[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
NIH IN THE 21ST CENTURY: THE DIRECTOR'S PERSPECTIVE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
JUNE 15, 2010
__________
Serial No. 111-133
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah JOHN SULLIVAN, Oklahoma
JANE HARMAN, California TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
C O N T E N T S
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Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 3
Prepared statement........................................... 5
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 9
Prepared statement........................................... 10
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 16
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 18
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 19
Hon. Christopher S. Murphy, a Representative in Congress from the
State of Connecticut, opening statement........................ 20
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, opening statement..................................... 21
Hon. Tammy Baldwin, a Representative in Congress from the State
of Wisconsin, opening statement................................ 21
Hon. Lois Capps, a Representative in Congress from the State of
California, opening statement.................................. 22
Hon. Gene Green, a Representative in Congress from the State of
Texas, prepared statement...................................... 80
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 83
Witnesses
Francis S. Collins, M.D., Ph.D., Director, National Institutes of
Health......................................................... 22
Prepared statement........................................... 28
Answers to submitted questions............................... 92
Submitted Material
Letter of June 14, 2010, from Senator Durbin and Representative
Shimkus to the National Cancer Institute....................... 90
NIH IN THE 21ST CENTURY: THE DIRECTOR'S PERSPECTIVE
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TUESDAY, JUNE 15, 2010
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 1:11 p.m., in
Room 2123 of the Rayburn House Office Building, Hon. Frank
Pallone, Jr. [Chairman of the Subcommittee] presiding.
Members present: Representatives Pallone, Dingell, Gordon,
Eshoo, Engel, Green, DeGette, Capps, Baldwin, Barrow,
Christensen, Castor, Sarbanes, Murphy of Connecticut, Space,
Waxman (ex officio), Shimkus, Whitfield, Pitts, Burgess,
Blackburn and Gingrey.
Staff present: Bruce Wolpe, Senior Advisor; Ruth Katz,
Chief Public Health Counsel; Sarah Despres, Counsel; Robert
Clark, Policy Advisor; Stephen Cha, Professional Staff Member;
Virgil Miller, Professional Staff Member; Anne Morris,
Professional Staff Member; Alvin Banks, Special Assistant;
Allison Corr, Special Assistant; Emily Gibbons, Professional
Staff Member; Lindsay Vidal, Special Assistant; Earley Green,
Chief Clerk; Clay Alspach, Minority Counsel, Health; and Ryan
Long, Minority Chief Counsel, Health.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Good morning, or is it afternoon, I should
say. We are having a hearing today and we are hearing from just
one witness, Dr. Francis Collins, the director of the National
Institutes of Health, and I think the members of the Energy and
Commerce Committee are of course well acquainted with your
great leadership that you have shown at NIH dating back to 1993
when you started your 15-year successful tenure as the director
of the National Human Genome Research Institute. Your efforts
as director of NHGRI resulted in discovering a number of
important genes including those responsible for cystic
fibrosis, neurofibromatosis, Huntington's disease, a familial
and doctrine cancer syndrome, and most recently, genes for type
2 diabetes. And this work contributed to your being awarded the
Presidential Medal of Freedom in 2007 as well as the National
Medal of Science in 2009, the highest honor bestowed on
scientists by the United States government. So we welcome your
well-informed perspective today.
I just wanted to say that the outstanding biomedical
research that NIH supports has had a transformative effort on
our national health. U.S. life expectancy has dramatically
improved over the past century as diseases once fatal have
enjoyed scientific discoveries resulting in targeted, effective
and personalized treatment strategies. Patients once crushed by
no treatment or toxic treatments of nominal value benefit from
the collaborative, innovative work done by some of the world's
best researchers here in Bethesda and all 50 States and in 90
countries around the world, and I am personally proud of the
great partnership the NIH has with Rutgers University in my
district as well as with the University of Medicine and
Dentistry of New Jersey Medical School, which is the Nation's
largest freestanding public health science university.
Now, we commend the progress NIH has made and cheer you on
for the discoveries we know you will realize in the future.
From Alzheimer's to autism to cancer to heart disease, we know
that our federal dollars are hard at work. While I could go on
at length about all the research you and your team are
undertaking, I just wanted to mention a couple of examples. As
you certainly are well aware, the war against cancer continues,
and for good reason. Nearly 500,000 people die annually of the
disease, but research conducted by NIH has resulted in the
overall cancer rate decreasing and treatment is no longer
reactive but proactively targeted to the genetic profile of
each patient's cancer.
Further, NIH's collaboration with public and private
entities strengthens the global effort to fight infectious
diseases. Antimicrobial drug resistance, which has been a
subject of examination by the Health Subcommittee, is a top
priority of NIH's National Institute of Allergy and Infectious
Diseases. NIAID has shepherded basic research on resistance as
well as facilitated partnerships with industry and nonprofit
organizations to develop programs aimed at better controlling
antimicrobial drug resistance. And just this week, NIH
researchers announced the identification of two previously
unknown steps in the spread of malaria in the bloodstream.
Progress like this could have a profound effect on our global
health, and today malaria kills over 1 million people annually,
the majority of whom are young children in sub-Saharan Africa.
I wanted to say the Energy and Commerce Health subcommittee
is proud of its long and productive relationship with NIH. We
support the cross-cutting collaboration of researchers across
disciplines and empower the NIH to continue to promote
innovation in the bipartisan NIH Reform Act of 2006. We look
forward to hearing an update today on the fully implemented Act
including the work realized through the Common Fund.
Dr. Collins, if I could just take a minute, though, before
I turn over to our ranking member, Mr. Shimkus. I wanted to
take a minute, if I could, from my colleagues' time or, you
know, add to our time to thank a long-time member of my staff
and the Energy and Commerce Health Subcommittee, Bob Clark or
Bobby Clark. I always call him Bob and everybody else calls him
Bobby. Would you stand up a minute, Mr. Clark? Most of you know
him as being a staff member of the Health Subcommittee but
actually he is kind of--I don't know--I guess the best example
I have ever had of someone who actually walked into my district
office as an intern at Rutgers University, worked as an intern,
then was hired to work on the campaign, then worked as a staff
person in the district office for a couple years, and then said
he wanted to go to Washington, which I thought was a good idea.
He came down to Washington, worked as a legislative person.
Were you the receptionist before you even did that? I think he
was even the receptionist for a while. And then he became a
legislative assistant and then he went to Georgetown and got an
M.A. in public health or health. Then he came back and worked
as the legislative person on health care, and then finally went
to the Health Subcommittee. Now he is moving on again. But I
think he is probably--he may have been the only person who did
absolutely everything, you know, from being the Rutgers intern
all the way now to being on the Health Subcommittee staff. And
you can't imagine the things I had him doing, not just health
care but Native American and everything else on earth, and he
is also obviously a proud alumnus of Rutgers University. So I
just wanted to take the time to mention that Bob is leaving at
the end of this week and we wish him Godspeed.
I will now yield to Mr. Shimkus, our ranking member. Thank
you.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman.
Let me join you in wishing Bobby Godspeed in his new
profession. He now gets to go into the private sector. He may
become more Republican because of that, and I look forward to
visiting with him real soon.
Thanks for the hearing. It is an important hearing. NIH is
something that we all have said for numerous years is an
important thing even when I first came here just doubling NIH
funding which, you know, happened under Republican stewardship,
was a big deal. We never have enough money for basic research
and we always ask for more. So we are all very supportive of
what can be done. We are particularly excited about, as the
ranking member on the Health Subcommittee and even before that,
the personal experiences of individuals with diseases of
cancers. We are excited in this cancer genome atlas gastric
cancer is now going to be included.
Everybody wants more money for every research facility but
I do think that in this discussion of cancers if we focus on
those that aren't cured right now or can't be delayed in doing
the research like on the gastric survival rate, getting people
to survive, then we can move in a direction. So I know the
committee was gracious in testimony we had earlier this year.
That has been followed up by appropriation hearings. For
Americans age 25 to 39, one's likelihood of being diagnosed
with gastric cancer has increased almost 70 percent since 1977.
So it is something, everyone has causes and that is one that we
have been working on. So we will focus on that.
I am going to keep my opening comments short. We are
concerned about the influx of cash in the stimulus bill and the
2-year focus because most of your stuff goes longer years than
that and we are concerned about, well, what went well and what
went poorly and because of the limited time frame.
I can't leave a health care hearing without talking about
the new health care law. We were told it would save average
premiums $2,500 a year. CBO says it is going to increase
premiums $2,000 a year. But next week the new temporary high-
risk pool program should go online, and informal discussions
with some States, these high-risk pools are going to have to do
something we said we weren't going to do. They are going to
have to cap enrollees. They are going to have to create
preexisting condition exclusion. Those are things we could fix
if we would just talk about this new law and try to address
some of the reforms.
So not as long as I normally go, Mr. Chairman. Thank you
for your time and I yield back.
[The prepared statement of Mr. Shimkus follows:]
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Mr. Pallone. Thank you, Mr. Shimkus.
I yield to our chairman of the full committee, Mr. Waxman.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Chairman Pallone. I thank
you for this hearing. And I also want to pay tribute to Bobby
Clark. While he was part of your subcommittee staff, he was
part of the team working tirelessly on health reform. He was
famous among the staff for his amazing command of detail and
his calm-in-the-storm demeanor, and we will miss him and we all
wish him well in his new endeavor.
For the hearing today, it is a great pleasure to have the
new director of the NIH, Dr. Francis Collins, come and testify.
He is a renowned researcher who among other scientific
achievements led the government's effort to map the human
genome. NIH is the preeminent health research institution in
the world. It is recognized across the country and around the
globe its outstanding work, and with good reason. The research
NIH supports and conducts not only has resulted in cutting-edge
scientific breakthroughs, it also led to real and meaningful
improvements in public health.
But the work of NIH truly is never done. Even, as we learn
more about disease and the human condition, the list of
research challenges grows. Some 40 years ago, for example, we
thought of cancer as a single disease and now--it is much more
complicated. Because of its outstanding work, we continue to
look to NIH to help solve the trickiest of medical riddles such
as Alzheimer's disease, diabetes, autism, spinal cord injury,
Parkinson's disease and many others, and we also look to NIH to
figure out how to prevent disease and disability wherever we
can. Our job in the Congress is to ensure that NIH has the
funding it needs for its researchers to continue their world-
class work. Money is in short supply, I know, but federal
support for NIH is not where we can afford to cut back.
In this time of both endless research possibilities, basic
and translational, and difficult economic challenges, Dr.
Collins has come forward to lead NIH and the brilliant
researchers it supports. We are eager to hear from him about
his plans and how best in the years ahead to meet NIH's mandate
and continue the institute's longstanding legacy for making an
immeasurable difference in the lives of all Americans. Thank
you very much, Dr. Collins, for being here and to share your
plans and priorities at NIH with us.
Yield back the balance of my time.
[The prepared statement of Mr. Waxman follows:]
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Mr. Pallone. Thank you, Chairman Waxman.
Next is the gentleman from Texas, Mr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman.
Welcome, Dr. Collins, to our humble little committee.
I am going to submit my statement for the record and
reserve time for questions because we rarely get a witness with
this much firepower, and time is better spent for questions, so
I will yield back.
[The information was unavailable at the time of printing.]
Mr. Pallone. Thank you.
Our chairman emeritus, Mr. Dingell.
Mr. Dingell. Thank you, Mr. Chairman. I commend you for
this hearing. I look forward to the result of it, and I ask to
revise and extend my remarks. I have an admirable statement
which everyone will enjoy reading.
[The prepared statement of Mr. Dingell follows:]
[GRAPHIC] [TIFF OMITTED] T7910A.010
[GRAPHIC] [TIFF OMITTED] T7910A.011
Mr. Pallone. Without objection, so ordered, and any member
may submit a statement and we will make it part of the record.
Thank you, Chairman.
Next is the gentleman from Georgia, Mr. Gingrey.
OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Gingrey. Mr. Chairman, thank you.
The United States is a global leader in medical research
and innovation, and we in large part have the National
Institutes of Health to thank for these efforts. Today, roughly
30 percent of the funding for disease research equaling almost
3 percent of our gross domestic product comes from the NIH and
our federal government. These investments have advanced our
understanding and treatment of many life-threatening diseases.
Recently, an NIH-funded organization at the University of
Illinois-Chicago made national news when they reported finding
key genomic markers common in autistic children. These findings
may one day support our effort to understand what factors
contribute to this disease.
Additionally, a dozen competing drug companies announced
late last week that they would be taking the unusual step of
sharing data on Alzheimer's disease. The hope is that this
database of information created in consultation with NIH will
spark news ideas for treatment of that grave disease. I would
like to commend you, Dr. Collins, for helping to foster this
groundbreaking collaborative approach.
In addition to these efforts, NIH grants have resulted in
the discovery and development of many lifesaving medical
treatments. Since coming on the market, the combination of the
drug Herceptin with chemotherapy has been shown to increase
both survival and response rates for patients with breast
cancer including reducing the risk of relapse by 50 percent
when given to patients immediately following surgery. However,
I do want to strike one note of caution. The drug Herceptin is
widely available in the United States, but this was not always
the case in Britain. England initially denied coverage of the
drug and only relented after many public demonstrations
including a protest march by thousands of women through the
streets of London.
I raise these points because, as many of you know, Dr.
Donald Berwick was recently nominated director of the Centers
for Medicare and Medicaid Services by President Obama. This is
the same Donald Berwick who just last year stated, and I quote,
that ``the decision is not whether we will ration care. The
decision is whether we will ration with our eyes open.'' To be
frank, I fear that the groundbreaking treatments funded by NIH
that we are celebrating here today will not be made available
to our seniors if the political philosophies of Dr. Berwick are
in charge of our Medicare program. Mr. Chairman, our seniors
cannot afford that, that kind of support of health care
rationing.
I look forward, Dr. Collins, to hearing from you. We are
honored with your presence.
Mr. Chairman, with that, I yield back my time.
Mr. Pallone. Thank you, Mr. Gingrey.
Next is the vice chair of our full committee, the
gentlewoman from Colorado, Ms. DeGette.
Ms. DeGette. Thank you, Mr. Chairman. I too will submit my
statement to the record in order to have more time to ask the
wide range of questions I have for Dr. Collins. We are glad to
have him here.
[The information was unavailable at the time of printing.]
Mr. Pallone. Thank you, and as I said, all members'
statements will be submitted for the record.
Next is the gentlewoman from Tennessee, Ms. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman. Thank you for the
hearing, and I want to thank our witnesses for taking the time
to be with us.
I will have to tell you that I am one of those that really
enjoys watching the research that is taking place in my State
of Tennessee. We have over 1,000 NIH research awards totaling
over $440 million that were granted in 2009 alone. Tennessee
organizations such as Meharry Medical, Vanderbilt University,
St. Jude's Children's Hospital as well as several small
privately held companies are making advances in the medical
field that will improve the lives of everyone. Through the use
of NIH funding, the Vanderbilt Institute for Clinical and
Translational Research has pioneered many biomedical research
advances including important discoveries regarding autism,
diabetes and ADHD. Also, with the NIH funding, Vanderbilt
Ingram Cancer Center is the only NCI-designated comprehensive
cancer center in Tennessee that conducts basic translational
and clinical research. Likewise, St. Jude's Children's Hospital
in Memphis is using grant money from NIH to lead the way in
cancer research and I think we have all noted that St. Jude's
was recently named the best children's cancer hospital in the
Nation by U.S. News and World Report.
In addition to funding large research institutions, these
NIH grants to small privately owned businesses throughout
Tennessee such as Max Mobility, which is a small business of
less than 10 employees located in Antioch, Tennessee, are
producing great results. Max Mobility has used NIH funds to
create innovative wheelchair designs and products to greatly
assist regular wheelchair users and it is clear that research
grants from NIH provide the opportunities for organizations to
make and continue these discoveries.
In 2006, this committee passed the NIH Reform Act to cut
bureaucracy, increase transparency and streamline interagency
communication in order to increase efficiency and to hopefully
decrease waste in the funding process. My hope is that we are
going to continue on that path. My concern is that with the
recent changes in the Administration and the passage of the
health care bill that we are going to see a change in those
matters.
So I am looking forward to the hearing today, and I yield
back my time.
Mr. Pallone. Thank you.
The gentleman from Connecticut, Mr. Murphy.
OPENING STATEMENT OF HON. CHRISTOPHER S. MURPHY, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF CONNECTICUT
Mr. Murphy of Connecticut. Thank you very much, Mr.
Chairman. Welcome, Dr. Collins. In discussions beforehand, we
realized that Dr. Collins spent some time in my hometown of
Cheshire, Connecticut, and his kids actually went to the
elementary school in our local neighborhood so it is good to
see that it is a small world.
Dr. Collins, in Connecticut we have been wildly successful
in the last 4 to 5 years investing in stem cell research lines.
Due to federal restrictions, we passed the Nation's first law
putting State funds into our two main research institutions of
Yale and U. Conn. Yale has been able to leverage about twice as
much in private investment money as public investment money due
to these funds, and we are right now opening on the U. Conn
campus an incubation center for spin-offs from the 40-some stem
cell labs that we have at U. Conn today to move into private
sector commercialized developments. It is very exciting but it
presents our State, sort of new to the area of scientific
investment, with some very interesting questions about how to
match public and private partnerships and how to make sure that
our State investment in some of the basic stem cell research
ends up with us sharing in some of the monetary gain to be
happened through the commercialization of some of those
partnerships.
And so whether it is in your testimony or in some of the
questioning, one of the things that I am eager to hear about is
how NIH continues to evolve in its thinking about how the
scientific research that you fund when it becomes
commercialized accrues to the benefit of the taxpayers that
have made those investments. I know you are not a biotech
venture capital firm. You are in this for the science of it and
the lifesaving research, but I hope that we are constantly
thinking as we are in Connecticut of new ways to protect
taxpayer investments when it leads to a private sector solution
that can reap large rewards to a private company even though it
is based in part on federally funded research. We are thrilled
that you are here. We are very eager to hear your testimony
about the new and exciting things happening at NIH so we can
bring your stories back to our constituents, and I appreciate
the chance to ask some questions later on.
Mr. Pallone. Thank you, Mr. Murphy.
The gentlewoman from the Virgin Islands, Ms. Christensen.
Mrs. Christensen. Thank you, Mr. Chairman.
Although my opening statement is not as brilliant as our
chair emeritus, I am going to submit it for the record, and I
would like to welcome Dr. Collins.
[The information was unavailable at the time of printing.]
Mr. Pallone. Thank you.
The gentlewoman from Florida, Ms. Castor.
OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Ms. Castor. Thank you very much, Mr. Chairman, for calling
the hearing, and welcome, Dr. Collins.
I think medical research in America today is very exciting,
and the potential for continued breakthroughs and advances, the
potential is unlimited, and in my hometown of Tampa where I
represent a large research university, the University of South
Florida, that is collocated with a premier cancer research
institute in the Moffett Cancer Center.
All of these NIH awards are terrific. The grants are great,
it improves the public health, but they are important for our
workforce as well as we try to find our way out of economic
recovery. What it means to our workforce needs and the
potential for young people to have good-paying jobs in a
profession that has a great future just cannot be understated.
So I am very interested in your testimony today about the
future of NIH, how we can improve all the grant making that you
do and provide young people with opportunities in this field
and all the great opportunities that lie therein. Thank you
very much.
Mr. Pallone. Thank you.
The gentlewoman from Wisconsin, Ms. Baldwin.
OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF WISCONSIN
Ms. Baldwin. Thank you, Mr. Chairman. I appreciate the fact
that you are holding this hearing today, and Dr. Collins, I am
very grateful that you are here today to share information
about the vital role of the National Institutes of Health in
our health care system and in our economy.
The NIH is especially important to my hometown of Madison,
Wisconsin. It is the largest and most critical source of
research funds for the University of Wisconsin-Madison which in
my own unbiased opinion is one of the word's premier research
institutions.
Basic and applied medical research has and will continue to
have a significant impact on the health of Wisconsin's
residents and the State's economic growth. Biomedical research
has helped raise the average life expectancy of Wisconsin
residents from 52 years in 1920 to 79 years in 2005, and every
year Wisconsin citizens save an estimated $1.6 billion in
health care costs, thanks to public investments in biomedical
research and development. And finally, Wisconsin researchers
bring in a greater percentage of federal bioscience funding per
capita than any other federal program or expenditure in the
State generating thousands of high-quality, high-paying jobs
for our residents.
And I want to add just a little personal note. As somebody
who was raised by her grandparents and having one grandparent
who was a biochemist, I was certainly personally raised off NIH
funds, so I have a personal debt of gratitude to the NIH and
the grants. NIH grants have trained students and created jobs.
They have fostered significant scientific progress and saved
lives.
Yet certainly challenges lie ahead. Budget constraints and
limited funding for infrastructure improvements restrict the
capacity of research institutions to take biomedical research
to the next level, and we must nurture young researchers and
ensure that the next generation of scientists stays in the
field.
So I look forward to your testimony, Dr. Collins, and thank
you for being here today, and Mr. Chairman, I yield back the
remainder of my time.
Mr. Pallone. Thank you.
Next is our subcommittee vice chair, Ms. Capps.
OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mrs. Capps. Thank you, Chairman Pallone, for inviting Dr.
Collins to testify before us today, and thank you, Dr. Collins,
for joining us here. I have been waiting for this occasion, and
I will take less than a minute just to say this is really about
us listening to you, about the fascinating work being done at
the Institutes now, the direction you would like to take the
Institutes into the future and how Congress can best legislate
the authorities for you to meet your goals which are our goals
as well.
Most importantly, how can we keep up with the pace and the
direction of scientific discovery? How can we move to more
quickly translate those discoveries into practice, both in
treatment and in prevention? I bring up prevention because so
often we think about basic research that leads to the
development of chemical drugs, biologics, medical devices, but
there are also very many opportunities to nip disease in the
bud, to diagnose more efficiently and more quickly, and to
prevent diseases before they ever develop.
So I look forward to hearing from you. Thank you very much.
Mr. Pallone. Thank you. I think we have had every member of
the subcommittee do an opening statement so we will move to
you, Dr. Collins. And let me say to the members that Dr.
Collins had asked to speak longer than usual. I don't know if
it was 12 or 15 minutes, something like that, and I said fine,
because he is our only witness today and I think he needs some
extra time to basically develop his testimony. So with that, we
welcome you and thank you.
STATEMENT OF FRANCIS S. COLLINS, M.D., PH.D., DIRECTOR,
NATIONAL INSTITUTES OF HEALTH
Dr. Collins. Thank you, Mr. Chairman, and thank all of you
for those wonderful opening statements. It is clear I am
speaking to a very well-informed group of members. I have been
looking forward this chance for a conversation for some time
and will very much enjoy the questions, and hopefully some
answers that occur after a little bit.
But I did want a chance to say something in the way of a
introductory set of remarks about NIH. It is a great honor to
have a chance to share my vision for the future of biomedical
research as we move into the second decade of the 21st century.
I have submitted my full written testimony for the record, and
I am not going to read from that. I would like to share with
you some major themes that were in that statement, and I have a
few visuals that will appear up there on the screen.
So I would like to thank this committee for your steadfast
support of NIH's mission, which you see here on the slide is
twofold: to discover fundamental knowledge about the nature and
behavior of living systems, yes, but also to apply that in
extension of healthy life and the reduction of the burdens of
disability and illness, and has as already been pointed out by
a couple of you in your opening statements, we are making real
progress there. As you can see, U.S. life expectancy has been
climbing over the course of the past few decades, and if you
look at disabilities, those also have improved substantially in
the course of just the last few years. You can see here the
incidence of disability in the elderly has dropped from more
than 25 percent back in 1982 to now less than 20 percent. But
let me emphasize that human biology is not an end to itself. We
wake up every day trying to think about how to further improve
those outcomes.
Right now, of course, one of the most urgent goals that
everyone is concerned about relates to the BP Deepwater Horizon
oil spill. This is an environmental tragedy of unprecedented
proportions. For the past several weeks, NIH has been
partnering with our sister agencies in the Department of Health
and Human Services to protect the health and meet the medical
needs of Gulf residents and cleanup workers. For example, the
National Institute of Environmental Health Sciences has
provided training and safety information to protect the health
of responders. Its educational course on hazard awareness and
safety is now required for all oil spill workers hired by BP.
More than 30,000 to date have been trained by NIEHS including
the distribution of a safety handbook. I have a copy here that
has been distributed to first-line responders and beach
workers.
But we have to do more here, and so today I am announcing
that NIH will devote another $10 million in existing funds to
support research on the potential human health effects of the
oil spill. NIH through NIEHS will recruit a cohort of 15,000 to
20,000 exposed cleanup workers and Gulf residents. We will
collect their health histories and tissue samples as well as
information about cleanup work they performed and the nature of
their exposures. In the near term, NIH will establish a
baseline of such information and then we will monitor cohort
member for respiratory, immunological and neurobehavioral
effects. So that is an example of some urgent responses, and we
do feel that is part of our job, to respond to those as they
arise.
But we also have to look ahead to tackle our Nation's many
ongoing health problems: obesity, cancer, heart disease,
diabetes, autism, to name just a few, and you all in opening
statements have mentioned quite a number of these. One of my
first actions upon being named NIH director was to scan this
landscape of biomedical research opportunity to try to identify
areas that are really ripe for major advances that could yield
substantial benefits in the coming years, and while that list
of specific projects could go on forever, I have identified
five areas with exceptional opportunity. At your place, there
is a reprint of an article in Science magazine and I would like
to very briefly tell you what these five themes are that seem
particularly ripe now for investments by NIH researchers, and I
will go through them one at a time.
First of all, we have seen invented in just the last 4 or 5
years a number of dramatically powerful high-throughput
technologies that give us the chance to ask comprehensive
questions about how life works, what are all the proteins in
the cell, what are all the components of the immune system,
what are all the steps in development. We couldn't really ask
those questions before and now with technologies like genomics
and imaging, computational biology, nanotechnology, we can do
those things, and the chance to apply them is really
unprecedented in its scope.
A second area that I think is a natural partner to this is
to take all those basic science discoveries that are beginning
to pour out of our laboratories and accelerate the pace by
which those are brought into clinical benefits. NIH
traditionally has partnered with the private sector in doing
this, and we intend to continue that, but we have the chance
now to play an ever-larger role in the front end of drug
development pipelines that previously academic investigators
didn't get involved in, and we aim to try to push that agenda
as quickly as we can in order to take basic science discoveries
to the bedside at an unprecedented pace, and by the way, I
might say the Common Fund, by the NIH Reauthorization Act,
putting it into legislation, is now a major opportunity for me
as the NIH director will be investing substantially in both of
these areas in the coming years because this is an example of
the kind of research that touches on all diseases. It is not
limited to any single institute.
A third area is for us to try to provide the kind of
evidence that is going to be needed to make wise decisions
about health care reform, and that includes things like
personalized medicine, pharmacogenomics, comparative
effectiveness research. It includes health economics to try to
understand how we can better figure out incentives that will
both improve outcomes and result in better care.
And at the same time, we also need to think about, and the
fourth theme, extending outside of our own boundaries to the
rest of the world. We have opportunities in the global arena
now to both create and deploy new kinds of diagnostics and
therapeutics for AIDS, tuberculosis and malaria and for the
neglected tropical diseases that have had relatively little
work done upon them but they affect hundreds of millions of
people.
And finally, the fifth of the five themes is our own
research community, probably our most critical resource. We
certainly will depend upon these wonderfully bright minds in
order to make these discoveries in the coming years and we need
to be sure that we encouraging the best and brightest of the
next generation to come and join us, that we are inspiring
innovation and not just crank turning, that we are improving
the diversity of our workforce, and I might also say that we
are encouraging and stimulating and insisting upon the
integrity of the process to be at the highest level.
Let me just say a word about that. In the process of
overseeing NIH research, one of my priorities to be sure that
we are vigilant about managing any potential conflicts of
interest or even the appearance of such conflicts. I am
determined that NIH should lead in this area, and that is why
we are in the midst of proposing a new set of regulations that
will require more complete disclosure from NIH-funded
investigators about their dealings with industry in order to
maintain the public trust. The need for enhanced trust of
financial conflicts of interest has been made particularly
salient by the news last week that described a particularly
egregious case of failure of an investigator to disclose. In
this case the scientist was sanctioned by his university but
then went on to move to a new university and thus evaded the
sanctions. We are going to fix this problem. The pending notice
of proposed rulemaking about conflicts of interest gives us an
opportunity to address cases where there are such violations of
NIH and university financial disclosure rules. We can clarify
our options for enforcement actions against both individuals
and institutions. So I am committed to making sure that we earn
the public trust and ensure the highest standards of research
integrity and transparency.
Now I want to go on to share several exciting examples of
how NIH-funded researchers are using some of these
revolutionary tools and technologies to expand our
understanding of human biology. The more we learn about how the
body works, the greater our ability to transform that knowledge
into cures and treatments for the many diseases that plague
humankind.
Alzheimer's disease has already been mentioned. Currently,
more than 5 million Americans suffer from this degenerative
brain disorder, and with the aging of the American population,
that number could more than double by 2050 and would greatly
increase the disease's already steep financial toll. If current
trends continue, the annual health care costs associated with
Alzheimer's disease would rise from $172 billion to more than
$1 trillion over the next 40 years.
Now, because Alzheimer's disease has proved to be such a
tough opponent, researchers are now attempting to fight it on
many fronts, and the first prong of attack is an interesting
one that might not have seemed obvious a couple of years ago,
and that is immunotherapy. This involves enlisting the body's
own immune system to prevent the accumulation of beta amyloid,
which is the protein thought to be a major culprit in
Alzheimer's disease. About a decade ago, there was much
excitement about a clinical trial of the vaccine but enthusiasm
flagged when some participants developed brain inflammation,
obviously a serious side effect. Since then, much work has been
devoted to figuring out ways to improve the safety profile of
such vaccines. One new approach which combines immunotherapy
with anti-inflammatory agents has produced encouraging results
so far in animal tests. Other recent work by NIH-funded
researchers has uncovered a possible new drug target for
Alzheimer's disease and one which interestingly brings this
disease into closer molecular harmony with Parkinson's disease
and with Huntington's disease and a few others. In a study just
published last week, researchers describe how a particular gene
that is associated with Alzheimer's, presenilin 1, acts to
cause this disorder, and interestingly, what they learned was
that this protein normally helps clear debris from the brain
but mutations block the normal plan for the trash pickup system
in the brain, leading to a potentially toxic accumulation of
discarded proteins. We already know of a few drugs that would
stimulate the trash pickup, and this is raising new ideas about
an approach to Alzheimer's that people have not thought about
before.
A third effort, and this is a public-private partnership,
is the Alzheimer's Disease Neuroimaging Initiative, which is
combining various clinical neuroimaging, genetic and spinal
fluid measures to understand the events that lead from normal
cognition to Alzheimer's disease to finding biomarkers. Such
data have been rapidly made available to the worldwide research
community and now thanks in this case to an infusion of
Recovery Act dollars from NIH, this initiative, ADNI is
stepping up its efforts even further.
I also want to talk about cancer. Several of you have
mentioned it already. A major project that has been accelerated
by Recovery Act funds is this cancer genome atlas, or TCGA.
Already, TCGA has produced comprehensive molecular
classification systems for ovarian cancer and for glioblastoma,
which is the most common form of brain cancer and a very
serious one. The team survey of glioblastoma recently revealed
five new molecular subtypes of the disease that we didn't know
existed before. In addition, researchers found that responses
to therapy for glioblastoma vary by subtype and that may help
doctors do a better job of matching individual patients with
the therapies are most likely to work for them. What is more,
the findings may lead to new therapies directed at the
molecular changes underlying each type of glioblastoma,
providing targets that we very much need to have in order to
develop the next generation of therapy.
So now in the next phase of the project, again encouraged
by the Recovery Act, TCGA will build comprehensive catalogs of
the key genomic changes in 20 major types and subtypes of
cancer including gastric cancer. These data are being shared
rapidly with the worldwide scientific community and will
provide powerful new clues for all who strive to develop better
ways to diagnose, treat and prevent cancer.
Those are general stories, but to give you a real-life
example, I would like to share the story of Beverly Sotier.
When she was diagnosed with stage IV non-small-cell lung cancer
several years ago, this nonsmoker was told she probably had 6
months to live. Beverly received standard chemotherapy but her
tumors kept growing. Devastating news for her and her children
and grandchildren. But then last July based on a genetic
analysis of her tumor at the Dana Farber Cancer Institute in
Boston, she signed up for a clinical trial of a new genome-
based drug called crizotinib. Now, look at the scans. It may be
a little hard to see where you are but maybe the red circles
will help you, but if you look on the left in both of those
images, her lungs, the black areas, have big white spots in
them. Those are large tumors growing in her lungs. On the right
is after treatment some 5 months later, and those tumors are
essentially gone. So she has had a dramatic result, and in the
first 6 months of treatment most of her tumors have
disappeared.
But this doesn't work for everyone. This particular drug
actually seems only to be successful for about 5 percent of
people with lung cancer, but we know now which 5 percent
because, you see, this drug works on specific genomic changes
called a fusion of a gene called ALK with another gene. If your
lung cancer has that fusion, this is the drug for you because
most of those patients, about three-quarters of them, respond
dramatically to this new therapy. This was just announced a few
days ago at the American Society for Clinical Oncology. People
in the room were blown away by this kind of response and by the
ability to make such a precise prediction about who was going
to respond. So this demonstrates the potential of personalized
medicine, of the value of matching the right treatment with the
right patient at the right time.
Interestingly, Beverly's story also points out rapidly this
can happen. When she was first diagnosed, nobody knew about
this genomic change in lung cancer. That was discovered just 3
years ago and now here she is showing this dramatic response to
a new drug. So it need not be the case that the new
therapeutics take many, many years. Clearly, we need a lot more
stories like Beverly's, not only for cancer but for asthma,
diabetes, depression, heart disease and many other conditions.
The brochure you have at your place outlines some of those
exciting advances.
So it is my hope and my expectation, Mr. Chairman, that
NIH-funded research will bring us much closer to turning
discovery into health for all Americans and to do so quickly.
If our Nation is bold enough to act today upon the many
research opportunities that lie before us, I believe we will
all be amazed at what tomorrow brings.
Thank you very much, and I would be glad to answer your
questions.
[The prepared statement of Dr. Collins follows:]
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Mr. Pallone. Thank you, Dr. Collins, and we are going to
have members ask questions now. Some have 5 and some have 8 if
they didn't do an opening statement, and I will start with
myself for 5 minutes.
Dr. Collins, I am just regularly visited as you can imagine
by families and advocates with very compelling stories about
diseases they have grappled with, and of course the message
almost always is, please increase NIH research for, you know,
the particular disease and particularly of course during the
appropriations season, and of course, every one of us has had
one disease that may have had a profound effect on our lives
either personally or our families. The reason I bring that up
is because many of us believe that we should allow science and
the public health, not politics, obviously, to determine the
research priorities of NIH, and I think that generally
speaking, that is true, and that has been the case. But to be
sure, there are times when the relationship between national
spending, science and public policy have to be considered. Some
diseases like Alzheimer's, for example, are responsible for a
massive strain on our Medicare and Medicaid programs. Other
developmental disabilities like autism have a significant
effect on our families from a very young age and on our school
budgets and social services programs. Obesity, for example, is
skyrocketing and has a major economic impact and is responsible
for loss of productivity, restricted activity, absenteeism. The
point I am trying to make is that it is difficult because many
times the effects of some diseases or disorders has a huge
impact on the economy and the question of how much we spend and
how many dollars are lost, so it is hard to completely take out
funding and politics from the scenario. But what I wanted to
ask you is, what factors you consider when formulating NIH
budget and how can we best work with you to ensure that NIH is
maximizing its research dollars. Do you think that, you know,
perhaps we are being too--you know, that we are not giving you
enough input or perhaps the way we are going about prioritizing
things needs to be changed?
Dr. Collins. Thank you, Mr. Chairman. This is certainly an
issue that at NIH we discuss probably just about daily, are we
getting our priorities right. The factors that go into that are
numerous and they do change over time. Certainly the burden of
a disease has to be a major consideration. I mentioned
Alzheimer's in my opening statement particular because of the
concern about the burden this disease places on people today
and that it may place on people tomorrow, and if we certainly
need breakthroughs in a disease, Alzheimer's is near the top of
that list. Sorry, I seem to have a disease myself today. I am
trying to struggle with the aftermath of some sort of
respiratory virus.
So certainly the burden is one factor, but if we only
studied common diseases that affect hundreds of millions of
people, then what about the rare diseases? If a rare disease
strikes your family, it probably doesn't matter to you too much
that it is rare. You hope that somebody will be doing something
for that. Gastric cancer was mentioned, which is growing in its
frequency and we don't know why, but it is still a rare cancer.
Should we ignore it and just study the common cancers? That
doesn't sound right either.
Then of course, there is the matter of scientific
opportunity. In a circumstance where there has been a new
realization of opportunity to make a real advance in a disease,
even if that is not as common as a different disease, you
wouldn't want to pass that up, so that folds in there.
Fortunately, peer review, which NIH does probably better than
any organization in the world, is one of the ways of trying to
make sure we are using our investment wisely, and we do have a
two-level peer review system. The first level is to look at
scientific excellence of a proposal but the second level looks
at program needs, and there again that is an opportunity for
our experts to come to our advisory councils from universities
and companies all over the country and sometimes the world to
give us advice about should you steer your ship a little bit
further in this direction or the other.
The other thing I should say is that basic science not
attached to any particular disease is also a critical part of
our portfolio and needs to be so because that is the foundation
upon which we build the future, and if we solely made decisions
on the basis of diseases, we might miss out on those important
investments. I guess what I am saying is, it is a very complex
calculus and it should be, but I do think it is best made by
people who have a sense of the entire landscape. I am
sympathetic with what must happen to you every day when someone
with a very compelling story where more resources clearly would
help in terms of the advances that are needed in research is
asking for your help because I have those same conversations
all the time, and obviously more resources in many instances
would help but we have a limited opportunity here in terms of
the budget, the resources that the taxpayers are willing to
give us. I do think the best plan is for those decisions to be
made on the basis of science, and I think at NIH, not just
speaking for myself but for those 27 institute and center
directors and all the advisors we have with all of their
expertise, I think we do a pretty reasonable job.
Mr. Pallone. Thank you very much.
Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman. First I would like to
ask unanimous consent that we can submit this letter into the
record. It is a very historic letter because it is a letter
signed by Senator Durbin and myself, and you will not see these
letters signed on a similar issue. It is on gastric cancer, as
was mentioned by Dr. Collins.
Mr. Pallone. Historic because Dick Durbin signed it? Is
that what you mean?
Mr. Shimkus. We both signed the same letter. That is why it
is historic.
[The information appears at the conclusion of the hearing.]
Mr. Pallone. Oh, I see. Without objection, so ordered.
Mr. Shimkus. Thank you, Mr. Chairman, and welcome.
I want to commend NIH's commitment and emphasis on this
translational research and to give basic researchers a tool to
covert their discoveries into therapies for patients. This, I
believe, is one of the most important parts of the research,
that part that makes a difference in patient survival. How do
you hope to expand NIH and NCI's work in this area?
Dr. Collins. So if the question is about the basic part of
cancer research, I think we are at a remarkably exciting time
in terms of our understanding of what makes cells grow and what
makes them stop growing, and really that is the nature of
cancer, is the loss of control that a cell normally has. When
you see cells that have lost that control, even in their proper
location or worse yet, if they have spread to other parts of
the body, that is a malignancy. We have learned a lot in the
last 10 or 20 years about the signals that control the on and
off switches for cells but we have a lot more to learn there. I
am particularly delighted to welcome on July 12th the new
director of the National Cancer Institute, Dr. Harold Varmus,
who will be coming back to NIH after 10 years after president
of the Sloan Kettering Cancer Center in New York and Nobel
laureate as he is, and somebody who won his Nobel Prize in this
very area, and I think it could hardly be a more exciting time
for exploring and finding the additional answers we don't know
about yet in terms of the basic understanding of cancer, and
that is going to shine a bright light on prevention and
treatment strategies.
Mr. Shimkus. Great. Thank you. My time is limited. Let me
go to--in my opening statement I mentioned in the stimulus bill
but also just regular funding the 2-year program versus a 4-
year program, and how does that help or how does that hurt, and
the real question is, would it have been better in the stimulus
bill had we went to longer-term strategies and in the remaining
stimulus dollars that haven't been spent would you like the
opportunity to be able to shift that to longer-term research
programs that you have?
Dr. Collins. I appreciate the question. Certainly the
availability of support from the Recovery Act was a wonderful
opportunity for NIH. We had gone through a 5-year period where
the budget had been relatively flat, and that meant inflation
had been eroding our buying power to the point where we had
lost about 16, 17 percent of our purchasing power, and there
was a great pent-up interest and need on the part of the
scientific community for new resources to spur innovation. So
the availability of those dollars from the Recovery Act
resulted in an incredible outpouring of grant applications. One
particular kind of application that we designed very quickly
and put out there for people to respond to called Challenge
Grants. We thought we might get 4,000 or 5,000 applications. We
got more than 20,000, and it took quite a lot of work to get
the reviews done and decide what we could fund. So clearly
there was a need, and I would argue that the dollars that came
to NIH from the Recovery Act are extremely well spent. They are
going to produce very interesting scientific advances. But you
are quite right, that 2 years is a very short cycle time for
most scientific projects. I understood, and I think all of us
did, why that was the case. We were, after all, and still are
in an economic downturn of considerable magnitude, and the
point here was not just to do great science but also to
encourage job creation and to stimulate the production of goods
and services, and I think NIH money has done that really quite
remarkably well, 50,000 jobs----
Mr. Shimkus. My time is running out, but can you address
the remaining stimulus dollars and putting it to longer-term
prospects?
Dr. Collins. So we have essentially allocated all of our
$10 billion. We were given a chance for a few of those dollars
to be put into multi-year projects but most of them are in 2-
year efforts.
Mr. Shimkus. Let me just find an end with this. There is an
NIH-funded study called Changing Lanes, Changing Times: The
Risks Facing Female Drivers Today. Isn't that better a NHTSA
study versus an NIH study? So the question is, what is the
process by which you decide to do NIH-funded research that
probably should be a NHTSA one versus what you have decided?
And it is not an insignificant amount of money. For 2009, it
was $7,000 but $260,000 for 2008. So it is a pretty big chunk
of change.
Dr. Collins. So Mr. Shimkus, I am not familiar with that
particular grant. The process we follow----
Mr. Shimkus. I think the best way is if you could just come
back and give me a response to that later on, I would
appreciate it.
Thank you, Madam Chairman.
Ms. DeGette [presiding.] Dr. Collins, could you also
provide this committee with a copy of the slides that you
showed today? Our aging eyes had difficulty seeing over there.
Dr. Collins. I would be delighted to, yes.
Ms. DeGette. Thank you.
The Chair will recognize Chairman Dingell for 8 minutes.
Mr. Dingell. Thank you, Madam Chairman. I have a great
concern about how NIH addresses its investments in research. We
have several considerations that go into this. The first is
that some diseases impose an enormous fiscal burden on
Medicare, Medicaid and the American people. For example,
Alzheimer's costs three times as much to Medicaid as other
chronic diseases. In Medicaid, it costs nine times as much. So
you have the cost component. Next you have the good scientific
approach. In other words, which is best to go into from the
scientific standpoint. And then there are some other
considerations, one of which is we confront the problem of the
deep concerns of people who have this as a part of their
experience, the disease. And how do you prioritize stopping of
high-cost diseases like Alzheimer's and how do you mix these
concerns?
Dr. Collins. So Mr. Dingell, I think that has been one of
the strongest mandates that I as the NIH director and the other
27 institute and center directors share is the need to look at
those priorities and to try to balance those considerations
between the burden of the disease, which means how serious is
it, how many people does it affect, what is its cost to
society, what is its personal cost to the individual and to the
family but also factor into that the scientific opportunities
which may in some instances be more ripe than in others. As I
said earlier, I think that we also have to be sure we are not
neglecting those rare diseases which are in many instances
opportunities not only to help people who are suffering from a
condition that might otherwise be a bit neglected but often
shed light on common diseases. We would not, for instance,
right now have the statin drugs had not been for the study of a
rare disease called familial hypercholesterolemia that Brown
and Goldstein, who later won the Nobel for this, figured out
this whole pathway that led to the discovery of statins.
Mr. Dingell. Do things like we have done with regard to
viruses and genetic research which enabled you to address the
questions that would lead us, for example, to a cure for polio.
But let us come back. How do you prioritize addressing diseases
like Alzheimer's and how do you balance this against the
scientific opportunities and how at the same time do you deal
with the problems of getting the biggest bang for your buck
while at the same time doing the best job we can in areas? And
to come back to Alzheimer's, what about the situation? How much
are we putting into Alzheimer's and how are we evaluating what
we are doing there?
Dr. Collins. So Alzheimer's disease is particularly an
emphasis at the National Institute on Aging but several
institutes at NIH invest in Alzheimer's research. In 2009, $534
million of NIH money was put into this, and that includes $77
million from the Recovery Act, and that included a wide range
of research investigations from such things as the ability to
understand the genetic contributions to Alzheimer's going
beyond the well-known APOE e4 to other variants that have now
been demonstrated as playing a role to new imaging approaches
that allow us to assess whether a treatment is working without
having to wait years to see if that is the case, biomarkers of
response to therapy to immune therapies which are actually
looking quite promising as a way to potentially reduce the
formation of these beta amyloid plaques to new ideas that
suggest maybe a new drug therapy approach. There are 30 drug
trials that are either in place or getting ready to go into
action in terms of Alzheimer's approaches. So there is a lot of
activity here but I share the sense that this is a time bomb. I
mean, it is already upon us but it is going to get worse if we
don't come up with better strategies for prevention and
treatment in the future.
Mr. Dingell. Let us talk here about cooperation and
collaboration with other agencies, which you just mentioned.
FDA plays an integral role in the translating basic discoveries
into new diagnostic and treatment advances in the clinic. There
has to be both a smooth transition and it has to work between
discovery and FDA analysis. The Administration is recognizing
this and they are recognizing we can do a better job in
biomedical research planning and regulatory review of newly
discovered therapies. How do you feel this will provide the
needed predictability for industry as they make investment
decisions?
Dr. Collins. Very important question, Mr. Dingell, and
certainly from my perspective, the need for close connections
between NIH and FDA has never been greater. Accordingly, Peggy
Hamburg, the commissioner of the FDA, and myself have
established an NIH/FDA leadership council and we had a public
input meeting just 10 days ago to see what issues that council
might take on, and we have begun a scientific research effort
in regulatory science to try to give the FDA some new tools to
be able to do review of new and creative research clinical
trials in order to speed up the process of assessing whether
truly new approaches are safe and effective. I think it is
timely indeed to have those kinds of opportunities brought
forward, and I think industry is welcoming the way in which Dr.
Hamburg has brought the idea of regulatory science into the
present time in order to try to handle some of these more
creative approaches to design and testing of new therapy.
Mr. Dingell. Now, I have a further concern here. We have
put some money into health reform research tax credits. The new
health reform law provides tax credits to support biological
research and biomedical research for small firms, something
which you know rather much about from your time at University
of Michigan. How helpful do you think this tax credit is going
to be in producing new therapies and in addressing unmet
medical needs?
Dr. Collins. So this is the program called the Qualifying
Therapeutic Development program which is supposed to make it
possible for biotechnology companies with less than 250
employees to be able to get a tax credit if they are involved
in therapeutic or other clinical advances in medicine. I
actually think this could be a very useful program at a time
where many of these companies are really starved for capital.
With the economy in its downturn, venture capital has been hard
to come by and so this is a chance for companies that have
projects that have stalled for lack of support to be able to
obtain tax credits or grants to get those things going again.
Dr. Collins. Doctor, there are two questions I want to get
in the record here. Why is it important that this credit be
targeted to smaller biotech firms, and second, how will the
applications be prioritized amongst diseases and amongst the
hopefulness of a particular treatment or a particular firm?
Dr. Collins. I think the goal particularly was to try to
provide relief for small companies who have been dependent on
venture capital that is no longer easy to come by. Hence, the
reason for small companies. As far as the prioritizing, NIH has
been asked to do the reviews of the applications and we have
welcomed the chance to do that. We will prioritize on the basis
of the likelihood of success of particular projects and the
importance therefore of providing additional financial
resources to make that happen.
Mr. Dingell. Thank you, Doctor. My time is up.
Thank you, Madam Chairman.
Ms. DeGette. Mr. Gingrey.
Mr. Gingrey. Madam Chairman, thank you.
Dr. Collins, let me ask you a couple of things. You mention
in your testimony the promise that high-throughput
technologies--that was one of the bullet points on the slide--
high-throughput technologies hold for our understanding of the
causes of many diseases and new pathways for potential
treatment. Can you explain what high-throughput technologies
are and how this technology might benefit our health system?
Dr. Collins. Certainly. Thank you for the question. High
throughput is essentially referred to new approaches that
understanding how life works in a cell, usually a human cell,
where you don't just look at one protein at a time or one gene
at a time or one metabolite at a time. You are trying to look
in a very rapid fashion at a very large amount of data.
Genomics is one of those high-throughput technologies where we
used to satisfy ourselves with focusing in on a single gene
that caused, for instance, sickle cell disease, but now we can
sequence the entire genome, all 3 billion letters of the code
in the space of about a week. That is high throughput. Now,
that is a challenge then to be able not just to generate the
data but to make sense of it, so another part of high-
throughput technologies is a lot of computational needs so that
marriage of biology and computers, which has been coming along
for a while, is now really fully underway and a very productive
marriage it is indeed.
Mr. Gingrey. Thank you, Dr. Collins. Let me go back to in a
way something that Chairman Emeritus Dingell was talking about
in regard to how you make the decision on what to fund, and I
think the gentleman from Connecticut and the gentlewoman from
Tennessee both mentioned about job creation and that sort of
thing. When an application is going through the peer review
process, how much weight is given to the number of jobs that
the grant will support in contrast to, say, what Chairman
Emeritus Dingell was talking about Alzheimer's and the
significance of that disease on the cost to our overall health
care system? How do you balance that?
Dr. Collins. So our primary reason for doing that first
level of review is to look at the excellence of the science. We
want to be sure we are supporting the very best scientific
ideas. The second level of review then really looks at program
relevance and balance and may very well take some account then
into what kind of project is this and how many people would be
supported. But frankly, the difference between the types of
grants that we would support in this process in terms of how
many jobs they would create is not going to be very huge. Most
of this will be defined by the dollars that are being invested
in research because in general about 30 to 40 percent of our
research dollars are going to support the salaries, the jobs of
the individuals doing the work. And so whether we pick this
grant or that grant----
Mr. Gingrey. I am sorry. What percentage?
Dr. Collins. Thirty to 40 percent, somewhere in that
neighborhood of what we are spending in terms of our direct
costs are generally----
Mr. Gingrey. The personnel involved in the research?
Dr. Collins. Exactly. The average grant that we give out
supports seven jobs.
Mr. Gingrey. Well, the reason I ask that question, I spent
6 years on the House Armed Services Committee and was a strong,
strong advocate for the F-22 Raptor. Now, it happened to be
finally assembled in my Congressional district and it involved
at least 2,000 jobs, and whenever I advocated on behalf of that
program, I think I was rightly challenged to justify my support
based on air superiority and the defense of the country and not
just jobs that would be created in my Congressional district.
And again, I think it is the same thing in regard to this and
that is why we ask these questions. We all love to see our
great research universities like in Georgia, I will mention
Georgia Tech first because that is where I went to school, but
the University of Georgia as well and the Medical College of
Georgia and my hometown of Augusta, Georgia, all these
institutions are absolutely fantastic and have great research
programs and I hope to see them continue to utilize NIH grants
in a way that will foster hopefully the cure of diseases like
Alzheimer's and, you know, maybe this business as you mentioned
beta amyloid plaque prevention by vaccination. I think that is
very exciting.
I know you have got a huge challenge, Dr. Collins, and we
wish you well and the wellness of the country of course is
dependent on the research that is being done directed by you
and these 27 institutions in NIH. So we thank you for being
here, and I will yield back my time, Madam Chairman.
Ms. DeGette. The Chair recognizes herself.
Dr. Collins, it has been almost a year now since the NIH
approved the final guidelines for human embryonic stem cell
research. What is the status of the embryonic stem cell
research being funded by the NIH?
Dr. Collins. Well, I am happy to say that has resulted in a
significant set of advances in terms of both stem cell lines
that are available now for federally funded researchers and for
new projects that NIH has funded with that new capability that
the President's executive order has made possible, and in fact,
as of now there are 73 human embryonic stem cell lines that
have gone through our very careful process to make sure that
they have been collected with the most stringent kind of ethics
involved in the informed consent and are now available for
federally funded researchers to use, and they are all listed on
the registry that NIH has put up for investigators to look at.
Ms. DeGette. Are there additional cell lines that are
waiting for approval, Doctor?
Dr. Collins. There are more than 100 other lines that
either already have their applications complete and they are in
the process of being reviewed or have started the application
process and the investigator who is going to submit has not
quite finished supplying all of the data. So this number is
going to continue to grow in a very gratifying way.
Ms. DeGette. And what is the budget, the NIH budget being
spent right now in stem cell research?
Dr. Collins. So for fiscal year 2009, in terms of human
embryonic stem cell research, the total comes to $148 million--
I am sorry--$119 million, and that does not include some
additional ARRA funds, a total then for ARRA funds in human
embryonic stem cell research of another $22.5 million.
Ms. DeGette. So that was in fiscal year 2009?
Dr. Collins. Right.
Ms. DeGette. Has that increased in----
Dr. Collins. In fiscal year 2010, which we of course are
still in the middle of so I can't give you exact numbers but I
believe that is going to be higher because we have had a lot of
new applications as a result of the availability of these new
lines.
Ms. DeGette. OK. Do you think that the scientific community
would benefit from knowing that the ability to conduct this
type of human embryonic stem cell research would be codified
versus just contained in an executive order?
Dr. Collins. So I appreciate the question. I think the
executive order has provided the scientific community with a
great deal of excitement in terms of the ability to begin to do
experiments that were previously not allowable. Whether that
would be further increased in terms of confidence about the
future by having this codified in legislation is not something
I am probably in a good position to be able to comment upon but
I understand----
Ms. DeGette. Let me ask you this question then, because
what I hear from a lot of the researchers is oftentimes these
research projects because they are basic scientific research
take a number of years to complete. Would that be correct, to
your knowledge?
Dr. Collins. Yes, and researchers would certainly like to
be confident that their particular experimental approach can go
forward without risks of somehow being no longer allowable.
Ms. DeGette. I mean, some of these projects people tell me
can take 5, 6 even more years to complete.
Dr. Collins. Science is a marathon, not a 100-yard dash.
You are quite right.
Ms. DeGette. Yes. OK. And I also want to ask you, in
November 2007 scientists were able to successfully revert human
adult skin cells into an embryonic-like state because they
inserted a retrovirus. Those resulting cell lines, as you well
know, are called induced pluripotent stem cells, or iPS cells.
I would like you to tell me about what progress has been made
in the iPS research and is this something that the NIH is also
funding?
Dr. Collins. Absolutely. I have to tell you, Congresswoman,
when I read Shinya Yamanaka's paper in 2007 describing how he
had been able to take a skin cell and by adding just four genes
to it cause it to essentially go back in time and become
pluripotent, the hair stood up on the back of my neck. It was
one of those moments where you realize this is a publication
that changes everything. Who knew it was going to be that
possible? So yes, the potential here because you could then
produce pluripotent cells from any of us that would therefore
be possible to use in the future for therapeutic purposes
without rejection.
Ms. DeGette. Because they would be a genetic match?
Dr. Collins. It would be a match.
Ms. DeGette. Now, to date, let me ask you this. To your
knowledge, Dr. Collins, have the iPS cells substituted for the
embryonic stem cells? Because that is the press accounts that
we have seen that now we don't need embryonic stem cell
research anymore.
Dr. Collins. They have not. I think we are still trying to
understand what is the same and what is different between a
human embryonic stem cell, which is the gold standard for
pluripotency, and the iPS cell, which has a lot of the same
properties, but if you look very closely by some of the
measures that can be done about things like epigenetics, DNA
methylation and so on, it is clear that an iPS cell is not
identical to an embryonic stem cell.
Ms. DeGette. And in fact, a lot of the researchers have
told me--I am a layperson so that is why I asked--is that in
fact all these types of stem cell research when done ethically
are important to support because the researchers can use all of
them to sort of help validate the other research and to help in
the lab.
Dr. Collins. I believe that those who are studying iPS
cells are pretty much all committed to doing side-by-side
comparisons to human embryonic stem cells to see what the
similarities and the differences are, and that comparison
continues to be really important.
Ms. DeGette. That is what the researchers tell me too.
I want to talk to you for just a moment about the recent
regulations that the NIH has developed on the conflicts of
interest because many of us were on this committee in 2004 when
we conducted our last investigation of the conflicts of
interest at the NIH with your predecessor, and I know that you
have got draft guidelines out for comment. My question, we sort
of had thought we had solved this problem several years ago,
and I know Dr. Zerhouni was quite committed to solving it. What
do these new draft regulations contain that are not in the
regulations that were promulgated a few ago and do we think
this is going to help solve some of the very real conflicts of
interest that we are seeing with researchers?
Dr. Collins. So the discussion that you had with Dr.
Zerhouni a few ago was largely focused on investigators who
were NIH employees who worked in the intramural program of the
National Institutes of Health, and there were some egregious
examples of conflict of interest that came to light. The
consequence of that was to tighten those rules up very
significantly and they remain, I would say, above reproach in
terms of the way in which those have limited any kind of bad
behavior. What has not been taken on at that time, though, was
to consider all of those grantees out in universities across
the country who are not NIH employees, they are employees of
universities, and NIH therefore has a different relationship,
but recognizing that there were examples there as well where
investigators who were NIH grantees were not disclosing that
they were supposed their financial conflicts. NIH has now
stepped forward to require institutions to take a much more
heavy hand here in terms of checking out whether their
investigators are engaged in conflicts of interest, and there
are several proposals here as part of the NPRM that we are now
seeking comment on that would require a much more extensive
disclosure of any kind of financial conflicts that
investigators might have including posting those on a public
Web site so that it is possible for anyone to see what is going
on and not have this being done behind a curtain. This also
requires the institutions to have a much clearer plan about how
they are going to review and notify NIH about those financial
conflicts. Again, we are seeking comments on those over the
course of the next month. There has been this recent
observation that in one instance an investigator left one
university and was able to escape sanctions on that basis and
we are now considering what could be done to prevent that in
the future as well. So there is a lot that we can do here,
although we are to some extent limited in that our relationship
is primarily with the institution and not with the
investigator.
Ms. DeGette. But if you required the institution to make
disclosure, then that burden would be on them.
Dr. Collins. Indeed, and that is the goal of the NPRM.
Ms. DeGette. The Chair now will recognize Mr. Whitfield.
Mr. Whitfield. Thank you very much, and Dr. Collins, we
appreciate you being with us here today very much.
I know that NIH is involved in a lot of projects like the
Molecular Library Initiative and your collaboration with FDA,
EPA, the National Chemical Genomics Center and others to
identify small molecules, their biological behaviors and so
forth leading to I guess what we refer to as a big biology or
human metabolome project, and I was wondering if you could just
give us sort of an update on the money that is being spent on
agencies on this and what you view the prospects are for this
type of initiatives.
Dr. Collins. So I believe this is a very exciting area.
This is bringing chemistry and biology together in a new and
exciting way and making those resources available to academic
investigators. It is another kind of high-throughput science.
The idea here is that if you are interested in developing some
kind of a compound, an organic molecule that might ultimately
become a therapeutic, a drug, you need a way to empower
academic investigators to get engaged in that process and not
just hope it is going to happen, and that has given us the
impetus to put together a series of four of these high-
throughput screening centers, and you mentioned one of them,
the NIH Chemical Genomics Center, but there are three others.
Collectively, we spend about $60 million each year on these
centers, but it makes it possible for an academic investigator
who has just made a basic science discovery to move into this
possible translational application in ways that just weren't
happening before. I would like to see us push that really hard
right now, because we are in a circumstances where there have
been a lot of basic discoveries that are perhaps even more ripe
for translational applications than ever before, but many of
them are too early for the private sector to necessarily see
them as ripe enough for them to take on. If we could come up
with a strategy for academic investigators, take it a certain
way, de-risk a project, and then hand it off to a private
company who would then carry it the rest of the way to
approval, that is a pretty good model. Companies like that. We
at NIH like that. This may be our path towards the future.
Mr. Whitfield. Now, it looks like there would be some real
exciting breakthroughs and an opportunity here for partnerships
with private entities as well.
Dr. Collins. I totally agree, and I think that is a new
model that maybe hasn't really been tried to this extent
before. Companies would tell you they are also really looking
for new models. The development of new therapeutics has not
been going all that well for them in the last few years. Here
is a way to speed that up.
Mr. Whitfield. And I have also been told that some of these
new techniques have been used in analyzing the dispersants that
they are thinking about using in the Gulf oil spill. Is that
correct?
Dr. Collins. That is correct, so we have a marriage here
between the EPA and the National Institute of Environmental
Health Sciences, the National Toxicity Program and this NIH
Chemical Genomics Center to try to use the same technologies
that are being used to develop drugs to also study toxins.
Mr. Whitfield. Well, do you think you could put up with
some of us sometime coming out to see the National Chemical
Genomics Center?
Dr. Collins. We would welcome that, Congressman. Just let
me know. We will set you up with quite a tour, and I guarantee
you, you will be amazed at the way in which this operation has
taken shape with a robot that is capable of screening hundreds
of thousands of chemical compounds in just a few hours. It is
amazing to see.
Mr. Whitfield. And Madam Chairman, I would like to yield
the balance of my time to the ranking member, Mr. Shimkus.
Ms. DeGette. The gentleman is recognized.
Mr. Shimkus. Thank you. I just wanted to follow up in
Chairman Emeritus Dingell's comments on the ARRA benefits on
the tax credit--not the ARRA but the health care bill. I have
been crying and asking for hearings on the health care law
since I became ranking member. I am glad he took the
opportunity to address the health care law. I do think
questions like that could be done in a hearing on the overall
law. I just want to put in the record that $27 billion in tax
increases to the pharmaceutical companies makes it more
difficult for them to do the R&D for new drug development. The
1099 provisions for small companies that require a 1099 form
for every $600 cost added will add additional burden to small
companies to be able to do that. So where there may be some tax
credit help, I think a lot of people would say that the burden
on the small pharmaceutical companies are increased under the
health care law.
And I will just end on, the iPS system, as my good friend
was talking, it may--there may be scientists who want them both
to go on but the iPS does evade a very important question that
would help unify us versus divide us. It does address some
moral ethical problems that many Americans have on embryonic
stem cell research, and I yield back.
Ms. DeGette. Mrs. Christensen.
Mrs. Christensen. Thank you, Madam Chair, and welcome
again, Dr. Collins.
As you know, one of the great successes in the health care
reform bill was elevating the National Center on Minority and
Health Disparity Research to an institute, something that we
are very excited about, and all of us who have worked for years
in health equity or the elimination of health disparities are
really anxious to hear about the role that you envision for
this new institute at NIH, so my first question would be, what
are your plans to ensure that the new institute will play a
pivotal role in helping to ensure and coordinate all research
efforts across all of the other institutions and centers so
that they would include health disparity elimination variable
and measures throughout the entire research design and
spectrum?
Dr. Collins. So we also were delighted to see that the
health care reform bill included this important redesignation
of NCMHD now becoming the National Institute for Minority
Health and Health Disparities under the direction of Dr. John
Ruffin, and this does bring that part of NIH into the same
status as the other institutes that direct many other kinds of
research. It certainly underlines the critical way in which
NCMHD and now NIMHD plays a correlating and organizing role in
the entire NIH's agenda for health disparities. That has been
going on for some time but this further strengthens the hand
that Dr. Ruffin holds, and I think we all welcome that.
This will of course further add to the importance of those
rolling 5-year health disparity strategic plans which NIMHD is
charged with putting together with input from all of the other
institutes. It will take lots of collaboration between the
institutes, but I can tell you, having been at NIH now for 17
years, the importance of health disparities and the investments
that need to be made there is certainly a shared goal across
all of the leadership but it is nice now to have an institute
that stands up in a very visible way to take charge of that.
Mrs. Christensen. Well, thank you. In a recent interview, I
think it was Science, you spoke of the pressures of year-to-
year budgeting and the possible impact of our Nation's current
economic situation, but if you had to find, as you said and you
alluded to the possibility of it, you find yourself cutting
grant budgets or cutting back on some areas of science or have
to decide which institutes get the 3.2 percent increase and
which don't, I hope that you will consider that the new
institute is starting out brand new, is grossly underfunded, so
as part of your plan as you implement the Patient Protection
and Affordable Care Act to bring its budget in line with the
other institutions.
Dr. Collins. Of course, I would love to see that happen,
and the challenge of course as you probably well know is all of
the other stresses that we have on the overall NIH resource
total as we face what may be a particularly difficult year in
fiscal year 2011, recognizing the economic downturn and the
ending of the Recovery Act dollars. We are going to be stressed
in all kinds of ways trying to maintain the resources and the
environment of the biomedical researchers who are so critical
to our future. Estimates are that our success rates in fiscal
year 2011 may fall to historic lows across the board, and of
course, you can appreciate, I hope, that that makes any special
kind of corrections even more difficult than they otherwise
would be. We all hope for times where those things will be
easier but I don't think that next year is likely to be an easy
time.
Mrs. Christensen. Well, we don't expect it to be an easy
time but they are starting out at such a low budget, and if
they are really going to function as an institute, their budget
would really have to be greatly increased, and given the extent
of the health disparities in racial and ethnic minorities, you
know, it really needs to be a priority.
In your testimony, both written and what you gave here
today, you talked about diabetes, Alzheimer's, cancer, all of
which disproportionately impact African Americans and other
racial and ethnic minorities but African Americans in
particular, yet there was no mention of the disparities or how
NIH would direct research to close those gaps. In that same
interview that I read, you talked about a big think that
occurred and the outcome of that big think were several areas
that may need more focus and attention. Were health disparities
one of them, and if not, is there going to be a big think about
health disparities?
Dr. Collins. I appreciate your question. Yes, it was one of
the very significant conversations we had. The big think was a
meeting where I brought together about 55 or 60 individuals
that I think are able to really look at the entire landscape
and give advice about where investments are most needed and
most opportune, and certainly one of the groups we had of the
three groups focused very much on this general area, what can
we do about the health of the Nation and health disparities
emerged as a particularly powerful part of that. Reed Tuckson
led that particular discussion.
Mrs. Christensen. Good.
Dr. Collins. And I think we got some strong messages, and
of course, the summit that was held a year and a half ago that
Dr. Ruffin organized very much focused on health disparities
and itself produced a blueprint of additional needs. The only
thing I would want to say, although I would agree, we are not
putting enough resources into health disparities, we are not
putting enough resources into many other things too, but I hope
it is clear that the investments in research on health
disparities are not limited to that one institute, that every
institute at NIH has an important portfolio in this area, and
Dr. Ruffin's job is to be sure that we are coordinating that in
a way that we get the maximum benefit from the dollars we are
spending.
Mrs. Christensen. Right. I am aware that the other
institutes and centers are doing research but we want to make
sure that he does have that ability to coordinate.
You also said in that interview that we have a lot to do,
and this is sort of a quote, at least part of it is a quote,
``We have a lot to do to figure out how do people decide about
altering behavior.'' In the case of racial and ethnic
disparities or any health issue, behavior is one of the many
issues along with environment, access and others that requires
research. Does your response where you say ``We have a lot to
do to figure out how people decide about altering behaviors,''
does that response mean that we will see a greater emphasis on
behavioral research at NIH?
Dr. Collins. I think it is timely to focus a lot of
attention on behavioral research if we are talking about
prevent especially. So much of what we are learning won't do
any good if it is not transmitted to people in a way that they
understand and if it doesn't motivate health behavior changes
whether it is diet or exercise or other activities, and I think
you will see--in fact, one of our new initiatives in the Common
Fund is called the Science of Behavior Change, how do we learn
more about what actually is involved when somebody changes
their health behavior, how do we inspire that in circumstances
where we have the evidence but we haven't been very good at
actually getting the result. You are going to see a lot more of
that.
Mrs. Christensen. Well, you partly answered one of my other
questions about what were you focused on in the Common Fund,
but I am going to yield back.
Ms. DeGette. Mr. Pitts.
Mr. Pitts. Thank you, Madam Chairman.
Dr. Collins, a recent article in the New York Times claims
that the Human Genome Project which you worked on has not
yielded many medical benefits. Is that an accurate statement?
Dr. Collins. Well, you might not be surprised to hear that
I didn't quite go along with Mr. Nicholas Wade's story. Mr.
Wade has over the years been a bit of a cynic about genomics,
and I think that came through loud and clear. Today's New York
Times in a different article by a different reporter has, I
think, a much more upbeat and balanced view about the way in
which genomics is inspiring new ideas about therapeutics. In
sort of responding to Mr. Wade's rant, I sat down for 10
minutes just to see if I could come up in 10 minutes with 25
significant advances in medicine that come out of genomics, and
I had no trouble doing so. Somehow they didn't appear in his
article.
Mr. Pitts. OK. Thank you. To follow along the line of
questioning of the chairwoman, you said that regarding the
regulations on conflict of interest that there had been
egregious examples of conflict of interest with federal
employees. Can you explain the type of example you are talking
about?
Dr. Collins. Well, I will tell you the one that got
attention in the last week, so a psychiatrist who was doing
research at Emory University, Dr. Charles Nemeroff, was found
to have been receiving large sums of money from pharmaceutical
companies that he had not disclosed. Those sums of money were
in the same general area as his own research, casting into some
question whether his research results were in some way tainted
by the receipt of those dollars. When that finally came to
light, he admitted that he had been receiving those funds and
claimed that he didn't know he had to disclose them. Emory
University in consultation with the NIH decided to strip him of
his chairmanship and to also remove him as the head of his
particular grant. Dr. Nemeroff then actually in the space of a
year or so after that sanction moved to a different university,
the University of Miami, where because of the current rules,
because NIH's arrangements are with institution and not with
individuals, Dr. Nemeroff was now able to apply for new grants.
He has not received any grant funding from NIH, I am quick to
tell you, but he was able to apply, and I think that raised a
lot of questions.
Let me say, because I think it is important to put this
into the record, that an individual was also involved in a
certain way by innuendo in this, Dr. Tom Insel, who is the
director of the National Institutes of Mental Health, was in
some way implicated by a reporter as not having conducted
himself properly. I would really like to defend Dr. Insel in
that regard and to say that in his many years of service to the
NIH, Dr. Insel has proven to be an exceptional scientific
leadership, has led the NIMH with great skill, has encouraged
innovative advances in biomedical research. He has been a
person of great integrity, a dedicated and visionary public
servant, and I am fortunate to have him on my team at NIH.
Mr. Pitts. Thank you.
Let me go a little further in embryonic stem cell research.
About, if you can ballpark it, how many years have we been
doing research on embryonic stem cell research, how many years
in humans, how many years in mice? Can you just ballpark it for
us?
Dr. Collins. So in mice for quite a few decades. In humans,
it was in Madison, Wisconsin, Ms. Baldwin, where Jamie Thompson
first developed the human embryonic stem cell.
Mr. Pitts. What year was that?
Dr. Collins. That was 1998.
Mr. Pitts. Nineteen ninety-eight?
Dr. Collins. Right, so about 12 years.
Mr. Pitts. Have there been any clinical trials using
embryonic stem cells that have produced improvement for human
patients?
Dr. Collins. So there has only been one clinical trial for
human embryonic stem cells that have been approved by the FDA,
and that is a trial by the company called Geron for spinal cord
injury, and they have not yet enrolled the first patient
because of safety concerns but are expected to later this year,
so it is still early.
Mr. Pitts. OK. What about with adult stem cells? Have there
been any clinical trials using adult stem cells that have
produced improvement for patients?
Dr. Collins. So adult stem cells covers a lot of territory.
Certainly stem cells found in the bone marrow have been
utilized for a long period of time for bone marrow
transplantation and have saved many lives in circumstances
where that was an important task. But importantly, those kinds
of adult stem cells don't have the same pluripotency that an
embryonic stem cell would and so their applications would be
limited to certain things and would not be possible, for
instance, to use those for all the applications that embryonic
stem cells are being contemplated for.
Mr. Pitts. But there have been human protocols developed
for human treatment, right, therapy for human patients with
adult stem cells that you are aware of?
Dr. Collins. Again, bone marrow would be the one where most
of those experiments have happened, so that has been very
successful in that limited set of applications but would not
have been possible to apply for other applications like
Parkinson's----
Mr. Pitts. What about with iPS cells?
Dr. Collins. IPS cells are a new development as was already
raised, very exciting, not yet tried in any human applications.
We have just announced the formation of an iPS cell center on
the NIH campus to try to speed up those applications for human
therapeutic purposes but it will probably be a few more years
before we are sure that they are safe because those cells are
capable of forming tumors.
Ms. DeGette. The gentleman's time is expired. Mr. Murphy.
Mr. Murphy of Connecticut. Thank you, Madam Chair.
My apologies if you covered this particular piece of this
debate already, but I think last week the NIH advisory board
authorized three new stem cell lines for research, and I just
wanted to ask a broad question on that subject as to how that
process of approving new lines is working and if you sort of
feel that that process is moving swiftly enough in a sufficient
manner.
Dr. Collins. So I think it was seven new stem cell lines
that were put forward by the advisory committee advising me. I
have not formally made the decision but expect to do so in the
very near future. That brings to 73 the number of human
embryonic stem cell lines that have been approved for use with
federal funds.
I think the process is actually working quite well.
Basically we ask investigators who have derived the stem cell
lines to supply documentation about the nature of the informed
consent that was used to obtain those because we want to be
absolutely sure that that was done at the highest ethical
standards. If they are able to do so in a fashion that is right
down the line to every detail consistent with the NIH
guidelines, we approve those administratively and we can do
that quite quickly once we have all the documents. But some of
the stem cell lines were derived years ago and the process of
getting consent and the specifics of the details have changed a
bit over that time but we have a working group of distinguished
bioethicists and biologists who look at those circumstances to
try to see whether those particular stem cell lines at least
follow the general principles that we would like to see, and if
they agree that they have, then they put those forward for
approval as well. They have approved quite a few of those.
Interesting, last week, though, they recommended
disapproving a whole set of lines where they thought the
consent had a problematic clause in it, which was basically
what we call exculpatory language, which according to the
common rule really should not be in an informed consent process
and they didn't feel if were doing this carefully that we could
allow that. That was a bit of a heartache because that was a
whole lot of lines that a lot of people were I think hopeful
they would get access to but if we have guidelines, if we have
ethical standards, we probably need to pay real close attention
to them.
Mr. Murphy of Connecticut. And I appreciate even in the
face of some resistance your holding that line. I think the
future of this research depends on people believing that there
are ethical boundaries and qualifications for this research,
and so I think it is to your credit.
To switch topics fairly dramatically, I wanted to go back
to something I talked about in my opening statement about the
intersection of private and public research. I have got a real
interesting company in Cheshire, Connecticut, Alexion
Pharmaceuticals, that produces a drug for a rare blood disorder
that I won't attempt to butcher the pronunciation of. The drug
is called Soliris, and it is an example frankly of a rare
instance where a company has been able to commercialize a drug
with a fairly limited application, only a couple thousand cases
in the United States at a given time. And I guess my question
is this. There are a number of different factors that go into
your decision on where you place research. Clearly the top of
the list is what in the public interest, what are the diseases
and conditions that we have the greatest national interest in
confronting, but I would assume an element is also what kind of
research is most likely to be done in the private sphere and
what research is most likely to not be done there and has to be
taken up by public funds. So in the context of rare diseases, I
guess I would ask for your opinion as to how that calculation
plays out with regard to rare diseases and whether we see more
companies like this one in Cheshire being able to do this on a
private basis or whether we continue to see the need to have a
larger public role in that space.
Dr. Collins. I think it is going to be a little different
for each disease, and I appreciate the question. I think for
many rare diseases, the economics just aren't going to be
sufficient to inspire a company to make the investment in
taking something all the way to therapy if there is not already
a pretty good idea on the table, and what academic
investigators supported by NIH can now do increasingly is to
make that possible.
There is a new program called TRND, which stands for
Therapeutics for Rare and Neglected Diseases, funded by the
Congress, $24 million this year and $50 million requested next
year in the President's budget, which is exactly to try to
provide that kind of de-risking opportunity for these rare-
disease projects, not to take them away from a company's
interest but actually to try to get them far enough along to
inspire a company's interest, and we are seeing that happening
now. That program has already started five new pilot projects
for rare diseases. One is for a disease called hereditary
inclusion body myopathy. Now, who has heard of that? Relatively
few people affected, but there is a very promising therapy and
it just needs a little push to get to the point where a company
like the one in Cheshire might be willing to pick it up. We are
trying to do that, and with rare diseases not only they affect
real people and you want to do something for those real people
but we often learn things from rare diseases that have a
broader reach. My own lab, because I have a small research lab
at NIH studying an incredibly rare disease called progeria,
which is a form of most dramatic aging, and we could only find
30 kids in the world to try on this clinical trial, which is
currently underway at an amazingly rapid pace because we just
discovered the cause of this a few years. But what we are
learning from progeria is turning out to have pretty
significant implications for normal aging and maybe that will
turn out to be one of the most exciting things that has come
along in a long time in terms of understanding the aging
process, all by studying this vanishingly rare disease.
Ms. DeGette. The gentleman from Texas, Mr. Burgess.
Mr. Burgess. Thank you, Madam Chair.
Dr. Collins, again, welcome to our committee. Just on the
issue of rare and neglected diseases for just a moment, this
past week in the New England Journal of Medicine they had an
article about the curious case of colchicine, a drug that has
been around for 3,000 years, and yet the FDA decided that since
we have never studied this maybe someone ought to, so someone
did, and they were given exclusive rights for colchicine for 3
years, an additional 7 years under the Orphan Drug Act, so
people who suffer with gout, colchicine is a second-line drug
of choice, but went from pennies a dose to several dollars a
dose. For people with familial Mediterranean fever where
colchicine really can be a benefit are now left facing a
situation where their costs are going to significantly go up,
so would the NIH be interested in proactively funding any of
the research on some of these compounds that have been around
for a long time to sort of preclude this problem from happening
again to some other illness? Again, not many people with
familial Mediterranean. The figure they gave the New England
Journal of Medicine was 100,000. I don't know whether that is
in the country or globally but it is not a large universe of
people, but the people who have it are now significantly
affected by the activities of the Food and Drug Administration.
Dr. Collins. Dr. Burgess, that is a great question. Dr.
Daniel Casner at NIH is the world's expert on familial
Mediterranean fever, and I know there is a good deal of anxiety
about what this is going to do in terms of the costs of taking
care of these patients. Exactly, I think this is something that
NIH can do. I mentioned this program called TRND, Therapeutics
for Rare and Neglected Diseases, and one of its explicit goals
is to try to identify compounds that have been out there for a
long time and repurpose them for uses for rare diseases where
they might actually have considerable benefit but nobody
actually tried that, because if you do that, you have ended up
with something which may be both inexpensive and actually you
are pretty close to the point of being able to ask the FDA to
approve it without going through those long, long steps of
developing a totally new compound. It is a great idea. When we
are searching for a new compound for a disease that there is no
therapy, we always make sure, we check all the available ones
that have already been given to patients that we know are safe
and once in a while you turn up with something really exciting.
Mr. Burgess. You famously were interviewed on the Colbert
Report, and----
Dr. Collins. Yes, it is true.
Mr. Burgess. --talked about making--attracting more young
people to the study of science and the things you could do to
make science appealing to young people. I think the term that
was used was ``to make science sexy.'' How are you coming in
that endeavor?
Dr. Collins. Well, maybe you a better judge of that,
members, than I am. You may recall that Colbert suggested that
if I really wanted to attract scientists into the field that I
needed to sort of loosen up a little bit, take your glasses off
and shake out your hair, and against my better judgment, I did
that on national television. But I am not doing it this
afternoon.
So we are really interested, to get serious here, in terms
of trying to recruit the best and brightest of the next
generation. We were big participants in National Lab Day where
we sent a lot of scientists out to high school classrooms to
try to make science a little more real and hopefully less geeky
than it often appears to be to the next generation. We are
hoping to play some role in whatever happens next in terms of
beefing up science in K though 12 education because clearly the
way science gets taught to a lot of young people isn't very
exciting, and it should be. This is the century of science,
especially biology. So many opportunities for people that we
would love to see them just jump on and come and join us
because this is going to be an exciting time beyond any that
anybody has experienced before. In the next few years, we are
going to learn all this stuff. We are going to figure out how
to apply it. What a great career.
Mr. Burgess. And I know this question has already been
asked, but I was out of the room and I just wanted to ask you
to address briefly the--well, Dr. Zerhouni came to us right
before--your predecessor--right before he left the post and
talked about the wondrous things that have happened with the
human genome and cracking the genetic code, the single
nucleotide polymorphisms where there was just three in 2003
when I started in Congress. There were now, I don't remember
how many he said last fall and there were more being discovered
literally every week. But there was some disappointment with
the clinical applications of sequencing the human genome, so
where are we on that?
Dr. Collins. Well----
Mr. Burgess. Is it the brave new world that Dr. Zerhouni
talked about or are we on a dead-end street?
Dr. Collins. You know, the first of technology says that
when you make a major discovery, the anticipation of its
immediate effects is always going to be overblown but the
anticipation of the long-term effects will generally be
underestimated. I think that is going to be true of genomics as
well. There were a lot of wild claims made in 2000 about how
this is going to change everything overnight. You and I knew
that there was a lot more steps involved from understanding
what the letters are in the DNA code to figuring out what to do
with them. But I think the advent of personalized medicine is
certainly coming along now in a quite gratifying way.
In today's New England Journal, by the way, and I put this
at your place, is an article by myself and Peggy Hamburg called
``The Path to Personalized Medicine'' going through some of
these really exciting advances and also making it clear how FDA
and NIH are working together to support them. So I think any
declaration that the outcome of the genome project has been
disappointing is probably just not based upon realistic
expectations. I do think that revolution is going to be quite
something when it takes full shape in the next 10 years.
Mr. Burgess. I want to come back to that partnership of NIH
and FDA in a minute but before we leave the concept of the
human genome, in the interest of full disclosure, I had my
genome sequenced and it is a fascinating study, and I actually
am glad I did it, but there has been some controversy about the
direct-to-consumer marketing of these tests. In fact, our
committee, our Subcommittee on Oversight and Investigations, is
going to be conducting or is conducting a bipartisan look into
that. I guess at this point what I would ask you is, would you
be willing to work with our staffs on both the majority and the
minority side as we look into this issue? Obviously we want
this done correctly. We don't want people hurt or misled by the
process, and I think that is what raised the initial concerns
when one company was marketing it in a commercial drugstore and
then withdrew it, and it raised a lot of questions. You know,
there is no question of the value of the procedure.
On the issue of the FDA, I mean you guys got a ton of money
in the stimulus bill. I mean, it was almost immeasurable the
amount of money you got, and no one ever had seen that much
money before even in government. And so you produced--you put
it to work and you are producing all this stuff. Now, the FDA
as we heard the other day in another subcommittee hearing, it
is kind of a little bit like a bottleneck in the pipeline. So
how are you and Dr. Hamburg working out these problems between
your two institutions?
Dr. Collins. So two ways and probably many other smaller
ones but two major ways. One is the formation of this NIH/FDA
leadership council, which will have senior leadership from both
agencies at the table on a regular basis with projects and
ideas coming to us both from industry and from the advocacy
groups, all the stakeholders, to really try to say where are
the bottlenecks, what are we going to do about it, let us get
serious here.
The second is to have an actual scientific organizational
plan about how are we going to give FDA some additional
information about how to do regulatory science because many of
the things that are coming at them are new. If you have a
clinical trial where everybody in the trial is on a slightly
different combination of therapeutics, as will happen soon for
cancer where combination therapy is going to be the name of the
game with all these various targeted therapies that are
possible, how do they review that? We need science to
understand that. That particular regulatory science program is
funded jointly by FDA and NIH but actually because FDA is a
little strapped on cash, the NIH has come up with a larger
proportion of the funds and we are happy to do that, and I am
happy to work with a scientist and a physician with the
capabilities of Dr. Hamburg. I think we are actually forming a
pretty good partnership.
Mr. Burgess. Can we expect a----
Ms. DeGette. The gentleman's time is expired.
Mr. Burgess [continuing]. Report at some point from you on
that? Are you going to be getting back to the committee on that
issue?
Dr. Collins. I would be happy to do that.
Mr. Burgess. OK.
Ms. DeGette. The Chair will announce that we are expecting
a series of three votes on the floor. The Chair will recognize
the gentlelady from Florida for questioning, 5 minutes, and
then we will recess for the votes. We will return immediately
upon the completion of the votes because other members want to
question, and if Dr. Collins agrees, if people have additional
questions, we may come back for a brief second round.
Dr. Collins. I will be happy to be here as long as you
like.
Ms. DeGette. The gentlelady is recognized.
Ms. Castor. Dr. Collins, the Clinical and Translational
Sciences Awards are very popular. These awards are focused on
translating NIH research into an understanding of health
impacts. Does NIH plan to expand the initiative to create more
CTSAs nationwide and include additional rounds of funding? I
know that there is currently one CTSA in Florida at the
University of Florida but the University of Miami has applied
several times and has been denied, and the University of South
Florida would like to get into that CTSA. They are popular
because they include training funding, and there is a concern
about where training funding will come from if CTSA grant
applications are denied and will applicants still be eligible
for training dollars from the National Center for Resources or
other institutions under NIH?
Dr. Collins. Well, I appreciate your question because the
CTSAs are a very important part of NIH's clinical research
network and our plans including all kinds of new and innovative
approaches to clinical applications, therapeutics, diagnostics
and so on. We have currently funded 46 of the CTSAs around the
country. It is a very competitive process. There is another
round of competition that has just gone on, and there will be a
few more announced as a result of that, and then there is one
more competition coming next year, but the goal was to fund a
total of 60. That pretty much will exhaust the dollars that are
possible to put into this, which is now coming close to half a
billion dollars for these 60 centers.
We do very much expect that they are going to link up in
interesting networks both regionally and nationally so that the
whole will be greater than the sum of the parts, and every one
of the CTSAs has been encouraged, as your question pointed, to
focus on training, to focus on bringing together disciplines
that maybe in the past had not talked to each other, even
within an institution, but also to building networks around
each of the CTSAs of other local institutions including
community hospitals, and community outreach is a big part of
this as well.
I wish we could come up with the dollars to fund 100
instead of 60 but 60 is probably as far as we can go. We do
expect that out of this will arise a whole new way of
approaching clinical research. I have been to visit now four of
these and I will go see another one actually tomorrow, the one
in St. Louis. It is very interesting. They are all a little
different, and they are taking advantage of what they have
locally in terms of special expertise to make themselves
different, and it is pretty exciting when you see the ways in
which they have people talking to each other who never would
have been in the same room before, and they are certainly
encouraging training in clinical research, which has been a big
concern because many physicians have been sort of staying away
in droves when it came to research because they had big debts
to pay, it wasn't clear what the pathway was, it wasn't clear
where they were going to get mentored. The CTSAs are really
helping to turn that around. It is going to be a tough process,
of course, to turn that around because there are so many other
things pulling on physicians, but I think this is going to be a
really interesting few years to watch. The first CTSAs are just
now coming up for their first renewal because this is a pretty
new program. We have high hopes.
Ms. Castor. Good. I will look forward to talking with you
more about how they evolve.
Training awards are also critical for our medical schools.
These awards are relied upon to train medical students in
specific disciplines, and most training awards are within
discipline-related institutes under NIH, for example, the
National Heart, Lung and Blood Institute. I understand that it
is increasingly difficult to get training awards. Is this
because of a lack of resources and will there be additional T-
32, T-35 training grants available and will additional funding
be available for career development awards both individual and
institution?
Dr. Collins. So we certainly believe that training is
critical for our future and every one of the institutes has a
special way of trying to support that. The National Institute
of General Medical Sciences, NIGMS, is a particularly important
part of NIH for training organizational efforts and they fund,
for instance, the M.D./Ph.D. training programs, the medical
scientist training programs, which are a way in which we are
hopefully nurturing a particularly energetic and inspired group
of future leaders who get both the M.D. and the Ph.D. degree.
We have been both concerned about whether we are training
enough individuals and whether we are actually supporting them
adequately. One of the things that we are trying to do is to
catch up on the stipends for trainees, which have been flat for
a long time, and we are clearly asking people to remain in
training positions. Many of them are already with doctoral
degrees and really quite low salaries, and that is beginning to
be a problem in terms of recruiting people to do this, and we
are going to try to pick up a little bit on that.
Again, resources. I keep coming back to that with many of
the questions with the fact that we are facing potentially a
very difficult time in fiscal year 2011 and perhaps beyond. We
would love to expand training programs but where would we take
the dollars from in order to do this with so many other needs
for disease research, for grants and so on. We are every day
trying to figure out how to get that balance right.
Ms. Castor. Thank you.
Ms. DeGette. The committee will be in recess until the
completion of the third vote.
[Recess.]
Ms. DeGette. The committee will come to order, and the
Chair recognizes Mr. Space.
Mr. Space. Madam Chair, if I could, I don't expect to
exceed the 5 minutes but I did not do an opening statement
today, if I could be permitted the luxury of 8 minutes?
Ms. DeGette. Yes, you are recognized for 8 minutes.
Mr. Space. Thank you, Madam Chair.
Thank you, Dr. Collins, for joining us today, and for
offering your testimony and for the work you do at NIH. I
personally think it is an underappreciated agency that we
should be devoting more resources and assets toward.
I wanted to focus my questions today, however, on one
specific disease, and that is diabetes. As you probably know,
the ADA recently conducted a comprehensive study in which it
was determined that--these are 2007 numbers, by the way, which
undoubtedly are significantly lower than they would be today,
but they determined that we are spending as a Nation about $174
billion every year. Most of that money represents costs
associated with health care for those suffering from diabetes
and particularly those in the chronic stages, but a significant
portion also represents lost productivity, and this is one
disease in one year we spend more as a Nation than we did, for
example, in just about any year during the war in Iraq.
Obviously if we were to be able to cure this disease, we would
mitigate and in fact eliminate the expenditure of trillions of
dollars over the next 50 years in terms of the long picture.
I happen to have a son who suffers from type 1 diabetes. He
is 19 now. His name is Nick, and he was diagnosed when he was 6
years of age, and after his diagnosis my wife and I, we knew
very little about diabetes at the time but we began to educate
ourselves on this devastating disease, and this was in 1996.
Here we are 14 years later. In 1996, it was my impression that
we were 10 years away from a cure, and this was based on
exhaustive studies and research that I committed myself because
of an obvious personal interest, and here we are 14 years later
and I am still hearing the same thing, we may be 10 years away
from a cure. And I am familiar with the closed loop system and
the concept of an artificial pancreas, that if every type 1
diabetic in the country had it would eliminate countless
episodes of suffering, premature death and disability but it
would also end up saving a lot of money in the long run.
And my question to you is regarding the special diabetes
program. I understand that this has been funded at $150 million
per year. Incidentally, it sounds like a big number, it is a
big number, but if we are spending $174 billion a year
combating this disease and when you take 10 percent of that
figure and spread it out over 5 years, say, $17 billion, just
round it downwards to $15 billion, if we spend $3 billion a
year over 5 years, my opinion is, we could give every type 1
diabetic in the United States a closed loop system that worked
and that was reliable and would more than pay for itself in a
few short years. My question to you, Dr. Collins, is, what is
your assessment of the special diabetes program, its importance
to researching and developing advanced methods of treatment,
maintenance and possible cure when it comes to type 1 diabetes?
Dr. Collins. Mr. Space, I appreciate your question, and
especially the personal experience you have had with your son
Nick, and I think parents who have had that experience must be
like you, frustrated that we don't yet have a better solution
to this clearly important and very serious disease of type 1
diabetes. The special diabetes program, which, as you point
out, is $150 million a year, it is set to expire at the end of
fiscal year 2011, and I know there are some anxieties amongst
the investigators working in those projects about whether they
are going to have to phase out their efforts at that point. It
certainly includes a number of, I think, rather ambitious
efforts, and certainly the artificial pancreas is one of those
dreams that we all hope will come true in a broader sense in
the not-too-distant future but obviously many challenges there
in terms of how you get the engineering and the biology right
so that you have a system that is reliable, because obviously
any system that has the capability of delivering insulin needs
to be failsafe because overdoses would be potentially very
serious. I think there is real progress being made there but I
am sure from your perspective and from mine, it is slower than
we wish it could be.
In terms of type 1 diabetes and what causes it in the first
place, we have I think a much better idea of what the genetic
factors are. We now have accounted for more than half of the
heritability of type 1 diabetes, and there is this program
called TEDDY which is now following several thousand children
who are at high genetic risk to see whether in fact they begin
to show some signs of the autoimmune component, which is the
sign that the disease is getting started because as you
probably know, by the time a young person shows up with actual
symptoms of diabetes, most of those beta cells in their
pancreas have already been destroyed by the autoimmune process
and the best hope is to catch that early and then treat it with
appropriate drug therapies including a new therapy called
rituximab.
So I would say there is reason to be optimistic that the
steps are moving forward but I hear what you are saying, that
you heard that in 1996. I am impatient too. I want to see this
disease conquered. I want to see the best ideas supported to
make that come true. It is challenging to figure out for us
exactly how to take the resources we have got and apply them in
the best way. We do what we can in terms of estimating what is
going to work or what is not going to work. There are steps
forward. Sometimes there are setbacks, especially in clinical
research where you know you have to come up with something that
is both effective and safe, but I think with the way that the
field is moving, and it is hard for me to see that that dream
you were promised in 1996 is not going to happen. It is very
hard to put timetables on these kinds of trajectories. I wish I
could.
Mr. Space. Apart from the obvious benefits associated with
the alleviation of human suffering and saving lives, is it your
assessment that that would also save a lot of money?
Dr. Collins. A lot of money, absolutely, and I certainly
hear what you are saying both for type 1 and for type 2
diabetes the huge sums of money that we are in our medical care
system are going to take care of individuals. We also have very
vigorous research programs on type 2 diabetes, particularly now
in prevention where we have the ability perhaps for people who
are starting to tip over into that to be able to prevent the
full onset of the disease, following up on the results of the
diabetes prevention program, which has taught us how to do that
with simple things like diet and exercise and lifestyle changes
that can be successful if properly managed.
Mr. Space. And just finally, in the event that the special
diabetes program were not to be reauthorized, would that have a
deleterious or negative effect on advances in he field?
Dr. Collins. It certainly would. I mean, with all the
momentum that has been generated because of that special
program, the idea that those dollars would sort of come to a
halt would force the NIDDK, the diabetes institute, to make
some very difficult decisions about what they could continue
and what they could not.
Mr. Space. Thank you very much, Dr. Collins.
Ms. DeGette. Mr. Space, the Chair will announce that we
have for--the Diabetes Caucus has asked for a full hearing on
NIH efforts towards diabetes research and prevention and so we
will look forward to that hopefully later this year.
Mr. Space. And I look forward to that as well, Madam
Chairman.
Ms. DeGette. The Chair recognizes the gentlelady from
Wisconsin, Ms. Baldwin.
Ms. Baldwin. Thank you, Madam Chair. I have ambitious plans
with my 5 minutes of questions but we will see how far I get
into this.
First I just wanted to make a comment. I was present when
Dr. Christensen was talking, asking questions and bringing all
of our attention to the issue of health disparities in minority
populations, and I just wanted to share with you my interest in
expanding the way we think of that to include also the lesbian,
gay, bisexual and transgender population. In years past when we
have had predecessor in front of the subcommittee or other
agency heads, I have asked about the state of knowledge on LGBT
health and what sort of data collection we have, what sort of
information, and I am sad to say that the answer was, you know,
either we will get back to you or we are not aware of anyone
even asking questions related to sexual orientation or gender
identity to be able to gather the evidence and the data. I
don't know what role you might have personally played in the
focus that the IOM is now putting on this question but I am
delighted and want to commend any role that you did play in
bringing that together because I think it will examine the
current state of knowledge and hopefully produce
recommendations of where we can obtain even greater knowledge.
So that is just a comment.
Really, with the rest of my time I wanted to get as much of
a status update on some new programs, et cetera. If you don't
have the information available today, please feel free to
respond at a later point. But last year the Christopher and
Dana Reeve Paralysis Act was signed into law. I had authored
the freestanding bill before it was included in the public
lands bill. And this authorized NIH to undertake two grant-
making processes. One would fund grants for consortia in
paralysis research, and the other would grant funds to maintain
a clinical trial network with sites focusing on people living
with paralysis. I am wondering if you can give me any update on
the implementation of this new legislation.
Dr. Collins. I would be happy to. Very quickly, in terms of
LGBT, we are in fact supporting and we have done an inventory
here some 272 projects through NIH research costing over $239
million, so there is a research portfolio there. But we are
very much looking forward to the results of this IOM study,
which I strongly support, to try to learn more about the needs
and the research opportunities that NIH should be addressing.
In terms of the Christopher and Dana Reeve Paralysis Act,
yes, there certainly has been as a consequence of that the
formation of a network here which is funded by the National
Center for Medical Rehabilitation Research, which is within the
Child Health Institute. Traditionally that is where
rehabilitation research has been located. But together with the
Neurology Institute and the National Institute for Bioimaging
and Biotechnology, that resulted in solicitation of a whole
bunch of interesting proposals and in fact seven sites that
received the best peer review recommendations are now being
funded by those three institutes, and they are going to look at
biological, medical, behavioral, social aspects of paralysis
and very much try to make this a consortium effort as opposed
to a collection of disconnected research projects.
Ms. Baldwin. Great. Thank you. Recovery and Reinvestment
Act funds were awarded through the National Center for Research
Resources to address the critical research infrastructure needs
across the Nation but I would say that the funds were
inadequate to meet all the critical needs that are out there,
and so I am wondering moving forward, once the recovery dollars
are expended, will funds for construction or remodeling of
facilities be a priority and be allocated to NCRR?
Dr. Collins. So yes, we were delighted in the Recovery Act
to have a billion dollars to put forward for construction and
renovation, and those grants were rigorously reviewed and
fairly recently decisions made and announcements put forward
and those $1 billion is going to support grants and new
construction in 146 projects in 44 States and the District of
Columbia, so this was clearly one of those occasions where
dollars from the Recovery Act were going to support both
medical institutions and the economy in terms of the
reconstruction efforts. Future funding is not included in the
President's budget for fiscal year 2011, and I must tell you
that when budgets are tight, as we fear they may in fiscal year
2011 and beyond, dollars for this kind of application are often
hard to come by, and that is something that Congress decides,
we don't decide. If we don't have an allocation in that part of
our budget, we are not allowed to spend the money on buildings
and facilities so we wait to see what the appropriators tell
us.
Ms. Baldwin. I see I have run out of time. So I will
conclude. Thank you.
Ms. DeGette. If the gentlelady has a couple more questions,
we had said we would be willing to do a second round, so you
can----
Ms. Baldwin. Oh, I would be delighted to use just a couple
more minutes and then I won't need a second round.
The University of Wisconsin has long been responsible for
running the National Stem Cell Bank. This year we have been
informed that NIH would like to take this process through a
competitive rebid, and I wonder if you can tell me a little bit
about what the timeline and the selection criteria will be for
the rebidding of the National Stem Cell Bank.
Dr. Collins. So the University of Wisconsin has been such
an important leader in this whole field. I think I mentioned
earlier the contributions of Jamie Thompson and the way in
which the Wisconsin effort led to the formation of this bank
was certainly an important resource for individuals who would
want to get access to these stem cell lines and knew that they
had been properly maintained and they could count on their
quality. Now that there are, as I mentioned earlier in this
hearing, 73 such lines that have been approved and going up, we
are going into the hundreds before long, there is a big
question mark in many people's minds about exactly what is the
right way to make sure the lines are accessible to
investigators who want to use them. Some of them will probably
be used more than others. There will be some favorites, no
doubt, as has been the case in the past.
What we are trying to ascertain is whether it is actually
time for this kind of banking activity to move into a
competitive private sector enterprise because certainly in
other circumstances where there are biological resources that
many individuals are interested in, the time sometimes arrives
where it is more efficient and more cost-effective to have this
conducted by a small company who would then be basically
recovering their costs of distribution by a modest chart. What
we don't want to do, however, is to have that end up resulting
in excessive cost for NIH investigators. That would sort of
defeat the purpose.
So we are still exploring what the right pathway might be
but it seems likely that we will want to set up a circumstances
where there is more than one bank, because obviously you
wouldn't want to have the entire field resting upon a single
resource, and it will be, I think, a few more months before we
have a clear sense of what is the best strategy for making sure
that we have cell lines that are maintained at high quality and
made available to investigators at reasonable cost.
Ms. Baldwin. I have two more topics. In the fiscal year
2010 appropriations bill, Congress called on the Office of the
Director to engage in specific efforts to improve research on
women's pain including coordination of a trans-institute
research initiative in fiscal year 2010 that will support
studies aimed at identifying common etiological pathways and
with the goal of identifying potential therapeutic targets, and
secondly, a conference to be held along the same lines. Could
you tell me about the status of your efforts in this area?
Dr. Collins. So we certainly read that part of the health
care reform bill carefully and we are happy to be called upon
to work in this area of pain, which we agree is extremely
important. There is a pain consortium at NIH which has been in
place for several years which involves quite a number of the
institutes that have an investment and an interest in this
area, and this is another sort of encouragement for that effort
to get even more involved. We are in fact planning the
conference that is being asked for, which I think is to be
hosted by the Secretary in the not-too-distant future because I
think there was a timeline on that, and there is also an
exhortation in the Affordable Care Act bill about coming up
with some new Common Fund ideas for pain research which is
certainly something that is being looked at by the pain
consortium to see if there are opportunities there.
In addition, there have been a number of specific workshops
focused on particular subsets of pain to try to bring
investigators together with new ideas, and I must say there are
some exciting things coming along. I will just mention one,
which is another example of how a rare disease can really lead
you to a very interesting new hypothesis. There are rare
individuals who are born with what is called congenital
insensitivity to pain. There was a particularly dramatic
publication a year or so again studying a Pakistani family
where a number of the siblings were completely unable to feel
pain, which is not actually good for you. These siblings end up
involved in street theater where they would walk on hot coals
or they would actually pass knives through their arms,
obviously amazing people going by, not feeling pain but of
course putting themselves in great jeopardy. The cause for that
has been discovered and they are basically missing one of these
sodium channels that normally transmits the pain signal in the
nervous system, and they are otherwise entirely well. Now, that
is a really interesting finding and that says if you can
identify a drug, a small molecule that blocked that activity
and the rest of us transiently, that would be an incredibly
powerful pain reliever, an analgesic, and many companies have
now jumped on that description of a very rare family thinking
this might be the best clue we have in a long time for a
totally new approach to pain management.
Ms. Baldwin. Very interesting.
My last question, and you have been very tolerant of my
battery of different updates, I am curious about the National
Research Service award funding program. Are there any efforts
underway to reframe that, change the amount or the allocation
or training funds under that program?
Dr. Collins. So we are aware that stipends for NRSA
trainees, the Ruth Kirschstein NRSA awards, have fallen behind
over the course of many years without having a substantive
increase in quite a long time and so we have supported a 6
percent increase in the current circumstance to try to make up
some part of that and there has been a sense of the Congress
and we agree with this that we should continue to try to catch
up a big here. We depend on these trainees to do a lot of the
front-line research. It is part of their training, but they are
also really important for the productivity of the enterprise.
We certainly wouldn't want talented minds to go elsewhere
because they just couldn't figure out how they are going to buy
groceries, so we are doing what we can to try to catch up on
that, recognizing that we have fallen behind.
It of course comes at a tough time if we are seeing a more
stringent budget looming in the future. If we are going to
increase stipends, we may have to decrease the number of
trainees because there has got to be an ultimate reckoning, and
we would hate to do that too so it is just more example of the
tough decisions that may be facing us at a time where the
economy is struggling.
Ms. DeGette. The gentleman from New York, Mr. Engel, is
recognized.
Mr. Engel. Thank you, Madam Chair.
Doctor, before I came here, I was at my other subcommittee
on the Energy and Commerce Committee, which is the Energy
Subcommittee, and we were questioning the BP executives and
some of the other executives, and I can tell you this
subcommittee is much more friendly today.
Dr. Collins. Yes, I am glad I am at this time and not in
that other room.
Mr. Engel. I want to first of all personally thank you for
the good work that you do. I followed your work and I am very
impressed. You spoke at the New Dems several weeks ago, I was
there and very, very impressed with what you had to say, so
thank you, first of all, for all the good work that you do.
At that meeting with the New Dems, you had mentioned a drug
called, I think it was Iressa, about breast cancer. I am
wondering if you could just again tell us about that, and if
somebody would want to sign up for it or anything like that, is
that possible?
Dr. Collins. There are certainly trials going on, so Iressa
for which the generic name is gefitinib, is one of these new
targeted therapies for cancer about which there is a great deal
of excitement, so Iressa basically works by blocking the action
of a particular kinase, which is an enzyme that is normally
present in cells but in cancer cells from some tumors gets
overly activated by a mutation, and if you are somebody who has
a cancer that has that specific mutation, Iressa can be
extremely effective. I think I told the story of a woman whose
cancer was diagnosed--well, she had lung cancer which was
already metastatic to her brain in 2002 and expected to live
for a few months. She is doing fine today, I am happy to tell
you, because this drug was the perfect antidote to her
particular tumor mutation.
Now, that is the good news. The troubling part of this is
that Iressa doesn't work for about 85 percent of people with
lung cancer because they don't have that mutation. They have
some other way that their cells have gone haywire and are
causing the cancer in their system, but it does say that we are
reaching the point with Iressa, with the drug I talked about in
my opening statement which is another example of this sort of
targeted therapy for cancer where you can sample a tumor and
say oK, what is here and then look at your list of drugs that
are available and do the match. As that match gets more and
more possible because the list of drugs and the lists of
targets gets longer, we are going to see a real transformation
in the way that cancer is approached, and that is a great thing
but it is personalized therapy we are talking about now instead
of giving everybody the same does of chemotherapy.
Mr. Engel. Thank you. I would like to ask you a question on
gestational diabetes. According to the American Diabetes
Association, gestational diabetes affects 2 to 5 percent of all
pregnant women, and that is 135,000 cases every year in the
United States, and it occurs, I am told, in pregnant women who
have never had diabetes before but develop it between the 24th
and 28th week of pregnancy, and while it generally goes away
after pregnancy, it can have health impacts for both the mother
and the baby. I am told that there is currently an insufficient
system for monitoring cases of gestational diabetes to uncover
trends and target at-risk populations, and for that reason, I
and Dr. Burgess have introduced the Gestational Diabetes Act of
2010, and I am wondering if you could discuss some of the
research currently underway to address the need for
comprehensive information on the causes and best treatment of
gestational diabetes.
Dr. Collins. It is a very important problem and one that we
need to address both in terms of research and in terms of just
the public health and trying to identify individuals who have
risks of this sort. Gestational diabetes is in fact a risk to
the pregnancy as well. It is associated with higher birth
weight with prematurity and certainly something that you want
to try to control because the mother who has out-of-control
gestational diabetes is also likely to end up with
preeclampsia. But more than that, if you get the mother through
this experience, and most do, the risks that that woman will go
on to full-blown diabetes are substantially increased and
ultimately about half of women who have gestational diabetes
will ultimately become diabetic.
So it is apparently one of those circumstances where
pregnancy is kind of a stress on the system, and somebody who
may already be predisposed, it becomes more clear in the course
of a pregnancy that that is the case. So we need both better
methods to monitor during pregnancy, which means our medical
care system needs to be of course accessible to those who need
those services. It is not particularly difficult to assess this
if that person is getting adequate prenatal care, and we need,
of course, methods to prevent it in the first place, and it
appears at the present time that the risk factors for
gestational diabetes are pretty much the same as the risk
factors for type 2 diabetes in general, which is to say family
history, which is to say body mass index, obesity and exercise,
and what we have learned in terms of how to take people who are
predisposed to diabetes and prevent that from things like the
diabetes prevention program are probably very applicable here
as well. But certainly women who have gone through this
experience and had gestational diabetes ought to have a
particularly good opportunity to recognize the risks to their
future health and to be given the same kinds of interventions
that we now offer to people with pre-diabetes to try to reduce
the risk of coming down with the disease. So there is a lot we
can do there, but I agree, that has not been fully realized.
Mr. Engel. I would like to ask you about Charcot-Marie-
Tooth disease. There is an innovative partnership between the
NIH's National Chemical Genomics Center and the Charcot-Marie-
Tooth Association. I have worked with that association, and I
think that this could serve as a model of future rare-disease
research and drug development, so am wondering if you could
describe the program and offer your thoughts on it.
Dr. Collins. I appreciate the question because I do agree,
this is a very exciting program. My father-in-law has Charcot-
Marie-Tooth disease, so this is a disorder that is not only
something from my clinic but also from my family experience.
And this is an interesting disorder which causes a weakness of
the legs particularly but also the hands over the course of
time, and can be quite debilitating, but it is well understood
now what the cause of that is, the genetic abnormality has been
now laid out in great clarity, but what could you do about it.
So working with the NIH Chemical Genomics Center, which is a
remarkable facility that has been mentioned already at least
once in this hearing, an effort is being made to identify a
small molecule, which is sort of a drug that would basically
compensate for the genetic problem that is found in individuals
with this type of Charcot-Marie-Tooth disease, so called CMT
1A, and that is an early-stage effort but it is a good example
of this therapeutics for rare and neglected diseases effort
that NIH is putting increasing effort into.
Charcot-Marie-Tooth is too rare for companies to generally
see this as a good investment for them in terms of developing a
therapeutic but with the Chemical Genomics Center working with
academic investigators who know a lot about the disease, if
they can push this forward to the point of identifying a
promising compound, then you could imagine a company getting
pretty interested in licensing that out and carrying it all the
way through to a clinical trial.
Mr. Engel. Thank you. With the Chair's indulgence, I would
like to ask you about mental health problems of children and
adolescents, because in my district, we have the Nathan Klein
Institute and it is an internationally known psychiatric
research facility, and they believe that the unmet mental
health problems of children and adolescents is one of the most
important continuing problems that haven't yet been adequately
addressed, and the research funded by NIH establishes that 50
percent of all mental disorders begin in pediatric ages and 75
percent onset by age 24, and yet as of 2 years ago only about 8
percent of the budget of the NIMH was dedicated to addressing
the needs of children and adolescents. So let me ask you this.
How does research of pediatric and adolescent mental health
issues fit into the themes of opportunity you have identified
within your first year?
Dr. Collins. Well, I agree with you. Those are critical
issues because certainly the onset of a mental health problem
in childhood or adolescence means that that individual if not
properly diagnosed and treated is going to have a very long
course. One of the things that I think we are trying to
understand is, what are the advantages of early diagnosis and
intervention. I think there is a lot of need also just to
understand in terms of basic neuroscience what is going on in
the brain in bipolar disorder, in schizophrenia, in major
depression and a number of the other conditions that do tend to
come on in adolescence. The Human Connectome Project is an
effort to try to do that in a more systematic way, putting
together genetic variations with what the linkages are in the
brain between various regions and how those neurological tracks
are different in people who develop one of these diseases.
But I hear what you are saying about the need to focus
particularly on early onset risks, and here I think the
National Institute for Child Health and Human Development
working with NIMH, which has been the main source of mental
health research, and also with the neurology institute, NINDS,
is undertaking, I think, a pretty important effort to try to
develop a better understanding of normal brain development in
young people and then also to apply that to trying to see what
happens in the course of the development of one of these
diseases. Certainly the National Children's Study when it gets
fully up and going will also have the chance to look for very
early influences on mental illness in terms of environmental
exposures, genetics, et cetera, because we have not really had
a very good database and that study which will study now
100,000 individuals from preconception until they age 21 should
provide some other important clues.
Mr. Engel. Let me ask the indulgence of the Chair. I have
another question. Could I--one more question.
Let me ask you about HIV and AIDS research because I think
that is really important, and 56,000 people every year are
living in the United States become newly infected with HIV, and
in your opening statement you mentioned the many ways that NIH
research has contributed to the information that we know and
the increased life expectancy for HIV-infected people. We had
discussed previously an innovative program in the Bronx where I
am from. Can you discuss that program and also the current
state of HIV/AIDS research, specifically at the community level
that NIH is conducting?
Dr. Collins. So the program you are referring to is an
innovative idea about testing and treating and then linking to
care. Let me explain what this is and why it seems to be
potentially very beneficial. You are right, 56,000 new cases
each year, and that has been pretty flat for the past few
years. We are clearly not successful in reducing the new cases
of this epidemic, even though we have developed effective
antiretroviral therapy and individuals who are HIV positive can
now expect to live many decades. Still, we should be doing
better in terms of ending the epidemic.
The idea here is that most of the new cases of HIV or many
of them, anyway, are actually acquired from individuals who do
not know that they are HIV positive because at the present time
many individuals do not get diagnosed until they have already
developed some symptoms, they are found to have their immune
systems already compromised. At least by mathematical modeling
and by some small studies done in other parts of the world, it
looks as if you tested every one of us every year to see who is
HIV positive, and as soon as somebody turned up positive began
treating them then, you would both improve their likelihood of
a good outcome but importantly you would drop their viral load
substantially so that their likelihood of passing the virus on
would go way down. So the idea here is that you essentially
reduce the viral load of the whole population by identifying
infected individuals as early a time as you could and
mathematically it looks as if that could actually end the
epidemic without having come up with a vaccine, which has
obviously been an enormously frustrating circumstance. To test
that, this test and treat link to cure, TLC effort--link to
care--has been piloted just recently in the Bronx and here in
Washington, D.C., with support from the National Institute of
Allergy and Infectious Disease so that we are going to be able
to see does this work, not in a mathematical model but in the
real world, and we kind of thought Washington, D.C., was the
real world and we thought the Bronx was too.
Mr. Engel. I do too. It is one of my favorite places. Thank
you very much.
Thank you, Madam Chair.
Ms. DeGette. Dr. Collins, I would like to ask you one
question on behalf of Chairman Waxman, who had other
obligations. He is concerned about the peer review process and
also the Cures Acceleration Network. As you know, the NIH
Reform Act of 2006 required that all research that the NIH
conducts or supports has to go through a peer review process,
and you pointed out in your testimony that the process is
critical to ensuring that federal dollars are spent on the
highest quality research. The health care reform legislation
that the President recently signed into law established this
Cures Acceleration Network, whose goal is to further research
into treatments for certain kinds of conditions, specifically
the ones we talked about earlier that have few existing
therapies. The legislation established a competitive process
for reviewing these CAN proposals but it didn't specifically
require that grants go through the NIH peer review process, and
so it is Chairman Waxman's understanding that the authors of
the provision do not intend for the grant proposals to be
subject to the process. What is your understanding of how CAN
grant proposals are going to be reviewed by the NIH?
Dr. Collins. We depend on peer review for everything we do,
and the way in which we would expect this program to go forward
would be to invite projects that see ripe for investments of
this sort which is moving them through the so-called valley of
death where you have a promising compound but you want to get
it all the way to a clinical trial. Those would have to be peer
reviewed to see where in fact are the most promising projects,
the most promising opportunities. This is high-risk,
potentially high-failure science, but we at NIH are very
motivated to push this forward, and the Cures Acceleration
Network would provide us with some flexibilities that we
haven't really had before. But it would be done with peer
review.
One thing I want to say is that the bill does offer some
DARPA flexibilities to NIH, so-called other transaction
authorities, which we would welcome in that once a project has
been peer reviewed and initiated, it gives the project manager
some flexibilities about how to move the project forward and to
kill a project if it looks like it is failing and missing
milestones. So we do embrace that kind of flexibility but I
want to assure Mr. Waxman that we would not imagine having
projects get into this pipeline without that kind of rigorous
peer review.
Ms. DeGette. Thank you, very much.
Mr. Shimkus. Madam Chairman.
Ms. DeGette. Mr. Shimkus.
Mr. Shimkus. Just to remind you of the importance of having
a hearing on the health care law. It is not a bill, it is a
law, and so we need to deal with it, so I am glad that Chairman
Waxman thinks that there are some questions that need cleared
up based upon the law.
And also, you promised a great litany of things that we are
doing and dollars spent. My opening questions dealt with this
driving research thing that you are doing, $250,000. You said
you would come back and give some answers on that. I would hope
you would, because then it is tough for us to defend the good
when we have questionable dollars going into questionable
directions that we need more clarification on. So thank you,
Madam Chairman.
Ms. DeGette. Thank you. And just to reiterate, several of
the members expressed to me during the votes that they will
submit their questions in writing, so if we can get responses
to all these questions, it would be great.
Dr. Collins. We are happy to do that.
Ms. DeGette. And I want to remind all of the members that
they may submit additional questions for the record to be
answered by the witness. The questions should be submitted to
the clerk within 10 days and then the clerk will notify all of
the offices of the procedures.
And I would like to just thank you in particular, Dr.
Collins. You have a very full plate. We are glad you gave us
your afternoon. It was a wide range of questions. The members,
I think, were impressed by the answers and we look forward to
working with you, and this meeting is adjourned.
[Whereupon, at 4:30 p.m., the Subcommittee was adjourned.]
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