[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]

THE NATIONAL INSTITUTES OF HEALTH: A REVIEW OF ITS REFORMS, PRIORITIES,
AND PROGRESS

=======================================================================

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES

ONE HUNDRED TWELFTH CONGRESS

SECOND SESSION

__________

JUNE 21, 2012

__________

Serial No. 112-153

Printed for the use of the Committee on Energy and Commerce

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COMMITTEE ON ENERGY AND COMMERCE

FRED UPTON, Michigan
Chairman

JOE BARTON, Texas HENRY A. WAXMAN, California
Chairman Emeritus Ranking Member
CLIFF STEARNS, Florida JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania EDOLPHUS TOWNS, New York
MARY BONO MACK, California FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina GENE GREEN, Texas
Vice Chairman DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma LOIS CAPPS, California
TIM MURPHY, Pennsylvania MICHAEL F. DOYLE, Pennsylvania
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California TAMMY BALDWIN, Wisconsin
CHARLES F. BASS, New Hampshire MIKE ROSS, Arkansas
PHIL GINGREY, Georgia JIM MATHESON, Utah
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio JOHN BARROW, Georgia
CATHY McMORRIS RODGERS, Washington DORIS O. MATSUI, California
GREGG HARPER, Mississippi DONNA M. CHRISTENSEN, Virgin
LEONARD LANCE, New Jersey Islands
BILL CASSIDY, Louisiana KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky JOHN P. SARBANES, Maryland
PETE OLSON, Texas
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

7_____

Subcommittee on Health

JOSEPH R. PITTS, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois EDOLPHUS TOWNS, New York
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
PHIL GINGREY, Georgia TAMMY BALDWIN, Wisconsin
ROBERT E. LATTA, Ohio MIKE ROSS, Arkansas
CATHY McMORRIS RODGERS, Washington ANTHONY D. WEINER, New York
LEONARD LANCE, New Jersey JIM MATHESON, Utah
BILL CASSIDY, Louisiana HENRY A. WAXMAN, California (ex
BRETT GUTHRIE, Kentucky officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)

(ii)

C O N T E N T S

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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 4
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 5
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 6
Hon. Leonard Lance, a Representative in Congress from the State
of New Jersey, opening statement............................... 7
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 8
Hon. Janice D. Schakowsky, a Representative in Congress from the
State of Illinois, opening statement........................... 9
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 53
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, prepared statement.............................. 54

Witnesses

Francis S. Collins, Director, National Institutes of Health,
Department of Health and Human Services........................ 10
Prepared statement........................................... 12
Answers to submitted questions............................... 55

THE NATIONAL INSTITUTES OF HEALTH: A REVIEW OF ITS REFORMS, PRIORITIES,
AND PROGRESS

----------

THURSDAY, JUNE 21, 2012

House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 9:36 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Joseph R.
Pitts (chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Burgess, Shimkus,
Myrick, Murphy, Blackburn, Gingrey, Latta, McMorris Rodgers,
Lance, Cassidy, Guthrie, Bilbray, Barton, Pallone, Dingell,
Towns, Schakowsky, Markey, and Waxman (ex officio).
Staff present: Sean Bonyun, Deputy Communications Director;
Brenda Destro, Professional Staff Member, Health; Sean Hayes,
Counsel, Oversight and Investigations; Debbee Keller, Press
Secretary; Ryan Long, Chief Counsel, Health; Katie Novaria,
Legislative Clerk; Andrew Powaleny, Deputy Press Secretary;
Krista Rosenthall, Counsel to Chairman Emeritus; Heidi Stirrup,
Health Policy Coordinator; Alex Yergin, Legislative Clerk; Alli
Corr, Democratic Policy Analyst; Ruth Katz, Democratic Chief
Public Health Counsel; Elizabeth Letter, Democratic Press
Secretary; and Anne Morris Reid, Democratic Professional Staff
Member.
Mr. Pitts. This subcommittee will come to order.
The Chair recognizes himself for 5 minutes for an opening
statement.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

Good morning. On behalf of the Subcommittee on Health, I
would like to welcome Dr. Francis Collins. I, and I know many
of my colleagues, have admired your work as a researcher on the
important Genome Project and now in your leadership role at
NIH.
Americans take great pride in the work of NIH, whose roots
date back to 1887. During that time, NIH has been in the
forefront of biomedical discoveries that have revolutionized
the field of medicine, including deciphering the genetic code
and finding treatments and cures for so many diseases. More
than 80 Nobel Prizes have been awarded for NIH-supported
research. This record clearly shows that NIH is a premiere
research institution and a great American achievement.
Since 1887 when it operated as a one-room laboratory, NIH
is now a large system of 27 Institutes and Centers. With the
passage of the NIH Reform Act of 2006, Congress addressed some
of the downsides of that rapid growth in order to improve
outcomes. I look forward to an update on the implementation of
the Reform Act, especially the role of the Scientific
Management Review Board and the Common Fund.
NCATS, the National Center for Advancing Translational
Sciences, is a new institute at NIH designed to catalyze
technology toward the diagnosis and treatment of disease. Even
though this is the first year of its operation, I would to like
learn about its progress and the funding of a pilot program
which partners with pharmaceutical companies to resurrect older
drugs for new therapeutic uses.
Finally, Americans expect us to spend their tax dollars
wisely. It is therefore very important that we set good
priorities. Faced with so many good causes, I would like to
know how NIH identifies the highest priorities in biomedical
research and then uses the review process to fund the best
research.
[The prepared statement of Mr. Pitts follows:]
[GRAPHIC] [TIFF OMITTED] T5674.001

Mr. Pitts. I would like to yield the rest of my time to the
vice chairman of the Health Subcommittee, Dr. Burgess.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS

Mr. Burgess. I thank the Chair for yielding, and Dr.
Collins, welcome to our committee. Any time that we get to
spend a few hours with one of the premier minds in research
science in the United States of America, and indeed, the world,
it is a good thing and it is a good thing for our committee to
have you here.
Certainly, all of us on this committee understand the
importance of medical research conducted at the National
Institutes of Health. I just have to say, in reading over your
testimony in preparation for today, the concept of a small,
inexpensive, high-powered microscope that could attach to your
iPhone to give you information about the safety of drinking
water, all I have to say is, is there an app for that?
You guys are doing the research, will, with the aid of the
private sector, lead the next great treatments of the next
century. This committee's commitment to authorizing the funding
for National Institutes of Health has allowed you to become one
of the premiere government health research foundations in the
world and certainly we should all be concerned that we maintain
that forward thinking and that we do not lose our position as
the world's premier leader in research.
We are obviously going to be looking to you to answer
questions, some questions that are now, some that have been
raised in the past--how are we doing, how are we doing with
keeping the lines of communication open between you and the
head of the Centers for Medicare and Medicaid Services, and of
course, with the Food and Drug Administration interposed
between the laboratory bench and the delivery system, how is
that bottleneck being resolved. How are genomics changing the
way that we identify and treat disease, and certainly, in
regard to the National Institutes of Health Reform Act, which
created a formal planning process, the mechanism to fund
interdisciplinary research projects and a grant of more
coordinating authority to the Director. Are you able to sharpen
your focus on diseases and conditions that heretofore have been
such formidable challenges to research, your community and of
course the world at large.
I am particularly interested to hear about the gains that
you have made with translational research at the National
Institutes of Health. We need to know what research has been
funded by you, by the Director's office, that allows the
allocation of funds from national research institutes to
centers to award grants for high-impact, cutting-edge medical
research, the intramural or extramural activities that go on
that fund not just research at NIH but also at institutions of
higher learning in Congressional districts throughout the
country.
We have got a lot to cover this morning, Mr. Chairman. I am
going to yield back the balance of my time.
Mr. Pitts. The Chair thanks the gentleman, and the Chair
now recognizes the ranking member of the subcommittee, Mr.
Pallone, for 5 minutes for an opening statement.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY

Mr. Pallone. Thank you, Mr. Chairman.
As we continue to work our way out of the recession towards
a thriving economy that offers economic opportunities to all
Americans, we must out-innovate, out-educate and out-build the
rest of the world.
NIH is the driving force behind the biomedical research
that has advanced and continues to improve the health of
Americans and strengthen the U.S. economy. Thanks in large part
to NIH research, Americans are living longer, living healthier
and suffering less from morbidity and mortality of countless
diseases when compared to the past. Not only has the general
health of the Nation improved, but these gains have added an
estimated $3.2 trillion annually to the U.S. economy since
1970.
NIH funds critical biomedical research in all 50 States and
the District of Columbia. It remains the leader not only in the
American biomedical industry but also serves as a significant
and sustainable part of our economy.
Now, let me use New Jersey as an example. New Jersey is
home to more than 2,000 biotechnology companies, institutes and
research facilities. During fiscal year 2004 to 2009, NIH
awarded $198 million to New Jersey biological science companies
and venture capital firms and invested an additional $4.1
million in biomedical firms during this period.
NIH also spurs innovation. In fiscal year 2011 alone, 28
New Jersey businesses received NIH grants towards R&D
technology with potential commercial applications and $4.9
million was awarded to train the next generation of scientists.
In my district alone, nearly $115 million was awarded in grants
to research institutions in fiscal year 2011, and this helped
not only provide jobs to establish a rich biomedical
environment for our current and future workforce but also helps
support the Rutgers University Cell and DNA Repository, the
largest university-based repository in the world that maintains
samples for the study of aging, longevity, substance use, and
neurological disorders, and the impact of the grants is not
limited to universities. Between 2000 and 2010, 37 startups
were formed based on Rutgers University research.
It is often said that government can support and advance
initial research that is developed by the private sector.
Declining or stagnant Federal funding for research and
development has an impact on all our sectors of our workforce.
It has been estimated that for every dollar of NIH funding, we
generate $2.10 in local economic growth. A report from United
Medical released in May argued that public investment in
biomedical research has a dual benefit. By establishing the
biomedical foundation upon which industries can build, public
funding also has a private rate of return of 30 percent and a
public return of at least 37 percent. Extensive studies have
shown consistently that public investment in health and
biomedical research improves health outcomes, alleviates
burdens of disease, bolsters the infrastructure for our
workforce, and provides quality jobs in our communities and
States.
Again, using New Jersey as an example, New Jersey has been
ranked as one of the largest R&D employers in the United States
with more than 211,000 jobs supported by health R&D including
50,000 direct jobs in health R&D. And the same report shows the
economic impact in New Jersey is $60 billion. Economic research
shows that public R&D and private R&D are mutually beneficial.
They complement each other, and one cannot be substituted for
the other.
And we do need to be honest: these are difficult economic
times. But while our circumstances are mirrored in the
international arena, our counterparts in Europe and Asia are
steadily increasing their investments for biomedical research
despite limited resources because of the long-term impacts on
their citizens' health and their economy. America's
competitiveness and status as a global leader depends on our
ability to innovate and support bright, creative minds,
transforming discoveries into health benefits and a stable
future.
So the government must be responsible for facilitating an
environment where Americans can continue to innovate. If
government abandons its role, we run the real risk of
squandering too many opportunities. And this should serve as an
important call to us that only makes our role all the more
critical. Are we willing to allow dramatic cuts and decreases
in funding to jeopardize our ability to fight cancer,
infectious disease, chronic illness and the development of
critical components of our workforce and industry. I think we
have a responsibility to the future now more than ever by
making wise investments that can lead to so many innovative
discoveries, the reduction of disease and so much in direct and
cascading economic benefits. That is the key to creating new,
thriving industries that will produce millions of good jobs
here at home and a better future for the next generation.
So Mr. Chairman, I think it is about priorities. Americans'
quality of life and bolstering our economy should be our top
priorities. Government can plant the seeds often with modest
investments relative to long-term payoffs in new products, new
discoveries, new jobs and economic growth, and greater funding
and support for NIH addresses both these priorities and it is a
way to keep the United States healthy, strong and competitive.
So thank you, Mr. Chairman. This is a very important
hearing.
Mr. Pitts. The Chair thanks the gentleman and now recognize
the chair emeritus of the full committee, Mr. Barton, for 5
minutes for an opening statement.

OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS

Mr. Barton. Thank you, Chairman Pitts and Ranking Member
Pallone. I want to thank also Mr. Waxman and Chairman Upton.
This is a hearing that is being done, I won't say primarily
at my request but it is a hearing that I have asked this
subcommittee to hold. I think everyone on the committee
remembers that back in 2006 when I was chairman, we did pass
the NIH reauthorization bill, the first major reauthorization
of the National Institutes of Health in, I believe, 13 years or
maybe even longer.
The NIH is the gold star for medical research in the world.
Under Speaker Gingrich's leadership and subcommittee Chairman
John Porter's leadership a number of years ago, we doubled the
budget of NIH. Unfortunately, in the last few years, we have
not been able to give NIH those sorts of additional resources
but the reform NIH reauthorization bill did give extra
flexibility to the NIH. It created what we call the Common
Fund. It helped reorganize the NIH and has been implemented, I
think, in a fairly effective fashion.
Today we are here to hear from the Director, the
distinguished doctor, how that reauthorization is proceeding
and also get his input on the things that perhaps need to be
done and need to be done legislatively that haven't been done.
We ant to make sure that the NIH is productive. We want to make
sure that it is effective. And to the extent that we can
increase funding, we want to provide transparency so that the
public knows how their money is being spent. We also want to
increase the communication and collaboration within the NIH and
to as large an extent possible eliminate duplicity and
redundancy. We also want to encourage emerging scientific
opportunities, and I know the Director is going to speak,
probably at some length, on that.
The reauthorization bill from 2006 has expired. It is my
hope that this hearing will lay the foundation to perhaps in
this Congress, and if not in this Congress, in the next
Congress, to do another reauthorization bill of the NIH.
I want to thank you, Dr. Collins, for your leadership at
the NIH, also for your friendship and your cooperation with me
and other members of this subcommittee and the full committee.
With that, Mr. Chairman, I can yield the balance of my time
to someone else.
Mr. Pitts. Mr. Lance from New Jersey is seeking
recognition.
Mr. Barton. I would like to yield the balance of my time to
the distinguished gentleman from New Jersey, Mr. Lance.

OPENING STATEMENT OF HON. LEONARD LANCE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW JERSEY

Mr. Lance. Thank you, Mr. Chairman, and thank you for
yielding, Mr. Chairman Emeritus.
Since the passage of the National Cancer Act of 1971, there
has been significant progress in the understanding of cancer
biology, risk factors, treatments and prognosis of many types
of cancer. However, in the past 40 years, we have yet to see
significant progress in the diagnosis and treatment of
pancreatic cancer.
Pancreatic cancer is the fourth-leading cause of cancer
deaths in the United States. It will take the lives of over
37,000 Americans this year, 74 percent of whom will die within
a year of diagnosis. In fact, the 5-year survival rate for
pancreatic cancer is 6 percent, the only major cancer that
continues to have a 5-year survival rate in single digits and a
number that has remained virtually unchanged for 40 years.
It is projected that the number of new pancreatic cancer
cases will increase by 55 percent between 2010 and 2030.
Despite these harrowing statistics, the National Cancer
Institute does not have a comprehensive and strategic plan to
address the disease and is currently allocating little more
than 2 percent of its research budget to do so.
My Democratic colleague on the committee, Congresswoman
Anna Eshoo of California, and I have introduced the Pancreatic
Cancer Research and Education Act that would do just that. It
has broad bipartisan support with 245 cosponsors. We believe
this bill is the important first step toward improving the
changes of survival for pancreatic cancer patients.
Thank you very much, and I yield back the balance of my
time.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the ranking member of the full committee, Mr.
Waxman, for 5 minutes for opening statement.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA

Mr. Waxman. Thank you very much, Mr. Chairman.
Today we have the great pleasure of hearing from the
Director of the National Institutes of Health, Dr. Francis
Collins. In addition to his responsibilities as the head of
NIH, Dr. Collins is a renowned researcher who, among many other
scientific achievements, led the government's effort to map the
human genome. We are delighted to have you with us, Dr.
Collins.
Regardless of our political point of view, Democrats or
Republicans, I know all members agree that NIH is one of the
Federal Government's real gems. Indeed, across the country and
around the globe, NIH is viewed as the preeminent biomedical
research institution. And with good reason. NIH research has
resulted in not only cutting-edge scientific breakthroughs, it
has also led to real and meaningful improvements in the
public's health.
From its work on cancer to hepatitis B; hypertension to the
H1N1 virus; HIV/AIDS to Alzheimer's disease, to name just a few
of our most pressing medical concerns, NIH researchers have
made discoveries, developed treatments, and even found cures
allowing us to live longer, healthier, and more productive
lives.
But the work of NIH is never done. As we learn more about
disease and the human condition, the list of research
challenges grows. Some 40 years ago, for example, we thought a
single, targeted war on cancer was all that we needed to wipe
out that illness. Today, of course, through the efforts of NIH,
the National Cancer Institute, we understand that cancer, in
all of its many forms, is a far more complex situation. It is,
in fact, a series of diseases with some unexpected
commonalities in tumors from one disease site to the next.
Thus, the NIH portfolio of cancer research has grown
significantly and become more sophisticated and multifaceted.
Because of its outstanding work, we continue to look to NIH
to help solve the trickiest of medical riddles such as
diabetes, autism, MS, spinal cord injury, and Parkinson's
disease, among others. And we must also look to NIH to figure
out how to prevent disease and disability wherever we can.
Meeting these expectations demands nothing less than the
best researchers, exceptional grant applications, strong
leadership, and sustained funding. Our job, the job of
Congress, is to ensure that NIH has the stable funding it needs
to continue its world-class work and global leadership. Money
is in short supply, I know, but Federal support for NIH is not
where we can afford to cut back.
At this juncture of endless research possibilities, both
basic and translational, and tough economic times, Dr. Collins
comes before us to discuss how he and NIH expect to address
these major challenges. We are looking forward to his
testimony.
I worry about the sequestration and automatic cuts in
programs that will happen. I am glad I voted against that bill
that calls for mindless sequestrations on the budget, domestic
spending as well as defense spending. It is not the way to run
a government, and of course, you are faced with that cloud
hanging over your head. It is unfair and it is unfortunate.
I have additional time, and I would like to yield it to Ms.
Schakowsky.

OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS

Ms. Schakowsky. Thank you for yielding.
Dr. Collins, I am so happy to see you here before this
committee, and I am such a great admirer of yours. My good
friend, Dr. Paul Farmer, who is known for his international
work, spoke at a graduation ceremony at Northwestern and he was
saying that sometimes bureaucracies are hampered by a failure
of imagination, and when I think of someone who is not so
limited, I think of you, Dr. Collins, as someone who really is
a visionary in the possibilities of how the United States can
be such a great leader in developing the cures and the
treatments for diseases that have plagued us for so long.
I also want to thank you for your role in the
implementation of a part of the Affordable Care Act, Obamacare,
the patient-centered outcomes research provisions. There are a
number of things in Obamacare I think that will make your job
easier. The ACA authorized Cures Acceleration Network program
and elevates the National Center on Minority Health and Health
Disparities at NIH.
I look forward to your testimony and doing everything I can
to help you in your mission. Thank you.
Mr. Pitts. That completes the opening statements of the
members.
We have one witness today, and I would like to introduce
today's witness at this point. Dr. Francis Collins is the
Director of the National Institutes of Health. As Director, he
oversees the work of the largest supporter of biomedical
research in the world, spanning the spectrum from basic to
clinical research. Dr. Collins is an elected member of the
Institute of Medicine and the National Academy of Sciences. He
was awarded the Presidential Medal of Freedom in 2007. He has
received the National Medal of Science in 2009. We are very
happy to have you with us today, Dr. Collins. Your written
testimony will be made a matter of record. You are recognized
for 5 minutes to summarize your testimony before the Q&A.

STATEMENT OF FRANCIS S. COLLINS, DIRECTOR, NATIONAL INSTITUTES
OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

Mr. Collins. Thank you very much, and good morning, Mr.
Chairman and members of the subcommittee. I want to thank each
of you for your continued support of NIH's mission, which is
science in pursuit of fundamental knowledge about the nature
and behavior of living systems and the application of that
knowledge to extend healthy life and reduce the burdens of
illness and disability, and some of my material will be up here
on the slides.
I couldn't help but also notice in this morning's
Washington Post an op-ed from Fareed Zakaria pointing out also
the economic benefits of which this particular author was taken
by, for instance, that $3.8 billion that the Human Genome
Project required from the government sources led to $796
billion in economic activity and raised $244 billion in
personal income within the first 7 years of its completion. So
certainly we also would say that medical research is not just
good for your health, it is good for the economy as well.
In my written testimony, I have summarized some of the
numerous challenges and opportunities that NIH faces, and
understanding you want me to be brief in my opening statement,
I am just going to focus on a few points.
One is that you asked me to update you on implementation of
the NIH Reform Act of 2006 and to report on this new National
Center for Advancing Translational Sciences, or NCATS, as we
call it. About 7 years ago, this committee began work on an
ambitious reauthorization of NIH. Your goals were clear: give
NIH's scientific leadership greater flexibility to pursue new
research opportunities, create new mechanisms and structures to
enable swift and facile collaboration amongst NIH's 27
institutes and centers, and increase the transparency in NIH's
portfolio and the accountability of its scientific management.
The technological revolution we are seeing right now in
biomedical research and the flexibilities that you granted NIH
in the Reform Act have enabled us to respond more nimbly to a
major challenge in getting therapies to patients.
In recent years, as you can see here, researchers have
succeeded in identifying the causes of more than 4,500
diseases. That is the good news. But unfortunately, treatments
only exist for about 250 of them.
So at the same time we have all these new molecular targets
within our sights, we face a situation in which only a few of
the thousands of compounds that enter the drug development
pipeline will make it into the medicine cabinet. As you can see
here, it takes an average of 14 years for an idea of a new
therapeutic to actually reach the market, and the failure rate
is more than 95 percent, and when you have to add up the costs
of all those failures, it takes a billion dollars or more to
bring a drug to market.
An engineer looking at this pipeline would say wait a
minute, there has got to be a better way. To address this
challenge, I asked the Reform Act Scientific Management Review
Board to consider whether there is more that NIH could do in
collaboration with the private sector. They studied the issue
intensively, took much public testimony, and in December 2010
they endorsed the creation of a new center, a National Center
for Advancing Translational Sciences specifically to address
the bottlenecks in the discovery pipeline. So now working in
collaboration, not competition with the private sector, NCATS
is designed to support rigorous scientific research to
reengineer the drug development process and move basic research
findings into treatments for patients more quickly and more
safely. The path to the creation of NCATS followed the
guidelines you put forward in the NIH Reform Act, and NCATS was
created on December 23rd of last year.
Just 4 months later, NIH was able to announce a major new
initiative entitled ``Discovering New Therapeutic Uses for
Existing Molecules,'' so how does this work? Working with
several pharmaceutical companies, NCATS is offering scientists
a shortcut: access to drugs that have already been tested and
proven safe in humans but failed to show efficacy for the
original application. Investigators in academia or in small
businesses will have the chance to see if these drugs might
work on other conditions or diseases.
As an example of how this could work, consider that AZT was
developed as a cancer drug but it became the first effective
therapy for AIDS patients. Another example, raloxifene,
developed for osteoporosis, now found to be highly effective
for breast cancer. We want to make this approach of repurposing
more systematic.
So in a nutshell, here is how this will work. Eight
companies have agreed--you can see them here--to make a total
of 58 compounds available through NIH--we are the matchmaker--
to researchers all across the Nation. Each of these compounds
has already had tens or sometimes hundreds of millions of
dollars of private money invested in its development and it is
now being crowdsourced to researchers in all sectors to find
new uses for these old drugs. The goal is to find new ways of
helping patients who suffer from diseases that currently lack a
treatment.
Let me just conclude by saying something about a patient's
story that illustrates the promise we see every day in NIH
research as we seek to address the challenges of Alzheimer's
disease, cancer, Lyme disease, influenza, obesity, diabetes,
and many other research frontiers. I want to tell you about
Kathy Hutchinson. She is a 58-year-old woman who became a
quadriplegic after suffering a devastating brain-stem stroke 15
years ago. Now, just last month, NIH-supported researchers
reported using a neuro interface called Brain Gate to train Ms.
Hutchinson to use her own thoughts to control the movements of
a robotic arm. Those results were published in the journal
Nature, and this video shows Kathy using the robotic arm in an
attempt, using just her thoughts, to pick up and take a sip of
her coffee. On that very first day she was successful. I think
the smile on Kathy's face and on the face of the young
researcher behind her tells you everything you need to know
about the promise of NIH research in just this one example.
So thanks for your time and interest this morning and thank
you for your support of NIH. I look forward to your questions.
[The prepared statement of Mr. Collins follows:]

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Mr. Pitts. Thank you, Dr. Collins, for that wonderful
testimony, and I will begin the questioning and recognize
myself for 5 minutes for that purpose.
The grant process at NIH is very important, and hopefully
is rigorous and transparent to ensure that the best projects
that address the highest priorities are chosen. One step that
generally raises a lot of discussion is the peer review
process. I have a few questions about that process, if you can
address them. First, how does NIH select reviewers and how are
review panels formed? Secondly, what criteria do reviewers use
and how are the criteria scored and how does NIH ensure that
the criteria are applied? Take those two first.
Mr. Collins. Well, I very much appreciate your question,
Mr. Chairman. Peer review is the main stay of how we make sure
that the taxpayers' dollars are utilized to support the very
best science. Our peer review system at NIH is considered as
the gold standard for the rest of the world, but we are
constantly trying to improve it. Basically, peer reviewers are
chosen in a particular area of science and medicine because of
their expertise. We seek to identify those who have both
detailed expertise about a technology that may be under a
review but also a broader picture about where that particular
field has been and where it is going. The reviewer choices are
made by our scientific staff, and these are scientific review
administrators who are talented, doctoral-trained individuals
who have chosen, many of them out of a feeling of public
service, to give their careers to this effort of making sure
our peer review process is done in a fashion that is as
exquisitely correct as possible.
Those reviewers are then brought together. They are given a
series of grants that have been received. They are assigned so
that each grant has oftentimes a primary and a secondary
reviewer who read it in great detail but the entire study
section looks at all of the grants. And then there is a
discussion about what the merits are and what the risks are in
terms of failure of particular proposals. The reviewers then
are asked to assign a numerical score to that particular
application between one and nine. One is good; nine is not
good. And they debate around the table the merits of this, so
there is a real-time conversation so that everybody in the room
has a chance to weigh in and you learn from those who maybe
know something special about this. And they vote not only a
single priority score and overall priority score but also for
various characteristics, and one of the ones that we recently
added is innovation. We want a specific priority set on the
basis of innovation.
When the dust all settles, those scores are tallied up,
averaged, then that is reported to our second level of review,
which are the advisory councils that each of the 27 institutes
has at their disposal and they aim to try to balance out the
portfolio. The first level is about scientific merit. The
second level is, where are the needs greatest here in terms of
where medical research needs to fill in gaps.
Mr. Pitts. OK. A couple of other questions I had. Are there
different levels in the review process and who makes the final
decision? Can applicants appeal the review process? And how
does NIH provide transparency for the research funded at NIH,
Web sites, databases? Who is responsible for overseeing the
databases and ensuring that they are current?
Mr. Collins. So the final decision ultimately after these
two levels of review is made by the institute director, who is
presented with the final results and then signs off on them. In
terms of transparency, the way in which all of the funded
grants are made is available is through a Web site, which is
very heavily utilized called Reporter. I would encourage you to
go and have a look if you want to see what it is that we are
funding and the roughly 50,000 grants that are currently being
supported. You can see there from the abstracts what the
research is all about, who the investigators are, what the
goals are.
Mr. Pitts. All right. Maybe you could have your staff meet
with our committee staff to go over the process a little bit
more. We have some other questions that we could ask, if you
would.
Mr. Collins. I would be very happy to.
Mr. Pitts. One final question. NIH has been working closely
with the FDA on regulatory science and other matters. Are you
working with the FDA to craft a timely clearance pathway for
next-gen sequencing, and if so, what specific role are you
playing?
Mr. Collins. So the FDA has for many years been looking at
the very rapid advances in DNA sequencing, and now with the
costs having come down from perhaps $100 million to sequence a
genome 10 years ago to less than $10,000, there is a great deal
of interest in having this find its way into medical care for
many different conditions, particularly cancer. FDA has been
studying carefully the issue about how to oversee that kind of
DNA testing, given that much of it is done in laboratories as
opposed to being distributed in kits, and that discussion is
still going on in terms of how to balance the desire to be sure
that individuals are given credible information that correctly
can advice them about their medical care but not do so in a
heavy-handed way that would slow down this remarkable
innovation that is happening right now.
I brought along with me, by the way, a DNA sequencing
machine. When I was in charge of sequencing the human genome,
the sequencing machines were as big as phone booths. This is
what they look now. The sort of marriage of biotechnology and
integrated circuits has happened and it is pretty impressive.
Mr. Pitts. Thank you. My time has expired.
I yield 5 minutes to the ranking member, Mr. Pallone, for
questions.
Mr. Pallone. Thank you, Mr. Chairman.
Dr. Collins, during these tough times, we in Congress are
often told that without sustainable budgets and some degree of
certainty, it is not feasible to maintain growth and
development in the private sector. So I wanted to ask you with
regard to the public sector, NIH, how does operating on
continuing resolutions and the threat of a sequestration affect
your ability to maintain constant funding to the best and
brightest scientists and adequately address the numerous health
burdens represented in the NIH research portfolio?
Mr. Collins. Well, thank you for the question. It does make
it challenging when science really is best sustained by having
stability so that investigators out there in all the States of
our Nation and some outside our Nation are able to pursue
research with the confidence that there is going to be some
support that will not just become somewhat questionable the
next year or the next month, and certainly, given the fact that
the NIH budget has to be decided upon every year and it rarely
has been decided by October 1st, as you all know, it does make
it challenging in terms of how we as science managers try to
steer this ship, particularly now with the uncertainty about
the sequesters, which have already been raised. That puts a
very significant source of concern as we try to plan where
science should go.
Most scientific projects do not have a cycle time of a few
months. It is more like 3 or 4 years. And so if we are deciding
to start down a path with a particular project, we expect to be
able to assure that investigator that we are going to support
it for that 3 or 4 years. Otherwise the initial money to go to
waste. But yet when we don't know from year to year exactly
what our resources will be, that makes it very tough.
I was at the BIO meeting yesterday in Boston. This is the
Biotechnology Industry Organization. It's their international
meeting. And I listened to the discussion at the lunch panel
about how the instability in the private sector makes it really
hard for biotech companies to know what to do, and boy, did I
relate to that. I think we all have the same issue that
stability would be a very desirable pathway if we could achieve
it.
Mr. Pallone. Thank you. I wanted to ask you about
pancreatic cancer research. Part of the reason is personal
because my mother passed not long after she was diagnosed with
pancreatic cancer. Despite years of funding for cancer
research, pancreatic cancer still has a terribly low survival
rate with only about 6 percent patients diagnosed with
pancreatic cancer alive 5 years later. So in my opinion, in
talking to others, there doesn't seem to be any real
improvement in survival for over 30 years. Yet it is my
understanding that only 2 percent of the NCI budget is devoted
to pancreatic cancer research.
I know it is not an easy question, but can you explain why
the overall cancer 5-year survival rate is 67 percent and the
survival rate for pancreatic cancer is still just 6 percent?
And what is NIH research strategy to improve survival rate for
pancreatic cancer patients?
Mr. Collins. I appreciate the question, and Mr. Lance
already raised this issue, and I am certainly personally very
deeply concerned about the situation with pancreatic cancer,
having just lost a friend, who is one of the founders of my
field of medical genetics, a couple of weeks ago, Dr. David
Rimoin. Clearly, with pancreatic cancer, one of the big
problems is the inability to know it is there until it is
already very far advanced. Recent data tell us that actually
pancreatic cancer doesn't actually grow that quickly, but by
the time somebody is diagnosed, they probably had the cancer
for 15 or 20 years.
Mr. Pallone. If I could interrupt you, I know in my mom's
case it was because she was jaundiced because the tumor was
affecting----
Mr. Collins. Pressing the bile ducts?
Mr. Pallone. So it was manifested, and my understanding is,
that is the only time usually or one of the few times you know,
but in most cases they don't see the jaundice.
Mr. Collins. Exactly, because it is deep in the body in a
place where one doesn't have the ability to know that there is
a lump there. It doesn't create symptoms until very late. So
one of the things we desperately need is new approaches to
early detection, to catch those cancers a decade sooner where
they probably then could be much better managed. There is a lot
of interest and effort going on in terms of both imaging
approaches and also biomarkers that might be circulating in
peripheral blood that would give a hint that this disease was
present long before it was otherwise apparent.
The other thing we need to do is understand how to treat
this disease, and to understand that better, we need to know
what is going on at the molecular level. We have major advances
now happening for all cancers but a big focus on pancreatic
cancer.
Mr. Pallone. But it is a very little percent of your
budget, though. Why is that?
Mr. Collins. Well, it is modest. I will say it has
increased 311 percent in the last 10 years. So the increase in
support for pancreatic cancer is greater than for other cancer
types. Clearly, there is a great need to do something to move
this along.
I will tell you, just recent at the ASCO meeting, there was
a whole other set of data about a potential approach to this
involving something called protein kinase C that looks
extremely promising. The cancer researchers who came away from
that said this was the most interesting, potentially exciting
thing they had heard about pancreatic cancer treatment in a
long time. So we are working on it.
I understand the frustration that people feel, and I am
sure Dr. Varmus and I would be glad to continue that
conversation. We have meeting with the pancreatic cancer folks
and others. I hope we can work on this together.
Mr. Pallone. Thank you.
Mr. Pitts. The Chair thanks the gentleman and now yields 5
minutes to the vice chairman, Dr. Burgess, for questions.
Mr. Burgess. Thank you, Mr. Chairman, and Dr. Collins,
again, thank you for spending time with us this morning.
Let me just stay on the issue of pancreatic cancer for a
moment. I had some questions in that regard also. But in our
conversation just days ago when you informed me about the
chronicity aspect to pancreatic cancer, as a clinician, I am
always aware that this is a difficult problem to treat. You
can't palpate it. There are no skin changes, very little in the
way of symptoms until it is well advanced.
So marry up, if you will, what might happen in the field of
genomics as well as you referenced protein kinase C, which I
assume is a new marker that may be available. Is there a way to
couple the ability to discover a vulnerability through
knowledge of the human genome with an aggressive marker
campaign that actually might lead people who are in the chronic
phase of pancreatic cancer, the pre-palpable form, if you will,
that would then lend them to a degree of earlier treatment than
they have ever received before.
Mr. Collins. Doctor, that is a really wonderful model that
we are very much embracing and trying to pursue. So how do we
identify individuals at higher risk for this? We know about a
few of those risk factors. Certainly, family history is one of
them, and at least one gene, which happens to be a rather
famous one for other reasons, the gene called BRCA2, which
places women at risk of breast and ovarian cancer, also
increases the risk of pancreatic cancer. So if we had an
imaging modality that we were convinced was reliably able to
detect a cancer which it is still small and surgically curable,
we would want to apply it first to those individuals at higher
risk and that is very much under consideration now.
But I think we also want to look for other kinds of markers
beyond imaging that may help us detect the presence of disease
at the earliest stage. Here is where the whole proliferation of
science around the field of genomics is giving us windows into
what is going on in the body that we didn't really have until
very recently. Are there signals? Are there in fact evidences
in the immune system that is reacting against the presence of a
cancer that we could detect by looking at those immune cells,
which of course circulate in the body. Those kinds of
approaches are certainly very much on our front burner, but
also the therapeutics. The protein kinase C delta looks as if--
let me back up a second.
Almost every pancreatic cancer has a mutation in a famous
gene called KRAS. It is a driver mutation. It is a major factor
for why these good cells went bad. But we don't yet have a way
of specifically targeting KRAS. That has not worked. It turns
out that just downstream of that, there are other things that
happen that are targetable, and that is where this PKC delta
has come forward, giving some new ideas, and this is an
important paradigm. As we learn more about how things are
connected within the cell, even if you can't target the primary
problem, you can sneak around and target something that is just
upstream or downstream and achieve the same result. That is
what a lot of science about cancer right now is aimed at.
There was a meeting going on organized by the AACR
yesterday at Stanford. I am waiting to hear what other new
ideas came from that in terms of pancreatic cancer diagnosis
and treatment.
Mr. Burgess. Now, is this an example of where that
translational research that crosses all of the silos at NIH, is
this where that is helpful?
Mr. Collins. Absolutely. Certainly, companies are intensely
interested in developing cancer therapeutics. I have spent a
lot of time with pharmaceutical companies in the last couple of
years trying to be sure that we are partnering effectively, and
cancer is an area where they are also very excited because of
all these molecular studies. But there can still be those
bottlenecks about how do you pick the right targets from a long
list that is emerging from things like the Cancer Genome Atlas
and then how do you, once you pick that target, move it quickly
to the point where you can be confident it is going to be safe
and potentially effective in a patient. There are all kinds of
steps there.
Mr. Burgess. And then are you equipped to deal with your
counterparts at the FDA because there can be other bottlenecks
outside of the walls of your hallowed institute that can
present a problem?
Mr. Collins. Peg Hamburg and I when we first came to our
respective roles at FDA and NIH formed a joint leadership
council to tackle exactly this kind of circumstance. Are there
areas where NIH and FDA can inform each other, work together,
can we provide regulatory science platforms that would assist
them in making decisions about what is safe and effective? Can
they educate us about the ways in which investigators that we
support could be smarter about how they design their approaches
both pre-clinical and clinical so that they will end up with
the data that FDA needs for approval.
Mr. Burgess. In the brief time I have left, do you have a
couple of examples that you could provide to us of things that
have been successful?
Mr. Collins. So one that we are working on right now is a
new approach to pre-clinical toxicology. Now, that sounds--when
I was a medical school student, I would have thought must be a
really boring science but it is actually really interesting.
How do you decide that a particular chemical compound that you
would like to try out in a clinical trial is safe to do that?
Generally, we have used animal models--small animals, large
animals--and we look for a signal that maybe that compound is
causing trouble in liver or heart. Now we can do that more
cleverly, and we are doing this as a partnership with FDA and
with DARPA, the Defense Advanced Research Project Agency,
building bio chips that are loaded up with human cells
representing three-dimensional examples of human liver cells,
heart cells, kidney, brain and so on, and using that as a test
of whether a compound is safe or not by looking to see whether
those cells get happy or unhappy when you give them a
particular test substance. That could be much faster and much
more accurate, and it is an example of how we and the FDA have
gotten together and said there is a bottleneck, let us tackle
it, let us do something about it.
Mr. Burgess. Very good.
Thank you, Mr. Chairman. I will yield back.
Mr. Pitts. The Chair thanks the gentleman and now yields to
the ranking member of the full committee, Mr. Waxman, for 5
minutes for questions.
Mr. Waxman. Thank you, Mr. Chairman.
Dr. Collins, it has got to be very difficult to go year by
year without knowing what your budget is going to be. That has
got to lead to a lot of instability. But you are facing
something as other parts of our government much more dramatic
at the end of this year, the sequestration. What it really
means is across-the-board cuts that was called for in last
year's budget agreement, and that will go into effect in
January unless Congress changes things. It looks like are still
deadlocked on changing things. By the Congressional Budget
Office estimates, this would mean an approximately 8 percent
reduction in NIH's budget, or roughly $2.4 billion less
available funding, taking NIH back to its 2004 funding levels.
If this funding went into effect, at least 2,300 fewer
grants would be awarded. I assume this is on your mind and it
is on the minds of a lot of people back in my southern
California district. People are talking about in the aerospace
and defense industries, how do they make plans for the
sequestration. And I know as a government leader, you have to
make plans for your sequestration. What is your thinking about
it? How would NIH absorb this $2.4 billion in lost funding?
What cuts would you make? Would you make it across the board?
Would you pick and choose which institute and centers get hit,
by how much? If you made a decision not just across the board,
what criteria would you use to pick and choose?
Mr. Collins. Mr. Waxman, this is certainly on my mind. In
fact, it is on my mind sometimes at 3 o'clock in the morning.
If there is something that I am most concerned about in terms
of an event that could really disrupt and do series damage to
the progress that we now see in medical research, this is it.
You have correctly quoted the numbers as I understand them from
the CBO about what the sequesters would do to NIH, and that
loss of 2,300 grants, which would come already 3 months in the
fiscal year, would represent about a quarter of the total
grants we would give for that entire year.
Exactly how that would be distributed of course would
depend upon scientific priorities but it would clearly stretch
across all areas. There would be cuts in cancer and diabetes
and heart disease. There would be cuts in common diseases and
rare diseases. There would be cuts in basic science. There
would be cuts in training. We would have to basically spread
the pain. We wouldn't do it in a completely blind fashion like
a haircut but everybody's hair would get cut pretty
significantly. There would be a lot of people with very short
hair at the end of this.
So I think maybe if people understood a little better than
we have been able perhaps to convey just how much momentum
there is right now and how much enthusiasm and anxiety there is
amongst our biomedical research workforce, which is our most
precious resources, the consequences of this perhaps would
become more apparent. Clearly, if you are an investigator
coming to NIH with your best and brightest idea, we already are
at the lowest rates in history for success in getting your
grant funded, about 17 percent, where we have traditionally
been at 30 percent. To drop that even further, which would
clearly happen dramatically were the sequesters to kick in,
might deal a blow to many of those investigators that they
simply would not be able to sustain.
Mr. Waxman. One of the reasons that we haven't been able to
work all these problems out is that the Republicans, who run
the Congress, are afraid to increase taxes even on
billionaires. I have a lot of wealthy people that I know. A lot
of them live in my district. I can't imagine if they heard
these kinds of results would happen to NIH and other areas,
they wouldn't be willing to say look, we will put in more
money. This is an important function of the government. We
shouldn't allow this to happen.
I was struck by the statistic in your testimony that we
have identified the causes of nearly 4,500 diseases but only
have effective treatments for roughly 20 percent of them so the
new initiatives that we have in the Cures Acceleration Network
sound very promising but we have got a lot of work to do, even
if we get by the sequestration issue. Isn't that the case?
Mr. Collins. We do, and it is both a wonderful new
opportunity because of this proliferation of new discoveries
about the molecular causes of disease that we just didn't know
until recently but we don't want to have them just sit there as
publications that everybody says wow, look at what we have
discovered. We want to move that forward to therapeutics.
I am working with the pharmaceutical industry on an
initiative where together we might try to look at where are the
highest-priority new targets because in many ways, there are so
many of them now, you have to decide where is your best chance
of success. So we just ran a pair of workshops on what is
called target validation with industry R&D chiefs getting
together with academic leaders and NIH to talk about how we
could together move this forward in a way that will accelerate
translation, accelerate moving that number that have diseases
that can be treated higher and quicker. That is our goal.
Mr. Waxman. Thank you very much. My time is expired. I
appreciate, Mr. Chairman, your calling on me.
Mr. Pitts. The Chair thanks the gentleman and now yields to
the chair emeritus of the full committee, Mr. Barton, for 5
minutes for questions.
Mr. Barton. Thank you, Mr. Chairman. I think we have got
the answer to what to do about our deficit. We will just do a
special tax on Chairman Waxman's rich people in his district.
Apparently they want to pay higher taxes and Mr. Waxman wants
them too, so if we can find a way to do it constitutionally, I
will be a cosponsor of that bill.
Anyway, to get back to the hearing. Dr. Collins, you and I
have had several meetings in my office, so I just want to get
on the record some of the things that you have told me in our
private conversations. What is your view of the Common Fund
that the reauthorization bill back in 2006 created?
Mr. Collins. Well, Mr. Barton, Common Fund, I think, has
been a brilliant addition to NIH's ability to support high-risk
but high-reward projects that don't fit neatly within the remit
of any one of the 27 institutes and centers but could actually
have profound impact on all diseases and all organ systems. As
the NIH Director, one of the most important opportunities I
have is provided by the Common Fund, which you and Dr. Zerhouni
discussed and which this committee then put forward and is now
put in statute as part of what we are aiming to do in that
space of sort of venture capital, and I think of it as our
venture capital. And it has funded a variety of really quite
remarkable projects. I will just mention one, the Human
Microbiome Project, which was much written about in the last 10
days or so in the press because of a series of about three
dozen publications that came out describing those microbes that
live on us and in us in breathtaking detail in ways that
clearly make it possible for us to understand how we interact
with them for health or sometimes for disease. This is really a
nice example of something that probably couldn't have happened
without the Common Fund.
Mr. Barton. What is the funding level right now in that
fund? What is your balance?
Mr. Collins. It is about $500 million, which means it is
only about 1.6, 1.7 percent of the total NIH budget. The
authorization would be carried all the way to 5 percent if the
budget of NIH as a whole were able to grow. It has been
difficult in the past few years to be able to change that.
Mr. Barton. And how much do you obligate each year,
approximately, from that Common Fund?
Mr. Collins. So most of the projects that are funded by the
Common Fund are funded for 5 years so while it varies from year
to year depending on what is moving out and what is moving in,
then it would be roughly 20 percent of that 500, so about $100
million.
Mr. Barton. If Chairman Upton and Ranking Member Waxman,
Mr. Pallone and Mr. Pitts were interested in doing another
reauthorization bill at NIH, what are some items that you think
should be included in that bill if we were to do a new
reauthorization bill?
Mr. Collins. You know, I would have to think hard about
exactly what would require that kind of step. You did such a
good job in 2006 that many of the issues that needed attention
were very effectively dealt with, so there is much a shorter
list now, I think, of urgencies.
Mr. Barton. If you could give that some thought and
formally let the committee know, I would appreciate that.
Mr. Collins. I would be happy to.
Mr. Barton. In my last minute and a half, I want to go to a
little more sensitive subject, Title 42. As you know and the
committee knows, this is a special title that gives the ability
to pay above SES-level salaries to very special people to keep
them in government service or to attract them to government
service. It was intended to be sparingly used and for only
exceptional or at least potentially exceptional employees. I
think it has been misused. You may not share that view. Could
you tell us what percent of the employees at NIH right now
generally received Title 42 compensation?
Mr. Collins. So we have 19,000 employees at NIH and roughly
24.8 percent of them are in the Title 42 appointment mechanism.
These are mostly individuals with doctoral-level training, and
we have recently, working with HHS, instituted a new policy
where only doctoral-level individuals will be eligible for
Title 42 appointments, changing a practice that has been
present in the past which we now feel we should not continue.
Mr. Barton. And on balance, I know there is really no such
thing as an average Title 42 salary, but could you give a
general idea of what a Title 42 salary is as compared to the
highest SES salary?
Mr. Collins. Well, the vast majority of Title 42 salaries
are below $200,000. Again, these are Ph.D. or M.D. or M.D./Ph.D
level individuals. Only a small percentage, about 465, of these
are at salaries above $200,000, and those are the individuals
at the highest level of seniority and expertise. Those are
institute directors, people like Dr. Fauci. I have to tell you,
Mr. Barton, and you and I have discussed this, if we did not
have this hiring ability, we would not be able to recruit the
best and brightest to come and join our scientific and medical
workforce, and if one wants NIH to be the most excellent
scientific and medical research organization in the world, we
have to be able to recruit those people. We are still paying
them less on the average that they could get in a university
and much less than they could get in the private sector, and we
are counting therefore on their public spiritedness, but at
least to be in the game, Title 42 helps us to be able to
maintain----
Mr. Barton. I know my time is expired. I am preparing draft
language to reform the Title 42 program. I will be sharing it
with the committee leadership and NIH, and you had indicated
that you had some thoughts too. If you would care to get those
to my office, I would appreciate that.
Mr. Collins. I would be happy to do that.
Mr. Barton. I thank the chairman for his discretion and
yield back to the Chair.
Mr. Pitts. The Chair thanks the gentleman and would remind
the members, we are going to be facing a time constraint when
we hit the floor votes, so if you can constrain your time,
please.
The Chair recognizes the gentlelady from Illinois, Ms.
Schakowsky, for 5 minutes for questions.
Ms. Schakowsky. Thank you, Mr. Chairman.
Dr. Collins, in a recent article you expressed concerns
that if it gets worse than the current rate of one in seven
grant applications receiving NIH funding, which would occur if
NIH funding is cut, we may lose this generation of young
researchers. Could you discuss what this would mean to our
ability to discover new medical breakthroughs and to maintain
our global leadership in biomedical research?
Mr. Collins. Well, certainly, young investigators and
investigators in mid-career and our senior leaders are all
feeling the stress here in terms of the difficulty of getting
supported in the current climate whereas you mentioned and I
cited earlier the success rates have fallen to the lowest
levels that we have ever seen. That means that investigators
spend an inordinate amount of their time writing new grant
applications, just missing the pay line, revising, trying
something else instead of actually doing the research, so it is
a very inefficient use of their time.
Particularly for investigators just starting out, we are
trying to identify a path for them. Are they going to be able
to pursue the ideas that got them interested in this field in
the first place? This can be very demoralizing when after
several tries you still have not succeeded in receiving funds.
We try to do everything we can to give those early-stage
investigators a leg up. They compete against each other instead
of against more experienced investigators, but there is only so
much we can do. And clearly, I hear from them on a regular
basis, those that have really kind of reached the end of the
line and some of them are simply saying I can't keep doing this
anymore, I am going to find some other kind of work; I will go
to teaching instead of doing research, maybe I will go to law
school, maybe I will think about another country. And certainly
when it comes to those who have come to our scientific
workforce from other countries and we have depended on that
talent for many years and been greatly benefited by it and many
of those individuals stay in our country and become our
leaders, they are much less likely to do that with these
stresses upon them and with much more attractiveness of
positions being offered to them in places like China and India,
which are increasing their support for biomedical research at a
dramatic rate even as ours is losing ground to inflation.
So it is not a pretty picture. If we are determined to
maintain the leadership that America has enjoyed in biomedical
research for the past 20 or 30 years, we can't just assume that
that will happen because it has in the past. We clearly have to
look, as a recent study done by the Information Technology
Innovation Foundation, at how America is stacking up in global
competitiveness, and it is not an easy thing to look at if one
is interested in seeing our economic future be as bright as it
needs to be.
Ms. Schakowsky. And what happens to the research itself
aside from the researchers if there is a start and a stop? Are
we hamstringing ourselves in that regard?
Mr. Collins. Certainly, science tends to build on itself,
and if a good idea has been started and there is something that
you have added to that that takes you in a new direction, you
don't want to see that simply go on hold while waiting for the
next cycle of potential research support, and certainly
scientists are themselves people we invest in. You are talking
about a doctoral-level individual at a university. We probably
helped train them through a training grant or through their
participation in research. So we already have a big investment
in that person, and the idea that we might now lose that
investment by not being able to sustain their career is a
double loss.
Ms. Schakowsky. Thank you. In the interest of time, I will
yield back, but I thank you, Dr. Collins, for your response.
Mr. Pitts. The Chair thanks the gentlelady and recognize
the gentleman from Georgia, Dr. Gingrey, for 5 minutes for
questions.
Mr. Gingrey. Mr. Chairman, thank you.
Dr. Collins, in a recent meeting at NIMHD July 27, 2011,
you charged the Research Centers at Minority Institutions
Transitional Research Network, RTRN, with providing additional
opportunities for multi-site clinical and translational
research among minority and collaborating institutions. What
will be the proactive strategy of the National Center for
Advancing Translational Science, NCATS, and NIH to collaborate
and enhance the capability of RTRN to accelerate its missions
to address health disparities? I know that is a mouthful, and I
am sure you followed that. I will be glad to repeat if you
would like for me to do that.
Mr. Collins. No, I think I get the gist of it. Thank you,
Dr. Gingrey.
Clearly, they need to work intensively on health
disparities is one of our most challenging and most important
missions, and we have in fact over the years identified
institutions that are particularly well designed to do so, and
we have an entire institute at NIH, the National Institute for
Minority Health and Health Disparities, with that focus. We
just last week held a meeting of my advisory committee where I
asked a very high-level group to focus on this whole question
of diversity in our workforce, which is another component of
this, and they made a number of very strong recommendations
about what we should be doing in order to increase the numbers
of individuals who work in medical research who themselves come
from underrepresented groups. Oftentimes those individuals have
special interest in health disparities and oftentimes are our
best researchers in those areas.
So there is a great deal of interest in promoting this
through various programs through NIMHD, through the RCMI
program, and I am certainly strongly in support of all of those
individuals because I do think we have not much as much
progress as we should in dealing with the fact that not all
populations enjoy the same health as all others and one of the
ways that we in research can identify the causes and
interventions.
Mr. Gingrey. Dr. Collins, for that answer. Of course, we
need to see a return on investments for taxpayers' dollars,
especially in areas that impact so many Americans, and one
costly disease that estimates are impact 26 million Americans
is diabetes. Medical costs of Americans with diabetes are more
than twice those without the disease. So in light of these
rather startling but accurate figures, I recently shared my
support for the Special Diabetes Program in a letter circulated
by my colleagues, Representatives Whitfield and DeGette. Can
you share with the committee the return on investment of this
program and how is it helping Americans burdened by diabetes?
Mr. Collins. I appreciate the question. I agree with you,
this is an urgent matter for our country. Not only are there
those 20-some million individuals with diabetes, there are
about 70 million with pre-diabetes who if nothing is done are
likely to become diabetic in the not-too-distant future. This
is a very high priority for research.
[Medical incident in hearing room.]
Mr. Collins. Coming back to diabetes. Did we lose Dr.
Gingrey?
Mr. Pitts. Dr. Gingrey has gone out with the patient so he
will have to follow up in writing.
Mr. Collins. I would be happy to follow up for the record.
Mr. Pitts. At this time we will yield to the ranking
emeritus, Mr. Dingell, for 5 minutes for questions.
Mr. Dingell. Mr. Chairman, I thank you for your courtesy.
Good morning, Doctor. I would like to begin by asking this
question. Would you please submit for the record information
regarding the proposed merger of NIDA and NIAA? And I would
hope that you would give us the premises under which the budget
neutrality of the combining of these two institutes was
established.
Mr. Collins. I would be happy to submit that for the
record.
Mr. Dingell. Thank you, Doctor.
Now, do you believe that NIH has lost purchasing power over
the years due to inflation and that this now impairs the
ability of your employees and grantees to do good science? Yes
or no.
Mr. Collins. In my professional judgment, sir, yes.
Mr. Dingell. Doctor, while I recognize that all of China's
biomedical research is funded by the government and that the
United States has the advantage of government and private-
sector funding, which is critical to creativity and innovation,
it is notable that China is significantly increasing its
spending on scientific research and the state-of-the-art
facilities. Is it fair to say that at this rate, Chinese may
outspend us in biomedical research in the foreseeable future?
Yes or no.
Mr. Collins. Yes, it is fair to say that, sir.
Mr. Dingell. Now, Doctor, do you think that the loss of
American research dominance could lead to a decrease in
investment dollars and jobs in our scientific arena? Yes or no.
Mr. Collins. In the sense that clearly NIH research
supports jobs, about seven jobs for every grant, yes.
Mr. Dingell. Thank you, Doctor.
Now, the University of Michigan, with which I am sure you
are familiar, is the largest research institution in my
district, and I know you have roots back in Ann Arbor, and I am
sure you agree that this brings a lot of promising young
constituent scientists into my office and into Washington. Many
of them share with me their fears and frustrations about how
difficult it is to get good science funded properly and to
generate a sustainable career. Previously, NIH was able to fund
30 percent of new grant applications. Today, the number has
decreased to 17 percent. Do you believe this dearth of funding
will drive the students the Federal Government has invested in
away from research?
Mr. Collins. So those same individuals come to see me after
they come to see you, and yes, they are deeply concerned and
some of them are being driven away.
Mr. Dingell. Thank you, Doctor.
Now, finally, understanding how NIH sets its research
priorities, it is important to us here in the Congress and to
patients throughout the country. As Members of Congress, we get
inundated by advocacy groups requesting more NIH resources
dedicated to their own particular disease or disease concerns
and to support the legislation which would move research in
their disease forward. While the suffering and frustration that
is here is not easily cured, I also recognize that allocating
funding based on which advocacy groups have the most presence
on the Hill hurts other diseases such as rare diseases. Is this
an accurate statement? Yes or no.
Mr. Collins. With great sympathy for those advocacy groups,
it is a risk of having one battle against the other. We would
be better to support all of those.
Mr. Dingell. Thank you, Doctor.
Now, Mr. Chairman, I want to thank you for holding this
important hearing. As this Congress knows, science, technology,
engineering and math are the future of this country's economy,
and we have to be at the cutting edge of all. Both parties,
Democrats and Republicans, acknowledge the importance of
working steadfastly to promote the training of our youth in
these fields in order to secure our title as the world's leader
in innovation and to bring the blessings that come with that
kind of activity.
Today, the National Institutes of Health is the premier
biomedical research institution in the whole world dedicating
to promoting the public's health and wellbeing through
research. The NIH has also had the foresight to recognize that
cutting-edge advances in areas such as biology with the
forefront of technology is where the next generation of life-
altering advances will come from. So it is easy to see then how
NIH's ability to be competitive in worldwide research is not
only critical to our citizens but also to our economy, and I
worry that the United States may be losing its competitive edge
and that countries like China may be taking away the jobs and
the future of our young people
So Dr. Collins, I appreciate your assistance here, your
presence today, and Mr. Chairman, I thank you for your kindness
in this matter.
Mr. Pitts. The Chair thanks the gentleman and recognizes
the gentlelady, Ms. McMorris Rodgers, 5 minutes for questions.
Mrs. McMorris Rodgers. I thank the chairman, and I want to
thank Dr. Collins for coming today, and I echo the comments and
just so appreciate your leadership at NIH and everything that
you are doing. I appreciated your testimony this morning.
I had the opportunity recently to meet with Dr. Chris
Austin from NCATS and was very excited to learn about NCATS and
particularly one pilot project, the Discovering New Therapeutic
Uses for Existing Molecules Program, and I understand that this
program will bridge the, quote, valley of death, that we hear
so much about during the FDA reauthorization process.
I wanted to ask, do you think that this kind of an
expansion of a role at NIH is going to improve NIH and better
reflect the health care needs in our country, given that some
are suggesting that this kind of an expansion of mission from
medical research to drug development may be beyond what NIH
should be doing?
Mr. Collins. Well, I understand the concern, and certainly,
when NCATS was first being rolled out, there was a lot of
misunderstanding about what its goals really were. I asked a
distinguished group of experts from the private sector, people
like Moncef Slaoui of GSK, Marc Tessier-Lavigne recently of
Genentech, Brook Byers, venture capital expert, to look at the
NCATS potential and advise me about whether this really made
sense in terms of advancing the cause of developing new
therapeutics in a fashion that built on NIH's sweet spots and
was not sort of a deviation from what our mission should be.
They started out intensely quizzical and ended up wildly
enthusiastic, and I would be glad to share their report with
this committee.
That certainly encourages the conclusion that we are moving
in a place that science now allows us to do in a partnership
with the private sector to make sure that we are collaborating
effectively, but with the main goal of speeding up this
development of therapeutics. This is not, however, going to
detract from our basic science engine, which is, of course, the
critical way in which we develop new ideas for treatments of
the future. That will remain about 50 percent or 51 percent of
what we do. It is mostly reorganizing capabilities that we had,
and you learned about some of those from Dr. Austin, into a
more effective engine for doing this kind of discovery focused
on the bottlenecks.
Mrs. McMorris Rodgers. Well, it seems like a commonsense
approach in starting to break down some of the silos that so
often are difficult for us.
On another vein, I know that you are aware of the specific
biologic link between Down syndrome, that duplicate 21st
chromosome, and Alzheimer's disease. I am also aware that
people with Down syndrome appear to have a protection from the
development of some types of cancer, and this seems to be a
population from which many researchers could learn many things,
not only that would help people with Down syndrome but to help
the general public, and I wanted to ask what other efforts do
you see as a catalyst for improving collaboration between
scientists and institutions?
Mr. Collins. Well, I do agree that Down syndrome is an
important model for understanding a variety of things that you
mentioned, the Alzheimer's risk, which we believe comes about
because on that 21st chromosome is the gene for beta amyloid
and it is amyloid that builds up in the brain of individuals
with Alzheimer's, and Down syndrome individuals have extra
amounts of it because of that extra chromosome. The fact that
there is a protection against cancer has recently come to light
and is certainly intriguing, suggesting that we could learn
something there as well.
I know you have spoken with Dr. Guttmacher, who is the
Director of the National Institute of Child Health and Human
Development, and he has now recently formed a Down syndrome
consortium bringing together NIH and a variety of other
organizations to focus on such things as, should there be a
Down syndrome registry to be able to be sure that we have the
maximum opportunity to collect that kind of data and even to
offer clinical trial participation in a broader way, and I am
excited to see where that goes. I am trained as a geneticist
myself. Certainly, Down syndrome has taught us much and we owe
those individuals and their families everything we can in terms
of understanding how that extra chromosome results in all the
consequences that it does. So it is an area of great, intense
current interest.
Mrs. McMorris Rodgers. Thank you, and much potential.
I am going to yield back the balance of my time.
Mr. Pitts. The Chair thanks the gentlelady and recognizes
the gentleman from New York, Mr. Towns, 5 minutes for
questions.
Mr. Towns. Thank you very much, Mr. Chairman, and thank you
for this hearing, and thank you very much, Dr. Collins, for
coming.
My question, Dr. Collins, is, according to the most
recently available data in an area that I represent, Brooklyn,
72,000 children in Brooklyn suffer from asthma, and I know the
disease disproportionately impacts children in high-poverty
neighborhoods, but there is a pocket of middle class, and of
course, the superintendent of the school indicated that a third
of the kids in that school that reside in that area that have
missed 50 days or more of school because of asthma, and they
have not been able to determine in terms of what is really
going on in that area. Is there any kind of special grants that
you could have to look at a situation like that?
Mr. Collins. Well, I appreciate the question and I
certainly agree that asthma is a cause of great concern, and
NIH has major programs focused on research in this condition,
primarily through the National Heart, Lung and Blood Institute.
And asthma has been increasing in its frequency in children and
certainly that is also somewhat of a puzzle. Clearly, asthma is
a classic example of a genetic-environment interaction. We know
it runs in families. I had severe asthma as a child, as did two
of my brothers, and yet it is not sufficient to have the
genetic risk, there are triggers, and we think that some of
those that we know about are animal hair and feathers and house
dust mites, which is a big part of this.
But to actually develop better interventions is a big part
of what we are now trying to do, and it does seem that one of
the things, Mr. Towns, that we have to understand better is to
how to break this disease which we just call asthma into
subsets that are actually different in terms of their natural
history, in terms of their response to therapy, and try to see
whether within that disease are actually 10 different diseases
that if we understood them better, we would realize how to
personalize the approach to prevention and treatment, and that
is one of the things that is making some progress, in part
built upon genetics because we are understanding now what some
of those risk factors are and which kids have risk factor may
in fact have a lot to do with their response to treatment.
But we have a ways to go. Clearly, this is an area that in
terms of pediatrics, the Child Health Institute, also intends
interest in. We are running a number of clinical trials to try
to test out new approaches. It is right in that space of
needing to encourage translation that we have been talking
about this morning.
Mr. Towns. Right. I know that the former chairman of the
committee mentioned the merger. Have you looked at the merger
from a cost analysis? Have you done that already?
Mr. Collins. You are talking about the merger between the
Drug Abuse Institute and the Alcohol Institute?
Mr. Towns. That is correct.
Mr. Collins. Basically, what we are doing is thinking about
how we could best support the science of addiction by bringing
together grants that are funded through these two institutes
and putting them under one roof. There was no expectation here
of a shrinkage or an expansion of the overall portfolio but a
rearrangement of the way in which they are overseen. So the
costs should essentially not be changed more than a small
amount based on simply perhaps a small amount of administrative
savings from having one institute instead of two, although I
really wouldn't want to emphasize that as being particularly
significant because almost all of our budget goes into the
grant portfolio, and we would not expect that to change.
Mr. Towns. And so research funding will not be impacted by
this?
Mr. Collins. It will not. The overall research funding
envelope for addiction research will remain in the same place.
Now, it may be that over the course of time, science will drive
that in certain directions so that some parts of addiction
research will get more attention than others. That is the
nature of our business but we won't keep that total support for
addiction research on the same path that it has been on.
Mr. Towns. My time is almost expired. Let me ask, back to
asthma again, is there any areas in the country where you have
seen this where it is the middle class or an area where you
have this high asthma rate?
Mr. Collins. Absolutely, and, you know, there is a theory.
In fact, there is a piece about it today in the Times that one
of the problems that we have in some environments is that our
efforts to make the environment squeaky clean has actually
increased the likelihood of asthma, that in the old days when
children were exposed to lost of different kinds of dirt
substances or infectious disease substances early in their
life, they learned how to deal with that, and in some way we
protected kids against that kind of exposure. Their immune
systems haven't gotten revved up when they were supposed to so
they get over-revved up later on. There is a fair amount of
support for that theory, and that may apply particularly in
circumstances where there are a lot of resources in the family
and a lot of attention to having everything spic and span.
Mr. Towns. Thank you very much, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman and recognizes
the gentleman from Louisiana, Dr. Cassidy, 5 minutes for
questioning.
Mr. Cassidy. Hey, Dr. Collins. Thank you for being here.
There is an article by Gillum, first author, NIH funding
levels and burden of disease. It relates to the interval
between 1996 and 2006, and not your watch, but still, and it
speaks about how in 1996, only about 39 percent of the variance
between what a disease, if you will, is funded relative to its
disability associated life years, etc., was explained by
objective factors. And actually, between 1996 and 2006, that
actually declined from like 39 percent to 33 percent. On your
watch, can you tell us if there is now a better correlation
between how diseases are funded relative to their impact upon
mortality, morbidity, disability, etc.? Because I am looking at
your Web site. It is very difficult for me to figure out if
that is the case or not.
Mr. Collins. Thank you for the question, Dr. Cassidy.
Certainly, one of the things the Reform Act gave us the
opportunity to do was to form a new division, a division that
has as part of its mandate doing portfolio analysis
systematically across the entire NIH, trying to identify
whether we have a reasonable match between public health needs
and our own investments in research, and we now have more tools
to do that certainly than they did in 2006, especially now that
all of our grants are online and you can compute on them and
see what they are actually covering. So we are looking at that
with more capability and more intensity.
Mr. Cassidy. Now, can I interrupt just for a second because
time is so limited? I apologize.
Mr. Collins. Yes.
Mr. Cassidy. When I look at the funding back in 2006 where,
for example, AIDS/HIV, particularly if you add pediatric HIV,
incredibly important disease, is getting more than ischemic
heart disease, even though ischemic heart disease is the
leading cause of death, and obesity, which you mentioned in
your written testimony as being so important, affecting 30
percent of our population, is, I think, 40th in terms of the
ranking of your priorities as you have it listed. Now, there is
some double counting so maybe it is higher, but it is like, I
think, $800 million a year versus $2.5 billion. So it seems,
since that was also in 1996 and 2006 its relative ranking, has
there really been that much change?
Mr. Collins. There has probably been a little, but let me
say, I think one needs to be careful not to have this kind of
analysis based on dailies being the sole way in which decisions
are made about research opportunity. In addition to public
health needs, there are circumstances where science provides
lots of opportunity for things to go quickly and others where
simply throwing the money at the problem there is no great new
idea----
Mr. Cassidy. But there is no way to know that previously,
right? There is going to be a paradigm shift and so suddenly it
would seem like throwing money is opening a door.
Mr. Collins. Well, right. So there is a connection there.
That analysis, by the way, seemed to indicate that Alzheimer's
disease actually was getting the kind of support that maybe it
should, and I think I----
Mr. Cassidy. No, no, no. What I see on Alzheimer's disease
when I just looked at it, and again, you mentioned that in your
written testimony, it is really way down there in its funding.
I had it written down someplace but in my mess I can't tell,
but I was struck how low the funding is relative to its
potential burden.
Mr. Collins. In that regard, as you know, and this may come
up in other speakers, certainly Alzheimer's has emerged as a
scientific opportunity in the last few years and everybody
would agree is a major public health initiative so we have made
significant new investments in the current fiscal year of an
additional $50 million for Alzheimer's.
Mr. Cassidy. But relative to its overall burden, $50
million is nice in an absolute number. Man, I wish I had $50
million. On the other hand, relative to your overall funding,
again, I am struck that HIV/AIDS has remained at the top, $2.5
billion, and then ischemic heart disease is here, obesity is
there and Alzheimer's really here. So in terms of an absolutely
amount, that is a lot, but in terms of its future burden to our
society, it almost seems miniscule.
So let me ask you, how often do your councils actually
redirect funding?
Mr. Collins. That is their job, so----
Mr. Cassidy. But do they do it?
Mr. Collins (continuing). Every time the council meets,
they look at the grants that are in front of them. They decide
what new requests for applications to approve. That is their
job.
Mr. Cassidy. But how often do they do that?
Mr. Collins. Oh, the NIH councils are looking at new
requests for applications which steer money in a new direction
every----
Mr. Cassidy. So if I were to look at your funding over
time, I could see between these different categories that there
would be a significant shift between funding levels?
Mr. Collins. You would see some shift. Again, it would not
be driven by daily. It would be driven also by scientific
opportunities, and some of those don't match, as we just said a
minute ago.
Mr. Cassidy. But if the correlation was 33 percent in 2006,
is that correlation better now--do you follow what I am
saying--with disease burden, etc.? Because scientific
opportunity is frankly inertia to a certain extent. This is
what we have always funded. They have got a lab set up and we
are going to continue a grant. It may be--I am out of time, we
have got to vote, but I will submit that for the record. Thank
you.
Mr. Collins. Thank you very much.
Mr. Pitts. The Chair thanks the gentleman.
We are being called to vote on the floor with 20 votes and
a motion to recommit that is going to go a while. Dr. Collins
has other commitments. So I would suggest that we go to at
least 1 minute per member so everyone can get an opportunity to
ask questions. If that OK, we will go to Mr. Lance from New
Jersey, 1 minute for questions.
Mr. Lance. Thank you, Mr. Chairman.
Thank you, Dr. Collins, for your enormous service to the
Nation and I look forward to working with you on the pancreatic
cancer issue.
I recently was made aware of a June 2011 article that you
wrote entitled ``Mining for Therapeutic Gold,'' and I was
interested that you mentioned the need for incentives for
further development and commercialization and the importance of
intellectual property considerations. Sir, would you please
elaborate on the challenges that intellectual-property
considerations present?
Mr. Collins. Very briefly, I would like to see intellectual
property used in a way that I think Ben Franklin intended,
which is as an incentive for commercial development. When it is
used in that way, it benefits everybody, the public. When it is
used prematurely to claim intellectual property on information
that really should be in the public domain, then it can
actually have a counteractive effect.
Mr. Lance. Thank you very much.
Thank you, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman and goes to Mr.
Latta from Ohio for 1 minute for questions.
Mr. Latta. Thank you, Mr. Chairman. Since Dr. Gingrey had
to render assistance, I yield my minute to him.
Mr. Gingrey. Mr. Chairman, I sincerely thank the gentleman
from Ohio, and Mr. Chairman, I thank you also. I know that I
was in the midst of asking a question of Dr. Collins in regards
to the Special Diabetes Program, and I was informed that you
will respond, Dr. Collins, to that question in a written
format.
Let me just take the remaining seconds of the minute that
my friend from Ohio has yielded to me to thank you, Dr.
Collins, for responding to the minor medical emergency that
occurred. The young lady is fine. But I think it should
reassure every member of this committee of the quality and
character of our witness today, and you can find that out by
reading his bio. I did. We have a lot in common, that chemistry
degree you got and of course went on and got an advanced degree
in physical chemistry, but when you finally took a biochemistry
course, you decided you wanted to become a physician. I took
that first physical chemistry course and made a D in it, and I
knew immediately that I wanted to become a physician. So we
have a lot in common. I just thank you for your compassion and
kindness of responding to the medical emergency. Thank you, Dr.
Collins.
Mr. Collins. Thank you, Doctor.
Mr. Pitts. I thank the gentleman and yields to Dr. Murphy
from Pennsylvania 1 minute.
Mr. Murphy. Dr. Collins, recently when we met, I had asked
you how much is spent in NIH grants on overhead and indirect
costs. You said it ranges from 60 to 90 percent. I believe most
universities are around 50 percent. I understand indirect cost
rates for private research funded by the Leukemia and Lymphoma
Society is 25 percent, Juvenile Diabetes Research Foundation is
20 percent. Bruce Alberts of the University of California at
San Francisco said schools' reliance on the NIH to pay not only
the salaries of scientists but also the overhead or indirect
costs of building and construction and maintenance is a
perverse incentive that encourages U.S. universities, medical
centers and other research institutions to expand their
research capacities.
In 2006, Yale University with an endowment of $18 billion
received $348 million in Federal research grants. Their own
spending in the university for research was $29 million.
Stanford University with an endowment of $14 billion received
$540 million in Federal research funds and only spent $40
million of its own money for research. MIT with an endowment of
$10.5 billion, $476 million in Federal research funds, spent
only $10 million of its own money. Excuse me. Their endowment
was $8.3 billion. Harvard University, a $40 billion endowment,
larger than the NIH budget, they spend zero of their own
dollars on research but they have 75 percent overhead costs.
Can you justify this for the U.S. taxpayers and other
researchers who cannot get funding for pancreatic cancer,
cystic fibrosis, mitochondrial disease why you do it this way
when these universities aren't spending their own money?
Mr. Collins. I know I have very little time. Again, NIH
does not set the indirect-cost rates of those----
Mr. Murphy. But other places can do it for 20 or 25 percent
over it. I recognize this is a huge question. As an adjunct
associate professor at the University of Pittsburgh, which is a
recipient of a lot of NIH funding, I hope we can talk more
about this because it deeply concerns us to have money
available. The answer is not just to raise taxes. But I really
hope that is something we can work more with you on to find
solutions.
Mr. Collins. I would be happy to do that.
Mr. Pitts. The Chair thanks the gentleman and recognizes
the gentlelady, Ms. Myrick, for 1 minute for questions.
Mrs. Myrick. Thank you, Mr. Chairman. Thank you for being
here, Dr. Collins.
I am sure that you believe holding the integrity of the
peer review process is very important not only because of
scientific reasons but also because of the taxpayer dollars
spent. I have a question about conflict of interest at NIH
relative to the selection of scientific review groups and study
sections. Just looking at this one list of chair members of a
particular behavioral science group, it looks like several of
the individuals are serving or have served received grants
while they were actually serving on the board who determines
who gets the grants, and, you know, a couple of them, one of
them was meth addicts to take their medicine, that kind of
thing. So my question really is, does that not run counter to
the conflict of interest and would you--I know our time is
short but could you get back to me in writing? And then I have
got a couple others I would like to submit to you.
Mr. Collins. I would be happy to get back to you. We have,
I think, very careful methods in place to try to avoid that
kind of conflict so somebody in that position would not have
their grant reviewed by that same----
Mrs. Myrick. Well, this particular one says that they
actually did receive the grant, so I will get it to you. Thank
you.
Mr. Pitts. The Chair thanks the gentlelady and goes to Mr.
Bilbray for 1 minute for questions.
Mr. Bilbray. Doctor, what percentage of NIH's research goes
right from the researchers to the consumers and medical
service?
Mr. Collins. You mean direct clinical application?
Mr. Bilbray. Right.
Mr. Collins. I would say a rather small proportion because
generally it has to go through commercialization.
Mr. Bilbray. What percentage of your research goes through
the private sector commercialization?
Mr. Collins. The vast majority.
Mr. Bilbray. Give us a percentage.
Mr. Collins. Again, 51 percent of our budget is basic
research, which doesn't have a specific commercial connection
when it is being done, although it may ultimately----
Mr. Bilbray. But it is fair to say an essential component
of getting your research to the patient is the private-sector
involvement in the transition from basic research to practical
application?
Mr. Collins. Absolutely, and a central component of their
success is our providing them with that information.
Mr. Bilbray. Are you aware there are some people in that
field of venture capital for medical research that have
indicated that we could have in the last few years lost almost
50 percent of venture capital that builds that bridge between
your research and the patients who need the breakthroughs?
Mr. Collins. There has been a serious stress on that system
for sure.
Mr. Bilbray. I have been informed that because of the
valley of death not being closed and other regulatory issues
that there is a possibility we could lose a half of what exists
of what is left over. What kind of impact will that have in
this country if we don't have that private-sector investment to
be able to bridge that gap between your research and the
patients?
Mr. Collins. Well, it would be devastating. We need that
partnership.
Mr. Bilbray. Mr. Chairman, I appreciate that. I would just
like to point out, Mr. Chairman, that it has been estimated we
have 1.4 to 2 trillion of American dollars overseas, and one of
the things that my research people said that maybe Democrats
and Republicans could get together and say look, if you put
your foreign capital into medical research here in the United
States, that both sides of the aisle should agree not to take
35 percent of that in Federal taxes but to basically focus it
to bridging this gap, and I yield back, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman and recognizes
the gentleman, Mr. Markey, 1 minute for questions.
Mr. Markey. Thank you, Mr. Chairman, very much.
Dr. Collins, if sequestration goes into effect on January
1st of next year and across-the-board cuts occur, will there be
reductions in research for Alzheimer's at NIH in terms of the
grants?
Mr. Collins. Absolutely, as well as reductions in virtually
all the fields that we support.
Mr. Markey. So just as we recognize that we spent $140
billion in Medicare and Medicaid last year on Alzheimer's
patients, we would begin to reduce the research for the cure
for Alzheimer's?
Mr. Collins. With $2.4 billion being removed from the
budget, there would be no way to actually spare any field of
medical research from at least degree of cut.
Mr. Markey. Oh, my goodness. Oh, my goodness. That would be
tragic.
Thank you, Doctor. Thank you for your good work.
Mr. Pitts. The Chair thanks the gentleman.
I am sorry we have been interrupted by Floor votes. This is
an excellent hearing.
We will urge the members to follow up with questions in
writing to you. I remind the members that they have 10 business
days to submit the questions for the record, and ask if you
would please respond to the questions promptly.
Thank you very much, Dr. Collins, for your excellent
testimony and answers to our questions.
Members should submit their questions by the close of
business Friday, July 6th. Without objection, the subcommittee
is adjourned.
[Whereupon, at 1:50 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]

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