people, as a critical step in research to combat this disease. We are
seeing some exciting new technology that can help, and I would be
honored to work with you to advance these important clinical trials.
Question 2. Dr. Bertagnolli, having grown up in rural Wyoming, you
have written extensively about disparities in access to clinical trials
for rural populations and have suggested several opportunities for
improvement including by use of tech platforms, information sharing
among academic networks, improved Electronic Health Record
interoperability, and aligning with the close-knit cultural bond of
rural communities.
a. Given your personal experience working with rural
populations, how do you plan to close the gap in research
conducted far from major population centers, especially among
rural AI/N populations? How do you propose to perform research
in rural areas without care delivery sites?
Answer 2. I have seen firsthand what it means to deliver care to
those living in rural communities. NIH strives to make clinical trials
as accessible as possible and has established programs to increase
participation among rural communities. Several NIH programs are seeking
to expand the footprint of clinical trials to more patients including
rural populations through decentralized trial design and remote
monitoring.
To give you a concrete example of my own work, when I ran a cancer
clinical trials group, one of my main goals was to make sure those
trials reached as many communities as we possibly could. And we
partnered with a wonderful physician practice in Laredo, Texas, serving
the border community; a dedicated physician who served the Oglala Sioux
community at Pine Ridge Indian Reservation; and a wonderful oncologist
in my own hometown of Rock Springs, Wyoming. I understand firsthand
that the challenge of bringing both care and research to all
communities is considerable, but it is one that we must overcome.
NIH research must reach everywhere; and there are many, many
centers of great excellence that we should have the ability to engage.
Question 3. The estimated yearly impact of menopause symptoms on
the economy annually is $1.8 billion due to missed workdays, but there
have been few advancements in treatment in the last few decades.
Research in this subject area has been deprioritized since the early
2000's.
a. As NIH Director, would you commit to prioritizing research
on women's health in general, and identifying improved
treatments for the adverse health conditions associated with
menopause in particular?
Answer 3. Multiple NIH Institutes are funding research to advance
the understanding and impact of changes experienced by women during
menopause, providing effective alternatives for the relief of
menopausal symptoms, and examining the ways menopause affects women's
overall health and well-being. If confirmed, I commit to continuing to
this important research.
Question 4. Alaska continues to be plagued by preventable chronic
infectious diseases such as tuberculosis and hepatitis C. As of 2021,
Alaska had the highest incidence of tuberculosis in the country due to
very high rates in rural areas, especially in our Southwest region.
Rates of hepatitis C have been noted to be increasing statewide for two
decades despite the availability of curative treatments. The NIH has
also recently reported promising research around temperature-stable
vaccines for TB.
a. How would the NIH approach coordinating with other Federal
agencies, state, local, and Tribal governments toward the goal
of eradicating chronic infectious diseases such as tuberculosis
and hepatitis C?
b. Under your leadership, would you commit to funding research
for technologies such as temperature stable vaccines for
tuberculosis which could help to address disparities in
infectious disease treatment and prevention for rural
populations?
Answer 4. I would be very pleased, if confirmed, to work with you
to address these specific issues for the people of Alaska. As you
mentioned, an experimental tuberculosis vaccine that can be stored at
room temperature was safe and provoked an immune response in a phase 1
clinical trial. If proven effective in larger trials, the vaccine could
make tuberculosis prevention more accessible to those most at risk.
This is just one example of more approaches to combating infectious
disease in diverse communities. NIH is eager to work with state, local,
and tribal governments to advance this research.
senator mike braun
Question 1. Recently, leaked documents indicated that HHS has
implemented a new mandate requiring all its employees to use a person's
preferred pronouns, even if those pronouns do not align with the
person's biological sex. Alarmingly, the policy does not mention any
first amendment rights against compelled speech or the free exercise of
religion, the Religious Freedom Restoration Act, or any religious
accommodations.
a. Do you support this policy?
Answer 1. I firmly support employee rights and protections related
to gender identity.
Question 2. Will you commit to ensuring that all at NIH are granted
their full first amendment rights by protecting religious
accommodations and free speech?
Answer 2. If confirmed as NIH Director, I am committed to ensuring
that all Constitutional rights, including first amendment rights, are
protected for all NIH employees.
senator marshall
Question 1. We appreciate your statement that you would preserve
the integrity of the Bayh-Dole Act. However, we would like you to
clarify what you mean on preserving the integrity of the Bayh-Dole Act.
Earlier this year, the U.S. Department of Health and Human Services
announced a working group to review its march-in authority, and it
remains unclear the agreement reached by the Biden administration and
HELP Committee Majority in moving this nomination forward. One needs to
look no further to confirm the intent of the Bayh-Dole Act than the
letter of the law and the U.S. Senators that wrote it. In a 2002,
former Senators Birch Bayh and Bob Dole penned an op-ed in response to
misinformation on march-in rights authority and the intent of the Bayh-
Dole Act.
a. If confirmed, will you follow the letter of the law and
precedent set by the Obama, Trump, and Biden administrations,
along with your predecessor Francis Collins, that you do not
have the authority to weaken IP protections by marching-in on a
drug because of its price?
b. Do you acknowledge that the Administration does not have the
legal authority to use march-in rights to lower drug prices?
Answer 1. March-in authority is a powerful tool designed to ensure
that the benefits of the American taxpayer's investment in research and
development are reasonably available to the public. It is my
understanding that there is a whole-of-government effort to develop a
march-in implementation framework that will consider how different
factors, including price, impact these decisions. I look forward to
seeing this framework, and if confirmed, I will follow both the letter
and the spirit of the law.
Question 2. To build capacity in biomedical research across the
entire United States, NIH uses the Institutional Development Award
(IDeA) program, which is vital to Kansas and institutions like the
University of Kansas and its medical center, as well as specific
initiatives like the Centers of Biomedical Research Excellence (COBRE)
and IDeA Networks of Biomedical Research Excellence (INBRE). What do
you see as the most important benefits and successes of the IDeA
program thus far?
a. Despite the program targeting half of the country, IDeA's
budget is only around 0.9 percent of the overall NIH budget. If
Congress were to prioritize more funding specifically for IDeA,
how would you, as NIH Director, look to expand the program?
b. Do you support increasing the IDeA program's participation
beyond the currently available mechanisms, to programs such as
those supporting biomedical research facilities,
instrumentation, and training?
Answer 2. If confirmed as NIH Director, I look forward to expanding
that program not only by partnering with the outstanding academic
institutions within the IDeA states as they grow out their educational
and research outreach programs, but also for programs that we have that
are national infrastructure, such as the National Clinical Trials
Network and other infrastructure that literally goes down into
individual communities. I view increasing the IDeA program's
participation as one way we can engage more of the American people in
the research that we conduct, and I think it would be very positive.
Question 3. First launched in 2015, the All of Us Precision
Medicine Initiative has the potential to transform medicine and health
care by providing an in-depth look at how genes, lifestyles, and
environments impact human health. How will NIH continue to prioritize
precision medicine and engagement with all communities--from urban
centers to rural areas across the country--to advance precision
medicine to enhance patient care among different patient populations?
Answer 3. The All of Us Research Program is an ambitious effort to
gather data over time from 1 million or more people living in the
United States, with the ultimate goal of accelerating research and
improving health. Unlike research studies that are focused on a
specific disease or population, All of Us will serve as a national
research resource to inform thousands of studies, covering a wide
variety of health conditions. Researchers will use data from the
program to learn more about how individual differences in lifestyle,
environment, and biological makeup can influence health and disease. I
fully support this program, and affirm its commitment to delivering
results that benefit all people, in all communities.
senator tuberville
Question 1. The NIH funded a study recently about the ``Psycho-
social Functioning in Transgender Youth After 2 Years of Hormones.''
According to the letter NIH sent to Ranking Member Cassidy and me, the
``research seeks to understand physical and psycho-social effects of
medical intervention to evaluate the effectiveness of existing medical
treatments already in use among transgender youth.'' Two young people
committed suicide who were part of this study.
a. If you are confirmed, how will you make sure nothing like
that happens again on your watch?
b. Has the NIH funded research--through this study, or others--
that might tell us the long-term impacts of puberty blockers,
hormone therapies, surgeries, or other alterations on an
individual's bones or muscles?
c. Specifically, how those interventions might alter an
individual's bones or muscles to make them stronger or weaker?
d. Given the interest in society today around this issue, do
you think that's something the NIH should consider in a future
study--safely, of course?
e. How will you undertake future studies?
Answer 1. Like you, I share deep concern over the mental health of
young people, particularly those in the LGBTQ+ community who face
unique challenges. The study you reference was not funded by NCI. If
confirmed, I will ensure that NIH takes seriously the protection of
participants in NIH-funded clinical research while also better
understanding the impact of medical treatment in transgender youth.
Question 2. The NIH used to be a universally respected non-
political organization before COVID. But that trust has been broken,
especially in rural parts of the country like Alabama. People in these
parts of the country in particular have lost confidence in our public
health institutions. They feel totally overlooked.
a. What would you do as NIH Director to help gain back some of
that trust, especially among rural populations?
Answer 2. NIH is the steward of our Nation's medical and behavioral
research, and I am committed to ensuring that NIH continues to be a
force of innovation and discovery. To do that, we need to rebuild trust
in science and engage with the American people transparently and
consistently in our efforts. No. 1, I believe deeply in the doctor-
patient relationship. A patient comes and puts their life and their
health in the hands of their doctors. Anything that we can do to
strengthen the doctor-patient relationship is something that we should
fully pursue where possible. Second, I believe that patients are valued
and full participants in the research and science. A strong researcher-
patient relationship engenders great trust in the process if it's done
in a respectful and appropriate way.
Question 3. In your past job as a cancer researcher and in your
current job as the head of the National Cancer Institute, you've had
hands-on experience with the kind of groundbreaking drugs and therapies
that have changed the outcomes for so many patients and families. This
Administration has made curing cancer a huge priority, which I support.
They--and our Chairman--also talk a lot about lowering drug prices.
a. In your experience, would these breakthrough therapies and
drugs have ever been possible without substantial research and
investment from pharmaceutical companies?
Answer 3. Industry can play a critical role in helping develop
drugs and their partnership can be paramount in helping drive
innovation. But I believe it is also imperative that NIH-funded
research must be conducted in a manner that ensures a fair return on
the taxpayer investments.
Question 4. Setting aside any speculation about suspected origins
of the COVID virus, I think we can all agree that the NIH has a lot to
do to regain the trust of the public--both in the U.S. and
internationally.
a. As head of the NIH, how would you ensure that taxpayer
dollars don't go toward funding dangerous research--like gain
of function--in countries of concern?
Answer 4. If confirmed as NIH Director, I am committed to adhering
to all relevant oversight policies and protocols for programs that
engage in enhanced potential pandemic pathogen research, to make sure
that they are conducted safely.
Question 5. Do you regret signing a letter in May 2020 urging
governments to implement mask mandates ``in all public places'' and
``public buildings''?
Answer 5. If confirmed as NIH Director, my responsibility would be
to bring forth the data for public health officials and policymakers to
make informed decisions about public health. Having reviewed the data
myself, I appreciate the benefits of masking and slowing the spread of
COVID-19, especially in the early days of the pandemic.
Question 6. The aforementioned May 2020 letter that you signed
states that ``laws appear to be highly effective at increasing
compliance and slowing or stopping the spread of COVID-19.'' Given this
statement, do you support the following mandates imposed by the Biden
administration:
a. The vaccine mandate imposed through the Occupational Safety
and Health Administration, which was blocked by the Supreme
Court in January 2022?
b. The vaccine mandate imposed by the Department of Defense
issued in August 2021, which Congress voted to rescind in the
fiscal year 2023 NDAA?
c. The vaccine mandate imposed by the Center for Medicare and
Medicaid Services issued in November 2021 requirement?
Answer 6. While NIH helps to support research on vaccines,
therapeutics, and diagnostics regarding COVID-19 and other threats, we
do not make the decision on whether to recommend or mandate use of any
vaccine.
Question 7. Please describe your role as Chair of the National
Cancer Institute's Equity Council.
Answer 7. The council is comprised of a diverse group of leaders
from across NCI with a passion and commitment to: ensuring that NCI has
a robust research portfolio to effectively address cancer disparities;
nurturing a workforce at all career levels that is representative of
all the people we serve; and cultivating and ensuring that a community
at NCI that is diverse in thought and representation, including at
leadership levels across the institute. As chair, I am responsible for
helping guide the agenda of the council to best achieve our mission.
Question 8. Please describe any materials that the council has
endorsed related to diversity, equity, and inclusion.
Answer 8. NCI makes information about equity, diversity, and
inclusion available on its website. This includes publicly available
content such as blogs focused on health disparities research, and
presentations focused on equity, inclusion, and diversity from NCI
leadership and program staff, as well as NCI-supported researchers.
Question 9. The NIH has funded a number of troubling projects in
the recent past. Please comment if you think that it is appropriate to
continue to fund this research and if not, how you would ensure it does
not continue:
a. According to media reports, the NIH spent more than $8
million on a research study that pays gay and transgender boys
as young as 13 hundreds of dollars to report their sexual
behavior on a mobile app, all without parental permission. NIH-
funded researchers at Columbia University offer up to $275 to
gay and transgender boys, between the ages of 13 and 18, to
document their sexual activity on MyPEEPS Mobile, including
whether they have ``condomless anal sex.'' \2\
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\2\ https://freebeacon.com/latest-news/taxpayer-funded-study-pays-
gay-minors-to-report-sexual-activity-without-parental-permission/.
b. According to media reports, between 2016 and 2020, NIH
awarded approximately $1.5 million to Pitt for a project
related to the GenitoUrinary Developmental Molecular Anatomy
Project (GUDMAP) program to provide the scientific and medical
community tools to study ``congenital diseases of the
genitourinary tract (kidneys, bladder, ureter, uretha)'' by
obtaining such organs from aborted babies for research. \3\
---------------------------------------------------------------------------
\3\ https://www.foxnews.com/politics/congress-letter-biden-admin-
pittsburgh-fetal-tissue-research.
FOIA documents from NIH indicate that University of
Pittsburg may have been altering abortion procedures solely to
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obtain fetal tissue, which is illegal under 42 USC 289g-1.
The reports show that university researchers may have
caused the death of the children by harvesting organs from
babies who were old enough to live outside the womb.
Answer 9. As the current NCI Director, I am not familiar with the
projects that you listed and cannot speak to their appropriateness.
Question 10. Previously, you sat on the board of Natera, which has
drawn attention from the New York Times for promoting prenatal tests
for various diseases, which apparently have a False Positive Rate of 85
percent or higher. Tragically, these false positives prompt many
parents to abort their unborn child.
a. Were you ever aware of the high false positive rate for
neonatal tests?
b. If so, when were you made aware?
c. Did you ever exercise oversight of the prenatal tests?
Answer 10. The article that I believe you are referring to had this
incorrect test accuracy claim removed. The Natera test is accurate in
>99 percent of cases.
senator mullin
Question 1. If confirmed, would you maintain the current policy of
the NIH that allows taxpayer dollars to fund research on the effects of
gender transition procedures on youth? If so, would you allow NIH to
fund studies on procedures such as sterilizing surgeries, cross-sex
hormones, or puberty blockers in minors?
Answer 1. Transgender children and adolescents are a distinctly
understudied population in the United States. If confirmed, I will
ensure that NIH takes seriously the protection of participants in NIH-
funded clinical research while also better understanding the impact of
medical treatment in transgender youth.
Question 2. The NIH gave almost half a million dollars to fund a
study published in 2023 called ``Psychosocial Functioning in
Transgender Youth after 2 Years of Hormones.'' The study evaluated the
impact of gender transition procedures on youth, and two of the study
participants tragically committed suicide. Do you think it was ethical
for the NIH to fund a study evaluating gender transition procedures
that led to these outcomes?
Answer 2. Transgender children and adolescents are a distinctly
understudied population in the United States. If confirmed, I will
ensure that NIH takes seriously the protection of participants in NIH-
funded clinical research while also better understanding the impact of
medical treatment in transgender youth.
Question 3. If confirmed, would you maintain the Biden
administration's current policy that permits NIH research using fetal
tissues that are derived from abortions?
Answer 3. Fetal tissue research is critical to our understanding of
a variety of diseases. I recognize and appreciate the great sensitivity
and passionate feelings of many people on the issue of fetal tissue
research, and I want to be respectful of that. As I shared before the
Committee, it is my belief that my job is to serve everyone, including
the communities who care deeply about how fetal tissue is used. As NIH
Director, it is my responsibility to follow the laws of the land in
every aspect and ensure that while we work to achieve the maximal good
for people, we do so in a way that follows our principles of review and
oversight of fetal tissue. As NIH Director, I would ensure full
compliance and inclusion of the review boards when considering the use
of fetal tissue.
Question 4. In 42 U.S. Code Sec. 289g-2(a), the law prohibits a
person from knowingly acquiring, receiving, or transferring any human
fetal tissue ``for valuable consideration if the transfer affects
interstate commerce.'' Would you say that it is a violation of the law
for abortion and tissue procurement entities to profit off of the
remains of aborted children?
Answer 4. If confirmed NIH Director, I am committed to following
all applicable laws related to human fetal tissue.
Question 5. Should the NIH be conducting research using the fetal
tissue remains of unborn children who were aborted at 24 weeks
gestation or later?
Answer 5. Fetal tissue research is critical to our understanding of
a variety of diseases. If confirmed, I will ensure we are continuing to
follow existing policies and statutory requirements on fetal tissue
research.
Question 6. What guidelines are in place to ensure that the fetal
tissue from unborn children used in NIH funded research is not coming
from illegal abortions that could occur in pro-life states like
Oklahoma?
Answer 6. Fetal tissue research is critical to our understanding of
a variety of diseases. If confirmed, I will ensure we are continuing to
follow existing policies and statutory requirements on fetal tissue
research.
Question 7. According to the Office of Director congressional
Justification Fiscal Year (FY) 2024, ``NIH has long prioritized
supporting a safe and respectful workplace, free from harassment and
discrimination, wherever NIH-funded research is conducted.'' Over the
past several years, however, there have been concerns raised over NIH's
handling of sexual harassment complaints involving scientists funded
through NIH. In one particularly troubling case involving an NIH-funded
scientist at San Diego Biomedical Research Institute, it appears that
NIH failed to stop ``pass the harasser.'' If confirmed, will you commit
to answer all congressional requests concerning the NIH's handling of
sexual harassment complaints and will you commit to working with
lawmakers to address these concerns?
Answer 7. Over the past several years, NIH has taken many
substantive actions within the scope of NIH's grant authorities to
address harassment and discrimination in NIH extramural biomedical
science, including the development and implementation of policies and
processes. I appreciate Congress' continued interest and support as the
agency works toward ensuring safe and respectful workplaces, free from
harassment and discrimination, wherever NIH-funded research is
conducted. I commit to working with you on this important issue.
senator budd
Question 1. As an oncologist, what opportunities do you see for
more targeted research on rare and orphan diseases including non-cancer
genetic disorders and prion-based illnesses?
Answer 1. At NCI, the Center for Cancer Research (CCR) has a
mandate to confront the special challenges presented by rare cancers
and diseases as well cancers that may be predominant in medically
underserved populations. In many cases, the knowledge CCR's
investigators gain from studying and treating rare cancers and related
diseases provides them with insights into the mechanisms that underlie
other more common malignancies. CCR, working with the NIH Clinical
Center, brings together patients from around the world who share rare
disease diagnoses. If confirmed, I look forward to working with you to
expand this work.
Question 2. How can we best leverage interagency cooperative
efforts, similar to those used in the fight against cancer, against
other rare diseases? Is NIH appropriately structured or are there
institutional hurdles that currently prevent us from maximizing the
return on moneys spent on biomedical research in the United States? And
if so and confirmed, how would work to address these hurdles?
Answer 2. NIH's collaborative efforts with other HHS agencies are
vital to transforming fundamental scientific and technical information
into effective, knowledge-based approaches that advance the health and
safety of the public, such as disease treatments, preventive
interventions, protective health policies and regulations, and public
health campaigns. In turn, the information provided by other HHS
agencies on public health needs informs the policies and priorities of
NIH-funded research. Recent cooperative efforts include ending the
pandemic, tackling health disparities, and strengthening behavioral
health. If confirmed, I look forward to working with my colleagues
across HHS and the U.S. Government to do even more to improve the
health of the American people.
Question 3. If confirmed to serve as the next NIH Director, what
specific actions will you take to continue advancing the science behind
prion-based illnesses such as Creutzfeldt-Jacob Disease (CJD), and
ensure that NIH does not miss opportunities to advance our
understanding of rare diseases that share biochemical pathways with
other diseases? How will you ensure that the patient voice is equally
leveraged across NIH, including with respect to intra and extramural
biomedical, clinical, and translational research for rare diseases? How
do you plan on collaborating with your colleagues across HHS, including
those at FDA, so that the learnings from this NIH work might also be
applied in their endeavors on behalf of patients?
Answer 3. NIH supports dozens of studies on Creutzfeldt-Jakob
disease (CJD) and other prion diseases such as transmissible spongiform
encephalopathy. NIH's collaborative efforts with other HHS agencies as
well as across government are vital to transforming fundamental
scientific and technical information into effective, knowledge-based
approaches that advance the health including rare disease treatments.
If confirmed, I look forward to working with patients and their
families as well my colleagues across HHS and the U.S. Government to
advance scientific understanding to improve the health of the American
people.
______
[Whereupon, at 12:30 p.m., the hearing was adjourned.]
[all]