[Senate Hearing 110-874]
[From the U.S. Government Publishing Office]
S. Hrg. 110-874
THE BROKEN PIPELINE: LOSING OPPORTUNITIES IN THE LIFE SCIENCES
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
ON
EXAMINING FUNDING OF THE NATIONAL INSTITUTES OF HEALTH, FOCUSING ON
OPPORTUNITIES IN THE LIFE SCIENCES AND BIOMEDICAL RESEARCH
__________
MARCH 11, 2008
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut MICHAEL B. ENZI, Wyoming,
TOM HARKIN, Iowa JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico RICHARD BURR, North Carolina
PATTY MURRAY, Washington JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island LISA MURKOWSKI, Alaska
HILLARY RODHAM CLINTON, New York ORRIN G. HATCH, Utah
BARACK OBAMA, Illinois PAT ROBERTS, Kansas
BERNARD SANDERS (I), Vermont WAYNE ALLARD, Colorado
SHERROD BROWN, Ohio TOM COBURN, M.D., Oklahoma
J. Michael Myers, Staff Director and Chief Counsel
Ilyse Schuman, Minority Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
TUESDAY, MARCH 11, 2008
Page
Kennedy, Hon. Edward M., Chairman, Committee on Health,
Education, Labor, and Pensions, opening statement.............. 1
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming,
opening statement.............................................. 3
Mikulski, Hon. Barbara A., a U.S. Senator from the State of
Maryland, statement............................................ 4
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio,
statement...................................................... 6
Faust, Drew Gilpin, Ph.D., President, Harvard University,
Cambridge, MA.................................................. 9
Prepared statement........................................... 13
Rafael-Fortney, Jill A., Ph.D., Associate Professor, The Ohio
State University, Columbus, OH................................. 17
Prepared statement........................................... 18
Miller, Edward D., M.D., Dean of the Medical Faculty, The Johns
Hopkins University School of Medicine, Baltimore, MD........... 21
Prepared statement........................................... 21
Lewis, Dana, Student and Diabetes Advocate, American Diabetes
Association, Huntsville, AL.................................... 25
Prepared statement........................................... 25
Rankin, Samuel M. III, Associate Executive Director, American
Mathematical Society, Washington, DC........................... 27
Prepared statement........................................... 28
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Senator Bingaman............................................. 41
Senator Clinton.............................................. 42
(iii)
THE BROKEN PIPELINE: LOSING OPPORTUNITIES IN THE LIFE SCIENCES
----------
TUESDAY, MARCH 11, 2008
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 11:02 a.m., in
Room SD-430, Dirksen Senate Office Building, Hon. Edward M.
Kennedy, chairman of the committee, presiding.
Present: Senator Kennedy, Mikulski, Brown, and Enzi.
Opening Statement of Senator Kennedy
The Chairman. We will come to order. I welcome our
committee members to today's hearing on the funding of NIH and
its impact on innovation. I welcome President Faust, Dean
Miller and other distinguished witnesses and look forward to
hearing their conclusions and recommendations.
Imagine holding a hearing on medical research 100 years
ago. At that time even the idea of vaccines against polio or
measles or whooping cough would have seemed far fetched. A
hearing 50 years ago might have spoken of effective treatments
for cancer as a distant dream, perhaps never to be achieved.
Twenty years ago the participants at such a hearing might
have raised the hope of treatments for AIDS, but would have
cautioned that this hope might not become a reality for
decades. Even 15 years ago witnesses might have spoken of a far
off day when the complete sequence of the human genome would be
decoded. Today breakthroughs that were once distant dreams are
reality that make a difference in the lives of patients in
every community in America. They draw their inspiration from
many sources, but they all have two core elements in common,
the brilliance of medical researchers and the support of the
American public.
What will be discussed at a hearing on medical progress in
5 or 10 years from today? Will we review a decade of continued
progress with new breakthroughs in diabetes, spinal injury,
Alzheimer's disease and other serious afflictions or will we
look back in regret at a decade of missed opportunities and
squandered potential?
The actions that Congress takes in the coming months will
help to determine which of these two possible futures becomes a
reality. We cannot close our eyes to the consequences of
continued failure to capitalize on the progress that we've made
in medicine in recent years. Thanks to thoughtful research and
scholarship at a consortium of universities that includes many
of our Nation's leading centers of innovation, we have before
us a chilling statement of where our current budget policies
for NIH will lead.
The report conclusions are a call to action for Congress
and the Nation. President Faust of Harvard, one of the authors
of the report, will present the findings in more detail. Even a
brief review of some of the major conclusions should shock
those who hear them.
Due to inadequate funding the success rate for grant
applications has dropped 32 percent in 1999 to 24 percent
today. For young researchers the situation is even more dire.
Their success rate in applying for first independent research
grants has dropped from 29 percent in 1999 to 12 percent today.
That means a young researcher has just one chance in eight of
getting a grant.
As a result, the age at which a researcher gets his or her
first independent research grant has risen from 39 years old in
1990 to 43 years old today. Many young scientists conclude that
it's not worth the wait and pursue other career options. Even
though scientists who do get funded are forced to spend more
time writing grants and less time doing research at the bench.
Many turn to industry jobs where they can benefit from funding
security despite losing the freedom to pursue academic
research.
I recommend that every committee member look at the
excellent comments from scientific leaders that are included in
the report. One to me was particularly striking. It was my
friend Joseph Boger, the CEO of Vertex Pharmaceuticals in
Cambridge and President of Vioxx summarized the risk of our
current course this way.
``You can lose a generation of researchers pretty
fast, 5 or 10 years. You create such a discouraging
atmosphere they just go somewhere else instead of
academic research. We don't have to lose 50,000
researchers, just 50 really good ones. Once it happens
we won't get those people back.''
If we lose the talents of a generation of young
researchers, we put in peril, not only medical progress, but
America's leadership in life sciences too. The culture of
innovation and discovery does not just happen it must be
nurtured or it will wither.
The United States has a long tradition of being a global
innovative leader, but we can't take our leadership for
granted. Today it's at risk. Thirty years ago U.S. researchers
published 90 percent of all scientific literature on
information technology. Today it's less than half. Unless we
invest in the life sciences we'll lose our global leadership in
biotechnology.
As a nation we must make a choice between continued
progress or the stifling of innovation.
I thank President Faust, Dean Miller and all our
distinguished witnesses for joining us today to give their
recommendations on this important issue. I look forward to your
comments and to our discussions. I'll be delighted to hear from
our friend, Senator Enzi and then Senator Mikulski who's been
such a leader in terms of NIH. Not just funding but in policies
and so many different areas. We're delighted to have her.
Opening Statement Of Senator Enzi
Senator Enzi. Thank you, Mr. Chairman. I appreciate you
holding today's hearing. I want to thank our roundtable
participants for taking the time to join us. I look forward to
hearing your views, your insights, your suggestions about our
life sciences system and what's working well and what needs to
be improved.
Your recommendations will greatly assist us in the effort
to insure that we not only make progress in this field but
continue to be a world leader in the effort to research and
find cures for the diseases that continue to inflict so many
Americans. Throughout the history of our Nation generations of
American scientists have looked for ways to improve the human
condition and address the problem of disease and the
afflictions of old age. As they conducted their research each
scientist's work was built on the discoveries that preceded it.
The results they achieved over the years have enabled us to
live longer, healthier, more productive lives.
Over the years the progress we've made depended on new
generations of scientists taking up and carrying on the work of
those who came before them. The Federal Government played a
central role in that effort by providing the funds that were
needed to sustain and support the work they were doing and
train those who were doing the research. Our investment in life
science and NIH has been a central part of that effort.
NIH-funded research has played an integral role in most of
the discoveries of the past 50 years that have improved human
health. In the United States alone NIH research has lead to an
80 percent overall 5-year survival rate for childhood cancers,
a 70 percent decline in AIDS-related deaths between 1995 and
2001, a more than 40 percent decline in Sudden Infant Death
Syndrome rates between 1994 and 2000, 41 and 51 percent
declines respectively in the death rates from heart disease and
stroke between 1975 and 2000, the ability to eliminate or
greatly reduce symptoms in 80 percent of schizophrenia patients
and to improve the quality of life for more than 19 million
individuals suffering from depression and a blood supply that's
the safest in the world.
In addition to saving lives, our investment in research has
lead to the creation of a new industry and the jobs that were
needed to sustain it. Because of the investment in NIH and the
technology that spun out of it, the United States has been a
world leader in health care. We have developed a long list of
vaccines, therapeutic medicines and devices to combat disease.
To ensure that the NIH continues to be a driver of innovation
we passed the NIH Reform Act during the last Congress.
This act provided the Director of NIH with the flexibility
and the resources needed to address a changing list of
priorities. I'm pleased that the Director, Dr. Zerhouni has
used the authority to create new programs, to encourage young
investigators and to then fund innovative, cross cutting
research. It's particularly worth noting that he was able to do
this with an appropriation that did not meet the authorization
levels that this committee enacted.
Appropriations that match authorization levels are
important to allow administrators and the NIH to plan and
budget. It's also important to remember that our resources are
finite. Ultimately, the NIH needs to have the flexibility to
put the resources it's given where they can be used to the best
advantage, funding scientists and science that are deemed the
most appropriate to fund. That's our current status, but it may
not stay that way for much longer.
The budget and the priorities that we set are continuing to
be squeezed tighter and tighter by the demands of each years
mandatory spending. It's a difficult problem with planning and
a compelling vision for the future; it's one that can be
overcome. Although this hearing will focus on NIH, it's
important to remember the fact that the research arm of the
Federal Government is made up of more than just the NIH.
The National Science Foundation, the Department of Defense,
the Department of Energy, the National Aeronautic and Space
Administration and the USDA are important components of the
Federal Government's commitment to science and research. Just
like life sciences, material sciences, mathematics, aerospace
and electronics are crucial to our future health and well-
being. Further it's clear that advances outside of the health
sciences drive the advances made in life sciences.
As we examine this report it's important that we look to
the experience at NIH and apply these lessons to the National
Science Foundation. President Bush's announcement that the
Administration wants to double the National Science Foundation
should serve as an invitation to learn from the NIH doubling
experience and the success it's proven to be.
I want to thank all of you for coming today. I look forward
to your discussion and the implications on this issue. There
will be no greater influence on the quality of our future than
the ability of people to lead happy, healthy and fully
productive lives.
I thank you, Mr. Chairman for making this possible. I look
forward to the comments of the Senator from Maryland who has
played a great role in all of this.
The Chairman. Thank you very much, Senator Enzi. Senator
Mikulski, would you like to say a word?
Statement of Senator Mikulski
Senator Mikulski. Well thank you very much, Mr. Chairman. I
will be brief. I'm very excited about this hearing today and
look forward to hearing from our wonderful panel from people
distinguished in academia medicine and research and heading up
our great universities and the young people themselves who want
to have a career in these fields and make this world a better
place to live in.
For many years I've been a strong supporter of increasing
the funding at NIH. I was so proud to be part of a bipartisan
effort to double the funding of NIH. You know when we work
together we actually make a difference.
We have worked in a bipartisan basis to double the funding.
Yet, when we look at the President's budget this year, he's
coming in with a request for $29.5 billion. That sounds like a
lot, but really that's a couple of weeks in Iraq.
It is flat funded at the 2008 level which means that it's
actually shrinking because of what it takes to be able to do
research and the rising cost of even energy and utilities to
keep the lights on in the lab let alone keeping the lights of
hope and opportunity on for our young researchers. What's so
frustrating is that we were on a trajectory to increase NIH,
but in 2003 it stopped. So now we're just sputtering and
turning our wheels because once we hit 2003 with the stagnation
that occurred in these last 5 years, there has not only been
less money and less opportunity to pursue research grants, but
there is a lack of predictability. It's a disincentive for
people to either choose the field or stay in the field.
Now as a U.S. Senator from Maryland I just have a
spectacular job. The National Institutes of Health is in my
State. What a great thing to be able to say because every day I
know thousands of people are getting up every day to make this
world and people's lives a better place.
Not only that, because of the genius of the American system
working with academic Centers of Excellence in my own State, of
course, Johns Hopkins University as well as the University of
Maryland. Again using the best of academic medicine where
people who have the responsibility for not only research but
training the next generation of medical and health leaders. At
the same time actually treating people and taking medicine from
the bench to the bedside and working on it together.
We have these fantastic places. Not only that, Mr.
Chairman, we not only have the greatest civilian places where
research is done, but in my own State, too we have military
installations, like Fort Detrick, that has the responsibility
to protect us against biological and chemical attack. While
we're looking at protecting the war fighter against malaria.
Fighting malaria, as Senator Brown has so long advocated,
around the world--a lot of that research is being done in the
civilian sphere.
We really want to listen and we want to learn. we need to
act. We need to have both the will and the way. We need to have
a national will, a national commitment and then a national
wallet.
We have seen the changes that have been made. I'll just
speak to one area of women's health. When I came to the U.S.
Senate, women were not included in the protocols at NIH. That
famous study, ``take an aspirin a day keep a heart attack
away'' occurred through 10,000 male residents. While working
together through this committee, with the leadership of Dr.
Bernadine Healy and NIH, we changed that. We established the
Office of Women's Health.
So what does all that mean? I'll tell you what it means.
Through the work that was done by this committee--funding what
it needed to do and NIH being what it is--working both at NIH
and with academic centers came the famous longitudinal study on
hormone therapy.
What came out of that? Be careful. What came out of being
careful and re-evaluating the use of hormone therapy, breast
cancer has declined in this country by 15 percent. Wow, what a
difference.
Then when we looked at something we finally got around to,
taking that aspirin a day to see if it would prevent a heart
attack or what it does in women. What do we now know? Women
experience cardio symptoms differently. We need different
focus. We need different tools of identification and we're
dealing with it and preventing it.
We could go through all the research. Then there's this
other issue that we've worked on which is called diversity in
science. When I came again, everybody said, ``gosh, science is
all white guys.'' Well, the white guys did a pretty good job,
but we wanted to open it up to all of America.
All of America began to dream and they didn't only focus on
great institutions like Meharry, our premier institution for
educating African-American doctors. We reached out. We wanted
to include people. We wanted to do more.
Now that we've begun to increase our diversity which is
women coming into research, people of color choosing this field
that's so wonderful and exciting. We begin to turn off the
spigot. We're turning off the spigot to our own future.
This Congress has focused on something called innovation.
We were even self congratulatory because we passed something
called the America Competes Act. Pat ourselves on the back.
Let's move on.
When we passed this legislation where does it leave us? We
know that we still are not in a competitive place. A country
that does not innovate stagnates. If you stagnate, you fall
behind.
This is our future. Miss Lewis is our future. We need to
meet the future because the future is us.
I believe that in this year's budget, this year's
appropriation, we have a rendezvous with destiny to get us on
the right track. To make sure we all understand this,
colleagues, I'll say this and I'll conclude, whatever we pass
this year for the NIH appropriations will be the operating
budget for the first year of the first term of the next
President. The next President gets sworn in January 2009. We
pass the appropriations in October 2008. October 2008 to
October 2009 is the operating budget for the first year of the
first term of the next President.
Let's meet our responsibility. Let's meet our rendezvous
with history. Let's take our lessons learned and let's get with
it.
I conclude my statement.
The Chairman. Good. Thank you so much. Senator Mikulski
always has a way of getting to the nub of the problem quickly
and eloquently and passionately. We always welcome her
comments.
Senator Brown, I think you would like to be recognized to
make an introduction.
Statement Of Senator Brown
Senator Brown. Thank you, Mr. Chairman. Senator Enzi and
Senator Mikulski, thank you. While we don't have NIH in Ohio,
we have some great research universities like Ohio State and
I'm so thrilled to represent them.
I want to start by presenting my former colleague in the
House and friend, Eric Fingerhut, who's the new Chancellor of
Education in Ohio and the terrific job he's doing. He's here
and Eric, welcome.
I would briefly reiterate what Senator Mikulski said. That
I was in the House at the time as the Ranking Member of the
Health subcommittee at the time when we doubled NIH funding
while having a Democratic President and Republican Congress.
There was almost, perhaps, unanimity, close to unanimity on
doubling the research budget of NIH with the understanding that
scientists were making good decisions as we move forward.
Understanding then, if my recollection is right, that the
government was funding something like one in three, one in
four, applications. That's the number we should aim at again
where now my understanding is 1 in 9 or 10 applications.
Understand what that does to young scientists that want to make
their living. Some of the young, brightest scientists in our
country and how difficult it is as those grants are more likely
to go to older scientists who are contributing much. Perhaps
not in our future as much as the younger scientists, who are
perhaps less skilled in working out the grant applications, but
equally skilled and with a future that they have.
I was just, a moment ago, given this blue wristband--it's
Autism Awareness week--and was talking about NIH funding for
them and environmental causes and all the things that we need
to look at. The work that all of you do as scientists is so
very, very important to us.
Dr. Paul DiCorleto, who's head of the Lerner Research
Institute in the Cleveland Clinic in northern Ohio says that
Ohio institutions that support biomedical research can't afford
to make up the shortfall in grant money. We've lost some $88
million over the past 2 years. This is in one State alone.
Multiply that throughout the country and you can see the
direction that we shouldn't be going in that we, unfortunately,
are going in.
It's my pleasure to introduce today, Associate Professor to
the Department of Molecular and Cellular Biochemistry at Ohio
State, Dr. Rafael-Fortney. We welcome you and thank you for
your service.
I would add, Mr. Chairman, I'd like to enter into the
record an article from today's Columbus Dispatch about her
visit here. She might not have seen this yet. It will be in the
record if the Chairman would----
The Chairman. It will be so included.
[The information previously referred to follows:]
[The Columbus Dispatch, March 11, 2008]
(By Suzanne Hoholik)
OSU SCIENTIST TO TESTIFY ABOUT NEED FOR FUNDING
3
Columbus, Ohio.--An OSU Medical Center researcher has found that a
protein is either gone or severely reduced in the hearts of patients
with heart failure.
Her next step would be to prove that the loss of this protein,
called claudin 5, causes heart failure, but a decline in Federal grant
money has slowed progress.
Jill Rafael-Fortney is an Ohio State University associate professor
in the Department of Molecular and Cellular Biochemistry. She needs
four people in her laboratory working on the project. She's down to one
full-time person and a part-timer.
She received a $250,000-a-year grant for 5 years from the National
Institutes of Health but is unsure whether it will be renewed. She
hopes so, for the fate of some of the 5 million Americans living with
heart failure.
That's what Rafael-Fortney plans to tell members of the U.S. Senate
Committee on Health today when she talks to them about increasing
funding so research such as hers can continue.
National Institutes of Health grants have been flat for the past
several years at about $20 billion each year. They haven't kept up with
inflation, meaning researchers are doing more with less.
Besides raising taxes, some researchers see one solution.
``Decreasing the war effort, I think, would be No. 1,'' said
Caroline Whitacre, vice dean for research at Ohio State.
OSU is among seven academic medical centers--including Harvard,
Vanderbilt and Duke--sending people to Washington today to talk with
lawmakers and the news media about researching funding.
The universities are concerned that if Federal funding stays the
same, frustrated ``young'' investigators who don't get their first
Federal grant will leave the field. The average age of a scientist
getting a first grant from the National Institutes of Health is 43.
Fewer scientists with creative research ideas could mean the Nation
will lose out.
``The type of medicine that we're going to be receiving in the
future depends on the research being done now,'' said David Moore,
senior associate vice president for government relations for the
Association of American Medical Colleges.
``It will take longer for new cures, longer for new diagnostic
procedures to get to the American public.''
Despite flat Federal funding, OSU Medical Center has received
increases in grants--$119 million last year, compared with $79.8
million in 2003.
Getting more is important because the grants are a key component to
Ohio State achieving its goal of being a top 20 academic medical
center.
The trip to Washington is about more than OSU or the six other
medical centers. It's about small universities seeing declines in
Federal grants and faculty members who get discouraged when grant
applicants are repeatedly denied.
``It's a morale issue at the moment,'' said Sandra Degen, vice
president for research at the University of Cincinnati.
``I haven't seen it yet, but that's the worry--that we might start
losing very good people.''
Senator Brown. Thank you.
The Chairman. Delighted.
Senator Brown. It gets better press out of the Columbus
Dispatch than I do, Mr. Chairman.
[Laughter.]
I work sometimes.
The Chairman. I think you do ok.
[Laughter.]
We'll hear from Dr. Drew Gilpin Faust, President of Harvard
University, accomplished historian. Dr. Faust served as the
first dean of the Radcliffe Institute, was the Annenberg
Professor of History, Director of Women's Studies program,
University of Pennsylvania, has served as part of the faculty
for 25 years. She's been aware of the issues facing young
scientists and engineers for 25 years, and oversaw the Harvard
Task Force on Women in Science and Engineering in 2005.
Dr. Jill Fortney is an Associate Professor at the
Department of Molecular Cellular Biochemistry at Ohio State,
University of Medicine. Her laboratory studies muscular and
heart disease in order to design treatments for muscular
dystrophy and heart failure. In addition to publishing 40
research papers she's received support from the NIH, American
Heart Association, Muscular Dystrophy Association, and was the
recipient of the Burrough's Wellcome Fund Career Award.
Senator Mikulski. Mr. Chairman, could I talk about Dr.
Miller.
The Chairman. Sure.
Senator Mikulski. I'm sorry. I didn't mean, if you were
finished with Dr. Fortney's extensive and stunning
accomplishments.
Dr. Miller is the Chief Executive Officer at Johns Hopkins.
He's the Dean of the School of Medicine and also Vice President
for the Hopkins University. He himself is a scholar who's
focused on cardiovascular effects of anesthetic drugs and
published over 100 scientific papers, abstracts and chapters.
What I also think is important is, Dr. Miller comes and
says, ``What does it take to run a great institution?'' and
also, ``what does it take to train that next generation of
leaders?'' And how do we? He has seen them from their bright
and shiny days of when they walk into the Medical School or the
School of Nursing or the School of Public Health, all eager and
ready to go. And then as they choose a career in research where
do they go?
His practical insights, I think, will be very helpful to
the committee on both policy and budget. We're happy to have
him.
The Chairman. Dr. Miller, we welcome you here as well. I
have valued our opportunity to spend some time together on
different occasions and certainly support what Senator Mikulski
has mentioned.
Ms. Dana Lewis is a sophomore major in public relations and
political science, University of Alabama. Since her diagnosis
of Type I diabetes 5 years ago, she has worked as an advocate
for others suffering from the disease. In 2005, she was
appointed the American Diabetes Association National Youth
Advocate and continues to volunteer locally and abroad and
empower the young people with diabetes. You are very welcome.
Dr. Samuel Rankin is the Executive Director of the
Washington, DC office of the American Mathematical Society.
Prior to coming to Washington, Dr. Rankin was Professor of
Mathematics at West Virginia University, Worcester Polytechnic
Institute, Virginia Tech. Dr. Rankin also serves as Chairman
for Coalition for National Science Funding and Association
Advocate for the National Science Foundation. We're glad to
have him here today.
Dr. Faust, we welcome you. We congratulate you on all their
good work on this program. You've had a banner year at Harvard
and leading the way in terms of opening up new opportunities to
students who attend our great universities and with limited
incomes. And you have set really a very important example
that's being followed by many other colleges and universities.
Needless to say, author of a very distinguished book which I've
had the good opportunity to get partially through.
[Laughter.]
I look forward to finishing it during this next Senate
break. It's a very stirring, moving story for those of us who
are always fascinated by the Civil War and the starkness of
that conflict and the loss of life in that conflict. You bring
an insight into that whole subject matter that is unique and
special and incredibly informative and moving.
We're here today on another reason to hear from you. We'll
certainly look forward to your comments.
STATEMENT OF DREW GILPIN FAUST, Ph.D., PRESIDENT, HARVARD
UNIVERSITY, CAMBRIDGE, MA
Ms. Faust. Thank you very much, Chairman Kennedy, Ranking
Member Enzi and members of the committee for this important
opportunity to come before you to illustrate some troubling
findings about how Federal funding of the National Institutes
of Health is affecting both the pace and the direction of
medical research.
For decades universities and the Federal Government in
partnership with States and philanthropists have built and
sustained a brilliant, powerful and vibrant research and
educational enterprise that has moved the world improving
health, growing economies and indeed growing whole industries
and seeking always the next frontier. This underlying theory of
the partnership resonates as clearly today as at its inception.
Investment in basic research at our universities delivers
transformative research today and simultaneously trains the
next generation of scientists, engineers and seekers of cures.
To borrow a term from biology, this pluripotent system
regenerates our research capacity. Seamlessly assuring that
tomorrow's leaders will be ready to fill the shoes of those
giants of yesterday and today.
We are here today because we know that these powerful
structures of innovation are also very fragile. I have come to
speak to you because of what I am hearing from post-doctoral
fellows and students considering careers in basic research.
They find themselves confronting new limits, not in ideas,
energy, intelligence or enthusiasm, but in opportunity.
First, Senator Kennedy and members of the committee, I want
to thank you for your thoughtful leadership in higher education
but specifically today, for your consistent support for the
National Institutes of Health and for the biomedical enterprise
in the United States. Your dedication over decades has helped
build a system that is the envy of the world. A system that
countries around the world are working hard to replicate.
As you know the bipartisan doubling of the budget in the
NIH between 1998 and 2003 had a critical impact on biomedical
research. This support enabled the research community to
harness powerful new tools and complete the human genome
project launching the United States and the world into a
biological science revolution.
The critical infusion of funds fertilize whole promising
new fields like genomics and proteomics. This has unleashed our
researchers to analyze biological phenomena beyond our reach
only a decade ago. It has resulted in new therapies that are
improving patient outcomes, has produced a host of medications
that are currently in clinical trials and has transformed the
scientific foundation upon which today's researchers are
building new approaches to vaccine public health problems.
At a time when many lament the ability of Congress to
collaborate on great issues of our day, one need only point to
the commitment for supporting NIH as a resounding example of
bipartisan cooperation and accomplishment. However, as the
committee is well aware, funding since 2003 has been virtually
flat. Erosion through inflation has been taking a significant
toll.
In 2006 your committee completed a comprehensive review of
NIH when you crafted reauthorization. One of your most
important recommendations was a call for substantial increases
above inflation for funding at NIH through 2009. Sadly those
increases have not been realized.
To quote a recent commentary in the New England Journal of
Medicine, ``The Nation's biomedical research enterprise has
never experienced a recession of this magnitude or duration.''
Today a consortium of seven institutions is releasing a new
report, ``A Broken Pipeline? Flat Funding of the NIH Puts a
Generation of Science at Risk.'' This report follows a related
report issued last year just this time entitled, ``Within our
Grasp--or Slipping Away? Assuring a New Era of Scientific
Medical Progress.'' Attached to my testimony is a full list of
the 14 institutions and the 32 researchers who contributed to
the findings of these two reports as well as the leading
associations that have supported this work.
What these reports show is that the 13 percent loss in real
dollars over the last 5 years is having a cascading impact that
is slowing progress and threatening future research that could
lead to cures and even to ways to prevent disease entirely.
Leading scientists with quality grant proposals are caught in a
protracted review process that plays out often over years, not
months. As a result investigators are downsizing labs, slowing
research and producing more conservative, less ambitious
proposals, more likely to secure funding.
Junior faculty who witnessed the struggles of their
advisors are asking themselves how they can possibly compete
with their mentors for a piece of the reduced research pie. At
the same time, they are working to encourage the next
generation of students who could and should be tomorrow's
pioneers in science. The result too often is a ladder of
discouragement that we hope our country recognizes and begins
to address today.
Says Anil Potti, a young researcher from Duke University
who's using genomic strategies to improve the outlook of
patients with lung cancer, ``I worry most about what this means
for patient care. It takes a long time, not only to get
approved, but also to get the funding once you are approved.
The whole cycle can take 12 to 18 months and that's if you're
successful on the first or second try. In the meantime I'm
seeing patients everyday who could benefit from this
research.''
When we produced the first publication in 2007 every one of
the 20 senior researchers interviewed expressed optimism at the
scientific possibilities created by the powerful Federal
investment Congress made in NIH at the turn of the century.
They enthusiastically describe their ongoing work and their
plans to prevent the ravages of Alzheimer's, to attack cancer,
to stop the twin epidemics of obesity and diabetes, to repair
spinal cord injuries or fight emerging infectious diseases.
Their elation has been dampened by years of tightened budgets
which they say are eroding their ability to harness and advance
those potential breakthroughs.
Perhaps the most alarming message we heard was the growing
sense among senior researchers that the future may be at risk.
Because those most affected by the budget crisis are the
emerging, young investigators. We interviewed 12 brilliant
junior faculty at seven institutions across the country who
work in several different fields. While they each remain
powerfully drawn to the promise of alleviating pain and
suffering they are confronted with a reality that diminishes
many of their hopes and dreams.
Anne Giersch, an assistant professor at Harvard told the
interviews,
``I don't think one researchers funding plight means
anything much in the scheme of things, but I think my
difficult experience is being played out many times
over. I hate to think of all the lost opportunities for
scientific progress that are going unfunded and the
loss of economic competitiveness that will accrue if
these funding trends continue.''
These young scientists have the best training, were
mentored by leaders in their scientific fields have been
recognized for their early work and hold tremendous promise for
the future of science. If these scholars are struggling it is
clear that as a nation we must have a problem.
Consider a few facts. The average age of a first time
recipient of R01 grant, the premier NIH research grant that
launches careers is 43 years old, up from 39 in 1990. The
success rate on an R01 grant application when first submitted
is only 12 percent today, a severe drop from the 29 percent it
was in 1999.
For even top senior scientists success may mean two or
three submissions of a grant application over an 18-month to 2-
year period. This results in significant time taken from
science for grant writings and re-writings. Ultimately yields
grants whose sizes have been substantially reduced from 5 years
ago.
Nancy Andrews, the Dean of the Duke University Medical
School puts it this way. ``What a strange business this is,''
she says.
``We stay in school forever. We have to battle the
system with only a 1 in 8 to 1 in 10 chance of getting
funding. We give up making a living until our 40s. We
do it because we want to help the world.''
There is a related issue we all need to be concerned about.
Through our long-term commitment to funding medical research
the United States has built a system of scientific innovation
that simultaneously trains our own best and most talented
people and attracts the best and the brightest from all around
the world. We have in-sourced talent, combined it with our own,
and pushed the boundaries of innovative approaches to fighting
disease that has served the world.
Today, China, India, Singapore and others have adopted
biomedical research and the building of biotechnology clusters
as national goals. Suddenly those who train in the United
States have significant options elsewhere.
Mr. Chairman and members of the committee, we are well
aware that the scientific justification for financial support
will always outstrip our ability to fully invest and that your
very difficult job is to strike the appropriate balance. It's
also a fact that NIH will spend $30 billion this year in labs
across the country that will continue to produce startlingly
new results.
We thank you for this sincerely. Where will we be in 10
years if we discourage a generation of trail blazers. We simply
cannot afford to tread water.
Last year we reported that our ability to harvest the
fruits of previous scientific investments was truly slipping
away. Today we present new evidence in a report with a more
troubling message. The current system is discouraging our best
minds from entering or remaining in academic biomedical
research.
The message in both these reports should be a wake up call
to all of us. We agree with Dr. Zerhouni, the Director of NIH
when he says,
``Without effective national policies to recruit
young scientists to the field and support their
research over the long-term in 10 to 15 years we'll
have more scientists older than 65 than those younger
than 35. This is not a sustainable trend in biomedical
research.''
Nor, I would add, is it a sustainable trend for these
gifted young scientists, nor for the tens of thousands of
Americans whose lives would be improved, prolonged, perhaps
even saved by their discoveries. Thank you very much.
[The prepared statement of Dr. Faust follows:]
Prepared Statement of Drew Gilpin Faust
Thank you Chairman Kennedy, Ranking Member Enzi and members of the
committee for this opportunity to come before you to illustrate some
troubling findings about how stagnant Federal funding of the National
Institutes of Health is affecting both the pace and direction of
medical research.
For decades, universities and the Federal Government, in
partnership with States and philanthropists, have built and sustained a
brilliant, powerful and vibrant research and educational enterprise
that has moved the world: improving health, growing economies--indeed
growing whole industries--and seeking always the next frontier. The
underlying theory of this partnership resonates as clearly today as at
its inception: Investment in basic research at our universities
delivers the research ``goods'' today and simultaneously trains the
next generation of scientists, engineers and seekers of cures. To
borrow a term from biology, this ``pluripotent'' system regenerates our
research capacity, seamlessly assuring tomorrow's leaders will be ready
to fill the shoes of the giants of yesterday and today.
This fierce force of innovation is also a fragile chain. A link in
the chain is wearing thin and I am compelled to be here today because
of what I am hearing from post-doctoral fellows and students
considering a career in basic research. They see a future defined by
new limits--not in ideas, energy, intelligence or enthusiasm--but in
opportunity.
Today, a consortium of seven institutions is releasing a new
report, ``A Broken Pipeline? Flat Funding of the NIH Puts a Generation
of Science at Risk.'' This report follows a related report issued last
March, ``Within our Grasp--or Slipping Away? Assuring a New Era of
Scientific Medical Progress.'' Attached to my testimony is a full list
of the 14 institutions and the 32 researchers who contributed to the
findings of these two reports as well as the leading associations that
have supported this work.
First, Senator Kennedy and members of the committee, I want to
thank you for your thoughtful leadership in all areas related to higher
education, but specifically today for your consistent and persistent
support for the National Institutes of Health and the biomedical
research enterprise in the United States. Your dedication over decades
has helped build a system that is the envy of the world--a system that
countries around the world are working hard to replicate.
As you know, the bi-partisan doubling of the budget of the NIH
between 1998 and 2003 was a transformative force for biomedical
research. This support enabled the research community to harness
powerful new tools and complete the Human Genome Project, placing the
United States--and the world--at the crossroads of a biological science
revolution. The critical infusion of funds fertilized whole new
promising fields like genomics and proteomics. It unleashed our
researchers to analyze biological phenomena beyond our reach only a
decade ago. It has resulted in new therapies that are improving patient
outcomes, produced a host of medications that are currently in clinical
trials, and transformed the scientific foundation upon which today's
researchers are building new approaches to vexing public health
problems. When the public laments the inability of Congress to
collaborate on great issues of our day, one need only point to the
commitment for supporting NIH as a resounding example of bipartisan
cooperation.
However, as the committee is well aware, funding since 2003 has
been virtually flat and erosion through inflation has been taking a
significant toll. In 2006, your committee completed a comprehensive
review of NIH when you crafted the reauthorization. One of your
important recommendations was a call for funding increases at NIH for
2008 and 2009 of 7 and 8 percent respectively. Sadly, those numbers,
which the reauthorization was built around, have not been realized and
flat or below inflation increases have persisted.
Two years ago, concerned that protracted flat funding in biomedical
research at NIH was damaging our ability as a nation to capture the
true promise of the doubling, a group of concerned institutions set out
to closely examine what was happening on campuses and in medical
centers as a result of this downturn in the funding trajectory. These
results were captured in the two reports being discussed today.
What we have found is that the 13-percent loss in real dollars over
the last 5 years is having a cascading impact that is slowing progress
and threatening future research that could lead to cures and even ways
to prevent disease.
Leading scientists with quality grant proposals are caught in a
protracted grant review process that plays out often over years, not
months. As a result, investigators are downsizing labs, slowing
research and producing more conservative, less ambitious proposals that
are more likely to secure funding.
Junior faculty who witness the struggles of their advisors are
asking themselves how they can possibly compete with their mentors for
a piece of the reduced research pie. At the same time, they are
mentoring their own students and working to encourage the next
generation of scientists who could and should be tomorrow's pioneers.
The result too often is a ladder of discouragement that we hope our
country recognizes and begins to address today.
Says Anil Potti, a young physician researcher from Duke University
who is using genomic strategies to improve the outlook and treatment of
patients with lung cancer:
``I worry most about what this means for patient care. It
takes a long time not only to get approved . . . but also to
get the funding once you are approved. The whole cycle can take
12-18 months, and that's if you're successful on the first or
second try. In the meantime, I'm seeing patients every day who
could benefit from this research.''
When we produced the first publication in 2007, every one of the 20
senior researchers interviewed expressed optimism at the scientific
possibilities created by the powerful Federal investment Congress made
in NIH at the turn of the century. They enthusiastically described
their ongoing work and their plans to prevent the ravages of
Alzheimer's, attack cancer, stop the twin epidemics of obesity and
diabetes, repair spinal cord injuries or fight emerging infectious
diseases. Their elation has been dampened by years of tightened
budgets, which they say is eroding their ability to harness and advance
those potential breakthroughs.
Perhaps the most alarming and consistent message we heard was the
growing sense among senior researchers that those most affected by the
budget crisis are the emerging young investigators. Their careers are
being stifled. We were told repeatedly that brilliant young
researchers, whose training coincided in some degree to the excitement
of the doubling, are stuck behind their mentors in a funding queue that
is stalling promising careers in academic research and pushing many
with substantial promise to seek alternative paths.
Fearful that our Nation's dampened commitment to biomedical
research was hindering scientists' ability to speed therapies to the
bedside, our attention was collectively drawn to an even more damaging
longer term impact--the loss and discouragement of a generation of
researchers.
We sought this year to find out more. We interviewed 12 brilliant
junior faculty at seven institutions across the country, who work in
several different fields. The findings are more uniform and obvious
than any experiment any of them are likely to do in their careers.
While they each remain powerfully drawn to the promise of alleviating
pain and suffering, they are confronted with a reality that diminishes
many of their hopes and dreams.
Michael Rodriguez, a physician-researcher at UCLA says,
``24 hours a day, 7 days a week, you're thinking about your
grant proposals and wondering how to survive in this world
where fewer people are getting funded, and proposals that are
funded aren't being fully funded or are being cut.''
Anne Giersch, an assistant professor at Harvard told the
interviewers,
``I don't think one researcher's funding plight means
anything much in the scheme of things, but I think my difficult
experience is being played out many times over. I hate to think
of all the lost opportunities for scientific progress that are
going unfunded, and the loss of economic competitiveness that
will accrue if these funding trends continue.''
These researchers were trained at some of the best institutions in
the world, mentored by leaders in their scientific fields, have been
recognized for their early work, and hold tremendous promise for the
future of science. If these scholars are struggling, it is clear that
as a nation we most certainly have a problem.
Consider a few facts:
The average age of a first-time recipient of an R01
grant--the premier NIH research grant one needs to establish
credibility--is 43 years old, up from 39 in 1990.
The success rate of an R01 grant application when first
submitted is only 12 percent today, a severe drop from the 29 percent
it was in 1999.
For even top senior scientists success may mean two or
three submissions of a grant application over an 18-month to 2-year
period resulting in a grant whose size has been substantially cut from
5 years ago.
The response to rejected grants are downsized labs, lay-
offs of post docs, slipping morale, and more conservative science that
shies away from the big research questions.
After multiple submissions and a protracted process, only
about 20 percent of grants will ultimately be funded.
The percent of R01's that will go to first-time
investigators was 25 percent in 2007, down from 29 percent in 1990.
Nancy Andrews, Dean of Duke University Medical School, puts it this
way:
``What a strange business this is: We stay in school forever.
We have to battle the system with only a 1 in 8 or 1 in 10
chance of getting funded. We give up making a living until our
forties. We do it because we want to help the world. What kind
of crazy person would go for that?''
There is a related issue we all need to be concerned about. Through
our long-term commitment to funding medical research, the United States
has built a system of scientific innovation that simultaneously trains
our own best and most talented people and attracts the best and
brightest from around the world. We have ``in-sourced'' talent,
combined it with our own and pushed the boundaries of innovation for
our economy and, indeed, the world.
Today, China, India, Singapore and others have adopted biomedical
research and the building of biotechnology clusters as national goals.
Suddenly, those who train in America have significant options
elsewhere.
Mr. Chairman and members of the committee, we are well aware that
the scientific justification for financial support will always outstrip
our ability to fully invest, and that your difficult job is to strike
the appropriate balance. It is also a fact that NIH will spend $30
billion this year in labs across this country that will continue to
produce startling new results--for which we thank you sincerely.
We cannot afford to simply tread water. Last March, Dr. Joan S.
Brugge, Chair of the Department of Cell Biology at Harvard Medical
School, testified before the Senate Committee on Appropriations where
she discussed the impact of the aging baby boomer generation and
warned,
``We cannot afford to stand still--the demographics are
against us. There is an impending increase in cancer due to the
baby boomers aging into their cancer-prone years, which has
been referred to as an impending tsunami. You are all keenly
aware of the ramifications for government of Medicare
entitlements associated with this surge in cancer. Unlike a
real tsunami, which comes unexpectedly with no time for
preparation, we are well aware of this impending crisis. We
know that the congressional investment in basic and cancer-
focused research has positioned the cancer research community
to make more rapid progress in translating basic discoveries
into diagnosis, treatment, and eventually, prevention of
cancer.''
Past investment has positioned us to make key advances on the broad
range of disease and we cannot afford to retreat.
However, the New England Journal of Medicine recently featured a
commentary proclaiming that, ``the Nation's biomedical research
enterprise has never experienced a recession of this magnitude or
duration.''
Last year, we reported that our ability to harvest the fruits of
previous scientific investments is truly slipping away.
Today we present new evidence in a report with a more troubling
message, delivered by 12 of the Nation's most promising junior
researchers. They are telling us that the current system is
discouraging them and their peers from entering or remaining in
academic biomedical research. We may be creating a climate where our
position as the primary destination for the best and brightest
researchers from around the world may be challenged.
The messages in both of these reports should be a wake up call to
all of us. We agree with Dr. Elias Zerhouni, Director of NIH, when he
says:
``Without effective national policies to recruit young
scientists to the field, and support their research over the
long term, in 10 to 15 years, we'll have more scientists older
than 65 than those younger than 35. This is not a sustainable
trend in biomedical research and must be addressed
aggressively.''
Thank you Chairman Kennedy and Senator Enzi for this opportunity to
provide this testimony on behalf of the consortium of concerned
institutions that sponsored these reports. I look forward to your
questions.
ATTACHMENT--CONTRIBUTING INSTITUTIONS AND RESEARCHERS
INSTITUTIONS
Report--``Broken Pipeline? Flat Funding of the NIH Puts a Generation of
Science at Risk''
Brown University
Duke Medicine
Harvard University
The Ohio State University Medical Center
PARTNERSTM Healthcare
UCLA
Vanderbilt University
Report--``Within Our Grasp--or Slipping Away? Assuring a New Era of
Scientific Medical Progress''
The University of California
Columbia University in the City of New York
Harvard University
Johns Hopkins Medicine Johns Hopkins University
PARTNERSTM Healthcare
The University of Texas at Austin
Washington University in St. Louis
The University of Wisconsin Madison
Yale University
RESEARCHERS
Report--``Broken Pipeline? Flat Funding of the NIH Puts a Generation of
Science at Risk''
Nancy Andrews, M.D., Ph.D., Dean, Duke University Medical School
Carthene Bazemore-Walker, Ph.D., Assistant Professor, Department of
Chemistry, Brown University
Joshua Boger, Ph.D., Founder and CEO, Vertex Pharmaceuticals, and
Chair,
Biotechnology Industry Organization
Isla Garraway, M.D., Ph.D., Assistant Professor, Department of Urology,
University of California Los Angeles
Rachelle Gaudet, Ph.D., Associate Professor of Molecular and Cellular
Biology, Harvard University
Anne Giersch, Ph.D., Assistant Professor, Harvard Medical School and
Brigham & Women's Hospital
Denis Guttridge, Ph.D., Associate Professor, Department of Molecular
Virology, Immunology, and Medical Genetics, The Ohio State
University
William Lawson, M.D., Assistant Professor, Division of Allergy,
Pulmonary, and Critical Care Medicine, Vanderbilt University
Susan Lindquist, Ph.D., Member and Former Director of the Whitehead
Institute, and HHMI Investigator and Professor of Biology,
Massachusetts Institute of Technology
L. Kristin Newby, M.D., M.H.S., Associate Professor of Medicine, Duke
University
Anil Potti, M.D., Assistant Professor of Medicine, Duke University
Jill Rafael-Fortney, Ph.D., Associate Professor, Department of
Molecular and Cellular Biochemistry, The Ohio State University
Michael Rodriguez, M.D., M.P.H., Associate Professor, Department of
Family Medicine, University of California Los Angeles
Larry Schlesinger, M.D., Professor of Medicine, Molecular Virology,
Immunology, Medical Genetics, and Microbiology, The Ohio State
University
Tricia Serio, Ph.D., Assistant Professor, Department of Molecular,
Cellular Biology, and Biochemistry, Brown University
Pampee Young, M.D., Ph.D., Assistant Professor, Department of
Pathology, Vanderbilt University
Report--``Within Our Grasp--or Slipping Away? Assuring a New Era of
Scientific Medical Progress''
Joan S. Brugge, Ph.D., Chair of the Department of Cell Biology, Harvard
Medical School
Jon Clardy, Ph.D., Professor in the Department of Biological Chemistry
and Molecular Pharmacology, Harvard Medical School
Richard Davidson, Ph.D., Vilas Professor of Psychology and Psychiatry,
University of Wisconsin-Madison
Jorge Galan, D.V.M., Ph.D., Professor of Microbial Pathogenesis and
Cell Biology and Chair of the Section of Microbial Pathogenesis,
Yale University School of Medicine
Carol W. Greider, Ph.D., Director of Molecular Biology and Genetics at
the Institute of Basic Biomedical Sciences of The Johns Hopkins
University School of Medicine Baltimore, MD; Co-winner of the 2006
Albert Lasker Award for Basic Medical Research
Brent Iverson, Ph.D., University Distinguished Teaching Professor of
Organic Chemistry and Biochemistry, The University of Texas at
Austin
Thomas M. Jessell, Ph.D., Investigator, Howard Hughes Medical Institute
(HHMI); Professor, Department of Biochemistry and Molecular
Biophysics, Columbia University
Eric Kandel, M.D., University Professor, Columbia University;
Investigator, HHMI; Nobel Laureate, Physiology or Medicine (2000)
M. Daniel Lane, Ph.D., Professor of Biological Chemistry in the
Institute for Basic Biomedical Sciences of The Johns Hopkins
University School of Medicine, Baltimore, MD
Ira Mellman, Ph.D., Sterling Professor of Cell Biology and Immunology
and Chair of the Department of Cell Biology at Yale University
School of Medicine, New Haven, CT
Vamsi K. Mootha, M.D., Assistant Professor of Medicine at Massachusetts
General Hospital and Assistant Professor of Systems Biology at
Harvard Medical School; Recipient of a 2004 MacArthur Foundation
Award
Nicholas A. Peppas, Sc.D., Fletcher S. Pratt Chair and Director of
Center on Biomaterials, Drug Delivery, Bionanotechnology and
Molecular Recognition, The University of Texas at Austin; Member of
the National Academy of Engineering
Lee Riley, M.D., Professor of Infectious Diseases and Epidemiology at
University of California, Berkeley
Robert Siliciano, M.D., Ph.D., Professor of Medicine and Investigator,
HHMI, at The Johns Hopkins University School of Medicine,
Baltimore, MD
Samuel L. Stanley, Jr., M.D., Director, Midwest Regional Center of
Excellence in Biodefense and Emerging Infectious Diseases Research;
Vice Chancellor for Research, Washington University in St. Louis
Stephen Strittmatter, M.D., Ph.D., Professor of Neurology and
Neurobiology, Yale University School of Medicine
Leon J. Thal, M.D., Professor and Chair of the Department of
Neurosciences at the University of California, San Diego; Winner of
the Potamkin Prize for research in Alzheimer's disease in 2004
Amparo C. Villablanca, M.D., Professor of Internal Medicine and
Cardiovascular Medicine and Director of the Women's Cardiovascular
Medicine Program at the University of California, Davis, School of
Medicine
Richard K. Wilson, Ph.D., Professor of Genetics and Microbiology and
Director of the Genome Sequencing Center, Washington University in
St. Louis
Jerry Chi-Ping Yin, Ph.D., Professor of Genetics and Psychiatry,
University of Wisconsin-Madison
The Chairman. Thank you very much. Very compelling
testimony.
Dr. Rafael-Fortney. Thank you.
STATEMENT OF JILL A. RAFAEL-FORTNEY, PH.D., ASSOCIATE
PROFESSOR, THE OHIO STATE UNIVERSITY, COLUMBUS, OH
Ms. Rafael-Fortney. Good morning and thank you, Chairman
Kennedy, Ranking Member Enzi, who's not here at the moment, and
Members of the HELP committee. My name is Jill Rafael-Fortney.
I'm an Associate Professor in the College of Medicine at Ohio
State University.
My laboratory conducts biomedical research with the goal of
transforming health care for patients with muscular dystrophy
and for those with heart failure. We have a potential new
target for the treatment of heart failure. This exciting
research is sitting in the freezer because our grant did not
get funded as a direct result of the flattened NIH budget.
My story is one of countless others. I am here to represent
the best and the brightest young scientists and implore this
committee to consider the effects of an NIH budget that does
not keep up with inflation. The current NIH budget has led to a
funding crisis where the most innovative ideas that are most
likely to lead to the biggest breakthroughs are not being
funded.
This situation is beginning to drive even the most
talented, the most well-trained and the most passionate
scientists out of biomedical research and young physician
scientists into private practice. Behind us we're losing the
generation of students that we're training.
At a time when we're poised to make the most momentous
discoveries in biomedical research, losing these generations of
scientists and their science will be devastating and this
situation will have catastrophic effects on the future of
health care in our great country. Thank you very much.
[The prepared statement of Dr. Rafael-Fortney follows:]
Prepared Statement of Jill A. Rafael-Fortney, Ph.D.
I would like to sincerely thank Chairman Kennedy and Ranking Member
Enzi for holding this hearing on the very important topic of the
serious threat to scientific discovery in our country.
When I was 6 years old, I started watching the Jerry Lewis telethon
for Muscular Dystrophy every Labor Day weekend. I found it horribly sad
that children just like me were living their lives in wheelchairs and
facing a certain death before I would graduate from college. I did what
I could at the time; I saved up my allowance and donated it to the
telethon every year and vowed that I would spend my adult life trying
to help these children.
In 7th grade science class I first learned about genetics, and I
realized that this was the road to fight neuromuscular diseases. I
looked for Universities where I could gain hands-on skills in genetic
research. For 3 years as an undergraduate student at Cornell University
and during the summers I conducted a research project in a genetics lab
and completed an Honor's thesis. I also spent a summer in a clinical
genetics setting where I was able to make an informed decision to not
seek a medical degree, so that I could spend more of my young life
doing research and more time trying to find cures instead of telling
patients that I couldn't help them.
After graduating in the top 10 percent of my class from Cornell, I
went to the most competitive Human Genetics Ph.D. program in the
country at University of Michigan. I trained with the leaders in the
muscular dystrophy field; Jeff Chamberlain as a Ph.D. student, and Kay
Davies as a post-doctoral fellow at the University of Oxford in
England. Professor Davies has been honored by the Queen of England for
her contribution to biomedical research in the UK and is now a Dame. As
a graduate student and post-doc, I published over 20 peer-reviewed
papers on muscular dystrophy, including some in the very best journals
such as Cell and Nature Genetics.
I accepted a tenure-track faculty position at The Ohio State
University because of the clinical strength in neuromuscular and
cardiac diseases. I did so with the vision of carrying out breakthrough
basic and translational research focused on the skeletal muscle and
heart pathologies of muscular dystrophy. Rather than merely continuing
some aspect of the work ongoing in the labs of my mentors, I took the
difficult path of initiating research projects in my own lab to address
two different important scientific questions that weren't being
addressed elsewhere. The first project focused on heart disease in
Duchenne muscular dystrophy. The second focused on identifying novel
mechanisms at the neuromuscular junction.
The neuromuscular junction is the site where the nervous system
controls muscles and the root of the problem in neuromuscular diseases.
My lab identified receptors that had never before been documented at
this site. This discovery highlights how new knowledge will never be
learned if you're only looking for what you already know is there.
Patients with Duchenne and other muscular dystrophies also have
heart failure in addition to debilitating skeletal muscle problems.
Therefore, we also focused on defining the mechanisms of this heart
disease with the long-term goal of identifying novel targets for
treatment. We found a gene that is specifically downregulated in
muscular dystrophy cardiomyopathy that progresses to heart failure. We
confirmed that the protein is lacking only in heart cells of this heart
failure model. In collaboration with an OSU cardiologist, we next
looked to see if this protein was missing in patients with heart
failure. Surprisingly, we found that at least 60 percent of heart
samples collected from patients who had heart transplants showed an
absence or major reduction in the levels of this protein. What is so
significant about this number is that it represents 60 percent of
people who develop heart failure as a result of a wide variety of
primary causes, not just muscular dystrophy. It could be a common
pathway to heart failure for at least 60 percent of the 5 million
people who are living with heart failure in the United States today and
the 500,000 additional cases diagnosed every year. I want to emphasize
that these are not people who suffer heart attacks and either quickly
recover or die from them. Rather, people with heart failure are
hospitalized for long periods of time, are on life support, and are on
the waiting list for heart transplants. One can just begin to imagine
the economic and quality-of-life benefits that would result from a way
to prevent heart failure from this or similar research. To pursue this
line of research, we submitted an R01 application to the NIH proposing
the next set of definitive experiments. The application proposed to
determine the ability of this protein to cause and prevent heart
failure in mouse models and to test specific hypotheses in patient
samples of how this protein is lost. It represents a collaboration
between me (a molecular geneticist), a cardiac physiologist (Paul
Janssen), and a cardiologist (Phil Binkley). That application received
a score that would have been funded a few years ago, but missed the
funding line in the current environment. This example is just one of
hundreds of exciting, potentially groundbreaking biomedical science
projects that are not being funded today.
While we can't predict exactly how these research projects will
benefit patients or impact the economics of the U.S. healthcare system,
biomedical research is on the cusp of a breakthrough. It has been said
that the 20th century was the Century of Physics with incomprehensible
advances in flight, communication and silicon technology. The 21st
century is the Century of Biology. The Director of the Research
Institute at Nationwide Children's Hospital, Dr. John Barnard, gave a
perfect example in a speech I heard a few days ago. At the beginning of
the Century of Physics the Wright Brothers probably couldn't envision
that their invention would evolve into the global companies of Boeing
or Netjets or that John Glenn would travel into Space, but they knew
they were on to something big. At the present, while we can't predict
where we'll be at the end of the century, or even in 10 years, we know
we are on to something big. We have advanced to the point of having all
of the right tools and all of the background knowledge. We, as
scientists, know that we are on the verge of major breakthroughs in
Biology and Medicine.
What's the problem with the flat NIH budget? Well, it comes down to
the same economic issue as everything else. A flat budget equates to a
loss of buying power. It is certainly not going to flamboyant salaries,
although I'm happy to report that we do provide healthcare for our
trainees and employees. In addition to this obvious economic issue,
funding of individual investigator-initiated innovative science via
hypothesis-driven R01 grants has been impacted to an even greater
extent. The public push to translate everything in the research
pipeline into clinical applications has led to the creation of
milestone driven research. While milestone-driven translational
research is important and certainly should be funded by the NIH,
research designed to meet milestones results in discarding any novel
observations made along the way. This type of research design will push
anything with clinical potential out of the pipeline. The question is:
what will fill the pipeline?
The individual initiated R01 is the grant mechanism that feeds the
pipeline. The payline for R01's is currently around the 10th
percentile. From my perspective also as a grant reviewer, you have to
bet on 1 grant out of a pile of 10. When you can select only 1 grant,
it is against human nature to not select the grant from the established
lab with the long track record, where many of the proposed experiments
are already complete. As one colleague said, ``it has the horrible
consequence of pushing research agendas to the `tried and true' variety
rather than the risky, innovative, and high pay-off, even for senior
investigators.'' That effect is even more dramatic for junior
investigators who have not built powerhouse labs, but have the really
innovative ideas that are not getting funded. These junior
investigators are spending inordinate amounts of time writing and re-
writing their proposals instead of actually conducting innovative
research. The low NIH budget is driving young scientists into teaching
careers, industry, publishing, or sending them to law school. We're
losing a generation of scientists.
They're people like me. People who graduated at the top of their
classes from Ivy League Universities; people who were trained by the
best scientists in the world; people who have had a passion for what
they do their whole lives. I'm not talking about people who were never
successful. I'm talking about people who have multiple first author
papers in the best scientific journals: Cell, Nature, Science. They're
people who may have had their first R01 successfully funded, but can't
get a renewal funded; and will lose all of the trained personnel in
their labs while they're trying. We're losing them. The United States,
which has been a world leader in scientific discovery is falling
behind.
We're losing physician scientists who have had enough passion for
finding new ways to treat human disease to obtain both M.D. and Ph.D.
degrees or who do a research fellowship. My clinician scientist
colleagues are going into private practice when they can't get their
R01's funded. They're making this decision not based on personal
financial reward, but based on the funding situation that prohibits
their progress towards what they passionately believe will aid
humankind.
Behind us, we're losing the students and postdocs that we're
training, because they don't want to go through the rejection and
adversity that they're seeing us go through. We're really losing two or
more generations of scientists.
As we allow inflation to erode NIH funding, it declares to the
international community that the United States does not believe that
science will play a role in the development of its society. It is
short-sighted.
To me, the biggest disappointment is that we've come to a point
where science and medicine have so much overlapping technology and
there is so much common knowledge between the bench and the bedside,
that scientists and physicians are really poised to work together to do
momentous things. The effects of losing our generation will be
devastating.
What will I do if my R01 doesn't get funded? I'll still be a co-
investigator on a milestone-driven multi-investigator translational
project that will support a part-time person in my lab. I'm part of
another large translational application that will be reviewed soon. If
that gets funded, my salary won't get cut and it will keep my lab
slowly moving along, but only to refine what we already know, not on
any of our promising new discoveries. While working in large groups of
clinicians and scientists on these large translational projects are
also exciting and have immediate potential impact on patients, they're
not enough for me. They let me use my organizational and technical
skills, but not my passion that leads me to innovate and envision the
potential to make the completely novel breakthroughs. I feel fairly
confident that I could get funded to do research on some minutia of the
known, but that's not a good enough reason to spend that much time away
from my wonderful 5-year-old son and 2-year-old daughter.
I am confident that the innovative research from my laboratory will
lead to dramatic improvements in the quality of life for patients with
muscular dystrophy and heart failure while at the same time
dramatically decreasing healthcare costs. There are countless other
cases like mine. If NIH funding was in the same relative state a decade
ago, children with leukemia would still be dying, instead of going on
to live normal lives. We would not have the imaging capabilities to
detect and prevent many cases of breast and prostate cancer and the
treatments that extend survival and improve quality of life. In the
next decade we are likely to have treatments for diabetes, Alzheimer's
disease and heart disease, but not if the NIH funding crisis continues.
As a country, we should be thinking not of how we are going to solve
this crisis for the coming year, but we should be developing a 50-year
plan to maintain the expertise of scientists and remain at the
forefront of scientific discovery and applications to healthcare. We
need to invest in the next generations of scientists and we need to do
it now.
The Chairman. Thank you. Thank you very much.
Dr. Miller.
STATEMENT OF EDWARD D. MILLER, M.D., DEAN OF THE MEDICAL
FACULTY, THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE,
BALTIMORE, MD
Dr. Miller. Senator Kennedy, Senator Mikulski, Senator
Brown, thank you very much. I'm Ed Miller. I'm the Dean and CEO
of Johns Hopkins Medicine and I've done it for 12 years now.
I think I have a pretty good insight into some of the
issues. You may wonder why we're here today even though the
doubling of the NIH ended in 2003. I think you're really now
seeing the very depths of what that flat funding has meant--
actually a decrease in funding.
I want to thank you for your sustained support over the
years, especially Senator Kennedy and Mikulski that have really
allowed us to do what we needed to do. What we need at NIH is
actually sustained funding now that is better than the rate of
inflation so that young investigators and also older
investigators will be able to be funded.
One of the things that I'm noticing now is that our older
investigators are having difficult times. They are the mentors
for the younger investigators. If they need to spend more and
more time writing grants so that they can have their funding in
tact, it's less time for the young investigators to be mentored
by them.
One of the issues that I think is very important is that we
have a sustained level of funding over a period of years, 10 or
15 years that will allow us to go forward. I also think that
your support of the reauthorization of NIH was extremely
important. It has allowed the Director to be able to be more
flexible in the use of the funds and to address issues that
affect the country in a more rapid way then they have in the
past. I think you can see that we have been able to meet that
challenge.
And last, I think it's very important to not forget the
past. As you pointed out in your opening comments, incredible
progress has been made in the care of the Nation because of the
funding of NIH. I think we do not want a generation of
researchers to be lost and therefore lose our chances to
improve the health of this country.
Again, I think it's very important we have sustained
funding of NIH that goes over periods of time that will support
both the young investigator, but also the older investigators.
Thank you, Senator Kennedy.
[The prepared statement of Dr. Miller follows:]
Prepared Statement of Edward D. Miller, M.D.
INTRODUCTION
Mr. Chairman and members of the committee, thank you so much for
inviting me to testify today at this very important hearing. I am Ed
Miller, Dean of the Medical Faculty and CEO of Johns Hopkins Medicine.
Johns Hopkins Medicine is the organization that represents the Johns
Hopkins University School of Medicine and Johns Hopkins Health System.
I am pleased to be here to give you my perspective on the findings
of the report: ``A Broken Pipeline? Flat Funding of the NIH Puts a
Generation of Science at Risk.'' The report highlights, in a very
personal way, the impact of the current funding environment on the
careers of some of our country's most promising young scientists. As
the person charged with the privilege and responsibility for the
operation of one of the many institutions across this country whose
mission is to train future physicians and researchers, as well as
provide patient care, I can tell you that my counterparts at other
universities and I struggle everyday to help all our investigators
navigate the current funding climate.
I believe we may lose a generation of enthusiastic, inquisitive
scientists if they conclude NIH grants are out of reach. The statistics
are very discouraging. Today only one out of every four grants is ever
funded--8 years ago it was one in three. Only 12 percent are funded
after the first submission. For first-time applicants these odds seem
insurmountable and they are discouraged. They spend many weeks and
countless hours preparing their proposals only to be told their score
was not high enough and they should rewrite and resubmit. Or worse yet,
they are not scored at all. No wonder they are discouraged. I also
believe that in the quest to obtain funding, all of our scientists,
both young and more senior, are becoming risk-averse, and curtailing
their proposals and the most cutting edge science may remain undone
because in an environment of scarce resources only the safe-bets are
funded.
First, I commend you and your colleagues in Congress for their
historical commitment to biomedical research and National Institutes of
Health (NIH) and the support this provides to our Nation's research
universities. What many Americans may not realize is that 85 percent of
the funding that Congress provides to NIH actually comes back to their
local communities. Many of the startling advances in identifying early
indicators and causes of diseases are the result of those well-spent
Federal research dollars. I am convinced we are on the cusp of a
dramatic transformation in health science discovery and cures.
Unfortunately, since 2004 the levels of funding for the NIH have not
kept pace with inflation and NIH has lost upwards of 13 percent of its
purchasing power. Not only have we lost ground to inflation, but at
Johns Hopkins we have seen an actual decrease in our total awards from
our peak level in fiscal year 2005. This is having an impact across our
entire institution but has had a particularly insidious effect upon our
young investigators.
Going forward, NIH needs at a minimum, funding increases at least
equal to the biomedical research inflation index (BRDPI). Anything
less, is a real cut to science, threatens the careers of our young
faculty and will weaken the Nation's role as a worldwide leader in the
biomedical field. The current projection for BRDPI for fiscal year 2008
through 2013 is 3.5 percent. But if past is prologue (in fiscal year
2007 it was 3.9 percent and fiscal year 2006 was 4.6 percent) one might
expect actual BRDPI levels to exceed current projections. The
biomedical research community is seeking an increase of $1.9 billion
which represents BRDPI plus 3 percent. This infusion of $1.9 billion
will allow research labs to keep pace with rising costs and provide
resources for new and innovative projects.
We, in academia, are cognizant of the overall fiscal situation that
Members of Congress and this and future Administrations face. We are
also aware that there are many compelling demands upon the
discretionary funds available to appropriators. Nonetheless as a
community, we feel it is critical that we come before you to reiterate
how important it is to support biomedical research not only for
ourselves but future generations. The plight of our young investigators
exemplifies perfectly both the current and future risk of allowing our
international leadership in this area to erode.
FUNDING CLIMATE HINDERS HIGH IMPACT RESEARCH
I hear from my faculty that NIH study sections, with the limited
funding available to them, tend to favor safer bets. Study sections
look for increasingly more preliminary data in grant applications. In
essence they are seeking so much preliminary experimental information
that many applicants say most of the proposed project would have to be
already done before they get funding. They are funding incremental
steps, not bold initiatives. This modus operandi clearly discourages
creativity and cutting edge ideas.
I also hear that because the chance of being funded is much lower,
all investigators--especially the younger ones--are spending more of
their time in grant writing instead of doing the creative research. I
fear that their goal then is not to do creative research but to survive
by going for more sure bet type of research for the sake of securing
continuous funding.
We also hear that many highly accomplished investigators are also
suffering with limited funding. The upshot is that the government has
invested tremendously in the past into our intellectual capital, and
now we may not reap the benefits.
Let me share an example that clearly demonstrates the tremendous
value of supporting our young investigators and the nature of cutting
edge research. In September 2006, Carol Greider, Ph.D. (Professor and
Director of Department of Molecular Biology and Genetics, Johns Hopkins
University School of Medicine), Elizabeth Blackburn, Ph.D. (Professor
of Biology and Physiology in the Department of Biochemistry and
Biophysics, University of California, San Francisco) and Jack Szostak
Ph.D. (Professor Department of Genetics, Harvard Medical School),
Harvard were awarded the most prestigious prize in American medicine--
the Lasker Award. They shared the award for their work in telomerase:
an enzyme that helps maintain the ends of chromosomes. The award is
based on findings the three made with respect to cell function and
genetics, 22 years ago, and is considered today to be one of the most
advanced areas of biomedical research. At the time Dr. Greider was in
her early 20's. Her more senior colleagues Szostak and Blackburn were
in their early and mid-30's respectively. These three were well below
today's average age of 43 for obtaining the coveted first R01 grant.
Subsequent research has revealed that telomerase is elevated in more
than 85 percent of all human cancers. It enables cancerous cells to
divide indefinitely, making them virtually immortal. Several biotech
companies are now devising anti-cancer drugs to block telomerase. If
Doctors Greider, Blackburn and Szostak were seeking funding for this
same body of work today, would current success rates provide them
funding?
I can not help but worry that groundbreaking work such as this is
being delayed or left completely undone today. A case in point is that
of Joel L. Pomerantz, Ph.D. an Assistant Professor in the Department of
Biological Chemistry and the Institute for Cell Engineering at Johns
Hopkins University School of Medicine. He wants to use new technologies
that are the keys to ground-breaking biomedical discoveries. These new
technologies or high-throughput methods provide an opportunity to
examine entire biological systems, which are large networks of
interacting molecules. The high-throughput technologies have provided
young investigators new ``microscopes,'' with which to observe
thousands of genes in complex biological systems and generate new
hypotheses, producing ground-breaking ideas.
His laboratory has developed ways for using such methodology to
screen for genes involved in the normal immune response (lymphocyte
activation), and also for genes that function in signaling pathways
that are dysregulated in different forms of human cancer and in
autoimmune disease. Thus, his screens promise to yield genes that could
advance our knowledge of basic immunology and cell biology but might
also emerge as targets for the development of novel therapies for
cancer, autoimmunity and other diseases of aberrant cell growth and
function. It is important to note that it has only recently been
possible to do such research. This has been made possible by: the
sequencing of human, mouse and other genomes, and the emergence of RNAi
technology and the ability to generate genome-wide RNAi libraries that
can interrogate the function of most, if not all, known or predicted
human or mouse genes.
We now find that study sections are slow to embrace this more
novel, creative and unbiased global approach, preferring the
traditional hypotheses that link one event to another in a linear way;
yielding a potential biased view of a complex system. Dr. Pomerantz and
others tell us, given that these technologies cannot guarantee a
specific outcome, their use to screen for genes involved in specific
pathways or disease status in an unbiased way has been met with
resistance. As such, the more traditional, simple hypotheses are
proposed rather than the more creative, unbiased way to discover
critical biological and disease pathways. This situation is
particularly heightened because of the limited NIH funding--leading to
a regression rather than progression in the way we do science.
Fortunately for Dr. Pomerantz and the members of his lab, Johns
Hopkins has been able to provide some institutional support and private
foundations have funded his research on a small scale, and they have
already made interesting insights in only a few years. But the
conventional wisdom is that the NIH will not support such ventures in
an R01 application, unless the applicant is already well-established,
well-funded, and one of the very, very few lucky recipients of a
Pioneer or Innovator award.
Dr. Pomerantz is 40 years old, has tremendous credentials (degrees
from Brandeis and the Massachusetts Institute of Technology and has
trained with two Nobel Prize winners: Philip Sharp and David
Baltimore), and a very promising career before him. He recently
submitted an R01 application which was scored on the first round, but
failed to meet the 12 percent payline. He now has 2 more chances to re-
submit. Without NIH funding, the fate of Dr. Pomerantz's proposal is
uncertain.
Let me share the story of one more of our faculty whose experiences
also parallel with what you see in the ``Broken Pipeline'' report
released today: Ben Ho Park M.D., Ph.D. Dr. Park is an Assistant
Professor of Oncology with a joint appointment at the Johns Hopkins
Whiting School of Engineering, Department of Chemical and Biomolecular
Engineering who has some novel ideas about treating breast cancer.
Using powerful molecular genetic techniques, his lab is attempting to
identify genes involved with clinical drug resistance. It has been
previously demonstrated that loss of tumor-suppressor genes and/or
their downstream effectors can confer resistance against certain
chemotherapies. The lab hypothesizes that there are other genes where
inactivation in a recessive manner can also lead to clinically relevant
drug resistance. This problem is of extreme importance to clinical
oncology, as the emergence of drug-resistant cancers is what limits the
effectiveness of current therapies.
The lab is also trying to understand pathogenic mechanisms of
growth/hormone receptor signaling. The continuous exposure of breast
tissue to estrogens and other growth factors likely plays a role in the
carcinogenic process that transforms a normal breast epithelial cell
into a cancer. The lab is trying to elucidate the molecular mechanisms
of aberrant receptor signaling that contributes to this process.
Returning to our focus today, the young investigator, I believe it
is critical to point out that most ideas that turn into Nobel Prizes
come from investigators before they reach the age of 40. While we can
not pinpoint today, whose work will ultimately be recognized in this
way, it exemplifies why support for their work must continue and why we
must support ``out-of-the-box'' thinkers during the early stages of
their careers. Who knows, perhaps the work all these scientists are
conducting--or would hope to conduct if funding were more readily
available--could be as critical to future breakthroughs in healthcare
as that of past Nobel and Lasker award winners. It would be a shame to
never know.
Instead of thinking about breast cancer research, Park says he is
spending 90 percent of his time chasing grants. He even has his
trainees applying for their own grants to make up for the lab's drop in
NCI dollars. He reports that 9 out of 10 applications do not get funded
and for those that do, R01 awards are then reduced 29 percent. His
$218,000 grant is now only $155,000.
Park says he has not had to let people go from his lab, but ``I
can't think about science any more. I have to focus on getting grants''
from foundations and philanthropists. Even those grant applications
from his trainees have to be reviewed and rewritten by Park to give
them the best chance of getting approved. It means time away for all
from their research into developing novel means for treating breast
cancer.
Dr. Park reports that, unfortunately, his story is not unique and
he worries that if the current funding environment is not reversed
soon, we are going to lose a lot of very talented people in science. In
a letter to the editor that appeared in the Baltimore Sun last spring
Dr. Park and a fellow cancer researcher at the University of Maryland
wrote:
The tragedy stems from our inability to continue to do bold
new research that can ultimately affect the prevention,
diagnosis and treatment of a myriad of diseases such as cancer.
Working in academics is a privilege because it affords
scientists the ability to strike out on new creative and
innovative projects that would not be allowed in most biotech
or pharmaceutical companies. . . . Thus, the ultimate
repercussion of decreased Federal funding is not loss of
academic scientists, but rather the millions of lives that
biomedical research could have otherwise saved.
CONCLUSION
Federal support for biomedical research has helped to transform our
ability to detect disease, treat patients, and deliver healthcare with
greater effectiveness and affordability. At the same time, the return
on investment for the American taxpayer has been high, as research has
fostered discoveries that have led to new patents and products, and to
the creation of new companies and job opportunities.
The recent enactment of the America COMPETES Act as well as the NIH
reauthorization legislation enacted at the end of the last Congress,
demonstrates that the President and Congress have embraced the notion
that funding for basic research is essential to strengthening America's
competitive standing in the world. However, the funding levels
envisioned in neither bill have been realized--particularly with
respect to NIH. The reauthorization bill called for appropriations of
$30.3 billion for fiscal year 2007, NIH only received $29.1 billion.
For the current fiscal year 2008, $32.8 billion dollars was authorized,
NIH received only $29.5 billion. For the upcoming fiscal year 2009 the
bill authorized ``such sums as are necessary.'' The President has
proposed a freeze at the 2008 level and I understand that the budget
resolution currently before the Senate calls for an increase to $30
billion. The fact is: Federal investments in biomedicine and basic
science across the disciplines have taken the United States to the
leading edge of innovation. The question we now face is whether as a
country we are willing to pay the price to remain in the lead.
The Chairman. Miss Lewis.
STATEMENT OF DANA LEWIS, STUDENT AND DIABETES ADVOCATE,
AMERICAN DIABETES ASSOCIATION, HUNTSVILLE, AL
Ms. Lewis. Thank you and good morning. My name is Dana
Lewis and I battle Type I diabetes. Five years ago when I was
first diagnosed I was sure my doctor would prescribe me
medicine and I would be all healthy. But, I was wrong.
I am here today because there is currently no cure for
diabetes. I walk, talk, sleep and dream for a cure, but it does
not yet exist. Type I diabetes means that my body does not
create insulin on its own. I must administer insulin throughout
the day in order to survive.
Diabetes is more than just daily injections. It is the need
for a constant balance of insulin with the carbohydrates I
ingest, the exercise I get while assessing factors such as
emotions, stress and illness. I strive for tight control
because research has established that this is the way to avoid
the devastating long-term complications of diabetes.
I have benefited from the incredible value of diabetes
research technologies. When I was first diagnosed I tested my
glucose levels 12 to 15 times per day using a meter that is
bigger and heavier than a blackberry. I also had to self
administer insulin two to three times everyday.
Thanks to innovations in research, today I use a continuous
glucose monitoring system and wear an insulin pump. The monitor
provides a 24-hour view of my blood sugar instead of 15 still
photos throughout the day. The pump has eliminated my need to
administer multiple insulin injections each day. Instead I
inject insulin directly into the pump every few days. This
combination is much less evasive to my body and allows me to
more easily maintain good control.
All the wonderful technologies only help fight the battle
to stay healthy while I wait for a cure. When you are a young
adult like me, it is difficult and frustrating to add diabetes
and thoughts of future health complications into a busy
academic and social schedule. Knowing that research for
diabetes in ongoing provides me with hope. Again, thank you for
letting me speak with you today.
[The prepared statement of Ms. Lewis follows:]
Prepared Statement of Dana Lewis
Mr. Chairman and Senators of the committee, good morning. Thank you
for the opportunity to speak today. My name is Dana Lewis and I am from
Huntsville, AL. I am a sophomore at the University of Alabama pursuing
degrees in Public Relations and Political Science, with a minor in
Computer-Based Honors. I have an interest in working in public health.
I appreciate you holding this hearing on the importance of research
funding opportunities. My interest in this field and reason for
speaking with you today stems from my battle of living with type 1
diabetes.
Tired, achy, always hungry, always thirsty--these symptoms,
combined with losing around 15 pounds, preceded my diagnosis of
diabetes during my freshman year in high school. Being diagnosed seemed
like it should be the end of my problem--my doctor should have said the
magic phrase, ``I think you have diabetes,'' hand me some medicine, and
I'd be all healthy again. But that isn't what happened. My diagnosis
was not the end but rather the beginning of a love-hate relationship
that has played a significant role in my life for the past 5 years, one
that will remain with me until I die.
There are 20.8 million Americans living with diabetes, a condition
in which the pancreas either does not create any insulin, which is type
1 diabetes, or the body doesn't create enough insulin and/or cells are
resistant to insulin, which is type 2 diabetes. Insulin is a hormone
that allows glucose or sugar to move from the blood stream into the
cells where it is used for energy. Since my pancreas no longer produces
any insulin, I must administer it throughout the day in order to
survive. After diagnosis, I quickly learned that diabetes is more than
just daily injections. While a normal pancreas is able to secrete just
the right amount of insulin, I have to balance these doses of insulin
with the number of carbohydrates I ingest. It is not a simple puzzle
that can be solved by filling in the right formula, nor does diabetes
pose as a sphinx, requiring a correct answer before letting you cross
the road to good health. When this balance is off, I suffer from what
is referred to as high blood sugar (hyperglycemia) or low-blood sugar
(hypoglycemia).
It can be difficult to maintain blood glucose level in a safe
range, yet it is essential. I strive for tight blood glucose control
because research has established that this is the way to avoid the
devastating long-term complications of diabetes. In order to manage my
diabetes I need to carefully monitor my blood glucose levels and make
adjustments about the amount of insulin I administer, taking into
account the food I eat, and the exercise I get, while assessing factors
such as emotions, stress and illness that are affecting my body.
One wrong step, one miscalculation, and the consequences can be
life threatening. A severe low blood sugar could cause a seizure,
unconsciousness, brain damage and even death. While a severe high blood
sugar is also very dangerous, and could send me into a coma, in the
long term, it is high blood sugars that lead to the many complications
of diabetes--including blindness, heart disease, kidney disease, and
amputation. Therefore, I constantly test my blood sugar. I test first
thing when I wake up in the morning, between classes, walking across
campus, before I snack or eat a meal and an hour or so afterwards. I
test before I get in the car to run errands, every few hours while
studying and each night before going to bed.
Experiences with highs and lows influence my every day routine. I
am forced to remain diligent because diabetes affects my behavior. If I
receive good news or get excited, adrenaline surges and my blood sugar
will skyrocket and later plummet. If I read news of a tragedy or stress
over an upcoming exam, my blood sugar slowly creeps upward. When I
incorrectly calculate the number of carbohydrates I eat in the dining
hall, my blood sugar spikes and I get dehydrated, my brain feels fuzzy,
and my eyesight is very unclear. It affects my performance in the
classroom because I can't concentrate. If I forget to adjust my pump to
give me less insulin before walking across campus, my blood sugar may
drop. When this happens, I start weaving on and off of the sidewalk, I
stumble, I mumble, and I cannot complete the simplest tasks such as
opening a door and then walking through.
If my blood sugar is low or high during an exam, I may not clearly
articulate my skills and abilities or may perform poorly. It could
affect my grade in the class, my GPA, and possibly my career. I could
pass out in the middle of class or worse, never wake up from nights
sleep. In addition, if my body develops ketones (acids that build up in
the body due to illness or high blood sugars), people can detect the
fruity odor on my breath and think poorly of my hygiene or incorrectly
assume that I have consumed alcohol. These may seem extreme, but are
all part of the many consequences that those of us with diabetes face
all of the time.
My life with diabetes is like this because there is no cure. I
walk, talk, sleep, and dream for a cure but the truth is, one does not
yet exist. Insulin is not a cure. In the meantime, I am thankful that
there have been tremendous improvements in the technologies used to
care for diabetes in the past 5 years since I have been diagnosed.
These improvements have been life-altering.
When I was first diagnosed, I pricked my fingers to measure my
blood glucose levels 12-15 times a day and self administered insulin
shots 2-3 times a day, adjusting the amount of insulin as discussed
above. Additionally, the glucose meter that I used was bigger and
heavier than a Blackberry. I had to constantly use it to prick the side
of my finger tips. It was cumbersome and left my fingertips looking
like I sewed without a thimble. It was also embarrassing to have to
test in front of people who didn't know I had diabetes because it
looked like an obscure handheld computer monitor. Today, I have a very
small glucose meter that weighs less than my cell phone. It fits easily
into my pocket or an eyeglass case. It also provides quicker test
results and allows for alternate site testing so that I do not always
need to use my fingertips.
I went on an insulin pump 18 months after I was diagnosed. Insulin
pumps deliver rapid--or short--acting insulin 24-hours a day through a
catheter placed under the skin. Going on the pump allowed me to
eliminate individual insulin injections and instead inject insulin
directly into the pump once every two to three days. Rather than
administering insulin injections and matching my life to how the
insulin reacted, the pump has allowed me to more easily match insulin
around my activities while stabilizing my blood glucose levels within
my target ranges.
Last year, I went a step further and began using a continuous
glucose monitoring system (CGMS), a device that provides continuous
``real time'' readings of glucose levels. The CGMS allows me to better
manage my diabetes and decreases the frustration of high and low blood
sugars. I now have a 24-hour view of my blood sugar activity, instead
of 15 still photos that don't tell the entire story. This allows me to
not only better understand the current level of glucose, but also see
when my levels are rising or falling, and to intervene to prevent it
from going too high or too low. The nights I sleep wearing my CGMS set,
I do not have to fear not waking-up, because the system has safeguards
and alarms that will wake me--even from a dead sleep--if my blood sugar
plummets or skyrockets during the night. Because of the extensive
research done in developing this device, we are now one step closer to
a ``closed loop'' artificial pancreas system, which could someday
regulate insulin delivery and bring us one step closer to a cure for
diabetes.
The technology I rely on would not be available if not for the
extensive research of dedicated scientists. Research is so important
for people with diabetes because it provides hope for a cure. It is
difficult to remain motivated day in and day out to keep control of my
blood sugar and to keep myself healthy. When you are a young adult, it
is frustrating to add diabetes and the thoughts of future health
complications into a busy academic and social schedule. My peers
without diabetes do not carry syringes, packages of glucose tabs, and
spare test strips in every purse or backpack they use. They do not
count every bite of food placed in their mouth and they do not need to
know exactly how long it will take for different types of food to
affect their blood sugar. All the wonderful technologies only help
fight the battle to stay healthy while I wait for a cure. For me,
knowing that research for diabetes is ongoing is what keeps me
fighting.
I am not alone in living with this disease. Many of your wives,
children, siblings, parents, cousins, friends, coworkers, and peers are
also affected. We are all fighting diabetes and we need the help and
support of researchers and Congress to do so. Diabetes will not be
cured by apathy and sitting back while more people are diagnosed and
suffering complications of this disease. We need additional funding to
maintain and increase research to create better technologies and to
find a cure for diabetes.
Please help me fight diabetes. Increase funding for diabetes
research. Help me get a cure ``sooner'' rather than ``later.''
Again, thank you for the opportunity to speak here today.
The Chairman. Very good. Thank you very much. You know it's
never easy to talk about one's own health challenges, but I
think your comments are enormously valuable to the committee
and have a way of impressing all of us as a result of your own
personal kind of experience. We thank you very much.
Dr. Rankin.
STATEMENT OF DR. SAMUEL M. RANKIN III, ASSOCIATE EXECUTIVE
DIRECTOR, AMERICAN MATHEMATICAL SOCIETY, WASHINGTON, DC
Mr. Rankin. Thank you for the opportunity to speak to you
today. In the recent fiscal year 2008 Omnibus Appropriations
bill, science research was not funded at a level that will
ensure our ability to compete globally. The United States must
make adequate yearly investments in science research. These
investments must be stable in the long-term.
Dependable increases will allow for planning,
infrastructure development, feasible expectations, a manageable
pipeline of graduate and post-doctoral students and the
creation of positions that can be sustained over time. The
predictable pattern of funding will facilitate a continuous
stream of high level research and researchers. We should
consider a mechanism of funding research that insures year over
year funding that supports growth and competitiveness of the
U.S. science enterprise.
Current modes of budgeting jeopardize jobs and
opportunities for researchers and students as well as to have a
tendency to create imbalances in the U.S. science portfolio. We
need to develop a budget index for agencies like the NIH and
the NSF. This index should be based on economic, competitive
and sustainability factors as well as U.S. goals. Without such
an index we will continue to have up cycles followed by down
cycles and thereby prohibiting our capacity for innovation.
For example, when adjusted for inflation both the NIH and
NSF budgets peaked in fiscal year 2004. Currently the fiscal
year 2008 budgets for both agencies are less than their
respective 2003 budgets. This is not good for research.
It is not good for enticing students to study science,
engineering and mathematics. It is not good for planning. It is
not good for U.S. competitiveness. Thank you.
[The prepared statement of Dr. Rankin follows:]
Prepared Statement of Samuel M. Rankin, III
Thank you, Chairman Kennedy and Ranking Member Enzi for the
invitation to speak to the committee today. I am here to speak about
the National Science Foundation (NSF), an important Federal agency
supporting science research and education and about the importance of
the United States having a sustained investment in science research.
In the recent fiscal year 2008 Omnibus appropriations bill, science
research was not funded at a level that will ensure our ability to
compete globally. The United States must make adequate yearly
investments in science research, and these investments must be stable
over the long-term. Dependable increases allow for planning,
infrastructure development, feasible expectations, a manageable
pipeline of graduate and post-doctoral students, and the creation of
positions that can be sustained over time. A predictable pattern of
funding will facilitate a continuous stream of high level research and
researchers.
We should be developing a mechanism that ensures year over year
funding that supports the continued growth and competitiveness of the
U.S.-science enterprise instead of the practice of doubling agency
budgets over some time period. After reaching a goal of doubling an
agency's budget, the temptation is to consider the ``job'' done and at
best to level funding the agency for a considerable number of years in
the future. This mode of funding ignores the expectations of the
scientific community supported through the agency as well as the loss
of positions and opportunities for researchers and students. Current
funding methods have a tendency to create imbalances in the U.S.-
science portfolio.
As the primary source of Federal support for non-medical basic
research in colleges and universities, the NSF is the only Federal
agency whose mission includes comprehensive support for all the
sciences, mathematics, and engineering. Equally important are
investments in people who will apply new knowledge and expand the
frontiers of science, mathematics, and engineering. Through its support
of research and education programs, the agency plays a vital role in
training the next generation of scientists, engineers, and
mathematicians.
Over the past half century, the NSF has had monumental impact on
our society. The NSF investment has paid dividends in building the
infrastructure of the individual scientific disciplines, as well as
laid the groundwork for innovative interdisciplinary research to meet
modern day scientific and technical challenges. Many new methods and
products arise from the NSF investment in research, such as geographic
information systems, World Wide Web search engines, automatic heart
defibrillators, product bar codes, computer-aided modeling (CAD/CAM),
retinal implants, optical fibers, magnetic resonance imaging
technology, and composite materials used in aircraft. NSF-sponsored
research has triggered huge advances in understanding our planet's
natural processes. This has provided a sound scientific framework for
better decisionmaking about Earth's natural environment. These methods,
products, and advances in understanding accrue from basic research
performed over many years, not always pre-determined research efforts
aimed toward a specific result. Furthermore, the NSF traditionally
receives high marks for efficiency; less than 4 percent of the agency's
budget is spent on administration and management.
Even with all its success in supporting cutting edge research, the
NSF has not received adequate funding in the last several years. The
2.5 percent NSF budget increase from 2007 to 2008 has put pressure on
many NSF programs and NSF projects. A few impacts of the fiscal year
2008 budget are: 1,000 fewer new research grants and 230 fewer Graduate
Research Grants will be awarded; several major program solicitations
and new facilities will be delayed for at least a year, and some
existing facilities will be reduced; the Faculty Early Career
Development and Research Experiences for Undergraduate programs will be
reduced; and start-ups of several planned centers will not occur in
fiscal year 2008.
In 2002 the Congress passed and the President signed the NSF
Authorization Act of 2002 (Public Law 107-368). Among other things this
act authorized the doubling of the NSF budget in the 5-year span 2002-
07, which would have brought the NSF budget to $9.84 billion in 2007.
Note that the NSF fiscal year 2008 budget is $6.03 billion. In 2007 the
America's Competes Act (PL 110-69) was passed into law. This bill
implicitly implied a doubling of the NSF in 7 years. The first
installment, $6.6 billion, was authorized for fiscal year 2008 and
$7.33 billion is authorized for fiscal year 2009 in contrast to the FY
2009 Budget Request mark of $6.85 billion. It is unlikely that the NSF
will see $7.33 billion in the next fiscal year.
Using the 1998 NIH budget as the baseline, the Congress focused on
doubling the NIH budget by the 2003 appropriation. During this time of
doubling, the NIH budget grew at an annual rate of 14.63 percent.
However, from 2003 to 2008 the NIH budget increased only at an annual
rate of approximately 1.7 percent. This means that over the 10-year
span from 1998 to 2008, the NIH budget grew at an annual rate of
approximately 8 percent.
In retrospect, a better approach would have been to steadily
increase the NIH budget at around 8 percent a year or some other
sustainable rate. Ramping up the budget in 5 years raised expectations
and promoted increases in the pipeline of students and the number of
post-doctoral and research positions in universities. Once this
dramatic influx stopped, many of these scientists were put in jeopardy,
and research labs could not be sustained at previous levels.
We need to develop an index of growth that makes the funding of
Federal agencies transparent. This index should be based on economic,
competitive, and sustainability factors as well as U.S. goals. Without
such an index, we will continue to have up cycles followed by down
cycles. This is not good for research; it is not good for enticing
students to study science, engineering, and mathematics; and it is not
good for U.S. competitiveness.
The Chairman. Fine. Thank you very much, Dr. Rankin and all
of you.
One of the observations during the build up in the doubling
of the NIH which was done, as Senator Mikulski said, in a very
bipartisan way--I can remember Connie Mack--I saw him the other
day. And I said come on back, Connie, we'll double that budget
one more time and put you to work with some of our colleagues.
Which was the real potential for very dramatic, important and
significant breakthroughs and we've seen them.
I mean this has been in the extraordinary, mapping the
human genome, all the imaging aspects here in the medical
device area. I mean, they have been just dramatic in terms of
what they mean to people in terms of the treatment. It's
difficult for me to believe that the American people don't
understand that.
It has incredible implications in terms of the health and
well-being of people in this country and unbelievable
implications in terms of our ability to lead the world in a
time of globalization. I mean, just unbelievable. I don't mean
just the bottom line in terms of economic with new industries.
With the power of dealing with the problems of malaria and
other health needs in areas around the world where the United
States is lacking influence.
I mean it is profound. We have not been creative,
imaginative, or thoughtful enough to try and recognize both the
opportunity from a humanitarian point of view. I think really
from a political point of view.
I think if for many of us who realize that this really is
the period of the life sciences. We're struck by the challenges
that we're facing now with the challenge with global warming.
People are concerned about global warming.
The fact is that the research is out there. went out to the
NIH just at the end of the year. The Senate had closed down and
spent several hours out there. The types of research that are
being done in life sciences have some real interesting
applications in terms of a lot of the other challenges that
we're facing, whether it's global warming or not. I mean this
is not a tunnel kind of vision.
I'm just wondering how to develop support. How we drive,
Senator Mikulski and ourselves, try to really awaken the
American people to understand the incredible opportunity that
is out there. It's really unique.
I made speeches 45 years ago about how we needed additional
research because of possible breakthroughs. Well now we've got
it. This is it. American life science with all of the other
kinds of implications it has in these other areas as well,
that's going to offer incredible opportunities, you know, for
our country in leading the world in terms of our economy. But
importantly, we get to be able to influence positive and
constructive forces around the world that could give us a more
peaceful and progressive world.
Now how do we come to that? How do we illustrate some of
that in ways that you think can be appealing to our colleagues?
What can you tell us about the opportunities that really are
out there.
It ought to be this combination of the progress that's
happening. It is happening. All of us should look at the
progress we've made in children's cancers, for example. I mean
it's been extraordinary.
I mean, maybe Dr. Faust? Could you take a crack at it?
Ms. Faust. As I listen to your concerns in this area I
think about how we, in a sense, are sending mixed messages or
the public is hearing mixed messages because on the one hand we
are talking about expanding science for undergraduates. We're
concerned about science teachers in the elementary schools.
We're concerned about education in the stem fields as they've
come to be known: science technology, engineering and medicine.
We're talking about that on the one hand. Yet when we do
bring brilliant young researchers into the field, we then
threaten them with these very difficult career developments. I
think about how the message needs to be explained.
That if we are to do the first set of agendas, which means
increase our scientific literacy and uphold science and make
all these discoveries possible, that there are certain
responsibilities that go along with that. That's one thing your
comments made me think about.
I think more generally how do we communicate about science
to the wider public. What are the ways in which we can share
these discoveries and the potential for them. I felt as a
historian, looking at what's happening in the biological
sciences right now as if we're in another scientific revolution
that this is a time of such unprecedented possibility because
of the new closeness between basic research and cure and that
kind of translational possibilities.
That's the message that we need to spread, I think that
this is a moment of unusual promise. And get that word out as
universities and as organizations that deal with knowledge.
Ms. Rafael-Fortney. Chairman Kennedy.
The Chairman. Yes.
Ms. Rafael-Fortney. May I have a chance to address that as
well?
The Chairman. Go ahead.
Ms. Rafael-Fortney. The basic research that we've done to
try to understand the heart failure, specifically in patients
with muscular dystrophy, has now had this broad impact that we
found it in 60 to 80 percent of all patients with heart
failure. When I talk about heart failure, I'm not talking about
heart attacks where patients either die or recover very
quickly. I'm talking about the people who are hospitalized for
months and years on life support waiting for heart transplants.
This has an incredible cost to our health care system. If
we have a novel target that we can--by studying muscular
dystrophy--potentially address heart failure in most of the
patients, the 5 million patients in the country currently
living with heart failure. The 500,000 patients diagnosed with
it every year.
These are the types of outcomes that happen from doing
basic research, studying perhaps a particular disease, but have
really broad implications, both economically to our health care
system and for quality of life issues for patients
The Chairman. Well, you know, I could, and Barbara please
jump in here at any time. It seems to me eventually we're going
to get to individualized health care systems. I mean we're
going to eventually get there. I mean when you find out the
number of prescription drugs people take that are advised that
only 30 percent of them do any good at all to anybody. We're
wasting all kinds of expenditures.
We're eventually going to be able to find out what you all
know about this. You're going to be able to have implants that
are going to be able to monitor the distribution of insulin
during the course of treatment or could amount to be detectors
for different kinds of illnesses and be able to perhaps
distribute the kinds of medicines that are going to be needed.
I think we're headed and we're going to go there. In that
kind of respect in the possibilities in terms of cost savings
are going to be breathtaking.
Ms. Rafael-Fortney. Amazing.
The Chairman. If we're looking in the back of our minds in
terms of trying to get a national health care and da de da de
da. The opportunities in here in terms of what this can mean in
broader context, not only in opportunities for breakthroughs,
but also try to deal with some of the current mundane kinds of
challenges that we're facing in the health care system are
profound. I mean, really profound.
You know we're not, at least, we're not talking about it.
We're not elevating the discussion to it.
Ms. Rafael-Fortney. I would like----
The Chairman. Yes, go ahead.
Ms. Rafael-Fortney. I would like to make one other point. I
think that, of course, I've only been a faculty member for
about 8 years. In my perception, the other thing that's very
different now than in the past is that clinicians and
scientists are speaking the same language.
The Chairman. Yes, that's good.
Ms. Rafael-Fortney. And working together. I have a
collaborator and we've put in another grant together where she
runs the cardiac magnetic resonance imaging lab and she can
detect changes in the heart of muscular dystrophy patients 2,
3, or 4 years before echocardiography can detect them. We now
have the capability to intervene with patient care so much
earlier to save the quality of life and the cost.
We're not getting this funding to move this forward when
together as scientists and physicians we can really do amazing
things that could never really be done before.
The Chairman. That's--Dr. Miller?
Dr. Miller. Just going to say, Senator Kennedy, you're
certainly correct. Just delay the onset of Alzheimer's for 5
years you would save a tremendous amount of money. We need that
kind of research.
The Chairman. It would empty two-thirds of the nursing home
beds in Massachusetts. I mean, that's what the implications
are.
Dr. Miller. It's just----
The Chairman. Cost. It's breathtaking.
Dr. Miller. It's over and over again. You can see various
disease states, chronic diseases where we could get a real
handle on it.
The other question you raise is how you sell it to our
population. How do you sell it to the world. I think most of us
would like people to think of the United States as a more
benevolent country than it is right now.
The most important thing in a person's life is their
health. Yet how do we export this information that we have from
basic laboratories in the clinical practice. How do we take
that to other parts of the world so that we are helping them
with their problems.
Whether it's Sub Sahara and HIV and how you prevent it.
Whether it's malaria research. Whether it's global infections.
All of these things come out of basic research laboratories
that are applied in the United States and then can be applied
in the rest of the world.
I think that is a tremendous way to sell what NIH has done
in the past and what it can do in the future. It will position
us back as a leader in the world.
The Chairman. I couldn't agree with you more. Ms. Lewis,
anything you'd like to add on to these general kinds of
observations?
Ms. Lewis. Thank you. I just have to say, from the patient
perspective in the 5 years I've had diabetes--just from the
public viewpoint--the public has become much more aware of
diabetes, from when I would tell people I was diagnosed. I have
Type I diabetes.
People would say what is that? Does that mean you can't eat
any sugar at all? Now, when I tell my peers or my teachers or
people I meet on the street I have Type I diabetes, they say,
``Oh, so you use insulin. You know, how is that? Do you do it
with diet and exercise? ''
Just from the science at the lab to out in the public
there's been huge changes. I think it has to do with the amount
of research that has come out of NIH and other places. I think
it's important to continue this research. As the research
continues it will make its way to the public so more people
become aware of this. It has implications for the public
understanding more about diseases as well as for people with
diseases like diabetes.
The Chairman. I think you're absolutely right. I think
these associations do a terrific job. You know how the Diabetes
Association and cancer, lung, heart, in terms of getting
information out and making the public aware, do an incredible
job.
It is interesting as you all know--like China, for example,
is replicating the NIH. They are replicating in terms of their
particular institutes. Not our institutes, not what they need,
but what they see us doing, even though they've got different
types of health challenges because of the success they got.
They're in phase in terms of increasing their budget that
would make your mouth water. They're starting way behind. We
won't see, for a few years, obviously, the jump.
They've got a pathway and a pattern that are moving ahead
on it. As was mentioned here you can't just legislate brilliant
minds and creative minds. We've got some very important
advantages. The idea that we can just remain still at anchor is
completely unrealistic.
Dr. Rankin, any ideas about how we can energize the public?
Senator Mikulski and I are fired up and ready to go. We're
interested in what your own sense is.
It's priorities. That's what we're voted in for. Certainly
our priorities are in support of what you've outlined here.
We've got to convince our colleagues of this.
Mr. Rankin. Yes, we are, the scientific community,
appreciates your efforts and Senator Mikulski's efforts on
behalf of science. I think one of the ongoing challenges is to
communicate the value of basic research to the general public.
I don't believe that the general public always understands what
kinds of efforts it takes to develop some of the technologies
and the benefits in terms of health care and other things that
is caused by science or the results of scientific research.
I also don't think that scientists interact enough with the
general public in a way that they can actually show them some
of the benefits. Indicate what kinds of efforts it takes to
make the discoveries that translate into new results that will
help us from a health care point of view or even from a
technological and economic point of view.
I don't have any quick answers to solve that problem. I
believe it's an ongoing problem. I believe that all of us that
value science and especially the scientific community needs to
take some responsibility in this type of education to the
general public.
The Chairman. It starts off first of all in respecting
science.
Mr. Rankin. Yes.
The Chairman. And the truth of science. I mean, we start
getting down where we don't respect the truth of science and we
have ideology and overriding that and then we get ourselves in
a lot of trouble. I mean, that is rather basic.
Senator Mikulski.
Senator Mikulski. Yes. Dr. Faust, I'm sorry. Did you want
to----
The Chairman. Did you----
Ms. Faust. I was just going to make a comment, just two
observations listening to my colleagues here. One is that I
think we are in a moment when there is a lot of discussion,
public discussion about health care and health care delivery
and to make research a part of that very widespread discussion
now.
I think it would be a real contribution if we could make
the conversation not simply about the health care system, but
about the ways in which scientific research can have a real
impact on cost, deliveries and attainments of the health care
system.
The second observation I would make is that these reports
are the result of a partnership among universities to try to
get the message out about the role that universities have
played in scientific research in alliance with the Federal
Government. I think universities, through actions like ours
today and other actions that we can take in partnership have an
important role to explain what they do in this regard. I think
it's been either taken for granted or not known by the public.
We need to explain ourselves much better in these ways.
The Chairman. Good. Good.
Ms. Faust. Excuse me for interrupting, Senator.
Senator Mikulski. First of all I think we all agree. I
would like to just go though, first to Dr. Rankin.
Dr. Rankin, I'm so glad you brought up the National Science
Foundation. Also raised the issue of what happened in last
year's appropriation. I chair the subcommittee that funds the
National Science Foundation and have been the ranking member
for a number of years, and along with Senator Bond advocated
its doubling.
Here's what happened, last year in this great euphoria we
found out we were in charge and off we went to hold our
hearings, to look and see what was under every rock. Under
every rock we found another rock and under that we found
unfunded good ideas and people looking to get their doctoral
fellows to go to school. Our subcommittee, on the bipartisan
basis put money into, and really began to implement the America
Competes Act.
Then we ran into the President's budget veto. President
Bush told our subcommittee, you have to cut it by $3 billion.
Now, our overall funding level is about $50 billion, having
said that, $3 billion would affect NASA, NOAA, NIST and of
course the National Science Foundation. We did it.
Mr. Rankin. Yes, you did.
Senator Mikulski. We did it. What you can see then is
exactly what you rightfully say, again the skimpy, spartan, two
point something or other percent increase. Now this is not
finger pointing, but there was dead silence from those folks
who benefit from the NSF community.
The larger community doesn't understand NSF. They
understand NIH because it's cures and prevention and so on. We
didn't hear from the scientific community at all until much
later and then it was sadness and hand wringing and gee, what
are you going to do.
One, I think you have to strike when the veto pen is about
to strike first. There needs to be an overall advocacy of
really going to the White House. That's your genius with all
the e-mails and phone calls. I believe in virtual rallies. I
believe in virtual protest. I believe in virtual picketing. I
believe in it all because I believe in grass roots.
Because we believe in you, it is to my dismay that the
funding of the National Science Foundation is pretty much what
we spend every year on our Federal prison budget. Stunning,
isn't it? Didn't that just kind of hit you? Well it's the same
way for us on the committee.
We spend $6 billion on Federal prisons. We won't even talk
about the war and tax cuts and so on. We need to get a lot of
the bad guys and some gals off the street, but, and I'm not
saying it's a trade here that oh, if we spent more on NSF,
maybe it could make a difference, you see.
One, we need your advocacy, of course, on research. Am I
right that the National Science Foundation is the premier
source of funding for the doctoral fellows in the basic
sciences?
Mr. Rankin. Yes, that's true.
Senator Mikulski. Isn't that right?
Mr. Rankin. Yes, the graduate fellows.
Senator Mikulski. Do you want to elaborate on that?
Mr. Rankin. The graduate fellowships are very important
fellowship for young researchers. One of the nice things about
the fellowship is it can be taken to any university. It's not
connected to any particular school. It's given to the student
that wins the fellowship.
Senator Mikulski. How many applicants do you think are
there at NSF for people who want to get Ph.D.'s in the basic
sciences? That would be biology, chemistry, and physics.
Mr. Rankin. I don't have the number on the top of my head.
Senator Mikulski. Well.
Mr. Rankin. I do know with this 2008 budget that 230 less
awards will be made.
Senator Mikulski. That's in research.
Mr. Rankin. Yes.
Senator Mikulski. That's in research. In order to do
research--so we could increase the research money, but then it
comes to the people. Actually what we're understanding is that
there's a steady decline in the number of fellows that could be
funded.
Dr. Rafael-Fortney, you told a very compelling story about
how you got excited in the seventh grade and you wanted to
change the world, etc. You went off to Cornell and actually one
of the people you studied under at Cornell was Dr. Kay Davis
who is from Oxford.
Ms. Rafael-Fortney. She is at Oxford. I did my postdoctoral
fellowship at----
Senator Mikulski. Well she was at Cornell with you. She's
now at Oxford and she kind of zipped along under that British
system where her research has been so recognized that Her
Majesty has made her a Dame and you're foraging for money.
[Laughter.]
Ms. Rafael-Fortney. She was my mentor as a post-doc, but
yes, that's true. I'm foraging----
Senator Mikulski. I mean isn't that exactly right?
Ms. Rafael-Fortney. That's true. So she----
Senator Mikulski. She's a Dame of the Empire and you kind
of feel like Orphan Annie. Now did you get your doctorate under
an NSF grant? How did you?
Ms. Rafael-Fortney. No, under NIH.
Senator Mikulski. I don't mean to----
Ms. Rafael-Fortney. I was on a NIH training grant as a
Ph.D. student for 3 years and then a recipient of other
fellowships throughout the rest of my graduate training and
that was at the University of Michigan and you know the best
human genetics department in the country at Francis Collins at
NIH was there at the time.
Senator Mikulski. Did the NIH take you? Well here--let me
get to the point of my question which is one, this sense of
discouragement and dismay among our young up and comers. What
about student debt?
When you talk about getting a doctorate, whether it's you
or your peers, about how much debt do you think someone----
Ms. Rafael-Fortney. So that----
Senator Mikulski [continuing]. Would incur?
Ms. Rafael-Fortney. The students who work in our labs, who
are getting their Ph.D.'s when we're done training them are
actually the work horses that produce the research. They're the
people in the labs doing the experiment that we design and
compose. They're the orchestra conducting the music. They're
the ones who do the research.
They actually get paid a very piddly stipend, but enough to
pay their rent and eat macaroni and cheese for dinner every
night. But they are----
Senator Mikulski. They better watch their carbs though,
right?
Ms. Rafael-Fortney [continuing]. Funded by our--this is
what our NIH grants pay for is to be able to pay for the people
working in the lab doing the experiments in addition to the
cost of the reagent. Out of the NIH money, we're creating a
huge number of salaries. When I needed to cut my lab from nine
people to one and a half people, those are seven and a half
people out of jobs.
Senator Mikulski. Coming back though, isn't one of the
questions and I'll turn now to Dr. Miller and Dr. Faust, that
essentially that as people move along, whether it's getting a
medical degree for research or a Ph.D. for research because so
much of research is also done by Ph.D.'s, that the occurrence
of student debt, by the time they're 30 is pretty significant?
Dr. Miller. I'll be glad to answer that.
Senator Mikulski. Dr. Miller.
Dr. Miller. In terms of M.D. at our school, the current
debt would be about $96,000 by the time they finish medical
school before they even begin a residency or go into a lab
which many of them do, so many of our M.D., Ph.D.'s and so
forth can run up much greater debt than that. It does influence
where their career choice is, especially if it looks like the
funding is not going to be available for sustained research
activities they will go to other areas.
The debt becomes an incredibly important factor in
direction of where people are going to go.
Senator Mikulski. So, when you get out of school you're
waiting to get your first grant. You now know it's 43. But,
you're 30 years old and you owe a lot of money. You wonder
where you're both going to earn a living and pay off this debt
and move on. Other fields in industry, financial institutions
would be attractive. Is that right?
Now let me go to another question about that if the
Chairman is indulgent. You, Dr. Miller, have talked about
whatever we do it needs to be sustained and predictable. I'm
going to ask you why you emphasize that.
Then I'm going to ask another question. This committee,
this Congress loves something called the Manhattan Projects.
Whenever something happens, they say ``Oh, let's have a
Manhattan Project.''
First of all, the people who worked on the Manhattan
Project probably couldn't get immigration visas. Second,
because of their politics, their lifestyle or region or
something, they couldn't get that. And third, if you thought
about them here where would their money have come from before
they were Manhattanized.
Now but when we talk about--I remember after 9/11 we held
hearings on vaccines because we were concerned about the
biological threat. Everybody was willing to throw lots of money
to it. There was panic. There was fear. There was whatever.
There is a belief in this country and challenge me if you
think I'm wrong, Doctor. I invite you to do that, which somehow
in this time and climate of muzzling science it doesn't occur,
Senator Kennedy said. We can't do Manhattan Projects because
there aren't people there. The way you do a Manhattan project,
is you start with the Bronx and the Brooklyns and the
neighborhoods, which means you start by training people as they
move through the pipeline. Then they do steadily, more
sophisticated work or collaboration within our own country, or
around the world for jobs that you're doing, Doctor and so on.
I worry that if there is a crisis there won't be people
there. We also fight war against disease, like we fought this
war. We don't think through the consequences. We think we can
muscle our way through any problem. We don't realize how many
people it takes, and what the people who are going to do this
need to be able to do this.
Anyway, I'll stop. Could you talk about sustainability,
predictability and if we want to come up with another Manhattan
Project, whether it's to find the cure for cancer or to save us
from possible predatory attacks against the United States.
Dr. Miller. Let me break it into two parts. First, in terms
of an M.D. training. You've got 4 years of medical school and
usually 5 years of post-graduate work.
That will just get you through to a point where you may go
into a lab. That's just the residency. You may have another
couple of years of fellowship. You've got somewhere around 10
or 12 years where people have to be sustained during their
residency and then into their fellowship and then into their
early years of research.
The Ph.D. side is about 6\1/2\ years to get a Ph.D. at our
institution. Then most of them do post docs for another 2 or 3
years. We're talking for most of the individuals, 10 years of a
need for support. After that they've just begun their career.
This is why the age of the first R01 is age 43, etc, etc.
People need to have that degree of support for a period of
time. Then it takes them another 3 or 4 years until they really
get good data so that they can continue to have a sustained
program. For an investigator to be kind of ``independent''
takes much more than just 1 or 2 years. It takes--as you know,
you're 8 years into that process.
That is one of the, I think, the reasons that you have to
have the ability to sustain this over a period of time. You
can't just ramp it up. I think you're exactly correct. If we
don't have those people that have those basic training skills
when an issue comes before us, as the United States, that we
need to pull people together and do what you're talking about,
we can't do it.
We have to have the fundamental training to be able to do
research.
Senator Mikulski. Dr. Rankin.
Mr. Rankin. Yes. Having a sustainable funding mechanism is
very important. 1998 was when the doubling for the NIH started.
It was doubled between 1998 and 2003. The annual growth rate
for the budget, the NIH budget, during that time was around
14.63 percent per year.
If you then look at--I am a mathematician, so I like to do
these calculations. If you look at the budget then from 2003 to
2008, the NIH is growing at about 1.7 percent a year. If you
put the 10 years together, the NIH budget is growing from 1998
to 2008 is on an annual budget growth rate of 8 percent a year.
Now you can look back in retrospect--is it better, would it
be better that the NIH be funded at some consistent rate like 8
percent a year from all those 10 years rather than what's
happened where they ramped up and then they're watching the
deterioration of all that capacity that was built. The
sustainability aspect of funding is very important.
Ms. Rafael-Fortney. May I address that as well?
Senator Mikulski. Certainly.
Ms. Rafael-Fortney. I'm not trying for my first R01. I was
against the odds, I guess, by the ages up there. I had my first
R01 at the age of 32 and my faculty position at the age of 29.
It's now where I'm trying to renew that grant that we've hit
this funding crisis.
In the meantime as people graduated in my lab and post docs
left, I couldn't hire anyone else because there wasn't enough
money and I couldn't promise them a salary for an extended
period of time. I now have to let people go who had 8 years of
experience. When the grant finally does hit, which hopefully it
will--I'm an optimist and keeping my fingers crossed--I'll have
to spend the first year re-training people instead of having
the trained staff who knew how to do everything, who knew where
everything was, who knew how to get things done, you know
within the university and where the different rooms are that
have the different pieces of equipment. I mean just that re-
investment. It costs money rather than keeping a consistent
flow of some amount of funding to individual labs.
Senator Mikulski. Most of all the predictability would
enable both recruitment and retention.
Mr. Rankin. Right.
Ms. Rafael-Fortney. Correct.
Senator Mikulski. I know our time is running out. Now I
want to ask iconic caustic questions. Dr. Miller, I'll turn to
you and then any others.
First of all should we begin to challenge the way NIH
decides research? I don't mean for us to micro-manage or
earmark or whatever. Look what you said here, that they decide
on the safe stuff.
Where, and again, this is not my position. I'm putting it
out for conversation and discussion. Is that a dated thing here
or should we----
Dr. Miller. Well.
Senator Mikulski. In other words, why do they go for the
safe stuff? Do we need to shake that up?
Ms. Rafael-Fortney. Sorry, I feel the need to address this
as well. It's not them, it's us. We're the ones who serve on
the study section conducting peer review.
I'm going to a study section next week, as a matter of
fact, week after to review grants. When you have to pick--I
have a pile of 10 grants and basically one of those is going to
get funded. When it comes down to picking 1 out of a pile of
10, you're splitting hairs over the 2 or 3 that are really
outstanding research that could move their respective fields
forward.
But, it is us. I don't think there's anything broken in the
peer review system and there's actually recently been----
Senator Mikulski. I didn't say broken. It just seems
stuffy.
Ms. Rafael-Fortney. But it's us and it's not stuffy. It's
just very hard when you're comparing a grant. I'm going in----
Senator Mikulski. Maybe. I'm not saying that it is, but it
sounds like it is.
Ms. Rafael-Fortney. Well, to give you an example.
Senator Mikulski. They say, ``Well there's not enough
money'' and that which they fund is really safe and it's
linear. And it's glacial.
Dr. Miller. I think you have a mechanism in place. I
totally agree with you in terms of the peer review. If there
are more dollars you wouldn't be micro-managing it at that
level. I also think the Director's Fund allows for some of the
pioneering work to be done.
There is a new mechanism available to kind of identify
people that are really doing risk taking research and to be
able to find funding for that. I think there are mechanisms in
place to do that. With more dollars coming to NIH I think we
can accomplish both of these things.
Senator Mikulski. This is my last question. This was
supposed to be the century of biology. The 19th century and the
20th was tachometry and physics and we benefited. The 20th
century, we were all so excited. It was going to be goodbye to
genocide and war and hello to peace and saving the planet, but
it was going to be the year of biology, both environmentally,
personally.
Here we are, having this conversation in 2008. One of the
things that happened was new ideas, primarily in mathematics in
the use of computation, where through computational biology,
now quantum computational techniques, etc. My question is, do
you think that we could and also, if we really organize
methodically and with predictability, that we could change also
the way research is done which is to accelerate the pace of
discovery for research because there are new techniques?
Mathematics has really been stunning in its computation. I
mean we would not have cracked the human genome without
computational biology. Whether you did it in a methodical way
that Francis did at NIH or Solera and Craig Venter did.
Either way it was a race and it was great. They were using
new mathematical techniques as well as new biological insights
and so on. Are we on that verge?
Dr. Miller. Oh, I think we are. I think everywhere----
Senator Mikulski. Not only in terms of doing more.
Dr. Miller. You see, whether it's at Harvard or Hopkins or
Penn or whatever, looking at where schools of engineering
working with the schools of medicine working across public
health, working with mathematics departments. We know that a
collision of two sciences together are going to make the
biggest step changes in real discoveries.
I think you just take a look at what's happening in the
whole area of imaging, where that area is going, early
molecular markers of diseases and new ways to find those
molecular markers. Over and over again you see where you can
bring one technology or knowledge base from one field and apply
it to something in medicine. Then you will get the kind of
changes you're going to see.
There's no question. I think it's the right way to go. The
Director's Fund for example, is an example of trying to make
those bridges happen. The CTSA grant is working with industry
to make that happen. All of those, I think are the right
science. We just need the dollars to do it and we need it
sustained over a period of time.
Senator Mikulski. Mr. Chairman, I don't have any other
questions. I would also just like to thank, Ms. Lewis. I'd like
to thank you, Ms. Lewis for what you stand for which is the
citizen advocates. You know people do vote, not only in voting
booths, but all of the great philanthropic work around this
country and in terms of cures has been done through citizens,
whether it's the famous Race for the Cure for breast cancer, or
the walks for cures for juvenile diabetes.
People do vote with their feet and they're willing to raise
private dollars. Philanthropy cannot be a substitute for public
policy for public funding. Those marches need not only to be
for money, but also that we have the will, as well as the
wallet.
I just want to thank you for being you. I want to thank all
of the people all over this country who every weekend are doing
things to either raise money for research or to raise
awareness. It's great to have you here.
The Chairman. Very good. The committee will stand in
recess. Thank you all very much.
[Additional material follows.]
ADDITIONAL MATERIAL
Prepared Statement of Senator Bingaman
Let me thank the Chairman for holding this important
hearing on health professions supply. This deserves our serious
attention.
In New Mexico, 30 of our 33 counties are federally
designated as health professions shortage areas or medically
underserved areas.
With a low per capita income, and a high uninsured
population, having a health provider in our towns can mean the
difference between getting care while problems are manageable,
or waiting until problems became so serious that they require
hospitalization or worse.
In New Mexico, we have worked on creative interdisciplinary
models of health delivery, such as the Health Commons models
that provide an enhanced primary care home, including medical,
behavioral, and oral health, to our most needy populations.
We train our health professionals in these venues, and they
end up working in them at two to three times the rate of other
trainees when they graduate. These programs work. Title VII
funding supported their success. New Mexicans depend on these
programs for health care.
These programs are under severe threat. The President
proposed eliminating title VII funding, severely cutting title
VIII funding, and unilaterally changing Medicaid rules through
CMS that will devastate training programs and will unravel our
tenuous safety net in New Mexico, and across our Nation.
We have witnessed the unprecedented growth of our uninsured
under this Administration with 48 million Americans who are
medically uninsured and over 100 million who lack oral health
coverage.
This would be exactly the wrong time to cut funding, as the
President has proposed. While I support the President's call to
expand community health center funding, it is cynical, it is
illogical, to cut the funding of the title VII programs that
assure staffing of those centers.
While 21 percent of the U.S. population live in rural
areas, only 10 percent of our physicians work in rural areas.
Our population will grow by 25 million per decade, and
those over age 65 will double by year 2030. Those over age 65
have twice the number of doctor visits as younger individuals.
Our Nation faces physician shortages which will grow to
over 200,000 by 2020, while nursing shortages may exceed 1
million. Currently, few dentists accept Medicaid and access is
impossible for our uninsured.
Let us focus our legislative attention on our pipeline of
health professionals and the distribution of these graduates
into the areas where they are most needed.
Let us support new interdisciplinary models of service and
learning, with a balance of urban and community-based
experience--addressing our Nation's most pressing health needs,
while admitting health professions students are more reflective
of our Nation's diversity.
It is time for us to pass measures, using funding
mechanisms like GME and IME through Medicare and Medicaid, to
assure training of health professions to address our current
and future health workforce and access needs. CMS should not be
cutting funding of these programs through rule changes that
will blow up our pipeline supply when shortages are severe, and
getting worse.
Americans deserve, and should expect, better health
professions outcomes and return on our Federal investment. We
should expand funding to programs that produce the types of
health professionals most needed, and that succeed in placing
them in the cities and towns where we most need them.
It is time for Congress to address these shortages, to
support the hard-working health professionals both in our
cities and in our small towns, and to fund programs that
clearly and conclusively work, including title VII and title
VIII physician, nurse and dental training, scholarship,
diversity, and loan repayment programs.
Prepared Statement of Senator Clinton
I look forward to working with my colleagues on the HELP
Committee to reauthorize the title VII health professions
program. These programs have a great impact on New York, both
as a State with multiple health professions schools, and as a
State that has underserved communities who benefit from these
programs. Our State has 15 medical schools with over 15,000
residents in training and 11 accredited nursing schools. Our
rural and urban communities have critical needs for primary
care physicians, dentists, nurses and other health
professionals. Over 50 of New York's 62 counties have Medically
Underserved Areas (MUA's) and many of those counties have
multiple MUA designations, in both urban and rural areas. In
some of our rural regions, there has been a significant decline
in the number of health professionals filling demand, and at
this point, we do not have enough primary care providers to
meet the growing needs.
In addition to ensuring adequate workforce for both rural
and urban underserved areas, I believe that the title VII
programs are an important tool in addressing the growing
diversity of the U.S. population, which is not yet reflected in
our health workforce. New York State has a minority population
of 36 percent, yet enrollment in our medical schools by
minority students lags far behind at 10 percent. This under-
representation is associated with poor health outcomes in
minority communities, and I think that by improving the number
of underrepresented minorities in the health professions, we
can reduce health disparities. Title VII Health Professions
Programs address these issues by providing educational
pipelines that target minority students at all levels of
education, helping them to gain interest in and pursue careers
in health care.
The President's proposed budget for New York health
professions' programs this year is $13 million, compared to $29
million only 5 years ago. Yet the shortage of primary care
providers only continues to grow. If we are to meet the needs
of underserved communities in New York and the Nation, we must
increase our support for the title VII programs that are an
essential component in improving access to care for all
Americans.
I believe that the title VII programs should be re-
authorized to a level that will make them effective in
providing a pipeline to encourage a diverse range of
participants to enter the health professions, retain a
commitment, through years of training, and to serve in the
urban and rural communities where they are most needed.
We need to assure that training programs are aligned with
healthcare needs. These programs should be amended to improve
data collection in order to track health professionals,
identify shortage areas, and evaluate specific outcomes.
We need to address the primary care shortage by improving
linkages between health professions schools to medically
underserved areas.
[Whereupon, at 12:29 p.m. the hearing was adjourned.]