[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

                        energycommerce.house.gov




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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

                              ----------                              
                                                                   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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