[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN
SERVICES, EDUCATION, AND RELATED AGENCIES
APPROPRIATIONS FOR 2017
_______________________________________________________________________
HEARINGS
BEFORE A
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
___________________________________
SUBCOMMITTEE ON THE DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES,
EDUCATION, AND RELATED AGENCIES
TOM COLE, Oklahoma, Chairman
MICHAEL K. SIMPSON, Idaho ROSA L. DeLAURO, Connecticut
STEVE WOMACK, Arkansas LUCILLE ROYBAL-ALLARD, California
CHARLES J. FLEISCHMANN, Tennessee BARBARA LEE, California
ANDY HARRIS, Maryland CHAKA FATTAH, Pennsylvania
MARTHA ROBY, Alabama
CHARLES W. DENT, Pennsylvania
E. SCOTT RIGELL, Virginia
NOTE: Under Committee Rules, Mr. Rogers, as Chairman of the Full Committee, and Mrs. Lowey, as Ranking
Minority Member of the Full Committee, are authorized to sit as Members of all Subcommittees.
Susan Ross, John Bartrum, Jennifer Cama,
Justin Gibbons, Kathryn Salmon, and Lori Bias,
Subcommittee Staff
___________________________________
PART 6
Page
National Institutes of Health................................ 1
Department of Education...................................... 167
Centers for Disease Control and Prevention .................. 215
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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Printed for the use of the Committee on Appropriations
___________________________________
U.S. GOVERNMENT PUBLISHING OFFICE
21-343 WASHINGTON: 2016
COMMITTEE ON APPROPRIATIONS
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HAROLD ROGERS, Kentucky, Chairman
RODNEY P. FRELINGHUYSEN, New Jersey NITA M. LOWEY, New York
ROBERT B. ADERHOLT, Alabama MARCY KAPTUR, Ohio
KAY GRANGER, Texas PETER J. VISCLOSKY, Indiana
MICHAEL K. SIMPSON, Idaho JOSE E. SERRANO, New York
JOHN ABNEY CULBERSON, Texas ROSA L. DeLAURO, Connecticut
ANDER CRENSHAW, Florida DAVID E. PRICE, North Carolina
JOHN R. CARTER, Texas LUCILLE ROYBAL-ALLARD, California
KEN CALVERT, California SAM FARR, California
TOM COLE, Oklahoma CHAKA FATTAH, Pennsylvania
MARIO DIAZ-BALART, Florida SANFORD D. BISHOP, Jr., Georgia
CHARLES W. DENT, Pennsylvania BARBARA LEE, California
TOM GRAVES, Georgia MICHAEL M. HONDA, California
KEVIN YODER, Kansas BETTY McCOLLUM, Minnesota
STEVE WOMACK, Arkansas STEVE ISRAEL, New York
JEFF FORTENBERRY, Nebraska TIM RYAN, Ohio
THOMAS J. ROONEY, Florida C. A. DUTCH RUPPERSBERGER, Maryland
CHARLES J. FLEISCHMANN, Tennessee DEBBIE WASSERMAN SCHULTZ, Florida
JAIME HERRERA BEUTLER, Washington HENRY CUELLAR, Texas
DAVID P. JOYCE, Ohio CHELLIE PINGREE, Maine
DAVID G. VALADAO, California MIKE QUIGLEY, Illinois
ANDY HARRIS, Maryland DEREK KILMER, Washington
MARTHA ROBY, Alabama
MARK E. AMODEI, Nevada
CHRIS STEWART, Utah
E. SCOTT RIGELL, Virginia
DAVID W. JOLLY, Florida
DAVID YOUNG, Iowa
EVAN H. JENKINS, West Virginia
STEVEN M. PALAZZO, Mississippi
William E. Smith, Clerk and Staff Director
(ii)
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR 2017
_______________________
Wednesday, March 16, 2016.
NATIONAL INSTITUTES OF HEALTH
WITNESSES
HON. FRANCIS S. COLLINS, DIRECTOR, NATIONAL INSTITUTES OF HEALTH
DOUGLAS LOWY, M.D., ACTING DIRECTOR, NATIONAL CANCER INSTITUTE
ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES
RICHARD J. HODES, M.D., DIRECTOR, NATIONAL INSTITUTE ON AGING
NORA D. VOLKOW, M.D., DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE
Mr. Cole. Good morning. It is my pleasure to welcome you to
the Subcommittee on Labor, Health and Human Services, and
Education to discuss the fiscal year 2017 National Institutes
of Health budget request. We are looking forward to hearing the
testimony of Dr. Collins, and his colleagues, I know, will be
brought in for questions along the way.
I would like to publicly thank Dr. Collins and the staff at
the NIH for hosting me and other subcommittee members for a
briefing and a tour at the NIH campus a few weeks ago, the
second of what I hope becomes an annual trek out to NIH by this
committee. We all left NIH with a deeper appreciation of the
exciting work your staff do every day to find ways to save
lives.
I am proud that last year this Congress was able to
increase NIH funding by $2,000,000,000, and I am confident that
through these efforts, one day we will find cures for diseases
like cancer and Alzheimer's. I was, therefore, especially
disappointed to see the proposed budget cut to the National
Institutes of Health this year by the administration.
A proposal to divert $1,000,000,000 of biomedical research
funds to the mandatory side of the budget ledger and rely on
new and possibly unlikely authorizations to continue the
advances that we have made in increasing the research funding
is disheartening. Frankly, I do not plan to let the
$1,000,000,000 cut stand. We need to ensure a sufficient basic
biomedical research base is sustained to pave the way for these
long-term advancements.
Proposing new one-time mandatory spending that may never
materialize is not the path to do this. I look forward to
discussing the effects of the President's proposed
discretionary budget cuts on your research this morning.
I also want to stress how important it is to ensure that we
continue to focus on the next generation of investigators. We
know how long it takes for a new drug or treatment to make it
from the lab to the patient. So without a pipeline of young
researchers committed to following the process, we won't be
able to find the cures we seek.
I will be asking some questions this morning about a
variety of issues like Institutional Development Awards,
Alzheimer's disease, and the Cancer Moonshot. I hope to learn
more this morning on how the increases we provided for the NIH
this year are being used to move us forward toward cures of
these diseases that cause so much suffering in our Nation.
So without much further ado, I want to welcome Dr. Francis
Collins, the NIH Director, to the subcommittee. Dr. Collins is
accompanied by four of his institute directors who can assist
in answering specific Member questions. They are Dr. Anthony
Fauci, the Director of the National Institute of Allergy and
Infectious Diseases; Dr. Richard Hodes, the Director of the
National Institute of Aging; Dr. Doug Lowy, the Acting Director
of the National Cancer Institute; and Dr. Nora Volkow, the
Director of the Institute on Drug Abuse.
As a reminder to the subcommittee and our witnesses, we
will abide by the 5-minute rule. But before we begin, we have
been joined by both the big chairman, as we like to call him,
and our ranking member. And so I am going to defer first to the
chairman for any remarks he would like to make.
Then I am going to move to Mrs. Lowey, and then I will move
to my good friend and ranking member, Ms. DeLauro. And then we
will move to the testimony.
So, Mr. Chairman.
Mr. Rogers. Mr. Chairman, thank you.
Mr. Cole. And may I add, the 5-minute clock does not apply
to you. [Laughter.]
Mr. Rogers. That means I have got to keep it under 1
minute.
Well, welcome, all of you, to this hearing, and thank you,
Mr. Chairman, for the courtesy.
Through all of our work together, Dr. Collins, you have
exhibited the highest level of professionalism and dedication.
And during a time of so much groundbreaking research in
addiction science, Alzheimer's, cancer, NIH surely has the
right man at the helm, I think, to meet the challenges that we
face.
The emergence of the Zika virus throughout the Western
Hemisphere, one of those challenges that you are undertaking,
underscores the importance of NIH's mission to gain and apply
knowledge to enhance health, lengthen life, and to reduce
illness and disability. Since most of its recent emergence in
Brazil 10 months ago, Zika, of course, has spread to dozens of
countries. And although CDC does not anticipate any widespread
outbreak in the U.S., we have had 193 travel-associated cases
reported thus far.
The chairman and I and others just returned from a visit to
South America night before last. We met leaders, health
officials about--talking about the virus. We are interested to
hear your thoughts on the role NIH can play and are playing to
develop vaccines and therapeutics based on existing and future
research to limit Americans' exposure going forward.
We met with various officials on that trip, particularly in
Brazil, and explored what they are doing to try to tamp out the
exposure--and others in the region.
Given the importance of NIH research, I am proud that we
were able to work in a bipartisan fashion to increase your
budget in fiscal 2016 by $2,000,000,000 to fund more
groundbreaking medical research. This year, the NIH budget
request prioritizes basic foundational research, precision
medicine, and applying big data to improve health outcomes.
In addition to the public health benefits that accompany
your work, the economic impact of medical research should not
be underestimated. NIH research dollars not only impact
research facilities and researchers, but they also help get new
drugs and devices to the marketplace.
Through these funds, we have established a strong
relationship between NIH and Kentucky, the Markey Cancer
Center, a National Cancer Institute designated cancer center at
the University of Kentucky, and the UK Center for Clinical and
Translational Science, that continue to perform transformative
research benefiting the entire region and country. We look
forward to continuing our work together to bring an end to
these devastating diseases.
That being said, funding toward that goal must come through
regular discretionary channels that allow us to respond to
needs as they arise. I am disappointed to see the request cuts
NIH discretionary funding by $1,000,000,000, including
$57,000,000 from the National Institute on Drug Abuse, NIDA,
and then backfills the hole with over $1,800,000,000 in
mandatory money.
However, I look forward to meeting your requirements
through the regular appropriations process. We don't like
mandatory spending. It has grown completely out of control. We
have had to cut discretionary spending the last 5 years by some
almost $200,000,000,000 in real cuts. In the meantime, the
mandatory entitlement side of the budget is soaring out of
control.
When I came to Congress, we appropriated two-thirds of
Federal spending. Now it is one-third. Entitlements were one-
third. Now they are two-thirds and growing. And unless we deal
with it, we can't even pay the interest on the debt with
discretionary funds.
So that is why we are so dead set against mandatory
increases. We need to keep control of the spending that takes
place. It is the only accountable way under the Constitution.
I am pleased to see Dr. Nora Volkow with us again this
year. She has been a champion for advancing the science of drug
abuse and addiction as the Director of the National Institute
on Drug Abuse for 13 years now. Beyond her personal expertise
in cutting-edge brain imaging, she has been with us since the
beginning of our battle against drug abuse in southern and
eastern Kentucky, where it really got its start.
I am anxious to hear about your recent efforts regarding
the abuse of prescription medications. As you well know, this
epidemic now runs rampant across our Nation. I hope you will
update the committee on your work with pharmaceutical companies
to evaluate the risks associated with the long-term use of
opioids and what NIH is doing to research abuse-deterrent
medications and opioid alternatives.
I am also pleased that you have both once again committed
to sharing these insights at the National Prescription Summit
in Atlanta in a few weeks, and we are excited about your being
there for this one. And we are hopeful the chairman and others
on the subcommittee will be able to make that fifth annual
summit as well.
Secondly, I look forward to hearing from you today about
your pursuit of the Adolescent Brain Cognitive Development
Study. I believe collecting extensive data on the effects of
marijuana and other drugs on a young person's brain will help
us finally appreciate the harm these substances can do over
time.
Federal law is clear. Yet States continue to rush to
decriminalize or legalize marijuana, despite the lack of
sufficient scientific data about its use. This study will help
close that gap and, hopefully, shift public perception back to
reality.
We appreciate this very esteemed panel being with us today.
We look forward to working with you during the year to make
sure that you are doing what the country expects of us.
Thank you, Mr. Chairman.
Mr. Cole. Thank you, Mr. Chairman.
We want to move next to our ranking member of the full
committee, the distinguished lady from New York, Mrs. Lowey.
Mrs. Lowey. And I thank you, my distinguished chair. And
thank you for holding this very important hearing. Pleasure to
be with you and Ranking Member DeLauro.
This is one of the most exciting hearings I attend every,
every appropriations session, and I would like to welcome Dr.
Lowy, Dr. Fauci, Dr. Hodes, Dr. Volkow, and of course, Dr.
Collins. I would also like to thank each of you for your
service, and it is because of your vision and your dedication
the National Institutes of Health are providing a bright future
for millions of Americans suffering from illness and disease.
I am very pleased you are here to discuss important
investments in biomedical research and the health of our
Nation. Thank you.
And I must say I was thrilled, as I always am, to meet with
many of you at the NIH 2 weeks ago. During our meetings, I saw
firsthand the lifesaving breakthroughs you are leading,
including gene therapies to treat patients with advanced
cancer; ultra high field MRI machines to get the clearest look
at an aging brain to date, allowing for advances in Alzheimer's
and other brain diseases; and clinical studies that are
improving mental health and reducing suicides and so much more.
These breakthroughs and the need for additional research
into hundreds of other diseases is why this committee fought to
increase funding for the NIH by $2,000,000,000 in the fiscal
year 2016 omnibus spending bill. NIH has the world's best
physicians, researchers, technology at our disposal, and I
worry that even a $2,000,000,000 investment will not go far
enough to ensure that the NIH can compete against foreign
research initiatives. It does not serve our national interests
if there are not enough grants to support young researchers or
if researchers are lured away to foreign countries to develop
medical breakthroughs abroad.
That is why last year, although I was pleased with the
$2,000,000,000 increase, I called on this committee to once
again commit to doubling funding for the NIH. I was here when
that bipartisan effort was made, and I do call on my
colleagues, both sides of the aisle, to double the funding for
the NIH.
We can't afford to let some of these brilliant researchers
not get the support they need. Your fiscal 2017 budget request
would be a positive step toward that end. Your budget includes
targeted investments, such as the Cancer Moonshot, increases in
the Precision Medicine Initiative, the BRAIN Initiative. In
addition, it would result in 600 additional research project
grants.
These investments not only fund research that eases
suffering, they would greatly reduce ballooning costs
associated with treatment down the line. By the way, I must say
I had the opportunity to visit Watson, the IBM research center
in my district, just last week. And in fact, I am not sure I
understood everything they were explaining to me, but what I
paid particular attention to was the coordinative efforts
between Watson and other research facilities and your precision
brain initiative.
It is so amazing to me that precision medicine and the
research that is being done at the NIH is coordinating with
many facilities. And I understand in my follow-up Watson isn't
the only place. So, Dr. Collins, I would love if you would
touch on that as well, the coordination that is going on and
the amazing work to think that someone could get their cancer
analyzed at the NIH and all the facilities out there in a
machine such as Watson that could certainly help lead us to new
discoveries and new cures.
Let me say, however, while representing a net increase of
$825,000,000, your budget will result in a $1,000,000,000 cut
in discretionary funding for NIH. And I assure you that this
chair and ranking member and the big chair, who I think is
still over there, and I will just not let that happen. As an
appropriator, the department's request for substantial sums in
mandatory funding is of concern.
Finally, in addition--and if you can get it, good luck to
you. I mean, that would really be great.
Finally, in addition to your budget request, the NIH is
also awaiting congressional action on the emergency supplement
to combat Zika. The world is looking to the United States to
lead, and I am concerned that delaying consideration of the
emergency supplemental is leaving the American public,
particularly women who are pregnant or could soon be pregnant,
at severe risk.
And I know you are doing additional research, Dr. Fauci. I
still am not satisfied that only pregnant women can suffer from
Zika. So I know we have touched on that in our discussions.
But the bottom line is we are already behind. We must act.
I urge this committee and Congress as a whole to meet this need
without delay.
And thank you, Mr. Chairman.
Mr. Cole. Thank you.
We now to go to my good friend, the ranking member of the
subcommittee, the gentlelady from Connecticut.
Ms. DeLauro. Thank you very much, Mr. Chairman.
And if there are any Yankee fans in this audience, you will
know the term ``murderers' row,'' which was Babe Ruth, Tony
Lazzeri, Lou Gehrig, and others. I want to look at this group
this morning as ``survivors' row'' and Volkow, Lowy, Collins,
Hodes, and Fauci. And you are, indeed, allowing people to
survive.
As I have said many times in the past, you give the gift of
life, and we are so honored really to have you here this
morning and to listen to you and have the opportunity to have a
discussion.
So, Mr. Chairman, again, I want to welcome everyone. And as
we discuss the budget, the NIH is the leading biomedical
research entity in the world. And with each scientific
discovery, each medical breakthrough, its research advances
human knowledge to improve the quality of our life and saves
lives.
Funding this research has the power to do more good for
more people than almost anything else within the purview of our
Government, and last year we were able to provide a significant
increase of $2,000,000,000 for the NIH. I want to say a thank
you to Chairman Cole, and to all of the members of the
subcommittee, for their bipartisan work to support NIH
research. The additional funds are helping NIH accelerate
research to find cures for cancer, Alzheimer's, and help them
move forward with exciting new programs like the Precision
Medicine Initiative and the BRAIN Initiative.
However, I was disappointed to learn that funding for HIV/
AIDS research is not increasing in fiscal year 2016. In its
2016 budget request, NIH had proposed an additional
$100,000,000 for HIV/AIDS research in order to advance its work
on a universal vaccine to prevent HIV infection. I think it is
a mistake to change course, and I hope to see NIH support that
research this year, and it is something that I will advocate
for.
NIH plays an integral role in responding to emergency
public health threats. In 2014, as Ebola raged in West Africa,
NIH accelerated its work to create an Ebola vaccine. More
recently, NIH has been working to develop a vaccine to address
the looming Zika crisis, which poses an urgent and serious
threat, as my colleague Mrs. Lowey said, to pregnant women and
their babies.
If you take a look at yesterday's New York Times,
``Pregnancies Shadowed by Fears of Zika.'' This is real in the
minds of men and women, and women particularly.
I look forward to hearing from Dr. Fauci about the current
status of Ebola vaccine candidates, as well as progress on
moving Zika vaccine candidates toward clinical trials. Some of
my colleagues have expressed a desire to shift unobligated
funds that Congress provided for Ebola to respond to Zika. I
strongly oppose that idea.
I would be anxious to know what activities we would have to
forego if we shift funds away from Ebola to Zika. We need to be
able to respond to multiple public health threats at the same
time, which is why in this Congress and the last Congress I
proposed funding a public health emergency fund that mirrors
the Disaster Relief Fund, which would enable the Federal
Government to immediately respond to public health threats.
I would also urge the NIH to use its statutory authority to
respond to the rising cost of prescription drugs. As you know,
when taxpayer-funded Federal research results in a drug patent,
NIH may require the patent holder to license the resulting
intellectual property to third parties, resulting in
competition that drives down drug prices.
It is outrageous that drugs invented under taxpayer-funded
grants can cost sick Americans hundreds of thousands of dollars
over the course of a year. The public pays at the front end,
and they pay at the back end.
I must note that while NIH is now funded at
$32,100,000,000, thanks to the $2,000,000,000 increase, that
funding has not kept pace with the rising cost of biomedical
research. NIH's fiscal year 2016 funding level remains
$7,500,000,000 below the 2003 level, adjusted for biomedical
inflation.
Fifteen years ago, NIH funded about one in three
meritorious research grants. Today, the rate has fallen to
about one in five, a slight improvement over recent years, but
still low by historical standards. We are missing opportunities
to work toward cures for life-altering diseases affecting far
too many people.
That brings us to today's topic and today's discussion, the
2017 budget request. So much good in the proposal, and I
applaud the ambitious proposal to increase cancer research by
$680,000,000 in 2017. As a 30-year survivor of ovarian cancer,
you have heard me say it before, I am alive because of the
grace of God and biomedical research.
I am pleased to see proposed increases of $100,000,000 and
$45,000,000 for the Precision Medicine Initiative and the BRAIN
Initiative. These initiatives have the potential to
revolutionize our understanding of a disease, as well as our
understanding of long-term physical and mental health.
I think we can do better. This budget is clearly
constrained by sequestration and arbitrarily low budget caps.
As I said earlier, I think we need to boost funding for HIV/
AIDS research and not relent until we have developed a
universal vaccine. This would save countless lives, as well as
save billions of dollars in treatment costs in future years.
We need to continue to develop new antibiotics or risk the
devastating consequences of antibiotic-resistant bacteria to
our public health and our entire public healthcare system. I
want to note my concern over mandatory funding for NIH in this
budget. It is the responsibility of this committee to fund the
NIH.
An increase to this subcommittee's allocation is the
straightforward and responsible way to support NIH research,
rather than to rely on mandatory funding that will not
materialize. We should also continue to uphold the longstanding
tradition of scientific independence in setting Federal
research agendas rather than override scientific judgment with
congressional preferences. That ability to allow scientific
independence has been a hallmark of this subcommittee.
I had the opportunity to introduce a bill last year that
would enable our committee to increase NIH funding by 50
percent over 5 years by providing a cap adjustment. Just like
what we do in a cap adjustment for program integrity funding,
we have a model. We do it there. We ought to be able to do this
for the NIH. That would ensure proper funding for research
without robbing other vital programs to do so.
Thank you again for everything that you do. Biomedical
research is one of the most important investments that we can
make as a Nation. As I said, it gives the gift of life.
Thank you. I look forward to your testimony and to our
discussion.
Mr. Cole. Thank you.
Dr. Collins Opening Remarks
And now, Dr. Collins, we will go to your opening statement.
Dr. Collins. Well, good morning, Chairman Cole, Ranking
Member DeLauro, Chairman--from the full committee--Rogers, and
ranking member of the full committee, Mrs. Lowey.
My colleagues and I are delighted to appear before you
today, and we were honored very much to host you at NIH with
several of your committee members. And by all means, let us do
it again next year. I think that was extremely helpful for us
to have you on our campus.
In this hearing on the last budget proposal of this
administration, I plan to reflect more broadly in my opening
statement here than usual on NIH's contribution to the Nation's
health. So I am going to break with tradition and make some
predictions.
PROGRESS 10 YEARS FROM NOW
Ten areas in which I believe we can expect to see major
progress 10 years from now, given a sustained commitment of
resources for NIH. So this is 10 for 10. So here we go.
First, the long arc of scientific discovery must begin with
basic science. Experiments that are going on, excuse me, right
now in labs across this Nation contain the seeds of
breakthrough discoveries that will transform medicine.
ONE: ANALYSIS OF INDIVIDUAL HUMAN CELLS
Let us fast forward to 2026 and the first of these 10
breakthroughs, and I think that will be advances in analysis of
individual human cells. Cells are the unit of life. Cells are
for biology like atoms are for chemistry.
And yet during the long history of medical research, we
haven't really had the technical ability to study individual
cells. We have had to deal with millions of cells, maybe
billions. With new technologies just invented in the last
couple of years, that is all changing.
As just one example, we can now decode the process by which
individual immune cells attack and destroy healthy tissue in
autoimmune disorders and transform the ways that we approach
lupus, rheumatoid arthritis, multiple sclerosis, and many other
diseases.
TWO: BRAIN INITIATIVE
On to breakthrough number two. In 10 years' time, tools
developed through the BRAIN Initiative will have identified
hundreds of different types of brain cells and, more than that,
major circuits responsible for motor function, vision, memory,
and emotion, all functioning at the speed of thought.
As a result, we will be able to diagnose conditions earlier
and more precisely, and we will have new targets to explore for
prevention and treatment of conditions like autism,
prescription drug addiction, traumatic brain injury,
schizophrenia, Parkinson's disease.
THREE: NEW IMAGING TECHNIQUES AND DISCOVERIES
Number three, aided by the BRAIN Initiative's new imaging
techniques and discoveries made with our private sector
collaborators, I believe we will be able to identify
individuals at high risk for Alzheimer's disease even before
any symptoms appear and provide them with effective therapies
aimed at slowing or preventing the disease. Personal and family
tragedies will be delayed or averted, and the economic savings
from this alone will add up to hundreds of billions of dollars.
FOUR: TREATMENT FOR SPINAL CORD INJURIES
Number four, I predict that 10 years from now, we will have
developed an effective treatment for spinal cord injuries.
Already, groundbreaking NIH research has allowed four young men
paralyzed from the waist down to walk by the use of electrical
stimulation that bypasses the severed cord.
If resources are available to follow up this proof of
concept study, we can give freedom of movement back to victims
of car accidents, sports injuries, and other spinal trauma.
FIVE: SAFE AND EFFECTIVE ARTIFICIAL PANCREAS
Number five, we will see the introduction of a safe and
effective artificial pancreas. For those with diabetes, such a
device will continually track changes in blood glucose levels
and provide precise doses of insulin, significantly improving
the management of their disease and preventing countless
complications.
SIX: OPPORTUNITIES FOR ORGAN TRANSPLANTATION
Number six, hope is also on the horizon for heart failure,
a major cause of death in this country. The development of
induced pluripotent stem cells, iPS cells, derived from a skin
biopsy, has opened up profound new opportunities for organ
replacement. Early experiments suggest that a patient's heart
could even be rebuilt using his or her own iPS cells. This
personalized rebuilt heart would make transplant waiting lists
and anti-rejection drugs obsolete.
SEVEN: NEW VACCINES
Number seven, new vaccines will be readily available.
Universal flu vaccines will protect against all strains of the
virus, preventing a worldwide pandemic, saving millions of
lives and eliminating the need for an annual flu shot. Early
clinical trials are already underway, and we are in active
collaboration with industry.
I am also optimistic that an effective vaccine for HIV/AIDS
will be available by 2026, giving us the opportunity to, at
long last, bring an end to this most frightening and costly
global epidemic.
EIGHT: TREATMENT FOR PAIN
Number eight, genomics, neuroscience, and structural
biology will unveil entirely new targets for the treatment of
pain, allowing researchers in the public and private sectors to
develop highly effective, non-addictive medications for pain
management, turning around the current alarming trend of
massive numbers of Americans becoming addicted to opiates.
NINE: TAILORED APPROACH TO MEDICINE
Number nine, we will have tailored approaches to medicine
that acknowledge not all people are the same, thanks in large
part to the Precision Medicine Initiative and the more than 1
million volunteers in the national research cohort that we aim
to enroll by 2019. The willingness of these participants to
share a wide variety of their health-related information will
ensure that major new insights emerge and Americans from all
walks of life will be healthier than ever 10 years from now.
TEN: PREVENTIVE STRATEGIES AND TARGETED THERAPIES FOR CANCER
And last, but certainly not least, I predict that a decade
from now, hundreds of thousands of individuals will be thriving
who without NIH's research efforts would have succumbed to
cancer. Powerful new prevention strategies and targeted
therapies will arise from research, accelerated by the Vice
President's Cancer Moonshot proposal.
If that sounds bold, consider what is happening right now.
Seven months after President Jimmy Carter revealed that
melanoma had spread to his brain and that he was beginning a
course of therapy to boost his immune system's ability to
destroy his cancer cells, last week he announced he is cancer
free and no longer needs treatment.
Our Nation needs a lot more stories like this. With the
sustained efforts of this subcommittee, I think it is possible.
With a strong, stable trajectory for support of NIH research,
the world can look forward to a healthier and happier future,
whether 10, 50, or even 100 years from now.
Thank you, Mr. Chairman. My colleagues and I welcome your
questions.
[The information follows:]
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Mr. Cole. Thank you very much, Dr. Collins.
ORDER OF QUESTIONING
Just for informational purposes for the Committee, I am
going to ask my questions. Then we are going to go to the
chairman of the full committee and the ranking member of the
full committee, and then my good friend, the ranking member of
the subcommittee. And then we will proceed in questions in
order of arrival.
IMPACT OF $1 BILLION CUT TO NIH BUDGET
As I mentioned, Dr. Collins, in my opening statement,
although the administration budget appears to request an
increase, that increase is sought through the mandatory side of
the budget, which is, of course, outside our jurisdiction as a
committee. The administration's request before this committee
actually proposes a $1,000,000,000 cut in the area that we
actually have jurisdiction over, discretionary spending.
If we were to appropriate exactly what the administration
has requested in your budget on the discretionary side, again a
$1,000,000,000 cut below current levels, what would the impact
on biomedical research in general be and on research into
diseases like Alzheimer's and cancer specifically?
Dr. Collins. Thank you for the question. And obviously a
very sobering scenario that you portray and one that we very
much hope will not happen.
Certainly, the impact would be severe. It would be felt
across every aspect of what NIH supports. All of my colleagues
here and the other 23 Institute and Center directors would have
to cut severely back in their programs. New initiatives would
not be able to get started. Whether you are talking about
cancer or diabetes or heart disease or Alzheimer's disease,
this would represent a very significant slowdown.
Again, I am just a simple doctor to the country. So the
idea of how you divide up appropriations between discretion and
mandatory is a little over my head. We are certainly pleased in
the President's budget proposal for an increase and very
gratified by your words, Mr. Chairman, and by others of the
intention of this Committee to figure out how to maintain the
trajectory that you started this year with the $2,000,000,000
increase.
I can't tell you what a shot in the arm it has been for our
biomedical research community. The morale, the enthusiasm, the
willingness to take risks and start new projects, which had
been pretty much at a slowdown for about a decade, is back. And
we want to be able to see that continue and appreciate your
support for that.
NIH'S USE OF ADDITIONAL FUNDS
Mr. Cole. Great. Let me ask you a sunnier, more upside of a
question now that we have gotten that out of the way because I
can assure you--and I have talked, obviously, to the Chairman
of the Full Committee, and the Ranking Member certainly made
her feelings known--this Committee is not going to cut
$1,000,000,000 of discretionary funding from the NIH. Just not
going to happen.
So in that sense, you don't need to worry about that in
front of you. But let us say last year the President proposed a
$1,000,000,000 increase, which was very welcome. This committee
actually, working in a bipartisan fashion, was able to double
that.
Dr. Collins. Yes.
Mr. Cole. Let us assume that we were able to go beyond what
the President asked for, beyond the $32,800,000,000, roughly.
If we were able to give you extra money, where would you direct
it? What do you think the most promising use of additional
funds might be if we were able to do it?
Dr. Collins. What a wonderful question. Certainly, in my
professional judgment, there are a lot of areas that are ripe
for expansion, and the opportunity to be able to go even faster
on those would be welcome, indeed.
As you know, a great deal of the research that we support
are ideas that come to us from investigators all over the
country. It is their bright brains that push forward the
envelope, and we would want to be sure to do something to
encourage even more of those grants to be fundable. As you
know, we are still under 20 percent for that success rate.
And that would have effects across the board. Antimicrobial
resistance would have more resources. Alzheimer's research
could move faster with additional resources. Cancer research--
even beyond the Moonshot, so many things are possible now.
Opioid abuse and other issues of drug abuse, and I could go on.
Diabetes, autism, all of these conditions, which right now are
scientifically poised for rapid advances, all of them would
have their opportunities lifted by the kind of wonderful
scenario that you portray.
THE STATE OF ALZHEIMER'S RESEARCH
Mr. Cole. Well, that is wonderful. Let me move to another
area of particular interest to the committee and certainly to
me. I saw a recent Time magazine article on Alzheimer's that
highlighted some of the early stage clinical trials based on
what I understand to be NIH-supported basic research.
In my visit at NIH a few weeks ago, it was very interesting
to learn how increased support from Congress over the last 3
years has expanded peer review science on Alzheimer's disease
and other dementia and has helped move the ball further. So if
you could, and this will probably go to Dr. Hodes, I am sure,
right away--and I don't have a lot of time--but sort of tell us
where you are at and what you see the prospects are in
Alzheimer's and other dementia.
Dr. Hodes. Well, thank you for the question. And first of
all, thank you very much for the increased funding this year,
which has made an enormous difference.
Fortunately, the good news is that the scientific
opportunities, what we are learning about the brain and
Alzheimer's disease, have expanded enormously so that resources
are really applicable to research that is well thought out,
well prioritized. In preparation, for example, in particular
for the bypass budget that we submitted for the first time last
year at congressional direction, we underwent a very extensive
planning process in which national and international experts
came together to identify priorities.
These got translated into milestones, i.e., what we had to
achieve to accelerate goals such as the establishment of an
effective intervention in the nearest possible terms. This
meant that with the additional funds, we were poised to act on
this full spectrum of well-defined priorities and milestones.
And for example, the initiatives that this year we were
able to embark upon include a spectrum: from looking at the
most basic biology and genetics to understanding new targets
for intervention, new clinical trials that take advantage of
the most promising of those interventions, and ways to
intervene with people who already have disease and the
caregivers who take so much responsibility in caring for those
who have Alzheimer's disease.
In health disparities, epidemiology, et cetera, across this
broad spectrum, we have seen a huge increase of applications,
from scientists who have been inspired by the availability of
resources. And across this whole trajectory, we see a very
bright future of accelerated progress thanks to the support of
Congress.
Mr. Cole. Well, thank you. I have violated my own rule and
asked you a tough question too near the end of my own time. So
I apologize to the committee for that.
And I want to move next, if I may, to the Chairman of the
Full Committee for whatever questions he cares to ask.
PRESCRIPTION DRUG ABUSE
Mr. Rogers. Thank you, Mr. Chairman.
Dr. Collins and Dr. Volkow, thank you for both actively
engaging the issue of prescription drug abuse. We lose 100
Americans a day from overdoses of prescription medicine and
heroin. We need a holistic, multipronged approach to the
epidemic that CDC says we have.
Before we get to the pills themselves, let me explore a
sizable part of the problem, oversupply of opioids. As you
know, over 250 million prescriptions are written each year for
opioids, many of which need not be written at all. And thanks
in part to deceptive marketing practices and reckless
overprescribing, these drugs have become a default solution, it
seems, for any pain rather than the severe pain for which they
were intended.
Doctors should appropriately target pain with appropriate
and proportionate medicines. Moderate measures for moderate
pain, more powerful opioids for those who really need them.
What are we doing to address the lack of effective non-opioid
treatment for chronic pain?
PAIN MANAGEMENT
Dr. Collins. Mr. Chairman, I want to thank you for your
leadership in this area over these years, and again, I think
many of us looking forward to the summit that you are bringing
us together for in a couple of weeks.
I am going to ask Dr. Volkow, though, to tell you about
some of the things that are being explored in other areas of
pain management.
Dr. Volkow. I would like to thank you for your leadership
in this whole area that has been very devastating. Research on
pain exists across multiple institutes at the NIH, and there is
a pain consortium that actually aims to integrate these
efforts.
So as it relates to the development of new strategies for
the management of pain, there are several approaches. One of
them is the one that helping develop abuse-deterrent
formulations of opioids that cannot be tampered with. That is
one of the approaches.
Another approach is the development of analgesics that are
potent that are not based on opioids and, therefore, are not
going to be rewarding.
There is a third approach that aims to the use of
stimulation technologies in the--that will affect the impulses
in nerves and in the brain to control and regulate pain. And
that relates to tools like transcranial magnetic stimulation,
or electrical direct current, that allows you to either inhibit
certain areas of the brain or stimulate them.
There is also research in terms of evaluating behavioral
and cognitive interventions that can improve the outcomes in
patients suffering from chronic pain. So there is a wide
variety of approaches to try to address the lack of effective
interventions that are safe for management of chronic pain.
NEW CDC GUIDELINES FOR OPIOIDS
Mr. Rogers. Yesterday, CDC announced new prescribing
guidelines for opioids. There are 12 recommendations, but I
think here is the bottom line.
Doctors should avoid using powerful opioids as the first
line of defense against pain, saying the risks from such drugs
far outweigh the benefits for most people. With respect to the
dosage, CDC says start low and go slow.
Do you think doctors are likely to follow the
recommendations that the CDC has put forward? And what steps
can we take to get the medical community more engaged in the
problem?
Dr. Volkow. Yes, and indeed, the CDC guidelines are
actually a step forward in helping improve the prescription
practices as it relates to the use of opioid medications,
particularly for the management of chronic pain. And again, the
CDC guidelines were excluding patients that lead to cancer pain
or hospice care pain.
The guidelines put a frame of reference that is based on
one hand on the current knowledge, but also on experiences.
There is not sufficient scientific evidence on how to properly
use opioids, and as a result of that and added with the fact
that there is an increased awareness that current prescription
practices of opioids cannot continue the way they are doing
right now--it is unacceptable--that that education on the
healthcare system and also in the public, along with guidelines
like the one of CDC, will facilitate the changing of practices
of how we prescribe these medications for the management of
chronic pain.
While at the same time, I think, because that is the other
aspect of it, providing adequate care for those patients that
suffer from chronic pain, which can be very devastating.
ROLE OF PHYSICIANS IN PRESCRIBING DRUGS
Mr. Rogers. You know, we fought for years, you and the
Congress and others have fought for years to get the
pharmaceutical companies to develop abuse-deterrent
formulations, to make opioids so they could not be crushed and
take away the time release of the drug in just a split second.
And now we have got, I think, five abuse-deterrent opioid pills
on the market, but doctors are not prescribing them.
I don't know whether they don't know about them or don't
care about them or whatever. But the bottom line is they are
not using what we have developed as an abuse-deterrent
strategy. What do you think about that?
Dr. Volkow. Well, it is likely there are different reasons
why doctors may not be using them, but one that is important
for us to be aware of is that we have to be certain because
these abuse-deterrent formulations require development. They
tend to be more expensive than the old opioid medications.
So we want to be mindful that there are insurances that
when a physician prescribe it, the patient will be reimbursed
for the cost associated with it. So we have to create a system
that incentivizes the utilization of these abuse-deterrent
formulations that by default are going to be in general more
expensive.
Mr. Rogers. And insurance companies are reluctant to pay
the increased cost because they say the regular opioids are
cheaper, and therefore, we are only going to cover the lower
cost. How can we deal with the insurance companies not paying
for the abuse-deterrent feature?
Dr. Volkow. I am going to call on Dr. Collins. I am just a
pure scientist, and that is above my pay grade. [Laughter.]
Mr. Rogers. I am way over time here, but can you answer
that one quickly?
Dr. Collins. Well, it is a complicated ecosystem you are
talking about in terms of what we need to do to educate
physicians about their role, and I think most physicians--I am
a physician, the people at this table are also--are focused on
trying to deliver the right care to patients.
But things take some time to filter down, and we need to
speed up that process of translating now what we know. And I
think the CDC guidelines are intended to achieve that.
In terms of the economics, however, that really comes down
to whether insurance companies can, in fact, be talked into
this kind of reimbursement if they are given a strong reason. I
think we have got a stronger case, yet, that needs to be made
about moving where we have been from drugs that are so abuse
prone to things that are safer.
Mr. Rogers. Well, if there is any insurance companies
listening, they would be very wise to allow coverage of these
abuse-deterrent featured drugs because they don't want to know
what would happen if they don't.
Thank you.
Mr. Cole. Thank you, Mr. Chairman.
And with that, we will go to my good friend, the ranking
member of the full committee, the gentlelady from New York.
CANCER MOONSHOT
Mrs. Lowey. Thank you very much, Mr. Chairman. And I want
to say we are all with our big chairman over there on this
issue.
But I want to get back to the Cancer Moonshot because when
you look at the numbers and you think of the number of people,
I am sure, in this room whose lives have been touched with a
loved one who is suffering from cancer, I am thrilled that we
are focusing on this issue. In 2015, there were nearly 1.7
million cases of cancer diagnosed in the United States. So I am
very pleased to see this focus of the President and the NIH.
Dr. Lowy, could you provide specific examples of what the
Cancer Moonshot hopes to achieve that current research and the
Precision Medicine Initiative do not address, and how would the
Cancer Moonshot target cancers that to date have been difficult
to detect and treat, such as kidney cancer and pancreatic
cancer?
Dr. Lowy. Thank you, Congressman Lowey.
We really appreciate your strong support, the support of
the Subcommittee, and the support of the Congress not just for
2016, but also the long-term support that has gotten us to this
point where incidence and mortality rates from cancer are going
down. But as you point out, not only is the incidence high, but
in addition, close to 600,000 people in the United States will
die this year from cancer.
The Moonshot is designed to look at many different aspects
of cancer and to take advantage of the enormous opportunities
that we have in this area. Two areas of focus are not just
areas of treatment, but also for prevention and screening.
In prevention, looking to develop vaccines not just against
targeted material from infectious diseases, but also
abnormalities in cancer. And then in addition, for screening,
taking advantage of new technology, such as Dr. Collins
mentioned for single cell analysis in peripheral blood, and we
can--we can make these changes looking at the blood and other
fluids to try to screen for early detection of pre-cancer and
cancer.
These are just two of the highlights in the Moonshot.
CAUSE OF AUTISM
Mrs. Lowey. Well, thank you. And I have a little time left.
Estimates, and I have been very concerned with the numbers
in my own district, that 1 in 68 children will have an autism
spectrum disorder. This is one of the reasons I am such a
strong supporter of the BRAIN Initiative, which could provide
deeper understanding of how the brain works and unlock
treatments for autism, as well as a host of other disorders.
And I think all of us here appreciate the work that you are
doing on Alzheimer's disease as well.
If you could tell us what has the research told us to date
about the cause of autism, both in genetics and environmental
factors, and how would the fiscal year 2017 budget request
bolster these research initiatives both under the BRAIN
Initiative, as well as other institutes throughout the NIH?
Dr. Collins. Well, thank you for that question because we
are enormously excited about what is possible now in terms of
research on the human brain, probably the most challenging
frontier in all of biomedical research, the most complicated
structure in the known universe. There are 86 billion neurons
in the brain. Each of those have about 1,000 connections, and
we are just bold enough to think we might be able to understand
how those circuits work and do the amazing things they do over
the course of the next 10 years in a very well laid out
blueprint for that research, which is guiding the BRAIN
Initiative and which is now in its third year.
And thank you, the Congress, for supporting it, and we hope
that will continue to be able to ramp up to its full funding.
Autism is clearly a complex heterogeneous collection. If
anybody thought we were going to come up with just one simple
molecular explanation, that chance has long gone by. It does
now seem that with careful analysis of DNA, looking at the
genome information, that something in the neighborhood of 20 to
25 percent of those with autism--and it tends to be in the more
severe end of the spectrum--do, in fact, have genetic changes
that happen for the first time in that child. Not in the
parents, but it was a mutation that arose during the course of
spermatogenesis or oogenesis.
And those have an interesting set of features when you look
to see what genes are involved. They are mostly genes that code
for proteins that are active at the synapse, the place where
neurons talk to each other, and that kind of makes sense that
autism is a circumstance where the communication systems in the
brain are not functioning in the normal way.
But, that gives us hope that we could begin with that
unifying theory of what is happening in autism, begin to
develop even better ways of introducing new therapeutics. But,
this will be one of the many consequences, I think, of the
investment in the BRAIN Initiative, which is, itself, a basic
science effort to understand the brain.
But, it builds a foundation upon which we can apply all
kinds of other research to understand autism, Alzheimer's
disease, Parkinson's disease, traumatic brain injury, drug
addiction, all of which have, of course, roots in the brain's
circuits that sometimes don't function the way they should.
So, it is an enormously exciting time for us to push this
forward. It has resulted in the recruitment of a really
fascinating array of people coming from different disciplinary
perspectives. The BRAIN Initiative has lots of technology and
lots of engineering and lots of neuroscience and
nanotechnology, all those things folded together.
Mrs. Lowey. Thank you very much.
And thank you, Mr. Chairman.
Mr. Cole. Thank you.
And we will next go to my good friend, the ranking member
of the subcommittee, the gentlelady from Connecticut.
Ms. DeLauro. Thank you very much, Mr. Chairman.
SEX BALANCE IN PRECLINICAL RESEARCH
Dr. Collins, last year we talked about NIH's relatively new
policy to require applicants to report their plans for the
balance of male and female cells and animals in preclinical
studies in all future applications. As you know, this is an
issue that Congresswoman Lowey and I have been working on since
we first came to the Congress.
In our discussion last year, you noted that Institute
Directors were in the process of finalizing their guidelines
for all grantees. Let me note a recent analysis in Nature
magazine. It is a March 3rd article, which showed that as
recently as 2014, only 53 percent of research papers recorded
both the sex and age of the animals used in the studies.
I realize the analysis looks at research papers that
predate the implementation of NIH's policy about sex balance in
preclinical research. Can you provide an update on NIH's
efforts to ensure that research includes both male and female
animals in preclinical studies, and can you update us on NIH's
efforts to ensure that preclinical research includes both male
and female tissues and primary cells?
Dr. Collins. Well, thank you for the question.
As you can see in the visual that I put up, this is
something that NIH has gotten very interested in and committed
to, and this article that Janine Clayton and I wrote in Nature
about a year and a half ago, very much points out that from
NIH's perspective, that you are right. And Mrs. Lowey, you are
right, and all those who have made this case are right that we
have not been taking enough attention as we should to balancing
males and females in preclinical research.
And in the process, because many animal experiments,
particularly with mice, have focused solely on males, we have
been missing out on important differences of biological
significance that might very well be things we need to know for
human medicine. We are determined to change all of that.
I saw the article that you mentioned in Nature, and I am
happy to say I don't think you would see that article being
written in another year or so. We did, in fact, put out a
notice back in June, and it went in effect on January 25th.
From now on, if you are an NIH-funded grantee and you are doing
experiments involving animals, you need to include males and
females.
If you have some idea that you are not going to do that,
you have to justify it. If you are studying prostate cancer,
you can probably get away with sticking just to males. But for
most other things, it is going to be absolutely required, and
it will be a condition of the review and the grant award.
Ms. DeLauro. And that is true with male and female tissue
and primary cells as well?
Dr. Collins. And I think that has been a real wake-up call
as well, that people thought, well, a cell is just a cell. But
a cell has a sex, too, and we are actually losing out on
information if we don't take account of that. And that has now
become part of the norm of the way in which we want to fund
research.
Ms. DeLauro. Okay. Thank you very much.
Dr. Collins. Thank you.
DRUG COSTS
Ms. DeLauro. Taxpayers provide more than about
$30,000,000,000 annually for NIH's research. Dr. Collins, you
have said that NIH conducts the basic science that ``fosters
innovation, ultimately leads to effective ways to treat complex
medical conditions.''
And yet, in so many cases, taxpayer-funded research leads
to drugs that are sold back to the taxpayers at exorbitant
prices. Example. UCLA led to a patent for Xtandi, a drug to
treat prostate cancer. The drug now costs patients $129,000.
The same costs patients in other countries about a third of
that amount.
Look, I realize the pharmaceutical companies invest their
resources. They bring a new drug to market. They should profit
from that innovation. But what I want to know is why U.S.
taxpayers are getting gouged for drugs that wouldn't exist
without the significant investment of U.S. taxpayers.
Can you better explain why U.S. taxpayers are paying for
biomedical research on the front end and paying exorbitant
prices at the back end? And I will just say that 50 of my
colleagues and myself have sent a letter to you and to
Secretary Burwell, requesting that the NIH and HHS assert
March-in rights when taxpayer-funded research leads to a
patented product that is not available to the public on
reasonable terms.
What are reasonable terms? A drug shouldn't cost $129,000
for people to get access to it.
Dr. Collins. Well, I know this is a topic of great
interest, and well it should be. And certainly, my heart goes
out, as all of us do, to patients who are in need of a
therapeutic which is outside of their financial means to be
able to gain access to, and that really ought to be the thing
that drives us trying to come up with better solutions.
I would say with regard to March-in rights, we read the
letter carefully. You saw the response from Secretary Burwell.
NIH does, in fact, have the ability to march in if reasonable
terms are not being met and if we have intellectual property
that is attached to that particular product.
Ms. DeLauro. What is a reasonable term?
Dr. Collins. Well, that is very much where it gets down to
the nitty-gritty, doesn't it? And we have looked at that
situation several times in the past, and have not felt like we
reached reasonable terms. But we are totally open to
considering that on a case-by-case basis, and we will be glad
to do that with other products that are brought forward for our
consideration.
We get it that this is a serious issue.
Ms. DeLauro. And let us have further conversation. And I
have gone over my time.
I thank you, Mr. Chairman.
Mr. Cole. Absolutely. Next, operating on the order of
arrival, Mr. Harris, you are recognized for whatever questions
you care to pose.
Mr. Harris. Thank you. Thank you very much.
And good to see all of you again. It was a great visit I
guess last month up to see what is going on. And you know,
meeting with Dr. Rosenberg and the patients just reminded me
of, you know, why I went into medicine. And what am I doing in
politics? Anyway----
[Laughter.]
VACCINE DEVELOPMENT
Mr. Harris [continuing]. Let me ask a couple of questions.
First of all, with regards to the strategic plan, you know, Dr.
Collins, you had mentioned that one of the 10 things on your
predictions, you know, is an HIV vaccine. And you know, part of
what is addressed in the strategic plan is that nonstatutory
set-aside for research. And when you look at the investment by
objective, vaccines or a vaccine accounts for less than
$400,000,000 out of a total of what I assume is now almost
$3,000,000,000.
So my question is specific. With the additional
$2,000,000,000 that was appropriated last year, how much of
that went into the vaccine development since that--it really
is--I mean, because you address, you know, the cost, if you can
bring that down to zero. But the only way to bring it down to
zero really is we are going to have to develop a vaccine.
So you are already spending only about 15 percent of the
budget on the vaccine on HIV. So is it--so the additional
monies, how much went into vaccines? How much went into non-
vaccine HIV programs?
Dr. Collins. Well, I appreciate the question, and you and I
have talked about this issue. And it has been very helpful to
have your perspective and that of other Members.
I am glad you mentioned the strategic plan. I hope people
have read. There is a copy of this at your place. This was
something you, the Congress, asked us for, and we put it
forward in a way that we thought could be very helpful in terms
of defining how we set priorities. So, please, have a look if
you have not looked at it previously.
With regard to HIV/AIDS, what we have decided is that it is
time, just as you have said, to focus on the most important
priorities to end this epidemic, and the vaccine is right at
the top of that list. There are other things on that list as
well.
And as a result, we have looked at our entire HIV/AIDS
portfolio this year, and we have identified projects which were
going to come back for competing renewal which we no longer
think fit into those highest priorities, four of them. And as a
result, the dollars that would have gone to renewing those
programs is becoming open for competition for things that are
high priority, and vaccine development is very much on that
list.
We will, in the course of probably the next couple of
weeks, announce how we are moving $66,000,000 out of areas
which were good science, but they don't seem to be high
priority for HIV/AIDS, into the areas that are. And a
substantial fraction of that is going to go to vaccine
preparation.
Mr. Harris. I would urge that you do that. I mean, there is
a line here. You know, $100,000,000 a year for basic behavioral
and social science research. I mean, honestly, I would much
rather see the $100,000,000 going to accelerating the
development of that HIV vaccine.
I just returned from Kenya, around Lake Victoria. Look, the
solution is we are going to have to vaccinate people in the
end. I mean, I am becoming convinced that you have treatment
penetration of only 50 percent. Until we can vaccinate, as with
other infectious disease, we are really not going to cure it.
MARIJUANA USE
Dr. Volkow, let me just ask you a question because the
Chairman of the Full Committee, who has left already, you know,
mentioned marijuana. And there is a--you know, SAMHSA surveys,
and they survey by State. And they--you can find charts that
look at the increased use of marijuana.
And it is interesting to look at what happened in Colorado
between the 2002-2003 survey for 18- to 25-year-olds and the
2013-2014 survey for marijuana use in the past month for 18- to
25-year-olds. And past month is not just I have used it once. I
mean, I have used it recently.
It went from 21 percent to 31 percent. 18 to 25, by my
understanding of the potential adverse effect of marijuana on
brain function and development, is probably the worst interval.
Maybe not, maybe even younger use would be bad. But certainly
up to age 25 is a bad interval.
The national use, by the way, in that age group went from
17 percent to 19 percent. So pretty clearly, and I think, you
know, what happened in Colorado is you legalized the drug.
Bottom line, you legalized the drug.
And there is a lot of misinformation out there about what
happened when you legalized the drug, but honestly, a change
from 21 percent to 31 percent use in a highly vulnerable
population is of concern to me. Is it of concern to you?
Dr. Volkow. How can it not be? I think that actually----
Mr. Harris. Well, Doctor, I will tell you that the
advocates for legalization say we shouldn't be concerned about
the usage figure. So I am interested in what your opinion is.
Dr. Volkow. Indeed, we are very concerned, and we are
particularly concerned by the very high rates of abuse of
marijuana not just on 18 to 25, but actually on teenagers 12 to
18 years of age. And Colorado has the highest rates in the
whole country of the use of marijuana in that age bracket.
We are particularly concerned because cannabinoids,
actually marijuana is a cannabinoid, interfere with the normal
formation of synapses, the connections between neurons, how
they talk to one another. And that process of connections is
happening from the moment you are born, actually before you are
born, until you are in your mid twenties.
So cannabinoids, our own endogenous cannabinoids regulate
that formation. So when you are smoking marijuana, you are
interfering with this very carefully orchestrated process by
which biology, nature ensures that our brain develops into the
most complex organ so far.
So, yes, indeed we are very concerned specifically because
of the potential developmental adverse effects that exposure to
cannabis may have in young people.
Mr. Harris. Thank you very much. I yield back.
Mr. Cole. Thank you very much. The chair is struggling to
enforce the clock even on himself, which I think shows how much
interest there is here. So I just would ask Members to try and
do the best they can in that regard.
With that, I will go to my good friend, the gentleman from
Pennsylvania, for whatever questions he cares to pose.
UPDATE ON BRAIN INITIATIVE
Mr. Fattah. Well, I resemble that remark, Mr. Chairman. I
see you said that right before you came to me.
But let me thank Dr. Collins and our guests. I authored
some language that created the Interagency Working Group on
Neuroscience at NIH, along with the National Science Foundation
co-chair. Simultaneous to this hearing, the National Science
Foundation is on another side of the Capitol giving a hearing,
and these two things are inextricably intertwined. That is the
science and the work at NIH together is how we are going to
make disruptive progress, I am convinced.
Now, we also have now in my other bill put some language in
creating an interagency working group on imaging, and I know
that NIH is at the--very engaged in this. What I am interested
in now is I see the numbers for this year's budget. Dr.
Collins, if you could talk to the committee for a minute about
what the 12-year cost is on the BRAIN Initiative so that we can
see it in totality?
I spent some time out at Stanford with Dr. Newsome and some
of his people, but I think it would be helpful. This is I know
we say the administration's initiative. In truth, it is a
partnership between the Congress and the Administration, and I
think that we need to make sure that we have a good
understanding of how the road--how the runway is out in front
of us in terms of what we want to achieve.
Dr. Collins. I appreciate the question because this is
certainly an area of great excitement. How do we figure out how
those circuits in the brain do what they do? That is a picture
of a recent diffusion tensor MRI showing you the ways in which
all the wiring works in the normal brain. That was taken on a
perfectly healthy individual who is quite awake at the time
this was done, new technologies that we didn't really have the
ability to do until fairly recently.
Yes, the BRAIN Initiative was, in fact, conceived of as an
effort that would result in a lot of technology development in
order to be able to do these measurements on circuits in real
time in the human brain, but then to move into applications in
its second 5 years. The overall budget for this was to ramp up,
beginning in the first year, fiscal year 2014, at $46,000,000,
and then ramping up to something like $400,000,000 a year,
which we hope to get to in the next year or two.
The overall budget over 12 years from--going from fiscal
year 2014 to fiscal year 2025 is $4,500,000,000 in the proposal
that was put together. This was an effort that was led by Cori
Bargmann of Rockefeller and Bill Newsome of Stanford and an
amazing dream team of neuroscientists who put together this
plan over more than a year and a half.
And that blueprint is out there and very much worth
studying and, of course, will be revisited as technology
develops. I would say right now we are ahead of our schedule.
Mr. Fattah. Thank you, Doctor.
Let me say that the Chairman and our ranking member, along
with members of the committee, we were very pleased to do the
$2,000,000,000 increase last year. And I know that the chairman
made some comments about the administration's proposal and
where we are on that, and I would join in the Chairman's view
that that is not acceptable.
I want to put this in some context. For a good part of the
years that we have been in Afghanistan, we have been spending
about $2,000,000,000 a week on average. So, just as a country,
when we think about all of the lives that are affected by the
diseases and disorders that you are seeking to cure, you know,
a $2,000,000,000, even though it is very significant and it was
some heavy lifting, in perspective, this is a nation that can
do more in terms of research in science and in medicine that
will make a difference for tens of millions of Americans. It is
just a matter of political will.
UPDATE ON ZIKA VIRUS
So I want to make sure that we are clear that the
$4,000,000,000 is where we have to get to to do the work that
we want to do. And if you could, I will conclude with my last
comment, which is Zika virus, is there anything more that we
need to be helping you do in that regard?
Thank you, Mr. Chairman. I yield back on time.
Dr. Collins. Dr. Fauci.
Dr. Fauci. Thank you very much for that question.
There is something that the Congress can do. As you know,
the President asked for a $1,900,000,000 supplement to enable
NIH, the CDC, FDA, and others, a variety of other agencies to
respond to Zika. We need that money urgently.
NIAID has already started a major program in Zika research,
particularly toward the development of a Zika vaccine, and we
are doing that with no new funds. And that is not going to last
very long because in order to prepare for the next phase of
studies--that would be the efficacy studies of a vaccine--we
plan to go into a Phase I trial for safety by the end of the
summer or early fall. We could not take it beyond these studies
if we do not have the supplemental funding.
Mr. Fattah. Thank you.
Thank you, Mr. Chairman.
Mr. Cole. Absolutely. We now go to the gentlelady from
Alabama for any questions she cares to pose.
RESULTS GAINED FROM NATIONAL CHILDREN'S STUDY
Mrs. Roby. Thank you, Mr. Chairman.
Dr. Collins, as a mother of two young children, I am very
interested in the health of the youth of our Nation. And
specifically, it has come to my attention that NIH has spent an
estimated $1,500,000,000 on the National Children's Study, NCS,
since 2000. This effort was halted in 2014 based on your
recommendation.
NIH conducted a shutdown of the Children's Study in fiscal
year 2015 and fiscal year 2016. And last year, the Omnibus
provided $165,000,000 for the Children's Study follow-on. The
President's fiscal year 2017 budget requests level funding for
this program.
In your fiscal year 2017 budget justifications, you mention
that NIH will use these funds on a new program, the
Environmental Influences on Child Health Outcomes--ECHO, I
believe is what you are calling it--which is designed to study
a wide range of pediatric conditions.
The budget justification also states that the ECHO program
is designed to take advantage of existing resources left over
from the now-defunct Children's Study. So, what I want to know
is can you begin by describing first the results that we gained
from the $1,500,000,000 that we spent on the entirety of the
Children's Study? If you will start there, and then I have some
follow-up questions.
Dr. Collins. So I appreciate your raising the issue because
this has been an area of intense interest for myself and my
colleagues. The National Children's Study, originally
authorized by the Congress 15 years ago, over the course of
time developed a number of features about its design that began
to look as if they had not kept up with the technology
developments and the other opportunities.
It was painful to look at this a couple of years ago and
conclude that we needed a different approach, that we didn't
want to continue to expand a program that clearly had
deficiencies. It was not going to be as successful as we had
once hoped. And that was the reason, with much advice from
experts, that we decided it was time to close down the National
Children's Study and come up with another strategy.
There are many samples and data available from the
individuals who were enrolled in the National Children's Study,
although it was a modest number. It was all pilot programs, and
those are available to researchers who are starting to mine
through them and see what data can be derived.
But, I think at this point, we very much turned our
attention to how could we achieve the same goals of
understanding, what are the environmental influences on
children's health, and how could we get those answers now in
2016 in ways we couldn't have imagined possible 15 years ago?
HOW WILL ECHO BENEFIT FROM NCS INVESTMENT
Mrs. Roby. But explain to us how that $1,500,000,000
investment will carry over into ECHO as specifically as you
can? What can we take from all of that investment and know that
now, with this additional money, the $165,000,000 that is
requested for fiscal year 2017, how can we know that that
$1,500,000,000 is not time and money wasted?
Dr. Collins. Well, it is not time and money wasted in the
sense that there are these pilot efforts that were run that
have research samples available that people can study, which
will help us guide what kind of decisions we want to make with
the new program ECHO in terms of what kinds of lab measurements
and environmental exposures are going to be most important.
If I can, ECHO is focused, in fact, on four areas, which
seem to be particularly compelling, based on what we learned
through the study of the National Children's Study--namely,
upper and the lower airway, asthma; obesity; pre-, peri-, and
post natal outcomes; and neurodevelopment, including autism.
That is where we want to go now.
But in a way that I think will be more efficient. It will
result in more meaningful data. It will get there quicker, and
it will involve many more data access opportunities for
researchers around the country who have good ideas about how
they will learn from these, how we can do a better job of
keeping our children healthy.
UPDATE OF ECHO REPORT
Mrs. Roby. And the report that was required, in the
language in the omnibus said that you should submit a spending
plan on the next phase of the study no later than 90 days of
the enactment of this act. Where are we on that? Can you give
us some highlights?
Dr. Collins. I would be glad to. We are planning to submit
that report a few days late because we are right now at a very
formative place for ECHO.
What we are doing with ECHO is to invite those who have
been running cohorts of children where they have already
collected a fair amount of data to join this effort--and we
will make it possible for them to have additional laboratory
measures added to what they were already doing--and create a
whole that is greater than the sum of the parts, with perhaps
70,000 or 80,000 individuals, children, on whose follow-up
information we can add further data.
That is going to be, I think, something we will learn about
fairly soon. The applications are due on April 15th for the
cohorts to come in and say they want to be part of it. We hear
a lot of noise out there about that.
I am in the process of recruiting a director for this
effort and have a very exciting candidate lined up. So there is
going to be a lot to report about how we are spending this
money. We are grateful to the Congress for your confidence that
this was something you wanted to continue and provide the
resources for, and I actually think, although we have gone
through a difficult transition here, we are on the path to do
is going to be much more successful than I would have thought
possible 5 years ago.
Mrs. Roby. Thank you. I yield back.
Mr. Cole. Thank you.
We will now go to my good friend, the gentlelady from
California, Ms. Roybal-Allard.
UPDATE ON ECHO ADVISORY PANEL
Ms. Roybal-Allard. Okay. Thank you, Mr. Chairman.
And I would like to follow up on the questioning of Mrs.
Roby with regards to ECHO. I think that you said that you are
putting together that 10-year plan and that you will include, I
assume, milestones and funding estimates in that plan. And when
do you expect that the recommended advisory panel with outside
experts to be established?
Dr. Collins. Those are highly appropriate questions. At the
moment, the plan is for a 7-year effort. We would very much
want to see how we do in 7 years, but expanding to 10 would be
the hope if this project is going well because it should
continue to yield up new information as we follow these
children over time.
The advisory committee is being put together. It will be
formed as a working group of our Council of Councils. That is
important because this ECHO program involves multiple
institutes at NIH. You might guess particularly the
Environmental Health Sciences Institute and the Child Health
Institute, but others as well. And we, therefore, need to have
this positioned in a place where we have advice from expertise
across many different disciplines. That is where our Council of
Councils comes in, and that is where we are going to position
the advisory panel for ECHO.
ECHO ACTIVITIES
Ms. Roybal-Allard. The congressional justification mentions
about six research activities for which NCS funds were directed
in fiscal year 2015. Are these the existing cohorts that will
be used going forward, or are you still identifying cohorts to
include in the ECHO initiative?
And then also I want to throw in one more question because
of time. Will the array of cohorts include broad population
samples and measures that are specifically designed to compare
the study cohorts to known national samples, such as the
National Health and Nutrition Examination Survey?
Dr. Collins. Great questions. In terms of what cohorts will
be involved, we have decided this was best handled as a
competition. So we put out a Funding Opportunity Announcement
and are waiting, as I said, for April 15th to come when we see
who comes in to apply to take part. And we expect many of these
cohorts will be very interested in taking part because it gives
a chance for their work to become even more meaningful. We will
want to see that happen.
And certainly, we will want to take full advantage of
NHANES, the national study that has much data in it about
environmental exposures and a variety of other measures of
health and nutrition, to do comparisons with what we see in
these cohorts. It is wonderful that we have that kind of
foundation from other studies to do this with.
I might say there is one other aspect of ECHO that deserves
mention, and that is an effort to set up in the IDeA States,
the States that do not currently have a research-intensive
university setting, a pediatric research network. There are so
many things that we could be doing in terms of pediatric
clinical research in those States, but we are not currently set
up to do so.
And so this is a proposal to build upon the expertise. It
is happening in those IDeA States through other programs to
create a pediatric research network and enhance our ability to
understand what are the influences in children's health that we
don't know about yet.
STATUS ON NCS ACTIVITIES
Ms. Roybal-Allard. Okay. And just one final question on
this, in this area. Your congressional justification also
states that the NCS-A will be assessed starting in fiscal year
2017, and that this could drive its future direction
significantly. When will that assessment begin, and who will be
involved in doing it?
Dr. Collins. So, again, we will very much count on our
advisory group that is being put together. In fiscal year 2017,
we will have these cohorts now funded and assembled together.
There will need to be a coordinating center to try to be sure
that all of this is working in the most effective and
comprehensive way.
So fiscal year 2017 will be the point at which we will have
an assessment to see whether this model is working and
producing all the data that we believe it should.
Ms. Roybal-Allard. Okay. Thank you.
Mr. Cole. We will next go to the gentleman from Tennessee,
my good friend Mr. Fleischmann.
PMI ACTIVITIES
Mr. Fleischmann. Thank you, Mr. Chairman.
And may I say to the chairman and the ranking member, it is
truly a privilege to be on this committee. When we see what the
NIH and the related agencies are doing, it is tremendous that
we see the great cooperation and efforts made in this critical
subcommittee, and I am privileged to be part of it.
Dr. Collins, let me thank you and your distinguished panel
again. Your efforts in combating the maladies which face us on
the health front are difficult, and again, I thank you for your
successes and your continued efforts.
I have got a three-part question, which I will read through
in the interest of time. Dr. Collins, I would like to take a
moment to address the Precision Medicine Initiative. My first
question is regarding the direct volunteer portion of the
research cohort.
As you know, Vanderbilt University is playing a leading
role in piloting the direct volunteer portion of the research
cohort. Can you elaborate further on how that pilot program
will inform the initiative going forward?
The second part of my question is regarding the approaches
NIH is using for recruiting and retaining people in the PMI.
While I am pleased to see NIH adopting novel practices,
including the use of social media, to attract these volunteers,
I would like for you to address some concerns that have been
presented to me by the scientific community.
Specifically, can you address NIH plans to interpret and
understand the inherent biases the approach presents,
particularly given that many people do not use social media at
all?
Finally, is the NIH working with the NCHS or other Federal
partners that fund or conduct large representative surveys to
understand the biases in the PMI million-person cohort?
Thank you, sir.
Dr. Collins. Well, great trio of questions, and let me
answer quickly because I know we are under a time constraint.
The Precision Medicine Initiative is getting launched this
year. Many of us are working 24-7 to get this up and going and
are very excited about its potential. Again, the goal is to
enroll by 2019 a million Americans as full participants in a
study that will collect information from them, including
electronic health records, laboratory data, genome sequences,
environmental exposures, their own reports of medical
experiences.
Allow us to really, with a very large-scale longitudinal
study, understand what are the factors that are involved in
health and disease. We have never had anything like this
before, and everybody who has heard about it is pretty excited
about the kind of inferences we could learn from this
initiative.
Yes, you are right. Vanderbilt is right out of the blocks a
major part of our first launch year because they just received
an award actually in partnership with Google, which is now
called Verily, to set up the effort to do a pilot effort to
recruit direct volunteers. And I say ``pilot'' intentionally
because we need to learn more about how to do this.
Your concerns about social media being a biased way of
involving people have certainly been apparent to us, and we
don't want to depend solely on that. But at the same time, with
a partner like Google and Vanderbilt working together, we do
believe we should be able, just in a few months, to learn more
about what is it that volunteers are interested in, what makes
it appealing to them to join this effort, and what things are
they turned off by. We want to get that really clear before we
launch.
Now admittedly, we have two different ways that people can
come into this. One is by a direct volunteer route, which is
going to be open to any American starting sometime this summer.
But, also, we are asking those health provider organizations
that already are running large cohorts to come in as our
partners because they already have access to patients and
information about them.
And that will be a very substantial part of the effort, and
that won't depend on any social media concerns. All of these
individuals will need to be asked their permission, and if they
decide to consent, then they will become participants in this
historic undertaking.
We are also reaching out to the traditionally
underrepresented groups by working through community health
centers with our partners at HRSA to be sure that those
individuals also have a chance to take part. And certainly, we
are also very interested in working with NCHS and NHANES as we
get into this to be sure that the kind of data we collect will
be generalizable to the population.
We don't want a set of individuals that are so different
than the population at large that we can't do that
generalizing, and that will be important then to talk about
with those experts at NCHS, which we have already been doing.
So, I guess you can tell I am pretty excited about this.
This is really something many of us have dreamed about for more
than a decade. We really appreciate Congress' support in
getting it started this year, and the appreciation for the
consideration of expanding it even further next year as we
really launch this initiative.
Mr. Fleischmann. Thank you, Dr. Collins.
It looks like my time has expired, Mr. Chairman. I will
yield back.
Mr. Cole. Thanks very much.
We will next go to my good friend from Pennsylvania, Mr.
Dent.
COLORECTAL CANCER
Mr. Dent. Thank you, Mr. Chairman.
Good morning to the whole panel, and again, thanks for
having us up at the NIH a few weeks ago. I really enjoyed that
opportunity.
Dr. Collins, I have been very involved in working on
obviously the fight against cancer, but including encouraging
screening for colorectal cancer. In fact, you will see a lot of
those folks up on the Hill today in their blue shirts.
The NIH's NCI, cancer institute, is pursuing new cancer
research to prevent, diagnose, and treat. What are some
promising areas of cancer research in this area of colorectal?
I don't know if somebody can talk about that?
Dr. Collins. I am going to turn to my colleague Dr. Lowy,
the Acting Director of NCI, to answer your question.
Dr. Lowy. Thank you very much, Mr. Dent.
As you probably are aware, March is Colorectal Cancer
Awareness Month, and part of the Vice President's Moonshot
initiative involves screening, which you also are vitally
involved in and to try to use molecular analysis in fluids for
making this more realistic so that we can have higher uptake of
colorectal cancer screening.
One of the big problems with colorectal cancer screening is
that many people don't follow the screening guidelines, and it
is really important to try to implement what we already know
works while we are also doing research to develop better tests
and more specific tests.
I can report to you that the incidence of colorectal cancer
is going down, as is the mortality, as a result of the
screening that we have to date.
SUPER BUGS
Mr. Dent. Thank you for that answer.
I will also move to the issue of superbugs. What is the
latest information on how NIH is working with the CDC on
treating and curing these antibiotic-resistant bacteria? And
what advancements have been made in this effort and if you have
any results you could share?
Dr. Collins. Dr. Fauci.
Dr. Fauci. Thank you very much for that question.
The NIH is part of a multi-agency approach towards
addressing of problem of antimicrobial resistance. This effort
is led by the White House, which, had an executive order and a
related initiative on Combating Antibiotic-Resistant Bacteria,
or CARB. NIH is a major part of the CARB activities.
As you know, the CDC is involved in surveillance and
detection of antibiotic resistance and in providing guidelines
for the use of antibiotics. The NIH component is research to
address antibiotic resistance.
And in that regard, we are responsible for determining at
the molecular level the basis of the emergence of resistance,
number one. Number two, we conduct early screening for new
types of antibiotics. For example, there has been recently
discovered the teixobactin antibiotic, which is a soil
antibiotic. This discovery has the potential to open up the
door to a whole new class of antibiotics for gram-positive
microorganisms, particularly methicillin-resistant
Staphylococcus aureus.
In addition, we have a clinical research network, which we
have modeled on the clinical networks that we built years ago
for HIV/AIDS, to test promising antibiotic compounds. And then,
finally, the most important issue about all of this is
diagnosis.
In order to really circumvent the problem of antimicrobial
resistance, you have to be able to make the diagnosis right on
the spot. We have been working on very sensitive point-of-care
diagnostics to determine if you have a viral infection versus a
bacterial infection--because one of the biggest challenges is
the prescribing of antibiotics for a disease that isn't even a
bacterial disease. And so improving diagnostic tests for
bacterial infections is one of the things that we have been
working on.
We are also working on point-of-care diagnostics that can
determine the resistance profile of an infection. You put all
of those research activities together, along with the work of
CDC and others, and you have a rather comprehensive program. In
addition, we are participating in a diagnostic prize. We have a
$20,000,000 prize that we, the NIH, are partnering with BARDA,
the Biomedical Advanced Research Development Authority, in
order to develop a sensitive diagnostic to be able to quickly
diagnose infections and determine their resistance profiles.
FUNDING CLIFF
Mr. Dent. Thank you. Thanks, Dr. Fauci, for that.
And finally, I just want to mention in my remaining time, I
know the NIH funding cliff through mandatory spending has been
raised. We are all concerned about it, and I am concerned that
there is a decrease in discretionary funding at NIH and that an
increase in mandatory funding, which is obviously going to be
problematic.
Last year, you know, we did the $2,000,000,000 increase in
discretionary funding. This will create a funding cliff for
NIH, and how will NIH be impacted if the authorizers don't act
to provide mandatory funding?
Dr. Collins. Well, it would be pretty devastating if we
were to lose $1,000,000,000. Chairman Cole asked the same sort
of question at the outset of the hearing, and I guess I painted
a pretty gloomy picture, and it was not just because I was
feeling gloomy. It is because it would be, in fact,
devastating.
We would lose 1,000 grants that would otherwise have been
spent, would have been supported. We would, I think, have
really done terrible damage to the momentum that has been
started here in fiscal year 2016, thanks to the Congress. It
would be a terrible step in the wrong direction, comparable
only to the sequester in terms of the harm that it might do.
Mr. Cole. That was a very sneaky way because you knew I
would like that question. [Laughter.]
Mr. Cole. Very smart.
Mr. Dent. Anything to suck up to the chairman.
Mr. Cole. Yes. Well, we will next go to my good friend from
Idaho, Mr. Simpson.
IMPACT OF GOVERNMENT SHUTDOWN
Mr. Simpson. Thank you, Mr. Chairman.
And thank you all for being here today, and thanks for
hosting us out to the NIH a couple of weeks ago. I always come
back--I have been out there several times over the years that I
have been in Congress, and I always come back both amazed and
inspired.
It almost makes me feel guilty of having you all come up
here and testify because you have got actually much more
important things to do than testify before this committee. But
obviously, getting out what you do and what NIH does is part of
what is necessary.
But as we took a tour, you took us around and visited some
patients, a young man and his wife. The young man had melanoma.
And you talked to us about the treatment that he was getting,
and so forth and so on, and what you were trying to accomplish.
And somebody, I can't remember which Member it was, asked a
pretty simple question that I would like you to respond to for
the record. And that was what did the Government shutdown do to
you?
Because we sit here, and you know, most people see it
visibly as, gee, you didn't get into the national park, or
something like that, you know? Okay, go next week. I know you
travel a long ways, et cetera, et cetera, et cetera, but it is
not life threatening.
What did the Government shutdown for 16 days do to you, and
what happens if that occurs again, regardless of whose fault it
is? And we could argue that from now until the cows come home?
Dr. Collins. So I have been at NIH for 23 years. Those 16
days were just about the darkest that I can recall ever going
through. The laboratories where graduate students and
postdoctoral fellows and other remarkably talented scientists
were working were all dark. We had to tell everybody to go
home.
They were under threat of criminal prosecution if they came
onto the campus. Experiments that had been set up that needed
to go for several weeks were basically ruined and had to be
started all over again later on, if they got started at all.
But our clinical center, our largest research hospital in
the world, also very much affected by this. We were allowed to
continue the care of patients who were already there, but we
were not allowed to admit any new patients during those 16
days.
Those were people who had planned to come to NIH, their
last chance, many of them. We are the house of hope for people
where medical research is needed because there is no real
answer for what afflicts them. And we had to turn them away,
hundreds of them. And I personally had to oversee that.
The only exception was people who were at imminent danger
of death, and we were allowed to have a few, one or two or
three per day, with very high-level approval in order to do
that. And people couldn't understand this. How could this be
that something like this could have happened?
So I appreciate your asking the question. I hope and pray
we will never go back to that situation again. It was very hard
to preside over that kind of dark 16-day period and feel good
about the Government.
Mr. Simpson. I appreciate that answer, and because it is
the real effects of what happens that people don't see out
there. As I said, they can see the obvious. Trash didn't get
picked up on the way to Mount Vernon and stuff or by the Park
Service or whatever, you know? And they don't really think
about the life-threatening implications of some of these
decisions that we make that we make too light-heartedly,
frankly.
So I appreciate that answer. I could ask about a lot of the
other stuff that you have got going on, but I am not smart
enough to ask it. What I would say is that I appreciate this
strategic plan that you have given, and what I would encourage
the Members to do is to look at the last page. A few bold
predictions for America's future. Interesting.
If you think of the work that is being done out at NIH, as
I have said many times, it is the best-kept secret in America
and best-kept secret in Washington. That is both the good news
and the bad news.
And somehow we need to get the American people to
understand what goes on at NIH and how much of the research
that is done at universities and extramural programs and stuff
are done and funded by the taxpayers so that they know what
they are getting in return for the investment that they are
making. And quite frankly, we are politicians. We respond to
the public. And when there are public demands that we invest in
these types of things, that is when it happens.
So I appreciate you all being here today. I am sorry that I
have wasted your time instead of doing the important things
that you do.
Thank you.
Thank you, Mr. Chairman.
Mr. Cole. Well, I don't think my friend wasted anybody's
time, and I think that is something that needed to be heard
broadly, and I appreciate him doing that.
With the consent of the committee, we are going to move to
3 minutes so we can try and give as many people as possible an
opportunity to go. But not before Mr. Rigell gets his full 5
because you actually finish out the first order, but in the
second round, we will move to 3 minutes. But you get 5.
ALZHEIMER'S DISEASE
Mr. Rigell. Thank you, Mr. Chairman.
And I regret that I wasn't able to be here at the start. I
was, of course, at another hearing.
Dr. Collins and the full panel, thank you for being here.
We just really appreciate the good work that you do.
I have a little window into, I guess, growing old because I
have been blessed. My two parents are still doing well at 93
and 88, and you know, I speak to them every week. And there is
a sad part, though, because they will generally take me through
some of my childhood friends' parents that I knew growing up,
and they will just kind of walk through that so many of them
have Alzheimer's.
And of course, I knew them growing up, and that is just my
little window into this profound challenge. You know, we have
done a real good job I think generally of lengthening life, but
the quality of life side is lagging a bit.
And as it relates to Alzheimer's, and I don't have all the
quantitative data that I want right now. I am kind of working
in that direction. But I think that as we have increased the
funding sharply on a bipartisan basis, which I think is a real
win, but I wonder and I wrestle with this, that even though we
are in a great fiscal stress and that has my full attention, it
seems to me that this particular area warrants sharply
increased funding.
I mean, like this is a major national priority for a host
of reasons. And some of them, in all candor, are economic. I
mean, just the fact if we could get a hold of this. And so
would you comment on that, please?
And also how much funding could we--in a perfect world, if
you could have more--you know, at some point, you get
diminishing returns. You just can't put it all to good use. I
mean, you hadn't had that problem yet.
But how much do you think you could absorb and really,
really leverage the dollar and get the most out of it? And I
want to give you time to respond.
Dr. Collins. I am going to ask Dr. Hodes, who is the
Director of the National Institute on Aging, as our lead on
Alzheimer's disease, to answer your question.
Dr. Hodes. Well, thank you. Thank you for the question.
It is certainly true that just about everyone has had their
lives touched by loved ones, family members, who have suffered
from Alzheimer's disease. And with the great success of the
biomedical enterprise and the public health enterprise of
increasing life span, the projections are that unless we are
able to intervene better, there is just going to be more and
more of this. So it certainly is an area, among many you have
heard about today, which is in dire need of further research
and support.
In terms of the very direct question about whether a given
level of funding can be wisely used, it is a critical question.
It is not enough to have simply an urgent public health
imperative. We also have to have confidence that there is a
scientific opportunity behind it.
And one of the opportunities to test that has actually come
with the congressional request or requirement of NIH to deliver
a bypass budget each year--last year was the first one--which
asks us to estimate the degree of increased funding that would
be needed to maximally pursue an efficient spending in support
of research towards the goal, an end.
And we have taken this very seriously. When we have
composed that bypass budget, which was first released last July
for the 2017 budget, we began by convening groups of experts.
Last year, a summit of several hundred national and
international experts told us what the opportunities were, what
the priorities were. We translated that into milestones, all of
which are available in as much detail as people would like in
an online database.
And this was the real scientific estimate of what we could
accomplish or level of funding as an increment we could use in
fiscal year 2017. We knew when that budget was submitted that
there was a possibility, of course, that accelerated funding
could come in 2016, but we were not sure. And we thank you ever
so much for the fact that money was forthcoming.
What that money allowed us to do was to carry out the very
thoughtful plan accelerating what we proposed could be done
with increased funding in 2017 and using it in 2016. Now in
July of this year, we will be forwarding--Francis Collins on
behalf of NIH--the fiscal year 2018 bypass budget, which
really, I think, appropriately calls us to do just what you are
asking, to account for what level of research could be done to
ensure that we can have research supported efficiently without
any compromise in its quality with the resources available.
Mr. Rigell. So within NIH, I mean, there is--and I think I
have got about 20 seconds left here. But I mean, there is, I am
sensing here, just a true recognition that this is not to the
exclusion of other diseases and other things that are
afflicting us in our human journey, but this particular
challenge is getting increased recognition as one that really
needs to be addressed.
And Dr. Collins, perhaps you can close it out here?
Dr. Collins. If I may? I think we are not limited by ideas
about interventions that might be successful. We are not
limited by talent of scientists, all the way from basic to
clinical, who are really fired up about tackling this disease.
So resources are, in fact, much appreciated, and we have
nowhere near hit the point where we don't know what to do with
them. And again, the bypass budget is a great way to sort of
see if resources were available, what could we do? We could go
faster, and goodness knows, we need to. The cost of this
economically, over $200,000,000,000 every year.
Mr. Rigell. I thank you all.
Thank the chairman for the additional time.
NATIVE AMERICAN HEALTH
Mr. Cole. Thank you.
And again, we will move to 3 minutes, and I just do want to
add parenthetically, it was extraordinarily helpful to this
committee to have access to that kind of data in our decision-
making last year. So I would encourage you to continue that.
As you know, Dr. Collins, I have got a particular interest
in Native American issues, and just quickly, I know you look at
particular populations, and not everybody is the same.
Obviously, there are gender differences, racial differences,
all sorts of things. Can you give us an update on what the NIH
is doing specifically to address Native American health issues?
Dr. Collins. Well, we are very concerned about all
populations in the United States, and American Indians are a
special group, both in terms of their history, their culture,
and their tribal sovereignty, which has a major effect in terms
of participation in research that we need to be very respectful
of, and we aim to do that in every way.
Actually, thanks to the leadership of my Principal Deputy,
Dr. Tabak, NIH initiated a Tribal Council Advisory Committee,
bringing representations of the American Indian community to
NIH to listen carefully to what they see as priorities that we
should be focused on and to engage with them in topics like the
Precision Medicine Initiative.
And there are sensitivities there, particularly about what
kind of information is being derived about ancestry, what kind
of access to the information will be provided to people outside
of the community. As you know, there have been experiences in
the past that American Indian communities have gone through
that causes them to be somewhat less than completely confident
that researchers are always working in their best interests--
the Havasupai example, for instance.
So we really need to understand that. In that context, I
think we do have a number of important programs that have been
ongoing for a while. I think of the Strong Heart effort that is
looking at heart disease, for instance, in Indian Country that
has been conducted by the Heart, Lung, and Blood Institute.
And on a particular project that I have just recently read
about that we are supporting, which is aiming to try to deal
with high-risk pregnancies in the Native American community and
particularly providing resources to women who are about--early
in their pregnancy about how to maintain a situation that will
result in a good outcome, with a very impressive outcome of
that particular pilot project that has now been implemented
across many different tribes across the U.S.
So we are always looking for ways that we can do research
that is acceptable and embraced by the community, but very
sensitive to the special nature of those concerns in those
communities.
Mr. Cole. Thank you very much for that and appreciate it
very much.
And in the interest of time, I will move directly to my
good friend, the Ranking Member of the Full Committee.
Mrs. Lowey. I am going to talk very quickly, Mr. Chairman.
First of all, I want to say, Dr. Collins, your 7 years of
service have left an indelible mark, and I hope you continue
your work because we really appreciate you.
Thank you.
Secondly, ``even the lab rats are all male'' has been a
great laugh getter at cocktail parties, but it is really
serious. And I hope that will continue because it is
unacceptable.
Third, Dr. Volkow, I appreciated Dr. Harris' comments. I
don't think the majority of people in this country understand
the serious impact of marijuana on the brains, 12 to 18, 18 to
25, and I do hope you can be aggressive in getting this message
out.
VACCINES
And I thank you, Dr. Harris.
And lastly, my friend Dr. Fauci, the Zika vaccine. We know
the seriousness of dengue. We know the seriousness of
chikungunya, and I wonder, if there are any seconds left,
whether the Zika vaccine, they all come from mosquitoes, same
areas, will certainly have an effect on chikungunya and dengue?
Dr. Fauci. Thank you for the question, Congresswoman Lowey.
We have a vaccine for dengue, one that has been approved in
Mexico and the Philippines and Brazil. It is not as effective
as we would like. It is about 67 percent effective.
The NIH started in January a Phase III trial for an NIAID-
developed dengue vaccine in Brazil in association with the
Butantan Institute. For chikungunya, we have data from a Phase
I trial of a vaccine we developed that shows the vaccine is
safe and induces a good immune response. We have had some
trouble, and I don't think we are going to have much more
trouble, in getting pharmaceutical partners to work with us for
the advanced development of this vaccine candidate.
I think the Zika outbreak has really emphasized the urgency
of responding to these outbreaks because we now have
pharmaceutical partners who are interested in working with us
on a chikungunya vaccine. Importantly, for Zika, although there
are always challenges in the development of a vaccine, we
desperately need a Zika vaccine to protect pregnant women
because they are the most vulnerable to negative outcome from
Zika. If you get infected during your pregnancy, there is a
disturbing percentage of fetal abnormalities.
We will start a phase I trial of a Zika vaccine candidate
likely in September of 2016 based on the expertise that we have
developed over a decade or more in working with vaccines for
similar viruses. And I want to thank you and the committee for
supporting the work we have been doing and our ability to
respond rapidly to emerging infectious diseases.
We have about six Zika vaccine candidates that are in the
queue. The one that is the furthest ahead, we had a meeting 3
or 4 days ago with the FDA to discuss plans for the Phase I
trial that I mentioned would likely start in September, and
then transition into a Phase II trial likely by the beginning
of 2017.
How fast we get an answer on whether the vaccine is safe
and effective will depend on two things. One, how effective it
is. And two, how many infections there are.
If there still is a big outbreak in 2017, we will get an
answer much more quickly. If the number of infections go down--
it will be good for the public health--but it may take longer
to get an answer on the vaccine's effectiveness. But we are
vigorously pursuing Zika vaccine development.
Mrs. Lowey. And I just want to say, Mr. Chairman, I
appreciate your leadership and our Ranking Member and the whole
Committee in getting the extra $2,000,000,000 and I appreciate
this extraordinary panel and all the work you are doing.
And I look forward to working with you so we can say the
chairman of this committee has doubled once again in a
bipartisan way money for the National Institutes of Health
because I can't, frankly, think of a more important investment.
And thank you so much for all the really important work you do
and your leadership.
Let us do it, Mr. Chairman. We will go down in history.
Thank you.
Mr. Cole. Are you advocating for my budget, or are you just
pressuring me? [Laughter.]
Mrs. Lowey. A little bit of both.
Mr. Cole. A little bit of both. With that, we will go to my
good friend Mr. Simpson again. Members are advised we are at
the 3-minute limit.
NIH AND DOE RELATIONSHIP
Mr. Simpson. They have already started timing, and I just
barely got--no, quick question. The Cancer Moonshot that the
President announced in his State of the Union and, by the way,
which I think was great. I support it. Republicans don't always
criticize everything the President does.
I think this is a good start. It is Government wide. I
chair the Energy and Water Development Subcommittee. The
Department of Energy is going to have a role in this also. They
are getting more and more involved in the biological sciences
and stuff. And when I ask them about it, they say, well, you
know, we were originally involved in the biological sciences
because of radiation and the cancer caused by radiation from
weapons development and other things over the years and stuff
like that.
What is the relationship between NIH and the Department of
Energy? What are we looking at in the future? What will be that
relationship, do you know?
Dr. Collins. Well, I will start by saying there is a task
force at the highest level, which was appointed to support this
effort across Government with the Vice President's leadership,
and that very much includes the Department of Energy, as well
as FDA, NIH, strong input from NSF, and a variety of other
parts of the Government that are involved here, including
Commerce because of IP issues.
But I will turn to Dr. Lowy, who could tell you something
about a direct involvement that is already ongoing between DOE
and the Cancer Institute.
Mr. Simpson. And when you answer that, could you also talk
a little bit about radio--or the medical isotopes, and with the
Canadian reactor shutting down, are we going to have access to
the medical isotopes that are necessary?
Dr. Lowy. Thank you, Dr. Simpson.
First, with regard to the Department of Energy, we have
initiated very recently three pilot projects with them in
cancer research, and they will form a key part of the Moonshot,
and we are continuing to have ongoing extended discussions with
people from the Department of Energy, including Secretary
Moniz, about further extending this because largely they have
extraordinary computing power and also machine learning, which
is able to do things that really would be extraordinarily
helpful in the cancer research area.
Given the time, let me get back to you for the record in
terms of the isotope issue.
Thank you.
[The information follows:]
Medical Isotopes
Thank you for the question, Congressman. We do expect to have
access to the medical isotopes we need in the United States, both for
medical research purposes, and for their use in medical imaging needed
to diagnose and monitor cancer and other conditions outside of the
research setting. The critical isotope is known as molybdenum-99
(Mo99), which is processed into generators that make technetium-99m
(Tc-99m), which is widely used for cardiac and bone scanning, as well
as scans of the thyroid. The enactment of the American Medical Isotopes
Production Act of 2012 positively supported reliable supplies of Mo-99
produced without highly enriched uranium (HEU), and NCI and others no
longer need to rely on the Canadian reactor for their supply of Tc-99m.
NCI also participates in an interagency effort led by the Department of
Energy's National Nuclear Security Administration and the Office of
Science and Technology Policy to continue to support sustainable means
of producing Mo-99 without using HEU.
Mr. Simpson. Thank you, Mr. Chairman.
Mr. Cole. Thank you.
With that, we will go to the Ranking Member of the
subcommittee, my good friend from Connecticut.
PRECISION MEDICINE AND CANCER RESEARCH
Ms. DeLauro. Thank you, Mr. Chairman. I am going to talk
fast.
On antibiotic research, I just came from an Ag Committee
hearing. I just will say this to you. Seventy percent of
antibiotics sold in the U.S. are bought for livestock
production. There is industry guidance today that is voluntary
through the FDA.
I don't know what collaboration you have with USDA, with
FDA, but it is critical. We should not be in silos here. You
talked about 23,000 deaths. If we know what is going on, let us
get their research, your research, and look at how we can cut
that number in half, as you said last year, Dr. Collins, that
we could do.
So it truly is unbelievable, and it is voluntary. We need
to think about guidance--not guidance, voluntary guidance. We
need to think about how we tell people that and the
pharmaceutical companies that in a mandatory way, in my view.
Let me move to the Precision Medicine Initiative, and I
will just cut to the chase. I was alarmed by a New York Times
article that raised concerns about the lack of success in
utilizing genetic testing to identify personal treatment for
breast cancer patients.
Just Dr. Lowy, Dr. Collins, what is the clarity on this
issue and guidance to practicing breast cancer physicians or
patients?
Dr. Lowy. Thank you very much, Ms. DeLauro.
I think that this area really exemplifies both the
strengths and the limitations that we have of any clinical
test. You do a clinical test, and for some people, it is
enormously helpful. And for other people, the results are
ambiguous.
The genetic tests that we have can be enormously helpful in
pointing people with cancer in the right direction in terms of
treatment, but not for all of them.
Ms. DeLauro. But is it accurate in terms of the success
that has been in other areas other than breast cancer? Is
breast cancer a specific disease that is not responding to PMI,
or am I--or is this article off base? But help us.
Dr. Lowy. There have been--there have been specific
inhibitors. For example, Herceptin, which was the first
targeted inhibitor, was specifically for breast cancer, and EGF
receptor inhibitors. So there are specific inhibitors for
breast cancer. The problem is that when you get an abnormality,
not all of them are clearly actionable, and not all of them are
going to be responsive.
Ms. DeLauro. I would like to continue this conversation to
look at breast cancer particularly. And I might just ask you to
take a look at the Wall Street Journal this week. Bristol, and
this is Bristol-Myers Squibb bets against Precision Medicine. I
would ask you to take a look at it and tell us, you know, what
Bristol-Myers Squibb is thinking about or talking about when we
are trying to move in this direction.
ZIKA
Ah, I have got 4 seconds left. La-da-da. All I will just
say is, and this is to Dr. Fauci, if, one, I want to make sure
that any vaccine that we deal with for Zika is going to be
available and affordable for people. This is this reasonable
terms issue.
But secondly, I will just offer my view. I think it is
critical for us to deal with supplemental emergency resources
in order to address this issue and this problem. You are right.
I will tell you that we are now sending blood products to
Puerto Rico in response to a Zika outbreak.
What happens when we are looking at a blood supply that is
potentially going to be difficult or people are not going to
understand the safety of a blood supply with regard to Zika,
and what kind of problems that is going to cause here in the
U.S.? And let me just tell you, American women are not going
to--they are going to be outraged if we are not doing something
about them and about their ability to be pregnant and to bring
a child to term.
So thank you for the great work that you are doing in this
area.
I have another question, but that is okay.
[Laughter.]
Mr. Cole. Well, I am not sure that was a question, but it
was----
Ms. DeLauro. Genetically modified mosquitoes. Are they--is
it--genetically modified mosquitoes?
Mr. Cole. I am going to ask the gentlelady to take that one
for the record.
Ms. DeLauro. Okay. All right. Thank you.
[The information follows:]
Resarch on Mosquitoes
The National Institute of Allergy and Infectious Diseases (NIAID)
conducts and supports a wide variety of vector research that aims to
reduce the spread of infectious diseases, including research focused on
the mosquitoes that carry flaviviruses such as Zika. NIAID supports
research on mosquito biology, host-virus interaction, novel vector
control methods, new insecticide targets, and vector competence studies
to understand the replication and transmission of flaviviruses and
other pathogens. Currently, NIAID is supporting research on methods to
reduce the population of the Zika virus vectors, Aedes aegypti and
Aedes albopictus, including studies to evaluate the efficacy of
Wolbachia bacteria as a vector control strategy against these
mosquitoes. NIAID is in discussions with researchers pursuing a variety
of novel approaches to vector control, including the development of
several genetically modified mosquito approaches currently under
investigation for control of infectious agents, including Zika virus.
Evidence regarding the impact of transgenic mosquito technology on
disease still needs to be generated. It is possible that the use of
transgenic mosquitoes over a large area may not be sufficient and that
other supplementary vector control methods may need to be used as well.
One example of a company NIAID is currently discussing transgenic
mosquito technology with is Oxitec, the company that has tested its
self-limiting mosquito technology in controlled release studies in
Brazil
Mr. Cole. Because I want to make sure our remaining two
Members get an opportunity.
So, with that, Mr. Harris, you are recognized for 3
minutes.
MARIJUANA ADDICTION
Mr. Harris. Thank you very much.
Dr. Volkow, let me just continue and just follow up a
little bit because the marijuana use and full legalization is a
huge issue. It comes before this Congress. It is, you know, we
have a rider that affects the District of Columbia on our
appropriations bills usually.
And let me just--you know, you were a co-author on a 2014
review article in the New England Journal of Medicine, pretty
prestigious medical journal. And let me just review some of the
statistics in it and just confirm that these are still true.
With regard to marijuana addiction, although the overall
rate is around 9 percent, if you look at young users or if you
look at daily users, it is higher with young, perhaps as high
as 17 percent. Daily users, 25 to 50 percent. Is that still
true? That is still the state of our knowledge?
Marijuana dependence, though, can be much higher, and
depending upon other--because it depends on other factors as
well, can even be twice that, 20 percent just in general use.
With regard to the gateway theory, because this is
continually controversial, my best understanding is there is
some reason to believe from other studies in rat models that
potentially there is a gateway. It is a gateway drug, but it is
still not clear whether that is true in humans. Is that true,
or are we developing an understanding that it, in fact, is a
gateway drug to other addictive behavior?
Dr. Volkow. Animal studies, there is evidence that, yes,
marijuana could change the sensitivity of the reward centers of
the brain to other drugs, which would provide a means by which
you become more vulnerable for addiction. But you cannot
necessarily directly translate into humans, and the issue in
humans is still being investigated.
Mr. Harris. Okay. So, but it is not settled science that it
is not a gateway drug in humans?
Dr. Volkow. It is not. And all of the epidemiological
studies show that it is a drug that frequently precedes the
addiction to other drugs.
Mr. Harris. Right, and it is associated with or it is
causal. I understand. I did animal research. I understand you
can't always extrapolate to humans.
Finally, which was interesting to me that when you look at
the effect on school-age children, and if you are not careful
in how you control the access to children in school, that it
impairs critical cognitive function for days after use, which
was interesting. And that was stated in the article. Is that a
fact?
Dr. Volkow. That has been replicated by independent
investigators.
Mr. Harris. So that if we don't write the laws carefully
and you allow children in school access to it, that critical
cognitive functioning can, in fact, be impaired for days. And
this is--and again, this is in the setting of where we want to
actually have children go to school and learn and be
cognitively functional.
From a scientist point of view, would you urge
jurisdictions that are looking into fully legalizing marijuana
to exert extreme caution in taking that position at this point?
Dr. Volkow. I basically ask people to look at what the data
is telling us. We have seen consistently that the most
devastating effects of drugs in our country are from the legal
drugs, not from the illegal. Not because they are more
dangerous, but the legal status makes them much more available
and more likely to expose many more people and explains why we
have so many more adverse effects from legalization.
So I always say do you want to have a third legal drug? Can
we as a nation afford it?
Mr. Harris. Thank you very much. I yield back.
Mr. Cole. Thank you.
Now for the last question of the day, we go to my good
friend, the gentlelady from California.
ZIKA VIRUS'S RELATIONSHIP TO MICROCEPHALY
Ms. Roybal-Allard. Dr. Fauci, my colleague Congresswoman
Herrera Beutler and I have recently started a new congressional
caucus on maternity care to promote optimal birth outcomes for
women and to highlight issues like the Zika virus that pose a
risk to childbearing women. And so we have been following with
great interest the World Health Organization's finding and
counsel regarding this disease.
The Committee stressed the urgency for research and
development of the Zika virus vaccine, which you have talked
about earlier. But the WHO urgency committee also recommended
both retrospective and prospective studies of the rates of
microcephaly and other neurological disorders in areas known to
have had Zika virus transmission, but where such clusters have
not been observed.
So my question is whether or not it is possible that the
Zika virus has been responsible for cases of microcephaly in
the United States over the past three to four decades, and has
there ever been any tracking of this birth defect to see if
there have been clusters or increased incidences of it in the
United States?
Dr. Fauci. That has not been formally examined with regard
to retrospective studies, but there has been no Zika virus in
the United States previously. We know that is true because when
we do serological surveys of what has been in the United
States, we have not detected locally acquired Zika virus in the
United States.
What we have now in the United States are more than 190
cases that have been imported, mostly people who have been in
the Caribbean and South America who were infected there and
came back home to the United States. What we haven't had is
local outbreaks of Zika virus in the United States similar to
what we did see a few years ago with dengue in Florida and
Texas and with chikungunya in Florida.
There is a very important surveillance capability, which
will tell us the answer to your question--we haven't had Zika
in the United States in the past--but will also tell us if and
when we do have Zika outbreaks in the United States in the
future. And unfortunately, it is probably likely that we will,
as the summer comes, see local outbreaks, particularly in the
Southeast, the Gulf Coast States, Texas, Florida, et cetera,
because the mosquito--Aedes aegypti, which is the major
transmitter of Zika virus--is in those areas of the country, as
it is in Puerto Rico and in South America.
Finally, what we do have in South America are cohort
studies to determine definitively what is the fundamental
baseline level of microcephaly and what is the relationship of
microcephaly to pregnant women infected with Zika. Two relevant
studies were recently published. One came out a week ago,
showing that if you looked at Zika-infected women who were
pregnant and pregnant women who were not infected with Zika in
Brazil, 29 percent of the Zika-infected women had ultrasounds
indicating abnormalities of the fetus, which is very
disturbing. This is the reason why we feel very compelled to
develop a vaccine to protect not only the people in South
America and the Caribbean, but if necessary, if it comes to
that, in the United States.
Ms. Roybal-Allard. Let me just give you the personal
reason, my personal interest in this particular area. My
grandson was born with microcephaly. This had to be probably
over about 12 years ago. And as a result of that, both my
daughter-in-law and my son took every test imaginable to find
out what the cause was, especially since they planned on having
other children. And they could find nothing, none of that
research.
And so I am just wondering, we are trying to figure out
what possibly could have been the cause?
Dr. Fauci. There are a number of causes of microcephaly.
That is an excellent question, Ms. Roybal-Allard, a very
important question. People sometimes get the misimpression that
microcephaly is only associated with Zika because of the
publicity we are seeing now about Zika.
Microcephaly has been observed in infants forever, and it
is typically associated with something that happens usually in
the first trimester. The cause could be a viral infection such
as cytomegalovirus, or CMV. The cause could be any of a number
of viral infections. The cause can be fetal alcohol syndrome.
The cause could be a variety of things that interfere with the
developmental process, usually concentrated in the first 15 to
20 weeks of pregnancy.
Although we do know now from a recent study that even women
who get infected with Zika in the second and early third
trimester can also have abnormalities in the fetus. These
abnormalities may not necessarily be microcephaly, but the
abnormalities are nonetheless concerning. Again, this gives us
further motivation to develop a vaccine.
Dr. Collins. Another cause, just to mention, is genetics.
And in the days gone past, it was very hard to actually nail
that down. The technology wasn't good enough.
Now that we have the ability to look at the complete genome
sequence in a situation like that, and many centers are now
doing that, we are uncovering causes of microcephaly that are
due to DNA changes that we previously didn't know about.
Ms. Roybal-Allard. And now they have three healthy,
beautiful----
Dr. Collins. And that is wonderful.
Ms. Roybal-Allard [continuing]. Bright, intelligent----
Mr. Cole. Well, thank you very much, Dr. Collins. Let me
begin by thanking you and your colleagues for not only your
appearance here today, but obviously, your accessibility to all
of us when we have questions. And appreciate the wonderful work
that you do.
This may be--well, we will have plenty of opportunities to
continue to work together, may be your last appearance before
this committee. That will be a decision, I would suspect, of a
new President of the United States at some point. But we hope
it is not your last appearance here, quite frankly, just
speaking for myself personally.
And I again want to thank you for the exceptional
leadership that you have shown at the NIH for a lifetime, and
that would go to all of you, quite frankly, of putting the
health and security of our people, but all people as your
principal goal in life. It is a quite remarkable achievement,
and you are all very, very distinguished in your own fields.
And to see the manner in which you collaborate together and
work across disciplinary lines and institutional lines is
really very, very inspiring. And so we, again, just appreciate
the values that you show and the basic and decent humanity that
each of you exhibit.
And it is no surprise to me that it is the NIH that tends
to bring this committee together, where it puts aside partisan
differences, ideological differences, and really does try to
work in common to advance and support the splendid work that
you are doing. And I am sure that will continue.
We have plenty of other things, I guess, we can fight
about, but this isn't going to be one of them. This is going to
be one of the areas where we work together and, frankly, where
we protect the discretionary funding that you got last year due
to the bipartisan efforts on this committee. And well, we try
to build on that, and frankly, where hopefully, Dr. Collins, we
can go to the sunny question I asked you in the first round,
and that is perhaps do a little bit better than even the
President proposed, who certainly has proposed a generous
increase.
But if we can go beyond that and put additional means in
your hand, then I know, on a bipartisan basis, we will want to
do that.
So thank you, and we are adjourned.
Ms. DeLauro. Thank you very much, Mr. Chairman. You speak
for all of us.
Thank you.
Mr. Cole. Thank you.
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Tuesday, March 22, 2016.
DEPARTMENT OF EDUCATION
WITNESSES
HON. JOHN KING, SECRETARY, DEPARTMENT OF EDUCATION
THOMAS SKELLY, CHIEF FINANCIAL OFFICER, DEPARTMENT OF EDUCATION
Opening Remarks by Chairman Cole
Mr. Cole. Good morning, Mr. Secretary. It is my pleasure to
welcome you on your first visit to the House Subcommittee on
Labor, HHS, and Education to present your budget request for
fiscal year 2017 for the Department of Education. We are
looking forward to hearing your testimony.
And I want to congratulate you again on your recent
confirmation. As we all know, watching the Senate: that is no
small feat, so well done.
Since the subcommittee last met to discuss the Department
of Education budget last year, Congress achieved the
significant and long overdue accomplishment of reauthorizing
Federal K-12 education programs through the Every Student
Succeeds Act. This legislation streamlined and improved many of
the Department's programs and devolved much of the authority
over K-12 education issues to the States and school districts
and was a tremendous bipartisan and bicameral achievement.
The next step is to support States and school districts in
their new role by providing sufficient resources to help them
build capacity. I have concerns about whether your budget
request for fiscal year 2017 for the key formula and block
grant programs that support all States and school districts,
including IDEA, Title I, and the new Student Support and
Academic Enrichment State Grant, is sufficient to successfully
implement the new law.
In addition, you propose almost--or over $7 billion in
mandatory spending that the Subcommittee has neither the
authority nor the inclination to implement. We will have to
remain in discretionary allocation that the full Committee
ultimately allocates to the Subcommittee.
With regard to higher education, the Department plays an
important role not only in assisting students to finance higher
education, but also in helping them to prepare for, complete,
and succeed in their studies. I was happy that we were able to
maintain funding for Pell Grants and provide a significant
increase for TRIO and GEAR UP in fiscal year 2016. I look
forward to hearing more about your proposals to make higher
education more attainable and affordable to students most in
need in the upcoming year.
I look forward to having a discussion with you this morning
to identify your top priorities for the year so that we can
invest the American taxpayer dollars in the wisest way, given
our funding constraints.
As a reminder to the subcommittee and to our witnesses, we
will abide by the 5-minute rule so that everyone will have a
chance to get their questions asked and answered.
I would now like to yield to my good friend, the Ranking
Member of the full Committee, the gentlelady from New York,
Mrs. Lowey, for any opening remarks she cares to make.
Opening Remarks by Ranking Member Mrs. Lowey
Mrs. Lowey. I want to thank our Committee Chair for your
leadership of this committee. It is a pleasure to be here
today.
Before I begin, Mr. Chairman, I want to note that Tom
Skelly, the highly respected CFO at the Department, is making
his last appearance before the Subcommittee today. You have
been an indispensible resource--42 years in Government
service--I understand. We congratulate you on your much-
deserved retirement, and we wish you the very best of luck.
Thank you.
Mr. Skelly. Thank you, Mrs. Lowey.
Mrs. Lowey. Okay--so, for today's students to be successful
in the 21st century economy, we need a renewed focus that will
enable them to compete in the global market. It is imperative
that implementation of the Every Student Succeeds Act be swift
and thorough.
And I know, Secretary King, you are aware of Common Core. I
think we have had many discussions about that, and we know that
in New York, policies can succeed--or elsewhere--or fail based
on their implementation. It is my hope that with the ESSA, we
can learn from what has worked and what has failed to ensure
that this new law provides students, teachers, parents, and
administrators with the tools to provide children with the best
education possible.
I know you care deeply, Mr. Secretary, about this mission.
I look forward to hearing your testimony on how we can best
achieve it.
In December, this committee came together to make sizable
investments, particularly in K-12 education. Among those were
increases in Title I grants to school districts for students in
need as well as increases in IDEA special education funds.
Still, much work remains, and we must build on last year's
effort.
You come before us today with a budget request that would
provide the Department of Education with an increase of 2
percent, or about $1.3 billion. Your budget includes advances
in computer science, STEM, and career technical training to
help students gains the tools to smoothly transition to the
workforce.
I am pleased that the President has proposed measures to
increase college affordability, such as year-round Pell and
bonus incentives for students to take additional credits.
Together, these initiatives will help low-income students,
increase graduation rates, and reduce debt, all while allowing
them to enter the workforce faster, increasing their earnings
and stimulating our local economy.
The President's Pell initiatives are a win-win, and I hope
that Congress acts to make these proposals a reality for
students. However, as you know, Pell is not available to
everyone. That is why the Federal student loan programs,
including Direct Loans, Perkins Loans, and Federal Work Study,
are so vital.
Student loan debt is not just a check that is written at
the end of the month. It is a weight on the shoulders of those
trying to build a career and can make it more difficult for
hard-working Americans to save for a home, for retirement, and
one day to pay for college for children of their own. I look
forward to hearing more from you on how we can increase college
affordability and reduce the debt burden on our students.
Lastly, I would be remiss if I didn't mention your proposed
cuts to after-school programs. For many students, particularly
in underserved areas, funding through the 21st Century
Community Learning Centers provides after-school enrichment and
a safe place for students to learn and develop their skills. I
would like to hear from you what led to this proposed cut,
especially when additional after-school programs are badly
needed in communities throughout the country.
Thank you.
Thank you, Mr. Chairman.
Mr. Cole. I thank the Gentlelady.
Next, I want to make a point, and then I want to go to my
friend, Mr. Fattah, who is effectively Acting Ranking Member
today. I know you are aware of this, Secretary, but we have
three Members traveling with the President today--so that is
why attendance is a little bit sparse.
They are three of our most dedicated Members. They are
almost always here, but they trust Mr. Fattah so much that they
have left him, single-handedly, to hold us all off. So, with
that, I recognize my very good friend from Pennsylvania for
whatever opening remarks he cares to make.
Opening Remarks by Mr. Fattah
Mr. Fattah. I thank the chairman, and I thank him moreover
for his leadership on many of the issues affecting education we
have worked together on over the years.
One area is GEAR UP, and I would be interested in hearing,
I know that the proposed $69.4 billion budget would hold GEAR
UP at a hold harmless number from last year. Last year's number
was an increase, in part because of many people on the
committee support it, but mainly because the chairman was
prepared to hold the line on that increase.
I was out in Oklahoma at the University of Oklahoma and saw
some of the GEAR UP kids in a pre-engineering program just
doing a fabulous job--so I am going to be very interested.
This is the Nation's largest early college awareness
program. I authored it some 17 years ago. Millions of young
people have benefited. The graduation rates are above the
national average, as are the college completion rates.
I am interested in where the Department may go inasmuch as
it is a great program, but it is still at the margins. That is,
we still have so many of our young people and schools that are
not benefitting from a program like GEAR UP, and we still have
a need, as the President has laid out, to return the Nation to
being the number-one nation in the world producing college-
educated adults.
We have a program that works. It works in rural communities
and urban communities. It works particularly among populations
that we have had challenges with in terms of educational--
access to educational opportunity and, therefore, attainment. I
am interested in where you sense we can go in terms of creating
a college-going culture in communities that heretofore haven't
benefited from even our most successful efforts like GEAR UP.
Now I have worked with the administration on the American
Opportunity Tax Credit, and I sponsored the bill that created
it in 2009. It has helped millions of people and put billions
in the pockets of families to pay for college costs. And you
know, I know that we have now made it permanent in the tax
code, which is a major achievement and a partnership between
the Congress and the administration to make another $10,000
available.
It is not coming out of the education budget. It is coming
via the IRS, but it is part of the puzzle with the maximum
Pell, the tax credit, work study.
But as the Ranking Member from New York, Nita Lowey, said,
we also have to deal with loan repayment issues. It may come as
a surprise to some, but we tucked into the Affordable Care Act,
when we passed it, a loan repayment plan that allowed young
people to have parts of their loan forgiven to the degree that
they engage in public service; if they join a local police
department or they become a teacher or a local public servant
in some capacity.
They can have a fifth of their loan retire each year that
they serve in a public-spirited opportunity in their local
community. I want to hear more about where we are and have that
being known to more young people being taken--for them to take
advantage of.
And the last question is around--and it is going to be part
of your prepared testimony, I understand--this whole question
of equity. You came out of the New York circumstance, so you
know all too well that young people in our rural and urban
communities still have the least of everything that we know
they need in order to get an education compared to those in our
wealthier suburban communities--so I am interested in the
department's efforts in this regard.
We want to welcome you today, and I thank the Chairman.
Introduction of Witness
Mr. Cole. I thank the Gentleman.
And Mr. Secretary, it is indeed a great pleasure to have
you here today, and you are recognized for whatever opening
comments you would care to make.
Opening Statement by Secretary of Education John King
Secretary King. Thanks so much.
Chairman Cole, Ranking Member Lowey, and members of the
Committee, thank you for inviting me to discuss the
Department's 2017 budget, the first under the new Every Student
Succeeds Act. I look forward to building up on our bipartisan
collaboration as we implement ESSA and work to address our
biggest challenges in education.
Increasing equity and excellence in public education has
been my life's work. Before joining the Department, I led the
New York State Department of Education and served with Uncommon
Schools, a network of high-achieving charter schools.
I began my career as a high school social studies teacher
and co-founded one of the highest-performing urban middle
schools in Massachusetts. I am also the proud parent of two
public school students. These experiences inform and inspire
every decision I make at the Department.
This year, the Agency is focused on three principles, which
reflect themes in our budget. First, ensuring every child has
the opportunity to access a quality education. Second,
supporting our Nation's teachers and elevating the teaching
profession. Third, improving access, affordability, and
completion in higher education. Allow me to take each of these
in turn.
The budget invests in programs to increase educational
equity so all children--regardless of background, native
language, zip code, or disability--can achieve their potential.
For example, the budget ensures our youngest learners get a
strong start through President Obama's landmark Preschool for
All initiative.
In addition, the HHS budget increases funding for the
jointly administered Preschool Development Grants. To help
close opportunity gaps, the request provides $15 billion for
Title I, which is a cornerstone of the Federal effort to ensure
that all students, especially our most vulnerable, graduate
from high school prepared for college and careers.
The Computer Science for All proposals would advance
comprehensive State and local efforts to offer rigorous
coursework for all students, with a focus on those who have
been underrepresented in the STEM fields.
The budget also would support community efforts to improve
the educational and life outcomes for children and youth. The
request increases funding for the Promise Neighborhoods
program, for example, as well as Native Youth Community
Projects, which support community-driven, comprehensive
strategies to improve the college and career readiness of our
Native children.
Through our Stronger Together initiative, we would help
local leaders create more high-achieving, socioeconomically
diverse classrooms and schools. In today's knowledge-based
economy, we know we must do more to provide students with
rigorous and relevant learning experiences. Consequently, the
budget includes proposals for Next-Generation High Schools and
Career and Technical Education that will prepare students to
transition to postsecondary education and real jobs by engaging
in project-based learning, having the opportunity to earn early
college credit, and building career-ready competencies.
Recognizing that educators are our Nation builders and
vital to our children's success, the budget invests to recruit,
develop, support, and retain outstanding teachers and school
leaders. The Teacher and Principal Pathways Program would
strengthen our pipeline of effective educators, while Teach to
Lead grants would capitalize on teachers' leadership for
education improvement.
To help educators advance through their careers, the budget
supports innovations in human capital management systems and
programs like the Teacher and School Leader Incentive Fund. We
also are proposing RESPECT (Recognizing Education Success,
Professional Excellence and Collaborative Teaching): The Best
Job in the World to rethink ways to structure teaching in high-
need schools to attract and retain effective teachers where we
need them most.
The programs in our 2017 budget also would make higher
education more affordable and help additional students earn
quality degrees. America's College Promise would make 2 years
of community college free for responsible students. This budget
also would drive innovations in Pell Grants by supporting
students who take classes year-round, rewarding those who take
at least 15 credits per semester, and rewarding institutions
with high enrollment and completion rates for Pell Grant
recipients.
While this budget is focused on helping to meet challenges,
I also want to acknowledge our country's remarkable gains. High
school graduation rates are at an all-time high, and dropout
rates are decreasing. We have seen the largest and most diverse
class completing higher education in our history.
This budget leverages local leadership, the source of
strength for our Nation's education system, to help more
students thrive from preschool through college. Throughout our
proposals and programs, we are committed to using and
developing evidence and data to maximize results for students
and taxpayers.
The Department's 2017 budget would support local and State-
led efforts to ensure that in every community and in every
school, students know that their education can provide them
with the knowledge and skills to achieve their greatest
aspirations.
I look forward to discussing these ideas with you in more
detail and would be glad to answer your questions.
Thank you.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Cole. Thank you, Mr. Secretary.
TRIO DEMONSTRATION
Let me begin the questioning. I am concerned about the
Department's request to reduce funding for the more traditional
grants in the TRIO program to make room for an additional or
proposed $20 million demonstration project. As I know you are
aware, there is broad bipartisan, bicameral support for TRIO,
as these programs are effective in improving access to and the
completion of higher education for students from disadvantaged
backgrounds.
What is the issue or the concern with TRIO programs that
the Department hopes to address through this proposed
demonstration project?
Secretary King. The hope with the demonstration project is
really to build on the success of the TRIO programs. We see
TRIO and GEAR UP as critical to our Nation's effort to get back
to being first in the world in college completion. We think
evidence is critical to that, and the demonstration project
gives us the opportunity to build in an evaluation process that
would generate evidence about what works most effectively in
TRIO programs. This would then inform the rest of the TRIO
investment.
However, as you point out, it is a relatively small
investment in the context of the overall funding level for
TRIO.
Mr. Cole. Can you give me a little bit more in the way of
specifics in terms of what the evidence is, what are we looking
for, and how we go about doing that in the proposal?
Secretary King. Yes. In many ways, this builds on the work
we have done with what is now called the Education Innovation
and Research Program within the Every Student Succeeds Act. The
idea is that we are to do either a randomized controlled trial
or research using quasi-experimental design to try to produce
good evidence about best practices that then can inform work
that is happening across our programs.
For example, there have been research efforts that have
shown that exposing students to other first-generation college
students like them who can talk about their experience from a
personal perspective is more effective than receiving the same
information from folks who didn't share that experience. There
is good research evidence that this makes a meaningful
difference in students' retention, their grades, and so forth.
So that is the kind of information that we would like to be
able to feed into the larger TRIO effort. We think that the
small investment of $20 million, in the context of the overall
program, is worth it to try and leverage good information about
what works.
Mr. Cole. As you know, TRIO has a very active support group
and advocacy group of many years standing. Do you know, are
they supportive of what you are trying to do? Have they taken a
position on this, one way or the other?
Secretary King. I will have our team follow up. I don't
know if there has been a collective response from all the folks
who are interested in TRIO.
[The information follows:]
TRIO STAKEHOLDER SENTIMENT
We do not feel that it is appropriate for the Department to
characterize the positions of the TRIO community, which is comprised of
national and regional organizations as well as educational leaders and
individual TRIO alumni, especially when, to our knowledge, none of our
stakeholders have made such positions publicly available. However, the
Department believes that such a Demonstration would be most successful
if it is informed by feedback from the community, and we look forward
to continuing outreach efforts in that area.
I will say there has been a lot of enthusiasm for our work
on the Education Innovation and Research efforts.
Mr. Cole. Okay. Well, good. We would appreciate any
information you found, if you do have a chance to do that
follow-up.
NATIVE YOUTH COMMUNITY PROJECTS
Mr. Secretary, in the fiscal year 2016 omnibus, we provided
an increase of $20 million for the Native Youth Community
Projects to support culturally relevant strategies to improve
college and career readiness amongst Native American children.
I am pleased to see that you proposed an additional increase
again this year.
Can you please give us an update on what you think has been
accomplished so far in this program and describe how you
propose to build on that with your 2017 request for an
additional $31 million?
Secretary King. Yes. We are certainly early in the process,
but what we have seen is that by bringing together tribal
communities to think about what it would take to have
culturally responsive instruction in the schools, leverage
students' Native language, to try to ensure that students are
on a path for college and career readiness, that we can see
real educational improvement.
We think this is an important investment. If you look at
our high school graduation rates as a country, almost every
group has seen improvement over the last few years except, in
our most recent data, for Native Americans, who did not make
improvements. This illustrates that we have more work to do to
ensure that Native youth understand that college is possible
for them, that jobs are possible for them.
You know, when we have met with Native youth and Native
educators who are working on the Native Youth Community
Projects, they have talked about the hopelessness you often see
in many communities. I know you are familiar with this from
your State.
That hopelessness then translates into students not being
motivated in school, not sticking through to graduation, not
going on to college. So we think this strategy of bringing
communities together around college and career readiness can be
high leverage. That is why we proposed a significant increase
for this activity.
Mr. Cole. Well, I just want to commend you for doing so and
appreciate your focus, the department's focus, certainly the
Administration's focus on this population in this area. You are
to be commended for it.
With that, I would like to go my good friend, the Ranking
Member for the Full Committee, for whatever questions she would
care to ask.
OPTING OUT OF STATE ASSESSMENTS
Mrs. Lowey. Thank you, Mr. Chairman.
As you well know, Mr. Secretary, a number of students in
New York have opted out of taking State assessments. Under both
No Child Left Behind and the ESSA, the department has the
ability to penalize school districts by reducing Title I
funding if less than 95 percent of students take State
assessment exams.
Mr. Secretary, I represent a number of school districts
that did not meet the 95 percent threshold despite the
participation of the overwhelming majority of students. I am
very concerned that if the Department does not work with local
school districts, students--the majority of which sat for State
assessments--will be punished as a result of a small number of
students who opted out of the test.
Will the department provide flexibility to school districts
who are putting forth a good-faith effort on participation
rates to ensure that needy students are not punished?
Secretary King. We think it is hugely important for
families and educators to have good information about students'
progress each year. That is the goal of the assessment system
as required in the Every Student Succeeds Act.
We have communicated to States their continuing
responsibility to ensure that all students participate in the
assessment system, and our experience has been that States are
working diligently to try to talk with their districts, with
parents, and with communities about the importance of the
assessments and the role that they play. We expect States to
move forward with that.
There were a small number of States that did not meet the
participation requirement last year. We have communicated with
those States what their responsibilities are, and our
impression is that States are working diligently to address it.
So, I am optimistic that States will ensure that the districts
get to a better place where we have seen these issues.
Mrs. Lowey. I hope I am optimistic, and the issue is of
critical importance, as you know. I am going to continue to
monitor the Department's role to ensure it carries out the
goals of the new ESSA, but it is important that we provide more
flexibility to those at the local level.
READY TO LEARN AND OPEN EDUCATIONAL RESOURCES
A question about Ready to Learn and Open Educational
Resources. You are aware: I am sure, this past fall, the
Department published a Notice of Proposed Rulemaking related to
Open Educational Resources. The proposed rule is far-reaching,
and would require that any intellectual property produced, even
in part, with department grant funding be openly licensed and
available for use, modification, and dissemination free of
charge by other companies, organizations, and individual
members of the public.
After speaking to many people, I have concerns about the
negative impact this proposed rule would have on public media,
which already distributes the content created in part through
the department's Ready to Learn grant to nearly every household
in the country for free. How does the department plan to
address the challenges this proposed rule would pose to
essential partners like public media?
Secretary King. The context for this proposed rule is that
Open Educational Resources can be a lever for equity. One
challenge across communities is access to high-quality
curricular resources. We see particularly in some of our high-
needs urban and rural communities, a lack of access to those
materials translating into fewer opportunities for students.
The premise of the Open Educational Resources effort is
that where the Federal Government invests funds in the creation
of materials, we ought to make those materials broadly
available to advance equity. We are in the stage of reviewing
public comment on the proposed rule, and we will try to address
any of the concerns that we have received from grantees.
As a general matter, I think the reception on the Open
Educational Resource rule has been very positive because of the
belief that it will be a lever for equity. But we certainly
appreciate the important role that public television and public
media play in American culture and want to make sure that we
are sensitive to those issues. Certainly, our staff can follow
up with yours on this issue.
Mrs. Lowey. Thank you.
Thank you, Mr. Chair.
Mr. Cole. Thank you.
We will go next to Mr. Fattah for whatever questions he
cares to pose.
GAINING EARLY AWARENESS AND READINGS FOR UNDERGRADUATE PROGRAMS
Mr. Fattah. Thank you, Mr. Chairman.
Let us start with GEAR UP. The department is, and
rightfully so, focused on evidence and data. Why don't you
share with the committee what the evidence and data is relative
to GEAR UP?
Secretary King. The overall results of the GEAR UP program
have been very positive. I think you made the point in your
opening remarks that the TRIO and GEAR UP programs have both
had positive effects particularly on graduation rates, but also
on students' readiness to transition to college.
That is why we think they are important programs. That is
why the President preserves the funding increases from last
year in our proposed budget.
Mr. Fattah. And how many children do we have in GEAR UP
programs per day?
Mr. Skelly. Five hundred thousand----
Mr. Fattah. Five hundred thousand.
Mr. Skelly [continuing]. Students are served by GEAR UP.
Mr. Fattah. And they are spread through how many States?
Secretary King. It is--I think it is 39 States?
Mr. Skelly. Yes, thirty-nine States.
Secretary King. Yes.
Mr. Fattah. And with the increase that the committee
provided of some $20 million, is there going to be a new
competition?
Secretary King. We do expect to have a grant competition to
add additional programs.
Mr. Fattah. Okay. Now I have worked with Senator Coons on a
proposal that the Department, I think, piloted last year or the
year before to take a few thousand students and seed small
college savings accounts--it is called the American Dream
Accounts effort--and to marry it up with online higher ed
counseling. This is based on some evidence. It is empirical
analysis that shows that poor children, even when they have as
small as $100 in a savings account focused on them going to
college, their grades improve. The expectations improve for
them by their teachers.
And I know we are in the early stages of this, but does the
department have any--this pilot program I think now has some
10,000 kids in it through GEAR UP. Do we have any information
about that?
Secretary King. I don't at the moment, but I will have our
staff follow up with you on that.
[The information follows:]
Student Savings Pilot Program Participation
We are unable to provide this data because we do not collect
student-level data on the GEAR UP program.
STUDENT LOAN FORGIVENESS
Mr. Fattah. All right. The loan repayment efforts that were
embedded in the Affordable Care Act, this opportunity for loans
to be forgiven for public service. Can we shift gears and you
talk to us a little bit about where that is and how many young
people are taking advantage of it?
Secretary King. Yes. I don't know the precise number of
students who are taking advantage. We do worry that, in these
public service forgiveness programs, there is inadequate kind
of public knowledge and public awareness on the part of
students.
One of our goals is to try to increase student awareness of
the programs, particularly on teaching. There are a number of
teaching loan forgiveness programs, but the participation rate
is not as high as we would want. This budget proposes actually
consolidating those teacher loan forgiveness programs to create
a streamlined program to provide $10,000 of loan forgiveness,
up to $25,000 if students have attended what their State rates
as a ``highly effective'' teacher preparation program.
This is a place where we are focused on trying to make sure
that students are as aware as possible of their options.
Mr. Fattah. All right. This is broader than just the
teachers, and what we did was we said there were two
approaches. One was that you could cap your total repayment or
your amount you had to repay to 10 percent of your income over
your lifetime, right? Secondly, there was an opportunity to
have your student loan forgiven, to the degree that you decided
to go into public service as a police officer or a teacher or
some other public service profession.
I was wondering whether the department has some sense of
whether this is getting out there, or that young people are
utilizing it and to what benefit?
Mr. Skelly. We had a tremendous push in the income-driven
repayment programs to let people know about the availability of
them and many more students are signing up for them. It is
still a little early for students to have achieved the
necessary number of years in public service to get a loan
forgiven. So we don't have any hard data----
Mr. Fattah. Right.
Mr. Skelly [continuing]. Really worth much--on how many
people are getting loan forgiveness, but it looks like it is a
very popular option that helps people deal with high student
debt if they have got it.
We have a number of proposals in the budget this year to
reform some of the proposals. That is because it is possible
the public service forgiveness is giving people an
inappropriate signal or incentive to borrow more than they
need, particularly in graduate school. The undergraduates, not
so much, but a lot of people exceed the $57,500 cap available
for undergraduate borrowing when they go to graduate school.
We wanted to make sure that folks know they shouldn't be
borrowing just because they could and potentially get the loan
forgiven after 10 years.
[The information follows:]
Public Service Loan Forgiveness Participation
As of February 2016, there were a total of 359,975 borrowers who
could potentially participate in Public Service Loan Forgiveness
(PSLF). This figure represents those who have been formally certified
based on full-time qualifying employment or conditionally certified
based on part-time qualifying employment. Please keep in mind that this
number is a total, as we never `release' a borrower from the total
potential PSLF population, so it may include some borrowers who are no
longer holding employment, have since paid in full, etc.
Through the end of 2022, the Department estimates that 331,000
borrowers will receive Public Service Loan Forgiveness.
Mr. Fattah. Right. I will stop there, Mr. Chairman. I think
we need to do a lot more to let young people know about what is
available. Maybe we will do it after the reform, all right?
Thank you, Mr. Chairman.
Mr. Cole. Thank you.
We will next go to my good friend, the gentleman from
Tennessee, for whatever questions he cares to ask.
Mr. Fleischmann. Thank you, Mr. Chairman.
Good morning, Mr. Skelly, and Mr. Secretary, good morning,
sir.
Secretary King. Good morning.
STUDENT LOAN SERVICING
Mr. Fleischmann. Good to see you. Secretary King, I would
like to ask you a series of questions, sir, regarding student
loan servicing.
The contracts that the Department has in place with the 10
national nonprofit and for-profit servicers specify that
servicer performance will be measured semi-annually in the
areas of customer satisfaction and default prevention, and
these results will determine future loan volume allocations
twice a year.
I have a two-part question. The first question, sir, is
what rationale and under what authority is the Department using
to unilaterally reduce the allocation window from September to
July? And then secondly, doesn't this recent announcement
directly contradict the language included in your servicing
contracts, which requires the Department to allocate student
loan volume through services based on performance and capacity
through fiscal year 2016?
Secretary King. Thanks for the question.
Certainly our goal in servicing is to make sure that we
serve borrowers' interests well and serve taxpayers' interests
well. The 2016 Appropriations Act required us to reallocate
loans for this year using existing metrics of performance
between the not-for-profits and the TIVAS.
That process took place. We have done a loan reallocation.
However, one of the challenges is that our existing metrics
actually do not make an apples-to-apples fair comparison
between the different servicers. Our next step is to develop
metrics that more accurately assess performance across the
different types of servicers based on the mix of loans that
they have.
The mix of loans that you have affects many of these
performance indicators, so we are gathering input from the not-
for-profits and the TIVAS on those metrics now, and we will
develop new metrics in advance of the next academic year. By
July, we expect to have new metrics in place for the allocation
going forward, consistent with what is required in the 2016
appropriation.
Mr. Fleischmann. Okay, sir. As a follow-up, last week
Federal Student Aid announced it was creating new performance
metrics for loan allocation ``because of the significant
variation in the composition of loan portfolios between student
loan servicers.''
Several questions. What variation is FSA talking about,
sir?
Secretary King. The key issue is the nature of the loans
that are given. For example, if you are a servicer and you have
loans of currently enrolled students who are not yet in the
process of paying back their loans, that is very different from
having loans from students who may be high-risk borrowers. We
want to make sure that our methodology accounts for variations
in the loan portfolio.
Mr. Fleischmann. Okay. Why is the department creating new
performance metrics when it just completed such a process in
2014? As a follow-up to that, what new performance metrics is
the Department considering using going forward?
Secretary King. As we do the next round of loan
distribution, beginning this summer, we want to use the best
metrics to compare performance--again to protect the interests
of both borrowers and taxpayers. We haven't determined what
those new metrics will be. That is the process we are in now.
We are gathering feedback from both the not-for-profits and the
TIVAS on what those metrics should look like.
Mr. Fleischmann. Is the Department taking such steps to
circumvent the language included in the Consolidated
Appropriations Act, and wouldn't it be more appropriate to
incorporate such new metrics as part of the upcoming recompete
instead of changing the rules of the game midstream, sir?
Secretary King. Well, the challenge is that the 2016
Appropriations Act changed the methodology for this year from
prior years. This limited us to existing metrics that don't
necessarily adequately measure the differences in the loan
portfolios. We want to make sure before the significant tranche
of new loans takes place this summer--August/September, some of
the highest volume months--that we have the best possible
metrics, focused again on performance for students and
taxpayers.
Mr. Fleischmann. Thank you, Mr. Secretary.
Mr. Chairman, I will yield back.
Mr. Cole. Thank you very much.
We will next go to my good friend, the gentlelady from
Alabama, for whatever questions she cares to offer.
Mrs. Roby. Thank you, Mr. Chairman.
STATE AUTONOMY IN STANDARDS AND CURRICULA
Congratulations, Secretary, on your confirmation, and I
look forward to getting to know you and, hopefully, being able
to work together.
As you know, the ESSA includes provisions that specifically
prohibit you and your staff at the Department of Education from
using funding grants or special policy waivers to influence or
coerce States into adopting certain standards or curricula. And
as you may or may not know, I proposed that language when I was
on the Authorizing Committee in a standalone bill, and I worked
for 3 years to get it in the final bill.
It was borne out of frustration over department officials
habitually exercising undue and inappropriate influence over
State education decisions throughout the former Secretary's
tenure. So we both know old habits die hard, and it is not hard
to imagine bureaucrats thinking, ``Hey, we know better than
Congress. We are going to keep doing what we think is best,
despite the specific language that is included in the current
bill.''
Mr. Secretary, how can you assure this Committee and the
Congress that your Department will comply with this very, very
important provision of the law? And how will you change the
culture at the Department to prevent your team from falling
into the same bad habits of telling the States what to do?
Secretary King. Two important elements of the Every Student
Succeeds Act have important implications for your question. One
is the requirement that States have standards in place to
ensure students are ready for success after they leave high
school.
In many States across the country, and I know you are
familiar with this, we see students arriving on college
campuses only to be told that they need to take remedial
courses, which really is a euphemism for high school classes,
because they don't have the academic skills they need for
success in college.
We hear all the time from employers, as I am sure you hear
this from your constituents who say they are struggling to find
employees with the skills that are necessary. So ESSA
importantly requires States to have standards that reflect
college and career readiness. We think that is critical.
Second, ESSA requires that standards are the province of
States, for States to determine. We agree with that. The
Department's position during the last 7 years and today is that
standards should be determined by States, but those standards
should be high and should point towards college and career
readiness.
I think ESSA strikes the right balance, and we intend to
adhere to exactly what ESSA requires: the standards are the
province of the States.
Mrs. Roby. Well, thank you for your response.
I really appreciate hearing your commitment to that very
important provision of the law. I know, though, a lot depends
on rulemaking, and we need to ensure that those rules comply
with the intent of Congress. And so as a Member who fought very
hard for these provisions in the law, let me state very clearly
again that the intention is to stop Federal coercion in
education decisions, not just on Common Core.
I know that that is what the debate seems to center around
a lot. It is not just about Common Core, but it is the next
policy that the Department wants to push in the next year or 5
years or whenever. So I do appreciate your commitment to that.
We will see how much we can fit in in a minute and 22 seconds.
COMPETITIVE VERSUS FORMULA CAREER AND TECHNICAL EDUCATION GRANTS
There is the administration's request for $1.2 billion for
career and technical education. It is an increase of $77
million over fiscal year 2016 appropriation. The request would
provide $1.1 billion for State formula programs and $75 million
to fund a grant competition for American Technical Training
Fund.
So rather than funding a large competition grant, it seems
to me that the funds would be better used to support State
formula grants, which would ensure more students are able to
benefit from the CTE experience. So many of my constituents
benefit from this. Can you just address the competitive grant
versus----
Secretary King. Sure. The goal of the American Technical
Training Fund is to incentivize partnerships between higher ed
institutions, school districts, and employers and workforce
investment boards to provide high-quality career and technical
education experiences. We think that kind of cross-sector
partnership is critical to driving quality programs.
I was just at Alabama A&M last week, meeting with them on
the STEM programs they have developed in partnership with NASA
and Lockheed Martin. And you can see the strength of those
employer-higher ed institution collaborations.
Our goal in this program is to foster that alongside the
kinds of career and technical education programs that are
supported by the traditional Perkins program.
Mrs. Roby. We will continue this. My time has expired. So I
will yield back, but we will continue this if there is another
round.
Thanks.
Mr. Cole. I thank the Gentlelady.
We go next to my good friend, the Gentlelady from
California, Ms. Roybal-Allard.
Ms. Roybal-Allard. Thank you, Mr. Chairman.
And welcome, Secretary King.
INDIVIDUALS WITH DISABILITIES (IDEA) VERSUS DEMONSTRATION FUNDING
Each year, children and families are shortchanged when the
Federal Government does not meet its full commitment to special
education under the Individuals with Disability Education Act.
While school districts across the country have a serious need
for additional resources, IDEA is consistently funded well
below the 40 percent Federal cost share that was promised under
the bill's authorization.
Once again, I am disappointed that the President's budget
request only funds the Federal share of education for students
with disabilities at 16 percent. Given the tremendous need that
exists for students with disabilities, can you please explain
why the President's budget freezes funding for IDEA State
grants while requesting $465 million for programs that are
unauthorized and unproven?
Secretary King. Let me first say that I share your
commitment to the important role of IDEA in supporting the
success of our students with disabilities, as does the
President. The budget maintains the $415 million increase from
2016 for IDEA.
The budget also includes an increase for IDEA preschool and
IDEA infants and families, so there are IDEA increases.
One of the constraints in the budget process was to try to
balance advancing priorities with maintaining the caps that
were agreed upon in last year's budget agreement. The IDEA
budget reflects that, that we, again, maintained last year's
increase and then have an increase for preschool and infants
and families.
Ms. Roybal-Allard. The fact is, though, that the
President's budget does not reflect a dedicated effort to meet
our Federal obligation to special education and instead has
requested robust funding for new and unproven programs. And
that is a big concern.
STUDENT SUPPORT AND ACADEMIC ENRICHMENT
As you know, the Student Support and Academic Enrichment
Block Grant, Title IV-A under the Every Student Succeeds Act,
consolidates into a single block grant several programs that
protect the health and safety of students, promote well-rounded
enrichment opportunities, and invest in education technology.
Again, I am deeply concerned that the President's budget
proposes to fund this program at barely $500 million, which is
less than one-third of its authorized funding level. If the
President's budget request is implemented, school districts
will be seriously compromised in their ability to invest in K-
12 services, ranging from advanced placement courses to high-
quality digital learning.
Competitive grant structures risk leaving many under
resourced school districts without any Federal support. Can you
please justify your less-than-adequate funding request for
Title IV-A and your recommendation to turn the program into a
competitive grant?
Secretary King. We think the new version of Title IV under
the Every Student Succeeds Act has a number of very important
purposes, including, as you described, supporting well-rounded
education, school counseling, education technology, and efforts
by districts to offer Advanced Placement courses. The
preexisting programs that are folded into Title IV were funded
in the 2016 Appropriations Act at $278 million. We propose
Title IV funding at $500 million. That is a $222 million
increase over last year's spending.
It is less than the authorized level. Again, we were trying
to, in our budget, both advance the President's priorities and
stay within the budget caps that were agreed to in last year's
budget agreement.
But we are certainly open to working with you and others on
the Committee as we move forward in the budget process because
we do believe that Title IV has very important elements. The
proposal around competitive awarding of the grant is to give
States the option to award the grant competitively because we
worry that without that competitive element, you could have a
distribution in the State through a formula methodology that
results in school districts receiving $10,000, which may not be
enough to offer a meaningful program in school counseling, arts
education, or Advanced Placement courses.
So we propose giving States the option to make the grant
competitive within the State around State priorities with a
$50,000 floor so that we can ensure that the Title IV grant has
a meaningful impact for students.
Ms. Roybal-Allard. I recognize that argument, but on the
flip side of that, it also leaves a lot of very needy school
districts and areas--that don't have the resources--with the
inability to compete and be competitive for those grants. That
is the flip side of what you are saying.
Unfortunately, this funding continues the cycle of
inadequately funding necessary supports for a lot of students
and leaves out a lot of schools, particularly those that I
represent.
I see, Mr. Chairman, that my time is just about up, I will
wait until the next round.
Mr. Cole. I have enjoyed the questions. They are great
questions.
If I can, I will go to my good friend, the gentleman from
Arkansas, who is also the Vice Chairman of the Committee, Mr.
Womack.
Mr. Womack. Thank you, Mr. Chairman.
Mr. Secretary, Mr. Skelly, welcome once again.
Congratulations, Mr. King, on your appointment and your
confirmation.
CAREER AND TECHNICAL EDUCATION AND DEMONSTRATION
My colleague from Alabama opened the door on career and
technical education, and I would like to go back into that
subject for just a minute and save her questions later for
another topic, if she would like to do that.
First of all, I am a huge believer in career and technical
education, and it is my opinion, only my opinion, that our
country has maybe even duped an entire generation of young
people to believe that the only real road to success is a 4-
year degree, going to your local college or university and
getting that 4-year liberal arts degree, perhaps. And we left a
lot of opportunities for these kids begging.
In fact, when I travel my district, one of the first things
I hear from my job creators is the skills gap and the fact that
we had an opportunity to put a lot of kids in that pipeline and
just did not, and a lot of these skills are just simply not
able to match the job requirements.
I want to go back to the fact that there is level funding,
the $1.2 billion in level funding and the $75 million request
for a new competitive grant program and get your thoughts as to
why we would be opening up a new unproven program of $75
million when we are not able to meet the demands across the
rest of the spectrum?
So can you just kind of articulate on that, and then I have
one other question.
Secretary King. Yes. Again, I think our goal there is to
try to create a best practice model through a relatively small,
targeted competitive grant that would incentivize strong
partnerships.
We also would like to see Perkins Career and Technical
Education Act reauthorization in a way that advances this
notion of partnership. In my experience in New York, one of the
things we worked on was creating partnership high schools,
where high schools were partnered with community colleges and
employers. Students would graduate with high school diploma and
associate's degree, first in line for a job at those employers.
We created those all across the State, and what we found
was there is huge demand, just as you are describing, from
employers across industries--from advanced manufacturing to
pharmaceuticals to the tech industry. We think that notion of
partnership should drive reauthorization of the Perkins CTE
program.
The President also has a Next Generation High Schools
proposal, which would aim to get high schools to think
differently about their design so that they can do exactly what
you are describing--help students see that it is not
necessarily a question of college versus career. It is the idea
that postsecondary training is essential, and that it can lead
you on a career path that might bring you back to school
multiple times to hone your skills.
That career could be the hook that gets a high school
student interested and focused on their future.
DEPARTMENTAL COLLEGE RATINGS
Mr. Womack. On another subject, in our fiscal environment,
we have been taught that data and evidence-based approaches are
critical to improving our education system, and we are all
forced to do more with less. Everybody gets that, and I am a
big supporter of State and local control when it comes to
education.
But I think most of us can agree that there are some areas
where the Federal Government can play an effective role, and I
believe one of those areas is research and creating
transparency through data. I am glad to see the Department of
Education withdrawing its troubling plan to rate colleges. It
demonstrates a fine line between providing students and
institutions with more data and trying to generate a ``one size
fits all'' system for evaluation.
DATA TRANSPARENCY
I would argue that consumers are probably more suited to
judge whether an institution is right for them based on their
unique circumstances rather than a bureaucracy up here.
I mention this because I noticed in your budget proposal
that you request funding for an initiative launched this year,
InformED, that will make the Department's data and research
across education spectrum more available and actionable for
internal users and for the public. Can you explain in greater
detail in the last minute that I have behind this new
initiative and tell me your plans for making this data
actionable?
Secretary King. Yes. As you say, data can inform decision-
making at the local level, State level, and at the Federal
level. With the college scorecard, our approach was to make
transparent the Department's data and--while protecting
transparency--make that data available to nonprofits and others
who wanted to use it to inform consumers.
What we have seen, for example, is a program called Pell
Abacus, which helps students see within a minute how they might
calculate what their actual costs would be at a given college.
I was at a high school recently with students, watching as they
discovered that a college they thought would never be
accessible to them, based on their financial aid package,
actually could be within reach. That is a powerful way that
data can be leveraged.
The InformED proposal seeks to do that kind of work across
the department. The bulk of the funding, I think $13 million of
the $15 million is really for States to improve their data
quality, data management so that we can pull that data to the
Federal level in a way that helps it inform States, districts,
and ultimately students and families.
Mr. Womack. Thank you, Mr. Chairman.
Mr. Cole. I thank you, and--oh, the gentleman from Maryland
is gone. Okay. Well, I will move on and recognize myself then.
TITLE I FORMULA AND SCHOOL IMPROVEMENT ALLOCATION
Mr. Secretary, several education advocacy organizations are
concerned about the Department's funding request for Title I
grants to local education agencies because they believe it
would result in a reduction in Title I allocation in many
schools. In a sense, it is sort of building on the point that
my good friend from California made.
Are these groups correct in that, and if so, you know, why
does the request shortchange district and instead invest in
some unauthorized competitive grant programs, as opposed to
something sort of tried and true like Title I?
Secretary King. Let me give some context to how we
approached the Title I allocation. Our Title I proposal is
actually $350 million above the authorized level because we do
think Title I is very important in getting resources to our
highest-needs districts.
What we propose is to divide that $350 million between
formula dollars and school improvement dollars that would focus
on the schools that are struggling. For districts that have
significant numbers of struggling schools, they will likely see
level funding or an increase because of that school improvement
focus.
But because States will determine which schools are most in
need of improvement, and States are the ones who develop those
lists, it is not possible for us to project exactly what the
implications will be for any given district. It will depend on
how many schools they have that are deeply struggling.
Mr. Cole. Well, not to push this point too hard, but as I
am sure you are aware, there is a great deal of unease and
uncertainty because of that, because there isn't a
predictability there, and there is concern that some of these
schools will literally just fall through the cracks or will
have something done at a State level that really doesn't direct
the money to where it is needed. So I think that is something
that a lot of folks have considerable concern about.
EVERY STUDENT SUCCEEDS ACT IMPLEMENTATION
The Every Child Succeeds Act represented a significant
shift of control over K-12 education policies and programs from
Federal to the State level. How does your budget request
address this shift and assist in building capacity in States to
take over these new responsibilities?
And wouldn't a larger investment in block and formula
grants, as opposed to the new competitive grant programs
included in your budget, be a better way to help States to
succeed under the new law?
Secretary King. We certainly think that, like the increases
that we saw in Title I last year, the significant increase we
proposed in the Title IV programs will be important to Every
Student Succeeds Act implementation. We also have held public
hearings and have gathered significant public comment on
implementation. We have begun negotiated rulemaking in two
areas based on input from States and districts as well as civil
rights organizations and community organizations.
We intend to implement the law in a very collaborative way,
gathering feedback throughout as we develop guidance and
regulations. Driving our work on guidance and technical
assistance will be what we hear from districts and States about
what they need.
We do think some of the specific competitive grant requests
here advance key priorities within the Every Student Succeeds
Act, but it is worth saying that 94 percent of what we propose
is directed toward formula dollars. The vast, vast majority of
what is funded in the President's budget is through formula,
but we do think there are places where competitive grants can
highlight or incentivize particular practices that will help
drive educational improvement.
Mr. Cole. Well, and this is hardly your fault, but there is
some concern--certainly, I have concerns--that because Congress
was late in getting this legislation to you, you know, frankly,
the President and, with all due respect, you will only be there
for a certain period of time. A few months, really. I am very
skeptical about new initiatives when the people that are
implementing them aren't going to have the timeframe to
actually be there.
Do you have any concern of that yourself?
Secretary King. We think the proposals we have made really
build on the last 7 years of work, build on the bipartisan
agreement in the Every Student Succeeds Act, and point toward
important priorities that are shared bipartisan priorities. We
propose, for example, an increase in the Preschool Development
Grant Program because I think there is strong bipartisan
consensus, not only in Washington, but in State capitals,
around the importance of investing in early learning.
We propose a program around computer science because I
think everyone understands, again in a bipartisan way, that
computer science is a part of our future competitiveness and
that we ought to be helping districts and States think about
how to support their students in achieving around computer
science so that they are ready to compete for the 21st century
jobs that will rely on computer science.
Mr. Cole. Great. If I could, I will recognize my good
friend from Pennsylvania, Mr. Fattah.
Mr. Fattah. Thank you, Mr. Chairman.
EQUITY AND LOCAL CONTROL
I want to revisit this issue around equity, and I know my
colleague from Alabama talked about standards, and you said
that, you know, standards should be left to the States. I want
to return us to a different President, President Nixon.
He said this issue about local control is an injustice
wrapped up in a virtue, right? That in the Nixon school finance
commission, in its summary, it said that as long as we have a
property-based funded school system, poor children in our
country are going to disproportionately fail.
The reason for it is that if you are funding schools on a
property tax, then poor communities aren't going to be able to
put--they are going to have a higher millage, but they are
going to put less money behind each child.
So we have in the classrooms of the poorest children in our
country today--this has been true since Nixon was President.
They have in the main teachers who in the major subjects
haven't a major or minor in the subjects that they are
teaching--math, science, English--because these school
districts can't afford to compete with their wealthier suburban
districts for, you know, the teachers who are certified in
math, right?
They have, in many of our States, double the classroom
size. They have textbooks that haven't been printed in these
children's lifetime. When we stand here and we talk about,
well, you know, it is a local matter. It is, and it is an
unfortunate local matter, right? That is to say that our
States, you know, the politics of the statehouse is that the
poor communities and the rural communities in Appalachia and
big cities, poor communities get the short end of how these
things get worked out.
Even when States set up important standards like teacher
qualifications, they then grant waivers. Everywhere you can
find a predominant group of poor children, the State waives the
requirement, right, rather than create an impulse to actually
get qualified people in the classroom.
When Education Trust did the study in California, and they
found 57,000 teachers who had not majored or minored in the
subjects they are teaching, right? Now I am not blaming the
teachers--these are good people. But at my alma mater,
Overbrook High School, a young lady shows up. She has got a
degree in art history. The principal says, ``Look, I don't have
anybody teaching geometry. You have to go teach geometry.''
At the end of the school year, that young lady quit. Those
kids did not learn a lot of geometry. Down the street at the
middle school, at Sulzberger, 14 substitute teachers teaching
math during the course of one year. It is impossible for these
children under those circumstances.
I don't want us to pretend like, well, if we leave it to
State governments, poor children will get a quality education.
That has never been the history in our country, and if the
Federal Government doesn't insist, to some degree or another
as, a referee, that we have to have some form of equity, it is
not going to happen in any of our States.
FEDERAL ROLE IN EDUCATIONAL EQUITY
I just want the record to be clear on this matter that,
yes, we have a system of local control of schools. It has never
served poor children--and particularly children who come from
generational, intergenerational poverty--well. It won't today,
it won't tomorrow, we, at some point, if we want to get more of
our children headed in the right direction, we are going to
have to do something more about it.
Secretary King. I certainly share that view. You know, I
served on the Equity and Excellence Commission that you helped
to create, and that commission tried to make the point that the
fate of all of our children is bound up together. As we think
about local control, we have to remember that all of our
children are diminished if there are other children who do not
have access to opportunity.
We think the implementation of Every Student Succeeds Act
requires a strong civil rights role for the department in
ensuring equity. It is important that the law requires
equitable access to effective teachers and that the law
requires transparency around per pupil spending and access to
advanced coursework and access to early learning.
We expect to fulfill that civil rights responsibility.
Mr. Fattah. And I think it can be done, and I think we
can--we have local--we have a basketball team in Philadelphia.
They are not doing all that well these days. About as well as
the one in Oklahoma. But the court is the same size. The rim is
at the same level, right? The ball has got the same----
I mean, we can create some level of equity so that children
have an opportunity to succeed. You know, the Sixers have an
opportunity to play well. They just haven't gotten there yet,
all right?
Thank you, Mr. Chairman.
Mr. Cole. They just don't have Kevin Durant. [Laughter.]
Mr. Cole. With that, we will go to my good friend from
Maryland for whatever questions he cares to pose to the
Secretary.
Mr. Harris. Thank you very much.
And thank you, Mr. Secretary. Welcome.
OPPORTUNITY SCHOLARSHIP PROGRAM (OSP)
I am just going to concentrate on one program. It is the
one I have asked the person who sat in that chair for the past
3 years about, which is the Opportunity Scholarship Program.
Just, you know, the opportunity for low-income individuals to
get a chance.
The first thing I am going to say, I am glad that, again,
on page 9 of your--of the budget book, you know, there is this
effort to promote greater use of evidence and data. Actually,
on page 6 of your testimony, it says, ``Finally, we extend our
commitment to improving student outcome by increasing funding
for programs based on evidence of success.''
So, I am going to ask you, does the Department of Education
intend on increasing funding for the OSP? Because I think the
evidence is pretty good that it is successful. I mean, a
graduation rate of 90 percent, as opposed to 64 percent in a
regular D.C. public school, is pretty good evidence of success.
I mean, a 26 percent increase in graduation rate.
Is the Department, in accordance with your testimony about
using evidence and data to increase programs that work, are you
in favor of expanding the Opportunity Scholarship Program?
Secretary King. We are committed to implementing the
program as required by law but don't believe that vouchers are
a scalable solution to the challenges we face as a country.
Mr. Harris. So you are unwilling to expand the program?
Secretary King. Again, we will implement----
Mr. Harris. Now let me--let me refer to----
Secretary King [continuing]. The program according to the
law.
Mr. Harris [continuing]. What the Washington Post, you know
the Washington Post has editorialized about this and has called
the claims made by opponents of expansion ``specious claims.''
Just in case you don't know the meaning of ``specious,'' it is
superficially plausible, but wrong.
So do you believe the data is just wrong?
Secretary King. I don't believe that vouchers can be the
answer to the challenges we face at scale.
Mr. Harris. Well, let me follow up with that. Thousands of
families, again in that Washington Post editorial. I am going
to take them at their word that there are thousands of families
on the waiting list. Has the Department over the past few years
actually studied what happens to the children who don't get
into the program versus the ones who do?
Because we know the ones who do graduate at a 90 percent
rate. What happens to the children who don't get into the
program? What is their graduation rate?
Secretary King. There was an IES comparative study, I
believe in 2010, that showed a 12 percentage point difference
in graduation rates----
Mr. Harris. That would be----
Secretary King [continuing]. Between the participating
students and the nonparticipating students.
Mr. Harris. That would be an improvement in the graduation
rates. That is right?
Secretary King. That is right. That is right.
Mr. Harris. So, let us say there were 1,000 children on the
waiting list in a year. That would be 120 children who actually
graduate that year if they had been given an opportunity
scholarship. Do you believe that data? And that is old data.
Secretary King. The IES study was well designed, and there
is an ongoing evaluation. I would note that the District of
Columbia district schools have also seen a significant
improvement in graduation rates over that time period, and
there are very strong charter schools in the District of
Columbia.
Mr. Harris. The District's----
Secretary King. Not all, but some of the charter schools
are performing quite well.
Mr. Harris. The District's improvement rate was from 56
percent to 64 percent. Of that 100 students, you have helped 8
of them. Whereas the data shows that you would help 12 with the
OSP. So I am going to go to your testimony. You said, ``We
extend our commitment to improving student outcomes by
increasing funding for programs based on evidence of success.''
There is evidence of success, and what you are telling me
is you don't want to increase funding. Is it just some programs
that have evidence of success? Is it we pick the science and we
pick the studies, and if it is politically untenable to perhaps
go against some vested interest, we are not going to support
it?
OPPORTUNITY SCHOLARSHIP PROGRAM CARRYOVER
Anyway, so I want to ask you what about the carryover
dollars? I mean, we actually--there actually are dollars out
there that could expand this program. My understanding is that
the carryover dollars are not being allowed to be spent now by
the--by Serving Our Children, which is now the administrator of
the program.
Is that the position of your department that carryover
dollars are not allowed to be spent on expanding this program,
which has proven successful to help needy, low-income children
actually graduate? Is that the position of the department?
Secretary King. Just to be clear, the evidence of success
is an important factor, but another important factor is
scalability, and we believe public school choice, the district
and charter options in D.C., are the more scalable option.
That said, the carryover funds are dedicated to ensuring
that the students who are currently enrolled in the program
will have the opportunity to continue. We don't want to see an
eventuality where students have begun in a school, and there
isn't funding available, so they are forced to change schools.
So we have set aside the carryover funds to ensure that the
currently enrolled students are able to continue.
Mr. Harris. I yield back. I will yield back. My time has
run out, and I will just continue in a second round.
Thank you.
Mr. Cole. We will go next to the gentlelady from Alabama.
Mrs. Roby. Thank you, Chairman.
STATE CONTROL AND CURRICULA
Before I move on to a different issue, and I appreciate the
gentleman from Arkansas talking about the career and technical
education, I do want to tie a bow around the local control box.
The language is very explicit in ESSA that the Federal
Government, the U.S. Department of Education cannot use Federal
funds to coerce States into adopting certain curricula and
standards.
We have agreed on that, and you committed to upholding that
portion of the law. But I want to also make sure, to get one
step further, that you have no intention and under your
leadership the people that work for the U.S. Department of
Education will not use, per the law, grant programs or waiver
programs to then coerce States into adopting certain
curriculum.
I just want to make sure that our understanding is the
same, that the law is explicit in its language that you cannot
do that.
Secretary King. Yes. As we discussed, standards and
curriculum are the province of State and local decisions. I
will again say that we have an important civil rights function.
Mrs. Roby. Sure.
Secretary King. For example, if in a given district,
English language learners were not allowed to access programs
on an equitable basis, the Department would have a civil rights
responsibility to intervene.
Mrs. Roby. But you can't use waiver programs or grant
programs to require the State of Alabama to adopt certain
standards or curriculum?
Secretary King. That is right. The Every Student Succeeds
Act requires them to adopt standards that----
Mrs. Roby. I just want to make clear that when it comes to
curriculum and standards that the U.S. Department of Education
cannot use waiver programs--because what ends up happening and
what we have seen happen is that because of what happened in
the past under the old law is that States ended up spending
precious dollars to comply with waiver programs to adopt
because the Federal Government in the past has been able to
coerce States that could otherwise be implemented--used right
in the classroom.
Now with parents and teachers and administrators on a local
level in the driver's seat, those dollars can be best spent on
our children, and the States can make the decisions about those
curriculum and standards. But I wanted to specifically address
the waiver and grant programs, and I think we are clearly on
the same page.
ON-TRACK PELL BONUS
I want to move to the administration's proposal for the On-
Track Pell Bonus, which would give $300 to Pell Grant
recipients who enroll in 15 credit hours per semester in an
academic year. The objective is to encourage students to
complete 60 credit hours within a 2-year period and 120 credit
hours in 4 years.
So where the goal behind this program is commendable, I am
concerned that this Pell bonus might encourage students to
enroll in more credits than they can handle just to receive the
$300 bonus. Furthermore, I don't see how this program helps
nontraditional students who are unable to take 15 credit hours
because they have got a work schedule and/or family that they
take care of.
This idea seems to promote quantity over quality and like
many things that we do around here could lead to some very
negative unintended consequences. Can you tell this committee
in a minute and 30 seconds that the On-Track Pell Bonus would
not lead to abuse or diminished learning outcomes for students
who feel pressured because of this incentive to take on more
than they can handle just to get that $300 bonus?
Secretary King. The goal of the President's proposals
around college completion addresses the challenge that we see.
Many of the students who are defaulting on their debt are
students who start, but don't finish. They have--they don't
have a degree, but they do have debt. They can't pay it back
because they can't get a good job because they don't have the
degree.
So there is a set of programs that would work together.
There is good evidence that incentives to take 15 or more
credits make a difference for college completion. A number of
efforts around the country, including University of Hawaii,
have very strong evidence around a focus on 15 credits.
We also propose summer Pell, allowing students to access
Pell dollars during the summer, which, for the nontraditional
student, can be essential because that is an opportunity for
them to continue their coursework over the summer and stay on
track to on-time graduation. We also propose an institutional
bonus that would incentivize colleges and universities to focus
on completion support.
I was just at Georgia State last week, same day I went to
Alabama A&M. They have increased their graduation rate by 22
points over the last decade while nearly doubling the number of
students who are Pell-eligible through a focus on supporting
students through to completion--academic advising, support
services, good counseling on which courses to take and how to
fulfill their credit requirements for their major.
We think this package of efforts will help us address our
completion challenges.
Mrs. Roby. My time has expired, but I would just say that I
have concerns that this would not only lead to people,
individuals taking on more than they can handle, but also there
is an opportunity here for abuse to take place, as well as
diminished learning outcomes.
As a committee, I hope that we will continue to look into
this. I yield back.
Mr. Cole. Thank you.
Just for informational purposes, some of us have had an
opportunity to have two rounds. Some of us have not. We are
going to move to those people that have only had an opportunity
to have one round. We will start, if we may, with our
Distinguished ranking member of the Full Committee.
Mrs. Lowey. Well, thank you very much.
STUDENT LOAN DEBT
Because this issue is so important, although there are
about three or four hearings going on at the same time, I did
want to come back. Because this student loan debt, which has
reached $1.2 trillion nationwide for 40 million borrowers,
making the average student loan burden $29,000 upon graduation,
is a major challenge for all of us.
I want to say at the outset, I think it was 3 years ago or
three cycles ago that we took away the third cycle of Pell
Grants. When you visit the community colleges, as I do all the
time, these kids are now working three, four, five, six jobs.
If they could get another cycle continuing the three, four,
five, six jobs, they could get out there and work with a
degree.
I want to emphasize this again, ask our distinguished
chairman maybe we can do something through the appropriations
process. You are shaking your head. So I know you agree.
In 1980, Pell Grants covered 77 percent of the cost of a 4-
year college program. Due to the rising cost of college in the
2015-2016 school year, Pell Grants covered just 29 percent of
the cost, forcing students to take on additional debt, which we
have been talking about.
This is why I was very pleased that the budget request
includes the maximum value for Pell Grants and I am glad in the
request you are asking for the third semester, maybe trimester
of Pell eligibility and provide a bonus to students who take
additional credits, which, together, would help students
graduate more quickly with less debt and enter the workforce
faster.
To me, it is a win-win. Third cycle, let them get that
education, let them get out.
I am concerned that the current level of student loan debt
is absolutely unsustainable. In addition to your Pell expansion
proposals, I would like to know what the Department is doing to
reduce student loan debt and make our higher education more
affordable. As Congress is preparing to debate a Higher
Education Act reauthorization, what more can we do to ease the
financial burden on those trying to pay for college or a
vocational training?
Thank you.
Secretary King. It is a very important question. You know,
one of the things that we are seeing that is promising, as we
discussed earlier, was students enrolling in the income-based
repayment program. We propose streamlining that income-based
repayment process so that students can enroll in programs that
cap their student debt payments at 10 percent of their income.
We would like to see rapid expansion of that effort, and we
are reaching out to students so that they are aware of that
possibility. That would be helpful. There are a number of
proposals, including in the RED proposals around students'
ability to refinance, we think would be potentially helpful to
students if done in the right way.
The President has also proposed America's College Promise,
as you know, which would guarantee for hard-working students
that they would be able to go to 2 years of community college
for free or the first 2 years at a historically Black college
or university or a minority-serving institution. We think that
can be a powerful lever.
In the structure of that program, we also require States to
meet the national average commitment, and the amount that the
State gets is tied up with how close they are to that national
average commitment. The intention there is to incentivize
States to maintain or increase their investment in public
higher education.
As you know, one of the reasons why we have seen the
shifting of cost to students is in many States around the
country, we have seen a retreat from investment in public
higher education.
Mrs. Lowey. Thank you, and I hope to continue the
discussion. With my one minute, I just wanted to get another
issue on the record because I think it is so important, Title
VI and anti-Semitism.
TITLE VI AND ANTI-SEMITISM
The International Education and Foreign Language Studies
Program within Title VI advances national security, foreign
policy, and economic interests. I really have very great
concern about reports that some recipients of these funds are
disproportionally focused on or are biased against Israel. In
2014, the department revised many Title VI program performance
measures by focusing on quantitative metrics.
How did these reviews affect the International and Foreign
Language Studies Program? What step is the department taking to
ensure that Federal investments are not perpetuating an anti-
Israel bias? And, I just want to say, the reports I have been
getting, there is a bipartisan caucus, as you probably know and
are a part of, on anti-Semitism. And what is going on on the
college campuses, I have personally witnessed it, it is truly
outrageous.
So, Mr. Chairman, if you would give the distinguished
Secretary a minute just to tell us what you can do, what we can
do, and I know many of us are working together to address this.
Secretary King. Yes. In terms of the international
programs, international language and education programs, we can
follow up with more detail on those programs.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
I would say important to us is that in all of those
programs, we are supporting the celebration of diversity and
pluralism and how we approach those.
One of the first things I did on becoming Secretary is also
the last thing Secretary Duncan did, was we signed a joint
letter that went to all of our universities and school
districts around issues of tolerance and religious tolerance
and celebrating diversity and protecting students from bullying
and harassment based on religion or other issues of prejudice.
We are very committed to setting the right tone around
that, and certainly our Office for Civil Rights responds to
complaints we get, whether it is from higher education
institutions or districts, around intolerance, prejudice, and
harassment that may occur on campuses.
We had a convening last year with higher education
institutions focused on campus climate and issues of racial and
ethnic harassment. We are eager to continue to work with you
and others on the committee on this issue.
Mrs. Lowey. Thank you.
Thank you, Mr. Chairman. The reports I have gotten are
really outrageous. New York City public colleges, UCLA, we saw
those reports. I think this is an issue that we should pursue
together, as we are, Democrats and Republicans. Seeing what we
can do through the programs, which we fund, to address this.
Thank you.
Mr. Cole. I thank the Gentlelady.
We will next go to the Gentlelady from California for any
questions she cares to ask.
ADULT EDUCATION FUNDING
Ms. Roybal-Allard. Mr. Secretary, in California alone, 5.6
million individuals need adult education services. However,
under Title II of the Workforce Innovation and Opportunity Act,
the State is only able to serve about 500,000 with adult
education, skill training, and workforce preparation.
While Congress intended Title II of the Adult Education and
Family Literacy Act of WIOA to receive additional funding each
year, and this is reflected in the legislation's graduated
authorization levels, the budget request for WIOA adult
education State grant program is only level funded from fiscal
year 2016. Why has the Administration chosen not to request
funding that would allow adult education State grants to meet
their full authorized amount under the Workforce Innovation and
Opportunity Act?
Secretary King. Again, this is a place where one of our
challenges is how we pursue our priorities within the caps that
were agreed to in last year's budget agreement. We do propose
an increase in adult education funding because we think that is
hugely important.
We are working very closely with the Department of Labor on
WIOA implementation. The President also proposed on the
mandatory side $5.5 billion that would be directed towards
programs that are focused on adult education, training,
disconnected youth, and trying to make sure our disconnected
youth are connected to education and job readiness.
All of the mandatory proposals in the President's budget
are paid for in the budget and would result in a net reduction
in the deficit. We do believe that that set of proposals that
we made jointly with the Department of Labor would get at
exactly the issues that you were describing.
Ms. Roybal-Allard. Well, let me just explain my frustration
with the way this program is not being funded at the level that
it should be. In my district alone, only 51.7 percent of my
constituents 25 and older are high school graduates. Programs
under the Adult Education State Grant Programs, such as
Workplace Literary Programs, English Literacy Programs, and
Civics Education are absolutely essential.
So I would again urge that the administration prioritize
proven programs that are badly needed, as opposed to
unauthorized, unattested proposals as it has a tendency to do
when it presents its budget.
In closing, I just want to associate myself with the
Ranking Member's statement about the value and the importance
of year-round Pell Grants, and I was pleased to see that the
Pell for accelerated completion proposal was in the President's
budget request because it really is critical. In fact, the
year-round Pell has a very strong return on Federal investment.
Secretary King. Absolutely. Thank you.
Ms. Roybal-Allard. I yield back.
Mr. Cole. I thank the Gentlelady.
We will next go to the Gentleman from Maryland for whatever
questions he would care to ask.
Mr. Harris. Thank you very much.
OPPORTUNITY SCHOLARSHIP PROGRAM (OSP)
First, I want to associate myself with the Full Committee
Ranking Member's comments on the anti-Semitism that prevails on
some college campuses, and I would hope that as the Ranking
Member suggests, that since we fund a lot on those college
campuses, we ought to have a say when they deny diversity
because of your religious background, in this case, again,
anti-Semitism.
Let me go back to the Opportunity Scholarship funds because
I just don't understand what the evidence is that these aren't
scalable. I just don't--I mean, I am not talking about doubling
the problem. But you know, you can expand it 5, 10 percent.
I mean, is it that there aren't schools to accept these
students? Because I find that hard to believe. What is the
evidence that it is not scalable?
Secretary King. Well, the reality nationally is that there
is not the private school capacity----
Mr. Harris. Mr. Secretary, we are not talking about
nationally. We are talking about the District of Columbia. We
are talking about the Opportunity Scholarship Program. What is
the evidence in the District of Columbia that this program is
not scalable? Because you do understand, there have been more
students in this program in the past.
I mean, in fiscal year 2016 is the lowest number of
students in the past 5 years in the program. What is the
evidence that it is not scalable?
Secretary King. Well, both nationally and in the District
of Columbia, it is clear that private school capacity is not
sufficient to replace the important role of public education.
So our belief is that----
Mr. Harris. Mr. Secretary----
Secretary King [continuing]. The District's----
Mr. Harris [continuing]. I am going to have to interrupt
you here. I am not talking about replacing public education. I
am talking about an expansion of the program. I am not talking
about replacing public education. We are going to--if we are
going to have a serious discussion, you can't set up a straw
man that I am suggesting replacing public education.
What is the evidence that if we merely go back to the
levels of 4 fiscal years ago that we are not helping dozens of
students who would otherwise not graduate based on the
evidence? We have evidence. Yes, the public school system is
getting better. But we have a 90 percent graduation rate in the
OSP program.
OSP SCALABILITY
What is the evidence that it is not scalable to increase it
by 10 percent? Is there evidence? Do we have evidence?
Secretary King. Well, as we discussed, the original
question was about student access to current funding. We will
ensure that students are added in a way that spends current
funding.
A separate issue is the carryover, and our view on the
carryover is that that should be preserved so that the students
who are enrolled have the opportunity to complete their
educational program within the schools that they are enrolled
in.
We will add students this year--I don't know the precise
number, that will depend on attrition and so forth--to make
sure that we are spending current dollars. We will preserve the
carryover for the long term.
If the question is as a public policy matter, do we think
it is a good idea to expand voucher programs? No, because we
don't believe, as I said, that they are a scalable solution to
the challenges we face, and we would prefer to see those
resources invested in public school choice, quality district
and charter options.
Mr. Harris. Mr. Secretary, I fully get that. I am just
going to point page 6 of your testimony where you say, ``We
extend our commitment to improving student outcomes by
increasing funding for programs based on evidence of success.''
Let me summarize what you have said today. There is
evidence that the graduation rate is higher, right? The IES
study, the graduation rate is higher.
There is no evidence that it is not scalable to previous
levels, none at all. Zero. You have no evidence of that.
So, when I read your testimony, you want me to believe that
if you see the scientific study, which the IES study we could
argue is scientific study, based on evidence, you say you want
to increase funding in your testimony, written testimony, but
your verbal testimony is different.
Let me just point out one issue with the program is that if
a poor family has tried to do right for their student, and they
have scraped by and they are working two, three jobs to pay
that private school tuition, $7,000, $8,000, $9,000 in a lot of
cases, they are not eligible for this.
To be eligible for this program, is it true that they would
have to--their child would have to drop out of the school they
are in to then enter the lottery to be eligible for funding to
go back into that same school? Because income is the prime
determinant, but if you happen to be in a--not in the public
school system, you are not eligible for the lottery at this
point in time?
Is that a correct summary of the way things are run?
Secretary King. Well, the original intent of the program
was to create opportunity for students who otherwise wouldn't
have that opportunity, and so the funding is awarded in a way
that respects that intent. Otherwise, you would have the risk
of merely funding students who were already enrolled.
Mr. Harris. These are all--I mean, let us get it straight.
The income level is $22,000. To make a $7,000 or $8,000 payment
to a school for tuition, you are scraping by. You are a parent
who is trying to do what is right. As usual, the Government
kind of punishes you for that.
I get it, Mr. Secretary. I yield back.
STUDENT SUPPORT AND ACADEMIC ENRICHMENT BLOCK GRANTS
Mr. Cole. Mr. Secretary, I was surprised, and this touches
on a point that Ms. Roybal-Allard made earlier, but I was
surprised that your budget request included only $500 million
for the newly authorized Student Support and Academic
Enrichment State Grant. That is less than a third of the
authorized level.
The program is intended to be a flexible funding stream
that allows States and school districts to invest in those
areas that are most needed to improve the quality of education.
I was disappointed that the request seeks--I was also
disappointed that the request seeks to change the local
allocations from a formula basis to a competitive basis, which
would further shortchange many school districts and, frankly,
in my view, circumvents congressional intent.
Again, I understand the resources are limited here, and it
would be a challenge under any circumstances to fully meet the
authorized level. But the funding at the requested level seems
to me to significantly curtail its potential usefulness to
support school districts.
Why does your--is it simply a math problem, you know, a cap
problem that we are this low on this? Again, it seems to me
there are other areas where you have requested funding that,
frankly, I would rather see the money here in these kind of
things than perhaps in some of the other areas.
I want to give you an opportunity to elaborate on that.
Secretary King. Sure. You know, again, we were--we see this
as a significant increase over the preexisting program. The
four programs that were funded previously were only at $278
million. Taking it up to $500 million is a significant
increase.
We do think there is an opportunity for more discussion in
a bipartisan way about how to move forward with the Title IV
program. The competitive grant component would be an option for
States. We are not requiring--we are not proposing requiring
States to make it competitive.
The concern, as I mentioned earlier, was if the formula
delivers a grant that is just too small to do anything
meaningful, then that is a missed opportunity. We see this as
an opportunity for States to identify priorities within the
many available uses of Title IV dollars and then to have a
competitive process.
States could weigh in that process, you know, attention to
rural issues. They could weigh in that process attention to
perhaps pooling of resources across smaller districts. We want
to make sure that folks have an opportunity to advance the
purposes of Title IV around a well-rounded education, school
counseling, advanced placement courses, so forth.
Mr. Cole. Okay. Well, thank you for the explanation.
I will go to my good friend from Pennsylvania next.
STUDENT LOAN REPAYMENT
Mr. Fattah. Yes, I just want to circle back on this loan
repayment thing. I got my facts straight now.
In the portion of the Affordable Care Act that was entitled
the Student Aid and Fiscal Responsibility, which was a separate
bill altogether. We just included it on the train that was
going along, and Senator Kennedy and former chairman George
Miller and others worked on this. It says basically that for
new borrowers, starting in 2014, will be able to have their
payments capped at 10 percent of their discretionary income and
that, furthermore, that if for 10 years of public service work,
they could have their loans forgiven, right?
This doesn't affect people who already have loans, who are
already in the process. But it may be helpful for families and
students who are matriculating through higher education now or
contemplating it to understand that there will be a
circumstance in which managing their debt would be a lot more
plausible and even more affordable to the degree that they
followed the others into public service.
I just want to make sure that the record is clear, and I
think it would be very helpful if the Department could make
sure that families know about this. Because at least as for
myself, I have a 17-year-old who is looking around at colleges,
and you know, some of them are a little pricier than others,
but it is an important consideration, I think, for families as
to this.
I think even as we think about the Pell Grant, we also have
to think about the other things that the Congress and the
administration has done together, including the American
Opportunities Tax Credit, which I was proud to author, but is
another way where we are helping families and many of them at
incomes, you know, in which they might not think they could get
help, but they are receiving, you know, dollar for dollar, a
reduction on their higher ed cost, up to $2,500.
I want to thank you. I would be glad if you want to respond
to that, you can.
Secretary King. Yes, just I would say on the income-based
repayment portion, there I think we have seen very significant
growth. I think we are well over now 4 million folks who are
participating in income-based repayment and see a path to
adding many more.
On the loan forgiveness, public service loan forgiveness,
we will get back to you with the details that we have on
students participating now and what we project over the next
few years.
Mr. Fattah. Thank you.
Thank you, Mr. Chairman.
Mr. Cole. Thank you.
Mr. Harris, you are recognized for whatever additional
questions you would care to pose.
OPPORTUNITY SCHOLARSHIP PROGRAM (OSP)
Mr. Harris. No, I just want to thank the Secretary, and
welcome to the job. You know, as you probably figured out, I
have some passion for the Opportunity Scholarship Program. I
think we really have to provide educational choice.
I think the evidence is that when we do, everyone benefits.
That I believe that the increased graduation rate in the public
school system in D.C. is partly because there actually was an
educational choice alternative. And I think that that is part
of the solution.
Again, I hope to work with you on some way to be able to
bring the numbers up to their historic numbers in that program
and you know, again, just give these children of low-income
families a chance at the American dream.
Thank you very much for coming before the Subcommittee.
Secretary King. Thank you.
Mr. Cole. I will recognize my good friend from Pennsylvania
to make an additional point.
ROLE OF FEDERAL INVESTMENT IN EDUCATION
Mr. Fattah. I met with the Secretary Hite--I mean
Superintendent Hite--from Philadelphia yesterday, and he was
focused, and I know this has been mentioned earlier, on this
apprenticeship program. We had your counterpart, the Secretary
of Labor in last week, and we talked about apprenticeship
efforts. We have some wonderful programs in Philadelphia that
have been federally funded.
I know the chairman took some issue with that, but they are
doing great work. They are helping young people who are not
going to college, but to find their way into careers that allow
them to make a living capable of raising families.
So, thank you, and just wanted to put that in the record.
Thank you, Mr. Chairman.
Mr. Cole. Well, thank you, my friend.
First of all, Mr. Secretary, you got through the first one
without too much problem. So very fine job.
Secretary King. Thank you.
Closing
Mr. Cole. Mr. Skelly, I want to join our Ranking Member of
the Full Committee and just thank you for 42 years of wonderful
service to help educate young people and put this country in
the right direction. You had a wonderful career to be very,
very proud of, and you have earned your retirement.
We have probably kept you working for a few extra years
since you put a child through Grinnell. Believe me, having gone
there, that is an expensive proposition. We just thank you for
your wonderful service to our country.
Mr. Fattah. I agree. Thank you.
Mr. Skelly. Thank you very much, Mr. Chairman.
Mr. Cole. Okay. With that, we will conclude the hearing.
Mr. Secretary, again, it was great to have you.
Secretary King. Thank you.
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Wednesday, March 23, 2016.
CENTERS FOR DISEASE CONTROL AND PREVENTION
WITNESS
THOMAS FRIEDEN, M.D., DIRECTOR, CENTERS FOR DISEASE CONTROL AND
PREVENTION
Mr. Cole. Good morning. It is good to have you here, Dr.
Frieden. And it is my pleasure to welcome you to the
Subcommittee on Labor, Health and Human Services, and Education
to discuss the fiscal year 2017 Centers for Disease Control and
Prevention budget request.
I am looking forward to hearing the testimony of Dr.
Frieden. I look forward to discussing in greater detail
priorities that I know we all share, such as reducing opioid
abuse, antibiotic resistance, and chronic diseases in our
country.
I also want to better understand the steps the CDC is
undertaking to address Zika.
Last year, Congress provided CDC with a 4 percent increase,
double the request. This year, the administration has proposed
a 3 percent decrease for fiscal year 2017. I would like to talk
more today about the reason for this proposal and the impact it
may have on public health.
I understand two more countries now have met the World
Health Organization criteria to be considered free of the Ebola
transmission. We know the CDC has been actively engaged in the
Ebola fight and are glad to hear about such progress.
Many other public health threats face our Nation, and we
want to give you the resources you need to combat them. I want
to caution you, however, that we also want to ensure that
precious taxpayer dollars are not wasted on politically
motivated activities outside the mission of the CDC, such as
promoting gun-control or lobbying local communities to ban the
consumption of certain products.
Today, we welcome Dr. Thomas Frieden, the CDC director, to
the subcommittee. Although we will continue to work with you
throughout the year, this may be the last time you appear
before our subcommittee during this administration. In fact, I
want to publicly thank you for the splendid, splendid work that
you have done and how well you have worked with every member of
this committee and with Congress in carrying out your important
functions.
You genuinely represent the finest traditions in public
service. So we are so happy to have the opportunity to work
with you.
As a reminder to our subcommittee and our witness, we will
abide by the 5-minute rule. But before we begin, I also want to
announce some housekeeping. We will be voting sometime during
this hearing, so I want to go as far as we can in terms of
opening statements by everybody. When the vote occurs, we will
recess and then we will come back immediately after the vote.
So you do not have to worry about juggling back and forth. We
will recess the hearing, so people have an opportunity to put
their questions to Dr. Frieden.
I am pleased, obviously, we have the big chairman here
today. So if I may, I am going to yield to him for his opening
statement, and then I am going to go to the ranking member for
her opening statement.
Mr. Rogers. Mr. Chairman, thank you very much for your
recognition.
Dr. Frieden, welcome to the subcommittee, and your 2017
budget request for CDC.
CDC performs a critical mission to protect Americans from a
host of health threats, both domestic and foreign. Your request
of $7,039,000,000 constitutes a 3 percent reduction from last
year's enacted level, largely taken from immunization funds and
flexible Preventive Health and Human Services Block Grant
funding.
At the same time, like a number of agencies within the
Department of Health and Human Services, you have requested to
add $30,000,000 in new mandatory funding outside the purview of
this committee. Behavioral health is a topic meriting
discussion and our support, but it must take place within the
confines of our discretionary authority.
I look forward to working with you so this committee can
adequately fund your mission for fiscal year 2017.
I want to start off this morning thanking you and your
colleagues at CDC for your tremendous work to help build a
healthy work force through the prevention and treatment of
serious health concerns in my region and across the country.
As you know from having traveled in my district, we have
lost around 10,000 coal mining jobs in the past few years. To
help build a stronger economy for Appalachia, I have been
working with both the current Kentucky Governor Matt Bevin and
his predecessor, Governor Steve Beshear, on a regional
development initiative known as Shaping Our Appalachia Region,
SOAR.
As we build a network across the region to strengthen and
expand the economy, it is important to understand the vital
role of having a readily available and healthy work force.
Currently, Kentucky is plagued with some of the Nation's
highest rates of heart disease, cancer, diabetes, kidney
disease, and others.
I appreciate your visit to my district for 3 straight days
a couple years ago and for the wonderful work your CDC team
members are doing on the ground in Eastern Kentucky working
with SOAR. By helping coordinating what is called a health
hackathon with MIT scheduled for later this year, and assisting
with substance abuse, heart disease, and diabetes health
disparities, the CDC is truly making a difference in helping my
region address serious health concerns.
Another longstanding challenge in my region, as you know,
has been the abuse of prescription medications. As the abuse of
opioids, including heroin, has spread to new heights across the
Nation, you have rightly characterized this emerging threat as
an epidemic, and I thank you for dedicating your personal
attention and resources to addressing this terrible problem
that has taken too many lives and touched too many families.
In particular, I salute you for working to produce new
guidelines for prescribing opioids for chronic pain, just in
the last few days. These science-based and data-driven
recommendations constitute a landmark achievement.
A poll conducted since you released the guidelines last
week indicates that they earned tremendous support from both
the patient and prescribing community.
For too long, a narrow focus on opioids as a cure-all for
pain and runaway prescribing have directly led to many of the
40 deaths each day, I am told, from opioid overdoses. For the
first time, thanks to you and your colleagues, doctors will
have clear recommendations for what factors to consider before
prescribing opioids, how much they should prescribe when
warranted, how often they should check back in with their
patients after sending them home, and how to respond if their
patients succumb to addiction.
So your guidelines are a major step forward, and I
congratulate you and thank you for a signal achievement.
I am anxious to see that the medical community follows
through now with these recommendations and prescribes
responsibly.
In particular, I am glad to see you acknowledge the breadth
of options for treating pain outside of opioids. As your
recommendations reflect, addictive painkillers like oxycodone
are certainly appropriate when a patient faces serious pain and
has exhausted other options, but it should not be the default
option.
I am so glad that you emphasize the importance of the
continual interaction between doctor and patient. This
relationship can and should be the start of an honest
conversation at each step of the process. Fully embracing this
may well save tens of thousands of lives each year.
I know that this message will be well-received when you
address the National Rx Abuse & Heroin Abuse Summit next week
in your current home of Atlanta. And I thank you again for
taking the time to focus on these important issues. And I am
pleased to say that you will be joined at the summit this time
by the President of the United States, who will be addressing
this national summit, I think the best summit there is on
prescription drug abuse and heroin abuse, in Atlanta, the fifth
annual.
Finally, you and I have spoken extensively about your
request for Zika virus prevention and preparedness. I just came
back along with Chairman Cole and others from a visit to South
America, including Brazil, where we met with various leaders
and health officials about the spread of this virus.
Our committee has made countless inquiries to the
administration about the use of currently available dollars to
address this crisis, and I hope you came prepared with some
answers in that regard today.
Just to reiterate the position of our committee, when we
received the request from the administration for a
supplemental, we consulted and checked into the records. And
when we wrote you a letter, it was to explain that we stand
ready to help. We think there are available funds that are
unobligated from the Ebola campaign that could be quickly
utilized in an emergency basis to get the fight against Zika
going, giving us time then to see what else might be needed
down the road, in which case we can consider a supplemental, if
necessary, or take care the problem in the 2017 regular order
bills.
So that is sort of where we are, and we stand ready to
help. I want to make that clear, that we are here to help you.
We are trying to find out now from the administration what
monies are available for this purpose; whether or not they are
being used; and if so, how much and where; and what is the
bottom-line request or need that we can try to fulfill.
Thank you, Mr. Chairman.
Mr. Cole. Thank you, Mr. Chairman.
We have been joined by the ranking member of the full
committee, my good friend, the gentlelady from New York. She is
recognized for whatever opening comments she cares to make.
Ms. Lowey. I want to thank my good friend, Chairman Cole,
and Ranking Member DeLauro for holding this hearing.
I also want to thank you, Chairman Rogers, for your
leadership for quite a few years on opioids. It is your
leadership that is really making a difference, so I thank you
very much.
And I thank Director Frieden. For nearly 7 years, you have
guided the CDC with a steady hand from one public health crisis
to another. We appreciate your dedication, your skill, your
service, and your testimony today.
It was just a year ago that we were discussing how the
CDC's efforts mitigated the tragic losses due to Ebola. A year
later, we are faced with yet another public health emergency,
as the Zika virus is growing through South and Central America
and the Caribbean.
Our mission to eradicate Ebola is not yet complete, and the
CDC's efforts to combat Zika, in addition to other infectious
diseases, are pushing public health infrastructure resources to
the breaking point.
Last month, the administration requested an emergency
supplemental to combat Zika. Sadly, Congress has sat on its
hands while the number of Zika cases continues to rise. The
World Health Organization estimates Zika could eventually
affect as many as 4,000,000 people. As you know, this is
particularly dangerous for women who are pregnant or who could
soon be pregnant, causing birth and development defects that
could result in miscarriage or death.
The world is looking to the United States to lead on
combating Zika, and I hope Congress will face the seriousness
of this threat and act without delay.
At a time when CDC's resources are already stretched thin,
you come before us with a budget that would reduce CDC's
overall program level by 3 percent. I am really very concerned
about your proposed cut to chronic health and cancer
screenings, particularly at a time when diabetes, heart
disease, and more risks not only the health of the patient, but
the health of our Nation's economic well-being.
I was pleased to see a proposed increase for combating the
opioid epidemic, as well as a $15,000,000 increase for Global
Health and an additional $40,000,000 to combat antibiotic
resistance, which causes more than 23,000 deaths annually and
poses a serious risk to the future of our health system.
Finally, the budget once again includes $10,000,000 for gun
violence prevention research at the CDC. As you know, I have
been working to advance this research for 20 years, having
authored the first amendment to strike the prohibition from
this bill in fiscal year 1997. Since then, hundreds of
thousands of Americans have died as a result of firearms. Since
2001, nearly 10,000 children were wounded or killed as a result
of an accidental shooting.
Even Congressman Dickey has changed his mind and called for
the removal of his rider and for funding this important public
health matter. I am baffled, frankly, that Congress cannot come
together and find a bipartisan path forward on gun violence
research.
This is not about confiscating firearms or restricting the
sale of weapons. This is pure and simple about looking to
public health experts for research on how to make our
communities safe.
I do hope, Mr. Chairman, that, this year, we may be able to
solve this issue once and for all. We are talking about
research. Thank you very much.
Mr. Cole. I thank the gentlelady.
Now I move to my good friend, the ranking member of the
subcommittee, the gentlelady from Connecticut, for whatever
remarks she cares to make.
Ms. DeLauro. Thank you very much, Mr. Chairman.
I would like to welcome Dr. Frieden this morning and add my
thoughts and appreciation for the great work that you have done
over the years. It has been an honor to work with you and with
the Centers for Disease Control. Thank you so much for your
commitment, your personal commitment.
This morning, we discuss the 2017 budget request for the
Centers for Disease Control and Prevention. The CDC is the
first line of defense in protecting Americans from public
health emergencies. It is vital to the well-being and safety of
American families, and it is an essential part of our country's
defense and its security apparatus.
Most of CDC's funding supports core public health
infrastructure across the country, including State and local
health departments, public health laboratories, and nonprofit
and community-based organizations. The CDC also plays a primary
role in responding to emerging public health threats.
One year ago, we were in the midst of a worldwide response
to the Ebola outbreak in West Africa. CDC ultimately deployed
more than 2,000 staff to West Africa to respond to the Ebola
threat, protecting American lives, as well as those in West
Africa.
Right now, we are facing three public health crises on
three fronts, and the CDC is critical to confronting each of
them to protect American families and children--the Zika virus,
the opioid epidemic, and the lead poisoning crisis in Flint,
Michigan.
Unfortunately, Congress is dragging its feet, leaving
Americans at risk.
The Zika virus is affecting thousands of pregnant women and
causing their babies to be born with severe birth defects. It
is infecting travelers returning to the United States. And it
is even being transmitted sexually.
We are about to send hundreds of American athletes, men and
women, to Rio for the Olympics, and thousands more will attend
as spectators. We are sending blood supply to Puerto Rico.
We need to act quickly on the administration's request for
emergency supplemental appropriations to defend against this
serious threat.
Some of my colleagues have expressed a desire to shift
unobligated funds Congress has provided for Ebola to respond to
Zika. I strongly oppose that idea because of the activities we
would have to forgo if we shift funds away from Ebola to Zika.
And I hope that Dr. Frieden will discuss these today.
We need to be able to respond to multiple public health
threats at the same time. That is why this Congress and the
last Congress, I proposed funding the Public Health Emergency
Fund to enable the Federal Government to immediately respond to
public health threats. It is modeled on the Disaster Relief
Fund, which is at $7,300,000,000.
This fund enables a rapid Federal response following a
natural disaster. If we can act quickly to respond to floods,
hurricanes, and other natural disasters, we should be able to
act quickly to respond to public health emergencies.
I might add that, since 2010, when it has come to the CDC
cooperative agreement efforts with State and local governments,
we have cut that fund from 2010 to 2016 by 8 percent. Our
hospital preparedness program from 2010 to 2016 has been cut 39
percent. Then we wonder why we are not prepared.
Before I move to fiscal year 2017, I want to take a moment
to review the fiscal year 2016 omnibus. Last year, we provided
an increase of $308,000,000 for CDC. That is about 4.5 percent
over the 2015 level, including a critical investment of
$160,000,000 to address the threat of antibiotic resistance,
which has the potential to threaten the entire health care
system. And we provided an increase of $50,000,000 to respond
to the opioid and prescription drug crisis.
Of the over 47,000 drug overdose deaths in 2014, heroin was
a factor in 10,574 deaths, and opioids were involved in 20,808.
Sadly, opioid deaths are likely undercounted. Thousands more
people are addicted or are in recovery.
Responding to this crisis, I was pleased to see that the
CDC released new prescribing guidelines, helping providers and
clinicians to strike a balance between pain management and
patient safety. We must work to find alternatives to opioid
prescriptions and only use them when appropriate.
It is our responsibility to address this need, and Congress
should support the President's request for $1,100,000,000.
I am concerned we were unable to fund other high-priority
areas of health in 2016. The majority of last year's increase,
about 83 percent, was allocated to three programs--antibiotic
resistance, opioid abuse prevention, and the Strategic National
Stockpile. That means that only one-sixth of last year's
increase was allocated to support the rest of CDC's critical
work.
Chronic disease prevention was cut by 22 percent, including
a 3 percent cut to tobacco prevention. Prevention of HIV/AIDS,
hepatitis, STD, and tuberculosis was increased by less than
one-half of 1 percent. And environmental health was increased
by less than $3,000,000, including an increase of only
$1,500,000 for the Childhood Lead Poisoning Prevention Program.
Given what we are seeing play out in Flint, Michigan, we
need to support this program. I am disappointed that the
administration's proposal for this year would not fund lead
poisoning programs in all 50 States. We can and we must do
better than this.
Do we not understand that children and adults are at risk
of lead poisoning all over the country? And according to the
CDC, in the United States, more than 500,000 children under the
age of 5 have elevated blood levels. That is unconscionable
that we would cut back on this program.
That brings us to the 2017 budget request. There are good
proposals in this budget. There are modest increases for
antibiotic resistance and prescription drug abuse prevention,
as well as a request for $10,000,000 for gun violence
prevention research.
These are important initiatives, and I will support them.
But I am overall concerned that this proposal cuts CDC's
program level by $194,000,000 below current levels. I see that
once again, the budget includes cuts to cancer screenings,
immunizations, minority outreach, occupational health, as well
as complete elimination of the Preventive Health and Health
Services Block Grant.
These programs are critical to American families and they
are too critical for American families to sacrifice. That is
why this subcommittee's allocations that will be released next
month will be so important.
I hope my colleagues on the other side of the aisle will
join us in urging an increase for Labor-HHS in fiscal year
2017.
When I look at this budget, and I read the mission of the
Centers for Disease Control and Prevention, I cannot help but
feel that we are nickel-and-diming the Centers for Disease
Control, an agency whose mission is the defense of the American
people. The initiatives that you lead have the power to defend
American children and families from life-threatening health
crises. We need to treat the CDC funding level with the gravity
that it deserves.
I thank the chairman.
And I look forward to your testimony, Dr. Frieden, and
today's discussion. Thank you.
Mr. Cole. Thank you.
Dr. Frieden, you are recognized for whatever opening
statement you care to make.
Dr. Frieden. Thank you very much, Chairman Rogers, Chairman
Cole, Ranking Members Lowey and DeLauro, for your very kind
words about CDC. I greatly appreciate that. It is an honor to
lead the Nation's leading public health agency, the agency that
is responsible for protecting the country, our first line of
defense in public health.
We work 24/7, and we have the world's top experts in most
of the diseases that affect Americans. We support States,
tribal nations, communities, health care providers,
universities, and other groups to protect the Nation's health
security.
And we greatly appreciate the committee's support in fiscal
year 2016. I think you appropriately recognized that CDC and
public health is a best buy, that when we invest in prevention
and in supporting communities, we can not only improve health
and save lives, but also save money.
Thank you, in particular, for the emergency funding for the
Ebola and Global Health Security supplemental last year.
EBOLA
Ebola is not over. Just last week, a new cluster of cases
occurred in a remote area of Guinea, Nzerekore. I have been
there. It is difficult to reach. It is difficult to get to. We
have had, so far, six confirmed cases. We have more than 100
high-risk contacts who are being tracked. We have more than
1,000 potential contacts who are being tracked. We have 84 of
our own top doctors, scientists, nurses, other staff there
responding.
So Ebola continues. It has an unfortunately long tail of
this very challenging epidemic that we have been fighting now
for 2 years.
There has been, though, enormous progress. We have helped
these countries establish systems. The last seven clusters have
been promptly identified and promptly stopped. To do that, we
need a large infrastructure, and we need to continue to
strengthen the country's own capacity to detect and respond.
Much more is needed for us to understand how Ebola is
spreading. We still do not know all the details of what is
causing these recurrent clusters. To better deploy
countermeasures such as the vaccine, which is going to be used
in this and other responses, to finish our own vaccine and
therapeutic and other trials that are being done in West Africa
and elsewhere, these investments pay off.
GLOBAL HEALTH SECURITY
I recently returned from Tanzania where the Global Health
Security investments are helping to improve response to a
massive cholera outbreak.
I also visited Ethiopia, where a devastating drought is
causing severe health problems, and the Global Health Security
approach is being used to mitigate the health impacts there.
In Benin, Togo, and Nigeria, we are fighting Lassa fever,
another hemorrhagic fever analogous to Ebola that can also
spread through rodents and other measures.
In an indication of how much the world has changed, we had,
tragically, a death of a medical missionary from Lassa fever.
His organization called me at night a week ago. We were then
able to medically evacuate a second medical missionary to Emory
University Hospital, where he is under treatment.
That did not get anything like the coverage that the
evacuations got 1.5 years ago. That is a reflection of the
progress I think that we are making regularizing and realizing
that the new normal is that we are tightly interconnected as
the world, and an outbreak anywhere is potentially a threat
everywhere.
It would be dangerous to let down our guard now. It would
be dangerous to let down our partners now. There are many risks
out there, whether it is Ebola or Lassa or MERS or SARS or the
next HIV.
We are dealing now with a very large yellow fever outbreak
in Angola. This could spread throughout Africa and potentially
to Asia and outstrip available vaccine supply.
There are also new epidemic threats, many of which we
cannot predict with certainty. There are tickborne diseases
that can cause severe and fatal illness that we are now
identifying as more widely disseminated because of the Global
Health Security support.
Drug-resistant pathogens have the potential to undermine
our work. We are focused on keeping America safe and healthy.
Investments in CDC are a best buy. Congress and this
committee supported our request for advanced molecular
detection some years ago. Those resources are saving lives.
They are improving our detection of diseases such as
listeria, where we have been able to get contaminated products
off shelves faster and save lives. They allowed us to
accelerate our production of a Zika diagnostic test.
They are also enhancing our response to diseases such as
the outbreak of HIV in Indiana related to opioids. We were able
to rapidly sequence that and understand what was occurring.
And we can better respond to and prevent diseases, such as
improving our flu vaccination production.
I also want to thank you for your support for initiatives
in 2016 that are continuing in 2017, with the continued
increase in antibiotic resistance funding requests. This is
crucially important to protect modern medical care and reduce
the number of deaths, so we can rapidly detect outbreaks,
respond effectively, and prevent them wherever possible.
OPIOID OVERDOSE PREVENTION
Also, thank you, Chairman Rogers, for your long-term
leadership on the battle against opioid overdose. We continue
to struggle to make progress in this field, and it will require
all of us in society doing more to get to a better place with
our relationship with these dangerous medications and illicit
substances.
We know of no other medication used routinely for a
nonfatal condition that results in death so often. Our recent
guideline emphasizes that for patients and physicians to begin
an opiate is a momentous decision, and it needs to be taken
with a full understanding of the risks and the benefits that
this involves.
We also have a proposal to increase funding for Indian
country programs. We would be delighted to discuss this further
going forward.
ZIKA
Zika is an emergency, and there is much that we still do
not know about it. We are learning more literally every day. We
have already been able to get two new diagnostic tests approved
through the Emergency Use Authorization at FDA.
Our staff are working literally around the clock. We have
produced more than 500,000 test kits. We have more than 800
staff working on the Zika response now. We are scraping
together money from wherever we can find it to respond
effectively.
But a robust response, I do believe, will take emergency
funding. If you look at the definition of emergency--
unanticipated, potentially catastrophic, permanent damage--I
cannot imagine a situation that meets this more than Zika.
Unanticipated. There has never before been a mosquito-borne
illness that can cause a birth defect. We have never seen that
before.
Potentially catastrophic. Each child affected can cost more
than $10,000,000. And it is a horrific tragedy for the families
that are involved. And we do not know the full range of
illness. Microcephaly is a horrific birth defect, but that may
be just part of the spectrum of severe problems these infants
may face.
And permanent. These are lifelong disabilities that they
will be facing.
So I want to thank you very much for your support of CDC
and our work to protect Americans, and I will be happy to
answer any questions that you have.
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Mr. Cole. I thank you very much. As I know you are aware,
again, we have votes soon, and the chairman and ranking member
have multiple committees, so I am going to go first to them for
whatever questions they would care to pose.
So, Mr. Chairman, you are recognized.
Mr. Rogers. I thank you, Mr. Chairman, for that courtesy.
OPIOIDS
Dr. Frieden, your medical expertise and forward-leaning
approach is what helped put the wheels in motion for the new
guidelines for prescribing opioids. I am truly grateful for
your commitment and your actions in this fight that we are in.
A Harvard University poll conducted since you released the
guidelines for prescribing opioids shows that Americans are
overwhelmingly in favor of your recommendations. I, for one, am
pleased that these guidelines clearly address the problem
holistically, an approach that I have long advocated, as have
you.
There are a couple things I want to try to clarify with
you.
I am pleased that consultation of the prescription drug
monitoring programs in all States except Missouri is a key
recommendation for prescribers. PDMPs are an essential tool for
good medical practice, because it allows a physician or
pharmacy to find out whether or not a prescription they have
been presented has already been filled in some other place, to
prevent double-filling of the prescription.
Yet, doctors are not using the PDMPs. It is there for them,
and all they have to do they do is contact that State computer
number and find out if this person that is in to see them has
already been to a doctor and prescribed medicine. That is a
huge source of the pills that we find available for young
people to overdose on.
First, not all States are interconnected with one another
with the PDMPs. We still have a problem. And they are not real-
time. They are getting better. And interoperability is
available in some States, but not all.
But nevertheless, what steps can we take at the Federal
level to be sure that doctors consult PDMPs?
Now in Kentucky, the State Legislature passed a law
requiring doctors to consult PDMPs before they prescribe.
Is that the answer? Or is there a better answer?
Dr. Frieden. Thank you for your question, Mr. Chairman. And
again, thank you for your leadership on this issue.
I have a lot of sympathy for the physician who is often
harried, overworked, facing a patient who is in pain. There is
no objective measurement of whether that patient is in pain.
And I fully agree that PDMPs have tremendous potential, and
that potential is not being fully met.
There is a pilot that was done some time back that I think
is encouraging in this regard. This was the integration of the
prescription drug monitoring programs and electronic health
records, so that doctors do not need to sign onto two different
systems, and it pops up right immediately in their EHR system.
I think that would be a very important area to pursue. As
with so much with this terrible problem, I do not think there
is one simple answer. I do think that States that try things,
as Kentucky has done, trying those things, evaluating, seeing
what works, and scaling that up is going to be critically
important.
So I think the goals are clear, as you exactly outlined.
You used interoperable, real-time. I would add actively managed
by the State.
We need to work together both at the State and Federal
levels, and with private industry, including the electronic
health record vendors, to make sure that that happens.
Mr. Rogers. Let me ask you about naloxone. Guideline eight
says, ``Clinicians should incorporate into the management plan
strategies to mitigate risk, including considering offering
naloxone when factors that increase risk for opioid overdose
are present.''
Is that suggesting that doctors co-prescribe naloxone along
with opioids in these higher risk cases?
Dr. Frieden. Yes.
Mr. Rogers. Are you at all concerned that this might
actually have the unintended consequence of giving a patient
false sense of security that could lead to more cavalier
behavior?
Dr. Frieden. We are aware of that concern. But what we have
seen so far is that many of the overdoses are unintentional. In
fact, the overwhelming majority are unintentional.
One of the things that was so striking to me in the
evidence review running up to the release of these guidelines
was the astonishingly high rate of overdose in people at higher
doses. Once you got to over 90 or 100 MME per day, you
increased about ninefold the risk of overdose. When you were at
more than 200 MME per day, the risk of overdose in just a few
years was about 1 in 32. This is just an astonishing level.
These are very dangerous medicines. The fact that we do
have essentially a method of reversal suggest that they need to
be used.
So I would see these things in parallel. We need to reduce
the use of medications. But for those on them, we need to
increase the safety with which we use them.
Mr. Rogers. Thank you.
Mr. Chairman, my time is expired. Thank you.
Mr. Cole. Thank you, Mr. Chairman.
We will now go to the ranking member of the full committee,
the gentlelady from New York.
ZIKA
Ms. Lowey. Thank you, Mr. Chairman.
And welcome, again, and thank you for all your good work,
Dr. Frieden.
In addition to the budget request, the administration
requested more than $1,800,000,000 for an emergency
supplemental to combat the Zika virus. Nearly half of this
funding would support the CDC's efforts to respond to the
virus, including enhanced mosquito control, rapid response
teams, surveillance in domestic cases, and improved diagnostics
and laboratory capacity.
This is a huge task, and much of South America and the
Caribbean, including American citizens in Puerto Rico and the
U.S. Virgin Islands, are looking to Congress for leadership to
tackle this public health emergency.
How will the CDC work with physicians and public health
experts to get the best information into the hands of Americans
and, in particular, women who are pregnant or could be pregnant
in the near future, so they are protected from the dangers
associated with the virus? And if supplemental funds are not
provided, how would the CDC's response capabilities to both
Ebola and Zika be curtailed?
Dr. Frieden. We are doing everything we can to respond to
Zika. We are currently at our highest level of activation,
Level 1, for the Zika response. We have, as I mentioned
earlier, more than 800 staff working on Zika. We have already
dedicated essentially all of our dengue branch, which is
located in Puerto Rico, to Zika.
We have been working really on three different fronts. In
the continental U.S., where dozens of States have mosquitoes
that can sometimes spread viruses like Zika, and about a dozen
or little over a dozen States in the south of the U.S. have the
particular mosquito that is most efficient at spreading this
type of virus.
It is possible that, come summer, we will have a situation
where a woman gets pregnant and through bad luck is bitten by a
mosquito that is infected by Zika and may have an affected
child. We want to do everything in our power to prevent that
from occurring.
The second front is in the U.S. territories. Puerto Rico,
as you indicate, these are American citizens. Unfortunately,
through a bad roll of the dice, if you will, they have an
environment that is both a natural environment and a human
environment that is extremely conducive to the spread of Zika.
We know that when chikungunya infected Puerto Rico, within
2 months of the introduction, it was all over the island.
Within 8 months, nearly 1 in 5 adults were infected.
If this occurs with Zika, which it may well, we could see
thousands of affected pregnancies there. So we are really doing
everything we can to protect pregnant women, to support vector
control so we can optimize the control for mosquitoes--this is
a very challenging mosquito to control--and to increase access
to voluntary effective contraception for women who choose to
delay pregnancy.
The third front is international. Since they are at the
front lines of this, we can both help them and learn more about
what is occurring. We have teams on the ground in Brazil, and I
thank the committee for meeting with our team there, and in
Colombia. And they are really very robust and productive
partnerships there that will help us learn more and help them
control better.
I am concerned that, if we have to, we will take every
dollar we can find to work on the Zika response. But there will
be implications. All of the dollars allocated were allocated by
you, by Congress, for specific activities. We are aware that
there are tradeoffs.
With the Ebola and Global Health Security supplemental,
when I look at the international components of that
supplemental, all of those dollars are planned to be used.
In fact, I received last night a request from an Ambassador
in an African country where we had hoped to be able to put a
staff person, but we do not have the resources to do it.
Nothing related to Zika, but just because the Ebola and Global
Health Security dollars do not meet the entire need to protect
Americans and keep us safe by strengthening systems in
countries that most need it around the world. This was the
Ambassador to Benin, which is currently experiencing an
outbreak of Lassa fever, another hemorrhagic fever.
So I am challenged with recognizing that we do not have all
the resources in place to protect Americans as well as we
could, should, and would like to. Now we have this new
unanticipated challenge of Zika that we are really scrambling
to respond to as effectively as we can.
Ms. Lowey. Thank you very much.
Thank you, Mr. Chairman.
Mr. Cole. I thank the gentlelady. We are going to now put
the committee in recess, so members can go have the opportunity
to vote. We will resume immediately after votes. Again, we
apologize for the inconvenience.
[Recess.]
Mr. Cole. We are going to go ahead and reconvene the
hearing, if we can. Obviously, we will have members coming back
from votes. We have some that may be disappearing home.
So regardless, again, Dr. Frieden, we apologize for having
to interrupt the session. We appreciate your patience.
INDIAN COUNTRY
I am going to pick up a subject that we are just visiting
about before we reconvened the hearing. I want to thank you
again for some of the work that CDC is doing in Indian country,
particularly, as you mentioned in your testimony, the Good
Health and Wellness in Indian Country program. We appreciate
that. However, it is one program. As you know, we have multiple
issues with this population.
I would like, if you could, discuss that but also discuss
what your thoughts are on where the CDC could be helpful in
funding other programs in Indian country on issues like
suicide, motor vehicle accidents, cancer, HIV, the whole range.
This population obviously has a higher incidence of all these
things than the rest of the population.
So I would appreciate your focus and any thoughts you have
on things we ought to be doing or considering.
Dr. Frieden. Thank you. As you well know, Mr. Chairman, as
you have highlighted, these are really some of the most stark
health disparities that we know of in this territory.
Indian nations have a great degree of diversity with some
having health statuses that are relatively good and others
shockingly bad. What we have tried to do with the modest
proposal in the 2017 budget is indicate what could be done to
strengthen capacity within Indian country through tribal
epidemiology centers, through more information on what the
burdens are and what the potential ways to address them are,
and then to implement prevention programs, working in
conjunction with communities.
That means sometimes building on traditional practices that
are healthy, whether it is food, physical activity.
We have also seen some very positive results reducing motor
vehicle risks by working with communities, getting communities
engaged in reducing alcohol-impaired driving and improving
adherence to safety belt and car seat use.
So I think this involves the importance of getting data
there and involving the communities in the solution, and
recognizing that with hundreds of tribes, we have the challenge
between going deep or going broad, whether we work with a few
tribes and document what works well, or try to get a widespread
effort.
I think our approach is to try to get data, so we
understand both where the burdens are and what are the programs
that are likely to work best, and then engage communities in
solutions. There are some communities that have ample
resources, and it is a question of dedicating them to things
that make the most difference, like cardiovascular prevention.
There are other communities where there are dire needs for
everything from safe water to very fundamental issues of health
care access.
And in far too many communities, as we were just
discussing, there is a problem of substance abuse and suicide.
These are areas where solutions are not quick and they are not
simple. But there are things that we can do to support
communities, support parents, support families in reducing
risks.
Mr. Cole. We appreciate that and would ask you to continue
those efforts. As you know, in many cases you work directly
with State and local health departments, and quite often tribes
are just simply left out of that equation by States. So having
Federal involvement here to make sure there is some equity and
those communities are given ample attention I think is very
important.
HEART HEALTH
Dr. Frieden, in the minute or so I have left, the American
Heart and Stroke Association--remain our number one most
expensive killer. They cost us roughly $1 billion a day. This
committee significantly expanded resources in those areas last
year, increasing the amount by about $70,000,000. That includes
a $10,000,000 increase that doubled the National Diabetes
Prevention Program.
Could you explain to us how those funds are being awarded
and again look ahead a little bit and tell us what we ought to
be thinking about this year in that very important area?
Dr. Frieden. Thank you very much, and thank you for the
support there. Heart disease and stroke, as you know, are
leading killers. They are largely preventable, probably more
than half of all the heart attacks and strokes that occur in
this country could be prevented with today's technologies. Our
flagship project in this area is the Million Hearts program. We
think we can prevent 1,000,000 heart attacks and strokes over a
5-year period by implementing programs that are community-wide
and also individual.
One of those key areas is control of hypertension. High
blood pressure is the single leading killer, the single thing
that could save the most lives if we do a better job in our
health care system, and yet we are only at about 52 percent
control in the country as a whole.
We have a system to recognize leaders in hypertension
control. Treatment does not have to be expensive. It does not
have to be complex. It can be done by a health care team that
involves nurses and pharmacists, and community outreach
workers. I think this is one of the areas that has the most
potential for progress.
We also appreciate your support for the National Diabetes
Prevention Program, and I think we will be hearing more about
that today from Secretary Burwell.
Mr. Cole. Thank you very much.
I now want to go to my good friend, the ranking member of
the subcommittee, the gentlelady from Connecticut.
ZIKA
Ms. DeLauro. Thank you, Mr. Chairman.
Dr. Frieden, you have been showing a series of slides that
depict the rapid expansion of chikungunya, that infection in
Puerto Rico. It starts in a few pockets, spreads rapidly,
covers the entire island.
My understanding is that public health experts are
expecting the Zika virus to spread in the same way. I have
heard also from your CDC colleagues, as well as Dr. Fauci at
NIH, and they predict that clusters of Zika infections will
reach Florida, Texas, and parts of the Gulf Coast. It really is
only a matter of time, which is why, as you know, I support the
administration's request and the $828,000,000 that it proposes
for CDC.
And I wholeheartedly agree with Leader Pelosi that Congress
should stay in session until we have dealt with emergency
funding for Zika.
Let me pose a series of questions, so that you can get them
down.
How many States are you expecting to be at high risk for
transmission? Is the plan limited to the Gulf Coast States?
What about States that are too far north for the Aedes aegypti
mosquito?
Second, Puerto Rico is now importing its blood supply,
because the danger of Zika-infected blood is high. What does
that say about the risk of Zika to the health of the
population? What will happen to the blood supply in Gulf Coast
States when Zika is more prevalent in the coming months? Can
you talk about your work with State and local health
departments?
My understanding as well--this is the fourth question--FDA
recently issued an Emergency Use Authorization for a PCR assay,
a diagnostic tool that enables doctors to tell if an individual
is infected with chikungunya, dengue, or Zika. How many labs
will get access to the test? Is the CDC distributing this assay
across the country or to the Gulf States or Puerto Rico?
The Kaiser Foundation, in 2014, said there was a total of
783,000 births in Gulf Coast States--Texas, Louisiana,
Mississippi, Alabama, and Florida. Given the risk factors along
the Gulf Coast, is there an estimate for how many pregnant
women in those States are expected to be infected by Zika virus
in 2016?
Sorry.
Dr. Frieden. Okay, I will see how quickly I can do that.
First, the number of States at high risk. There are the
Aedes aegypti States, and the surveillance for mosquitoes is
not perfect. It is not up-to-date. That is one of the problems
with vector control, that we do not know definitively where it
is. But there are at least 13 States that have Aedes aegypti.
Aedes albopictus also can spread Zika. It is probably a
less efficient vector, and there are more than 30 States.
We tier our support to States based on their risk from
mosquitoes and the number of travelers that they are likely to
receive. There are more than 40,000,000 travelers to and from
the Zika-affected areas in the U.S. each year.
In terms of blood supply, we are hopeful that within a
month or so, there may be a way of testing blood for Zika that
would allow blood supply to resume in Puerto Rico. In terms of
the Gulf Coast States, if there are clusters, we are in active
discussion with the Food and Drug Administration, which is the
regulatory authority, about what would happen in that
circumstance.
Ms. DeLauro. But that is potentially at risk, the blood
supply in those States, as it is in Puerto Rico?
Dr. Frieden. There could be a risk, although we think the
risk would be dramatically lower than in Puerto Rico.
In terms of local and State governments, we have a Zika
action plan summit in Atlanta on April 1. We have more than 30
States that will be coming, and we will be working hard with
them on what their preparation plans are, what the needs are,
what can be done now.
We have a tremendous degree of interest and expertise from
the States, and we work closely based on the risk.
The supplemental, as you know, has as its largest component
the $453,000,000 of the $828,000,000 that would be support to
State and local and support within the continental U.S.
There are two different Emergency Use Authorizations from
the Food and Drug Administration.
We have superb laboratorians. They have done just
phenomenal work around the clock. On March 17, we had the
second EUA. This is a Trioplex Real-time PCR that can tell
Zika, dengue, and chikungunya. Also, earlier than that, on
February 26, we had an IgM, the CDC MAC-ELISA test, which is an
antibody test.
The MAC-ELISA test is currently up and running in six
States. We would like to get it up in as many States as wanted
through the Laboratory Response Network the CDC coordinates.
There are 28 labs that are already using Real-time PCR with
materials provided by CDC.
So we are getting these out as rapidly as possible. Our lab
in Fort Collins is working nightshifts around the clock 7 days.
So the quicker the States can do it, the better for us.
Ms. DeLauro. Across the country, just the Gulf, or Puerto
Rico? It is going to be across the country?
Dr. Frieden. Across the country.
Ms. DeLauro. Okay. The last question.
Dr. Frieden. In terms of the number of pregnant women----
Mr. Cole. Can we make this pretty quick?
Dr. Frieden. I do not have an estimate.
Ms. DeLauro. Can we get an answer to that and can we get a
list of the States, your first tier, your second tier, that are
going to be in jeopardy?
Dr. Frieden. We can get you a list of States.
Ms. DeLauro. Can we get the number of births in these
States that we can anticipate here, based on prior data and
prior statistics?
Dr. Frieden. The number of births, we can get you. The
number that might be infected would be hypothetical.
Ms. DeLauro. No, the number of----
Dr. Frieden. Yes, we can do that.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Cole. Thank you very much.
I am advised that our good friend from Virginia has an
appointment and is going to have to leave early, so Mr. Harris
is graciously allowing me to skip down to recognize Mr. Rigell
for his questions.
HOSPITAL ACQUIRED INFECTIONS
Mr. Rigell. Mr. Chairman, thank you.
And, Dr. Harris, thank you very much. I appreciate it. I
will try to reciprocate, if I can.
Dr. Frieden, thank you for being here and for your
testimony to us today. I count it as one of the privileges of
public service, certainly in the House of Representatives, to
be able to interact with you and engage you on these matters.
I want to just call your attention to a remarkable company
that I visited in my district. It may seem a bit self-serving
to bring this up, but I left there just really wowed by what
they are doing, optimistic about what they are doing, and
inspired, because I think this is what we do as Americans. We
innovate. We discover. We push the boundaries.
The company is called EOScu, and they have a preventative
biocidal surface. It is the only synthetic hard surface that
has been recognized by the EPA for health claims. It
continually kills harmful bacteria within 2 hours of exposure.
So we are looking at these uses in a hospital environment,
for the bed rails, for the sinks, anywhere.
My first question is just a general one. Are you familiar
with the technology and maybe even perhaps the company, EOScu?
And if not, just generally, the potential for this course of
action, the potential that it represents?
Dr. Frieden. I am not personally familiar. My staff may be.
We are looking always for new technologies, particularly
because hospital-borne infections, as you indicate, are severe
problems.
[The information follows:]
Rep. Rigell: EOS Synthetic Antibacterial Surfaces
CDC is committed to protecting patients and healthcare personnel
from infections, promoting safe, quality care across the continuum of
care, and addressing the role of the environment to reduce the spread
of antibiotic resistant bacteria. CDC is always looking for new
evidence based-technologies that reduce the risk of transmission of
pathogens from the environment to patients in healthcare settings. CDC
was not specifically aware of EOS, but we are aware of several other
surface technologies being developed to prevent healthcare-associated
infections. CDC values engagement with industry including hearing about
innovations that can improve patient safety. Each year, CDC hosts
several Vendor Days which allow industry to visit CDC and discuss their
healthcare products and technologies with CDC scientists. CDC will
contact EOS with information about this opportunity.
If we look, for example, at C. difficile, there are 500,000
infections and 15,000 deaths per year in the U.S. And new
technologies, including better ways to sanitize hospital
environments, are important.
Mr. Rigell. Well, I am glad that I have this opportunity
just to bring this company to you and your staff's attention.
Again, it might seem a bit self-serving, but as the chairman
often points out, I am not seeking reelection. It is just an
exceptional company doing really wonderful things. So I hope it
is looked at by the CDC.
PROSTATE CANCER
I want to pivot to another organization that I just
consider such a privilege to represent, and that is Hampton
University and specifically Dr. Bill Harvey. He is going to be
coming appear today, and the chairman was kind enough to agree
to an appointment to meet with him.
I have come to know him and respect him over the years. He
leads a historically Black university, Hampton University,
which is a real treasure to us in the Hampton Roads southeast
portion of Virginia. Several years ago, his leadership resulted
in the formation of the Hampton proton therapy center.
One of the things that they are really focused on there,
and not exclusively, but prostate cancer. It disproportionately
affects African-American men. The numbers that I have seen,
they are between 1.6 and 2.4 times more likely to be diagnosed
with prostate cancer.
In the couple minutes I have here, I wanted to just ask
your general assessment of that particular cancer, how it
disproportionately strikes our fellow Americans in the African-
American community, and the potential I believe--and I would
like to understand your view--on what proton therapy represents
for that.
Dr. Frieden. Thank you very much. You are absolutely
correct that prostate cancer is a serious problem and
disproportionately affects African-Americans.
Unfortunately, the current state of our science on the
prevention and treatment of prostate cancer is inadequate.
When objective groups have looked at this, there is no
clear benefit for early screening or early detection. There is
a fair amount of debate about that, and some groups believe
that there is a benefit for early screening and early
detection, but I think the weight of scientific evidence
suggests that, unfortunately, that may not be the case.
That being said, it is critically important that more
research is done on understanding the different types of
prostate cancer and what therapies may make the most sense.
In our minds, I think we have a model of cancer. That model
of cancer is: It is small. It grows. If it grows too big, it is
too late.
That model works for certain skin cancers, for cervical
cancer, for colon cancer. That model does not work for breast
cancer and prostate cancer, which are very heterogeneous
entities that work differently in different people, and for
which research will be needed, but currently public health
interventions are limited.
Mr. Rigell. Well, I am encouraged just as a fellow American
that there are good, hardworking Americans really cross the
land, certainly in Virginia's Second Congressional District,
who are pushing the envelope in these matters from a biocidal
hard surface to the good work being done in proton therapy
specifically at the proton center there related to Hampton
University.
I thank Dr. Harris. I thank the chairman for the time.
Thank you.
Mr. Cole. Thank you very much. We will next go to my good
friend, the gentlelady from California.
LEAD POISIONING PREVENTION
Ms. Roybal-Allard. Thank you, Mr. Chairman.
Dr. Frieden, I would like to go back to the issue that was
raised by Congresswoman DeLauro, and that is lead poisoning
prevention.
This is an issue that impacts millions and millions of
families in this country. I would like to use an example in my
own district, because while the entire country is rightfully
focused on that tragic lead poisoning of an entire community in
Flint, Michigan, not many people know about the battery
recycling plant in my 40th Congressional District that had been
emitting lead, arsenic, and other dangerous pollutants for over
20 years.
When the Vernon, California, plant was officially closed in
2015, State officials revealed that the lead contamination
extended as far as 1.7 miles from the plant and may have
contaminated schools, parks, and as many as 10,000 homes.
Last week, the California Department of Toxic Substances
Control reported that more than 99 percent of the roughly 1,000
properties tested so far have lead levels high enough to
require cleanup.
Many experts in the public health community believe that
Flint and Exide may represent the tip of an iceberg, and that
children in many communities across the country are at risk of
exposure to lead hazards from various sources.
Now I know that you know that lead is a poison that affects
virtually every system in the body, and it can cause
irreversible damage to the developing brain, the nervous
system, fetuses and young children. Lead poisoning lowers IQs,
limiting the opportunity for children to reach their full
potential. It increases learning disabilities, attention
disorder, and behavioral disorders. And lead-poisoned children
are six times more likely to drop out of high school and are
more likely to enter into the juvenile justice system.
The medical and special education expenses alone can equal
$5,600 for each child with serious lead poisoning, and lead
poisoning results in an average loss of lifetime earnings of
$723,000 per child.
The reason I have outlined this is because this is the
impact that we are seeing in the community that I represent
that is impacted by this lead poisoning.
For that reason, I am particularly concerned about the lack
of adequate funding for the CDC Healthy Homes and Lead
Poisoning Prevention Program, which provides critical
surveillance and monitoring of elevated blood lead levels and
community education to prevent and mitigate childhood lead
poisoning.
With the increased number of children who are now above the
updated lead reference level of 5 micrograms per deciliter,
what has the CDC done since 2013 to increase support to the
States it funds? And do you believe that your budget request
for $17,000,000 will be sufficient for CDC to provide critical
surveillance in every State in the country?
Dr. Frieden. Thank you very much.
Confronting and reversing and preventing lead poisoning has
been a priority for CDC for a long time. In fact, as you may
know, it was the NHANES survey of NCHS at CDC that identified
lead as a huge problem and led to the elimination of lead from
gasoline as well as the elimination of lead from paint in this
country, and that has resulted in a steady decrease in lead
poisoning.
But this is a far from finished effort. There are still far
too many children and far too many adults affected by lead
poisoning.
As you know, there was a large reduction in the CDC lead
poisoning prevention program several years ago. It was
partially restored several years back. And both in terms of
lead poisoning and larger environmental health tracking
programs, we have a very strong program, the world's best
environmental lab, terrific health professionals. We are not
able currently to support all States in monitoring lead levels
and intervening at the level of resources that we have.
Ms. Roybal-Allard. You are not able to?
Dr. Frieden. No.
Ms. Roybal-Allard. And yet the fact remains that there are
millions of homes and families who are exposed to this,
probably in every State in this country.
Dr. Frieden. That is correct.
Ms. Roybal-Allard. The Advisory Committee on Childhood Lead
Poisoning Prevention provided scientific and technical advice
to the CDC and HHS, but its charter expired in October 2013. In
light of Flint, Exide, and other incidents, do you believe that
a new charter should be established?
Dr. Frieden. What we did at CDC was to involve our Board of
Scientific Counselors of our National Center for Environmental
Health, which is superbly led by Dr. Pat Breysse, to have a
subcommittee on lead. We feel that is the appropriate way to
manage it. That incorporates input from scientific experts and
the community. It is a FACA operating under the FACA
responsibilities and can address any issue related to lead and
lead poisoning.
Mr. Cole. The gentlelady's time is up.
Ms. Roybal-Allard. Okay. I apologize.
Mr. Cole. We will come back.
Ms. Roybal-Allard. Okay.
Mr. Cole. With that, my good friend from Maryland, Dr.
Harris, is recognized.
SODIUM
Mr. Harris. Thank you very much.
I have a couple different areas I am going to touch on.
First, in regard to the sodium dietary guidelines, my
understanding is that the CDC may be engaging in a systematic
review of the scientific literature regarding sodium intake in
advance of developing a new DRI.
My question is, as you look at the systematic review, is
this going to be a review of all-cause mortality or is the
predominance going to be using blood pressure as some kind of
proxy for things that happen, with particular reference to the
study that shows that in some people actually restricting
sodium leads to an increase in all-cause mortality?
Dr. Frieden. The systematic review will look systematically
at all dated related to health.
Mr. Harris. So all-cause mortality will be considered in
it, I take it?
Dr. Frieden. I believe so.
COMMUNITY PREVENTIVE SERVICES TASK FORCE
Mr. Harris. Okay. Let me ask you a question about something
that has come up with some wording that was in the omnibus
bill, and that has to do with the Community Preventive Services
Task Force, which I think, if I am correct--I think it is
correct--that the language in the report stated quite clearly
the committee does not provide support for the community guide
or the operations the Community Prevention Services Task Force.
Can you affirm that since no funds were provided through
the Prevention and Public Health Fund, because that is where we
restricted it, use from that fund, that the task force is not
being funded in this fiscal year?
Dr. Frieden. We would have to get back to you on the
details of that. The task force is an authorized activity by
Congress and has support not only through the prevention fund.
Mr. Harris. So you may be using funds from other areas to
fund that, despite Congress' intent not to provide support for
it.
Dr. Frieden. We would have to get back to you on that.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Harris. Okay. Because that raises a concern. If there
is this money sloshing around CDC that can be used for
something that Congress actually took a specific position
against, I hope that it can slosh around to help you with Zika.
STRATEGIC NATIONAL STOCKPILE
With regards to the biodefense community, I have to ask a
question about coordination between BARDA and then, of course,
once things reach approval stage, things kind of get shifted
for stockpiling to CDC. Is the coordination adequate to make
sure that things do not get dropped in the pipeline, things
that BARDA has expended a fair amount of effort in developing,
actually get acquired at some point?
Dr. Frieden. I think we have very good coordination with
BARDA. We have had a very positive relationship along a whole
host of activities.
Just to give you an example, when we were working on the
vaccine trials for Ebola in West Africa, BARDA staff actually
traveled to West Africa and helped us with the implementation
of those trials. So there is very good coordination between
ourselves and BARDA.
I think the bigger challenge is that there are a great
number of needs and limited funds.
Mr. Harris. Sure. With regards to the SNS, because the SNS,
the role kind of expanded from this idea where it is going to
help us stockpile for bioweapons and now it is kind of
everything, natural disaster response, things like that,
providing medical things.
Is that going to be a problem in terms of having adequate
resources to do what it was initially established to do, which
is to stockpile against bioweapons?
Dr. Frieden. I think really, if I step back, our commitment
is to use every dollar that is entrusted to us to protect
Americans as effectively as possible.
With the SNS, we look at an all-hazards approach: What are
the things most likely to harm Americans? And what can we do
that has the most impact at mitigating those harms? And how can
we ensure that we are not just putting stuff in a warehouse
somewhere, but that in the event of an emergency, they would
actually be able to be deployed and used to protect Americans?
That is, in broad strokes, our approach to the SNS.
Mr. Harris. But it appears to me that perhaps a shift has
occurred from where it is stockpiling specific therapeutic
measures to stockpiling general medical supplies to----
Dr. Frieden. I do not think that is the case.
Mr. Harris. Then what was deployed, for instance, after
Superstorm Sandy, because things were deployed from SNS? And
that was not an infectious disease. That was not by a bio-
response.
Dr. Frieden. There are some Federal medical units that can
be provided in a disaster that would be basically the framework
for responding to an emergency. We have also looked at things
like respirators, because when we do models of what could be a
worst-case scenario, there is likely to be a shortage of
ventilators that could be critically important.
[The information follows:]
Rep. Harris: Is SNS expanding beyond its mission of preparedness
for bioterrorism to an all hazards approach? Is this consistent with
the initial intent of SNS or current authorities?
In 1998, Congress appropriated funds for the CDC to acquire a
pharmaceutical and vaccine stockpile to counter potential biological
and chemical threats that could affect large numbers of persons in the
civilian population. The program was originally called the National
Pharmaceutical Stockpile program, but on March 1, 2003, became the
Strategic National Stockpile (SNS) program and now includes not just
drugs but medical supplies and medical equipment required to protect
America's public health and safety from multiple hazards (terrorist
attack, earthquake, emerging infectious disease threats such as flu,
Ebola, Zika). As defined in 42 U.S. Code 247d-6b, the Secretary is
``directed to maintain a stockpile or stockpiles of drugs, vaccines and
other biological products, medical devices, and other supplies in such
numbers, types, and amounts as are determined consistent with section
300hh-10 of this title by the Secretary to be appropriate and
practicable, taking into account other available sources, to provide
for the emergency health security of the United States, including the
emergency health security of children and other vulnerable populations,
in the event of a bioterrorist attack or other public health
emergency.''
Mr. Harris. I understand the ventilators. Again, I am
concerned that the initial intent just has been expanded to
this disaster mitigation.
I yield back. Thank you.
Mr. Cole. Thank you very much.
I will now go to my good friend from Pennsylvania for
whatever questions he cares to pose.
ZIKA
Mr. Fattah. Thank you very much, Mr. Chairman. And thank
you, Doctor, for all the work that you are doing.
Obviously, there is a lot that we can talk about that is
very beneficial, but usually when we are talking to the CDC, we
are talking about more challenging circumstances, so I want to
return to the Zika virus.
This is a mosquito, the one that is transporting this
virus, that we have seen before in the Philadelphia area, many,
many years ago, bringing an epidemic to our city. So we know
that it can do so very effectively.
I know there is first a concern about young women and
pregnancy. I have seen reports that there could even be other
challenges for people who do not fall into that category. So I
wonder if you could just spend a minute and talk to the
committee about what we think the health consequences are. And
then I want to ask a question about what more we could be
doing.
Dr. Frieden. Thank you.
With regard to Zika, we are literally learning more every
day. It is a mosquito-borne virus spread by primarily two
different mosquitoes that are present in the U.S.
From the best of what we understand, for the vast majority
of people, it has few symptoms or none at all. When it does
cause illness, it tends to be for about a week with rash,
fever, red eyes, joint pain, and then it resolves.
But we have seen two consequences that are concerning.
One is Guillain-Barre syndrome. That is a form of paralysis
that is usually temporary. It follows many different types of
infections, so that is not particularly unprecedented. We have
seen this after influenza, after Campylobacter, and intestinal
infection, and after others. We anticipate that this will be
confirmed as a post-infectious complication of Zika.
What is really unprecedented is the birth defects that we
are seeing in Brazil now being reported in Colombia and Panama,
that we saw in one woman who lives in Hawaii, who traveled to
Brazil during the first trimester of her pregnancy.
We do not yet know many things. We do not know what
proportion of women who are infected with Zika will deliver a
Zika-affected child. We do not know what proportion of infants
who do not have microcephaly will have a severe neurological
complication.
But CDC's laboratories have actually identified the Zika
virus in the brain tissue of infants who died in the first 24
hours of life with severe microcephaly. This indicates to us
that it is what is called a neurotrophic virus. It targets the
brain.
We are very concerned that, in addition to microcephaly,
there may be many other consequences of Zika for infants who
are infected.
In addition, there was a recent article in the New England
Journal that suggested that it was not just the first
trimester, which we would think might be the most susceptible.
But in fact, even in the second and third trimester, there were
some severe complications of the Zika infection.
Mr. Fattah. So now the game plan is to detect this in a
variety of ways, all the way up to and including developing
male mosquitoes. Talk to us about us line of attack here.
Dr. Frieden. In public health, we use basically an approach
of find it, stop it, prevent it. So those are the three ways
that we work.
We find it by doing better diagnostics, and CDC labs have
worked around the clock to get test materials out around the
country, around the world, so that we know what is happening.
Stop it. Stopping Zika is not easy. It spreads in the same
way that dengue spreads. If you look at how dengue has spread
in many communities, it is explosive and very difficult to
stop. Efforts to mitigate dengue have been hard.
So it is a matter of mosquito control, and the four aspects
of that are outdoor mosquitoes, indoor mosquitoes, larval or
baby mosquitoes, and adult mosquitoes. For each of those four
areas, there are things that we can do. One of CDC's roles is
to figure out what works best.
It would be States and localities that are implementing
mosquito control activity, but what we can do is identify best
practices and help to spread those. In addition, in places like
Puerto Rico where Zika is likely to spread widely, we want to
ensure that if a woman decides to delay pregnancy, that access
to voluntary effective contraception is available to her.
Mr. Fattah. Thank you, Mr. Chairman.
Mr. Cole. Thank you very much.
We now go to the gentlelady from Alabama for whatever
questions she cares to pose.
Ms. Roby. Thank you, Mr. Chairman.
OPIOID ABUSE
And thank you, Dr. Frieden. It is good to see you again. I
know oftentimes in our visits over the years, we have talked
about my children, and I am very blessed today to have Margaret
Roby--you cannot see her behind the chair--with me. But that
has certainly been the inspiration for a lot of our
discussions, my two children. So again, I appreciate your
willingness to be here.
I am sure the chairman of the full committee touched on
this, but all of us on this committee share a very deep concern
about the opioid epidemic raging across our country.
I have just recently become even more aware. I very
recently watched the video that was put out by DEA and the FBI,
Chasing the Dragon, which really just brought it home for me to
see not only the mother of a child who lost her life but also a
mother who lost everything in her life because of her own
addiction.
So it has really hit home, having not walked through that
with a family member or anybody close with me, which I think
you have to do really deeply appreciate it. But that is a very
powerful video, and I encourage everybody on the committee to
watch that. It is easy to find.
I am encouraged as well by the recent CDC guidelines for
prescribing opioids for chronic pain. I hope these new
guidelines will help limit access of individuals who try to
game the system to get ahold of these prescription drugs.
While this development will attempt to decrease the overuse
and abuse of opioids over time, we have to focus in on the
impact of overdoses occurring every day. I was stunned to learn
that, in 2014, there were 47,000 overdose deaths in the U.S.
For years, organizations have offered opioid overdose
prevention services with training and kits containing naloxone,
a drug used to treat a narcotic overdose in emergency settings.
So my question is, could you began by addressing the
possible safety concerns of providing naloxone to untrained
individuals? And how are fellow drug users expected to help
someone suffering from cardiac arrest, which I understand is a
very real potential byproduct of this drug as it is being
administered as a result of reaction to the drug? And what
steps are CDC, in collaboration with other agencies such as DEA
and FDA, taking to address any concerns about nonmedical
personnel administering naloxone?
I know from the testimony from the administrator of DEA
that all of their personnel are trained not just how to
administer the drug, but also how to address any issues as a
reaction to the drug.
So if you could just start talking about that, that would
be great.
Dr. Frieden. Thank you.
Naloxone is a very specific reversal drug, so it reverses
an opiate effect on the human body. I have used it in patients
I have cared for. It has a dramatic impact on reversing
overdose.
Overdose is life-threatening. Someone stops breathing. So
every moment matters.
Communities around the U.S. have tried different things,
and we encourage communities to try things and rigorously
evaluate them.
One thing that has been expanding is naloxone access in
even ambulances, because not all ambulances have it. So that
should be universal, in my personal view.
The FDA has been very helpful in approving a new
formulation of naloxone that is intranasal, so it does not
require injection. That makes it easier for a layperson to
provide.
Training, as you say, is very important. We have seen
communities around the U.S. provide naloxone. There are now
problems with the cost of naloxone, and there are efforts being
used to reduce the cost.
But they report a large number of reversals, and the
recommendation is you just do not give naloxone. You give
naloxone and call 911 at the same time, because the person
needs emergency care. But that may buy you the 5 or 10 minutes
that may make a difference between life and death or between
permanent brain damage and not permanent brain damage.
So I think the optimal use of naloxone is something that
communities need to work out. There are a complex set of
issues, including Good Samaritan laws and issues of reporting
of drug paraphernalia and law enforcement. But as communities
work through those consistent with their values and their
service availability, it has a role, I believe, in reducing the
risk of fatal overdose.
Ms. Roby. Are there more specific things that CDC is doing
to work with these community organizations?
My time is running short, so maybe you can get back to me.
I think all of us have a shared concern about how we, as
Members of Congress, could help people at the local and State
level have access to not just prevention and how to deal with
this opioid epidemic, but also tools and solutions such as this
that can be utilized in the moment that someone is suffering
from that.
Dr. Frieden. Yes. We will get back to you. We work through
States. With the support from Congress, we are able to support
all States in opioid response. One component of that is
naloxone access.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Roby. Okay, great. Thank you so much.
Thank you, Mr. Chairman. I yield back.
Mr. Cole. Thank you very much.
I have been advised that your schedule is a little
flexible. If that is the case, what we would like to do, since
we missed so much time because of votes, is give every member
about 3 more minutes to ask any additional questions they might
have, so if you can indulge us, Doctor?
Dr. Frieden. Sure.
Mr. Cole. Very good. Then I will go first.
I am going to ask you a series of three interrelated
questions, if I may.
CDC BUDGET
First, obviously, we increased your budget last year by 4
percent, which was about double, if I recall, of the
administration request, because we thought that was important,
and all of us on a bipartisan basis appreciate the good work.
This year, the budget is being reduced by 3 percent.
So I am going to ask you, one, can you give us the
rationale for the reduction?
Two, I know you are working, as NIH has been working, on a
strategic plan to sort of prioritize your work, so could you
give us your top three priorities looking forward in the
context of this budget?
And three, I am going to ask you a happier question, which
is, if we found extra money, what would you do with it, beyond
what is in your budget?
Dr. Frieden. Thank you very much, Mr. Chairman. And thank
you so much for your support in the 2016 budget.
As with any budget proposal, the administration had
difficult choices to make. In fiscal year 2016, the House was
very supportive of CDC, and I hope to see that again in the end
with the budget.
CDC is a best buy and investing in public health saves both
lives and money.
In terms of a strategic plan or top three:
Antibiotic resistance, we have to continue to make
progress. The bugs are dividing every minute, and we need to be
able to try to get ahead of this very concerning trend.
The second is prescription drug overdose. We really
appreciate the support. As just mentioned, this allows us to
support every State in the country or offer support to every
State in the country. And we want to continue to extend that
and improve prescribing patterns. And our support for Indian
country we would really like to expand.
If we had additional resources, well, there is a lot that
we would like to do. The way I look at public health is I break
it into four quadrants, basically. There are the infectious
diseases in the U.S. There are the infectious diseases
globally. There are the chronic diseases in the U.S., and the
chronic diseases and injuries globally. So those are the four
areas.
In each of those areas, there are best buys. There are
things where we can save many, many lives through the efforts
that we implement.
I think we indicated in antibiotic resistance, for example,
that $264,000,000 a year over 5 years would allow us to save
$7.7 billion, prevent more than 30,000 deaths and 600,000
hospitalizations. So we would like to fully implement that
program, if resources were available.
Furthermore, on issues of preventing cardiovascular
disease, we have shown that some of the programs that we have
are remarkably cost-effective. We can save a life for less than
$3,000. There are not a lot of programs that can do that. And
yet, they are not fully funded for whole-year activities. If we
are able to do that, we could save many more lives and much
more money.
I think also our work on health-care-associated infections
is an unsung success story, but a very partial one. We continue
to lose tens of thousands of Americans to infections that they
pick up in hospitals each year. We would like to work very
closely with States and health care facilities to drastically
reduce health-care-associated infections.
Mr. Cole. Thank you. I noticed your very capable staff was
shoving answers up there when the idea of additional money came
up. So I look forward, offline, to talking to you about those.
Dr. Frieden. And I forgot to mention our buildings, which
are in desperate need of repair.
Mr. Cole. With that, we will go to the gentlelady from
Connecticut.
CHRONIC DISEASES
Ms. DeLauro. Thank you, Mr. Chairman.
Let me pick up on this chronic disease prevention and
antibiotic-resistant drugs.
Eighty-six percent of annual medical costs in the U.S., 70
percent of deaths, can be attributed to chronic disease. A
hundred million Americans live with one or more chronic
conditions.
We had a $66 billion increase for defense and nondefense,
and we actually cut funding for chronic disease prevention at
CDC by $22,000,000, or about 2 percent. Shortsighted, in my
view.
Talk about the threat of chronic disease, what will happen
to health care spending, if we fail to address chronic disease,
which is largely preventable.
And I would like to get to antibiotic-resistant question as
well.
Dr. Frieden. Chronic diseases are largely preventable with
current technologies. I mentioned the Million Hearts campaign,
hypertension control. Our Tips from Former Smokers campaign is
truly a best buy. It is saving tens of thousands of lives a
year. Our tobacco control program is helping to drive down
tobacco use rates in kids and others. And our injury prevention
control program also has been a real success story.
We should be able to invest in programs like prevention of
senior falls, document what works and then scale that up. Those
are extraordinarily not only expensive, but they undermine
independence of seniors all too often.
So this is a crucial area where we can protect Americans
from threats.
Ms. DeLauro. What I will do is follow up with you on where
are one or two places which, if we could increase funding in
terms of chronic diseases, what would make sense.
ANTIBIOTIC RESISTANCE
Antibiotic-resistant bacteria, we know all the dangers on
this. I just want to ask you about your work with the USDA.
Antibiotic sales for food animal production are significant
and increasing. They account for 70 percent of total medically
important antibiotic sales by volume, a 23 percent rise since
2009. Animal feed and the development of bacteria that cannot
be killed now by antibiotics, what are we doing in this area?
What kind of collaboration do you have with USDA, so that we
can look at scaling back in this effort?
Dr. Frieden. We work closely with both USDA and FDA. We
have a weekly conference where we review clusters that may
reflect outbreaks of infectious disease.
One of the things that does concern us is that we are
seeing a continuing increase in the volume of antibiotics used
in animal husbandry.
We had a summit at the White House last year and had more
than 150 commitments from organizations to do a wide range of
things, including reduce use in animals. I think one of the
things that is crucially important is to track the actual
numbers--what gets measured can get managed--and see if that
reduction is occurring.
Ms. DeLauro. Do we have oversight capability, knowing what
they have done?
Dr. Frieden. I cannot answer that question. We would have
to get back to you.
[The information follows:]
Rep. DeLauro: What Oversight Do We Have Over Antibiotic Use in
Agriculture?
CDC recognizes the importance of collection of antibiotic use data
in agriculture. Just as in human medicine, good data about antibiotic
use and resistance can help us identify areas of concern or
improvement. CDC strongly supports the important work of FDA, USDA, and
others to improve antibiotic stewardship in veterinary medicine and
agriculture. FDA's Guidance for Industry #209 and #213 are important
steps, and CDC applauds the actions that veterinary pharmaceutical
manufacturers and food producers are taking to effectively implement
these changes that end labeling of antibiotics for growth promotion and
bring the remaining uses of antibiotic under veterinary oversight.
Recognizing that minimal data on antibiotic use in animal agriculture
currently exist, CDC supports FDA's recently released funding
opportunity to support antibiotic use data collection in animal
agriculture (http://grants.nih.gov/Grants/Guide/rfa-files/RFA-FD-16-
046.html).
In addition, CDC is participating in an interagency working group
with FDA and USDA to evaluate approaches for measuring antibiotic use
in food animals and how use relates to antibiotic resistance. Tracking
the use of antibiotics is critical to know how we are doing with
stewardship. Good information about where, why, and how antibiotics are
used is the basic information needed to know when stewardship is going
well and when it can be strengthened.
CDC has led antibiotic stewardship efforts in human health that
could serve as a model for antibiotic stewardship in animal health. CDC
has also shared information with FDA and USDA about CDC's core elements
for antibiotic stewardship, antibiotic use and resistance data
collection in human health, and partnerships to promote antibiotic
stewardship. CDC partners with veterinary and agricultural
associations, veterinary schools, and food safety experts, for example,
working through the National Institute for Animal Agriculture to
discuss shared interest in reducing antibiotic use and shared CDC's
efforts to reduce use in clinical settings and measure antibiotic use.
Ms. DeLauro. Okay. Thank you.
Mr. Chairman, if I could put this into the record, it is a
Los Angeles Times article that talks about the Zika virus. It
raises more questions and answers for pregnant women.
Mr. Cole. Without objection.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeLauro. Thank you.
Mr. Cole. Thank you.
The gentlelady from California, is recognized for 3
minutes.
NEURAL-TUBE DEFECTS
Ms. Roybal-Allard. Dr. Frieden, for many years, the
Congressional Hispanic Caucus has been working with the March
of Dimes and the American Academy of Pediatrics to get corn
masa fortified with folic acid to reduce the elevated incidence
of neural-tube defects, especially among Hispanics.
It looks like the FDA will soon approve a petition to allow
this fortification, and hopefully it will result in a
significant decrease in spina bifida and anencephaly in our
communities.
Concerns have been raised, however, that recent
recommendations by the USDA to prioritize the consumption of
whole grains in the American diet and mandate 100 percent whole
grains in the school meal programs could result in lowering the
intake of fortified grains and reverse the progress that we
have made reducing neural-tube defects.
The CDC has been a leader in research, tracking, and
prevention of neural-tube defects for over 2 decades, and your
folic acid education program can take much credit for the
progress that we have made in raising awareness of the
importance of dietary folic acid for all childbearing women,
and lowering the incidence of these birth defects.
How does the natural folic acid in whole grains compare
with the levels found in enriched products? And for women of
childbearing age, what are your recommendations about the
consumption of whole grains versus enriched grain products?
Dr. Frieden. Well, Congresswoman, on the issue of corn masa
flour, this is something that we have been deeply engaged with
the company, with the March of Dimes, and with the FDA for more
than 7 years.
Ms. Roybal-Allard. I was going to say, we have been working
on it for years.
Dr. Frieden. Yes. And we have been trying hard to move
forward, so we look forward to FDA action on that.
On the issue of whole grains, I will have to get back to
you with a detailed answer of what our recommendations are and
what the analysis is of both fortified and unfortified.
[The information follows:]
Rep. Roybal Allard: Comparison of Natural Folate in Whole Grain to
Fortified Grains
The CDC recommendation remains that women capable of becoming
pregnant should take 400 micrograms of synthetic folic acid daily, from
fortified foods or supplements or a combination of the two, in addition
to consuming food with natural folate from a varied diet.
Studies have shown that there are many health benefits associated
with consuming whole grains. Because of those health benefits, CDC
supports the Dietary Guidelines for Americans' recommendation that at
least half of grain consumption be whole grains and we support USDA's
rule that 100% of grains in school lunches should be whole grain-rich
(at least 51% whole grain). Because of those health benefits, CDC
supports the recommendation by the USDA to prioritize the consumption
of whole grains in the American diet. Commercially prepared whole wheat
bread has about one-fourth the dietary folate equivalents (unit used to
combine and compare natural food folate and folic acid in foods) of
enriched white bread. If dietary patterns shift from enriched products
to whole grain products, we would anticipate a reduction in folic acid
intake.
Women can consume folic acid through both fortified foods and
supplements. CDC recommends that women who choose to consume no or
limited amounts of folic acid-fortified foods should be sure to consume
a supplement containing folic acid before and during early pregnancy.
This is consistent with the CDC and the Food and Nutrition Board of the
National Academy of Sciences Institute of Medicine recommendation that
to reduce their risk for an NTD-affected pregnancy, women capable of
becoming pregnant should take 400 micrograms of synthetic folic acid
daily, from fortified foods or supplements or a combination of the two,
in addition to consuming food with natural folate from a varied diet.
The recommendation specifies the dosage of folic acid intake from
supplements, because there are no studies of the amount of natural food
folate intake needed to decrease NTD risk. Therefore, the
recommendations rely on studies that show that folic acid supplements
or fortification of 400 micrograms per day before and during early
pregnancy reduces NTD risk.
Ms. Roybal-Allard. Okay, I appreciate that. Thank you.
Mr. Cole. And for the last round of questions, my good
friend from Pennsylvania is recognized for 3 minutes.
ZIKA
Mr. Fattah. I will try not to consume all 3 minutes.
You said there were going to be 30 States participating in
the conference on the Zika virus. The other States are not
participating because?
Dr. Frieden. They do not have the mosquito that spreads it.
Mr. Fattah. Okay. And there is no fear? You said there were
two types of mosquitoes?
Dr. Frieden. Yes. They do not have either.
Mr. Fattah. All right, we are good.
Thank you, Mr. Chairman.
Mr. Cole. Thank you very much. That was quick.
Dr. Frieden, again, I want to thank you very much for your
testimony. Thank you again for your terrific public service. We
look forward to working with you and your staff as we go
forward this year.
Again, I appreciate all the good work on behalf of the
American people.
Mr. Fattah. We are going to remember the buildings.
Ms. DeLauro. We will not forget you. Thank you.
Mr. Cole. With that in the record, we are adjourned.
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W I T N E S S E S
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Collins, F. S.................................................... 1
Fauci, A. S...................................................... 1
Frieden, Thomas.................................................. 215
Hodes, R. J...................................................... 1
King, Hon. John.................................................. 167
Lowy, Douglas.................................................... 1
Skelly, Thomas................................................... 167
Volkow, N. D..................................................... 1