[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN
SERVICES, EDUCATION, AND RELATED AGENCIES
APPROPRIATIONS FOR 2015
_______________________________________________________________________
HEARINGS
BEFORE A
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
________
SUBCOMMITTEE ON THE DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES,
EDUCATION, AND RELATED AGENCIES
JACK KINGSTON, Georgia, Chairman
STEVE WOMACK, Arkansas ROSA L. DeLAURO, Connecticut
CHARLES J. FLEISCHMANN, Tennessee LUCILLE ROYBAL-ALLARD, California
DAVID P. JOYCE, Ohio BARBARA LEE, California
ANDY HARRIS, Maryland MICHAEL M. HONDA, California
MARTHA ROBY, Alabama
CHRIS STEWART, Utah
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, Allison Deters,
Jennifer Cama, Justin Gibbons, and Lori Bias,
Subcommittee Staff
________
PART 5
Page
Oversight Hearing--Public Health Emergency Medical
Countermeasure Enterprise......................................... 1
U.S. Department of Health and Human Services..................... 119
Budget Hearing--Future of Biomedical Research.................... 283
________
Printed for the use of the Committee on Appropriations
________
Part 5
U.S. GOVERNMENT PRINTING OFFICE
92-629 WASHINGTON : 2015
COMMITTEE ON APPROPRIATIONS
HAROLD ROGERS, Kentucky, Chairman
FRANK R. WOLF, Virginia NITA M. LOWEY, New York
JACK KINGSTON, Georgia MARCY KAPTUR, Ohio
RODNEY P. FRELINGHUYSEN, New Jersey PETER J. VISCLOSKY, Indiana
TOM LATHAM, Iowa JOSE E. SERRANO, New York
ROBERT B. ADERHOLT, Alabama ROSA L. DeLAURO, Connecticut
KAY GRANGER, Texas JAMES P. MORAN, Virginia
MICHAEL K. SIMPSON, Idaho ED PASTOR, Arizona
JOHN ABNEY CULBERSON, Texas DAVID E. PRICE, North Carolina
ANDER CRENSHAW, Florida LUCILLE ROYBAL-ALLARD, California
JOHN R. CARTER, Texas SAM FARR, California
KEN CALVERT, California CHAKA FATTAH, Pennsylvania
TOM COLE, Oklahoma SANFORD D. BISHOP, Jr., Georgia
MARIO DIAZ-BALART, Florida BARBARA LEE, California
CHARLES W. DENT, Pennsylvania ADAM B. SCHIFF, California
TOM GRAVES, Georgia MICHAEL M. HONDA, California
KEVIN YODER, Kansas BETTY McCOLLUM, Minnesota
STEVE WOMACK, Arkansas TIM RYAN, Ohio
ALAN NUNNELEE, Mississippi DEBBIE WASSERMAN SCHULTZ, Florida
JEFF FORTENBERRY, Nebraska HENRY CUELLAR, Texas
THOMAS J. ROONEY, Florida CHELLIE PINGREE, Maine
CHARLES J. FLEISCHMANN, Tennessee MIKE QUIGLEY, Illinois
JAIME HERRERA BEUTLER, Washington
DAVID P. JOYCE, Ohio WILLIAM L. OWENS, New York
DAVID G. VALADAO, California
ANDY HARRIS, Maryland
MARTHA ROBY, Alabama
MARK E. AMODEI, Nevada
CHRIS STEWART, Utah
William E. Smith, Clerk and Staff Director
(ii)
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR 2015
----------
Thursday, February 27, 2014.
OVERSIGHT HEARING--PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURE
ENTERPRISE
WITNESSES
GEORGE W. KORCH JR., PH.D., SENIOR SCIENCE ADVISER TO THE ASSISTANT
SECRETARY FOR PREPAREDNESS AND RESPONSE
ROBIN ROBINSON, PH.D., DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND
DEVELOPMENT AUTHORITY
GREG BUREL, ACTING DEPUTY DIRECTOR, OFFICE OF PUBLIC HEALTH
PREPAREDNESS AND RESPONSE, CENTERS FOR DISEASE CONTROL AND
PREVENTION
LUCIANA BORIO, M.D., ASSISTANT COMMISSIONER, COUNTERTERRORISM POLICY,
FOOD AND DRUG ADMINISTRATION
MICHAEL KURILLA, M.D., DIRECTOR, OFFICE OF BIODEFENSE RESEARCH
RESOURCES AND TRANSLATIONAL RESEARCH, NATIONAL INSTITUTES OF
ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH
Mr. Kingston. Okay. The committee will come to order and
want to welcome everyone here.
I am going to start by welcoming Mr. Chris Stewart here,
who is our newest committee member. And Chris, it is tradition
of the new committee--number one, since you beat Mrs. Roby
here, you can send her for your coffee. [Laughter.]
That is after you get the rest of us coffee. So that is the
tradition, but we are glad to have both of you.
And I wanted to yield some time to my friend Rosa to
welcome you all as well.
Ms. DeLauro. I do welcome both of you. It is a fabulous
committee. I have had the opportunity to serve on it for a
number of years. I think it is probably of the Appropriations
subcommittees--I have to say for this and Agriculture because I
serve on both of those committees--but it is really the place
where there is such a broad spectrum of what affects people's
lives every single day.
And so, it is a delight. I know you are going to enjoy the
work, the camaraderie. And the chairman and I have had the
opportunity to work together over the years not only in this
committee, but in the Agriculture Subcommittee.
So I think it is a great place for you to be, and welcome.
And you will learn a lot from this committee and listening to
people like this this morning.
Thanks. Thank you, Mr. Chairman.
Mr. Kingston. Yes, I will say that this committee is just a
deep well in all the various issues it gets involved in, and
you can learn so much about so many things on it. And we have
got a great staff. I am sure you have gotten familiar with
them, and both the Democrat or the Republic side, they are
there for you.
And most of the issues we deal with are not partisan at
all. When you are trying to find a cure for a disease or
something like that, you know, the science is the guide. So I
think you will have a great time.
And with that, I wanted to welcome our witnesses today.
This is our Public Health Emergency Medical Countermeasures
Enterprise hearing, and it is the first hearing of the year.
And our witnesses are Dr. George Korch, who is the senior
adviser to the Assistant Secretary for Preparedness and
Response; Dr. Robin Robinson, Director of the Biomedical
Advanced Research and Development Authority, also which we all
call BARDA; and Dr. Luciana Borio, who is with the FDA and the
Assistant Commissioner for Counterterrorism Policy; and Dr.
Michael Kurilla, with the National Institutes of Health in the
area of allergy and infectious diseases; and Mr. Greg Burel,
who is the Acting Deputy Director of the Office of Public
Health Preparedness and Response, Centers for Disease Control.
So we are very happy to have all of you all here. And since
we do have so many witnesses, we are going to ask you to keep
your prepared comments to 3 minutes.
And then I want to say to the committee members,
particularly Mrs. Roby and Mr. Stewart, we go by 5 minutes. And
the first round of questions goes to who came here first, and
then we just get in the regular order of the dais.
But we will stick strictly to the 5-minute rule. And Ms.
DeLauro and I have been doing this for many years, both
swapping the gavel back and forth. And we have always found
that the shorter the questions, then you get more rounds in for
everybody, and it is better.
So, with that, Dr. Robinson, the floor is yours.
Ms. DeLauro. Opening statement?
Mr. Kingston. Oh, yes, excuse me. And let me yield to Ms.
DeLauro for an opening statement.
Ms. DeLauro. Thank you very much, Mr. Chairman. And as the
chairman is wont to know, I do make opening statements.
And I only just have one correction in names, Mr. Chairman,
and it is Luciana. Luciana Borio. [Laughter.]
I can't--I can't do all the pronunciations for everyone
else, but this one I do know. So----
Mr. Kingston. Wait a minute. Wait a minute. So you are
Italian? [Laughter.]
Ms. DeLauro. Ah, si.
Dr. Borio. Sicilian background, but I go by Lu to make it
simple for everybody. [Laughter.]
Mr. Kingston. Well, I am asking because Ms. DeLauro has
always said next time we have an Italian witness, she is
bringing lasagna, and----
[Laughter.]
Ms. DeLauro. You should have let me know that this was the
case.
Mr. Kingston. We will have that happen. But we are glad to,
of course, have anyone here, who is Brazilian or Italian,
whatever.
And Dr. Korch, I understand we are going to start on the
left and work our way over.
Ms. DeLauro. But, no.
Mr. Kingston. Oh, you haven't done your opening statement.
Yes.
Ms. DeLauro. Thank you.
I want to thank our witnesses for their insights and their
expertise that they will share with us this morning.
The subcommittee is evaluating our efforts to become better
prepared with outbreaks of deadly diseases, particularly
through development of new, better drugs and vaccines. Many of
the efforts we will hear about today are aimed at limiting the
harm from deliberate biological or chemical attacks, such as
the spread of anthrax here in Washington 12 years ago. These
programs were begun, greatly expanded in the last 10 or 12
years in response to growing recognition of serious gaps in our
public health preparedness.
There have been some successes. Flu, for example. There was
a time in the last decade when we were down to just one
manufacturer of flu vaccine in the United States with only
limited capacity to scale up production to respond to an
epidemic. Today, we now have a much improved production
capacity for the flu vaccine.
That being said, I think there are serious questions as to
whether the vast resources that are dedicated to these programs
are being spent in the most efficient manner to protect the
public health. For example, we find ourselves 10 years into the
BioShield program, having spent a whopping $3,100,000,000, and
we have to look at what do we show for that.
Certainly, an improved stockpile to deal with anthrax and
smallpox, yet there is clearly a much wider spectrum of threats
that confront us. We also need to be much better prepared to
deal with emerging threats that occur naturally. Threats like
the spread of novel diseases like SARS, the emergence of
microbes that have become resistant to drugs used against them,
and both pandemic flu and the ever-changing seasonal flu
viruses.
I realize that BARDA has produced a broader range of
products that are still in the development pipeline. But when
these efforts were launched a decade ago, we expected to be
further along by now. So I think our track record in developing
medical countermeasures is decidedly mixed.
Just as important, we need to recognize that public health
preparedness involves much more than simply developing and
stockpiling drugs and vaccines. We also need enough well-
trained epidemiologists, other health professionals to
identify, investigate, and track disease outbreak. We need
enough laboratory capacity to analyze large volumes of samples
and determine what pathogens are involved.
We need effective plans, enough supplies and personnel to
efficiently distribute and dispense vaccines and treatments. We
need the surge capacity in our hospitals and other facilities
to take care of large numbers of seriously ill patients.
All of this work needs to be done through partnerships
between Federal agencies like CDC, State and local health
departments, and the medical and first responder communities.
Unfortunately, we have spent the past 5 to 10 years cutting
Federal support for these critical State and local preparedness
activities.
Adjusted to inflation, CDC funding to State and local
health agencies has declined by nearly 50 percent in the past
10 years. Similarly, the Hospital Preparedness Program, which
provides grants to States to improve the preparedness and
resiliency of their healthcare system, has declined by about 60
percent.
These cuts cause State and local health departments to
eliminate staff. They cut training exercises. They forgo
critical medical equipment and technology. Addressing all these
needs has become a real challenge for our subcommittee in light
of the tight budget limits that are being imposed.
Much of the PHEMCE enterprise is really a new cost to this
subcommittee that has to be fit within our constrained
allocations. Until this year, all of BioShield and most of
BARDA had been supported from a 10-year advance appropriation
made back in 2004 in the homeland security bill. Much of the
pandemic flu preparedness activity has been supported through
balances of emergency supplemental appropriations made in 2006
and 2009.
However, now those funds have either expired, they are
almost depleted, and this subcommittee has got to start
covering the cost. That is $800,000,000 in 2014 through annual
appropriations.
What we had to do--and I want to say this to our panel as
well as those of us up here--that unless we look at a different
scale of allocation for this subcommittee, we had a serious
shortfall in my view in the last allocation where we had to,
because of the underfunding of some of the agencies that you
represent here, we had to take on the $800,000,000. And that
had to come from someplace. It had to come from someplace. And
it came from other areas.
These needs are all important. Investments provide tangible
returns for the public. This subcommittee has got to take care
of these issues. But with that tight constraint, it is going to
be difficult to provide the adequate support to these
countermeasure programs and take care of the many other public
health priorities.
I will just give you one, the NIH. We saw only 58 percent
of its sequestration cuts restored in the 2014 budget. And so,
much of the basic scientific support for these efforts as well
as other pieces at CDC and elsewhere necessary for public
health preparedness will suffer the real, potentially grave
consequences to the budget decisions that we make.
Weaker defenses against infectious diseases, slower
progress in advancing medical science generally may be one of
the consequences. So, today, I look forward to the discussion
of both the current status of the PHEMCE programs and the
challenges that we face ahead.
Thank you so much for joining us today, and I thank you,
Mr. Chairman, for the time. We look forward to your testimony.
Mr. Kingston. Thank you.
And if there are no other opening statements, Dr. Korch.
Dr. Korch Opening Statement
Mr. Korch. Chairman Kingston, Ranking Member DeLauro, and
distinguished members of the committee, thank you for inviting
me to testify on how the HHS PHEMCE is protecting the American
public as a model for innovation and accountability in the
Federal Government.
The Public Health Emergency Medical Countermeasure
Enterprise, otherwise known as the PHEMCE, is the Federal
coordinating body that oversees the lifecycle management of
those medical countermeasures we rely on in the face of
disasters arising from biological, chemical, radiological, or
nuclear threats, or from novel and emerging pandemic diseases.
These include those drugs, vaccines, and other medical
products the Congress and the administration have called for in
past legislation to protect our population. Lifecycle
management includes all aspects of the pipeline from initial
research of promising products all the way through development,
manufacture, purchase, stockpile, and distribution.
The PHEMCE assures that the talents and the authorities of
a number of Federal agencies are well coordinated in this
effort. The Assistant Secretary for Preparedness and Response
leads the PHEMCE in partnership with the HHS agencies
represented here today, as well as interagency partners from
the Departments of Defense, Homeland Security, Agriculture, and
Veterans Affairs.
Over the last 10 years, we have seen major returns on
investment. We have produced and procured innovative medical
countermeasures that will allow our Nation to better respond to
medical and public health emergencies, ultimately saving lives
and mitigating illness. This progress comes as a result of the
support of the current and previous administrations, the
Congress, and this subcommittee.
Above all, the PHEMCE mission, as stated in our strategic
plan, demands that we preserve and protect people's lives
against these major public health threats while exercising
strong and effective stewardship of the taxpayers' dollars. The
PHEMCE governance process and the decision framework aligns
efforts, clearly articulates priorities, ensures that our
resources are used effectively by all of our partners and for
all segments of our population.
We have recognized the need to look at longer time horizons
and to forecast our individual budget estimates in a cohesive
way so that each partner understands the important handoffs and
responsibilities across the lifecycle management of these
medical products. We are addressing this through the multiyear
budgeting process, a newly established tool the PHEMCE has
devised to foster efficiencies and harmonization across the
different stages of the medical countermeasure planning.
We also see the multiyear budget as an effective way to
communicate the PHEMCE's commitment and priorities to our
industry partners, who are key to the success of our program.
With better communication of priorities and resource needs, we
are able to provide a higher degree of predictability to our
partners and external stakeholders, including the Congress.
Coordinating resources and priorities of the partners that
are represented here today is essential to establishing a
sustainable and responsive medical countermeasure enterprise.
This is foundational to our ultimate objective, a resilient
nation prepared to respond and to recover from a wide range of
those potential threats.
Thank you, and I look forward to your questions.
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Mr. Kingston. Good job.
Dr. Kurilla.
Dr. Kurilla Opening Statement
Dr. Kurilla. Thank you, Mr. Chairman and members of the
committee. Thank you for the opportunity to discuss the role of
NIH in the PHEMCE.
I am the Director of the Office of Biodefense Research
Resources and Translational Research at the National Institute
of Allergy and Infectious Diseases, known as NIAID, which is
the component of the NIH with the lead for research on
biodefense and emerging and reemerging infectious diseases. In
fiscal year 2013, NIH funding for this research was
approximately $1,700,000,000.
The NIH supports foundational research towards the
development of medical countermeasures against biological,
chemical, radiological, and nuclear threats, including emerging
and reemerging infectious diseases. NIH collaborations with its
PHEMCE partners are critical and crucial to this endeavor. The
NIH holds senior leadership positions within the PHEMCE, and
NIH subject matter experts provide input to all PHEMCE working
groups that coordinate efforts on particular biodefense
threats.
NIH biodefense research aims to rapidly respond to manmade
or naturally occurring threats, including microbes, toxins,
chemical agents, radiation, and emerging or reemerging
infectious diseases, such as seasonal and pandemic influenza.
NIH transitions the advanced research and development of high-
priority medical countermeasures to BARDA, with the eventual
goal of FDA approval and possible inclusion within the SNS.
NIAID supports research and early-stage development of
medical countermeasures as well as platform technologies to
more rapidly and efficiently develop vaccines and diagnostics
for a variety of threats. Our migration from a ``one bug, one
drug'' approach towards a more flexible research paradigm is
yielding advances that will enhance our ability to respond to
the emerging public health threats of the future.
Recent successes in NIAID's biodefense program include a
next-generation smallpox vaccine and two smallpox antiviral
drug candidates that have been transitioned to BARDA for
further development. Other candidate products recently
transitioned from NIAID to BARDA include therapies for anthrax
and pandemic influenza. NIAID has also conducted studies that
supported the first antibiotic approvals for pneumonic plague
under the FDA's ``animal rule.''
Seasonal influenza and a potential emerging influenza
pandemic remain serious public health challenges. NIAID
supports research to develop medical countermeasures to
diagnose, treat, and prevent seasonal and pandemic influenza.
NIAID has collaborated with CDC, FDA, and BARDA to rapidly
develop a vaccine for 2009 H1N1 pandemic influenza, and current
efforts are focused on H7N9 avian influenza vaccine candidates.
We are also working to develop a universal influenza vaccine,
which could reduce the need for an annual vaccination and save
millions of lives.
NIAID research also aims to understand the damaging effects
of radiation and to develop medical countermeasures to diagnose
and treat radiation exposure. Twenty diagnostic--20
radiological candidates and 6 biodosimetry approaches supported
by NIAID have been advanced to BARDA for further development,
and NIAID has supported animal studies of Neupogen for the
treatment of hematopoietic acute radiation syndrome.
The NIH remains committed to meeting public health
emergency needs by advancing high-priority research for the
development of medical countermeasures. Together with our
PHEMCE partners, NIH will continue to pursue the development of
diagnostics, therapeutics, and vaccines that will increase our
national preparedness.
Thank you.
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Mr. Kingston. Thank you.
Dr. Robinson.
Dr. Robinson Opening Statement
Mr. Robinson. Good morning, Chairman Kingston, Ranking
Member DeLauro, and other distinguished members of the
subcommittee.
Thank you for the opportunity to speak with you today about
Government biodefense efforts. I am Robin Robinson, the
Director of BARDA, and Deputy Assistant Secretary for ASPR in
HHS.
BARDA, like ASPR, was established by the Pandemic and All-
Hazards Preparedness Act of 2006 and mandated to support
advanced development and acquisition of novel and innovative
medical countermeasures such as vaccines, therapeutics,
diagnostics, and medical devices for the Nation to address the
medical consequences of manmade threats and mother nature like
the H1N1 pandemic.
Medical countermeasure development is risky, lengthy, and
costly, with many inexperienced developers failing and larger
pharmaceutical companies avoiding this sector completely. BARDA
bridges the ``valley of death'' that prevents the transition of
many product candidates from early development to
commercialization and FDA approval by providing funding and
technical core service assistance.
BARDA has made good on the mandate in a number of ways.
First, BARDA has established a robust and formidable product
development pipeline of more than 150 product candidates,
including many for special populations like children. FDA has
approved 7 first-in-class products supported by BARDA in the
last 18 months.
From this pipeline, we have procured 12 novel products
under Project BioShield to date, including smallpox vaccines
and antiviral drugs, anthrax vaccines, and antitoxins which
have been licensed, botulinum antitoxins which have been
licensed, radionuclide chelators, anti-neutropenia cytokines
for radiation illness, and chemical agent anticonvulsive drugs.
BARDA has also built and expanded domestic manufacturing
capabilities for these medical countermeasures by establishing
national stockpiles for H5N1 and H7N9 vaccines and new
adjuvants for pandemic preparedness, created public-private
partnerships with industry, and have expanded domestic pandemic
influenza vaccine manufacturing surge capacity several fold and
developed new classes of antimicrobial drugs for biothreats and
prominent classes of antimicrobial drug-resistant pathogens
like CRE and MRSA.
BARDA has also established new and innovative ways to help
inexperienced companies through the Core Service Assistance
programs. These are animal studies networks, Centers for
Innovation in Advanced Development and Manufacturing, Fill
Finish Manufacturing Network, and Clinical Studies Network that
will be established this year.
Response capabilities from these Core Service Assistance
programs have already been utilized for recent public events
such as H7N9 outbreaks. BARDA has increased the sustainability
of these biodefense preparedness by actually moving from a one
bug, one drug paradigm to actually repurposing existing drugs
and developing multipurpose products that can be used for
biothreats and also everyday public health emergencies.
BARDA has also embraced the multiyear budgeting, but we
still have a number of obstacles to come. Complacency about
threats is here today, and we must remain vigilant about that.
I look forward to answering your questions as we go forward
and look forward to your continued support as we go forward in
this endeavor.
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Mr. Kingston. Thank you.
Mr. Burel.
Mr. Burel Opening Statement
Mr. Burel. Good morning, Chairman Kingston, Ranking Member
DeLauro, and members of the subcommittee. Thank you for the
invitation to be with you today.
Public health emergencies, such as the 2009 H1N1 influenza
pandemic or 2012's Hurricane Sandy, can quickly overwhelm State
and local public health resources. CDC provides scientific
expertise, guidance, and support for State and local public
health systems as they work to prevent, protect, mitigate,
respond to, and recover from all public health emergencies that
threaten the health of American people at home and around the
world.
This wealth of expertise and the drive to innovate helps
inform Federal decisions on responding to emerging threats,
including those decisions on deployment of assets from the
Strategic National Stockpile, the Nation's repository of
medical countermeasures currently valued at approximately
$5,900,000,000.
CDC supports the PHEMCE by providing subject matter
expertise and executive guidance, current information on the
assets held by the SNS, expertise in the management and
distribution of these assets to the States, and an
understanding of State and local plans to dispense these
medical countermeasures. CDC works with the PHEMCE to
prioritize and address gaps in the highest-priority threat
areas and transforms these recommendations into assets ready to
protect lives through procurement of materials and management
of those materials.
The SNS is a unique Federal asset, embedded in a public
health threat detection and response agency. The rapid response
to emergencies depends on robust State and local infrastructure
and planning.
The Public Health Emergency Preparedness Cooperative
Agreement, or PHEP, is a critical companion program to the SNS.
This provides funding and expertise to our State and local
partners to support their planning efforts to effectively
receive and make use of medical countermeasures delivered from
the stockpile.
These interconnected programs assured that during the H1N1
pandemic CDC was able to efficiently deploy stockpiled
antiviral drugs and personal protective equipment to our
partners throughout the Nation. It assured that Oregon was able
to conduct a mass vaccination campaign to respond to a
meningitis attack--or outbreak. And it assures that we can rush
antitoxins and treatments to any person exposed to anthrax,
botulism, or other public health threats.
As part of CDC's management responsibility, the SNS
acquires commercially available pharmaceuticals, devices, and
ancillary supplies. Besides outright purchases, CDC uses
vendor-managed inventory and a number of other innovative
purchase agreements based on the lowest cost to the U.S.
Government over the entire lifecycle of a product.
Additionally, CDC is responsible for replacing SNS-held
medical countermeasures licensed and/or initially procured by
BARDA. CDC develops policies and guidance for the use of these
medical countermeasures and forward deploys them to respond
quickly anywhere in the country.
We have always sought to maximize the effectiveness of
resources and investments. We are even more so focused in the
current fiscal environment. Efforts to maximize the impact of
our national--this unique national resource include recent
independent reviews by two Federal advisory committees and a
forthcoming congressionally mandated review by the IOM.
I thank you again for the opportunity to testify, and I
will be happy to answer any questions you may have.
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Mr. Kingston. Thank you.
Dr. Borio.
Dr. Borio Opening Statement
Dr. Borio. Good morning. Good morning, Chairman Kingston,
Ranking Member DeLauro, subcommittee members. I am happy to
appear before you and my public health colleagues.
I would not be here today if it were not for your strong
leadership on this issue, Chairman Kingston and Ms. DeLauro.
Three years ago, as the chair and ranking member of the
Agriculture Appropriations Subcommittee, you approved bill
language for the fiscal year 2011 appropriations act that
launched the FDA program that I lead. And in subsequent years,
you sustained or increased funding for FDA's Medical
Countermeasures Initiative.
And now Chairman Aderholt and Representative Farr are
continuing this support. So I thank you for your vision and
your leadership. On behalf of myself and my colleagues at the
witness table and on behalf of the Americans who may someday
need new medical products to address CBRN threats and the
Americans who will continue to benefit from advances related to
pandemic influenza and other emerging infectious diseases,
thank you.
FDA plays a critical role in protecting the U.S. from these
threats. We ensure that countermeasures--drugs, vaccines, and
diagnostic tests--are safe, effective, and secure.
Collaboration with our interagency partners is the cornerstone
of this critical public health responsibility.
FDA also partners with the Department of Defense to support
the unique needs of the warfighter. FDA employs its
authorities, such as the emergency use authorization, to
facilitate access to available countermeasures to respond to
public health emergencies even when products are not yet
approved for use. We also provide scientific and regulatory
counsel on stockpiling and deployment decisions.
The resources you approved allowed FDA to hire essential
expert staff and become even more engaged in the countermeasure
activities. With this increased engagement, we helped resolve
many regulatory challenges and impediments associated with
developing these highly complex medical products. We are
working to ensure that their development does not stall.
Your investment facilitated the approval of several
countermeasures, including a therapy for inhalational anthrax,
a botulism antitoxin, a next-generation portable ventilator,
and several influenza diagnostic tests and vaccines. We have
readied countermeasures for potential use and our EUA authority
against an array of threats, including smallpox, anthrax,
pandemic influenza, and nuclear threats.
We worked closely with this Congress on the passage of the
Pandemic and All-Hazards Preparedness Reauthorization Act of
2013, which created new authorities for the FDA, and we have
already put these new authorities to good use. We were able to
issue EUAs for diagnostic tests for the Middle East respiratory
syndrome coronavirus and for the avian influenza H7N9 virus,
including one requested by the CDC and another requested by a
commercial developer.
With input from our enterprise partners, FDA has
established a broad and robust regulatory science portfolio,
which is essential for our regulatory decision-making.
I want to conclude by emphasizing that developing
countermeasures is highly complex. Close cooperation is
essential, and the deep engagement represented here today
exemplifies public health synergy at its best. What we
collectively achieve on behalf of the American public is far
greater than the sum of our parts, and thank you for making
this possible.
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PANDEMICS
Mr. Kingston. Thank you.
Dr. Robinson, you mentioned complacency, and I do worry
about that myself. I was at the CDC about 2 weeks ago and was
making a statement about the lack of knowledge the average
person has about pandemics in the past, particularly 1918, that
area of time. And I don't know if you know any of those numbers
off the top of your head, but what I would like is if you could
give the committee members a memo, just a kind of a follow-up
and just say, you know, past pandemics.
And nothing really elaborate, but just the years, say, 1914
to 1920, the number of deaths, maybe the countries in which it
was concentrated, and the cause. Because I fear that the
average school child in America, while you learn about World
War I, World War II, and so forth, you don't learn about the
pandemics, which cost more lives.
And I don't know if you know any of those numbers off the
top of your head and want to respond on that, but I think it is
important for people to understand that these threats have been
out there, and the threat of them is lower than it used to be,
but it is still there. Do you want to----
Mr. Robinson. Congressman Kingston, I would be happy to
give you a memo. But in a nutshell, in 1918, the United States
estimates as low as 500,000 to 1 million people in the United
States lost their lives to the H1N1 1918 flu. Globally, it was
tens of millions.
Mr. Kingston. Yes.
Mr. Robinson. That was more deaths than were experienced
during World War I.
In 1957, we saw tens of thousands of individuals die in
this country with the H2N2. H3N2, in 1968, it killed tens of
thousands of people here, more than what we would normally see
in our usual outbreaks every year. And then, in 2009, the H1N1
pandemic, we saw levels that were especially severe in children
and pregnant women and other special populations at levels that
were above what we see in our normal influenza.
There are years, in fact, where there is not a pandemic,
but there are severe influenza attacks and outbreaks. And that
the constant vigilance of using vaccines and having antiviral
drug therapies there are a way to assuage the mortality that is
associated with these. But we will be happy to give you greater
details.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Kingston. I think it would be very helpful because it
is astounding the numbers, and it is astounding that we just
don't know that--you know, the average person just doesn't know
about this.
The second part to this in the complacency, and Ms. Lee and
I have visited PEPFAR clinics in Africa. But I think one of the
stories we are not telling is how the AIDS epidemic in Africa
has been greatly reduced and the cost of treatment per person
has gone down as the effectiveness of it has gone up, compared
to where we would have been 20 years ago. And I don't think
that people understand how much stride has been made in that.
And then one thing I am always talking about as well is the
success we have had in polio. And I love to go to senior
citizens homes and ask them how many are familiar with polio.
And every single hand is raised. And then I tell them if I go
to college campuses and ask that same question, maybe 10
percent of the kids have ever heard of polio.
And you know, it is one of those success stories that we
are not telling. And not that that is directly related to your
work, but it does fit into the bigger picture.
And so, and my time is about expired. I don't know if you
need to respond to that one way or the other. But----
Mr. Robinson. We will be happy to provide in a written
record response to that.
[The information follows:]
Complacency About Public Health Emergency Preparedness
Complacency about the need for public health emergency preparedness
against man-made and major natural events is a major national concern.
Historically our country responds very well after an event has
occurred, but prevention has not always been a strong feature of
American public health as state and local health department capacity
eroded and vaccination acceptance has been questioned. Despite clarion
calls from international infectious disease experts, the vaccine
industry has struggled over the past twenty years to successfully
address emerging infectious diseases without USG assistance. This is
corroborated by the lack of progress towards development of new
vaccines and antiviral drugs for emerging infectious diseases such as
coronaviruses (CoV) that are here today. Despite SARSCoV outbreaks in
2003, there are no vaccines and antiviral drugs in advanced development
for the on-going MERS-CoV outbreak in the Middle East and elsewhere.
The Amerithrax anthrax cases in 2001, serve as an example that we must
stay prepared for man-made biothreats. Medical countermeasures are one
of the national insurance policies that we must not allow to lapse, as
these threats, whether man-made or natural, do occur.
NATURAL VS. MANMADE THREATS
Mr. Kingston. Okay. Ms. DeLauro.
Ms. DeLauro. Thank you very much, Mr. Chairman.
And I never got to know my grandfather. He died in 1918 at
age 34, leaving 6 children behind, and died within about 4
days. But have seen the photographs of him, and an enormously,
6 foot, handsome man with--you know, strapping man that was
just, you know, in 4 days was gone because of the pandemic.
Programs we are discussing today came out of September
11th, focused primarily on another terrorist attack, whether it
was chemical, biological, radiological, nuclear weapons. Twelve
and a half years later, that the investment and the time to
develop the effective countermeasures is significant.
We also have threats that are evolving, naturally
occurring. And so, that there has been, as I understand it from
reading, in the biomedical community alarms raised because the
view is that there is a heavier focus on the--that the heavier
focus should be on emerging infectious diseases, growing
problem of antibiotic-resistant bacteria.
So it is actually a two-part question. Given fiscal
constraints, how do we go about setting the priorities between
manmade threats, naturally occurring threats?
The Department of Homeland Security, do they take
precedence with regard to a manmade threat? Does BARDA
prioritize its support based on the likelihood and severity of
a potential threat, regardless of whether or not it is manmade
or naturally occurring?
And how do you all determine the balance? Where is that
balance piece? And that is also in terms of the resource
allocation between these two categories of need.
Let me just add to that, if I can, how often does PHEMCE
reevaluate existing threats and the funding priorities that
match those threats? Do you have the nimbleness to, if you move
to look at something, if something was determined in the next
12 months that was an infectious disease, drug-resistant
bacteria, greater threat than a terrorist attack, how long
would that transformation in BARDA, that pipeline take to move?
And how prepared are we right now to address the most likely
threats to emerge in 2014?
So let us talk about the balance piece and then these
evaluation, continuing evaluation pieces.
Mr. Korch. Thank you for the multipart question. There is a
lot to unpackage there.
Ms. DeLauro. Right.
Mr. Korch. With regard to identification of what threats we
prioritize right now versus what threats we might see in the
future, we actually in the PHEMCE, in our strategy and
implementation plan, address this. For the first part of it----
Ms. DeLauro. The manmade and----
Mr. Korch. Yes. For the first part----
Ms. DeLauro. Okay.
Mr. Korch [continuing]. The manmade or the deliberate
threats, this is a function of an evaluation that we work with
the Department of Homeland Security and the material threat
assessments and material threat determinations. And from that,
we can project, while with BARDA's modeling capability, what is
going to be the public health impact, which then informs what
kind of medical countermeasures and how we do it. And that then
sets the stage for the investments that we make currently in
manmade.
Now on the aspects of----
Ms. DeLauro. And natural? Right.
Mr. Korch [continuing]. Naturally occurring or emerging
threats, one of the things that we look for in this program,
because emerging threats is part of our mandate, not so much on
the dengues and those types of problems of the world. But what
we are looking at right now--and Robin alluded to this a little
bit, as did Mike--is where can we develop medical
countermeasures that have either platform approaches, things
that we are working on right now in biodefense, that can be
almost instantly applied to other diseases that emerge.
Ms. DeLauro. This is naturally occurring?
Mr. Korch. To naturally occurring diseases that are
emerging. So different types of vaccines, other kinds of
antivirals or antimicrobial. Robin can provide more information
on the extensive program that is being developed right now on
looking at antimicrobial resistance, new products to address
the gram negative bacterial infections, naturally occurring----
Ms. DeLauro. Resource allocation, because my time is going
to--they are going to----
Mr. Korch. Okay. So let me move----
Ms. DeLauro. Resource allocation, how do you make this--you
know, make the distinction and the reevaluation process
involved in this?
Mr. Robinson. So annually within BARDA, and certainly
within ASPR and then the entire PHEMCE----
Ms. DeLauro. Right.
Mr. Robinson [continuing]. We reevaluate what those
priorities are and what the funding allocations are. So we are
constantly doing that. As each individual medical
countermeasure comes up for acquisition to the Project
BioShield and to give to the SNS, we go through a process that
goes to our senior leaders who actually say does this meet our
strategy going forward?
Ms. DeLauro. I will pick up afterward. Thank you.
Mr. Fleischmann. Thank you, Mr. Chairman.
And I want to thank each and every one of you all for being
here today. This is not only insightful to me, as a Member of
Congress and on the committee, but really it is educational and
it helps me do my job. So thank you in advance.
5-YEAR PLAN
The first question I am going to ask, I will open up to ask
if each and every one of you would like to respond. The second
one I definitely would like each and every one of you all to
respond to.
There has been a lot of discussion about the release of
your 5-year plan as required by the PAHPRA. We understand that
certain information that will be included in the plan cannot be
released publicly for security reasons. When do you plan to
release a public version of the 5-year plan?
Mr. Korch. The plan itself will be coming to Congress
hopefully by the end of March. That is our intended timeframe
to address the issues, the concerns. The plan will be made
available to Congress. The thought about publication to the
public itself remains in consideration, but certainly providing
the 5-year estimate of budget to Congress and to the
administration is a big priority that we have right now.
Mr. Fleischmann. Thank you.
ZOONOTIC DISEASE
My second question is directed to each and every one of you
all, please. As each and every one of you all have noticed how
quickly zoonotic diseases can spread once they are transmitted
from animals to humans, could you please share with the
subcommittee how each of you all coordinate with other offices
within the CDC and NIH, for example, and with the USDA, DHS,
DoD to leverage their research activities to prevent
duplication among Federal agencies and to make sure that you
are prepared to anticipate and respond to threats to human
health that originate in animal agriculture?
Mr. Korch. The PHEMCE itself is constructed to have a
dialogue on a regular basis with all the partner agencies that
you have just described. Biweekly we meet on the problems that
we face. As new problems emerge, the senior leadership of each
of our organizations assesses whether it falls into the lane of
the PHEMCE, per se, or happens to fall in a different part of
the HHS structure.
So PHEMCE itself deals with a number of the diseases that
we have described this morning, but not all diseases. Certainly
on some of the agricultural ones, USDA would be the lead for
that. And they would come to us, and they would bring to the
table issues that we may have that we can provide solutions to
or interact with, depending on the disease itself.
And I will turn this over to my other colleagues.
Mr. Fleischmann. Thank you.
Mr. Robinson. So let me give you an example where this
actually happened last year with H7N9 avian influenza outbreaks
in China, which have the potential to become a pandemic. They
can spread worldwide.
Unfortunately, we do have experience, and our great
colleagues at CDC were able to instantly detect this. In
working with our colleagues at FDA and the NIH and CDC, we were
able to make vaccines seed strains in record time, using new
technologies. And then actually getting those vaccines made
last spring and last summer and starting them in testing with
the vaccine manufacturers and with our colleagues over at NIH
to do those.
And we actually have now a stockpile of H7N9 vaccine that
is here in the United States, and the United States is prepared
if that were to become a pandemic, with a first strike
capabilities. But that is what we normally do.
We have worked together from H1N1 and other events now to
H7N9 and SARS and MERS coronavirus are other examples of where
we have worked together.
Mr. Fleischmann. Thank you.
Mr. Burel. I would concur with Dr. Robinson's statements.
We work closely across our agency and across all of these
operating divisions of HHS on a routine basis, and I think we
have good connectivity to understand how to pass this
information and do the right things with it for the American
public.
Dr. Borio. In addition to being members of the PHEMCE, our
steering committee at FDA that prioritizes our regulatory
science research is staffed by the PHEMCE to make sure that we
have full alignment with their priorities. And last year, FDA
also joined the NICBR, the National Interagency Confederation
for Biological Research, located at Fort Detrick, which allows
also to coordinate our research portfolio and, importantly,
identify potential areas of synergy and cooperation to make
some of the ongoing research even more useful for regulatory
decision-making at the FDA.
Dr. Kurilla. The potential for zoonotic diseases to really
create public health problems is something that NIH has
recognized for a very long time, and we work with a wide array
of partners who have available assets in terms of surveillance
and other types of capabilities that they can offer in terms of
being able to get the most productive results from those
research.
But it is largely agent specific in terms of who we work
with.
Mr. Kingston. Thank you.
Ms. Lee. Okay. Thank you very much.
I want to thank you, Chairman Kingston and Ranking Member,
for this very important hearing today, and thank all of our
witnesses for being here. But also, more importantly, for what
you are doing each and every day with, again, minimal
resources, quite frankly.
In my district, the Lawrence Berkeley National Lab receives
BARDA funding, and they work with this funding on a medical
countermeasure, and we are really pleased with that
partnership. I guess I wanted to ask a few questions first with
regard to partnerships with research universities as it relates
to research on infectious diseases and treatments.
PARTNERSHIPS WITH MINORITY-SERVING INSTITUTIONS
How are you--do you prioritize or do you work with
minority-serving institutions to develop a pipeline for diverse
investigators, such as with historically black colleges and
universities, Hispanic-serving universities?
Dr. Kurilla. So NIAID research funds are allocated and
distributed on a peer-reviewed system. There are a variety of
funding mechanisms to avoid everyone piling into the same
queue, and there are some that specifically address those types
of issues that you have highlighted.
And so, there are funding opportunities for those specific
entities that are available, still covered under peer-reviewed
system and awarded in a meritorious----
Ms. Lee. Okay. Available, but I would like to see a report
as it relates to minority-serving institutions, how they fare.
Are they receiving any of the funds for this very important
work?
Dr. Kurilla. I think NIH would be pleased to get back with
you with a written report on that.
[The information follows:]
NIAID Funding to Minority-Serving Institutions
The National Institute of Allergy and Infectious Diseases (NIAID)
conducts and supports basic and applied research to better understand,
treat, and ultimately prevent infectious, immunologic, and allergic
diseases. In fiscal year 2013, NIAID provided approximately $162
million in research funding to minority-serving institutions in support
of this mission.
Ms. Lee. Okay. Really appreciate that.
Dr. Robinson.
Mr. Robinson. BARDA has Small Business Administration
goals, including minority goals, and which we have surpassed
every year. And we would be happy to provide you.
Ms. Lee. You will give us that. Okay.
[The information follows:]
ASPR Small Business Goals
ASPR's small business goal in FY2013 was 15%, and 36% was achieved.
In FY2014 ASPR's small business goal is 15%, and we expect to exceed
that goal again.
FUNDING FOR HOSPITAL PREPAREDNESS PROGRAMS
Ms. Lee. Also I have heard from hospitals in California
that there is really a need for more sustained funding for
coordination with hospital preparedness programs as it relates
to sort of an integrated training with local and Federal
responders. How is this coordination taking place, and do we
need to do more?
Mr. Korch. Well, certainly, we have granting mechanisms.
The Hospital Preparedness Program is one of our main mechanisms
for providing State, local, tribal, and territorial public
health and healthcare coalitions with opportunities just for
those types of needs.
We make do at this point in time with the funds that have
been provided. We have seen a much more robust response in
development of healthcare coalitions coming together, to offer
community resilience with the funds that are provided.
The other mechanism, of course, is the PHEP grants, and I
will turn over to Greg Burel to describe a little bit more of
how those dollars also make it into the community for these
needs.
Mr. Burel. Thank you, George.
The Public Health Emergency Preparedness, or PHEP,
Cooperative Agreement funds are those funds that our State and
local public health partners use to fund their preparedness
activities, whether that be planning, exercising, training,
participating with hospital consortia or others in other
exercises. And we send those out through our Division of State
and Local Readiness, which is part of the office that also
contains the Strategic National Stockpile, so that we can work
closely with them and make sure that people are prepared to use
what we can give them.
Ms. Lee. Okay. So if we find hospitals that aren't aware of
this, can we let you know? Because they are calling and asking
us for this kind of information.
Mr. Burel. We could certainly carry that information back
to the right place, ma'am.
Ms. Lee. Okay. Great.
Mr. Korch. And the same thing with us, we will do with
ASPR, with our Office of Emergency Management. We do
participate in all the 10 FEMA regions. We have officers in
each of the regions to coordinate these programs.
Ms. Lee. Okay. Great. And finally, let me just ask you. I
held a couple years ago--well, a few years ago, a forum with
regard to emergency preparedness for vulnerable populations--
senior citizens, those living in nursing homes, assisted
living, low-income individuals, the disabled.
VULNERABLE POPULATIONS
How are we--it was very--not very robust at that point. Are
we coordinating and looking at vulnerable populations and
developing strategies in the case of an unfortunate attack?
Mr. Korch. I know that the Assistant Secretary for
Preparedness Response has made a top priority in making sure
that these other organizations, which we consider still part of
the healthcare community in any State and locale, they form a
very important aspect of medical treatment, of being able to
respond to the needs of citizens.
So those at-risk populations are part of the--of how the
organization, ASPR, looks to improve coordination and
capability. They certainly have over the last several years
become much more integrated in our--and the PHEMCE itself, in
terms of the needs of special populations, has it as one of our
major goals in the strategy that we have put together.
Ms. Lee. Okay. Thank you, Mr. Chairman.
Mr. Joyce. Thank you, Mr. Chairman.
MULTIYEAR BUDGET
Good morning. Realizing, for the panel now, the fact that
President Obama's budget has not been submitted yet. So you
don't have specific numbers. But did the budget process allow
for the professional judgment requirement that you have
identified in your multiyear planning document?
Mr. Korch. We are using professional judgment information
to prepare the 5-year program. So the professional judgment, of
course, operates against the as-of-yet determined amount that
is being forwarded by the administration. That, plus other
information that each of the agencies has with regard to what
it projects its needs are, even beyond that going into the 5
years, will constitute the information.
Some of it, present year, obviously, is known. Budget
projections for the future are still estimate, as you say. But,
yes, we are accounting for that information as we develop these
multiyear budgets.
Mr. Joyce. What steps, if any, do you think would be
required to better align your needs with the presidential
budget process?
Mr. Korch. Well, certainly we work with our Office of
Finance, the ASFR office. We work with the OMB offices. We work
also with the staffs here, with the administration, to identify
what we project as needs. And then, based on the
prioritizations that happen within the department and the
administration, we adjust appropriately to the level that
resources become available.
So our estimates are ones of what we project as need to
sustain the program, and then, hopefully, those are translated
into the reality of the funding.
Robin, do you want to have any more?
Mr. Robinson. Historically, BARDA has actually been doing
multiyear budgeting for a number of years because we knew that
in fiscal year 2014, as Congresswoman DeLauro pointed out, we
were about to go into the abyss because we no longer were going
to be able to tap supplemental and advance appropriations, and
we were moving, hopefully, because we were a mature
organization to be considered for annual appropriations. That
created a serious problem for us. It created a serious problem
for you and the administration.
As we have gone forward, we presented what the outlook
would look to be for the next 5 years and have done that
routinely over the last several years in coordination with the
CDC, FDA, and the NIH. And who is going to be doing what and
what do we actually need to fill the gaps, and then what can we
possibly do with budget austerity?
MEASURING SUCCESS
Mr. Joyce. Now Congress has required that PHEMCE evaluate
the progress of all activities from research through stockpile
distribution and utilization. How are you measuring success
across PHEMCE?
Mr. Korch. We look at success in a number of different
ways, one of which certainly is to what extent are we able to
move products through the pipeline that you have heard
described, which is a very expensive undertaking, into
Strategic National Stockpile.
So approval of a drug is a major success for us. Having a
drug available under emergency use authorization for the need
when it arises. Fostering a strong, sustainable base with our
industrial partners is a major goal. Being able to be sure that
when the drugs are in the Strategic National Stockpile that we
are working with our State and local counterparts, public
health counterparts, to be sure that those are distributed and
delivered appropriately.
We have metrics, and we have processes on all of those
fronts, from the industrial partners to the stakeholders at
State and local and all the way through our partners here. So
we do look at a number of things that we think of as
achievements and use as metrics.
We also have an implementation plan with a number of tasks
that have been outlined. Accomplishment of those tasks, in
turn, translates to an effective PHEMCE on the whole.
Mr. Joyce. Is there a way of improving that process as we
move forward?
Mr. Korch. Well, everything, all processes could stand
improvement. And what we have seen over the number of years
that we have been operating has been an increase in if you call
it the bureaucratic underpinnings of this, better communication
across all the members here, the ability to track our
portfolios much more effectively, to look at where the
challenges, the roadblocks are and to address those
immediately.
We are putting in practice and play mechanisms such as
portfolio tracking tools. BARDA and the CDC have very effective
mechanisms for looking at whether the resources that are being
used are being used in the most effective fashion. So a wide
variety of metrics and mechanisms to track our effectiveness.
Mr. Joyce. Great. Thank you, Doctor.
Mr. Kingston. Ms. Roybal-Allard.
Ms. Roybal-Allard. Thank you very much for being here.
PREPAREDNESS AND RESPONSE FOR AT-RISK POPULATIONS
My question has to do with preparedness and response as it
pertains to at-risk populations. And Dr. Burel, limited
English-proficient communities could be particularly vulnerable
during a pandemic, and the reasons include a lack of insurance
or access to regular medical care, lack of trust in
countermeasures distributed by the Government, and lower levels
of health literacy.
So this raises the concern that these populations could be
left without adequate information and support during an
emergency. I have three questions with that regard.
What is the CDC and its grantees doing to help ensure an
effective distribution of medical countermeasures to limited
English-proficient populations before and during an emergency?
What models are being created that can be adapted to meet the
specific needs of these and other high-risk communities?
And since many underserved, limited English-proficient
populations such as those in my district receive their primary
care in community health centers, what incentives to you have
to encourage your grantees to work with community centers in
developing their medical countermeasure distribution plans in
the event of a pandemic or other biological emergency?
Mr. Burel. Thank you for your question, ma'am.
We have done work in this area in a number of different
ways over the years. Some of this is focused particularly in
pandemic influenza material that we have available in a number
of different languages at this time.
We have also engaged translation services to help us
prepare material in advance of threats that we anticipate being
prepared for so that we can distribute them in a number of
languages that we know would be needed. Many of these are
specific to localities, and we have also worked with States to
make sure that they are prepared to do the type of messaging to
provide the type of information in the appropriate language in
their communities.
Some of the models that we have done to try to meet some of
these specific needs that we continue to try to work with that
show promise are we have personnel who work directly with our
State and local partners and then with private sector business,
private sector voluntary organizations who have a reach to
these types of populations. And we encourage our State and
local partners to continue to engage those organizations, as we
do as well at a national level.
Finally, in the community health centers, we encourage our
State and local partners, our grantees to work with community
health centers where in their plans for distribution and
dispensing of medical countermeasures that is the best place
for them to do that. And these plans always make use of, I
believe, the best cases in the particular locality and State to
reach the affected populations.
Ms. Roybal-Allard. And do you feel confident that that is
working? I mean, you use the word you ``encourage'' them to do
this. I know you can't require them. But are you finding that,
in fact, these efforts are being effective and that there is,
you know, movement and there will be success in the event that
we have to, unfortunately, take action in these communities?
Mr. Burel. We have seen good work in some of these areas.
We have heard stories from our State and local partners that
are indicative to us that there are plans and programs in place
and work being done that is effective. Anything can be made
better all the time, and we continue to try to find ways to
innovate and improve our capability to deliver these types of
medications and services to all of these populations.
Ms. Roybal-Allard. Okay. I would appreciate, if possible,
if maybe you could share with my office or the committee maybe
some areas where you think even we, as Members of Congress, can
be more helpful in encouraging either within our local
communities or within our State legislatures to take more
advantage of some of the things that you are proposing.
Mr. Burel. We would be happy to share that, and thank you
so much for that support.
Ms. Roybal-Allard. Thank you.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Roybal-Allard. Do I have time for one more or not?
Mr. Kingston. Yes.
VACCINE HESITANCY
Ms. Roybal-Allard. Okay. This is for Dr. Korch. Over the
past few years, we have seen a resurgence in vaccine
preventable diseases, such as whooping cough and measles. And
to some degree, it is likely tied to a growing trend among
parents and individuals who are opting out of these recommended
vaccines.
Last week, the CDC reported that only 34 percent of adults
age 18 to 64 got the seasonal flu vaccine, and requests for
exemptions from school vaccinations are also increasing in this
country. And this trend may reflect a growing lack of
vaccination confidence in the United States.
Are you concerned that vaccine hesitancy will be a problem
during a crisis requiring the immunization of segments of whole
populations of a community, especially if it involves the use
of a new vaccine or a product? And if so, what is ASPR doing to
address the lack of confidence in immunizations before there is
a pandemic or other health crises?
Mr. Kingston. And Dr. Korch, we will probably have to take
that for the record. But I am interesting in hearing the answer
to that and may just ask you on my time the answer to it.
Mr. Korch. Very well. Thank you.
Mr. Kingston. And Mr. Stewart? Having edged out Mrs. Roby
by about 3 seconds----
Mr. Stewart. I pushed her down when we were coming through
the hall. [Laughter.]
Mr. Kingston. You did. You held her up in the hall.
Mr. Stewart. All right. Thank you.
Chairman Kingston and Ranking Member DeLauro, we look
forward to working with you. I appreciate your welcome. I want
you to know I am happy to get your coffee. I was in the Air
Force for many years, and what we did to new pilots was way,
way worse than that. [Laughter.]
Rep. Stewart Statement
Mr. Stewart. So to the members of the panel, thank you. It
is a distinguished panel, and it is one of those panels and,
frankly, some of your comments make me wonder, you know,
whether I and the American people are kind of smart enough to
keep up with you on some of these things. And it is a little
bit frustrating for you, I think, and maybe for us as well,
because 3 and 5 minutes just isn't enough to really dive into
these questions at all.
I would like to come back and maybe in a second round talk
about some of the issues with funding and resources and whether
they are adequate or, you know, how we might do a little better
job of that. But I would like to keep a more broad picture, if
we could, kind of a bigger picture.
Dr. Robinson, I am going to talk or mention quickly
something that you said and that Chairman Kingston mentioned as
well, and that is the problem we have with complacency. I don't
know very many Americans who have ever heard of PHEMCE and
could tell us what it is or give us any idea, you know, of the
important work that you are doing. And this panel is an
opportunity to do that, I think.
You know, we had conversations about SARS, about bird flu,
about other things that, thank heaven, didn't turn out the way
that we feared that they might. And I worry that that gives
people maybe a false sense of complacency, thinking that, you
know, there are always people who are going to take care of
these things. That, you know, we will see a couple of news
stories about it, but it will always be in China or somewhere
else, and it is not something that is going to affect us as
much or very deeply.
Statement to the American People
So very quickly, with one specific question, and then I
want to come back to the rest of the panel and ask you to be
thinking about if you had 30 seconds to address the American
people, which I am giving you now, what is the one thing you
would say to them? What would you want them to know about the
work that you are doing?
FUNDING CONCERNS
But before we do that, Dr. Robinson, I know that the work
you do with BARDA, you are always measuring threats, both
manmade and natural occurring threats. You are prioritizing
those, I am sure. You are trying to attach resources to those
individual threats.
But at the end of the day, you run out of money. You just
don't have all of the resources that you need. No Government
agency does. And can you tell me quickly, are there--is there a
long list of concerns that you have that you don't have the
resources to address?
Mr. Robinson. As we said earlier, development of
pharmaceutical products, medical countermeasures is risky,
lengthy, and expensive. And what we do in advanced development
is the most expensive portion of the entire enterprise--the
clinical studies, the commercialization of the manufacturing
process. So if we had more funds, there would be ability to do
more clinical studies and to actually have facilities that
could make these products.
We have taken the dollars that we have been given by the
taxpayers to expand our response and preparedness capabilities
and have actually used those, both in H1N1 pandemic and also
now in the H7N9 outbreaks last year. So they are paying off
already, but we are looking at ways that we can actually
streamline and save the taxpayers more money by providing more
assistance with risk mitigation measures that decrease the
amount of failure with this whole process.
Mr. Stewart. Well, and the challenge you have--and then if
I could move on to the other members. I mean, we live in a time
when no agency has the resources that they would like and never
will, and that is going to be a growing challenge in the future
for every agency.
And again, I would like to come back to you maybe at some
future point to get a feel for how comfortable you are with
where we are and how you are going to meet that challenge
because I just think that is something that we have to
recognize.
Statement to the American People
To the other members of the panel, again, if you had just a
few seconds, a few sentences, what would you want the American
people to know about what you do and what they can do to be
more aware and more prepared?
And Doctor, yes, if we could?
Mr. Korch. Well, in 30 seconds, I think what we would want
to tell the American people is that this is the organization
and this is the group of people that are anticipating the
nature of both the deliberate and the naturally occurring
threats. And that as your watchdogs, we are formulating the
approaches, the needs, and the capability to bring to the
American people those necessary medical countermeasures that we
will rely on to mitigate the effects of any of these.
Look at mortality, morbidity. What can we do to reduce the
risk to the U.S. population?
Mr. Stewart. Okay. Thanks. Anyone else want their 30
seconds with a concise comment?
Mr. Burel. I think that we would like the public to know
how hard public health works to keep them protected not just
from these events, but from events every day, and how important
that is to them. And then also how they could look at
protecting themselves better in the future, and we offer many
opportunities to learn that.
Mr. Stewart. All right. Thank you, Chairman.
Mr. Kingston. Thank you.
Mrs. Roby.
Mrs. Roby. Thank you, Chairman and Ranking Member. It is a
privilege to serve on this committee. And so, I am thrilled for
the responsibility, and I look forward to working with
everybody here.
INFLUENZA
Last week, the Centers for Disease Control and Prevention
Director Tom Frieden provided a briefing on this year's
influenza activity. And it was very helpful when he noted that
the first line of defense is vaccination, but it is important
to remember that some people who get vaccinated may still get
sick, and we need to use our second line of defense, the
antiviral drugs.
Our focus on vaccination is appropriate, but we don't talk
enough about the importance of treatments for influenza,
particularly among children. According to the CDC, so far this
year 52 children have died from influenza, and 43 percent of
children who visit the hospital related to influenza had no
complicating medical factors.
Clearly, the flu takes a serious toll on our young and
vulnerable. And as a mother of two small children, I find that
very concerning.
I am also troubled about news reports regarding medications
that were in short supply in many parts of the country. That
being said, we can clearly do a better job of avoiding
shortages by having the Government be more flexible on how it
approaches the SNS, the Strategic National Stockpile.
So, Mr. Burel, for example, I understand that antivirals
purchased for a pandemic are packaged differently than those
sold commercially for seasonal flu. This complicates drawing on
a reserve to ease shortages that may occur in severe seasonal
flu outbreaks.
Has the Government thought of working on a system in which
the SNS stockpiles antivirals with packaging that could be used
for a normal flu season? And I am told in doing so that we
could expedite getting medications to the people who need them
while also yielding fresher medications with longer expiration
dates.
Mr. Burel. In just this year, we worked with the major
manufacturer of Tamiflu to offer to them stocks of our material
should they experience shortage in their supply chain. And
working with them, they were able to show us that the spotted
shortage they were seeing was not something that our material
at that time could be helpful for.
But we believe that trying to work towards packaging that
looks similar to the commercial product would be useful in
those instances. The packaging that we hold was developed
specifically for us, and it was specifically developed around
the time we were purchasing these materials for pandemic
influenza use only. But we have moved beyond that today.
INFLUENZA VACCINE SHORTAGES
Mrs. Roby. So what is the best way to avoid shortage
headlines in the future, and are more resources necessary or
can this be mitigated by implementing a better distribution
strategy? I mean, you can answer or anybody else that wants to
weigh in, feel free.
Mr. Robinson. So one of the things that BARDA has been
doing with our colleagues over at the FDA is there are ways
that we can use our new Fill Finish Manufacturing Network that
are domestic CMOs that can actually fill these drugs that are
in short supply in an emergency.
And so, we are putting forward together in 2014 a plan to
go forward with the FDA to be able to utilize these four
different partners that we have in the private sector.
Mr. Burel. At CDC, we continue to look for ways to work
with private sector partners that do this work every day for
the distribution and dispensing of these countermeasures or
these medications for seasonal flu, to look at is there a place
and is there the right opportunity to use some of our material
to assure that shortages don't occur and that things flow
through a normal supply chain, as people expect.
Mrs. Roby. Okay. Did you want to? Go ahead.
Dr. Borio. I would just add that FDA works very closely on
this issue, as well as CDC. And during the spot shortages, for
example, we sent communications out to remind pharmacists and
physicians that the label of oseltamivir, Tamiflu, contained
information about how to prepare pediatric formulation in the
absence of suspension.
And also we sent communication out to our State and local
health partners to remind them that certain stocks of Tamiflu
were still good for use based on our scientific analysis and
should not be discarded.
Mrs. Roby. Okay. And speaking of suspension, real quick, I
mean, how much are we supposed to have on hand for children
that can't--you know, that need this in the liquid form?
Mr. Burel. So I would ask to come back to you with the
specific numbers that our current stock requires in that area.
Mrs. Roby. Okay. Okay. That is great.
[The information follows:]
SNS Requirements for Oral Suspension Anti-Viral Countermeasure
The PHEMCE target goals for SNS antiviral suspension (specifically
oseltamivir) holdings total 1.6 million treatment regimens; however in
an effort to make the best use of taxpayer funds, CDC does not maintain
oseltamivir suspension in the SNS. If suspension product was needed
during an emergency, there are instructions available for compounding
suspension formulation from oseltamivir capsules. To meet the needs of
pediatric patients, SNS also contains pediatric strengths of
oseltamivir capsules (30mg and 45mg capsules). These capsules may also
be opened and put into different mediums to facilitate medication
administration for children who may not be able to swallow capsules.
These solid oral dosage forms can be purchased and maintained in
the SNS at significantly lower cost than suspensions, allowing CDC to
maintain greater treatment capability to protect the U.S population
within available funding resources.
Mrs. Roby. I yield back.
Mr. Kingston. Thank you.
And we will start our second round now, and I am assuming
everybody is staying for a reason.
VACCINE HESITANCY
Dr. Korch, I am going to ask you to answer Ms. Roybal-
Allard's question, but I want to put this specific on it that
we hear from time to time from constituents that some of the
vaccines have an unintended consequence of causing autism. So
there is some suspicion that these vaccines maybe aren't as
tested as they should be.
COMMERCIAL INTEREST AND FDA
So I would like you to answer that. But while he is doing
that, Dr. Borio, and I am going to give you a minute, and then
would like to talk--I would like you to answer a question in
terms of the commercial interests on FDA oversight. Drug
development companies is proprietary because they have to be
proprietary. They have to get approval, and they need to work
with you toward some of these goals.
And I would just like to ask you a general question in
terms of the balance. So you can be thinking about that while
Dr. Korch is answering the question.
VACCINE HESITANCY
Mr. Korch. Well, we certainly recognize the public
perception or perception in some part of the public with regard
to safety and efficacy of vaccines. Now, as you all know,
vaccines, the use of vaccines in our society has largely been
responsible or is a very important component of mitigation of
childhood diseases.
As you mentioned earlier, polio, well known to our
grandparent and parent generations, not so much known today.
That is a direct result of very effective vaccines. Even across
the world, the ability almost to control now polio across the
world, it has got its problems.
Now the question of the safety is extensively tested prior
to the release of the product and then after the release of a
product. We do postmarketing surveillance.
The literature that is expanded regarding the issue of
autism, its linkage to vaccines, there has been a tremendous
amount of focus in the scientific community, in the research
community, to look for those linkages. My understanding is,
from looking at the literature, that has largely been
disproven, at least in the scientific literature that has been
presented.
But the messaging around that still continues to be a major
challenge. The Centers for Disease Control, the Food and Drug
Administration, I think we all have responsibility, when you
talk about complacency, this is the flip side of that.
Complacency or not wanting to know what the issues are at hand
that we face on a daily basis is one aspect. But then the
effects of information that is spread in ways that when
evaluated against the scientific information we have still has
a corrosive effect.
We will rely upon these vaccines or some of the vaccines
that we are developing, should we see an event. I think the
cost-benefit ratio that people make on an individual basis
changes as a function of ``Am I facing an imminent threat or
not?''
Those are factors that we would have to weigh on as an
event happens. But certainly, our job is to make those products
available, make them safe, make them effective.
Mr. Kingston. So you would say wholeheartedly to the moms
and dads of the world get vaccinated. Get your children
vaccinated.
Mr. Korch. My kids are vaccinated.
Mr. Kingston. Okay. Dr. Borio.
COMMERCIAL INTEREST AND FDA
Dr. Borio. To that end, I will just add that surveillance,
safety surveillance of products in use is something that we all
take very seriously and collaborate on. And H1N1 was a real
important example of how product was deployed for use, and our
ability and close cooperation with the CDC took a lot of safety
information in near real time for over 100 million doses. It
was essential to give the U.S. Government the confidence they
needed to be able to communicate with parents and the
population the safety profile of the vaccine.
Mr. Kingston. Well, let me ask you about the commercial
balance and approval and that question.
Dr. Borio. So how we prioritize----
Mr. Kingston. Yes.
Dr. Borio. So FDA works with all sponsors and developers,
all sponsors and developers. Clearly, this area of
countermeasures is one of the most complex types of products
for us to help develop and to evaluate.
When resources are very, very limited, we will prioritize
the products in defensive pipeline because they do represent
the best thinking of the U.S. Government with respect to
priorities. Not uncommonly, however, we will also inform PHEMCE
of products that we encounter during our interactions with the
commercial sector that may be very promising, that have unique
features, for example, that ought to be considered.
So there is a constant exchange of information, but it is
our priority to support the enterprise with these resources.
Mr. Kingston. Thank you.
Ms. DeLauro.
Ms. DeLauro. Thank you, Mr. Chairman. I wasn't going to go
here next, but I will. I am presuming we have a third round.
PUBLIC INTEREST IN BARDA INVESTMENTS
This is a very, very interesting piece. Something that I am
interested in, and I think it gets me to you, Dr. Robinson, and
this is about the public interest in BARDA investments. Because
BARDA provides substantial assistance, financial and otherwise,
to companies for development of drugs, vaccines, and other
products.
What I want to try to get at here is the public interest
here, protecting that public interest and U.S. taxpayers with
regard to this investment. The return, which we would agree on,
is a benefit, whether there is a terrorist attack.
But what I want to know is--and I am going to send a list
of questions on this. So I am going to truncate what I want to
say is here is when you--how is it that we deal with the
contracts under BARDA and BioShield about negotiating, how does
BARDA negotiate contracts? How do we negotiate price with
regard to BioShield?
Is competitive bid laid out here in any way? Are the U.S.
taxpayers, just quite bluntly, are they paying for high profit
margins? And what are the--what have we been paying for product
development? What are we doing? It just appears that we--my
understanding is that we support the facility. There is a match
to do here that is then we support the technology and the
development, and then we are the purchaser.
So we support that effort. So I am very interested in how
these contracts and these prices are set and what we do to
monitor the costs of all of this effort.
Mr. Robinson. Thank you, Congresswoman.
You get to the heart of it, and that is how we be good
stewards of the taxpayers' dollars.
Ms. DeLauro. Amen.
Mr. Robinson. BARDA, we feel, is a really good steward
because we do get to see the entire process from when the NIH
turns over a product to us to actually then we going through
advanced development to turn it over to the Strategic National
Stockpile.
So we follow the Federal acquisition regulations. We use
independent Government estimates to determine what is the price
for like products out in the public. And we have actually done
a preliminary study that actually shows that the length of time
and the amount of money that the medical countermeasures that
BARDA, NIH, and CDC has supported is actually much less than
what we see in the private enterprise.
And in terms of about a $1,000,000,000 to $1,200,000,000 is
what it takes for a product to go from beginning to becoming a
marketed product. We are seeing anywhere from about
$300,000,000 to $400,000,000 for many of our medical
countermeasures. How are we able to do that?
Ms. DeLauro. Do you competitively bid? Do you go to various
places?
Mr. Robinson. We absolutely do. There has been only one
instance in which we did not, and that was for the urgency of
that product that we needed----
Ms. DeLauro. What was that, anthrax?
Mr. Robinson. That was for the smallpox antiviral drug.
Ms. DeLauro. Smallpox, okay.
Mr. Robinson. We have responded to that on a number of
occasions on why we did that. But it was, in fact, middle of
the road in its price range of commercial products that were
like other antiviral drugs, in fact.
As we go forward with our core assistance program, if we
can mitigate failure so that we have more successes, which from
the beginning usually is around 90 percent of the products, the
candidates that go through fail. We decrease that, then we
actually don't have to pay for all those failures. And we are
doing that through our core service----
Ms. DeLauro. Right. Because, look, we are the buyer. I
mean, you know, there may be commercial aspects of this, but we
are primarily the buyer.
Mr. Robinson. That is right.
Ms. DeLauro. We don't get the benefit of the commercial
profit. The companies get that benefit. Do we put a timeframe,
and are we watching the timeframe that says, okay, this is what
we said you were going to do. These are the milestones, et
cetera. You are not there. So, you know----
Mr. Robinson. Well, we----
Ms. DeLauro. Or are we saying, my God, this is the only
place we have to go, and we may have an emergency, which means
we just flood in more money to deal with what they said. You
know, do they come in budget and on time is what we are talking
about.
Mr. Robinson. You will probably hear grievances about BARDA
being pretty tough about down-selecting. We do products that
don't make it.
Ms. DeLauro. I will have a list of questions in this area,
which I would like to submit to you.
Thank you.
Mr. Kingston. Mr. Fleischmann?
Mr. Fleischmann. Thank you, Mr. Chairman.
PROJECT BIO SHIELD
And in, I guess, furthering the line of questioning from my
colleague Representative Stewart, Dr. Robinson, I have a
question for you, sir. The subcommittee was somewhat surprised
by the budget request that was sent up by the administration
last year, sir, for the Special Reserve Fund. I can imagine
that there is substantially more product you can purchase than
the $250,000,000 would allow.
In an ideal world and in your best professional judgment,
can you tell us how much money you could reasonably spend in
fiscal year 2015 to adequately and responsibly protect the
American public from the various forms of bioterrorist attack?
Mr. Robinson. Thank you for the question, Congressman.
In the President's budget that you will see coming forward,
you will see a significant increase in the amount of funds that
we will be requesting for Project BioShield and the Special
Reserve Fund above what we asked for in fiscal year 2015. That
will actually go towards three new products that we think that
we can bring to the American public in preparedness and
response.
Those would include a chemical agent antidote, a thermal
burn treatment, and also a biodosimetry device in which we can
actually measure the amount of radiation that someone has
actually experienced after an event.
Mr. Fleischmann. Thank you, sir.
STRATEGIC NATIONAL STOCKPILE
Mr. Burel, we have noticed a trend in recent years that
budget requests for the Strategic National Stockpile have
declined. In fiscal 2014, we appropriated $535,000,000, an
increase over fiscal 2013.
With over 80 products in the pipeline, in an ideal world
and in your professional judgment, can you tell us how much
money could reasonably be spent on the SNS in fiscal year 2015
to replenish existing products and purchase new products in the
BARDA pipeline to adequately and responsibly protect the
American public, sir?
Mr. Burel. BARDA has done a lot of great work to make sure
that we get the longest life span available from the products
that they provide to us, and I think that is a real success
story for us and BARDA together to have found ways to be able
to get the longest life out of what they have been able to
invest.
So I believe that we are prepared to invest appropriately
to replace anything that needs to be replaced from that BARDA
pipeline in the next year. But there is nothing specifically
that we need to replace from the BARDA pipeline, I believe,
until 2018.
Mr. Fleischmann. Thank you, Mr. Chairman. I yield back.
Mr. Kingston. Ms. Roybal-Allard.
CUTS TO PUBLIC HEALTH AND PREPAREDNESS
Ms. Roybal-Allard. Dr. Burel, a recent NACHO survey
reported that due to sequestration and other budget cuts at the
Federal, State, and the local level, health departments have
lost tens of thousands of public health jobs, and health
departments are reporting cuts to their emergency preparedness
programs.
As we approach the beginning of the fiscal year 2015 budget
process, can you explain to this committee the impact these
budget cuts and sequestration have had on our preparedness, and
what impact, if any, will additional cuts to the Public Health
Emergency Preparedness grants have on our ability to distribute
medical countermeasures?
And what needs to be done to help communities restore their
lost capacity to enable them to effectively respond to a health
crisis?
Mr. Burel. The work that our States and locals do with the
funds that were provided under the PHEP Cooperative Agreement
directly helped them be prepared to make use of the medical
countermeasures in the Strategic National Stockpile.
We believe that they continue to find more new and
creative, innovative ways to work within the funds that they
have. But as availability of funds continue to erode in that
area, we have to continue to work with them to provide them the
right things and tools and assistance to make the best use of
the medical countermeasures that we can give them and to help
them plan and prepare as well.
Ms. Roybal-Allard. But directly with these lost tens of
thousands of public health jobs, will you--with whatever these
new measures that you are talking about, will it be sufficient
to fill those gaps in the event of an emergency? Or do we need
to consider perhaps investing more into these grants to get our
communities better prepared?
Mr. Burel. We will continue to look at the measure data
that we have available, and we can come back to you with more
information about areas in which State and local public health
could benefit further.
Ms. Roybal-Allard. Okay.
Ms. DeLauro. Would the gentlelady yield for a second?
Ms. Roybal-Allard. I will yield, yes.
Ms. DeLauro. With all due respect, and I understand the
response to Ms. Roybal-Allard's question. But the fact is, is
that over the past decade, we have seen a real cut of about 42
percent, $465,000,000, to CDC if you count for inflation, et
cetera, for State and local agencies over this last 10 years.
That has got to have some impact on our preparedness at the
State and local level. It is not doing more with less. It is
doing less with less. And I think you have an obligation to let
this committee know what is happening out there to our
preparedness.
Ms. Roybal-Allard. That is the point, and I think that all
of us, regardless of what side of the aisle we are on, really
want to know what the impact is of decisions that we make. And
even within the budget restraints, we want to be able to do
whatever we can to make sure that our country is prepared.
So I agree. It is important that we have to have realistic
answers so that we, together, can make decisions on how we
could, you know, best support the needs of our countrymen. So I
will just leave it at that, and hopefully, if you could give us
some additional information, I am sure that all of us--in fact,
one of my colleagues on the other side of the aisle was asking
a similar question, wanted to get a better understanding of the
consequences of what we are having to deal with.
Mr. Burel. Thank you, ma'am, for that, and we will provide
additional answers.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Kingston. Mr. Joyce.
Mr. Joyce. I pass.
Mr. Kingston. Mrs. Roby.
Mrs. Roby. Thank you.
BARDA NOT-FOR-PROFIT FUNDING
Just real quickly, Dr. Robinson, given the contributions
for the not-for-profit research community to biodefense, how is
your agency utilizing the resources of these type organizations
to fulfill your mission?
Mr. Robinson. So we have a short history because we have
only been in existence for about 7 years, but we have worked
with a number of nonprofits. I will give you a really good
example of where we have worked with PATH and the World Health
Organization to actually build influenza vaccine manufacturing
not only here in the United States, but more importantly
because pandemics are everywhere in developing countries.
And so, we have actually worked since 2005 with WHO on
this, first with starting with just a single grant in Vietnam,
and then now moving towards 11 different countries and 13
different organizations in those countries to produce influenza
vaccines. We started with zero doses they were able to do.
Today, they can make 330 million doses.
Our goal by 2015 is 500 million doses. That relieves the
burden of what we have to provide to the rest of the world as
we go forward into these big events like a pandemic.
That contribution so far has been $65,000,000 that BARDA
has helped with. For every dollar we put in, there has been $5
to $7 in these different countries with other agencies and
those countries to build this capacity.
So we look forward to more engagement with Gates and other
nonprofit organizations going forward.
SPECIAL RESERVE FUND
Mrs. Roby. Can you talk just real quickly about the 10-year
guaranteed appropriation for the SRF? How that has had a
positive impact, and you know, companies and institutions have
been able to invest in R&D.
But now, and as I understand it--again, new member of the
committee--but the shift to the annual appropriations process
makes business planning more difficult. So how do you continue
to incentivize the industry so that these companies stay in
that space?
Mr. Robinson. This is really a good point, and this is sort
of one of the big points of this hearing, in fact, is what are
the next 5 years going to look like for companies out there
that have been steadfast partners of ours in the biodefense
space over the last 10 years?
So they have delivered 12 products so far. We think in the
next 5 years they will deliver another 12 under Project
BioShield. And how much money is that going to cost?
Well, Congress authorized $2,800,000,000 over the next 5
years to do that. Our estimates are that we will need every
single penny of that and maybe a little bit more in order for
those 12 products to be realized and to make us more prepared
and better to respond going forward.
Certainly, in our annual meeting that we call BARDA
Industry Day, we have indicated what those products are and the
amount of funding overall that we will need for that. In our
coming multiyear budget you will see, it will certainly reflect
that level of funding that we will need to make that happen.
Mrs. Roby. Thank you. I yield back.
BARDA PROCUREMENT AND CONTRACTS
Mr. Kingston. Dr. Robinson, in terms of your integration
with the Department of Defense, I am sure you work hand-in-
glove with them, but sometimes we worry about their
procurement, how effective it is, if there are stumbling
blocks. Do you work on the same processes and contracts, or
just how does that work?
Mr. Robinson. So biodefense has a long history with the
Department of Defense, and we and NIH and the CDC and FDA have
built off of what they started prior to 9/11. Going forward, we
have worked with them in some cases to actually pick up product
candidates that they were no longer able to fund because of
changes in their budget and also to coordinate on a daily basis
not only visibility of what they are doing and what we are
doing, but also then to shift over.
And we certainly have picked up a number of products from
them and certainly from NIH. We are coordinating those efforts
in animal studies, the types of candidates, and also with a new
strategy that we have for flexible manufacturing. We at HHS
have established three Centers for Innovation in Advanced
Development and Manufacturing. A fourth center is being
supported by the Department of Defense, and in several years,
that hopefully will be constructed and able to join in this
national effort to build a response network to provide these
medical countermeasure products.
Mr. Kingston. I am going to go ahead and yield the balance
of my time to Dr. Harris, just to expedite things. If you are
ready to hit the ground running, you have 3 minutes.
Dr. Harris. Thank you very much. I hit the ground running
fast.
PANDEMIC INFLUENZA AND STRATEGIC NATIONAL STOCKPILE
Thank you all for being here today, and I have a couple of
questions that one is that during--you know, we have this issue
of these kind of manmade versus natural emergencies. And of
course, the one that came up--the only one that has really gone
into effect since then, since this whole concept really is a
natural one. I mean, it was the pandemic.
So during the pandemic, 2009 pandemic, there were--my
understanding, there were several million, it is 12, 13 million
courses of antivirals distributed in anticipation of
requirement for the pandemic. And I don't know who would--I
don't know if they came out of the stockpile or not, but where
are they? What happened to them?
You know, the pandemic didn't pan out. I mean, so where--
what happened to that asset?
Mr. Burel. So the antivirals that were distributed from the
Strategic National Stockpile, some of those were actually
dispensed. Some of those were moved into State holdings so that
they could be used in the future.
To give you an exact breakdown, we would have to come back
to you with those numbers.
Dr. Harris. So they were dispensed, but they were--when you
dispensed them to the States, I take it that there are plans in
the future, for instance, if let us say I don't know where the
projects were that this pandemic was going to occur, but I
would imagine the projection is not that it is nationwide.
There would be pockets.
There are mechanisms to recall that item from those States
and redistribute? I mean, that is part of the planning in the
future?
Mr. Burel. In our current planning, once we release assets
to the States we don't pull those back to the stockpile. But
the States do have plans in place that they can cross-level
those materials in their States.
Dr. Harris. But through your--through the stockpile, or
that is left up to their own devices?
Mr. Burel. That is left up to the State.
Dr. Harris. Why?
Mr. Burel. The State has capability internally that we have
worked with them in their planning to assure that they can
provide medical countermeasures that we have given them to the
places where they need to dispense it.
So in some cases, States have chosen to place that into the
pharmacy supply chain. In other cases, they distribute it
through other means and places.
PHARMACY SUPPLY CHAIN
Dr. Harris. And when it goes into the pharmacy supply
chain, where do the funds--I mean, are they reimbursed through
the pharmacy supply chain? I mean, obviously, those get sold.
Money is exchanged. Does it come back to the Federal
Government? Does it stay in the States?
Mr. Burel. Product that is provided from the Strategic
National Stockpile, regardless of where it is dispensed, is not
charged. In the H1N1 situation, pharmacies were allowed to
charge a small administrative fee to dispense a drug, and I
believe that that was set by CMS pricing. But I would have to
check, sir.
BIOLOGIC THREATS
Dr. Harris. Okay. And when I reviewed the report, the GAO
report, you know, it seems that there are a lot of potential
targets/threats, goals. I mean, 255 I think was the total
number, whatever. But then when you look at what has actually
been procured and put in the stockpile, it seems that in terms
of diseases, there are only two, two things.
I mean, there is botulinum and--there is three. There is
botulinum, anthrax, smallpox. Are those the only biologic
threats that we have? I mean, how many other biologic threats
among those 255, you know, targets?
Mr. Korch. Well, there are 13 material threat
determinations across chem/bio/rad/nuc. Of those, we have got
anthrax, smallpox, bot, as you mentioned. There is tularemia,
plague, viral hemorrhagic fevers.
The products that we have procured already for the most
part were those products that were most mature, could be used
effectively with our Special Reserve Funds. The products that
are further back in the pipeline because they are less mature,
example, hemorrhagic fever viruses, for which there are at this
point still mostly candidate products way back at the tech base
in our research labs.
So the decision has to be made. You have got funds to spend
on products that are now currently available to bring them
across the finish line. That is the goal of BARDA to adjust.
Certainly, we look at what are the most important threats? What
do we think from our information and our working with
Department of Homeland Security really require the direct
attention?
The ones that you mentioned are important threats, and so,
but in addition to those, of course, we are looking at what do
we do for radiological and nuclear? How do we stopgap the
materials there as well?
The 255 tasks that you mentioned don't necessarily relate
to 255 different pathogens. They relate to----
Dr. Harris. No, I understand that. And will some of these--
some of this will be revealed in the plan that is going to come
out in the spring?
Mr. Korch. The spring plan will identify where we are
spending or what we project to spend on a threat-by-threat
level, yes.
Dr. Harris. Okay. Thank you very much.
Thank you, Mr. Chairman.
Mr. Kingston. Ms. DeLauro.
Ms. DeLauro. Thank you, Mr. Chairman.
SUBCOMMITTEE ALLOCATION
Just a quick comment to Dr. Robinson. I do hope the
industry partners will recognize that we have been steadfast
supporters of their efforts as well. And when we are going to
have to take a look at, as I said in my opening statement, if
the allocation to this subcommittee does not increase
substantially in the next go-around, that we will not be able--
we are going to have to create a balance as to what gets funded
and what doesn't.
So I think industry ought to--but they ought to be thinking
about the humanitarian aspects of their participation in this
effort. They certainly do get provided with a number of a lot
of U.S. tax dollars in order to do what they do, and they do it
very well. I don't take that away from them.
INFLUENZA VACCINE
Just a couple of questions on, just on the immunization
against flu. Dr. Kurilla, I understand that NIAID is doing
research on a universal influenza that is protection from all
strains. Can you give us an update on the status of that
research and how far are we from a human trial? And I am going
to ask for a short answer. I have got a couple of others and
then questions I want to ask as well.
Dr. Kurilla. Well, the development of a universal flu
vaccine has been the holy grail in seasonal flu and would also
address pandemic flu for a very long time. And we take seasonal
and pandemic flu very, very seriously.
The scientific basis conceptually for the potential for a
universal flu vaccine is something that has been emerging over
the last several years, and there are a number of various
concepts that are moving forward through preclinical. We hope
in the next couple years to be able to advance for some
clinical testing to test the feasibility of that potential, but
we are still a ways away from definitively having solved that--
--
Ms. DeLauro. So we are a ways away from clinical trials,
and then we are a ways away from the clinical trials until----
Dr. Kurilla. Large Scale Trials. Yes.
Ms. DeLauro. There again, in terms of the--okay. So it is a
ways off here? Okay.
Dr. Kurilla. Yes. But very promising.
Ms. DeLauro. I understand. I understand. With regard to
BARDA, recombinant flu vaccine technologies, Dr. Robinson, and
obviously, this was drawn up from the Council of Advisers on
Science and Technology as a way for us to move faster to have a
better response to the next pandemic.
INFLUENZA INVESTMENTS
Efforts in that area and what other investments has BARDA
made to speed up the response time in the next flu pandemic?
Mr. Robinson. So we have supported over the last 7 or 8
years the development of modern technologies, including cell-
based and recombinant-based, that resulted in Flucelvax being
licensed in 2012, and then last year in 2013, Flublok, a
recombinant-based vaccine, being licensed.
We are supporting two other recombinant-based vaccines that
are in late-stage development, and one of them actually went
forward. It was one of the first H7N9 vaccine candidates that
we had. It was tested and looked very promising for that.
And so, we, I think, have brighter horizons coming forward
with recombinant and also other technologies going forward for
flu vaccines and speeding it up. And we certainly had the H7N9
vaccines available quicker than we have ever had vaccines
available in the past.
ANTHRAX
Ms. DeLauro. Let me ask about next-generation anthrax.
Where are we with anthrax? Just someone bring us up to date.
The understanding is the existing vaccine is problematic,
that we need to produce a next generation that will be safer.
It is underway for years now and again spent a fair amount of
money already here.
Where does the product stand in the pipeline, and when do
you expect this next generation to be ready for the stockpile?
Dr. Kurilla. So in terms of anthrax, we regard the anthrax
program as a mature program because there are multiple products
in the stockpile to address the threat of anthrax, which
includes a vaccine, which we feel is safe and effective as it
exists, as well as antitoxins to deal with anthrax disease and
antibiotics, which are, in fact, the primary response to
anthrax.
That being said----
Ms. DeLauro. Is that the one that Department of Defense
uses, the one you are speaking about now?
Dr. Kurilla. Yes. But, so with a mature product, what we
look for for next generation is improved performance of that
product and other product attributes that are advantageous in
terms of enhancing our preparedness, as well as reducing the
cost and making easier distribution and administration of those
products.
And so, in the case of anthrax vaccines, we have a number
of candidates that are moving forward, some of which are
already into Phase II testing, that will reduce the number of
doses of anthrax vaccine that would be required to produce an
effective level of protection. We also are looking at very
early, which is just beginning clinical testing, the
possibility of an oral anthrax vaccine, which would really
simplify the degree of administration.
And then we have another of next-generation recombinant
vaccines, which are being looked at both in terms of product
stability, that is the potential to store the vaccine at room
temperature, which reduces storage, long-term storage costs,
extends the shelf life, and makes distribution much easier
because of elimination of the cold chain, as well as a number
of alternative delivery devices that require less trained
healthcare workers for administration.
Ms. DeLauro. How many years away are we from this? Just,
and I am not--this is not an----
Dr. Kurilla. Well, I can't predict the success of any
individual product.
Ms. DeLauro [continuing]. Adversarial question, just to get
a sense of where we are.
Dr. Kurilla. Based on industry standards, a Phase II
product, we are maybe looking in possibly maybe 3- to 5-year
timeframe to possibly be considered for licensure. Some of the
earlier ones entering clinical trials would add a few more
years. After that, we are maybe in the range of 10 years or
more.
Mr. Robinson. Mr. Chairman, may I have your indulgence just
so I can amplify? BARDA actually has four recombinant
candidates, and we think that by fiscal year 2018, we may
actually have one that is mature enough for consideration of
Project BioShield to put in the stockpile.
Ms. DeLauro. Thank you.
Chairman, I understand I can finish?
Mr. Kingston. Absolutely.
Ms. DeLauro. Okay. Thank you.
Mr. Kingston. Dr. Harris, you are finished?
Ms. DeLauro. Okay. Thank you. Thank you both very, very
much.
BARDA AND NCATS
BARDA and NCATS, we created the new Center for Advanced
Translational Sciences to focus on some of these issues--basic
research, viable drugs, therapeutics, diagnostic tools. They
seem to have many similar types of applications, the kinds of
problems that you both are working on.
Just quickly, the collaboration between the two
organizations and how you work with one another or how you will
work with one another because it is new?
Mr. Robinson. I will let my colleague Dr. Kurilla follow up
here. But we have worked with the NCATS with Chris Austin and
now with Pam McGinnis there. And actually are shaping up going
from concept to actual projects that we think that we can
actually have synergy on so that we are not duplicating what we
are doing.
Ms. DeLauro. Right.
Mr. Robinson. But actually together we can do something
that neither one of us can do together, especially maybe on
antimicrobial drug.
Dr. Kurilla. The other thing I would add is that NCATS does
offer some special features in terms of drug screening, and we
have taken advantage of that, particularly with emerging
infectious diseases, that is a collaboration between NCATS and
NIAID with regard to biocontainment requirements in order to
conduct those screenings.
And that is going on, and that is a potential being
utilized right now for the MERS-CoV and would be available for
other potential BSL-3 dangerous pathogens that would require
higher levels of containment.
With regard to biodefense in general and product
development for infectious disease, though, NIAID has all the
authority that it needs and the requisite mechanisms in order
to advance our candidate products through preclinical and into
early phase human testing to make them eligible for transition
to BARDA. And so, we can handle those ourselves.
Ms. DeLauro. Okay. Thank you.
SHELF-LIFE EXTENSION PROGRAM
Dr. Borio, 2004, the stockpile has been a participant in
shelf-life extension program, and you do the analysis to
determine beyond expiration date. I understand that FDA is only
authorized to provide this service to specific Federal
agencies--DoD, CDC. It is not available to State and local
agencies and their stockpiles of countermeasures.
State and local efforts have stockpiles--Cipro, Tamiflu, et
cetera. They are expensive to maintain and to replenish. Have
you explored the option of opening a self-life extension
program to State and local health agencies, or is there another
way that you are looking at in helping them to maintain their
own stockpiles?
Dr. Borio. So it is a fairly long answer, and I would like
to provide an answer to that to the record in written form.
Ms. DeLauro. Perfect.
Dr. Borio. But I would also like to say that PAHPRA gave us
explicit authorities to allow us to extend shelf life of
certain products, and we have used those authorities very
frequently since PAHPRA, including just this week with
intravenous saline shortage situation. For example, we were
working with CDC to extend the expire dating for their
products.
So we use the authority several times, and I will provide a
more comprehensive response.
Ms. DeLauro. That would be good because I know it is a big
concern with the State and local.
[The information follows:]
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MOST LIKELY THREATS
Ms. DeLauro. Final question is what are the most likely
threats in your estimation? What are they? And it is important
to get an understanding of not scaring people. That is not the
point, but how prepared are we to deal with this?
There has got to be a certain level of, I want to say
honesty, just focus on if we are or if we are not. And if we
are not, why not? But in your view, and I am happy to have
people, you know, everybody, you know, talk about what they
view what are the threats? What are the most likely threats to
emerge not just for 2014, but over the next several years--
natural, manmade, or whatever--and how prepared are we?
Go for it.
Mr. Kingston. Yes, and let me--let me elaborate on that a
little bit. But kind of putting it in a context of the question
I asked you about the pandemics in the past, but what if
members of this panel wanted to give a speech, you know, a 5-
minute on here is what the danger is, here is where we stand. I
think that would be useful for all of us so that we are just
able to translate this to the next rotary club.
Mr. Korch. Well, to answer your question, I would love to
know that as well. If I could predict what the next major
emerging disease was going to be, I think I would be making a
lot of money just in that prognostication. But that is not to
make light of it.
I think what we can see is, historically, we know that
influenza, and we are seeing that on a regular basis, all
these----
Ms. DeLauro. You all are very professional people. You have
opinions as to whether or not--what direction we ought to move
in here.
Mr. Korch. So I know that flu is constantly on the horizon.
It is, as you can see, historically as well as in current
times, with agricultural practices, with all the things that we
are doing, flu still remains a present and omnipresent threat.
The manmade or the deliberate threats, outside of having
perfect knowledge of what an aggressor tends to want to do, we
know that the threats that we are working on are the ones that
have emerged historically as the ones that present the biggest
challenges or have the biggest impact potentially.
The other threats that emerge, the coronaviruses that come
on up, the morbilliviruses, all these others, we are looking
not so much at do we have something specific that we can
address with that particular threat, but as you have heard all
across the board, how we are developing enough resiliency in
the products that we are looking at, in the infrastructure that
we are putting in place, so that we could turn that crank very
quickly?
It is not a function of predicting exactly what the threat
is going to be. It is more of a function of having this
infrastructure to rapidly respond when the opportunities start
arising, when we see, as early as we possibly can--either
through surveillance or through information--this capability
established across all these partners in terms of rapid
manufacturing, rapid identification, the recombinant
technologies, the platforms that you have heard about.
That is really it, going from what is the prediction to
what is the real innate capability to respond.
Mr. Kingston. Let me ask you on that. We know that Assad
has used chemical weapons. Do we--if that had been used on
Americans, what would have happened?
Mr. Korch. Hard for me to project what would have happened
under those circumstances. We certainly know that his use of
nerve agents, we have prepared to the extent that we have with
the CHEMPACKS that are forward placed in a number of localities
in the United States. That there are countermeasures for nerve
agent, for cyanide.
To our knowledge of what is a potential threat, we have
provided materials, especially on the chemical side, as far
forward as possible because you don't have the luxury of a lot
of time to develop a response. They have to be there when the
event happens.
And that has been the strategy that we have used, to
forward position those particular medical countermeasures at
hospital settings and in localities identified by the State and
locals and through CDC's Strategic National Stockpile to be as
far forward as possible.
And to the extent that we can understand what the next
range of chemical threat would be, we would be looking at what
we can do to mitigate that as well. But the scenario you build
with Assad's or the occurrences in Syria certainly are ones
that keep us awake with regard to are we prepared?
You also heard from Robin that there is new products that
have come down the line with regard to anticonvulsants, and
midazolam replacing what is currently in the stockpile.
So we are always looking to upgrade and asking how can we
make it easier to prepare, to have responses, to administer?
Those are all components. Safety and efficacy of the products
always are on our mind in terms of what we can do to respond.
Mr. Kingston. Go ahead.
Ms. DeLauro. No, I just wanted--is there concurrence on the
issue of influenza as----
Mr. Robinson. I would not only include influenza, but there
are other emerging infectious diseases that we know is not a
matter of if, it is just a matter of when.
And Dr. Korch said we can't make a medical countermeasure
for all 255 or 296 different pathogens, but what we can do is
we can have the infrastructure that did not exist 10, 15 years
ago to be able to do what we did for H7N9, and that is to
rapidly be able to take products, candidates that are very
early in the pipeline and move them rapidly forward and which
we can actually have those available.
Something BARDA actually moved forward with in MERS
coronavirus, with a drug that is licensed actually for
parasitic infections. We had been studying it for influenza,
and we said, you know, this might work for MERS coronavirus and
then worked with CDC and the NIH to actually determine whether
or not it may be an effective drug for MERS coronavirus.
Ms. DeLauro. Anyone else want to just end the conversation,
or is that final? FDA?
Dr. Kurilla. The point I would make is that just as you
mentioned with universal flu, if you are constantly looking or
trying to predict where the next flu pandemic is going to arise
from, the solution is rather than to get more refined and be
very clever about predicting is to just come up with a solution
like the universal flu that doesn't matter if you have
something that you know will work. And we are on the cusp of a
lot of scientific opportunities that offer that broad spectrum
potential, which we have seen in terms of antibiotics and
bacterial diseases.
We are on the cusp of being able to address that from
antiviral capabilities where one drug might actually be
effective against a wide variety of viral threats. So as a new
one emerges, we may end up already having something that people
are using for other things that will be effective.
Ms. DeLauro. Sure. Sure. It is like great research with--
you know, cancer research. You can use it both--anyway. Anyone
else? Because go ahead. FDA?
Dr. Borio. I think that assessing the threat is one of the
most extremely difficult tasks we have, which is why again just
to reiterate, you know, we do need very nimble response
mechanisms that focus on resilience. Also we talk a lot about
handoff from one place to another, but the truth is that we
work together all the time, and engagement continues. So FDA,
for example, is engaged from start to finish.
Just next month, we are having NIH researchers come to FDA
to present animal models of respiratory diseases.
Traditionally, we would have waited for a product. You know,
this is now how we work today. We are there very early on, and
if I dare to say, we have matured together as professionals,
and we actually like each other very much. [Laughter.]
NATURAL VS. MANMADE THREATS
Ms. DeLauro. That is good. That is always good.
I just want to say--and Mr. Chairman, Dr. Harris--it would
seem from the commentary, and it is not there because manmade
is out there. But the fact is, is that where some of the
dialogue and the conversation has been is around naturally
caused diseases here.
And I think it is important in terms of how we view the
resources that we utilize because in the past, and maybe even
now, the pot of money has been skewed to manmade threats, at
least with regard to, I believe, BioShield, that that money
then is for that side of it, the kind of manmade threat
assessment versus the infectious disease side of the equation.
I think as part of the overall--because when I asked my
first question about where you create the balance between the
two, we have to take a look at where this data and your
professional capabilities are carrying you so that we are
placing resources in the right buckets here, or maybe there
needs to be more flexibility as to where this goes, depending
on how this is moving. This is not static. This is fluid here.
Mr. Robinson. As you have pointed out, you are spot on on
this. We have to make the medical countermeasures that we are
developing for under BioShield have more applicability to
public health and the community of diseases.
Case in point. The dollars that we are putting into
developing new classes of antibiotics that are going to work
against biothreats like glanders, melioidosis----
Ms. DeLauro. Glanders, yes.
Mr. Robinson [continuing]. Plague, tularemia, they are also
being looked at for MRSA, CRE, and other hospital- and
community-acquired infections that are rampant out there. And
that is an approach across the board that we are doing, and so
what you are seeing is these drugs will be doing double duty
not just for Project BioShield and biothreats, but also for
public health emergencies and just everyday pathogens.
Ms. DeLauro. Mr. Chairman, thank you very, very much, and
thank all of you for your testimony.
Mr. Kingston. Thank you.
Dr. Harris, are you finished?
All right. Well, thank you very much for your time and the
good work you are doing.
And the Members will have 2 weeks in which to submit
further questions or comments, should they have them.
[The information follows:]
Mr. Kingston. And we stand adjourned.
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Thursday, March 13, 2014.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
WITNESS
HON. KATHLEEN SEBELIUS, SECRETARY
Mr. Kingston. Well, we will go ahead and call the committee
to order.
And, Madam Secretary, I welcome you to the Subcommittee on
Labor, Health, and Human Services.
And I will go ahead and have my opening statement. And I am
sure that, Rosa, you will have one, as well.
You are center of so many things that are going on right
now in Washington that we are going to have a lot of questions
for you.
But I wanted to, first of all, remind everyone on the
committee that we will do the 5-minute rule, as we always have.
And we will go in order of appearance, if somebody comes in
after this.
But, Madam Secretary, we are pretty strict on the 5
minutes. It applies to witnesses and Members.
I do have a lot of concerns in your budget. And, last year,
you had estimated in our questions that the cost of
implementing the Affordable Care Act was between $5 billion and
$10 billion. And that was, as I said, part of our Congressional
Record. That is a big swing, but it is still an
underestimation.
If you look at this year's request, there is an assumption
for $430-million brand-new mandatory program used for CMS
program management, and then you assume $1.2 billion next year
for userfees and then $639 million in annually appropriated
discretionary dollars for the exchanges. That totals to $2.2
billion, which is a 41-percent increase over last year, or $643
million.
So I am concerned about that. But then when we read further
in your budget, if you add in approximately 21 billion other
dollars that are out there for State exchange grants, consumer
operated/oriented plan, preexisting condition insurance plan,
early retirement reinsurance, transitional reinsurance, risk
adjustment program, and risk corridors, if you add those two
together, it is $23 billion to run Obamacare.
Right now, you have 4.2 million people who are in line to
enroll. Some of them are enrolled, but not all of them are
enrolled right now. Your estimation is that 8 million people
will be enrolled next year. If you look at that 8 million
people, compare it to the 23, it comes out to nearly $3,000 per
enrollee.
Now, the President said repeatedly--repeatedly--that the
average person would have a $2,500 premium decrease. But just
for the government to get involved, it is $3,000 per enrollee.
So not only has that decrease not happened, but you have this
huge government expansion and burden. Because in addition to
that $3,000, the insurance companies, of course, have an
overhead charge of their own.
So when we talk about this new law and the cost of it, to
me, that is the most disturbing of anything.
I will say, in my discussions with constituents, I have not
found anybody that has had a premium decrease. I have not
talked to many businesses who have created more jobs or found
Obamacare compliance business-friendly in terms of creating
more jobs. So, to me, it is a failure.
It was supposed to decrease premiums and increase access,
but when businesses are not creating jobs, or putting people on
a part-time basis in order to get around Obamacare, or keeping
the number of employees below 50, then it has been a failure on
both sides of it, the premium side and the access side.
So those are my concerns, and we will look forward to
having good exchanges on it.
And let me yield to my friend, the ranking member, Ms.
DeLauro.
Ms. DeLauro. Thank you very much, Mr. Chairman.
And welcome, Madam Secretary. Thank you very much for
joining us. Thank you for all that you have done and are
continuing to do to implement the Affordable Care Act, which,
in fact, is a transformative law for American families.
Before I begin, I want to make three important points to
help guide our conversation this morning and to set the record
straight.
First, and despite what we are likely to hear, Congress has
spent the last few years making deep and irresponsible cuts to
nondefense discretionary spending. If history is any guide, the
commentary will be to suggest that spending on these vital
programs has grown or even exploded in the past decade. This is
simply not true.
Let us look at the evidence. A common means of comparing
budget levels over time is to measure them relative to the size
of the economy as a percentage of the gross domestic product.
Using that measure, per capita inflation-adjusted spending on
programs funded in the Labor-HHS bill over the past decade has
been cut by nearly 15 percent, from 1.2 percent of GDP 10 years
ago to just 0.95 percent in the 2014 budget we enacted 2 months
ago.
NIH has been cut by almost $1.1 billion; HRSA by $1.4
billion; CDC by $723 million. Job training programs at the
Department of Labor have been cut by $696 million; Title I by
$107 million; IDEA by $32 million. The list goes on and on.
Some of my colleagues may applaud these deep cuts as a
necessary austerity, but in real-life terms what we are really
talking about here is less money for education, less money for
scientific research, less money for public health investments,
among other critical priorities across the Labor-HHS bill. We
are not doing more with less; we are doing less with less.
We are still working to recover from the worst recession in
generations, and yet we are shortchanging the critical
investments in our future that actually grow the economy and
save money in the long run. The recent budget agreement was a
small step in the right direction in that it reversed some, and
some only, of the deep and indiscriminate sequester cuts. But
we still have a long way to go. For example, the 2014 budget
restored only 58 percent of the sequestration for NIH, a
critical driver of jobs in health. CDC remains $100 million
below its funding level prior to the onset of sequestration,
despite the continued emergence of public health threats. Just
two examples of where we fell short. There are many more.
Second, I want to highlight the success of the Affordable
Care Act. We all know there were serious problems with the
initial rollout of HealthCare.gov last fall, and I expect we
will spend time this morning discussing what went wrong there.
But I also want to make sure we acknowledge and that we applaud
the many policy successes we have seen so far.
Since the HealthCare.gov Web site fixes went live,
enrollment numbers have shot up nationally. Over 13 million
Americans have signed up for affordable insurance coverage,
many for the first time. In my State, AccessHealthCT, the
State-run exchange, had a goal of enrolling 100,000 people by
March 1st. It has enrolled close to 160,000 Connecticut
citizens. It is coming in on time and under budget.
A new Gallup poll shows that since the Affordable Care Act
went into effect the uninsured rate in America is dropping
among every single demographic group, especially low-income
Americans. Healthcare spending growth is the lowest on record.
In fact, healthcare spending growth rates over the past few
years are less than one-third of the long-term historical
average going back more than 50 years.
Due to the slower growth in healthcare spending, CBO
projects that the Affordable Care Act will reduce Federal
deficits by $100 billion in the next 10 years and by an average
of $83 billion per year in the subsequent decade. I repeat,
CBO: Affordable Care Act will reduce the Federal deficit by
$100 billion in the next 10 years and an average of $83 billion
per year in the subsequent decade.
So, notwithstanding the rhetoric, evidence so far suggests
that the Affordable Care Act is working and it is providing
more Americans access to affordable insurance, a higher quality
of care, while working to slow the growth of healthcare
spending and healthcare inflation.
Let us not lose the forest for the trees. Americans do not
want us to repeal the Affordable Care Act. They want us to fix
what is not working as well as intended and to move forward.
Third, I want to turn to the main question before us today,
the Health and Human Services budget request for fiscal year
2015. I was pleased to see modest increases for critical
programs and priorities like biomedical research and early
childhood programs in the President's request. At the same
time, other parts of this request give me serious pause. For
example, the proposal would further reduce the Low-Income Home
Energy Assistance Program, or LIHEAP, by another $625 million.
Right now, LIHEAP's current funding is still below the pre-
sequester level. I am also troubled by the proposal to cut
community services programs by nearly one-half. And I hope we
can talk about these priorities.
Finally, I have a question for my fellow members of the
subcommittee, particularly those who are concerned about waste,
fraud, and abuse in health care: Why did we choose not to fully
fund the Health Care Fraud and Abuse Control Program in the
2014 budget?
This program acts as a deterrent against fraud and
overpayments in our Medicare system. It saves billions of
dollars of taxpayer money. It ensures that our seniors receive
the benefits that they have earned. And yet the majority left
an additional $329 million for this program on the table, even
though it would not have cost this committee a penny from other
programs due to the cap adjustment for program integrity
initiatives. These additional funds would have saved taxpayers
approximately $2.5 billion if we had included them in the
recent budget.
If we are concerned, and truly concerned, about stopping
healthcare fraud, reducing the deficit, we need to fund the
programs that work to do so. I hope my colleagues will commit
to fully fund this program for 2015.
So we have much to talk about. And with that in mind,
Secretary Sebelius, I thank you for coming today, for your hard
work on behalf of our families. It is a tough job. I look
forward to hearing your testimony and for the discussion. Many
thanks.
Thank you, Mr. Chairman.
Mr. Kingston. Thank you, Ms. DeLauro.
Perhaps we could find some compromise. We could take the
money out of Obamacare and put it into fraud. What do you
think? I don't think you like that----
Ms. DeLauro. You need to stop repealing--trying to repeal
the bill. Fifty-one times now, I think, you know? They say
``insanity'' is repetition over and over and over again.
Mr. Kingston. You mean like spending more money on big
government for solutions?
All right. As you can tell, Ms. Secretary, my good friend
and I may have a slightly different view of this, but we share
a lot of views in common on other issues. And we are looking
forward to your testimony.
So, with that, I will yield the floor to you. And, again, 5
minutes, so you may need to skip around, but we have your
written testimony. Thank you.
Opening Statement
Secretary Sebelius. Well, good morning, Chairman Kingston
and Ranking Member DeLauro, members of the committee. I am
pleased to be here again.
As President Obama has said, the budget you consider is
about more than numbers. It is about our values and what sort
of future we want to give to our children. Among these values
are opportunity for all, economic growth, and the security of
our families. HHS has a very important role to play in each of
these areas.
Opportunity for all begins at home. Every child deserves
the opportunity of a healthy start. And as the President
reminded us in his State of the Union, research shows that one
of the best investments we can make in a child's life is high-
quality early education.
Studies show that the return on early education investments
is at least 7 to 1, far exceeding any investment in the stock
market.
Our budget puts a special focus on a birth-to-kindergarten
pathway. It expands Early Head Start Child Care Partnerships so
we can give more children access to high-quality preschool and
child care. And if you move forward with the President's
Opportunity, Growth, and Security Initiative, with an
additional investment which could be paid for by closing tax
loopholes, we provide an additional 100,000 children with
access to high-quality early education.
The budget before you also invests and empowers children's
first and best teachers, their parents. It does so by expanding
voluntary home-visitation initiatives, which are fully paid for
by a tobacco tax. Not only are we able to help more children
and their parents without adding a dime to the deficit, but we
will be able to discourage more of our children from smoking.
Now, we know that the tobacco tax deters would-be smokers,
particularly young smokers. We also know that 3,000 young
Americans a day try their first cigarette and 1,000 of them
become daily smokers. Therefore, we are also investing in more
prevention, education, and media campaigns that have been shown
to deliver results. We believe that we can make this generation
a tobacco-free generation if we are willing to take action.
Early childhood and tobacco prevention efforts are
important strategies for expanding opportunity and providing
families with security. Affordable health care is another. No
one can start a new business or save for retirement when they
are drowning in medical bills.
This budget protects the progress we have made in the last
4 years to expand the opportunity of more affordable health
coverage to more Americans. Through the end of February, 4.2
million Americans signed up for affordable health insurance
plans through the Marketplace. And, as you know, these are
private plans in a private market. We expect this number to
rise by the March 31st deadline as more Americans learn just
how affordable health coverage really is.
This budget is a job-creator. It bolsters some of the most
important sectors of our Nation's innovation economy by
investing in the NIH-funded BRAIN initiative, vaccine
development, and other cost-cutting projects. It also creates
jobs by increasing our primary-care workforce through
investments in the Healthcare Workforce Initiative and the
National Health Service Corps.
Ultimately, we all agree that there can be no opportunity
without security, and the investments we are requesting in
ASPR, CDC, and NIH matter to the security of every family. This
budget requests funds to advance the development of medical
countermeasures against chemical, biological, and radiological
threats. We also move influenza preparedness forward, as well
as vaccine development and the search for antivirals that are
effective against drug resistance and virus mutation.
In addition, because no American should get sick as a
result of a hospital stay, the budget invests in CDC and AHRQ's
work to protect hospital patients from healthcare-associated
infections.
This budget also protects the security of some of our most
vulnerable populations. We expand elder justice initiatives
that protect our parents from abuse, neglect, and exploitation.
We support the Ryan White HIV/AIDS Program so we can expand
access to care and condition management to half a million
lower-income Americans living with HIV and AIDS.
We make these investments while also making tough, fiscally
responsible choices. Our budget contributes $369 billion to
deficit reduction over the next 10 years.
And we will, as Representative DeLauro has said, continue
to fight waste, fraud, and abuse. Every dollar we have invested
in the Health Care Fraud and Abuse Control Initiative, has
recovered $8.10. Last year, that totalled a record-breaking
$4.3 billion.
In summary, this budget expands the opportunity to more
Americans, including the opportunity of a healthy childhood,
the opportunity of affordable health coverage, and the
opportunity of a job.
And, with that, Mr. Chairman, I would be pleased to answer
the committee's questions.
Mr. Kingston. Thank you, Madam Secretary.
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AFFORDABLE CARE ACT AND CYBERSECURITY
Mr. Kingston. I was watching an interview with somebody who
was knowledgeable of cybersecurity, and he said that the
Obamacare Web page or the exchange sites--and I know there are
different ones, but he said it was 4 minutes away from being
able to be hacked by the average hacker to get income
information, healthcare information, family information.
Do you agree or disagree with that? And how secure are the
Web pages?
Secretary Sebelius. Well, cybersecurity is certainly a huge
issue and priority, and it is a huge issue for us.
And, Chairman Kingston, first of all, we collect no health
information because it is currently not needed because
insurance companies can no longer lock anybody out with health
information. So that is not collected.
Secondly, the Hub, which is the central focus of both
State-based Marketplaces and the Federal Marketplace, doesn't
store any information. It is a router to ping other secure
government systems and deliver back information.
But, finally, the website, the Federal Marketplace and the
States, have been built to the highest Federal standards. We
have ongoing and continuous penetration testing. As recently as
mid-December, we conducted a full security control analysis and
had a green light to go--no concerns were found in the end-to-
end testing that was performed in the secure lockdown site. We
have continuous testing not only from HHS outside entities but,
on an ongoing basis, penetration testing. And there has been no
successful malicious attempt to get personally identifiable
information.
But we are continuing to improve the site. I think the
private-sector site breaches that we heard about late in the
year with a number of top retailers have sent shock waves
through everyone. And I think it is incumbent on all of us, not
just with the new Marketplace, but we also run the Medicare
system; we have Medicaid information; so we have a lot of
personally identifiable information. It has always been a
priority, but, believe me, we are working on a continuous basis
to increase our security efforts.
AFFORDABLE CARE ACT IMPLEMENTATION
Mr. Kingston. Okay.
A question about the implementation. I know that there was
part of the law when it was passed that said that the White
House could waive certain provisions in order to implement it.
But now that the law has been the law of the land for 3 years--
--
Secretary Sebelius. Four almost.
Mr. Kingston [continuing]. Four, I don't understand the
authority in which the administration uses to waive certain
requirements on mandates. And how many mandates have been
waived? I hear 20, I hear 27, I hear 28.
Secretary Sebelius. Well, Mr. Chairman, first of all, I
think this has been a multiyear, as we just discussed,
implementation effort. And what we are attempting to do is have
a smooth transition into the new Marketplace. Our agency as
well as other departments across the Federal Government have
fairly broad discretionary authority in terms of implementation
efforts. And, at each point along the way, we have gotten legal
counsel approval for the steps we have taken.
Nothing has been discarded, in terms of the law. The law is
still very much in place. What we are doing with some of the
features of the law, is having a transition most focused on
people who have insurance coming into compliance with some of
the new features of the plans, and to gradually phase those in
over a period of time. But they will all be in place, they will
all be enforced, and they are all still very much a part of the
law.
Mr. Kingston. Could you provide us with that legal opinion?
Secretary Sebelius. I would be happy to.
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Mr. Kingston. And could you do it today?
I just don't want it to disappear.
Secretary Sebelius. Sure. It won't disappear, but I will do
it as quickly as we can.
Mr. Kingston. Okay.
I am going to yield to you, Rosa, because of the time.
Thanks.
AFFORDABLE CARE ACT
Ms. DeLauro. Thank you, Mr. Chairman.
Madam Secretary, I have spent my entire career fighting to
ensure universal access to high-quality, affordable health
care. And I want to again say thank you to you for your hard
work to bring this Nation closer to that reality.
I have three or four questions, of which I would like to
have you just confirm. There is, at this juncture, no need for
lengthy answers here.
Question: For instance, isn't it true that about 3 million
young adults have coverage today because the ACA allows them to
stay on their parents' plans?
Secretary Sebelius. There are about 7 million who are
staying on their parents' plan. The insurers tell us at least 3
million of those folks had no insurance prior to being on their
parents' plan.
Ms. DeLauro. Thank you.
Isn't it true that the American consumers have saved $1.5
billion in premium costs due to the Affordable Care Act?
Example: Medical loss ratio requires insurance companies to
spend at least 80 percent of their collections from premiums on
providing actual healthcare services as opposed to
administrative costs, marketing, or salaries for high-paid
executives. Hasn't this resulted in significant rebates to
American families?
Secretary Sebelius. Congresswoman, consumers have gotten
rebates, small-business owners have gotten rebates, as well as,
using the new authority that they have, a number of State
insurance commissioners have turned down what were double-digit
rate hikes and made it very clear that they are not allowing
those. So both have happened.
Ms. DeLauro. That last piece was true of the State of
Connecticut, in a double-digit rate hike.
Question: Isn't it true that seniors are saving almost
$1,000 per person on drug costs due to the Affordable Care Act,
due to closing the donut hole in Medicare Part D?
Secretary Sebelius. Well, the seniors who qualify for the
donut hole because they purchase those prescriptions have saved
at least $1,000 a piece, on average, because of the ACA
provisions, yes, ma'am.
Ms. DeLauro. One of the most important pieces of the
Affordable Care Act is its focus on increasing access to
preventive services. Isn't it true that more than 25 million
Medicare beneficiaries are receiving free preventive care as a
result of the Affordable Care Act?
Secretary Sebelius. Well, as you know, Congresswoman, not
only do seniors receive that, but now insurance policies offer
preventive services with no copays and no coinsurance. So
cancer screenings and flu shots and children's immunizations
are all part of insurance benefits.
Ms. DeLauro. Thank you.
Last 3 years, real per capita annual growth of national
health expenditures is only 1.3 percent, less than a third of
the long-term historical average, lower than the previous 3-
year period, which coincided with the recession. There are many
moving parts and pieces in the U.S. economy, but I think we
could say that the Affordable Care Act has been successful in
constraining the growth of healthcare spending.
Can you talk about the impact the ACA is having on
healthcare costs and healthcare spending? If the ACA continues
to constrain the growth of healthcare expenditures, won't that
wipe out a large portion of the projected future deficit?
Secretary Sebelius. Well, Congresswoman, we are seeing the
lowest healthcare increases, some people say, in recorded
history.
Medicare is growing at a slower rate. It was up over 6
percent year-in and year-out in the decade before the ACA was
passed. In 2010 to 2012, it grew at a rate of 1.6 percent per
capita. Last year, 0.7 percent per capita--a rate never seen in
the 50 year history of the program.
Medicaid costs across the country are rising at about half
the rate that they did prior to the ACA. If you compare the
decade before and the 4 years since, it is about half.
Overall health expenditures for the United States are
rising at half the rate they did in the decade before as
compared to the 4 years since the ACA. And private insurance
rates are rising at about half the rate.
Ms. DeLauro. Uh-huh. So, overall, we are seeing a bending
of that healthcare cost curve.
Secretary Sebelius. Significant. And, initially, people
said this was related to the recession. Health economists now
are saying there is some fundamental transformation going on in
the overall healthcare expenditures. And that is very good
news.
Ms. DeLauro. Okay. Thank you.
HEALTH CARE FRAUD AND ABUSE
I don't know if--well, let me move to the healthcare fraud
and abuse, which you addressed in your commentary. I mentioned
this in my opening statement. The Budget Control Act of 2011
authorizes two cap adjustments in program integrity initiatives
in the Labor-HHS bill. The cap adjustments are provided for
programs that actually reduce the budget deficit by preventing
fraudulent expenditures in Federal programs. Health Care Fraud
and Abuse Control Program is one of these programs, estimated
to save nearly $8 in taxpayer money for every dollar spent.
Can you tell us about the fraud-prevention activities that
HHS could be pursuing this year but can't because of the fiscal
year 2014 bill that didn't fully fund this program?
Let me just leave it there, because my time might be
running out.
Secretary Sebelius. Well, part of the lesser-known features
of the Affordable Care Act is it is probably one of the
toughest antifraud measures ever passed by the United States
Congress. You gave us a lot of new tools. You increased
criminal penalties for fraudulent activity, gave us new
resources to set up predictive modeling so we can do what the
private sector does, which is look at expenditures. And
additional resources were used to expand the very successful
on-the-ground strike forces of the Justice Department working
with our fraud investigators. That, combined, has increased the
number of arrests and trials and recoveries, so last year we
announced $4.3 billion was put back in both the Medicare and
Medicaid Trust Funds thanks to those efforts.
So we would be able to expand strike forces, do more
vigilant activity. Medicare is a huge program, as is Medicaid.
Fraud activity occurs. And the further we can get out ahead of
it, and not pay and chase, the better off we are going to be.
Ms. DeLauro. Can you just deal with what kind of money we
are talking about, what kind of savings? Is that possible to
predict?
Secretary Sebelius. Well, we have now over the last couple
of years returned 8 to 1 so for every dollar spent, $8 is put
back in the Trust Fund.
Mr. Kingston. The gentlewoman's time has expired.
Ms. DeLauro. Thank you. Eight to 1. Thank you.
Mr. Kingston. Mr. Fleischmann?
Mr. Fleischmann. Mr. Chairman, I understand that you wanted
me to yield about a minute of my time, sir?
Mr. Kingston. Let me just say this for the record to my
friend, Ms. DeLauro, and for the Secretary: Your budget last
year was $5.3 billion, and this year it is 23. That is not a
decrease. Going from $5.3 billion to $23 billion is not a
decrease in healthcare costs. Now, we can quote all this stuff
and have all these nice rhetorical exchanges, but the numbers
don't show that at all.
Mr. Fleischmann, thank you.
Mr. Fleischmann. Thank you, Mr. Chairman.
AFFORDABLE CARE ACT ENROLLMENT
Good morning, Madam Secretary.
Your administration has repeatedly given reprieve to
business by delaying the mandate that requires large employers
to provide healthcare coverage or pay fines, yet you refuse to
consider granting that same option to individuals who are
struggling to meet the requirements of Obamacare.
In fact, your agency stated on Tuesday that you do not
have--and I repeat, you do not have--the statutory authority to
delay the enrollment deadline. And in your testimony before the
House Committee on Ways and Means yesterday, you stated that
the administration will not delay the individual mandate or
extend the 6-month open enrollment period scheduled to end
March the 31st.
Madam Secretary, I would like you to clarify whether you
can think of any reason--and I state, any reason--HHS would
delay the March 31st deadline for enrollment, SHOP exchanges,
or any other Obamacare deadlines. Please provide this
subcommittee and the American people with a straight answer.
And I want a yes-or-no answer: Will you or will you not
delay the individual enrollment deadline on any other aspect of
Obamacare?
Secretary Sebelius. The enrollment deadline will not be
delayed, as I said yesterday.
The SHOP doesn't have a deadline. Small-business owners can
sign up at any point, so they don't operate in an open
enrollment period. That is the way that insurance market works.
They don't have to worry. Anybody eligible for Medicaid can
sign up at any time, as can small-business owners.
But the enrollment deadline, which was set out to end March
31st, will end March 31st.
Mr. Fleischmann. Okay. So then we agree that there is no
statutory authority to extend these deadlines and that they
will not be extended.
Secretary Sebelius. The enrollment deadline will be March
31st.
Mr. Fleischmann. Thank you.
Mr. Chairman, I yield back.
Mr. Kingston. Ms. Roybal-Allard.
Ms. Roybal-Allard. Welcome, Madam Secretary.
MINORITY HEALTH
As you know, minority health in our country suffers
disproportionately from the rest of the population. So it is
important that every effort is made to reduce the racial and
ethnic health disparities that exist in our country.
Yet, in your proposed budget, CDC's Racial and Ethnic
Approaches to Community Health, the REACH Initiative, which
funds community-based programs and culturally tailored
interventions to address health disparities, is eliminated.
Programs that focus on healthcare workforce diversity, such as
the Health Careers Opportunity Program and area health
education centers, are also eliminated. And on top of the
elimination of these programs, the budget of the Office of
Minority Health is scheduled to be cut by 37 percent.
I understand that these cuts are to replace REACH grants
with grants that focus on chronic disease. How will these new
grants replace the work and accomplishments of the REACH
program? And what is the rationale for eliminating proven
workforce diversity programs like HCOP and AHEC and for cutting
the Office of Minority Health budget by 37 percent, which is
about $21 million?
Secretary Sebelius. Well, Congresswoman, we share your
focus and attention on reducing health disparities and
providing funding for programs and services to improve health
in minority communities. And let's just start with the
Affordable Care Act, which has had a significant impact, and
probably the most significant impact on reducing disparities,
since African Americans and Hispanics are more uninsured, by
population, than their white neighbors and friends.
But the budget has $11.9 billion for programs and services
to improve the health in minority communities. We have an
additional $960 million going out to community health centers
with new access points and can serve up to 31 million patients.
Sixty-two percent of the health center patients are racial and
ethnic minorities.
There is new money going into the Indian Health Service,
one of the least-served populations, to continue projects and
reduce health disparities. And additional money will be
invested into the Ryan White HIV/AIDS program.
CDC suggests that, rather than funding the REACH program,
that new partnerships in community health, and grant programs,
as well as the chronic disease and prevention programs' funding
announcements will more than cover not only that target
population, but they think it will do it more efficiently than
REACH.
And while there is a decrease in the Office of Minority
Health, I would say that the grants are coming to a natural end
in that office, and we are looking at broader service programs
that can pick up that focus and effort.
Finally, we do have increased funding, which I think is
critically important, in the workforce areas to make sure that
we further diversify our workforce. So in HRSA, in our effort
to more than double the size of the National Health Service
Corps, where currently over 30 percent of the new Corps members
are minorities. We think that that will continue. More than
half of the 1,100 Corps members in the pipeline are minorities.
And that will make sure that people are actually in a more
diversified workforce setting than we have ever had before in
the history of this country.
Ms. Roybal-Allard. I think that the concern is that some of
the programs that you are talking about deal more with current
health providers and, you know, enhancing their work. And the
concern at least that I have is that the programs that you are
cutting are mostly about recruiting minority health providers
and building a pipeline for future healthcare workers.
So I guess my question would be, then how do these programs
that you have just mentioned specifically address recruitment
and retention of minority health providers, and how do they
build this pipeline that is going to be so critical in the
future?
Secretary Sebelius. Well, again, I would say that one of
the most successful programs that we have is the National
Health Service Corps. Thirty percent of the National Health
Service Corps members who receive scholarship and loan
repayments are minorities.
We currently have about 8,900 National Health Service Corps
members in the country. This budget would bring that number to
15,000 and keep it at 15,000. That is a whole lot of new
pipeline. And we will very much double down on the effort to
make sure that----
Mr. Kingston. Mr. Joyce.
Secretary Sebelius [continuing]. Minorities are
overrepresented in that population. That is a new group of
healthcare providers.
Mr. Kingston. Mr. Joyce.
Mr. Joyce. Thank you.
SMALL BUSINESS HEALTH OPTIONS PROGRAM
Madam Secretary, CMS rules require the Federal exchange and
all State exchanges to implement a Small-Business Health
Options Program, otherwise known as SHOP, that provides an
employer the ability to make available to their employees all
exchange health plans at a meta level--for example, bronze,
silver, gold, or platinum.
This employee-choice model is administratively complex. In
2013 and 2014, several States attempted to implement the
employee-choice approach but encountered technical issues that
required them to either take down or delay launching their SHOP
program. Yet, CMS still requires all States to have this ready
to go later this year.
An employee-choice SHOP is an enormous IT undertaking
across multiple business partners and vendors to allow for
online shopping, enrollment, automated employer billing, and
payment of health plans. However, there is little transparency
into CMS progress in implementing this new SHOP model for 2015.
In particular, details on key milestones for development,
testing, and availability have not been released outside the
government. More transparency is critical, since CMS will be
implementing SHOP in 37 States.
Based on media reports, enrollment in State SHOP exchanges
is miniscule. However, CMS hasn't released any data on how
successful it has been in enrolling employers to date.
Madam Secretary, how many employers are covered under the
Federal SHOP today?
Secretary Sebelius. Sir, I don't have that number off the
top of my head, but I can get it for you today.
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Mr. Joyce. Well, thank you. I would appreciate that today.
Secretary Sebelius. Our last enrollment report would have
it, and I just don't have the enrollment report with me.
Mr. Joyce. I would appreciate that today.
Secretary Sebelius. Sure.
Mr. Joyce. Thank you.
In light of the recent consumer experience rolling out the
individual exchanges and the late announcement last November
delaying SHOP on online enrollment for the Federal exchanges,
what assurances can you provide small employers that the
rollout of the FF-SHOP will be different from the individual
consumer experience last October?
Secretary Sebelius. Well, Congressman, I have repeatedly
said, and I will say it again, the launch in October was failed
and flawed. The good news was that the consumer had a very
different experience 8 weeks after October 1st, but that is no
excuse for the 8 weeks of, really, failed technology.
We announced prior to the launch of the ACA that in the
Federal Marketplace--States have made different choices with
the State-based market--that while we would offer SHOP plans,
we would not offer the second feature, as you say, employee
choice. So an employer can choose among plans in the market in
2014, and a number are. And they are dealing with agents and
brokers the way they have always dealt with small-business
coverage this year.
We are on track to have an automated system which will
allow us to go to step two in the Federal marketplace, so
employees can actually choose between plans, which is a feature
that a lot of small employers have never been able to offer.
That technology will start to be built after open enrollment
finishes.
And we can get you regular updates, but I just got a report
from the technology team that they feel it is feasible to have
it online by the time open enrollment starts on November 15th
of 2014.
Mr. Joyce. Well, see, Madam Secretary, last year when you
were here, I asked you if there was a place that consumers or
Americans could go to follow, somewhere within the government,
the rollout of the Affordable Care Act. And I got a letter----
Secretary Sebelius. They followed it.
Mr. Joyce. Yeah. Well, I got a letter back from you in
August saying that, you know, you would get back to me. And,
again, you know, we got to follow it, and it didn't follow out
all that well in October.
Last year, CMS determined that it wouldn't be able to allow
employees to select from any health plan on SHOP and would
instead focus on allowing small employers to enroll in a single
health plan. Then in November, CMS announced that it would not
be capable of even processing an enrollment for employers. This
meant that small employers that applied for coverage through
the Federal SHOP had to start over and apply for coverage
directly through participating health plans. That was very
disruptive to small employers.
Shouldn't CMS prove that it can implement what it had
planned for 2014 before attempting to implement the more
complicated systems that allow employees to choose from among
multiple health plans?
Secretary Sebelius. Well, that is exactly what we are
doing. This year, we have a system in place--if a small
employer wants to take advantage of the tax credit which is
available to some small employers with low-wage workers, we
have an arrangement with the insurers that they can qualify for
the tax credit and enroll with insurers.
If a small employer wants to offer coverage the way they
always have and has no interest in the tax credit or isn't
eligible for the tax credit, they are enrolling as they choose
this year. And, as I say, the automated version, including the
employee choice, will be up and running.
Mr. Joyce. Well, are CMS, its vendors, and business
partners working under a coordinated Federal timeline? And if
so, what are the deadlines and key milestones in that timeline?
Secretary Sebelius. For this plan, I, again, don't know
that off the top of my head, but I can get that for you.
Mr. Joyce. You can supply us those timelines?
Secretary Sebelius. Yes.
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Mr. Kingston. Ms. Lee.
Thank you.
Ms. Lee. Thank you, Mr. Chair.
Let me first say welcome and it is good to see you, Madam
Secretary.
Secretary Sebelius. Thank you.
HEALTH DISPARITIES
Ms. Lee. Following up with Congresswoman Roybal-Allard's
remarks--and I associate myself with all of her remarks with
regard to the budget cuts as it relates to the cuts to the
Office of Minority Health. One of the issues--Congresswoman
Roybal-Allard, myself, and Congressman Honda helped negotiate
the health disparities provisions in the Affordable Care Act
for the specific purpose to really prioritize--of course, in a
country that is rapidly becoming more diverse--to prioritize
closing these gaps in communities of color.
And so I am really worried about these budget cuts and the
fact that it doesn't really now appear that that is a priority,
and, in fact, we are not going to make a lot of progress in
this. So I hope that we go back to the drawing board and look
at this very, very carefully.
Secretary Sebelius. Well, again, Congresswoman, I would
suggest that the budget before you has an increase of about
$775 million in funding specifically for minority health
issues, and that does not include any of the direct efforts
through the Affordable Care Act to qualify people for health
insurance.
So, in addition to that effort, there is an additional--and
the programs include programs in HRSA, the Indian Health
Service, and in the Office of Research and Quality. But we
would be glad to enumerate those programs and get back to you.
Ms. Lee. It would be good to see----
Secretary Sebelius. Yes.
Ms. Lee [continuing]. Because, for instance, eliminating
the funding for the REACH Program, eliminating funding for the
centers for excellence, Healthcare Opportunities program, Area
Health Education Centers--all of those have been reduced or
eliminated. So we need to see how you are going to----
Secretary Sebelius. Absolutely. And in----
Ms. Lee [continuing]. Deal with this.
Secretary Sebelius [continuing]. Some of those cases, the
leaders of those agencies have made a determination not to
decrease their efforts in minority health but, actually, to
expand them into broader programs that they thought would reach
more of the population of interest.
Ms. Lee. Okay. Yeah, I hope we have a chance to walk
through this.
Secretary Sebelius. And I would be glad to do that.
GUN VIOLENCE
Ms. Lee. Let me ask you about gun violence. You know, it
has been more than a year now since the tragedy at Sandy Hook
in Connecticut and a month-and-a-half removed from the deadly
mall shooting in Maryland. Of course, Congress, for obvious
reasons, has failed to take a single step to address gun
violence in America taking innocent lives every day. Despite
overwhelming public support, we have really been unable to act
on something as noncontroversial as background checks. And so,
as we wait, according to the Children's Defense Fund, they
estimate that more than 21,000 children and teens have been
shot by guns since this Congress alone.
So I wanted to ask you about this study, the Institute of
Medicine report that proposes a research agenda on gun
violence, including key topics such as risk and protective
factors and the characteristics of gun violence.
Are you doing any gun violence prevention research? How
does this budget attempt to address this in your proposals? And
how do you see this gun violence issue as a public health
problem? Because many, many want CDC and others to begin to
define at least part of it as a public health issue.
Secretary Sebelius. Well, I don't think there is much
debate or dispute in the healthcare community that gun violence
is a major public health problem and not only has a serious
economic cost but a serious personal cost in the loss of lives.
In the President's ``Now is the Time'' agenda, some of
those suggestions were dependent on congressional activity,
some were Executive orders that could be carried out by
departments. And for our department one of them was to ask both
the NIH and the CDC to refocus on the issue. CDC will focus on
surveillance of gun violence and produce data and information,
which they are doing and will continue to do, and NIH will look
at various causes and effects.
We also have efforts in Substance Abuse and Mental Health
Services Administration that focus on not only the trauma that
is created by survivors of gun violence and efforts to help
victims, but a fairly significant increase in the 2014 budget
and also for 2015 in the number of mental health professionals.
I mean, a greatly underserved area is often early intervention
in mental health issues that could identify problems at the
front end.
Mr. Kingston. Dr. Harris.
Mr. Harris. Thank you very much.
PHS EVALUATION TAP
Let's turn our attention a little bit to the NIH budget,
which I understand comes in at $30.4 billion. And your
statement says it increases $211 million over fiscal year 2014,
reflecting the administration's priority to invest in
innovative biomedical and behavioral research.
But, in fact, in the same budget, you increase the tap from
2\1/2\ to 3 percent, taking back $152 million of that $211-
million increase. Is that correct?
Secretary Sebelius. The tap has always been a part of our
budget, yes, sir.
Mr. Harris. But you are increasing the tap----
Secretary Sebelius. We are increasing it, but that has
always----
Mr. Harris [continuing]. Taking $150 million more than you
would under the old tap. Is that correct?
Secretary Sebelius. That is correct.
Mr. Harris. Okay. So basically the increase really, because
of an accounting gimmick, is really only $50 million.
The tap you take from NIH is valued at--you would propose a
$900-million tap? So 3 percent of $30 billion? I mean, that is
a back-of-an-envelope estimation.
Secretary Sebelius. I assume that is correct.
Mr. Harris. Well, I think the math of 3 percent of $30
billion is $900 million.
Secretary Sebelius. I just wasn't clear----
Mr. Harris. So if we----
Secretary Sebelius [continuing]. That $30 billion was
correct, sir.
Mr. Harris. If, in fact, your office didn't take the tap,
you could triple Alzheimer research at the NIH, you could
increase Parkinson's research eightfold by leaving that $900
million in the NIH. I mean, you could double or increase 2\1/2\
times the breast cancer research. But instead you choose to
take a 3-percent tap from the NIH.
And the interesting thing is you say your budget reflects
the administration's priority to invest in innovative research,
but, in fact, the best measure of the administration's
priorities is, where does the tap money go? Because that really
is your ability to set priorities of the administration.
Am I correct that in fiscal year 2013, the last number that
I have available, zero tap dollars were sent back to NIH for
medical research--zero?
Secretary Sebelius. I can't----
Mr. Harris. Out of----
Secretary Sebelius. I can tell you Congress appropriates
virtually all of the tap from the HHS budget. So I think there
are about $40 million of discretionary funding. So if Congress
did not direct us to send tap money to NIH, it probably isn't
there.
Mr. Harris. Okay. So you would be okay if we directed tap
money to the NIH----
Secretary Sebelius. As I say, Congress has----
Mr. Harris [continuing]. Because of the priorities?
Secretary Sebelius [continuing]. For years appropriated the
money that comes in through the HHS----
Mr. Harris. So, I mean, you are not answering my question.
So you would be okay if we directed that additional $900
million that your budget takes out of the NIH budget, the tap,
back to the NIH to restore medical research?
Secretary Sebelius. We will certainly work with Congress on
whatever the direction is. But it is a congressional
appropriation that----
Mr. Harris. Good.
Secretary Sebelius [continuing]. Has come in year-in and
year-out to spend----
Mr. Harris. I understand, but----
Secretary Sebelius [continuing]. That money, so it is not
our discretion.
Mr. Harris [continuing]. It was not our decision to
increase the tap from 2\1/2\ to 3 percent. That was an
administration decision in this budget.
Secretary Sebelius. I think that is correct, but----
Mr. Harris. I know that is correct----
Secretary Sebelius [continuing]. You do appropriate the
money, sir.
MARYLAND HEALTH INSURANCE EXCHANGE
Mr. Harris [continuing]. Madam Secretary.
Listen, let's move on, because I only have a couple more
minutes. The Maryland exchange is a disaster. Your Inspector
General correctly agreed last week to inspect and to audit the
Maryland exchange.
But my understanding is they are coming back to the
Department for 30 million additional dollars to bail out an
obviously failed exchange. Is it the intention of the
Department to provide that additional emergency funding?
Secretary Sebelius. Sir, we do regular financial audits on
all of the State-based markets. I am not aware of this request.
We have all of the IT funding for IT that isn't working under
specific restrictions. And we will look at their proposal and
see where they are going forward.
Mr. Harris. When did the Department know that there were
tremendous problems in the Maryland exchange?
The Department is about to invest a total of $200 million,
which, by the way, could double the Parkinson's research in the
country if, instead of wasting it in the Maryland exchange, you
had funded Parkinson's research.
When did the Department know about the failures in the
Maryland exchange?
Secretary Sebelius. Sir, we got regular updates on when
they launched----
Mr. Harris. So the Department knew? So the Department knew
that this was a failure?
Secretary Sebelius. We did not know--we knew it was not
working properly starting in----
Mr. Harris. Well, then, Madam Secretary, I hope you don't
spend another $30 million there.
EPDIURALS
Finally, the last thing is, earlier this year, CMS
implemented extremely steep cuts to payments for certain
epidural pain procedures, procedures I am familiar with--I have
never done them, but I am familiar with them--to treat low back
pain. They decreased by 56 percent the payment for these. I
will tell you, Madam Secretary, that the effect of decreasing
that is to ration this procedure to seniors with back pain.
That is the effect of cutting 56 percent of payments.
Due to a magnitude of the cuts, does CMS intend to revisit
the decision through the agency's refinement process? You don't
have to tell me now. If you can get back to staff within a
couple of weeks, I would appreciate whether that is going to be
revisited through the refinement process.
Secretary Sebelius. I could certainly ask that question.
Mr. Harris. Thank you very much, Madam Secretary.
I yield back.
Mr. Kingston. Mrs. Roby.
AFFORDABLE CARE ACT
Mrs. Roby. Thank you for being here.
Over the last few months, thousands of health insurance
policyholders in my home State of Alabama have received notice
that their plans have been canceled or altered. The costs have
risen, some quite dramatically. A family with one income's
premium doubled from $420 to $940 a month.
That being said, there is already a 3.5 administrative fee
imposed on residents of States where the exchange is run by the
Federal Government, like Alabama. Mr. Cohen told Congress in
previous testimony that the percentage might have to be
increased next year.
Could you tell this committee when you expect to finalize
the payment parameters rule for 2015?
Secretary Sebelius. Well, first of all, Congresswoman,
there is no payment imposed on residents of your State. There
is a fee on insurance companies----
Mrs. Roby. That is passed on to the individuals.
Secretary Sebelius. If an insurance company chooses to do
that, they can. If they choose to take it out of their profit
margin, they can do that. They have rates already filed, so
they can't pass it on. If rates are in the market, then they
are locked in----
Mrs. Roby. But we are seeing--as a result of this
administrative fee, we are getting direct stories from these
individuals of a dramatic increase. So, clearly, the fee plays
a part of that.
Secretary Sebelius. And the rule has been finalized, so
that is the fee that insurance companies will pay.
Mrs. Roby. Do you believe it is reasonable to penalize
these individuals with this administrative fee if their State
was unable to operate, particularly because of insolvency,
fiscal insolvency, especially these individuals that have
already seen such a dramatic increase in their premiums?
Secretary Sebelius. Again, I am not sure who has fiscal
insolvency. This is a fee on insurance companies, who are
seeing millions of new customers come into their businesses
because of the Affordable Care Act. And the fee is to get us to
the point where the Marketplace will be self-sustaining. So the
users and the companies, who will make profit based on their
new customers, will actually be paying for the infrastructure
to sell insurance products.
Mrs. Roby. Right. And the reality, though, is that these
dramatic increases are having an unbelievable effect on
individuals that are having to make choices, quite frankly,
between paying their mortgage or being able to pay for their
health care.
And I am not making this up. They are calling my office.
They are sending their premium statements, showing us. These
are real lives that are being affected by these dramatic
increases.
I want to ask you just a series of questions based on your
testimony about the 4.2 million individuals that are enrolled
already--below the 7 million individual goal. And I heard you
say, I believe--correct me if I am wrong. You said--as far as
enrollees on the exchange that were previously insured, did you
state that number already?
Secretary Sebelius. I did not.
Mrs. Roby. Okay. Do you know that number?
Secretary Sebelius. I do not.
Mrs. Roby. Can you get back to us today, please?
Secretary Sebelius. Insurance companies have that number. I
do not have that number.
Mrs. Roby. Okay. How many enrollees have currently paid
premiums?
Secretary Sebelius. I do not have that number. As I told
the committee members yesterday, we have aggregate numbers that
are a month old from insurers. We do not have individual data
from insurers.
We will give you that as soon as we have it. I do not have
accurate, timely information, and I can't give you that
information. And we will never have, until the fully automated
system for the financial payment is in place, numbers on the
individuals who are customers, who are paying their premiums,
who are not eligible for the APTC.
Customers pay the insurance companies. They do not pay the
Federal Government. These are contracts between Blue Cross Blue
Shield or Humana or Kaiser and----
Mrs. Roby. So you don't know the cost per member or cost
per month of the individual----
Secretary Sebelius. I can look on the website and tell you
the cost per member and the cost per month. It varies by the
tax credit they are eligible for. But they are paying their
insurance company. This is a private insurance company.
Mrs. Roby. Why is HHS not tracking this information? I
mean, Congress and this committee has appropriated billions of
dollars to adequately implement this law, and, you know, it is
a wonder where the justification is for not having these
numbers.
Secretary Sebelius. We do not have accurate information now
because these are just being gathered. Insurers have more
accurate information. The last number I heard was a comment by
a couple of insurance leaders saying 80 to 85 percent of their
newest customers have paid premiums in the month of January.
Whether that is accurate or not, I cannot tell you. But we will
get you timely information, accurate information, as soon as we
have it. But customers don't pay us. They are customers of
insurance companies, not of the Federal Government.
Mrs. Roby. Yield back.
Mr. Kingston. Mr. Stewart.
Mr. Stewart. Mr. Chairman, I am sure you have heard the
phrase that Congress is kind of like Hollywood for ugly people.
You can see why I am nervous with the proximity of the camera
in that case.
Secretary Sebelius. I thought they were doing a dental exam
or something. That is awfully close. You know, I would have him
back up a little.
Mr. Stewart. Madam Secretary, thanks for being here this
morning. I have some questions. I would like to go quickly if I
could.
MARKETPLACE ENROLLMENT
In Ms. Roby's questions and your response to her, you
indicated that you don't have information on some things, and
one thing that we do know from the industry, not from the
administration, is that something like 25 to 27 percent of the
new enrollees through the exchanges previously did not have
insurance. Three quarters of them were insured before. Do you
find that an acceptable figure?
Secretary Sebelius. I am thrilled that people are
continuing to have coverage and that new folks are coming in.
My understanding is that those numbers are changing over time.
But, again, the insurance companies are the best validator. I
think what you are quoting may be a month or so old, so that
newer numbers may look different but, again, the industry has
those numbers.
Mr. Stewart. We have to reason to believe though that that
information, though, being a few weeks old is less accurate.
Secretary Sebelius. I am not talking about accuracy. I am
just saying that it is changing over time, that some of the new
uninsured individuals are coming in in larger numbers.
Mr. Stewart. Do you think it is going to be higher than 27
percent?
Secretary Sebelius. I think that is very likely.
Mr. Stewart. Okay. Do you have a figure how much higher?
Secretary Sebelius. I really don't, sir. What we know is
that a lot of people who have never had coverage before are
taking a lot longer to find out about the plan, to learn about
their options.
Mr. Stewart. We don't know, though. It may be less than
that figure. It may be that we end up with less than that?
Secretary Sebelius. I just said I don't know.
Mr. Stewart. It seems to me this has been a terribly
disruptive and a very infringing program to relieve what we
know is going to be 30,000,000 Americans without health
insurance 10 years from now. It seems to me it is kind of like
having a sliver under your nail and you cut off your finger to
alleviate that. This has been such a disruptive and such a
painful process, which will still leave tens of millions of
Americans uninsured. And the majority of them who are enrolling
had insurance previously.
Secretary Sebelius. Congressman, the individual market,
which is what the new Marketplace is looking at, as well as
people who didn't have insurance coverage, was about 5 percent
of insured Americans, 5 percent. And there definitely are
people in that individual market who now have new plans and new
policies, many at far lower rates than they had before because
they were locked into an old plan. There also are uninsured
individuals coming into that Marketplace, but we are talking
about the vast majority of insured Americans whose plans were
not impacted or affected, except for more consumer protections
than they have had before.
Mr. Stewart. Once again, Madam Secretary, you make my
point; 5 percent of these people, and yet this has been a
terribly disruptive program for many, many Americans.
Secretary Sebelius. I am saying those are the 5 percent.
The formerly insured individuals who were in this marketplace
are 5 percent of the insured number in America. The rest of the
people who had insurance coverage were in employer-based
coverage, in Medicare, Medicaid, in large group plans, and
those have not been impacted.
Mr. Stewart. I understand, but the point still being only a
small percentage of these who have joined in the exchanges were
uninsured before, and we will leave 30,000,000 Americans
without insurance at the end of 10 years.
If I could move on now, would you agree, and it seems like
it is not just the foundation, it is the very foundation of
this law, is the individual mandate, and without that mandate,
the entire bill will fail, and yet--let me elaborate on that a
little bit. That helps explain why the President has
consistently said that he would veto even a bipartisan bill
that delayed the mandate for any reason or in any way. And yet,
in the last few weeks, the administration has essentially done
that. They have delayed requirements that millions of Americans
purchase health insurance or pay a penalty. They have
essentially waived the individual mandate for the last few
years.
It seems to me this would be something that the American
people would need to know. And I would ask you when you made
that decision, did you hold any press conferences to announce
that delay?
HARDSHIP EXEMPTION
Secretary Sebelius. Sir, I assume you are talking about the
issue where people who have coverage currently who find their
coverage changes to be unaffordable could qualify for a
hardship exemption and then be able to purchase catastrophic
coverage. What we are trying to do is keep people in the
market, not have them leave the market, and that seemed like a
logical step for people who already had coverage to keep that
coverage.
The hardship exemption has always been part of the law. The
change was to say that if you had a hardship exemption because
your new coverage was simply unaffordable, you also would
qualify.
Mr. Kingston. The gentleman's time has expired, but let me
yield time to you to answer the question on my time.
Excuse me?
Secretary Sebelius. That was my answer, sir.
Mr. Kingston. Let me make sure I understand that, though,
because there was this news coverage that you could actually
apply for a hardship if you lost your current policy and were
unable to enroll, or it was too complicated to enroll. Is that
a myth?
Secretary Sebelius. No, no, no. There are nine categories
that were spelled out, eight or nine, in the law itself. The
hardship exemption has always been there, and it has been
really aimed at people who could not afford coverage, one way
or the other, that they would be exempted from the mandate.
There are a series of situations spelled out and then a
category that basically gave some broad discretion.
As part of the transition into the new Marketplace, we said
that if you are in the individual market right now and cannot
afford the new coverage, not only can you apply for the
hardship exemption, which was always the case, but you could
qualify to purchase--because you clearly want insurance, you
have been insuring yourself, you have been in the market--you
could qualify to purchase a catastrophic policy, which had a
fairly narrow group of people. You had to be under 30,
basically. So that was the change in the policy; not the
hardship exemption, but the fact that they could qualify to buy
catastrophic coverage to keep them in the market.
Mr. Kingston. Okay. So it is still financially driven, not
convenience-driven as the reports are?
Secretary Sebelius. Yes, sir. That is for the vast majority
of cases. There were situations where because of the technical
issues in a State or two, and people were documented as
attempting to purchase coverage and couldn't get into the site,
they will be eligible for retroactive coverage based on their
attempt to buy coverage. But it is really the case where it is
a financial issue. The hardship exemption has always been
there. We said that, for instance, if you live in a State that
has chosen not to expand Medicaid and you would be Medicaid
eligible, you are not liable for the individual penalty because
you are kind of out of luck if the State doesn't move forward
on Medicaid expansion, so we have those categories. But they
have always been part of the law.
STATE MARKETPLACES
Mr. Kingston. Okay. Let me ask you this, and maybe it would
be useful for us to understand which States would fall into
that category, but kind of moving on in a little slightly
different direction, getting back to Dr. Harris' question about
Maryland.
Maryland had such a disastrous rollout, but I understand
that Oregon, Hawaii, and Minnesota, there have also been some
enrollment problems. What kind of rehab do you have for those
States? What kind of penalties? Do you just take over it?
Because those Maryland numbers are unbelievable. I don't know
how you could mess something up more than Maryland did. But I
would certainly like to know that a State is, there is some
sort of penalty or rehab that would apply.
Secretary Sebelius. Well, as I indicated, Chairman, we have
a regular financial audit that takes place. The portion of the
Affordable Care Act that allows the State-based Marketplaces
has a funding stream, but we set up at the point that they put
together plans, there is no question that some of these
websites have been flawed and had more severe problems than the
Federal website had. We will look very carefully at any IT
money going out. It is screened and qualified. We want these
sites to work.
You know, we want the Federal site to work. It took us 8
weeks of additional work to get it fixed. It was not ready as
promised on October 1. It was very functional by December 1.
But that work is underway in the States across the country, but
we are restricting the IT funding. It goes out under audit.
Whether or not the State then recovers funding from their
contractors, repays the money, that is still an ongoing
discussion.
Mr. Kingston. Did anybody get fired over the rollout? Were
there vendors who were totally eliminated from future bidding
processes?
Secretary Sebelius. I can't tell you what has happened at
the State level. That is a State-by-State choice. I know some
of them have changed their vendors. I think a couple are suing
their vendors.
At the Federal level, we made a series of decisions. We
changed overall day-to-day management immediately at CMS. We
have changed contractors at CMS. We have--we are in the process
of hiring a full-time risk officer. We have asked the IG to
become engaged and involved, which he has agreed to do, with
his team and looking at all of the contractor issues, so we
have taken a variety of steps.
Mr. Kingston. Thank you.
My time has expired.
Ms. Lowey, we are very happy to have you with us.
Mrs. Lowey. Well, thank you so much, Chairman Kingston,
Ranking Member DeLauro.
And welcome, Secretary Sebelius.
I do apologize for arriving late. I was in a meeting with
the Ukrainian Prime Minister, and then there is another hearing
across the hall with Secretary Hagel and General Dempsey, so we
are very busy today, but I was looking forward to seeing you.
As so many of us would agree, the Department of Health and
Human Services is so very important, and the responsibility for
administering some of the key services and initiatives, from
early childhood education to seniors' nutrition, I strongly
believe that this committee must increase investments in those
areas to grow our economy and improve the quality of life of
all Americans.
NIH FUNDING
One of my top priorities is to increase investments in the
National Institutes of Health. Not only does NIH's work lead to
future improvements in quality of life and other benefits
stemming from basic research when it comes to diseases and
disorders, such as autism, Alzheimer's, cancer, diabetes, food
allergies, as well as the brain and big data initiatives, it is
also an economic engine, and we have to remember that.
Scientists in New York, for example, receive roughly
$2,000,000,000 annually in the NIH grants, and every dollar of
which generates $2.21 in economic activity. This is
particularly important as there is a government-wide innovation
deficit due to our inability to maintain adequate investments
in research and development. And in the last 10 years, U.S.
expenditures as a share of economic output have remained nearly
constant while China's has increased by nearly 90 percent;
South Korea nearly 50 percent. We cannot afford flat budgets
that hamper innovation. It is imperative that we increase
investments at the NIH.
I also strongly support proposed increases to help and
protect the most vulnerable, including Head Start, the Child
Care Development Block Grant, health care fraud and abuse
control, and to bolster safety and preparedness.
I also believe it is important that we adequately invest in
pandemic influenza bioshield BARDA, hospital preparedness, and
injury and violence prevention, including gun violence.
That said, I have significant concerns with a number of
proposed reductions, including CDC, LIHEAP, Children's
Hospital, GME, Community Development Block Grant, and the
Office on Women's Health and too many other vital initiatives
would receive stagnant funding, in some cases below the levels
where they were just 2 years ago, including family planning.
Madam Secretary, your Department has wide-ranging
responsibilities. I will do everything I can to ensure you have
adequate resources when the committee writes its fiscal year
2015 bill. And I would like to ask one question. The 2014 bill
restored some of the damage done to NIH by sequestration, but
as you know, we were not able to fully replace those cuts and
instead fell short by a little more than $700,000,000.
Meanwhile, your budget for fiscal year 2014 includes a small
increase of $200,000,000, but in my mind, this is far below the
level that we need for biomedical research.
And I just want to add, Mr. Chairman, I was privileged to
attend a dinner for Research America last night. John Porter
spoke. I was on this committee, as was my colleague, when he
doubled the investment in the NIH. His leadership, a member of
the Republican party, the chair of this committee, made an
extraordinary change. And when you heard these people with a
whole range of illnesses speak and talk about what investments
in the NIH have done for their families and other families, it
makes me proud to sit on this committee, to be part of the NIH
advocacy group.
So maybe you can share with us, for some who may not be as
involved in the NIH and don't interact with some of the people
whose lives have been saved, what research activities could NIH
pursue if additional resources were available?
Secretary Sebelius. Well, Congresswoman, I think that this
Administration certainly shares your view that now is the
absolute worst time to back away from investments in research
and that NIH, which is the gold standard of the world in
research, needs to be more adequately funded.
One of the reasons that the President, I think, put forward
the Opportunity Growth and Security Initiative, and with a
series of pay-fors, saying this is where we should be, NIH has
a huge portion of that investment. But the kinds of things that
are going on with the BRAIN research project, the new
accelerations for cures that are underway, and the
pharmaceutical collaboration with the scientists is all
breathtaking.
Mr. Harris [presiding]. Thank you very much, Madam
Secretary.
Mrs. Lowey. Thank you very much.
PHS EVALUATION TAP
Mr. Harris. I would hope you would join me in saying some
of that increased TAP money should just be turned back over to
the NIH. Maybe return that $150,000,000 over there and increase
that 211 to 350.
Anyway, Ms. DeLauro is recognized for 5 minutes for a
second round.
Ms. DeLauro. Thank you very much, Mr. Chairman.
Just to tell you that the TAP effort is directed by the
Congress, and particularly the TAP--it was the Bush
administration that wanted to bring the TAP number to 2
percent; 2006, it went to 2.4 percent. We are 2.5 percent, and
that is all directed through the Appropriations Committee. I
would concur that the difference between 2.5 and 3, that is
what is being proposed, but, please, people should understand
where that evaluation TAP restriction comes from and where the
responsibility lies. This Appropriations Committee needs to
deal with that.
Madam Secretary, let me ask you this question. How many
people will be insured by the end of the decade? What is the
anticipation that you think you would be able to insure?
Secretary Sebelius. By at the end of the decade?
Ms. DeLauro. By the end of the decade, yeah.
MEDICAID EXPANSION
Secretary Sebelius. Congresswoman, I don't know. I can't
give you that number. What I am hoping is that many more States
will join the 32 Governors who are in the process of expanding
Medicaid, which is a huge opportunity for lower-income working
adults.
Ms. DeLauro. Which, quite frankly, they have decided they
didn't want to do for whatever reasons they didn't want to do
that to expand coverage for people.
Secretary Sebelius. That is correct, but we do have 32
Governors, Republicans and Democrats, moving ahead. We know
that the recent Gallup survey indicates that the rate of
uninsurance in this country as of last month is already going
down, and it has gone down to the tune of they think 3,000,000
to 4,000,000 people. That is very good news. And I think that
will continue. I think we will make a very serious dent in the
so-called uninsured gap that currently is there because most
people wanted insurance. They just couldn't afford the
coverage.
AFFORDABLE CARE ACT
Ms. DeLauro. Which leads me to this comment that I want to
make, given the conversation that we have listened to today. I
think people sit here and believe that it was the halcyon days
of health care that we had experienced before the Affordable
Care Act. Let's just revisit. The health care system was
failing people every year. Health care costs skyrocketed. Small
businesses priced out of the market. Employers asking for
higher contributions in copays and then dropping coverage.
People with preexisting conditions who were being socked or
left on their own. Every single year, more people had no
insurance whatsoever. Annual and lifetime limits on coverage
that could lead to catastrophic expenses in the case of serious
illnesses. Premiums that varied widely based on factors of age,
gender, location and health status. You could be cancelled in a
nanosecond for treatment that you were undergoing at that
particular time.
It sounds to me like some of the commentary here this
morning is about taking us back, taking us back to what was
regarded as a failing health care system, when people were not
guaranteed coverage for maternity, pediatric care,
hospitalizations, families who, as I said, faced annual caps.
It takes us back to a health insurance market that rejects
people with a preexisting condition, and they could be denied
preventative services because they couldn't pay for it.
What are we talking about here? The American people do not
want to see the Affordable Care Act repealed. They want fixes
to be made, but let us look at together in the way, in the
bipartisan way that this committee came together around
research under a John Porter or a Ralph Regula that come
together to say, how do we fix the problem so that, in fact, we
can ensure people the opportunity for some for the very first
time in their lives, first time in their lives, to have
insurance coverage or not being told that their kid couldn't
get insurance because they had asthma or were autistic? Let's
focus on what the direction of this country ought to be in
providing affordable health care coverage for this Nation.
That is what our moral responsibility and our obligation is
to do instead of carping. Let's not carp but fix together what
we can do for the benefit of the people that we represent. It
is not about you and me, and I say that to my colleagues on
both sides of the aisle. It is about the people who are not in
the Chamber. These are the people we came to represent. That is
what the Affordable Care Act is doing, is to represent the
people of this country.
I yield back.
Mr. Kingston. Mr. Fleischmann.
OPEN ENROLLMENT
Mr. Fleischmann. Madam Secretary, thank you for confirming
that you will not extend the open enrollment period for
individuals the way that you all delayed Obamacare requirements
for businesses.
Will you delay the penalties under the individual mandate
to give the people of the Third District of Tennessee and
across this great Nation the same reprieve that you have given
businesses? If you are considering delaying the penalties, what
is your legal authority to do so?
Secretary Sebelius. The penalty will be applied for people
who can afford insurance coverage who choose not to sign up
during open enrollment. They will be liable for a penalty when
taxes are due in 2015, as is stated in the law.
Mr. Fleischmann. Okay. Let me say this then. I want a
clarification. If an individual does not select and pay for a
plan by March 31, will they or will they not be assessed a
penalty?
Secretary Sebelius. Sir, as it states in the law, they will
be assessed a penalty when their taxes are due in 2015. That is
what the law says, and that is what will happen.
Mr. Fleischmann. Thank you.
AFFORDABLE CARE ACT
In my remaining time, I would like to respectfully respond
to my colleague's last response and remarks, and I appreciate
my distinguished colleague's passion about this issue. I also
have a passion about this issue. I was not in this great
austere body when Obamacare was passed. I was elected in 2010.
But I will say this. We did need health care reform in this
country. There is no question about that, but we did not need
Obamacare. One-sixth of our economy taken over by big
government. In all due respect, I run into people all the
time----
Ms. DeLauro. Will the gentleman yield?
Mr. Fleischmann. No, I will not yield at this time. People
come up to me all the time, higher deductibles, higher
premiums, more Federal control. This is not good health care
reform.
Yes, we could have, we could have dealt with the issue of
preexisting conditions. We could have dealt with some of the
provisions that most people approve, keeping children on your
insurance until age 26. But we did not need, Ms. DeLauro, we
did not need----
Ms. DeLauro. Would the gentlemen yield.
Mr. Fleischmann. I will not yield.
Ms. DeLauro. You are calling me into question, and I am
listening to your rhetoric.
Mr. Fleischmann. I call Obamacare into question. I call
this administration into question, and I call the disaster that
this has caused in terms of job creation, in terms of an
overreach of government authority, in terms of an
administration that appears to just basically piecemeal choose
what they want to delay and not delay.
So, Ms. DeLauro, I will stand with the people of the great
Third District of Tennessee and this Nation to look for other
alternatives other than Obamacare to solve this nightmare.
Thank you. I yield back.
Ms. DeLauro. It is unfortunate for the debate on Affordable
Health care that the other side did not come forward with any
program.
Mr. Fleischmann. I yield to the chairman.
Mr. Harris. Thank you very much.
No, actually, I guess of the members on this side of the
aisle, none of us were here. But our understanding was--and I
applaud you--on this side, none of us were here when this bill
was passed--and I applaud you for calling for bipartisan. But I
also urge you to remember one of the reasons why this bill is
failing is because it was not passed with bipartisan efforts.
Madam Secretary, I am going to follow up in the balance of
Mr. Fleischmann's time. On that question of the hardship
exceptions, is the Wall Street Journal report from Monday
morning incorrect in fact that all an individual needs to do is
just to claim that they feel that the insurance policy is
unaffordable and they will get a hardship exemption? Is it
incorrect, their research? I am sure you have seen it.
Secretary Sebelius. Sir, what we said----
Mr. Harris. Madam Secretary, are they correct or not?
Secretary Sebelius. If you had a policy----
Mr. Harris. No. I am not talking about someone who didn't
have a policy. That is not what the editorial said. The
editorial said someone who didn't have a policy.
Secretary Sebelius. The editorial was incorrect. It applied
specifically to people who were in the market who found their
new policy unaffordable so that they could qualify. These were
people who were insured, who wanted to keep insurance----
Mr. Harris. So their editorial was wrong? Is that correct?
In that rule, someone will not get a hardship, but you said
that if you don't have a policy, in response to Mr.
Fleischmann, that if they can afford it, they will get a
penalty.
Madam Secretary, where is the definition of who can afford
a policy? I never met someone who said they thought their
policy was affordable. Where is the definition? You said, and I
quote you, if they can afford it. What is the definition of
``affording''? And my time is up, so you can answer on my time.
Secretary Sebelius. I would be happy to send you the rule
as it stands, and I am----
Mr. Harris. You are going to have to answer that for me.
Secretary Sebelius. This was specifically dealing with
people who were in----
Mr. Harris. Ms. Roybal-Allard.
Secretary Sebelius. Dr. Harris, could I answer your
question?
Mr. Harris. No, you will have your chance my round. When it
comes up, you can finish answering. Thank you, Madam Secretary.
CDC FUNDING
Ms. Roybal-Allard. Secretary Sebelius, each year, the
Department's annual budget request for CDC is smaller than the
year before. For example, the President's budget request to
Congress for fiscal year 2011 proposed a core budget for the
CDC of $7,600,000,000. That was a billion dollars more than the
$6,600,000,000 that you request today, even before adding
losses for inflation. This 14 percent drop in the CDC's request
over the last 3 years is actually stunning, and it seems to me
that the CDC continues to at disproportionately suffer from
cuts compared to other HHS agencies. In fact, this year's
budget request put CDC's budget authority at levels lower than
2003 and includes mandatory prevention money allocated to the
CDC from the Affordable Care Act that was intended to do more
for the prevention than the core CDC activities.
Given that State and local health departments rely on CDC
funding to ensure adequate childhood immunization rates,
develop capacity to respond effectively to public health
emergencies and to build capabilities to track environmental
hazards, and given the fact that we are seeing old and new and
sometimes mysterious diseases starting to pop up throughout the
country, how will CDC continue to support these critical core
public health functions with the cuts proposed in your budgets?
And what has been the impact of these cuts on CDC's prevention
investments over the past 4 years, especially when you consider
that the public health fund mandatory spending was intended to
supplement prevention efforts, not to supplant the CDC core
budget?
Secretary Sebelius. Well, Congresswoman, I would say a
couple of things. Our discretionary budget for 2015 is over a
billion dollars smaller than the discretionary budget target
for 2014. So we start with the fact that we have to allocate
funds in a reduced budget environment, and we certainly share
the concern, as I can assure you so does Dr. Frieden, that the
efforts of the Centers for Disease Control and Prevention is
not only critically important as the backbone of public health
but is increasingly important in our global health initiative.
So we have tried to focus the budget on the areas that he feels
are top priorities.
Some of the program eliminations were due to duplication of
programs in other areas. Some are able to be reduced because we
anticipate that more people will have health coverage to pay
for services that an independent program would have paid for in
the past. And the services will go on; we just don't need the
money through CDC.
But I am pleased that this budget does focus on things like
increasing efforts in antimicrobial resistance, which is a huge
health fear throughout the health system in the United States
and throughout the world. And the CDC has incredible expertise.
We are launching a new global health security initiative, which
actually keeps the United States citizens safer and more secure
to build capacity for surveillance detection. Again, those are
areas that Dr. Frieden wants to focus new funding, and so he
has chosen to reduce some of the funding allocations.
I would finally say that you are absolutely right, that the
Prevention Fund was to not supplant old efforts but to enhance
prevention efforts. I am pleased to tell you that given
Congress' activity in 2014, those efforts will be dedicated to
prevention efforts, not used to backfill programs. And I think
that we would see that going forward in 2015. We have, again,
not suggested that the Prevention Fund be used to supplant CDC
funding.
Ms. Roybal-Allard. So are you saying that these cuts have
had no negative impact then on public health efforts?
Secretary Sebelius. I would say that all cuts have negative
impact, and certainly we saw during the shutdown the very
difficult time that a lot of public--you saw the real impact
that CDC had when they had to ask employees to stand down, and
that sent shock waves through States throughout the country. So
every cut has an impact, but we, as I say, have a billion-plus
dollars less to work with in 2015, and we are trying to be very
strategic about how those funds are moving forward.
Mr. Harris. Thank you very much.
Before I start my question, I am just going to comment. You
know, we have still I think five members remaining in the
second round. I know your time is valuable, so we have got to
keep it to exactly five minutes so that we respect your time
and your limitation here.
HARDSHIP EXEMPTION
So let me go ahead and let you answer the question that I
interrupted your answer before for time purposes. It has to be
very specific. When you said that if they can afford it,
someone who has never been insured before will get the penalty
on this year's taxes. That is what you said, if they can afford
it.
Secretary Sebelius. In 2015----
Mr. Harris. Correct.
Secretary Sebelius. The fee will apply.
Mr. Harris. And who decides if they can afford it?
Secretary Sebelius. There is a hardship exemption. If you
self attest----
Mr. Harris. So self attest--so the Wall Street Journal was
right on track then?
Secretary Sebelius. Sir, there are criteria in the bill.
There are nine categories.
Mr. Harris. I understand it. That is exactly what the Wall
Street Journal said, self attestation.
Secretary Sebelius. There are nine categories.
Mr. Harris. Now, Madam Secretary, let's talk a little bit
about some--first, by the way, I just want to make a comment. I
hope that you have the same enthusiasm for a non-medical-
marijuana-free generation that you have for a tobacco-free
generation. As you know, the Attorney General has decided not
to pursue, not to enforce the Controlled Substance Act in two
States. And I hope you agree with me that marijuana is at least
as dangerous as tobacco.
ABORTION
But let me go ahead and talk a little bit about some
transparency because I think Mr. Shimkus asked you back in
December about the transparency of whether or not you can
determine whether a plan on the exchange covers abortion. You
said all you have to go is to the summary of benefits to see
that. These are the summary of benefits of every exchange plan
in Maryland. None of them have an indication whether they cover
abortion in the summery of benefits. It is not transparent
whatsoever. I don't know if this is true in any other State.
All I know is, in my State, you can't do it. Do you believe it
should be fully transparent to the person visit being the Web
site?
Secretary Sebelius. I think it should be transparent. All
the benefits are.
Mr. Harris. Thank you very much. Now, and just so you know,
it is not transparent. So when you look at these Web sites and
provide oversight, please make sure, and this is not just from
us. I mean, Planned Parenthood of Northwest has made the same
complaint. It is very obscure. You can't tell.
Secretary Sebelius. I understand. I think people should
know what the benefits are.
Mr. Harris. We are going to agree. You see. We are going to
agree on something.
Now, let's go ahead a little further, though, and talk
about the billing because the Maryland insurance commissioner,
she has said that, in fact, the insurance companies don't have
to invoice separately for abortion coverage and non-abortion
coverage in plans that cover abortion. I mean, literally she
has said that. I assume that the plain reading of the law that
says there has to be a separate charge means that you actually
have to be able to determine a separate amount somewhere? Is
that correct? Is that your interpretation of the----
Secretary Sebelius. Again, I can't speak to what the
Maryland Insurance Commissioner said or didn't say, but I can
assure you we will follow the law in the Federal Marketplace.
Mr. Harris. But you actually have to oversee all the
exchanges, don't you, not just the Federal marketplace, don't
you?
Secretary Sebelius. Well, we have supervisory----
Mr. Harris. Correct. You do.
Secretary Sebelius. No. Sir, the States run their
marketplaces. They qualify the plans, but they have to follow
the law also.
Mr. Harris. Correct. If, in fact, the Maryland
commissioner, if, in fact, that is her determination, that
there doesn't have to be even a separate invoicing of it; that
that would, in fact, be a violation of the law.
Secretary Sebelius. I would be happy to take a look at what
she said and follow up with our team.
MARKETPLACE ENROLLMENT
Mr. Harris. I hope you do because, again, the reading of
the law is pretty plain to me.
Now, let me ask you a question because this was brought to
my attention by an insurance agent in my State. April 1 comes,
April 10, somebody sees a rerun of the, you know, ``Between Two
Ferns'' deal, and a young healthy patient says, you know, what,
the President convinced me; I want to go out, and I want to be
insured. Healthy young person, exactly the kind of person we
want on our exchanges. They can't, can they, in most States?
Secretary Sebelius. As any open enrollment, they need to
wait until November 15 when it opens again.
Mr. Harris. So we designed a system where that healthy 25-
year-old who wants to buy insurance on April 15 can't buy
insurance. Now, that is different, the system before--and I
agree with the ranking member, there was plenty wrong with the
system before. But I will tell you that on April 15, a healthy
young person could have gone out and bought a policy. So when
that healthy young person, God forbid, has an accident in
August--let me follow up--the individual market, and ranking
member suggests go to the individual market--those policies
can't be purchased, unless you have a qualifying event, those
policies can't be purchased, can they?
Secretary Sebelius. They can. Absolutely.
Mr. Harris. They can be purchased where?
Secretary Sebelius. They can be purchased outside the
Marketplace in the individual market. They cannot qualify for a
tax credit until the next open enrollment season, but they can
purchase an insurance policy at any time. They just can't use
the open enrollment through the Marketplace and qualify for a
tax credit.
Mr. Harris. And, Madam Secretary, in Maryland, it is not
available. In Connecticut, only one plan.
Secretary Sebelius. What is not available, sir?
Mr. Harris. That purchase of that policy for the
individual----
Secretary Sebelius. I don't think that is correct. I think
in every State, there are individual policies sold inside and
outside the Marketplace.
Mr. Harris. Mrs. Lowey.
Secretary Sebelius. Dr. Harris, if I might take a moment, I
want to correct a statement I made earlier to, even though
Congressman Joyce is not here. I have been told I misspoke. And
I did that unintentionally. The SHOP data enrollment is not in
the current enrollment report, but I will give him the
information that we have and send that up today, but I just
wanted to make that clear.
Mr. Harris. Thank you very much.
Mrs. Lowey.
Mrs. Lowey. Thank you, Mr. Chairman.
Before I ask the question, ranking member would like 30
seconds.
Ms. DeLauro. I thank the gentlelady. I think Mr.
Fleischmann has said that we shared the concern that the health
care system was failing people and that we needed to reform it.
Well, I would just like to mention to you that we had 6 years
of a Bush administration, where, if that was the case, nothing
was done to address it. We waited a 100 years to get an
Affordable Care Act passed. The majority today, as it did when
those of us who were here were going through this process, the
majority has no program, no plan, except to repeal it. If you
have a plan for dealing with affordable care for the people of
this Nation, I would please ask you to come forward with it and
just lay out what it is that you would do. I thank the
gentleman.
Mr. Joyce. Will my friend yield? Will my friend yield? But
I do have a plan.
Ms. DeLauro. No. Mr. Fleischmann would not yield to me, so
I have asked Mrs. Lowey if she would yield me 30 seconds.
Mrs. Lowey.
Mr. Joyce. Unanimous consent that it won't be charged
against you.
And I just want to make sure my friend, the ranking member,
said number one--unfortunately, I am going back and forth
between Defense, and I have got some issues across the hall, so
that is why I am not here, but when I come back, I will always
be happy to yield my friend time for a good spirited discussion
on any subject.
Mr. Harris. Thank you.
Mrs. Lowey, you are up. We stopped the clock for that.
Mrs. Lowey. Thank you so much.
And before I ask my question, again, I mentioned John
Porter and how we worked together in a bipartisan way. And as
with any large program, any large program, whether it is Social
Security and Medicare, there have been revisions. So I do hope
that we can be constructive, not only in these hearings but in
other discussions. And if there are specific changes that you
would like made, I do hope we can have healthy discussions to
amend it. You have seen that happen as we move along.
AUTISM
So I would like to ask a question about autism. It is
amazing. I go on an autism walk every year, and the numbers are
just increasing tremendously. As prevalence rates have
increased, and we know the rates have increased dramatically in
the last 20 years. There will be increased demands for services
for children and young adults. Could you share with us how the
budget request helps families and individuals with autism?
Secretary Sebelius. Congresswoman, I would say several
things. One is that if a family has a child or even an adult
with autism, that individual will now qualify for health
insurance, where they may not have in the past if that family
was in the individual market. That is a big step forward just
in terms of underlying care and being able to access it. There
is some very important research underway at the National
Institutes of Health. Autism is also one of the areas in the
brain mapping structure that will be focused on by the NIH, and
I think that bears very promising resources.
We also have an autism working group coming up with a
series of strategies and suggestions, everything from hospice
care and home-based relief care to strategies about community
events and enhanced research that is part of the ongoing autism
effort. So I would say there is basic underlying care. There is
additional research. There is additional funding. But, again, I
think the need is huge in this area. And as more identification
takes place of who all is in the autism spectrum, those numbers
grow.
Mrs. Lowey. So, in addition to the research, I do hope we
can get together, whether it is HRSA, the Institute of
Community Living, there is a lot that we have to do.
Is my time up? No? Okay.
Mr. Kingston. Fifteen seconds.
CDC FOOD ALLERGY GUIDELINES
Mrs. Lowey. Let me just say in the 15 seconds, I have been
working on food allergies, celiac disease, for a long time. And
I probably don't have time, but I hope you can share with me at
another time CDC's efforts to disseminate the voluntary
guidelines to schools and the Department efforts because it is
a really important issue.
Secretary Sebelius. Be happy to do that.
Mrs. Lowey. Child has an anaphylactic reaction, too often
too many people don't know what to do.
Thank you, Mr. Chairman.
Mr. Harris. Thank you.
Mrs. Roby.
ABORTION
Mrs. Roby. Thank you. Just a quick follow up on my first
line of questioning. There was an article that came out today,
the insurance industry takes issue with the administration's
claim that you do not have the information that I asked and
that you testified about yesterday. The insurance industry says
that they have a lot more information than they are letting on,
and they have real hard data about the percent that it paid.
And if the administration and if they have not processed those
yet and compiled the data, that is a choice they are making,
but they have the data. So the insurance industry obviously
takes a differing position than that of this administration.
But I have short time, and I have got another important
line of questioning that I want to ask. According to Paul
Bedard writing in the Washington Examiner last week, and I
quote, ``Planned Parenthood is going to bat for the White
House, hosting more than 500 events in 18 cities to get
Americans into the health insurance system. In eight States,
officials from the women's health and abortion provider will go
to grocery stores and even indoor soccer fields to enroll
people. It also plans to dispatch 500 canvassers and knock on
25,000 doors.'' Earlier this year, the New York Times reported
that Planned Parenthood is one of the most aggressive groups,
going door to door to enroll individuals into Obamacare. And
last year, we learned that Planned Parenthood affiliates
received at least 655,000 in navigator funds to help with
Obamacare enrollment. And I am sure you know Planned Parenthood
is the largest abortion provider in the Nation, carrying out
more than a quarter of all abortions in this country.
So I would like for you to tell us, has the 500 events, 18
city Planned Parenthood enrollment initiative that I mentioned
received Federal funds? And what is the total amount of
Obamacare-related funding that has been directed to Planned
Parenthood or its affiliates either directly or as a subgrantee
or subcontractor?
Secretary Sebelius. Congresswoman, I can get you the
information on the Navigator grants. I don't have that State by
State. Those were competitive grants of known community
organizations, and I am happy to provide that.
The activities that you talk about are ones that I assume
the organization is conducting. They have no funding from the
Federal Government. I do think that Planned Parenthood is a
provider of preventative care across this country. Over
6,000,000 people get cancer screenings and well woman checkups
and contraception----
Mrs. Roby. Could you please for this committee, because
this is a very important issue, could you please provide for us
at some date certain, you know, by end of next week and
guarantee us that you will give us an itemized list of each
grant or contract that has been made available to Planned
Parenthood or a Planned Parenthood affiliate under Obamacare?
Secretary Sebelius. I can give you the Navigator grants,
which as I said, were competitive grants in communities across
this country.
Mrs. Roby. If you can give that to us, that would be
helpful.
HEALTH INSURANCE COVERAGE
Secretary Sebelius. Yes, ma'am.
Mrs. Roby. According to April 12, 2010, edition of the New
York Times, President Obama agreed to volunteer to enroll in a
health insurance exchange. For the record, will you tell us
what political appointees at HHS have enrolled in the health
insurance exchanges?
Secretary Sebelius. Well, I think you will be pleased to
know that I don't access people's personal information, and so
I cannot give you that information, nor will I ask anybody
about their information. Their employee coverage is paid for as
part of the Federal plan. The Marketplaces are for people who
don't have coverage in the employer market.
Mrs. Roby. The point is, Madam Secretary----
Secretary Sebelius. If you have affordable employee
coverage, I assume they will stay where they are.
Mrs. Roby. The point is this, if it is good enough for the
American people, it should be good enough for political
appointees.
Secretary Sebelius. It isn't about political appointees. It
is people who don't have affordable employer coverage. Federal
employees, State employees, have affordable employer coverage,
and they would not access the Marketplace.
Mrs. Roby. We today have spent time, and we have differing
opinions, obviously, but we have spent time today pointing out
deficiencies that we see in this law. And, again, I think it is
important for the folks back home in Alabama and people all
over this country to know that the Federal Government is not
exempting themselves that they mandating that the American
people have.
Secretary Sebelius. Again, no one in Alabama who works for
one of the new auto factories who has an employer-based plan
will be accessing this Marketplace. No one who works for city
or county government will access this plan. This is for people
who didn't have employer coverage, affordable employer
coverage, and they now have an option.
Mr. Harris. Thank you.
Ms. Lee.
AFFORDABLE CARE ACT
Ms. Lee. Thank you very much, Mr. Chair.
First, let me just say to you, Mr. Chair, and others who
made a comment about the Affordable Care Act not being
bipartisan or receiving one Republican vote. I, during that
period, chaired the Congressional Black Caucus and led many of
our efforts--and, Mr. Chairman, I want to mention this--led
many of the efforts on the negotiations on the Affordable Care
Act.
Much to my disappointment, our leadership and the President
accepted many Republican suggestions in the Affordable Care
Act, one by one by one. Not one single vote on your side. So I
can't sit here and let you say that you didn't get, we didn't
get bipartisan support when, in fact, the President and our
leadership reached out, incorporated many of your suggestions.
And you all still didn't vote for it, and I was there. I saw
this go down, and I think many of us understood what was taking
place. And I was very disappointed, but in the spirit of
compromise, we went along with it.
SEX EDUCATION
Let me say to you, Madam Secretary, I want to commend you
and the administration, based on what we are seeing as it
relates to HIV and AIDS and other sexually transmitted
infections, as it relates to young people in terms of
preventing teen pregnancy. I want to just see how does the
budget reflect this ongoing commitment because I think you all
are doing a really good job in developing comprehensive sex
education for young people.
LIMITED ENGLISH PROFICIENT POPULATIONS
And then, secondly, I serve as co-chair of the
Congressional Asian Pacific American Caucus, and of course, we
have been dealing with this issue as it relates to inadequate
translation services provided to limited English proficient
populations, both in the translated applications, as it relates
to the Affordable Care Act, the call centers, given that there
are so many different languages. And so how does this budget,
you know, help address the issue of linguistically appropriate
services in health care and the exchanges and to get the
information out and to help those who need to understand how
this works.
Secretary Sebelius. Let me take the last part first. We
share your concern that this is a very diverse and rich
country. Based on its diversity and having language-appropriate
information is essential. So the call center can answer
questions in up to 150 languages. We have printed paper
applications in five languages. That is not enough, and we are
looking at what resources we might need to expand the paper
application process so that we could have more printed
applications available.
The website as you know, is available in Spanish and
English. Again, one of the goals is to look at how culturally
diverse the website could be. It would be, I can guarantee you,
virtually impossible to have the Website in every language that
is spoken in this country. So having translators available,
having a variety of help available is one of the things.
We are also looking at how we diversify our Navigator force
on the ground, so even if you can't go to the Website in your
native language, you may be able to have someone on the ground.
All of those are underway. And with the resources available, we
are trying to take that very seriously, gathering information
from what we know now where the highest problem areas and where
the markets are.
I would say in the HIV/AIDS area, you know that having a
National Strategy is a first time for any Administration. It
never has occurred before. We are taking that very seriously,
focussing resources on the high-risk populations at high-risk
and the communities at high-risk and certainly testing,
treatment, and access to ongoing treatment are the three areas
we are refocussing on, trying to get rid of some of the stigma
around testing but also making sure that people are routinely
screened and come forward and then connecting them to treatment
and keeping them connected to treatment, because that is a very
effective life-saving strategy.
POVERTY
Ms. Lee. And finally, and I have a few more seconds. I just
want to say that this subcommittee really is the subcommittee
that can address issues as it relates to poverty and income
inequality. We passed several amendments to all of our bills
talking about and laying out our efforts to reduce the
existence of poverty. So I hope in this budget, we can see some
antipoverty ladders of opportunity, provisions, and a way to
really address income inequality through your agency.
Mr. Harris. Thank you.
Mr. Stewart.
Mr. Stewart. Yes, Mr. Chairman, and I understand you would
like me to yield you 30 seconds.
Mr. Harris. Thank you very much for yielding 30 seconds.
AFFORDABLE CARE ACT
Madam Secretary, in response to the last answer that you
can buy insurance on the individual marketplace after March 31,
you ought to tell USA Today, Kaiser Health News and AARP, all
publications that say you can't do it in the individual market
or the exchange after March 31.
Yield the balance of that time to Mr. Stewart.
Mr. Stewart. Thank you, Mr. Chairman.
Madam Secretary, I admire your courage. I really do. I
think you have this incredibly difficult task of defending this
law before the American people, and I am so glad that I don't
have to do that. I was a small business owner. I know how
difficult it used to be and how hard we worked to provide
adequate insurance for my employees, but I am telling you, this
is worse. In many ways, it is much worse, and the American
people know it. The health insurance program that we had before
in country wasn't perfect. I don't think anyone has ever
claimed that it was, but the vast majority of Americans were
satisfied, which is why we told them, or the administration
told them: If you want to keep your doctor, you can keep it. If
you want to keep your health insurance, you can keep it. And we
now, of course, know that that is not true. Much of that turned
out not to be true as well, of other specifics of this law.
I would like to talk just quickly about the innovation
centers, which and I am quoting, they are created to provide
innovative payment and service delivery models to reduce
payment expenditures. Essentially, they are there to review and
to fund grants. In 2011, there were only 68 FTEs that were
involved with the innovation centers. This year, there is going
to be 450, which seems like an awful lot of people to review
and to, you know, streamline this process of granting these
government grants. Can you assure the committee that there is--
none of these employees in the innovation centers are involved
in the marketplaces?
Secretary Sebelius. Congressman, there is no involvement of
the Innovation Center in the Marketplace. There is one
Innovation Center--it is a center in the agency of Centers for
Medicare and Medicaid Services. It is funded through the
Affordable Care Act.
And I would say, for the first time, we have a research and
development arm aimed specifically--and it isn't about the
Marketplace at all. It is aimed specifically at how quality can
be improved and costs can be lowered for Medicare and/or
Medicaid programs, the big public programs run by CMS. That is
what the aim is.
I think the work that they are doing will benefit everyone,
even if you are not in Medicare and Medicaid, because things
like lowering hospital-acquired infections, looking at
preventable readmissions, looking at elective deliveries that
could cause long-term harm to infants, those kinds of efforts
are very much under way. But it has nothing to do with the
Marketplaces.
Mr. Stewart. Okay. And, as well, you can assure us, then,
that they are not involved with the implementation activities
of Obamacare?
Secretary Sebelius. That is correct.
Mr. Stewart. Okay. Thank you.
In recognition of the shortness of time, then, Mr.
Chairman, I will yield back my last 30 seconds.
Mr. Kingston. Mr. Womack.
AFFORDABLE CARE ACT IMPLEMENTATION
Mr. Womack. Thank you, Madam Secretary, for your testimony
here this morning. I apologize for being late. I am sorry, I
missed a lot of it.
But at a House E&C hearing back in November, Henry Chao,
the CMS Deputy CIO who oversaw technical development of the
exchanges, said there were some back-office functions that were
not complete yet.
And I want to go straight to an issue that is relative to
my district specifically. I have the largest home of
Marshallese population in the United States. Many of these
individuals have Medicaid-qualifying incomes, but, as a COFA
migrant, they are not Medicaid-eligible. However, they are
eligible for the premium subsidy under the Affordable Care Act.
But, as I understand it, their applications are being kicked
back and forth between the State, which cannot provide Medicaid
coverage, and the exchange, which cannot process the
applications, ultimately bouncing the applications out of the
system on the back end.
And I know the Arkansas insurance commissioner has sent
word to D.C. that they have this problem. So I am asking, are
the back-office operations and IT support functions fully
operational and secure?
Secretary Sebelius. Sir, we are in the process of testing,
State at a time, all of the Medicaid inbound and outbound. They
are built, and each State has a slightly different system. What
we are finding in some States--and I can't tell you off the top
of my head if Arkansas is one of them--that the State is not
able to receive the automated account, so we are doing a more
manual workaround.
But we have a very high priority to make sure that people
who are eligible get enrolled in a timely fashion, and we will
do that.
Mr. Womack. Can you give us a timeline?
Secretary Sebelius. Of enrollment?
Mr. Womack. When these functions will be operational, when
you can get back to Jay Bradford and say----
Secretary Sebelius. They are operational now at the Federal
level, both outbound--so if someone comes to the Federal Web
site and appears to meet the State qualifications for Medicaid,
they are automatically sent to the State. Some of the States
can receive that automated information now. Some States do not
have the capacity to do that, so they are sent a paper file
application. When someone comes to the State and appears to be
qualified for the Marketplace, they are referred the other way.
So the automated functions now are built. We are testing a
State at a time to make sure that they can receive back and
forth.
Mr. Womack. Would it be an unreasonable request to have
somebody from your office contact the Arkansas insurance
commissioner----
Secretary Sebelius. Not at all. I would be happy to.
Mr. Womack [continuing]. And close that loop?
Secretary Sebelius. Sure. Absolutely.
Mr. Womack. Okay.
MEDICARE ADVANTAGE
And then, finally--and I know I am closing and you have a
hard time to be out of here--the President's budget, released
last week, proposes nearly $35 billion in additional Medicare
Advantage rate cuts over 10 years. And it is a huge thing for
my district, as it is for a lot of people.
Can you guarantee my constituents that they won't lose
their Medicare Advantage plans?
Secretary Sebelius. Absolutely.
Medicare Advantage, I think, Congressman, is a very
positive story with the Affordable Care Act. The allegation--
and it has already been said that many of the Members were not
here in 2010. The allegation was that if you pass the
Affordable Care Act, you will destroy Medicare Advantage, no
one will have a choice, it will be gone. Just the opposite has
happened. Enrollment is up 30 percent. Premiums are down almost
10 percent. More enrollees are in higher-quality plans than
were in 2010. We have seen a very positive growth in the plan;
we anticipate that will continue.
What is happening, though, is insurance companies are no
longer being overpaid based on the care that they are
delivering. The fees are closer right now to a fee-for-service
in Medicare. And so I think that we see that progress
continuing.
Mr. Womack. I thank the Secretary.
Thank you, Mr. Chairman.
Mr. Kingston [presiding]. Thank you, Mr. Womack.
Madam Secretary, we appreciate your being here today. I do
want to close with a few quick question, and we can do those
for the record.
And Members will have 2 weeks to submit further questions.
[The information follows:]
The transcript record states that ``Members will have two
weeks to submit further questions.'' There does not seem to be
an actionable insert located here?
AFFORDABLE CARE ACT OUTREACH
Mr. Kingston. I am concerned about the advertising budget.
I think it is about $770 million. And yet it will be past the
enrollment period, so I am not sure why it needs to be so high.
Secretary Sebelius. Sir, I don't really--I wish we had $770
million of any kind, but I don't know what----
Mr. Kingston. It is the Consumer Information and Outreach,
so maybe----
Secretary Sebelius. That is the office--that is not
advertising.
Mr. Kingston. Okay.
Secretary Sebelius. The Consumer Information and Outreach
Office is the office that actually manages the entire
Marketplace program, both at the State and Federal level. Those
are employees in the Marketplace functions, but that is not an
advertising budget.
Mr. Kingston. Okay. I am still concerned as to why we need
that, but, you know, we will follow up with some questions.
Secretary Sebelius. I would be happy to give you
information----
Mr. Kingston. Yes.
Secretary Sebelius [continuing]. About what they do. That
is the third big center in the----
Mr. Kingston. Also, Ms. McCollum and I have been critical
of some of the military recruitment ads as being ineffective.
And I am always suspicious when I see Federal Government ads
anyhow. One that caught my eye, and, frankly, as a male, it was
very offensive, as the father of two sons, the ``bro''
insurance ad for health care. I am not sure if that was a
Federal ad or one of the State exchange ads----
Secretary Sebelius. It was not a Federal ad.
Mr. Kingston [continuing]. But it had young men doing
handstands on a keg of beer.
And so I am just interested, and I will follow-up with you,
in terms of how effective some of these ads are and what kind
of metrics you use. Because we have found with some of the
military ads, they did not have metrics that showed the
effectiveness of it.
Secretary Sebelius. I would be happy to share with you what
the CMS folks found in focus groups and others, in terms of the
advertising. But the ``bro'' ad is not ours.
Mr. Kingston. Okay. Because I know there was another one
that was not yours also that they had in Colorado.
The other thing, getting back to Ms. Roby's question about
political appointees and Obamacare, the President did sign up,
very visibly, on December 23rd about it. And I think that what
the concern is Congress has had a lot of public input on
signing up Congress, signing up our staffs, subsidies for them.
And so I think the question is--and I will submit it to
you--is on political appointees in general and their staffs.
I also wanted to ask you how navigators get rated, in terms
of their effectiveness.
MARIJUANA
And then, switching gears--and, Rosa, I don't know if you
saw this, but Patrick Kennedy was on TV, and he is, you know, a
former colleague of ours. He had, very publicly, some drug
issues, drug addiction issues. And he is very concerned about
marijuana.
And one of the things he said that caught my attention is
that the States are getting so many tax revenues, and there is
so much profit in it, and he said, yet, their natural market is
going to be teenagers, and they are going to make sure that it
is very attractive to teenagers.
And so, as we go through this murky water of State laws
changing, contrary to Federal laws, it is something that I
think your agency needs to be very concerned about.
And then, kind of getting back to what Dr. Harris said is,
you know, is there a position of Health and Human Services that
medical marijuana, or marijuana in general, is more harmful
than tobacco?
Secretary Sebelius. Well, I would be happy to get you--we
certainly have done a lot of research and a lot of information,
and I would be happy to get that to you.
I can tell you that there certainly are harms and some
long-term brain harms that go along with smoking marijuana over
a period of time that have been clearly documented. There is a
lot of public health information.
But I would also tell you that there is no comparison in
terms of health risks for someone who is smoking tobacco and
addicted to nicotine versus marijuana, in terms of cancer and
death and secondhand smoke.
So there are dramatic health differences, but I would be
happy to present the information.
TOBACCO
Ms. DeLauro. All I would just say with regard to that, Mr.
Chairman, is--and I did a press conference on these new e-
cigarettes and e-hookahs. That is an area that we ought to be
trying to focus on, where the tobacco industry, the way they
market it to 12-year-olds for cigarettes, because that was
their new market, they are now marketing again to 12-year-olds
for e-cigarettes and e-hookahs.
But the information was 480,000 people die every year from
a tobacco-related illness. Now, we went to war in Afghanistan
with the 3,000 and almost 4,000 people who died, and yet we
continue, when we can prevent these deaths from tobacco.
Thank you.
Mr. Kingston. The marijuana thing is--just when I heard
Patrick talk about it, it really caught my attention.
But thank you very much for your time, and thank your
staff.
Secretary Sebelius. Thank you, Mr. Chairman.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Wednesday, March 26, 2014.
BUDGET HEARING--FUTURE OF BIOMEDICAL RESEARCH
WITNESSES
FRANCIS S. COLLINS, M.D., PH.D., DIRECTOR, NATIONAL INSTITUTES OF
HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
HAROLD E. VARMUS, M.D., DIRECTOR, NATIONAL CANCER INSTITUTE
ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES
STORY C. LANDIS, PH.D., DIRECTOR, NATIONAL INSTITUTE OF NEUROLOGICAL
DISORDERS AND STROKE
GARY H. GIBBONS, M.D., DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD
INSTITUTE
Mr. Kingston. Well, the hearing will come to order, and I
welcome the NIH team today and welcome all the committee
members to this hearing on biomedical research and the public
health budget. And, Dr. Francis Collins, you know that this
committee supports biomedical research. We support the NIH and
the good work that you are doing.
I kind of have two ongoing discussions with you, as you
know it. Number one, I do not think we really tell the story as
well as we could about what NIH has done, and I always wish
that you would just come in here with a table full of displays
and assortments of things that you have invented and lives you
have improved.
You know, I have said many times that I wish all of America
knew about the 1 percent reduction in cancer rate in the last
several years and how that saves $500 billion a year to the
taxpayers. I do not think we brag enough about what has
happened with AIDS in Africa in terms of the reduction of that.
And I do not think we brag enough about polio, and I know that
is partly NIH and CDC and a lot of other efforts. But there are
so many things that have gone on that I think we need to brag
about it more.
And the other part, which is maybe the yin and the yang,
you might say, is the pushback that we get particularly from
the conservative side of public side in terms of how some of
those grants end up with questionable grantees. And you may
remember last year Dr. Harris brought up a $7 million grant to
a group in California that wanted to make a determination of if
a Tea Party was receiving tobacco money or not. And while
somebody might want to know that, I want the money going into
the cure for cancer.
You know, and in some of our discussions you have said,
well, you know, 33,000 grants, we cannot control all of them.
But, you know, I would say also when we are spending tax
dollars, if I went over to the Library of Congress and just
tore up one of the books, one of the millions of books that are
over there, it would still be egregious. And so, I think we
have to have zero tolerance when it comes to frivolous grants.
There are some other examples, and I will just list them,
and we have had discussions about this. But the influence of
personal responsibility rhetoric on public health, the impact
of New York City's sugar sweetener beverage policies on
calories purchased and consumed, a randomized trial of internet
access to nicotine patches, research ethics education in the
Balkans and Black Sea countries, capturing the content of
adolescent Facebook communications, experimental design of a
social security system in the Yucatan, cigarette smoke
detecting underwear, public health education campaigns in
China. And so, you know, to me the question is not completely
on the merits of this research because I can understand how
some people somewhere would want to know about the social
security system in the Yucatan. But the reality is it does not
have to do with biomedical research.
And so, what we need to do as good stewards of taxpayers'
money is what I have said so many times to you publically and
privately, and I think you and I are on the same page, is I
want the money to go to the scientists with the white jacket in
the lab finding the cure to the next world-changing cure, you
know, disease or whatever that we can be ahead of. And I have
also said to you part of it is helping me help you. And when we
get the pushback on these other things, then it hurts our
ability to help you.
The other thing that I wanted to mention is when people
come into our offices, which they do all year long, and they
are absolutely always welcome. But so often they know about
your budget, but they do not know about the $800 million tap,
which this Administration takes out of the NIH. After we have
appropriated the money, this Administration assesses you $800
million and actually wanted to assess you more.
And the thing about these grants is if you do a grant to a
group that we do not necessarily like or maybe we do like,
maybe we embrace, maybe we denounce. But it is transparent. The
tap money that goes back to Health and Human Services, it is
not transparent, and we do not know what happens to that money.
Not that that is your responsibility at all, but I do wish that
in the advocacy family of NIH, people would realize that the
tap does take $800 million out of money that we appropriated to
you. So I wanted to say that.
Ms. DeLauro, I want to yield to you and Ms. Lowey. Well,
let me go ahead and yield to you, and then I will introduce the
panel, if that is okay. All right? Thanks.
Ms. DeLauro. Thank you very much, Mr. Chairman. I would
just say one comment before I make my statement, actually two
very short comments. I think with your comment with the regard
to the grant and the lobbying connection, I think it is
important to note that the OIG, the Office of the Inspector
General, at HHS said in response to the letter that you wrote,
and they wrote back on September 9th, ``In our review of the
records for these four grant awards, we found no evidence that
the grants violated prohibitions on the use of Federal funds
for lobbying, publicity, or propaganda.'' I think that ought to
be part of the record.
Ms. DeLauro. And sometimes with regard to research, I know
when I sat on the Ag Committee--I still sit on the Ag
Committee, but I was both ranking member and I was chair of
that committee. When someone said to me we were going to do
research on the glass-eyed sharpshooter, I said and what could
that be research on? Well, if you talk to any of the vintners
all over the Nation, the glassy-eyed sharpshooter destroys
vines and grapes, et cetera, which destroys an industry. So
sometimes just to the eye of the observer, it is not always
what it appears to be. And though it would be good to express a
view on what some of that research is about and how it comports
with the kinds of research that is important.
Let me just say thanks, Mr. Chairman, and good morning.
This is thrilling, it really is, and I think I may have said
this in the past--Dr. Collins, director, Dr. Varmus, Fauci,
Landis, Gibbons--and to talk about the 2015 budget for the NIH.
I am a Yankees fan, and so I will transpose this phrase. It
used to be when it was DiMaggio and the rest of the folks, it
was Murderers Row, but I would say that this is a savior's row
that we have here this morning. So thank you so much for your
insights, for your expertise, for all that you do every single
day in saving lives. And you push the frontiers of medical
science.
You all do know that I am a cancer survivor. It is 28 years
actually this month, March, cancer free, and I am here by the
grace of God and biomedical research and the work that you do.
So I am in awe of what you do. The work supported by NIH saved
my life as it has saved countless other lives. So as we discuss
the issues today, I hope the subcommittee will not just look at
the budgetary costs of NIH programs, but also the huge costs to
our health, our society, and our economy, and even to knowledge
itself if we fail to invest in health research and disease
prevention.
The simple fact is the scientific and medical breakthroughs
supported by NIH have allowed millions of Americans, myself
included, to live happier and healthier lives. Because of this
life-saving research, we have seen dramatic reductions, as the
chairman pointed out, in heart disease, stroke fatalities. The
5-year survival rate for childhood leukemia has risen to 90
percent. Fewer than 50 babies are born with HIV a year in
America. We now have a cervical cancer vaccine.
NIH has given us all of this while growing our economy at
the same time. Every dollar that goes to NIH grants results in
$2.21 of local economic growth. It is over a 100 percent return
on the investment. Discoveries arising from NIH funded research
are the foundation for our entire biomedical industry. That
vital sector exports an estimated $90 billion in goods and
services annually. It employs one million U.S. citizens with
wages totaling an estimated $84 billion.
Just consider the economic benefit of one NIH supported
research initiative. Our $4 billion investment in the human
Genome Project spurred an estimated $796 billion in economic
growth from 2000 to 2010. It is a 141-fold return on our
investment. I cannot say enough to you, Dr. Collins.
Congratulations on the triumph. And I do not want to even think
of what we would be doing and where we would be without the
Genome Project.
Given the priceless value of better health and longer lives
for so many Americans, as well as the amazing rates of return,
ensuring that the NIH is adequately funded should be a
fundamental priority for this subcommittee. It is why we came
together in a bipartisan way to double the NIH budget 15 years
ago. And yet recent budget policies have been shrinking NIH.
Its total funding is now $700 million less than it was before
sequestration, $1.2 billion than it was just 4 years ago. Only
58 percent of the deep sequester cuts were restored in the 2014
budget.
When adjusted for increasing costs of medical research, NIH
has lost more than 19 percent of its purchasing power since
2005, and here again, NIH is being forced to do less with less.
And if our allocation is not increased, it will be much harder
to do right by the NIH and all of our other priorities moving
forward. The cuts have a direct, devastating impact on
innovative medical research that saves lives, that boosts our
economy.
NIH estimates that it will be able to support over 2,000
fewer research project grants in 2014 than it did in 2012, and
over 5,000 fewer grants than in 2004. Ten years ago, NIH was
able to fund almost 1 out of every 3 applications for research
grants. Now that ``success rate'' is down to less than 1 in 5.
Understand the loss. Cutting medical research is an
incalculable loss: the discovery of fundamental knowledge about
how we grow, how we age, how we become ill. And that may be
dramatically slowed down, and so, too, may new treatments for
the prevention and treatment of disease.
Biomedical research gives us the gift of life. That is what
the NIH represents. I hope and I trust that we will keep that
in mind as we consider how we move forward today. Thank you
very, very much, Mr. Chairman. And particularly thank you to
all of our witnesses this morning.
Mr. Kingston. No passion.
[Laughter.]
Mr. Kingston. Ms. Lowey.
Ms. Lowey. Thank you, Mr. Chairman. Thank you, Madam
Ranking Member. We have been sitting together on this panel for
a very long time, and I often say to my good friend I feel a
little guilty. You are coming here to answer our questions and
respond when you really should be doing so much more important
work in your individual laboratories, your offices. And we
thank you for your brilliance and your contribution. Thank you
for being here.
I must say there is no agency that I am prouder to support
than the National Institutes of Health. My top priority in this
subcommittee is to increase investments in biomedical research.
In fact, I saw you the other night, Dr. Fauci, at Research
America, and John Porter spoke. And we remember when he took
the lead on the other side of the aisle. We worked together to
double investments in biomedical research.
This has never been a Democrat or Republican issue. We have
all worked together. Maybe we will do it this year, Mr.
Chairman, again, and then you can be honored by Research
America. It was a wonderful, wonderful evening. Years ago we
did this. It was, as I mentioned, bipartisan, and it
substantially increased our investments. Not only does the
NIH's work lead to future improvements in quality of life, it
is also an economic engine with every dollar generating 2.2 in
economic activity.
And I recall, Mr. Chairman, those days before we had a
budget, before we were able to work together. And I spoke to
some people in some of the labs in our major institutions that
are doing research funded by the National Institutes of Health.
And they were saying those labs are really at a standstill, and
a lot of the best and the brightest kids were not signing on.
They went off to Google probably or someplace else in the
private sector because they did not know when the next grants
were coming, and this is really key. And I always remind all my
friends that investments in the NIH is an economic engine as
well with every dollar generating $2.21 in economic activity.
So if we want to remain a global leader, we must make
research and development a priority. Germany's federal
investment in health R&D has increased by 60 percent since
2005. A number of others are accelerating investments. This is
consistent with overall research and development spending. In
the last 10 years, U.S. expenditures as a share of economic
output have remained nearly constant while China's has
increased nearly 90 percent, South Korea's nearly 50 percent.
We cannot afford flat budgets that hamper innovation.
Mr. Chairman, I had an interesting chat with one of the
scientists in my district. It was a small laboratory, three of
them, and they went over to China just to see what was going
on. They were offered a laboratory--I do not know if they are
as brilliant as any of ours--with 45 scientists, a whole
equipped lab. And this is what China is doing to try to
increase their investments in their NIH.
So, Mr. Chairman, we cannot afford flat budgets. I am in
awe of the brilliant leaders here today, and I thank you so
much for having this hearing. I yield back.
Mr. Kingston. Thank you, Ms. Lowey, Ms. DeLauro. Do any
other members wish to have an opening statement?
[No response.]
Mr. Kingston. If not, I will go ahead and introduce our
very distinguished panel. Dr. Harold Varmus, who is no stranger
to the Hill. He is now the director of the National Cancer
Institute, and a Nobel laureate, and the former director of the
NIH. And I guess we are skipping around--Dr. Landis--I'm not
sure why. Dr. Fauci, National Institute of Allergy and
Infectious Disease, we are glad to have you here. And back to
you, Dr. Story Landis, director of the National Institute of
Neurological Disorders and Stroke, and Dr. Gary Gibbons,
director of the National Heart, Lung, and Blood Institute. And,
of course, Dr. Collins, Francis Collins, the Director of NIH.
We stick with the 5-minute rule here, and so whether you
are speaking or whether committee members, the clock is blind,
and so we are going to adhere to that. However, Ms. DeLauro and
I find that sometimes spilling over that, there are some
advantages of it. And I would like to ask unanimous consent to
just, because I have already seen your testimony, and I have to
go, as I had explained to you earlier, to two other hearings.
But if I could ask the committee for unanimous consent to cross
examine the witness before. I just want to have a question. Are
we okay with that?
HUMAN GENOME DEMONSTRATION
Do you have the human genome demonstration in your pocket
that you sometimes carry?
Dr. Collins. I do.
Mr. Kingston. I did not see that in your testimony. I am
extremely happy that you brought that. And maybe before I
leave, you can explain--that is not in your testimony.
Dr. Collins. It is not because there is so much that I
could say.
Mr. Kingston. Okay. Well then, this is my unanimous request
to the committee. Could you explain that because that is the
kind of see and tell thing members of the public need to know
about. And so, before I leave, I would like you--and this will
not count against your 5 minutes.
Dr. Collins. Would you prefer that I do that first or give
the statement?
Mr. Kingston. I would love to hear it now because I am very
excited about it, and I am sure Rosa and Ms. Lowey have seen
it, but I do not know if the rest of you all have seen this.
And he is not going to say this, but he was actually the one in
charge of the project that mapped the human genome.
Dr. Collins. And, Mr. Chairman, that was an amazing ride, I
can tell you, to have the opportunity to oversee an effort,
which when it was first started in 1990, many people thought
was a little bit too ambitious, and maybe not something that
could be achieved in a 15-year period. But we did it. In fact,
we got that project done ahead of schedule and under budget,
and I am glad to say with Federal funds involved. And you
already heard the way in which this has paid off economically
with 141-fold return on that investment in terms of what has
happened since 2003.
But one of the things that has happened is this continued
amazing set of advances in the technology, much of which has
been stimulated by a grants program through the Genome
Institute at NIH to try to encourage people to come up with
ever-faster, cheaper, better ways to do DNA sequencing. And
that has gotten us in the space of this 10-year period from the
cost of a human genome running at about $400 million now to
this year an announcement by one of the companies that is
making these machines built upon NIH technology that they can
do it for $1,000. And that has been sort of this mythical goal
that you would get to the $1,000 genome, and 2014 seems to be
the time where that has happened.
This particular gadget I am holding is a DNA sequencing
machine that uses very micro-scale technology, as you can
imagine, and allows you to sequence a complete human genome in
the space of about 2 and a half days. This fits into a larger
machine that actually does the read out, but this is it. You
put the DNA sample in. You add re-agents to these ports, the
chemical, and enzymatic reactions are carried out. The letters
of the DNA code, A, C, G, and T, are read out, and there you
have it.
Imagining going from sequencing machines the size of a
phone booth or even bigger to this is, I think, a wonderful
testimony to American ingenuity and to the opportunity for the
Federal government to be really entrepreneurial to make these
kinds of things happen in partnership with the private sector
and all that they can do to make those dreams happen.
So thank you for asking about it. It is a great story to be
able to tell.
Mr. Kingston. Thank you, and I yield back. And you may
begin your testimony.
Summary Statement of Dr. Francis Collins
Dr. Collins. All right. Thank you. Well, good morning
again, Chairman Kingston, Ranking Member DeLauro, members of
the subcommittee. And I am not going to read my written
testimony, but a shortened version of it.
It is a great honor to appear before you. This panel has a
long history of supporting NIH's mission to seek fundamental
knowledge and apply it in ways that enhance human health,
lengthen life, and reduce suffering. NIH and millions of
patients are truly grateful for your leadership.
First, my colleagues and I would like to thank you for the
recent Fiscal Year '14 Omnibus Appropriation for NIH. This
subcommittee came together in a bipartisan way to reverse the
downward spiral of support for NIH that has cost us almost 25
percent of our purchasing power for research over the last 10
years. While difficult trade-offs made it impossible to reverse
completely the devastating effects of that sequester, we are
gratified it was at least possible to turn the corner this
year.
Thank you also for holding this hearing today. Indeed, the
future of biomedical research, the title of this hearing, has
never been brighter. And my colleagues and I look forward to
discussing a few of the many opportunities that lie ahead.
In recent years, we have made tremendous strides in our
understanding of human disease. Basic science has led the way.
Advances in genomics, proteomics imaging, and other
technologies have led to the discovery of more than a thousand
new risk factors for disease and biological changes that may
serve as future therapeutic targets.
But still, we must do more than aim to just understand
disease. We must find new ways to treat and prevent it. As just
one example, NIH-funded scientists are well on their way to
developing a universal influenza vaccine. Such a vaccine would
not only eliminate the need for an annual 'flu shot, but would
also provide protection against outbreaks, like the H5N1 and
H7N9 events in Southeast Asia that are causing considerable
concern right now.
Another major challenge is exploring what has been called
biology's final frontier, the most complicated structure in the
known universe, the human brain with its 86 billion neurons. As
you know, NIH is leading the brain research through advancing
innovative neurotechnologies--that is an acronym, BRAIN
Initiative--and we are grateful for your support. This
initiative will provide a foundational platform for major
advances in Alzheimer's disease, autism, schizophrenia,
traumatic brain injury, epilepsy, and many other brain
disorders.
A third area of scientific opportunity I want to highlight
today involves one of our Nation's biggest killers, cancer.
Until recently, our weapons for attacking cancer have been
largely limited to surgery, radiation, and chemotherapy, all of
which can be effective, but carry risks. Recent advances have
given us insights into the intricate workings of the cancer
cell using genomic tools, for instance, and a whole new
generation of targeted therapeutics is emerging, ushering in an
era of individualized precision medicine.
Furthermore, and this is very hot stuff, we figured out a
way to harness the body's own immune system to fight this
dreaded disease. In one of those new approaches, certain types
of immune cells, called T-cells, are collected from cancer
patients and engineered to produce special proteins on their
surface. When these engineered T-cells are infused back into
patients, they have the power to seek and destroy cancer cells.
Now, knowing how to turn T-cells into little Ninja warriors
required big investments in basic biomedical research over more
than a decade. But promising results in both adults and
children with leukemia led Science magazine to name cancer
immunotherapy as the 2013 breakthrough of the year, not just
for the U.S., for the whole world; not just for biomedical
research, but for all of science.
One patient who volunteered for this experimental therapy
is Doug Olson of Pipersville, Pennsylvania. Doug was diagnosed
with chronic lymphocytic leukemia at the age of 49. After four
rounds of chemotherapy over more than a decade failed to induce
remission, his only option was a bone marrow transplant, a
risky procedure with a 50 percent success rate. But then Doug
heard about a clinical trial of cancer immunotherapy at the
University of Pennsylvania, and he signed up. The therapy was
administered. Within days several pounds of cancer cells had
melted away. Three weeks later researchers could detect no sign
of leukemia in his blood. Today, more than 3 years later, they
still cannot find it.
From the standpoint of both the scientific and human
perspectives, that is truly amazing. And Doug is back to living
life to the fullest. If you look over here you will see that he
is even running a half marathon with his son. That is Doug in
the white tee shirt on the right.
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I believe there are many more stories like Doug's on the
horizon. Our Nation has never witnessed a time of greater
promise for advances in medicine. With your support, we can
realize our vision for accelerating discovery across the vast
landscape of biomedical research from basic scientific inquiry
to human clinical trials.
The National Institutes of Hope is ready to move forward,
so thank you for your support of NIH. My colleagues and I
welcome your questions.
[The statement of Francis S. Collins, M.D., Ph.D. follows:]
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Mr. Harris. [Presiding] Thank you very much, Dr. Collins.
And I am humbled to chair the hearing with such an esteemed
panel as I think the ranking member has said. And I could
listen forever to that. You know, it has been 10 years since I
have been in a laboratory.
Dr. Collins. Come on back.
[Laughter.]
Mr. Harris. Well, no, I can come in, but I do not recognize
anything that is there. You know, as I tell people, when I was
delivering obstetric anesthesia, of course, you know, narcotics
were part of the delivery. We could never understand, like, why
some women needed more, some women needed less. And, you know,
I think genetics are going to actually play a role, going to
make the field that I was in much safer when we look to how to
deliver things worldwide, make it safer worldwide, not just the
United States.
So I am going to open the questions, and my first is a
great deal of concern because I do think that the NIH is the
engine of biomedical basic and early translational research,
and that is what it ought to be. And, you know, we have had
this conversation. That is what I think the focus ought to be.
THE PRESIDENT'S BUDGET
So I am very concerned about what the President's budget
does to it because, you know, the Secretary was here last week
saying--or I guess 2 weeks ago--saying that the budget
``reflects the Administration's priority, the NIH budget, to
invest in innovative biomedical and behavioral research that
advances medical science while stimulating economic growth.''
And says that you can show that because there was an increase
of $211,000,000.
But when you go to the strategic goals sheet for your
budget that says what are the various strategic goals--and it
is to strengthen healthcare, advance scientific knowledge and
innovation, advance the health and safety and well-being of the
American people, and increase in efficiency in HHS--the
advanced scientific knowledge and education line actually was
cut by a $1,000,000,000, a 4 percent cut. And the money was
redistributed to emphasize primary and preventive care linked
with community, which went from $1,000,000,000 to $1.6 billion,
and ensure program integrity and responsible stewardship of
resources, which went from $1,000,000,000 to $1.5 billion.
So, in fact, although the Secretary said the
Administration's priority is to invest in innovative biomedical
research, there was a 4 percent actual dollar cut. We are not
counting for inflation. So I am going to ask you, Dr. Collins,
what is emphasized primary and preventive care linked with
community because I do not even understand what that is, much
less why it took $600,000,000 out of advancing scientific
knowledge and innovation. Could you enlighten me on this? I do
not even know what that means.
Dr. Collins. Well, Dr. Harris, thanks for the question. And
I am not quite sure exactly what this means either because this
is a very high level representation of budget priorities put
together at the Department level. Certainly at NIH's level, we
have our own very clear ideas about how to try to make the most
of the budget that has been proposed for Fiscal Year '15,
recognizing that because of the Ryan-Murray envelope, it is
going to be quite constrained.
Mr. Harris. So do you believe that we should be taking
$1,000,000,000 out of advanced scientific knowledge and
innovation and putting more than half of that billion into
emphasize primary and preventive care linked with community. I
have been in the medical field for a few years. I do not
understand what that is. I do not understand what the NIH is
doing with that. So you may have to get back to me.
Now, the other one is increase efficiency, and this is the
NIH. This is from the budget document we got. One category is
``increase efficiency, transparency, and accountability of HHS
programs.'' I am assuming they are talking about the NIH.
``Ensure program integrity and responsible stewardship of
resources,'' goes from $1,000,000,000 to about $1.6 billion.
Again, you know, if the Administration said, okay, let's put
another $2,000,000,000 into advanced scientific knowledge and
we will spend a little more here. But they did not. They
redistributed it.
What in the world is ``ensures program integrity and
responsible stewardship of resources?'' I mean, I just do not
understand. Have you seen this document?
Dr. Collins. I confess this is not a document that I have
paid much attention to, Dr. Harris.
Mr. Harris. Thank goodness because if you pay attention to
this, you are taking $1,000,000,000 out of cancer research and
the genomics research that you are doing. And, you know, it is
of grave concern to me that that decrease is occurring.
Dr. Collins. Well, let me say that I think, in general, the
Department has been recognizing the fact that the NIH as a
scientific agency is in the best position to be able to decide
what the priorities should be in the face of a given budget
allocation.
Mr. Harris. So you believe you will not have to comply with
these strategic goals.
Dr. Collins. I am not sure exactly how those goals would be
defined if one had to put a definition on it. But as----
Mr. Harris. That makes two of us because I do not know what
this means.
Dr. Collins. Yes, this does not seem like it overlaps
particularly well.
Mr. Harris. Now, even if we took that aside with the tap.
You know the tap increase is proposed to be $150,000,000 more
coming from the NIH going into whatever, non-NIH things. Well,
I am sorry, I think you have National Library of Medicine
there. And I will follow up in another round, but that only
leaves a $50,000,000 increase. And again, it appears all that
increase goes to these other things besides--I mean, again,
this is striking to me, a $1,000,000,000 cut. I am just shocked
by it. Anyway, but thank you very much.
Ms. DeLauro?
Ms. DeLauro. Thank you. Thank you very much, Mr. Chairman.
Since, Mr. Chairman, you are going to talk about evaluation
taps in a different round, I would be happy to address that
issue in a different round as well. So let me move to a
question that I have.
INCLUSION OF WOMEN IN CLINICAL TRIALS
Dr. Collins, 20 years ago, Congress passed the NIH
Revitalization Act of 1993, directed NIH to conduct research on
diseases and conditions that primarily affect women, and
required an appropriate number of women and minorities to be
included in all NIH-sponsored clinical trials. We worked very,
very hard on that, and I worked with my colleague, Mrs. Lowey,
again in a bipartisan way to do that.
NIH guidelines now, as I understand it, with limited
exceptions, require women to be included in phase three
research trials. Unfortunately, the guidelines do not require
female cells or animals to be included in phase one and two of
clinical research. In phase-three trials, females are not
represented proportionately to the disease prevalence. The
first step toward personalized medicine is having a better
understanding biological sex and gender differences.
Regrettably, we still have a lot of work to do in that regard.
Cardiovascular disease, the leading killer of women in the
U.S., affects men and women differently at every level:
prevalence, underlying physiology, risk factors, presenting
symptoms, outcomes. A 2009 review of cardiovascular disease
device clinical trials found that only one-third of trial
subjects are female, fewer than 31 percent of the trials that
included women reported outcomes by sex. True about depression.
American women are twice as likely as men to suffer from
depression, yet fewer than 45 percent of animal studies on
anxiety and depression use female lab animals.
Questions. Percentage of NIH basic research in phases one
and two of clinical research that includes female
representation. What do you perceive as barriers to increasing
female representation in the research so it is proportional to
disease prevalence? What can Congress do to help you facilitate
increasing female representation in basic research in phases
one and two of clinical research?
I will mention the brain piece as well at the moment
because very, very exciting development in research what you
are doing here. Will the BRAIN Initiative be mapping a male
brain and female brain? If not, why not? How will the BRAIN
Initiative data be collected, analyzed, and made available?
I really want to get to the questions that have to do with
the research and the involvement of women.
Dr. Collins. Great. Thank you for the question, and I will
give a quick response and maybe ask Dr. Gibbons to say a quick
word about cardiovascular disease and Dr. Landis about the
brain.
But first of all, we do keep track of participation in
clinical trials, males and females. Currently in Fiscal Year
'13, 57 percent of those enrolled in NIH clinical research were
women; 73 percent of those involved in phase three clinical
trials, phase three trials, were women. So we are responding to
the very serious issue that was pointed out 20 years ago by the
Congress about the fact that women were, in fact, not involved.
And thank you, Mrs. Lowey, and thank you, Senator Mikulski, and
others who brought that to our attention, of course, leading to
the Women's Health Initiative and many other issues.
But we have not achieved a perfect outcome. The recent
information about dose differences for Ambien, for instance,
raises that question again. And, of course, we do not control
the sex representation in trials that we do not fund.
I would say in terms of animal models, you have a serious
point there that oftentimes those who are working with animal
models choose to use males, and the reasons for that are not
compelling. They are reasons about estracycles that are
considered to be variables, but, in fact, we need to do
something about that.
Dr. Janine Clayton, who is the head of the Office of
Research on Women's Health, and I are actually going to submit
very soon a commentary exhorting the animal models folks to
change this practice because we are missing out on information
we need to have.
Very quickly, Dr. Gibbons, about cardiovascular disease.
Dr. Gibbons. Well, certainly the NHLBI has had a long
tradition of inclusion in its research projects. Indeed, the
iconic Framingham study back in 1949 included both men and
women, and that has been true of all of our cohort studies that
represent diverse parts of our population. And certainly, with
the lead of the Women's Health Initiative, which is a game-
changing clinical trial involving women, we have other studies
looking at coronary disease in women, the Wise study, for
example, to show the different sort of pathobiology of that
disease in that group.
Similarly, we continue to enhance awareness among women
that indeed it is the leading cause of death, five-fold greater
than breast cancer. So we are very much engaged in ensuring
that we have an impact on women's health.
Dr. Landis. So the BRAIN Initiative----
Mr. Harris. They may have to wait until the next round.
Keep your thoughts. Hold your thoughts, Doctor.
Ms. Roby.
REPRODUCIBILITY OF RESEARCH FINDINGS
Ms. Roby. Thank you all for being here today. Dr. Collins,
I was pleased to see that NIH is emphasizing the importance of
experimental rigor and transparency of reporting of research
findings in order to increase the ability for other scientists
to replicate that research. And we can all surely agree that
ensuring public trust and integrity of the scientific
enterprises requires rigor, reporting, and accountability.
Last year, an article in the Washington Post made
assertions that according to the National Academy of Sciences,
that the percentage of scientific articles retracted because of
fraud increased ten-fold since 1975. I understand the
redactions are higher than the number that are reviewed and
referred to the HHS Office of Research Integrity and eventually
pursued last year.
NIH has the authority to require repayment for the cost for
material violations of the cost principles and other terms and
conditions of NIH-funded awards. How many times in the past 5
years has NIH actually used that authority for any research?
And if so, you know, based on that number of times, how much
was required to be repaid and then actually repaid to the
Federal government?
Dr. Collins. So, Ms. Roby, it is a very important, and we
are obviously deeply concerned if we encounter situations where
fraud has been perpetrated in the publication of science
because science is all about determining the truth and making
sure that one is completely objective about reporting that.
I will have to answer for the record your question about
how many times NIH has had the opportunity to recover funds as
a result of a claim or a conviction of the conduct of fraud by
an investigator. Obviously the Office of Research Integrity,
which is part of the Department of Health and Human Services,
oversees those investigations, and they report publicly on when
they have identified an individual who is often then disbarred
from further research applications for a period of time. But I
do not know the total dollar----
Ms. Roby. If you would get that to me, I would appreciate
having that information. Does it apply to intramural
researchers as well?
Dr. Collins. I do not know of an example where there has
been a cost recovery from intramural, but I will find out for
you.
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Ms. Roby. That would be great, too. And in your January
2014 Nature article, you stressed that poor training is the
problem for the increased lack of scientific integrity. And so,
how did you ascertain that conclusion, and do you have data to
support that?
Dr. Collins. So let me make a really clear distinction here
between what we would consider as committing scientific fraud,
which is an intentional misrepresentation of the truth, versus
an issue where a published paper cannot be reproduced by
another group, and there are all kinds of reasons why that
might be--different conditions, different strain of animal,
different buffers, all of the things that you can imagine would
make it hard to reproduce, and yet, the intentions of the
investigation were completely honorable. I would not call that
a breach of scientific integrity. That is a problem with
somehow the way in which studies are designed or reported. Are
the details all there?
The article that Dr. Tabak and I wrote in January was
really about this issue of reproducibility because it is
terribly wasteful to have a study published, and then it turns
out that it cannot be reproduced. And in that instance, one of
the problems that we discovered is very much a reality, is that
many of the scientists who are doing particularly animal
studies where they are testing a new possible therapeutic have
not had the training in terms of how to design that kind of
study. How many animals should be used, male and female? Should
they be blinded to the investigator in terms of which animal
got the treatment and which did not? Are the statistics being
done in the most rigorous way?
It is clear that some of those studies have not lived up to
those kinds of principles, and that is the training that we are
aiming to try to introduce into the system.
RIGOR AND TRANSPARENCY OF REPORTING
Ms. Roby. Okay. Real quickly--my time is running short--can
you highlight for me in your 2015 budget request where you will
stress the importance of experiment rigor and transparency of
reporting these research findings, and how will that success be
measured?
Dr. Collins. So we will be introducing a training program
for graduate students and post-doctoral fellows to improve the
rigor in these kinds of analyses. We will be tracking then to
see what, in fact, are the consequences in terms of the ability
to reproduce experiments. Many of the institutes have initiated
pilot projects on their own in this area of reproducibility. We
have quite a long list of those. We will be evaluating those to
see which ones worked, and then trying to expand the ones that
seem most successful.
Ms. Roby. Thank you. My time has expired.
Mr. Harris. Ms. Lowey, the ranking member?
Ms. Lowey. Thank you, and welcome again. And before I get
to a question, I just want to follow up on my colleague, Rosa
DeLauro's, comment because when I got on this committee, as was
said, 20 years ago, I was alarmed to find out that only male
lab rats were used in research. So I kind of assumed this was
straightened out, and I do hope you get back to us in response
to the letter we sent because this is so important in terms of
the research you do and the real life clinical trials that are
taking place. So I thank you.
Dr. Collins. Yes, we will get that letter to you.
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VACCINATION RATES
Ms. Lowey. I want to ask you to comment--I think it is Dr.
Fauci--that in recent days there has been at least 20 confirmed
cases of measles in New York, including nine in children. Only
three of the 11 infected adults had records proving they were
vaccinated. This outbreak does highlight to me what happens
when individuals choose to not use vaccine. And I think it is
very important to see if they are choosing it out of ignorance,
poverty, not having the information, not be encouraged, or not
choosing it because of some--which have been proven false by
you--claims, such as thimerosal, et cetera, causing autism.
Can you tell us what are you doing to increase vaccination?
If you can clarify that.
Dr. Fauci. Well, first of all, let me just clarify the
incident and the experience that you are referring to in New
York. You are absolutely right on the numbers that you gave. It
has been our experience when we do surveys that the individuals
who do not get vaccinated are not vaccinated because of an
unfounded fear of adverse events associated with vaccines that
are either completely non-existent or are so rare that they
barely register when considering the risk-benefit ratio.
People forget measles, and that is one of the issues where
you are a victim of your own success. I got measles when I was
a child, and my sister got measles. At that time, before the
availability of the measles vaccine in 1963, we had about four
to five million cases a year in the United States with 500
deaths, 48,000 hospitalizations, and a thousand children per
year with chronic disabilities due to measles.
When the measles vaccine came out, with great enthusiasm
people wanted their children vaccinated because they had a
memory of the devastating effect of the disease. What happens
when you have a triumphant public health success as we have had
with measles elimination is that people forget because they do
not have the corporate memory. And then when you have that
insidious disinformation about the adverse events of measles
vaccine being worse than the disease, then you unfortunately
have mothers who read or hear that disinformation and do not
have their children vaccinated.
So we must remember that one of the most successful
extrapolations of basic research to a defined intervention is
vaccination. And a good example, Ms. Lowey, is that in the
United States we are down to 90 percent of people vaccinated.
That is not good enough. In the UK, they are down to 80
percent. And the United Kingdom has frequent outbreaks of
measles, more than just 20 children at a time, often hundreds
of individuals at a time.
The measles vaccine is 99 percent effective when you get it
with the first dose at 12 months and the second dose at 4 to 6
years. It seems such a shame and a tragedy for those children
who get infected with a disease that could have dire
consequences because of disinformation and misinformation about
vaccines.
Ms. Lowey. So we have to do more to get the word out. Okay.
Now, let me just say I am pleased that the budget deal allowed
us in Fiscal Year 2014 to restore some of the damage done to
the NIH by sequestration. But as you know, we were not able to
fully replace the cuts, and instead fell short by a little more
than $700,000,000. Your budget for 2015 includes a small
increase of $200,000,000. This is far below the level that we
need to be investing in biomedical research.
ADDITIONAL ACTIVITIES W/ADDITIONAL RESOURCES
So in the little time that is left, who would like to tell
me what sort of research activities that the NIH could be
pursuing if additional resources were available?
Dr. Collins. Well, goodness. In the little time available,
there must be hundreds of things from cancer to diabetes to
heart disease, infectious diseases, the BRAIN Initiative,
autism, Alzheimer's. All of these are areas where we have great
research potential, but we are not going as fast as we could.
Ms. Lowey. Okay. That red light is a red light to make it
clear we have to invest more in the NIH, right, Doctor?
[Laughter.]
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Mr. Harris. And submit the rest for the record. Mr. Joyce.
COPE: THIRD LEADING CAUSE OF DEATH
Mr. Joyce. Thank you, Chairman, Dr. Collins. And perhaps
this is best to address to Dr. Gibbons. But with COPD being the
third leading cause of death in the United States, I understand
the National Heart, Lung, and Blood Institute is the leading
body to address this disease. We must develop more precise,
personalized, and effective therapies to preempt chronic
disease. Please describe the work that you are doing on COPD
and the impact of that work on public health.
Dr. Gibbons. Thank you, Congressman. One more time, okay.
Thank you for that question. As you pointed out, COPD is a
major burden on the American people, a leading cause of death
and disability. And it is an area in which there is still much
to be learned by further research.
It is also an area in which there is great promise for more
personalized precision medicine. When I was in my training, we
just had a very crude notion of this chronic lung disease. But
now with the advances in genetics, we are starting to have an
appreciation for the various subtypes of this disorder in ways
of identifying the actual biological pathways that promote it.
For example, the recent discovery of this MUC5B gene that
appears to play an important mediator role and an appreciation
now for the role of the immune system in its pathogenesis. And
that is providing an opportunity for us to intervene and
identify patients at greatest risk and get the right drug to
them at the right time in ways that can change that natural
history.
INVESTMENT IN AGGRESSIVE CANCERS RESEARCH
Mr. Joyce. Thank you. Dr. Collins, if you will, a number of
Federal bills recently introduced target specific funding for
diseases such as breast cancer and pancreatic cancer. What is
the optimal appropriation level, and who should we best look to
to decide the level of funding to better invest in aggressive
cancers that we have not made significant progress in reducing
the incidents of or mortality of the disease, such as
pancreatic cancer, glioma, or small cell lung cancer?
Dr. Collins. I appreciate the question. I am going to ask
my colleague, Dr. Varmus, to say something about this since he
oversees the cancer research effort. I guess the overarching
principle, there are so many needs for research across many
diseases, including all the subtypes of cancer, that it does
make us somewhat uneasy if there is a top-down effort to try to
identify one as being more important than the other as opposed
to looking at the scientific opportunities and the public
health need. But I will ask Dr. Varmus to speak.
Dr. Varmus. Thank you for the question. The legislation we
are responding to does not give us a specific number for the
amount we should be spending on these diseases. Instead, what
it proposes is something that is very dear to the heart of most
NIH Institutes, and that is to take a problem against which we
are not making rapid progress, bring people together from
various fields that impinge on that problem, and try to come up
with some new suggestions for things to do.
In the case of the Recalcitrant Cancer Act that was passed
a year and a half ago, we were asked to do this specifically
for certain diseases that meet certain public health criteria.
And we have already submitted to Congress a report on
pancreatic ductal adenocarcinoma, in which we outlined four
important things, some of which we had already started, some of
which we had in our distant sights, a couple of which were new
as a result of the workshop.
For example, we have built a new program to study one gene,
which is implicated in over 95 percent of pancreatic
adenocarcinomas, a project we are carrying out at the Frederick
National Lab in Frederick. Secondly, we are emphasizing more a
topic that Dr. Collins introduced, the use of immunological
therapies in pancreatic cancer. Third, we are making note of an
important new observation about the frequency with which
pancreatic cancer is diagnosed after a diagnosis of diabetes
mellitus, type 1. And we are also taking advantage of some new
risk factors we had not previously appreciated that come from
both genetics and from pathology with the appearance of cysts
in the pancreas.
So those are projects, some new, some sort of new, that we
are pursuing more aggressively without worrying about the
actual dollars, but worrying about these tasks and trying to
find people to pursue them.
Mr. Joyce. I for one certainly hope you succeed, Doctor. I
yield back.
Mr. Harris. Thank you very much. Ms. Lee.
Ms. Lee. Thank you very much. And let me once again
reiterate everyone's real appreciation for the work that all of
you do each and every day. It really is about not only saving
lives, but enhancing the quality of life for each and every one
of us.
I just wanted to mention a couple of things. I have a
mother who is 89 with COPD. And I have recently learned that
COPD is the third leading cause of death in the Nation, and
that is one issue I would like to ask Dr. Gibbons about in
terms of the latest research as it relates to chronic,
obstructive pulmonary disease. That is one issue.
MINORITY RESEACHERS
Second is in terms of the minority researchers at NIH, in
2011 NIH--and thank you very much for that, Dr. Collins--you
commissioned a study which showed that minority researchers
receive fewer of the R01 grants than their counterparts, which
is an issue that we continue to raise with NIH. So I was
pleased to see that you announced the funding for the new
Enhancing the Diversity of the NIH Funded Workforce Program.
And I would like to just get a status of these new programs,
what the funding level is in the budget that you have
requested, and what the subcommittee can do to support that
initiative.
Also I wanted to ask, yes, I guess, Dr. Collins, you being
the person to know about this issue around the National
Institute of Minority Health and Health Disparities as it
relates to the, well, the fact that it did not receive an
increase where the other institutes, I believe, received
somewhat of an increase. The fact that minority health
disparities continue to be a big issue, you know, to me
warrants a larger increase in its budget to ensure that the
work is completed or at least is on par with the other
institutes.
So I am wondering what happened and what the decision was
not to ask for an increase in funding for the Minority Health
and Health Disparities Institute.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Dr. Gibbons. With regard to chronic obstructive pulmonary
disease, as you mentioned, a very common disorder, it is clear
that the NIH over the years has done a number of intervention
trials to change the natural history, documenting the
importance of providing oxygen therapy, for example, and
improving care options that include bronchodilators,
antibiotics, and so forth.
More exciting is the work in the COPDgene study that is
really helping us to dissect out the different subsets of
patients most likely to respond to those therapies. And indeed,
a recent study is using imaging techniques, finding out who is
at greatest risk for the progression of the disease. And it is
the identification of these particular high risk groups that
will be critical for us changing that natural history.
Ms. Lee. The cessation of smoking, of course, is the number
one preventive behavior change.
Dr. Gibbons. Absolutely.
Ms. Lee. Also in terms of just the third leading cause of
death, that is a fact. I mean, when I conducted the research
for this hearing, I did not know that. I mean, I know the
disease from a practical standpoint, but I had no idea.
Dr. Gibbons. It is a very common disorder predisposed by
exposure to tobacco smoke, as you mentioned. But even after the
individual stops smoking, there is often a continual inexorable
decline of lung function. We are still trying to understand why
that is. And so, although we want smoking cessation, it will be
critical to understand how the lung can better repair itself.
And so, indeed there is basic science discovery work being
done to actually put lung cells on a chip so we can understand
more about the biology of the lung and how it responds to a
toxin like tobacco.
Ms. Lee. Thank you. And still no cure. Dr. Collins? Thank
you very much, Dr. Gibbons.
RECRUITMENT AND RETENTION OF MINORITIES
Dr. Collins. So this 5-minute rule is brutal, is it not, so
let me quickly try to respond to your other two very important
questions. Yes, based upon the extensive work done by a working
group of my advisory committee to the director, we have a
variety of new programs to try to do something to increase the
recruitment and retention of minorities into our scientific
workforce.
The flagship of those programs right now is one called
BUILD, which aims to try to provide for underrepresented
individuals who are currently not coming into our workforce in
substantial numbers, real scientific experiences during the
summertime during their college years, and also for a year or
two after college to see if this is a good fit for them before
going onto graduate school and a career in science. This
program will be combined with another program on mentoring
because clearly mentoring is in short supply for many people
who are not from the majority groups. And also a careful
evaluation program to see what is working and what is not.
We are waiting for the applications to the BUILD program to
be received. They are due coming up in April. We are very
excited about this program, and we will be spending about
$50,000,000 a year on this combination of programs, which are
quite different than anything we have tried before. And we are
excited about seeing where they lead.
Ms. Lee. Thank you, Mr. Chairman. Will we have a second go-
round?
Mr. Harris. Yes.
Ms. Lee. Okay. Thank you very much.
Mr. Harris. Ms. Roybal-Allard.
Ms. Lee. Thank you.
Ms. Roybal-Allard. Dr. Collins, last August, I along with
80 of my colleagues in the U.S. House of Representatives sent
you a letter expressing our support for NIH funding of social,
behavioral, and economic research, which is clearly a link to
the Agency's mission and is essential to understanding the role
that socioeconomic status plays in the onset, progression,
treatment, and prevention of disease and disability. And to
date we have not received a reply to our August letter.
OPPNET
Also, we continue to hear reports from advocates that
health economist staff positions at NIH are not being filled
when people resign, and that fewer institutes are participating
in OppNet, the only trans-NIH initiative focused on basic
behavioral and social science research.
My questions are, is the interdisciplinary research,
including all the social, behavioral, and economic sciences,
still an important part of the overall NIH mission? What is the
participation level in OppNet at this point? And is the NIH
consciously attempting to downsize the number of staff
economists by not replacing positions that have been vacated?
And if so, why given that NIH support of behavioral and social
science research has yielded important scientific advances and,
in some instances, significant cost savings?
Dr. Collins. Well, thank you for the question. My apologies
that you have not received a response to the letter that you
mentioned. That is, quite frankly, an error on our part, and we
will be getting you that response. I read the letter when it
came in. I thought it was very thoughtful, but somehow we never
quite got into the system a response. And that does not usually
happen, and it is my mistake, and sorry about that.
Ms. Roybal-Allard. But we will be getting a letter?
Dr. Collins. You will be getting a letter, yes. And again,
it should have come much sooner than this.
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Dr. Collins. I would say in terms of NIH's commitment to
behavioral and social science research, including health
economics, that remains strong. We spend $3.5 billion of our
budget each year in behavioral and social sciences research. We
have just heard about COPD as an example of how critical it is
to try to understand behavior because it does contribute to so
many diseases, and the ability to come up with better
prevention strategies often depends upon that. And they are an
exciting set of new ways to approach this using, for instance,
mHealth, the use of cell phones to be able to interact with
individuals in real time in a way that encourages healthy
behaviors is something about which we are quite excited.
Many other things fit into that space as well, and OppNet
is engaged in that space. After all, it is something like 40
percent, and maybe as much as 60 percent, of the risks
associated with preventable premature deaths in the United
States are because of behavioral choices. And if we are going
to be responsible stewards of our mission here to try to
prevent unnecessary death, behavioral science has to be part of
that.
In terms of your question about health economics, I am not
aware of any plan to try to shrink the staffing of that
enterprise. I would tell you everything is under a terrible
squeeze right now, as you know. We have lost almost 25 percent
of our purchasing power for research. That means we have had to
cut back in virtually every area. And I am sure all those who
are affected by that are sure that their area is getting hit
harder than the rest, but nobody is really left untouched by
what has been a very difficult 10-year period.
Ms. Roybal-Allard. Okay. So your commitment remains the
same then.
Dr. Collins. We are strongly committed to behavioral and
social science research.
PANCREATIC CANCER
Ms. Roybal-Allard. Okay. Dr. Varmus, I want to commend you
for the timely appropriation of the scientific framework for
pancreatic ductal adenocarcinoma. As you know, I have had a
longstanding interest in this issue because of the disturbing
fact that pancreatic cancer has a 5-year survival rate or 6
percent compared to the 5-year overall cancer survival rate of
68 percent, and because treatment options and detection methods
for pancreatic cancer are extremely limited, as you know.
You mentioned your report, and that there were at least,
that I am aware of, four recommendations. One of the
recommendations is to research the relationship between
pancreatic cancer and diabetes, which I found very interesting.
Will the NCI be issuing a funding opportunity announcement in
this area? And if so, when will that announcement be made, and
how much will be the funding be for?
Dr. Varmus. Well, thank you for the question. Yes, one of
the more interesting discoveries at the workshop was this
inter-disease relationship which we think--my light is on.
Okay. Thank you. We have a technical problem here. We need
another agency to come in and work this out. But one of the
more interesting observations that was discussed at the
workshop was this apparent relationship between type 1 diabetes
diagnosis and then a subsequent diagnosis of pancreatic cancer.
One of the things this does, of course, is to narrow the
cohorts who could be watched to help us in making better
diagnostic approaches to early pancreatic cancer. When you have
a small cohort of people recently diagnosed with type 1
diabetes, there is a better chance of being able to test the
many proposals that have been made over recent years thanks to
other programs to improve early diagnosis of all types of
cancer in this particular situation, which, as you point out,
has been a very difficult one because of the position of the
pancreas in the body and our difficulty in seeing pancreatic
lesions early.
We have been in discussion with our colleagues----
Mr. Harris. Doctor, you are probably going to have to do
the rest of that answer for the record. I gave you some extra
time, but we really have to keep going.
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Dr. Varmus. Okay.
Mr. Harris. Thank you very much. Mr. Fleischmann.
Dr. Varmus. In preparation, we can discuss--we discuss it
later. Thank you for the question.
Mr. Fleischmann. Thank you, Mr. Chairman, and to the entire
group here today. I apologize. We have three subcommittee
hearings going on concurrently, and I know many of my
colleagues experience that same dynamic.
HHS STRATEGIC GOALS
Dr. Collins, I know there has been some discussion about
the breakout of NIH funds relative to HHS strategic goals, so I
apologize if any of this has already been covered today. But I
am very concerned, sir, about the apparent $1,000,000,000 shift
away from scientific discovery and towards ``strengthening
healthcare.''
It appears that strengthening healthcare funds are not
spent on biomedical research or discovery activities as are
listed in different categories. I believe this category in the
HHS strategic plan is where HHS focuses its Obamacare and
healthcare reform activity. Can you assure us, sir, that NIH is
not funding any activity relative to healthcare reform or
Obamacare?
Dr. Collins. Well, thank you for the question. This did
come up earlier in a question from Dr. Harris. And I confessed
my puzzlement somewhat with the page that is being referred to
in terms of how the NIH budget is broken down in these various
categories. Happy to assure you that at NIH we are taking our
budgetary priorities with great seriousness, and the way in
which we intend to spend dollars allocated to us by the
Congress reflects scientific opportunity.
We would only, I guess, be said to contribute to something
like healthcare reform in the sense that we generate data. That
is what we do. We provide evidence. We do research studies. We
do clinical trials. We publish the results. And then you can
find out from those results what works and what does not. But
other than that connection, sir, we are not part of that
enterprise.
Mr. Fleischmann. Okay. So the answer then is that you can
assure us that NIH is not funding Obamacare other than by
collecting data.
Dr. Collins. Other than providing a foundation of evidence
for good decisions in medicine, we are not.
Mr. Fleischmann. Okay. Thank you. With regard to this
funding and whatever activities will be funded in this
category, how do NIH and HHS coordinate multi-agency efforts to
avoid duplicating work that other agencies are already funded
to perform, sir?
Dr. Collins. Well, I appreciate that question. And I spend
a lot of time as the NIH director trying to be sure that we are
making the most of those synergies, avoiding duplication, but
also finding areas of significant possible collaboration where
we can go faster.
As an example of that, Peggy Hamburg, who is the
Commissioner of the FDA, and I set up a Joint Leadership
Council where NIH and FDA meet regularly to look at areas that
we can work on together. We had a recent meeting of that sort
to talk about adding microbial resistance and what to do about
a growing problem that both of our agencies have a significant
role with. Likewise with the CDC, we have multiple
opportunities and multiple interactions, and Dr. Fauci could
tell you quite a bit about those as they relate to public
health and infectious disease.
And outside of HHS, we have multiple other connections with
agencies, for instance, with DARPA, the Department of Defense's
Advanced Research Project Agency, where we have a joint effort
right now to develop a tissue chip that can be used for drug
toxicity testing. Before you ever give a new therapy to a
patient, you can test it on this chip instead. And I could go
on and on. A very important part of my job is to be sure that
we are looking for those collaborative opportunities and making
the most of them, and also with the private sector.
Mr. Fleischmann. Thank you, Doctor. Chairman, I yield back.
Mr. Harris. Would you yield me the last of your minute and
a half?
Mr. Fleischmann. I will yield, Mr. Chairman.
Mr. Harris. Thank you very much. I appreciate that. Let me
just follow up a little bit with what was--I think the ranking
member who has left, ranking member of the full committee had
asked, which is what you could do with that, you know, if your
NIH funding was higher. And I guess we cut you kind off halfway
through the litany of things.
I assume that the answer would be exactly the same for what
you could do with the $900,000,000, the tap that is being
requested in the President's budget. I am assuming it is an
identical list, right? It is just let's keep on going with the
priorities that we have. Would that be correct?
Dr. Collins. Sure. Resources could be utilized in a variety
of ways. Another way that this was formulated in the
President's budget is this Opportunity, Growth and Security
Initiative, $970,000,000, a similar kind of number. We could
expand the BRAIN Initiative. We could go faster on that. We
could do more for Alzheimer's disease research to go faster on
that.
Mr. Harris. So whether we would do it by expanding the
total amount or merely decreasing the amount that is taken away
for other things, it has the same functional difference in
terms of the number of research projects you are going to----
Dr. Collins. We would look at our spendable dollars and
make the most of what was there.
Mr. Harris. That is what I thought. Thank you, Doctor. Mr.
Honda.
Mr. Honda. Thank you, Mr. Chairman, and I want to thank the
panelists here. I will be brief in my introduction, but I
represent Silicon Valley, and probably one of the things that
we recall were the powerful drive of the innovation economy.
And, you know, NIH currently supports about 45 projects as a
total funding level over $18,000,000. But there is about
$30,000,000,000 in NIH funding that goes to medical research at
all the facilities, and the payback has doubled in our economy
across the country. So I guess the logical extension of that is
you put more into it, you get more returns on it.
And we talk about NIH turning discovery into health. I am
not sure where you draw the line when you want to say, you
know, are we going to apply the things that we learned into our
healthcare domain or are we not? That is not a question. It
just goes right on, and we apply the things that we learn in
our healthcare.
So I think that in terms of money, I think that we should
really go back to looking at complete sensible budget rather
than looking at how we do things with lists. And the other one
is, make do with what you get, and that the position we are in
right now, and I really appreciate that effort. And I think
that the message really is that we should start looking at our
budget in a holistic way so that we have a society that is
going to benefit from research, development, and its
application to our quality of life.
HEPATITIS B AND C
So in that, I have learned a lot of hepatitis B, and I know
that hepatitis B, the greatest sufferers are Asians. The
greatest cause of death among Asian Americans in terms of liver
cancer are Asian American men. And African Americans are more
than twice as likely to be infected with hepatitis C than the
Caucasian population. And viral hepatitis is the leading cause
of liver cancer, and one of the most lethal and expensive and
fastest-growing cancers in this country.
So two questions. One is, what is the National Cancer
Institute doing to ensure that liver cancer is a priority, and
that is a money question probably. And as a result, you know,
with other commitments to research and development we have seen
hepatitis C antiviral drugs come to the market in recent years
with more expected in the pipeline. So, NIH, what are you doing
to ensure that research for hep B drugs remain a priority so
that we can find a treatment and ultimately a cure, because we
have achieved that for hep C? Hep B we are real close. So I
would like to know how you are going to arrange your limited
resources to that end.
Dr. Collins. Well, we have the right people to answer those
questions. Dr. Varmus can say something about liver cancer, and
Dr. Fauci can tell you some exciting news about hep C.
Dr. Varmus. Mr. Honda, that is a very timely question
because the NCI just last week conducted a day and a half
workshop on liver cancer, which remains worldwide a very
important cause of mortality from cancer. And as you probably
know, we have been successful over the years in defining major
risk factors for liver cancer--hepatitis C and hepatitis B
infections, exposure to certain toxins in food, like aflatoxin,
and recently obesity and diabetes have proven to be important
risk factors as well.
The hepatomas, the liver cancers that arise, arise by
somewhat different pathways. We are making a clear statement
that we are interested in pursuing more vigorously some of
those opportunities. I will let Dr. Fauci talk in a moment
about the exciting new work done to treat hepatitis C virus.
There is the prospect in the long run of a hepatitis C vaccine.
One of the things that emerged in our meeting was that
although hepatitis B vaccine has been available for a long time
and actually is quite cheap, it is not being used as
effectively and as universally as many of us had thought. And
some studies of why that vaccine is not better used need to be
undertaken. So we are totally on board with your sense that
this is a very important cancer against which we have important
information, and a number of things will be done over the next
couple of years to try to ensure that people do not think that
liver cancer is a solved problem because we have a vaccine
against hepatitis B and now drugs against hepatitis C.
Dr. Fauci. Mr. Honda, thank you for that question because
it gives me the opportunity to say something that you do not
get a chance to say very often. The past few years have really
been representative of one of the more exciting breakthroughs
in biomedical research, and that is the potential and real cure
for hepatitis C.
We know hepatitis C is a very important problem, as you
mentioned, 3 million cases per year. The leading cause of liver
transplantation in the United States is hepatitis C. The
treatment for hepatitis C prior to these breakthroughs was a
long 48-week treatment with interferon alpha plus ribavirin,
which is a very difficult drug to take for 48 weeks with a
number of toxicities. The cure rate ranged from 35-40 to about
70 percent at the most. This disease disproportionately affects
African Americans, particularly individuals with HIV infection.
Over the last few years, what are called direct acting
agents, namely agents that are directly targeted against
hepatitis C, have gone to the point with clinical trials--many
of which have been involving the NIH, including the basic
science--where we have moved to what we call interferon-free
regimens using direct-acting agents. The recent data in a
flurry of papers that came out in multiple journals, show that
the cure rate even with the most difficult infections, type 1C
and others, even in people with advanced disease, has gone up
to anywhere between 85 and 95 percent.
Mr. Harris. Dr. Fauci, on that good news, I am going to cut
you off. We could listen all day to the wonderful cures, and
they really are, that are coming out. I recognize the vice
chair, Mr. Womack.
Mr. Womack. Thank you very much, and thanks to the panel. I
apologize. I was in another meeting, another hearing. We have
several of these going on at the same time, so I am joining you
late. I have gone from Warthogs in defense to warts, I guess,
here. You have got to kind of re-shift your thinking.
[Laughter.]
Mr. Womack. Dr. Collins, my home State of Arkansas has a
single academic health center, UAMS, as I am sure you are well
aware. And it received a total of about $47,000,000 and a half
in NIH funding in Fiscal Year '13. That is less than half a
percent of the research funding budget. You are aware of the
huge impact these investments have on our economy, and in
States with smaller populations and economies the impact is
greatly amplified.
THE IDEA PROGRAM
The IDeA Program targets funding for merit-based, peer
reviewed research and infrastructure grants at institutions in
23 States like mine that have historically received less NIH
research support. Together in '13, the 23 States secured just 9
percent of NIH research funding. In your '14 budget, you
proposed a $51 million cut to the then $276 million program.
Ultimately it was appropriated at $273 million level funding
for '15.
So I would like to know, given the proposed cuts and
request for level funding for the IDeA program, what the NIH is
otherwise doing to ensure that IDeA states remain competitive
when competing for this kind of funding.
Dr. Collins. Thank you for the question. The IDeA program
is very important to us, and as you pointed out, this is an
opportunity to try to give talented scientists in States that
do not have very high-powered research intensive universities
the opportunity to provide those kinds of research experiences
to train the next generation of scientists to do good work that
is going to contribute substantially to the biomedical research
enterprise.
I have visited a number of IDeA states. I have met with
folks who are working there in those programs, and some of our
centers of biomedical research excellence, the COBRE program.
And I am impressed with what is able to go on there. I have not
been to Arkansas, but maybe I should come by some time and see
what you are doing.
Mr. Womack. Consider this an invitation.
Dr. Collins. I hear you. We are, of course, in a very
stressed situation as far as our support for virtually
everything. And so, certainly if the situation were more
favorable, we would love to see the IDeA program also be a
beneficiary of that. Since we have lost now more than 20
percent of our purchasing power for research in the last 10
years, everything has kind of been in a squeeze.
We are a meritocracy. We try to make sure that the funds
that we put out there are for the very best science. I am
delighted to say that quite a bit of that goes on in States
like yours, and we want to encourage that. And we especially
look to see sort of what is the success of that. Are we, in
fact, encouraging people in the IDeA program to move forward,
to get a successful R01 grant, to train an individual who goes
on to become a leader in the field. And we are encouraged by
what we see there, but we would always like to see it even
stronger. It is a very important program for us.
Mr. Womack. Do you not sense that in a time when people are
making decisions, family decisions, quality of life, looking
for opportunities to go places to do this kind of research
where there is a great quality of life and a lower economic
impact on raising a family, putting them through college,
buying the homes, and those kinds of things, does it not make
sense that more and more of these types of individuals, these
very brilliant people are going to make brilliant decisions
about moving to great places like Arkansas?
[Laughter.]
Dr. Collins. You make a great case, Congressman. I think
many of them probably, especially those who have financial
constraints that would make it difficult to transition to a
place that is much more costly in terms of cost of living, will
choose to carry out their scientific programs in places that
are not as expensive and perhaps closer to family. And we want
to be sure if they do so, they have the chance to have the
full-blown experience of what it takes to become a successful
scientist.
Mr. Womack. One of the tough things that I have to address
when I have disease-specific people coming to my office, and
many of these people are not lobbyists, although they are there
to lobby. They are people who have been hardshipped or affected
personally by some of these particular issues. One of the
hardest discussions I ever have is to try to help them
understand where those disease-specific issues are in the
overall realm of the national priorities.
So help me--am I out of time already? If I have another
round of questions, I will come back to that----
Mr. Harris. We will have another round.
Mr. Womack [continuing]. Line of thinking. But thank you
very much.
PRIORITY SETTING AT NIH
Mr. Harris. So the first round of questions are done now,
so I will begin the second round of questions. I am going to
follow up on something the vice chair talked about and Mr.
Joyce talked about.
You know, as the vice chairman mentions, we get a lot of
people from advocacy groups coming to us, and Mr. Joyce asked,
I guess, how do you prioritize, you know, where you are going
to spend money on cross-diseases? And I will tell you, you
certainly do not want the legislature involved. I will just
tell you briefly.
In Maryland, when I first came to the State Senate in 1998,
we had this mandate that you have to provide hospitalization
after a mastectomy. Perfectly reasonable. But to make it
politically correct, they then coupled it with saying you have
to provide hospitalization after testicular cancer surgery. We
are the only State in the Nation that has this. Political
correctness is fine in some realms, but really science should
be devoid of political correctness, and those decisions should
be made devoid of that I think.
So I have got to ask, you know, we look over what the NIH
spends, and I guess, Dr. Collins, you can agree that the
legislature probably should not be telling you----
Dr. Collins. With you on that.
Mr. Harris. Okay. So I have a table of where we are
spending the NIH money now and looking at various major
diseases. And I am going to only concentrate on the ones where
we have more than a million people affected, so where the
prevalence is only a million people or more. And if you look at
the research dollars, whether it is by the number of people
with the disease per death from the disease, HIV/AIDS is 10
times the amount--10 times the amount--than, for instance,
research per death from breast cancer, diabetes, research per
person with 10 times the amount except pancreatic cancer where
there are fewer people involved--breast cancer, stroke, cancers
for all reasons.
I got to say, you look at this and you go, and we did
great. Look, I was there, and most of you on the panel who are
doctors, you know, started when we did not even know what
caused it. I mean, it was this mystery disease. We have gone to
pretty close to a cure, certainly with newborns transmission,
and maybe, in fact, we may have a cure.
Why are we spending that much per person when we have other
diseases that afflict more people? Why? And my understanding is
there is a 10 percent, you know, earmark that exists. First of
all, just to clarify, it is not statutory. This was not the
legislature came in and said we are going to do this. So if it
is not statutory, what is the origin? What is the history?
Where are we going?
And when these groups come in, and I have these groups come
in and they say, look, if you can just give us a 5 percent
increase in next year's budget, it will make up for inflation.
And you just say, maybe we should stop earmarking diseases
because internally and then we all of a sudden have 10 percent
more. What is the short answer? You do not have a whole lot of
time. It is literally $3,000,000,000.
Dr. Collins. So the answer needs to be a scientific one. I
am going to turn to Dr. Fauci who oversees that research budget
and have him respond.
Dr. Fauci. So thank you for the question. I could
understand the rationale for that question, but I think we need
to remember that despite the fact that we have had great
successes that you are very familiar with, and I need not take
time to go through them, that we are still in the middle of a
raging global pandemic. There are 36 million people living with
HIV. There were 2.3 million new infections, 1.6 million deaths
in 2012. In the United States, there have been 636,000 deaths,
and every year we have 50,000 new infections.
Mr. Harris. Doctor, I am going to have to interrupt you.
But you do not dispute that we spend about $200,000 per death
in the United States----
Dr. Fauci. Right.
Mr. Harris [continuing]. On AIDS/HIV research. And we spend
on stroke $2,000 per death, on heart disease $2,000 per death.
These are tremendous problems in the United States. We get
people in our offices all the time with all kinds of diseases.
We are spending 10 times by any metric that is a reasonable
metric.
If my constituents come to me and say how much are you
spending per person if I have heart disease, we are spending 10
times the amount, 15 times the amount.
Dr. Fauci. I understand, but if I can give----
Mr. Harris. Do you dispute those or do you think that is
about the ballpark?
Dr. Fauci. I do not dispute the numbers, Dr. Harris. But
what I would like to throw on the table, whether you accept it
or not, is that when you are dealing with an ongoing pandemic,
it is different than a disease, as serious as it might be, that
is essentially stable, that you want to bring down the death
rate. We have the opportunity of eliminating this disease. That
is the reason why we are putting so much money into it with
regard to a vaccine and a cure.
Mr. Harris. Let me ask. That is fine. I mean, who decides
on that 10 percent? I mean, it seems kind of arbitrary. I mean,
you know, if we had imposed a mandate and said you have to
spend 15 percent of your budget on heart disease, or 20
percent, or 25 percent, you would come back and say, how dare
you. Believe me because I have this. How dare the legislature
come and do this? You know, what is good for the goose ought to
be good for the gander on this. Thank you very much.
Ms. DeLauro?
Ms. DeLauro. Thank you very much, Mr. Chairman. God help us
if the legislature got involved in dictating to you what you
should do. That has been really the hallmark of this wonderful,
wonderful subcommittee is that we do not do that. We take a
look at what public health is about, global pandemics, et
cetera, and where public health and safety arise.
I would like to just before moving onto a question here,
this point has been made a couple of times, and I want to try
to clear the air on it. This is about the evaluation taps. I
think we should set the record straight here. Authorizing law
sets the maximum evaluation transfer percentage at 1 percent.
This committee has been since that time overriding the
authorizing law mandating a higher percentage. 2002 bill,
percentage was raised from 1 percent to 1.2 percent, less than
the increase to 2 percent proposed by the Bush Administration.
2006, percentage specified in the appropriations bill had been
increased to 2.4 percent. Since then it has been increased by
another 10th of a percent.
The perception here is that the transfers are the
Secretary's decision. Not the case. She has limited discretion
in this matter. The amount of the transfer, the specific uses
of transferred funds, are spelled out in considerable detail in
the annual appropriations bill. A small portion of the total is
left unallocated by this committee. The transfers are this
committee's doing, not the Secretary's doing. And anyone who
does not read the language in the Consolidated 2014
Appropriations Act, which talks about the portion the Secretary
determines, but not more than 2 and a half percent of any
amounts appropriated for programs authorized under the act
shall be made available for evaluation.
Now, if you have not read the document in terms of the
budget summary where it says where it goes. It does not just
disappear into the air. It says very clearly immunization and
respiratory diseases, evaluation top funding $12,864,000. We
approved it. This committee does this. Get the facts. Read the
summaries.
This committee said no to viral hepatitis, STD, and TB
prevention where the evaluation tap was $3,000,000. They said
no. Understand evaluation taps, what it means. And I do not
support going from 2 and a half percent to 3 percent. And I do
support making up the shortfall of $700,000,000. I wanted to do
it in the omnibus bill, but we could not get agreement on
setting that money. If we are so concerned about the NIH, then
let's put our money where our mouths are in this effort when we
have the opportunity to do it.
PHILANTHROPIC FUNDING OF MEDICAL RESEARCH
So thank you very much, Mr. Chairman. If I can, let me try
to get in a question on the issue of private philanthropic
funding of medical research. It is expensive, but we are
looking at contributions from wealthy individuals to support
medical research. I applaud the individual commitment, I really
do. I think it is terrific. But it is finding cures to diseases
that affected either themselves or people who are close to
them. Cancer survivor, as I am, life-threatening disease, it
inspires you to get involved in what you are doing.
The New York Times had an article that says that privately
funding research could be a replacement for publicly funded
research. I laud the private effort. I welcome it. I do not
believe our decisions on basic research should be outsourced to
the private sector.
What is the right balance, public, private investment in
biomedical research? How can we ensure that the national
priorities are remaining the guiding influence in biomedical
research? And let's go, and I will get back to it if I have a
chance of doing it. This is what I think is fundamentally
important about our future. Dr. Collins?
Dr. Collins. Well, I very much appreciate your question.
The article by Bill Broad in The New York Times laid out in
great detail the amount of philanthropy that is now being
focused on biomedical. And we are grateful to see that kind of
contribution to research in order to go faster.
But you are quite right. It could in no way substitute for
the major support of biomedical research in the United States,
which is the National Institutes of Health. It could not
substitute in quantity because if you add up all of the
philanthropy, it is still a small percentage of what NIH
supports, nor could it manage to survey the entire landscape to
identify where the needs are the greatest and make sure that
the distribution of funds is happening in a scientifically
balanced way. Just to say, as I say, we welcome those kinds of
partnerships. We would love to see more of them.
There is a very interesting op-ed in The New York Times
today responding to that, suggesting that one should be
thoughtful. Where is the greatest entrepreneur in the American
biomedical research enterprise? It is the Federal government.
You can see it over and over and over again.
Ms. DeLauro. Thank you. I would love to pursue this
conversation with all of you individually offline. I think it
is a critically important question for our future and where we
go, and I am sure you are all discussing it internally. I would
love to have the opportunity to talk with you about it.
Mr. Harris. Thank you very much. Mr. Womack.
INNOVATIVE VERSUS DISCOVERY
Mr. Womack. Second round is going good. Historically, NIH
is a discovery organization. However, it has focused more in
the past 5 years on innovation. Is there a clear role at NIH
for innovating? And I would like for you to explain the
difference between innovation and discovery and how the NIH
balances between the two priorities.
Dr. Collins. I love the question, and I would say
innovation and discovery are not mutually exclusive. There is a
lot of innovation that can be introduced into discovery science
where you are trying to find out what is the fundamental basis,
for instance, of how the brain works. Well, that is a
discovery, but, boy, it is going to take a lot of innovation in
terms of new technologies to be able to actually understand how
those 85 billion neurons between our ears are functioning in
remarkably complex ways, building circuits that can do things
that are really almost impossible to imagine in terms of laying
down memories and retrieving them and all that. So that is
innovation, but it is also discovery.
We are all about innovation, recognizing that, in fact, our
real engine of innovation in many instances is the best and
brightest minds out there in this country in our finest
institutions who are coming up with ideas that we probably in a
top down way could not have come up with. And so, a big part of
our portfolio is these so-called investigator initiated grants
that come to us, that go through the most rigorous peer review
system that get prioritized based on their promise, and then
funded these days if they happen to be in the top 16 percent.
And we are throwing away a lot of innovation because that
success rate has fallen so low.
We are doing other things to try to specifically encourage
innovation thinking with programs like the Pioneer Award. The
Pioneer Award, which has now been in place for 10 years,
encourages investigators to come to us with ideas that are
pretty out of the box, and which they do not have a lot of
preliminary data or to prove that it is going to work. They
have to be able to show that if it does work, it is going to be
groundbreaking. That program has produced a lot of very
exciting science, including just today in my blog, which I am
sure all of you read.
[Laughter.]
Dr. Collins. I wrote about a new discovery in Alzheimer's
disease, a master switch called REST, which was discovered by a
pioneer awardee, which is a whole new insight into what is
happening in the Alzheimer's brain that came completely by
surprise. Now, that was innovative, but we gave the
investigator the chance to do that.
We are considering at NIH expanding that kind of program,
giving more of our portfolio in a way that the Institutes are
going to experiment with to individuals who have out of the box
ideas rather than expecting them to write a very detailed
project-based kind of proposal to us.
In addition to that, we have large-scale enterprises
focused on specific areas that no single investigator could do,
but a team could. The Genome Project was perhaps the most
notable example, but we have many others--the MCODE Project,
the Microbiome Project, and this BRAIN Initiative, which aims
to bring together disciplines that have not necessarily worked
well with each other, get them to know each other and do
something significant.
STRATEGIC PLANNING AT NIH
Mr. Womack. Last question for you, and we can talk about
these kinds of issues forever, but I want to go back to my
priority question. I have got people in my office. They are
suffering from these disease specific--why do we not do more
pancreatic cancer, the high mortality rate, et cetera, et
cetera? How do we establish these priorities? And I agree with
my friend Ms. DeLauro that Congress should not be dictating
what these are. We are not qualified to do that. So how do we
discern?
Dr. Collins. In the report language for the Fiscal Year '14
appropriation, we are asked to put forward, and we will do so,
how we manage the strategic planning process. All 27 of the
Institutes, four of them represented here, have this process
where they survey the landscape, they look at their portfolio,
they try to see what other organizations are doing. They try to
identify gaps and identify opportunities, and then make the
decisions about how to distribute the funds that they have
direct control over in that fashion, but leaving a substantial
amount of the dollars for those unanticipated ideas that are
going to come to us from community that we want to be sure we
are supporting as well.
It is a very carefully planned complex process. You will
see a more detailed report about it later this year, but I
think it is the right way to take the scientific and the public
health needs and factor them into an outcome that does the best
with the dollars we are given.
Mr. Womack. Let's give Dr. Varmus a real quick chance.
Dr. Varmus. Just a couple of quick comments. Some of our
own investigators fail to recognize the power of what we call
program announcements. So if the NIH and the NIH Institutes
want to emphasize a certain area without setting money aside,
they can say, ``We are particularly interested. Send us your
best ideas, and we will fund them.'' And that is a very good
way for us to exercise both our judgment about what needs to be
done and to bring forth the best applications.
One point about innovation. I would strongly suggest that
we get greater clarity about the meaning of the word.
Innovation in my lexicon does not mean simply particularly
imaginative or exciting work. It means something that is
applied, and I think that you may have been meaning it in that
sense as well. And I think it is a legitimate discussion to
think about how much we should be spending on application as
opposed to fundamental basic discovery.
Mr. Harris. Thank you very much. Ms. Lee?
NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Ms. Lee. Thank you. Okay. Once again, let me ask Dr.
Collins about the National Institute on Minority Health and
Health Disparities. Health disparities in the African-American,
Latino, and Asian-Pacific American community are huge. And you
know what they are: life expectancy much shorter, hypertension,
diabetes, hepatitis. All of the diseases are disproportionate
in communities of color. So that is one of the missions of the
Institute, yet the funding does not seem to follow the huge job
that we have asked you to do.
So I just wanted to ask you in terms of the budget, given
that the Institute has a much smaller budget, I would have
wanted to have seen a much larger request. So can you kind of
explain what that is about? And also how the decision was made
to not propose an increase in funding for this very important
Institute.
Dr. Collins. Congresswoman Lee, thank you for the question.
I will tell you, health disparities is, from my perspective,
one of our highest priorities, and I would want to explain the
answer to the question that you have posed.
Let's be clear. The health disparities at NIH is conducted
by virtually all of the Institutes. The National Institute on
Minority Health and Health Disparities (NIMHD) acts as a hub to
build collaborations and to stimulate the kind of projects that
need to happen. But most of the money we spend on the health
disparities result is actually spent by the other Institutes in
collaboration with NIMHD, and you would want that because that
is where most of the budget resides.
In terms of what has happened with budget proposals going
from '14 to '15, I would ask you not to make a great deal out
of the small differences in terms of what has happened with
individual Institutes and Centers. Much of this was built upon
specific initiatives, like the BRAIN project, that needed to
have a ramp up in order to try to get onto a trajectory where
something could happen. And so, institutes that happen to have
larger parts of that, like my colleague to my right here of the
``Neurology Institute,'' saw an increment that looks more
promising, but, in fact, in reality the sort of base of full-
blown activities that go on across NIH, including in NIMHD,
there have not been winners and losers.
Frankly, everybody is pretty stressed as you can imagine
given the fact that we, even with the Fiscal Year '15 proposal,
we will still be a billion dollars short of where we were in
Fiscal Year '12, as has already been pointed out.
I want to point out something else that I failed to mention
when you asked earlier about our research workforce, and that
is the recruitment of a chief officer for scientific workforce
development, a new position that I have created. And this is
Dr. Hannah Valentine, a highly regarded cardiovascular
physician from Stanford who will actually be sworn in by me
next Monday as a person to take on this role, emphasizing again
just how seriously we are taking this opportunity.
I might also mention Dr. John Ruffin has just announced his
intention to retire after 24 years of leading Minority Health
and Health Disparities research, and we will be announcing
fairly soon a very impressive search committee to go out and do
a remarkable, strong national search to find a replacement for
somebody to lead that critical part of NIH.
Ms. Lee. Well, Dr. Ruffin has certainly done a phenomenal
job, and so give him my regards and my thanks.
I guess following up from what you just indicated, my
concern then is, with the Institute being the major
coordinating function, still without an increase, how does this
funding really enhance the coordination that this Institute,
the National Institute on Minority Health and Health
Disparities (NIMHD), has because that is a major, major job?
Dr. Collins. It is, and they are not unique in taking on
that kind of role in terms of being a hub for broader activity.
Look at our new National Center for Advancing Translational
Sciences (NCATS). And everybody would say translation is really
important right now. The budget for NCATS is actually quite
modest. But the ability to build those collaborations, the
impact is much greater. Look at the Genome Institute where I
used to be. Everybody is doing genomics now, but the ``Genome
Institute'' is a small fraction of that total.
NIMHD has the opportunity with their position in the scheme
of things to encourage, to recruit participation in a wide
variety of programs. Maybe I will just quickly ask Dr. Gibbons,
as somebody who has a lot of health disparity research going on
in his Institute, how does that work?
Dr. Gibbons. Well, certainly for our cohort studies, we
have a very diverse portfolio that is very inclusive and
reflective of America--the Strong Heart study of Native
Americans, the Jackson Heart study that I am sure you are
familiar with, and African Americans, the Hispanic Community
Health study, the largest study of Latino health with 15,000
participants, the Mesa study, the Multi-Ethnic Study of
Atherosclerosis. These are studies that we are doing to address
minority health many times in collaboration and in close
coordination with the NIMHD.
Mr. Harris. Thank you very much, Dr. Gibbons.
Ms. Roby, thank you for your patience. You are up.
Ms. Roby. Thanks. Thank you again, all, for being here
today. I have learned a lot, and being a new member of this
committee it has been really great to sit here and get to hear,
you know, specifically what you do and what you are
contributing to so many wonderful things. And I look forward to
many more success stories.
And so, we have a plethora of disease-specific questions
that we are going to submit to you for the record. You know, as
Mr. Womack pointed out, this is the time of year when a lot of
these folks come to our offices and come not with D.C.
lobbyists, but come, you know, as a survivor of a disease or
someone who is living with a disease. And it is very helpful to
be able to look them in the eye and report back to them about,
you know, what advances are being made, but also what
challenges are there and how to better advocate for their
disease. So if you will, when we submit this to you, if we
could get a prompt response that would be great.
Several other members have touched on the requirements in
the omnibus that you provide with this report within 180 days.
And I know this has come up, but I just wanted to give you one
opportunity again before the end of this hearing if you wanted
to share with this committee any specific or relevant updates
as it relates to the process for internal controls that you are
going through to help mitigate the possibility for duplication
across the ICs. If there is anything else you want to share
with us before we conclude this hearing.
Dr. Collins. You know, I have talked in a general way about
how the 27 Institutes do this. I am going to ask Dr. Fauci to
say in specific ways what has happened with NIAID as a place
that has been very careful about a strategic plan for their own
research efforts. Tony, can you say a word?
Dr. Fauci. We have a strategic plan that we update
intermittently in which we get input from outside
investigators, have program meetings, both policy and
programmatic meetings, and end up with a coordinated plan that
is available for everyone to see.
I just happen to have for you here an example--you like
things that hang around, so this is our strategic plan for
NIAID for 2013. And virtually every Institute does that, and as
we all meet very frequently, it essentially gets into one group
so that we have a very good idea about what we are doing and
what the planning situation is.
Ms. Roby. And that helps prevent that overlap.
Dr. Fauci. Oh, yes, but indeed I think we need to point
out, as I am sure any of my colleagues would say, that when you
talk about overlap, you want to make sure you distinguish the
synergy of things that you do from things that are unnecessary
and non-productive duplication.
Ms. Roby. Some of it is necessary.
Dr. Fauci. Yes, it really is. In fact, the fact is that the
biological disciplines interdigitate an awful lot. For example,
and, in fact, you just heard that when Harold Varmus and I
answered essentially the same question. You have a virus that
causes cancer. You have an Institute with extraordinary
expertise in cancer and an institute with extraordinary
expertise in infectious diseases. We work together an
extraordinary amount, not only with hepatitis B, hepatitis C,
human papillomavirus, EB virus, and all of those things, HIV
all the time because of the co-morbidities with cancer.
It is really something that when you really dig deep into
it, you see an extraordinary amount of synergy as opposed to
duplication and overlap.
Ms. Roby. Great. I yield back.
YOUNG INVESTIGATORS
Mr. Harris. Thank you very much. And we have enough time
for one more quick round because you are riveting us. You would
like not to be so riveted, huh?
Thank you. Again, thank all of you for the work you do. I
am going to ask you, Dr. Collins, to respond. I think there was
an op-ed was about a month and a half ago in the Wall Street
Journal written by Doctors Daniel and Rothman about young
investigators and funding. And you know it is one of the roles
that I believe the NIH has to have because there is no one else
who is going to do it, is make sure that we have young
investigators.
Can you confirm the data in the article, I mean, because it
always brought to our attention, well, you know, when you level
off funding, the trouble is that, you know, you cannot fund
this many young investigators you otherwise would. But the
article suggested that the number of young investigators
actually has gone down, so it has not leveled off. Actually the
distribution has now become where there are more senior, less
young investigators, a trend that would be very disturbing to
me because I actually think an increasing percent of the NIH
budget, not a decreasing percent, ought to be going to these
young, promising investigators.
So if you could just briefly say, how do you envision that
we can turn the tide on that? I mean, the trend line is not
good. I personally would like to see it reversed as soon as
possible, and to do that, you have got to do something
differently than you do now.
Dr. Collins. Well, I appreciate the question. Part of the
problem as shown on this graph, which shows you the overall
challenge that we face over the last 30 or 40 years with the
ability of an investigator to get funded. That is the chance of
being successfully funded if you sent your best idea to NIH,
and which has now reached a historic low of 16.8 percent.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Dr. Collins. That of course, does not just affect young
investigators. That affects everybody. But it is perhaps
particularly challenging for a young investigator faced with
that to decide whether they can get their efforts going or not.
It has resulted in many young investigators staying in post-
doctoral training period for much longer than is probably good
for them. The average age at first grant award has crept up to
about age 42, which is clearly not healthy.
We do various things at NIH to try to encourage young
investigators to be successful. One is what is called a K-99
award, which gives a post-doctoral fellow a chance to apply for
their own support, and if they are successful, it bridges them
over to an academic position. So they arrive at an academic
institution already supported for 2 or 3 years. That is a very
nice way to market yourself if you are looking for a faculty
position, and that has been a good program.
We have just started, and this is one of my own programs
that I am watching very closely, a program to allow individuals
who have just obtained a Ph.D. and are particularly innovative
and independent to go straight on to a faculty position. It is
the Skip the Post-Doc Award, because sometimes people are not
really needing that. We fund only a few of those, about 15 each
year. I go to their presentations. They are astounding.
Mr. Harris. But, Dr. Collins, with 15 a year, it will take
you decades to reverse the problem. How fast can we reverse
that problem, because, again, that trend is very, very
disturbing to me.
Dr. Collins. Well, frankly, Dr. Harris, until we are able
to do something about the overall problem of such a very
difficult support system----
Mr. Harris. Dr. Collins----
Dr. Collins [continuing]. It is going to be hard to have a
metric.
Mr. Harris [continuing]. That is only if you do not treat
young investigators differently and somehow get them out of
that pool.
Dr. Collins. Well, one thing we do, and I should have said
this, is young investigators compete against each other. They
do not compete against the established investigators, which
helps quite a bit in terms of their being able to get on the on
ramp to being supported, because otherwise they would do less
well than they currently do. That helps a bit, but----
Mr. Harris. The numbers just do not show it. You have got
to do something a little bit more. Dr. Landis----
Dr. Landis. If I could say, many institutes, including my
own, have a special pay program for early-stage investigators
where we pay them past the normal pay line for the general pool
of investigators, and we have a significant number every
council round. I look at each of those applications. Are they
truly independent? Is the idea meritorious? And we fund them
out of order, and we have seen a significant increase in our
pool of early stage investigators. The problem is when they
come in for their first competing renewal.
Mr. Harris. Sure. No, I understand. Dr. Fauci?
Dr. Fauci. So just to add to Story's last point, we also,
and I think most every Institute has a differential pay line
for new and young investigators. So they operate, as Francis
said, almost competing against each other.
Mr. Harris. I know, but it is not working.
Dr. Fauci. I know, but----
Mr. Harris. I just want to emphasize, whatever you are
doing, and I applaud it because it might even be worse if you
were not doing what you were doing.
Dr. Collins. It would be.
Mr. Harris. But it has got to get better. And my time is
up, and I would be more than happy to make a visit and discuss
this with you at length, you know, on the campus. This is of
great value to me.
Ms. DeLauro?
Ms. DeLauro. Thank you, Mr. Chairman.
Mr. Harris. Your turn to be passionate.
Ms. DeLauro. And accurate, I might add, because in this
regard----
Mr. Harris. Ouch.
Ms. DeLauro. Yes.
[Laughter.]
Ms. DeLauro. I think that what you have been doing, and we
did not talk about the Kirschstein Research Awards. There are
training stipends, and they have ranges. The post-doc award is
$42,000 to $55,000 a year, depending on your years of
experience. It falls short of a goal set in 2001 for the entry-
level stipend to start at $45,000. The NIH funding, I note in
this budget, would be about 2 percent. It is an increase in the
President's budget.
But if we are serious about pipelines, and new young
researchers and their success rate, and we put a very, very big
emphasis on this, then we need to be serious about the kinds of
allocations that this subcommittee gets so that, in fact, it
can place the resources where the priorities are. And if we
continue to put our heads in the sand with regard to
investment, whether it be in training or whether it be in
biomedical research or in other areas, then we move backward
instead of forward.
I have a couple of quick questions because I can follow up.
Dr. Landis, your study, male/female brain?
MALE/FEMALE BRAIN
Dr. Landis. So the----
Ms. DeLauro. You got to be fast. He will cut me off.
Dr. Landis. The BRAIN Initiative is focused primarily on
creating tools and technologies to allow us to understand the
brain. Let me give you an example of a study that is using
current technologies. It is the Human Brain Connectome,
producing connectome maps of 300 different young adults equally
balanced, male and female.
Ms. DeLauro. Male and female, okay.
Dr. Landis. Those data will be publicly available. And one
of the questions that will be answered in those data is what
are the differences between males and females.
Ms. DeLauro. Thank you. Thank you because Alzheimer's does
affect women more so than it does men. We need to find out.
Dr. Fauci, you talked about vaccinations with regard to
Mrs. Lowey before. You talked about measles. Just a quick
question on the cervical cancer vaccine. Should we have more
education on the use of that with regard to human
papillomavirus and cervical cancer?
Dr. Fauci. The answer is yes, and I will turn it over to
Dr. Varmus also. But the principle is a very important
principle. When you have a vaccine that really works, it is
important to educate people to get the vaccine.
Ms. DeLauro. And you have to avoid and respond to
misinformation. Dr. Varmus?
Dr. Varmus. Just very briefly, I would like to draw the
committee's attention to a recent report from the President's
Cancer Panel, which works in conjunction with the NCI, that
strongly recommends a number of measures we think would improve
the unfortunately low vaccination rates both for males----
Ms. DeLauro. And females. Bingo.
Dr. Varmus. Males are important here. It is a forgotten
subspecies in the use of this vaccine--there is an increased
rate of oropharyngeal cancer caused by a strain of the virus
that is covered by the vaccine, and we need to vaccinate males
as well as females.
Ms. DeLauro. And we have to move out of misinformation and
philosophical interpretation of these efforts. I am going to
send the NCI and funding and research, et cetera.
I must tell you, you talked about cancer immunotherapy,
which is extraordinary. It really is extraordinary. The tissue
chip we did not spend much time on, but I am going to just tell
you that this morning at an earlier meeting, I am going to tell
you, the Humane Society, over the top about this effort and
wanted you to know that you have got people that are, you know,
droves are supportive of this tissue chip effort. The
Accelerating Medicines Partnership, (AMP), a second on that.
Tell me where----
THE ACCELERATING MEDICINES PARTNERSHIP
Dr. Collins. Thanks for that question. This is a very
exciting new initiative, NIH partnering with 10 pharmaceutical
companies to take this deluge of new discoveries about the
molecular basis of disease and move them forward to generate
the next generation of drugs by identifying what are the drug
targets that have not previously been chased after that are
most likely to lead to success.
Ms. DeLauro. Drug targets.
Dr. Collins. You want to identify, and once you understand
the pathway that seems to go awry, say, in diabetes, which part
of that pathway could actually be interfered with in a positive
way by a drug? That would be the drug target to go after. AMP
is going after diabetes, Alzheimer's disease, rheumatoid
arthritis, and lupus, and that is just for starters. We would
like to see that list expand. It is just getting under way. NIH
and pharma are paying 50/50 to make this go, scientists sitting
around the same table and all open access to the data.
Ms. DeLauro. I will put questions in on asthma and allergy
research, and also on the issue of prescription drug abuse, but
I will get those for the record.
Mr. Harris. Thank you very much. Ms. Lee?
Ms. DeLauro. God bless you.
SICKLE CELL RESEARCH
Ms. Lee. Thank you very much. Dr. Collins, let me ask you a
couple of things about sickle cell research. Of course, this
subcommittee, and thank you very much for your work with regard
to the whole issue of sickle trait and diabetes and the A1C
test. I just wanted to know where we are. For those of you who
have not been following this, we learned, I learned, and this
was through talking and doing my own personal research, that
the A1C test could give a misdiagnosis if one has the sickle
cell trait. And the NIH and your institute, I think it was for
diabetes, digestive, and kidney disease, really helped mount a
public awareness campaign.
I want to make sure now that the doctors and labs know not
to give that A1C test, but to check first for the sickle cell
trait. And so, it is kind of a catch-22. So I want to know how
that is going, and are we seeing a change now and a shift.
Secondly, just what additional treatments for sickle cell
disease have been identified and pursued, and how the state of
the research is. And then thirdly, how in the world do people
really know they have the sickle cell trait?
I mean, I know when babies are born, I believe they are
tested. But when you turn 18 or 17 or 15 or 21 or 30, do you
get retested again? Are you encouraged if you have diabetes to
get tested for the sickle cell trait? I mean, how do we really
address this because it is very serious in communities with
Mediterranean descent, African-American communities,
communities of color, and its something that we have not really
gotten our hands around yet.
Dr. Collins. So I will start, and then I may ask Dr.
Gibbons to weigh in a little bit since sickle cell disease is
in the Heart, Lung, and Blood Institute's portfolio.
With regard to your concern, though about the diabetes
overlap, that is something that Dr. Rogers, who is the director
of NIDDK, has been tracking. And I actually anticipated you
might ask about this and spoke to him this morning. I think it
is quite encouraging that thanks to the awareness of this, and
you have helped with that, there are now tests that are the
ones that are generally now used that do not have this problem
of giving you a false positive for hemoglobin A1C because the
person happened to have sickle cell trait. That was the
difficulty. People were being given wrong information about
diabetes because of the overlap between these different types
of hemoglobin.
And now, it does seem that that is generally recognized in
most places. Of course, given our medical care system, I cannot
tell you it is 100 percent, but I think a lot of awareness has
happened, and the test that is now generally used does not have
this problem. So we have made a lot of progress there.
In terms of new therapies, goodness, a lot of excitement in
sickle cell disease, and well there should be after all these
years of trying to come up with an effective strategy going
beyond hydroxyurea. There is a phase-two trial going on that
was actually started within the National Center for Advancing
Translational Sciences, NCATS, as a collaboration with a
company in Boston that actually is a compound that keeps the
sickle hemoglobin from cycling. And it is looking pretty
exciting. It turned out to be very safe, and in a very small
study seemed to be showing some benefit in terms of
oxygenation.
And there is a whole host of new ways to try to understand
how to turn fetal hemoglobin back on because that can be
protective for people who have sickle cell disease or
thalassemia. And the discoveries coming out of genomics are
teaching us about something called, of all things, BCL11A,
which turns out to be a great new drug target that you never
would have guessed with all the right properties for this
disease.
Dr. Gibbons, please fill in there in terms of how do
people----
Ms. Lee. And, Dr. Gibbons, yes, can you let us know how
people know they have the trait or what is required now so
people will know their status?
Dr. Gibbons. Certainly a great boon has been the newborn
screening efforts that have helped to identify individuals with
sickle cell disease. Certainly we still need to do more
research in terms of sickle cell trait, and recognizing that
that reflects their ancestry in those endemic areas of malaria,
and that there are associations with other complications that
can occur with traits.
We are learning more and more about that. Indeed, there is
an interaction that is recently being identified between those
with sickle cell trait and another genetic variant that relates
to predisposition to chronic kidney disease.
Ms. Lee. But let me ask you, though, at 50 years old, how
does one know they have the sickle cell trait?
Dr. Gibbons. Well, certainly as Dr. Collins mentioned,
there are diagnostic tests.
Ms. Lee. Well, how do physicians determine to look for
that?
Dr. Gibbons. So as you point out, I think part of the key
is awareness and education to both patients and providers as
they understand the significance of the trait and us doing more
research to indicate why it is important for that to be
identified and the implications, and then disseminating that
information more effectively to patients and providers. That is
certainly something we need to do more of.
Ms. Lee. We need to do more, and I would like to follow up
with you because that is still a little too loose for me.
Mr. Harris. Thank you very much. We are going to gavel the
session to a close in just a minute. But, Ms. DeLauro, would
you like to make a closing comment?
Ms. DeLauro. Sure. Thank you very much, Mr. Chairman. You
are all aware, and this was something that my colleague, Mrs.
Lowey, talked about in her opening remarks, and that is the
issue of global competitiveness. And I know you are aware our
global R&D funding forecast was published in 2011, showed a
decline in U.S. research commitment relative to our GDP, as
other nations have moved progressively forward to increase
their investments in both research and in life science.
The New England Journal of Medicine really confirmed this
trend. From 2007 to 2012, countries' average annual investment
in biomedical R&D increased 33 percent in China, 12 percent in
South Korea, 10 percent in Singapore, and it fell by 2 percent
in the United States.
Dr. Collins. I just happen to have that graph, and I have
just put it up there that you were describing the figures.
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Ms. DeLauro. Our share, U.S. share, of biomedical R&D
expenditure declined from 52 percent to 42 percent despite what
is happening in the rest of the world. China's biomedical R&D
expenditure grew 313 percent during that period of time. I know
it is of concern to you. It needs to be of concern to us if we
are to be at the cutting edge of discovery as you are.
And if it is not about the humanity of what you do and its
benefits, then about the economic benefits of what you do. That
has to be of singular concern and of singular priority as we
move forward. You are moving forward. This subcommittee needs
to move forward in making sure that we are strengthening our
R&D capability in every area, but particularly, with that gift
of life that you provide.
Thank you very, very much for being here this morning.
Mr. Harris. Thank you very much. And just before I close,
you know, again, I appreciate that China is increasing their
investment a tremendous percent, but let's remember that their
public investment in that New England Journal article is $2
billion. That is it, the tap plus the decrease in funding to
advance science that the Administration in their budget would
equal the entire public funding of research in China.
You know, and because the accuracy was questioned, I am
just going to include in the record that the article that I
referenced from the Wall Street Journal indicated between 1980
and 2012 when the number of grants that the NIH funded doubled,
the number of grants issued to investigators under 35 decreased
by 40 percent, reflected and mirrored in the R01 experience as
well.
Mr. Harris. So I would urge you, again, I think this is a
very important topic. You have got to do something to reverse
that. I mean, I was a young investigator. I had young
investigators work for me. I would urge you to do that.
And with that, I am just going to remind the members and
the panel that we are going to keep the record open for 2 weeks
for additional questions to be submitted.
Mr. Harris. And I want to thank all of you for the work you
do and taking out the time. And I am going to agree with the
ranking member. You know, I think it was the ranking member of
the committee who had said it is probably best if you all just
get back to your work and help America's health, and spend as
little as possible here on the Hill.
Thank you very much.
Dr. Collins. We are on our way.
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W I T N E S S E S
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Borio, Luciana................................................... 1
Burel, Greg...................................................... 1
Collins, F.S..................................................... 283
Fauci, A.S....................................................... 283
Korch, G.W., Jr.................................................. 1
Kurilla, Michael................................................. 1
Landis, S.C...................................................... 283
Robinson, Robin.................................................. 1
Sebelius, Hon. Kathleen.......................................... 119
Varmus, H.E...................................................... 283
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